chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Synovial fluid crystal, Thyroxine free, Troponin I, Weight decreased
Clinical narrative: After 2nd vaccine, every inch of my body was in extreme pain. especially lower extremitys. I was not able & still not able to get out of bed on my own, shower or cloth I have lost 30-35 pounds I weigh 111.2 lbs today before my normal weight was 130-145 I am 5 ft 8in in height. Woke up with extreme muscle spazums in both legs lasting 15 to 20 minutes. My legs, knees & hands are very swollen. I passed out several times until hospital stay. I got the Covid vaccines as soon as possible so I could return to work April 2022 I was put on permenate disability. We/my husband & I went to less than 1/2 an income. I lost my car I purched for my 50th birthday & almost lost the house. I have spent my life trying to keep myself heathy. If there is anything else need, please let me know. Sorry this took so long.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: my chest got bright red; itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: EW0150) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "MS", start date: 2008 (ongoing); "Hashimoto's", start date: 2019 (ongoing); "GERD" (ongoing), notes: Onset date: 90's; "IBS" (ongoing), notes: Onset date: 90's; "IVF" (unspecified if ongoing), notes: I did not go for any boosters. I was doing IVF and was concerned how the vaccine might effect me; "G20210A" (unspecified if ongoing). Concomitant medication(s) included: AVONEX taken for multiple sclerosis, start date: 2008 (ongoing); ASPIRIN 1000 oral taken for factor ii mutation, start date: 2021 (ongoing); FAMOTIDINE oral taken for gastrooesophageal reflux disease, start date: 2010 (ongoing); L-THYROXINE [LEVOTHYROXINE] oral taken for autoimmune thyroiditis, start date: 2019 (ongoing). The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "my chest got bright red"; PRURITUS (non-serious), outcome "unknown", described as "itchy". Therapeutic measures were taken as a result of erythema, pruritus.  Additional information: It was reported that the patient had an allergic reaction after receiving both vaccine doses. The first dose around 4-5 hours later her chest got bright red and very itchy. I had to take Benadryl. She did not go for any boosters. She was doing IVF and was concerned how the vaccine might effect me.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, COVID-19, Chest X-ray abnormal, Cough
Clinical narrative: pt to hosp with c/o SOB, dyspnea, cough, congestion, nausea, vomiting, diarrhea, anorexia; increased O2 needs; placed on BiPAP; positive for COVID; bilateral multifocal pneumonia; given Remdesivir, dexamethasone, ABX, heparin drip; worsening respiratory status requiring intubation; transitioned to DNR/DNI with focus on comfort care; pt passed away in the hospital
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Endotracheal intubation, Pneumonia bacterial, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: pt to hosp with c/o SOB, dyspnea, cough, congestion, nausea, vomiting, diarrhea, anorexia; increased O2 needs; placed on BiPAP; positive for COVID; bilateral multifocal pneumonia; given Remdesivir, dexamethasone, ABX, heparin drip; worsening respiratory status requiring intubation; transitioned to DNR/DNI with focus on comfort care; pt passed away in the hospital
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, COVID-19, Cough, Death, Decreased appetite
Clinical narrative: pt to hosp with c/o SOB, dyspnea, cough, congestion, nausea, vomiting, diarrhea, anorexia; increased O2 needs; placed on BiPAP; positive for COVID; bilateral multifocal pneumonia; given Remdesivir, dexamethasone, ABX, heparin drip; worsening respiratory status requiring intubation; transitioned to DNR/DNI with focus on comfort care; pt passed away in the hospital
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dyspnoea, Endotracheal intubation, Nausea, Pneumonia
Clinical narrative: pt to hosp with c/o SOB, dyspnea, cough, congestion, nausea, vomiting, diarrhea, anorexia; increased O2 needs; placed on BiPAP; positive for COVID; bilateral multifocal pneumonia; given Remdesivir, dexamethasone, ABX, heparin drip; worsening respiratory status requiring intubation; transitioned to DNR/DNI with focus on comfort care; pt passed away in the hospital
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Positive airway pressure therapy, Respiratory disorder, Respiratory tract congestion, Vomiting
Clinical narrative: pt to hosp with c/o SOB, dyspnea, cough, congestion, nausea, vomiting, diarrhea, anorexia; increased O2 needs; placed on BiPAP; positive for COVID; bilateral multifocal pneumonia; given Remdesivir, dexamethasone, ABX, heparin drip; worsening respiratory status requiring intubation; transitioned to DNR/DNI with focus on comfort care; pt passed away in the hospital
Age: 88.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported.; Pharmacist reports administration of expired PNEUMOVAX 23 syringe.; vaccine expiration was not checked prior to administrating; vaccine expiration was not checked prior to administrating; vaccine expiration was not checked prior to administrating; This spontaneous report was received from a pharmacist and refers to a 88-year-old female patient. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 19-SEP-2022, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, at a dose of 0.5 milliliters (ml), lot #T031820, expiration date: 10-MAY-2022 (vaccination schedule, and route of administration were not provided) for prophylaxis on left deltoid site (expired product administered); other suspect vaccine included influenza vaccine inact split 4v (FLUZONE QUADRIVALENT), lot # VJ900AA, expiration date: 30-JUN-2023 administrated on left deltoid (strength, formulation, dose, route of administration, and indication were not provided). Additionally, the vaccine provider mentioned that the vaccine expiration date was not checked prior to administrating (product storage error) (product dispensing error) (product preparation error). No additional adverse events were reported.
Age: 88.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Expired product administered, No adverse event, Product dispensing error, Product preparation error, Product storage error
Clinical narrative: No additional adverse events reported.; Pharmacist reports administration of expired PNEUMOVAX 23 syringe.; vaccine expiration was not checked prior to administrating; vaccine expiration was not checked prior to administrating; vaccine expiration was not checked prior to administrating; This spontaneous report was received from a pharmacist and refers to a 88-year-old female patient. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 19-SEP-2022, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, at a dose of 0.5 milliliters (ml), lot #T031820, expiration date: 10-MAY-2022 (vaccination schedule, and route of administration were not provided) for prophylaxis on left deltoid site (expired product administered); other suspect vaccine included influenza vaccine inact split 4v (FLUZONE QUADRIVALENT), lot # VJ900AA, expiration date: 30-JUN-2023 administrated on left deltoid (strength, formulation, dose, route of administration, and indication were not provided). Additionally, the vaccine provider mentioned that the vaccine expiration date was not checked prior to administrating (product storage error) (product dispensing error) (product preparation error). No additional adverse events were reported.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Late in the day on 8/31/22, the administration rescinded the EUA order for the use of the monovalent Pfizer and Moderna vaccine as boosters for people aged 12 years and older. The information took a little time to trickle from the administration to staff and then to the staff administering vaccine. Because of this delay, some monovalent vaccine was inadvertently given after 8/31/22. The CDC stated that any monovalent vaccine administered as a booster dose after the EUA was rescinded would be considered a vaccine error. At a recent meeting, we discussed this and our medical providers stated that any monovalent vaccine given as a booster dose on 9/1/2022 or after should have VAERS report completed on them per the CDC's requirements.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Late in the day on 8/31/22, the administration rescinded the EUA order for the use of the monovalent Pfizer and Moderna vaccine as boosters for people aged 12 years and older. The information took a little time to trickle from the administration to staff and then to the staff administering vaccine. Because of this delay, some monovalent vaccine was inadvertently given after 8/31/22. The CDC stated that any monovalent vaccine administered as a booster dose after the EUA was rescinded would be considered a vaccine error. At a recent meeting, we discussed this and our medical providers stated that any monovalent vaccine given as a booster dose on 9/1/2022 or after should have VAERS report completed on them per the CDC's requirements.
Age: 65.0
Sex: F
Vaccine: FLUA4, FLUA4, FLUA4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: October  19,2022. I arrived  at the  clinic  @4:17pm. To get a flu vaccine. After  wating in the lobby.a woman called me back .we entered the room to left. I sat in the chair next to the door.i noticed  a trey with a needle in it with a orange  covering tip.  The woman ask me some questions  really vague. She then approached  me to the right and ask me to relax my right arm.she then administered  the shot. Immediately  therein the shot .I screamed  loudly Oh !!my God that hurt so bad.i turned  to her and asked her what happen what did she do. The pson was so intense. she replied  the flu shot hurts.  I replied I had flu shots all My life. I never  had a shot to cause that  kind if pain.  She dud nor show any compassion or concern. I exited the room. That evening  and the next days the pain was so intense  i was taking Tylenol. Icing my arm and shoulder.  On mon the Oct 24 I called the clinic  to inform  them what  pain I was in. The lady  at desk .told me I would need to speak to a person.  We spoke  .I explained  to her what I was gng thru.she said she would do report.  I read report .and there were  errors on report  pertaining to the arm  vaccine  was given  in.the nurse stated  the left arm.i told her that  wasn't true.and  why us she be untrue  is she trying to cover up smg she stated she would  redo..I went  to pick up report  as instructed  at clinic. She wasn't there  and I haven't received  the new report  yet. I was instructed  to speak to several  people  at clinic. They were  rude and unprofessional.  I have had to seek additional  medical care I will contact  veers at a later tome the out come.
Age: 65.0
Sex: F
Vaccine: FLUA4, FLUA4, FLUA4
Symptoms: Immediate post-injection reaction, Injection site pain, Screaming, Ultrasound scan, X-ray
Clinical narrative: October  19,2022. I arrived  at the  clinic  @4:17pm. To get a flu vaccine. After  wating in the lobby.a woman called me back .we entered the room to left. I sat in the chair next to the door.i noticed  a trey with a needle in it with a orange  covering tip.  The woman ask me some questions  really vague. She then approached  me to the right and ask me to relax my right arm.she then administered  the shot. Immediately  therein the shot .I screamed  loudly Oh !!my God that hurt so bad.i turned  to her and asked her what happen what did she do. The pson was so intense. she replied  the flu shot hurts.  I replied I had flu shots all My life. I never  had a shot to cause that  kind if pain.  She dud nor show any compassion or concern. I exited the room. That evening  and the next days the pain was so intense  i was taking Tylenol. Icing my arm and shoulder.  On mon the Oct 24 I called the clinic  to inform  them what  pain I was in. The lady  at desk .told me I would need to speak to a person.  We spoke  .I explained  to her what I was gng thru.she said she would do report.  I read report .and there were  errors on report  pertaining to the arm  vaccine  was given  in.the nurse stated  the left arm.i told her that  wasn't true.and  why us she be untrue  is she trying to cover up smg she stated she would  redo..I went  to pick up report  as instructed  at clinic. She wasn't there  and I haven't received  the new report  yet. I was instructed  to speak to several  people  at clinic. They were  rude and unprofessional.  I have had to seek additional  medical care I will contact  veers at a later tome the out come.
Age: 72.0
Sex: M
Vaccine: COVID19-2, FLU4, COVID19, FLUX, COVID19, FLU4
Symptoms: Balance disorder, Gait inability, Guillain-Barre syndrome, Lumbar puncture abnormal, Mobility decreased
Clinical narrative: guillain barre syndrome; prolonged injection site pain, sharp, shooting pain in both arms; Initial information received on 04-Nov-2022 regarding an unsolicited valid serious case received via consumer/non-hcp (doctor daughter) and doctor.   This case involves a 72-year-old male patient who experienced Guillain barre syndrome and prolonged injection site pain, sharp, shooting pain in both arms after receiving vaccines Moderna COVID-19 vaccine and Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA462123(same reporter).   On 26-Sep-2022, the patient received suspect Fluzone High-Dose Quadrivalent vaccine at dose 0.7 ml once (lot: UJ875AA) via unknown route in the right arm for immunization.  On 26-Sep-2022, the patient received a booster dose of suspect MODERNA COVID-19 VACCINE not produced by  at (unknown: formulation, strength, dose, lot number not reported via unknown route) in the left arm for immunization.  On unknown date in Oct-2022, at 2 weeks latency after vaccination of Fluzone High-Dose Quadrivalent vaccine and MODERNA COVID-19 VACCINE, the patient developed a non-serious prolonged injection site pain described as sharp, shooting pain in both arms (vaccination site pain).  The patient was hospitalized on 16-Oct-2022.  On 17-Oct-2022 the patient was diagnosed with a serious Guillain barre syndrome (Guillain-Barre syndrome) both at 22 days latency following the administration of Fluzone High-Dose Quadrivalent vaccine and MODERNA COVID-19 VACCINE. This event was assessed as medically significant. The patient was already hospitalized when the event occurred and still in the hospital.  Action taken: Fluzone High-Dose Quadrivalent and MODERNA COVID-19 VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered for both events.; Sender's Comments:  company comment 14-Oct-2022: This case involves a 72-year-old male patient who experienced Guillain barre syndrome and prolonged injection site pain, sharp, shooting pain in both arms after vaccination with Fluzone High-Dose Quadrivalent. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. The role of co-suspect Moderna COVID-19 vaccine could be confounder in case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 72.0
Sex: M
Vaccine: COVID19-2, FLU4, COVID19, FLUX, COVID19, FLU4
Symptoms: Motor dysfunction, Muscular weakness, Neck pain, Neuralgia, Pain
Clinical narrative: guillain barre syndrome; prolonged injection site pain, sharp, shooting pain in both arms; Initial information received on 04-Nov-2022 regarding an unsolicited valid serious case received via consumer/non-hcp (doctor daughter) and doctor.   This case involves a 72-year-old male patient who experienced Guillain barre syndrome and prolonged injection site pain, sharp, shooting pain in both arms after receiving vaccines Moderna COVID-19 vaccine and Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA462123(same reporter).   On 26-Sep-2022, the patient received suspect Fluzone High-Dose Quadrivalent vaccine at dose 0.7 ml once (lot: UJ875AA) via unknown route in the right arm for immunization.  On 26-Sep-2022, the patient received a booster dose of suspect MODERNA COVID-19 VACCINE not produced by  at (unknown: formulation, strength, dose, lot number not reported via unknown route) in the left arm for immunization.  On unknown date in Oct-2022, at 2 weeks latency after vaccination of Fluzone High-Dose Quadrivalent vaccine and MODERNA COVID-19 VACCINE, the patient developed a non-serious prolonged injection site pain described as sharp, shooting pain in both arms (vaccination site pain).  The patient was hospitalized on 16-Oct-2022.  On 17-Oct-2022 the patient was diagnosed with a serious Guillain barre syndrome (Guillain-Barre syndrome) both at 22 days latency following the administration of Fluzone High-Dose Quadrivalent vaccine and MODERNA COVID-19 VACCINE. This event was assessed as medically significant. The patient was already hospitalized when the event occurred and still in the hospital.  Action taken: Fluzone High-Dose Quadrivalent and MODERNA COVID-19 VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered for both events.; Sender's Comments:  company comment 14-Oct-2022: This case involves a 72-year-old male patient who experienced Guillain barre syndrome and prolonged injection site pain, sharp, shooting pain in both arms after vaccination with Fluzone High-Dose Quadrivalent. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. The role of co-suspect Moderna COVID-19 vaccine could be confounder in case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 72.0
Sex: M
Vaccine: COVID19-2, FLU4, COVID19, FLUX, COVID19, FLU4
Symptoms: Pain in extremity
Clinical narrative: guillain barre syndrome; prolonged injection site pain, sharp, shooting pain in both arms; Initial information received on 04-Nov-2022 regarding an unsolicited valid serious case received via consumer/non-hcp (doctor daughter) and doctor.   This case involves a 72-year-old male patient who experienced Guillain barre syndrome and prolonged injection site pain, sharp, shooting pain in both arms after receiving vaccines Moderna COVID-19 vaccine and Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA462123(same reporter).   On 26-Sep-2022, the patient received suspect Fluzone High-Dose Quadrivalent vaccine at dose 0.7 ml once (lot: UJ875AA) via unknown route in the right arm for immunization.  On 26-Sep-2022, the patient received a booster dose of suspect MODERNA COVID-19 VACCINE not produced by  at (unknown: formulation, strength, dose, lot number not reported via unknown route) in the left arm for immunization.  On unknown date in Oct-2022, at 2 weeks latency after vaccination of Fluzone High-Dose Quadrivalent vaccine and MODERNA COVID-19 VACCINE, the patient developed a non-serious prolonged injection site pain described as sharp, shooting pain in both arms (vaccination site pain).  The patient was hospitalized on 16-Oct-2022.  On 17-Oct-2022 the patient was diagnosed with a serious Guillain barre syndrome (Guillain-Barre syndrome) both at 22 days latency following the administration of Fluzone High-Dose Quadrivalent vaccine and MODERNA COVID-19 VACCINE. This event was assessed as medically significant. The patient was already hospitalized when the event occurred and still in the hospital.  Action taken: Fluzone High-Dose Quadrivalent and MODERNA COVID-19 VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered for both events.; Sender's Comments:  company comment 14-Oct-2022: This case involves a 72-year-old male patient who experienced Guillain barre syndrome and prolonged injection site pain, sharp, shooting pain in both arms after vaccination with Fluzone High-Dose Quadrivalent. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. The role of co-suspect Moderna COVID-19 vaccine could be confounder in case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 72.0
Sex: M
Vaccine: COVID19-2, FLU4, COVID19, FLUX, COVID19, FLU4
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Magnetic resonance imaging, Vaccination site pain
Clinical narrative: guillain barre syndrome; prolonged injection site pain, sharp, shooting pain in both arms; Initial information received on 04-Nov-2022 regarding an unsolicited valid serious case received via consumer/non-hcp (doctor daughter) and doctor.   This case involves a 72-year-old male patient who experienced Guillain barre syndrome and prolonged injection site pain, sharp, shooting pain in both arms after receiving vaccines Moderna COVID-19 vaccine and Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA462123(same reporter).   On 26-Sep-2022, the patient received suspect Fluzone High-Dose Quadrivalent vaccine at dose 0.7 ml once (lot: UJ875AA) via unknown route in the right arm for immunization.  On 26-Sep-2022, the patient received a booster dose of suspect MODERNA COVID-19 VACCINE not produced by  at (unknown: formulation, strength, dose, lot number not reported via unknown route) in the left arm for immunization.  On unknown date in Oct-2022, at 2 weeks latency after vaccination of Fluzone High-Dose Quadrivalent vaccine and MODERNA COVID-19 VACCINE, the patient developed a non-serious prolonged injection site pain described as sharp, shooting pain in both arms (vaccination site pain).  The patient was hospitalized on 16-Oct-2022.  On 17-Oct-2022 the patient was diagnosed with a serious Guillain barre syndrome (Guillain-Barre syndrome) both at 22 days latency following the administration of Fluzone High-Dose Quadrivalent vaccine and MODERNA COVID-19 VACCINE. This event was assessed as medically significant. The patient was already hospitalized when the event occurred and still in the hospital.  Action taken: Fluzone High-Dose Quadrivalent and MODERNA COVID-19 VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered for both events.; Sender's Comments:  company comment 14-Oct-2022: This case involves a 72-year-old male patient who experienced Guillain barre syndrome and prolonged injection site pain, sharp, shooting pain in both arms after vaccination with Fluzone High-Dose Quadrivalent. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. The role of co-suspect Moderna COVID-19 vaccine could be confounder in case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 72.0
Sex: M
Vaccine: COVID19-2, FLU4, COVID19, FLUX, COVID19, FLU4
Symptoms: Guillain-Barre syndrome, Vaccination site pain
Clinical narrative: guillain barre syndrome; prolonged injection site pain, sharp, shooting pain in both arms; Initial information received on 04-Nov-2022 regarding an unsolicited valid serious case received via consumer/non-hcp (doctor daughter) and doctor.   This case involves a 72-year-old male patient who experienced Guillain barre syndrome and prolonged injection site pain, sharp, shooting pain in both arms after receiving vaccines Moderna COVID-19 vaccine and Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA462123(same reporter).   On 26-Sep-2022, the patient received suspect Fluzone High-Dose Quadrivalent vaccine at dose 0.7 ml once (lot: UJ875AA) via unknown route in the right arm for immunization.  On 26-Sep-2022, the patient received a booster dose of suspect MODERNA COVID-19 VACCINE not produced by  at (unknown: formulation, strength, dose, lot number not reported via unknown route) in the left arm for immunization.  On unknown date in Oct-2022, at 2 weeks latency after vaccination of Fluzone High-Dose Quadrivalent vaccine and MODERNA COVID-19 VACCINE, the patient developed a non-serious prolonged injection site pain described as sharp, shooting pain in both arms (vaccination site pain).  The patient was hospitalized on 16-Oct-2022.  On 17-Oct-2022 the patient was diagnosed with a serious Guillain barre syndrome (Guillain-Barre syndrome) both at 22 days latency following the administration of Fluzone High-Dose Quadrivalent vaccine and MODERNA COVID-19 VACCINE. This event was assessed as medically significant. The patient was already hospitalized when the event occurred and still in the hospital.  Action taken: Fluzone High-Dose Quadrivalent and MODERNA COVID-19 VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered for both events.; Sender's Comments:  company comment 14-Oct-2022: This case involves a 72-year-old male patient who experienced Guillain barre syndrome and prolonged injection site pain, sharp, shooting pain in both arms after vaccination with Fluzone High-Dose Quadrivalent. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. The role of co-suspect Moderna COVID-19 vaccine could be confounder in case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE details or PQC.; patient was inadvertently administered an expired dose of VAQTA; This spontaneous report was received from  nurse and refers to a patient of an unknown age or gender.  The patient's, concurrent conditions, concomitant therapies  and previous drug reaction or allergies were not reported.  On 10-NOV-2022, the patient was vaccinated with  an expired hepatitis a vaccine, inactivated (VAQTA) at a dose of 0.5ml, lot #U033212, expiration date: 07-NOV-2022, administered for prophylaxis (route of administration was not provided) (Expired vaccine used). No additional adverse event was reported.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details or PQC.; patient was inadvertently administered an expired dose of VAQTA; This spontaneous report was received from  nurse and refers to a patient of an unknown age or gender.  The patient's, concurrent conditions, concomitant therapies  and previous drug reaction or allergies were not reported.  On 10-NOV-2022, the patient was vaccinated with  an expired hepatitis a vaccine, inactivated (VAQTA) at a dose of 0.5ml, lot #U033212, expiration date: 07-NOV-2022, administered for prophylaxis (route of administration was not provided) (Expired vaccine used). No additional adverse event was reported.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Interchange of vaccine products
Clinical narrative: The pharmacist at local pharmacy gave me the Moderna covid bivalent vaccine by mistake. I have received four Pfizer Covid vaccinations and registered for the Pfizer covid bivalent vaccine online at pharmacy website on 11/8/22.  I have a screen recording of the registration and several emails and texts from pharmacy confirming the Pfizer vaccination. I also have the hard copy registration that I was asked to fill out again at the store. It had Pfizer listed as the vaccine that I was to receive.  I did not notice that I received the wrong vaccine until I left the store. The pharmacist did not suggest that I wait 15 minutes as I expected so I went outside the store and came back in as soon as I noticed that my vaccine card listed Moderna and not Pfizer. I insisted on getting a copy of the paper registration and a picture of the vial and the pharmacist apologized several times.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Wrong product administered
Clinical narrative: The pharmacist at local pharmacy gave me the Moderna covid bivalent vaccine by mistake. I have received four Pfizer Covid vaccinations and registered for the Pfizer covid bivalent vaccine online at pharmacy website on 11/8/22.  I have a screen recording of the registration and several emails and texts from pharmacy confirming the Pfizer vaccination. I also have the hard copy registration that I was asked to fill out again at the store. It had Pfizer listed as the vaccine that I was to receive.  I did not notice that I received the wrong vaccine until I left the store. The pharmacist did not suggest that I wait 15 minutes as I expected so I went outside the store and came back in as soon as I noticed that my vaccine card listed Moderna and not Pfizer. I insisted on getting a copy of the paper registration and a picture of the vial and the pharmacist apologized several times.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse event was reported; Nurse reported that VARIVAX was accidently administered via IM route to a patient.; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 18-OCT-2022, the patient was accidently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, once, lot #W011626, expiration date: 06-APR-2024, administered via intramuscularly (IM) for prophylaxis (strength, dose, and anatomical site injection were not provided)(incorrect route of product administration). No additional adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE details; extra dose of VAQTA was administered to a pediatric patient who had already completed the series; This spontaneous report was received from a nurse prescriber and refers to a pediatric patient of unknown age and gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 24-OCT-2022, the pediatric patient was vaccinated with en extra dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5ml, lot #W006214, expiration date: 04-MAR-2023, administered for prophylaxis (strength, site, and route of administration were not provided) (extra dose administered). The patient had already completed the series on 27-MAY-2020. No symptomatic side effects reported. No additional adverse events details or product quality complaints were reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; an expired dose of MMR II was accidently administered to a patient.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history and concurrent conditions were not reported. The patient's concomitant medications included sterile diluent.  On 25-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (rHA) (M-M-R II) subcutaneous injection, at a dose of 0.5 ml, once, lot #T016198, was found to be valid, expiration date: 11-MAY-2022 (strength, route of administration and vaccination site were not reported) for prophylaxis (expired product administered). No additional adverse events were reported.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product use issue
Clinical narrative: No additional AE; a dose of improperly stored vaccine was administered to a patient on 21 OCT 2022; This spontaneous report was received from a vaccine coordinator and refers to a 12-month-old patient of unknown gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 21-OCT-2022, the patient was vaccinated with a dose of improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #U034522, expiration date: 22-JUN-2024, administered for prophylaxis (dose, strength, site, and route of administration were not provided) (product use issue). The temperature excursion included 33.6 Fahrenheit (F) for 3 hours and 46.9F for 1 hour 48 minutes. The previous temperature excursion included 34.3F for 48 minutes, 34.3F for 1 hour 42 minutes, 34.9F for 1 hour 18 minutes and 34.3F for 1 hour 18 minutes. No additional adverse events details or product quality complaints were reported (no adverse event).
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; Patient was accidently administered PROQUAD via intramuscular route.; This spontaneous report was received from a medical assistant concerning a 6-year-old male patient.  The patient's pertinent medical history, other drug reactions and allergies, concurrent conditions and concomitant therapies were not reported.  On 19-OCT-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot number W012741has been determined to be valid for measles, mumps, rubella and varicella (oka-merck), expiration date reported and established as 16-OCT-2023, via intramuscular (incorrect route of product administration) as prophylaxis (strength not provided). No additional adverse events were reported.   At the time of reporting, the outcome of the events was not provided.
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE; received a Shingrix vaccine by mistake instead on her second "varicella vaccine"/uncertainty of whether the patient received VARIVAX as her first dose of "varicella vaccine"; This spontaneous report was received from a nurse referring to a 34-year-old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 28-OCT-2022, the patient was vaccinated by mistake with varicella zoster vaccine rge (cho)(SHINGRIX) (dose, lot number, expiration date and route of administration not reported) for prophylaxis, instead of a second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (wrong product administered). No adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; HCP states that ROTATEQ was administered to a patient after temperature excursions; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 30-SEP-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot number W002561, expiration date 07-OCT-2023 (dose and route of administration not reported) for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion was of 9.13 degrees Celsius (°C) for 1 hour and of -8.4°C for 37 hours and 15 minutes. No previous excursions were detected.
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs/no PQCs; a dose of PROQUAD was administered on 10/31/2022 after a temperature excursion.; This spontaneous report has been received from an office manager referring to a 6 years old patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions, or concomitant medications.     On 31-OCT-2022, the patient was vaccinated with an improperly storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA)(PROQUAD) lot # W017571 with an expiration date on 29-NOV-2023, for prophylaxis, after a temperature excursion.  The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA)(PROQUAD) was exposed to a temperature excursion of 6 degrees Fahrenheit (°F) up to 14°F (10.91 F), during a time frame of 1 hour. There was no prior temperature excursion and no adverse events were reported.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs/no PQCs; a dose of PROQUAD was administered after a temperature excursion.; This spontaneous report has been received from an office manager referring to a 12 month old patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions, or concomitant medications.     On 10-OCT-2022, the patient was vaccinated with an improperly storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA)(PROQUAD) lot # W017571 with an expiration date on 29-NOV-2023, for prophylaxis, after a temperature excursion.  The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA)(PROQUAD) was exposed to a temperature excursion of 6 degrees Fahrenheit (°F) up to 14°F (10.91 F), during a time frame of 1 hour. There was no prior temperature excursion and no adverse events were reported.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs/no PQCs.; a dose of PROQUAD was administered on 10/31/2022 after a temperature excursion.; This spontaneous report has been received from an office manager referring to a 12 month old patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions, or concomitant medications.     On 31-OCT-2022, the patient was vaccinated with an improperly storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA)(PROQUAD) lot # W017571 with an expiration date on 29-NOV-2023, for prophylaxis, after a temperature excursion.  The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA)(PROQUAD) was exposed to a temperature excursion of 6 degrees Fahrenheit (°F) up to 14°F (10.91 F), during a time frame of 1 hour. There was no prior temperature excursion and no adverse events were reported.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No addititional AEs; CMA called to report administration of expired vaccine.; This spontaneous report was received from a medical assistant and refers to a 52-year-old female. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 18-OCT-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #T034380 rHA, expiration date: 08-JAN-2022 (Expired product administered) administered for prophylaxis (strength, and route of administration were not provided).  No additional adverse events were reported.
Age: 3.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: No other AE; The caller said a 3 year old patient received PROQUAD and VARIVAX today; This spontaneous report was received from registered nurse and refers to a 3-year-old. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 01-NOV-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot #W003821, expiration date: 02-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided); and  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 1 dose, lot #W010524 rHA, expiration date: 25-SEP-2023,  (strength, and route of administration were not provided) administered for prophylaxis (overdose.)  No adverse symptoms were reported.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; This spontaneous report was received from pharmacist via Pfizer and refers to a 75-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2020 (reported as two years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, (dose, lot #, expiry date, route of administration and anatomical location were not provided) for prophylaxis.  On 23-OCT-2020 (reported as 9 days ago), the patient's COVID test showed positive result (SARS-CoV-2 test positive). The outcome of the event was not reported  The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Postural orthostatic tachycardia syndrome
Clinical narrative: other severe autoimmune injuries; postural orthostatic tachycardia syndrome ("POTS"); Information has been received from a lawyer, regarding a case in litigation and concerning a female patient (pt) of an unknown age. No other information concerning the pt's medical history, concurrent conditions or concomitant medications was provided. On 30-SEP-2016, the pt was vaccinated with quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On that day, the pt was injured "injured by a quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) injection which led her to develop postural orthostatic tachycardia syndrome ("POTS"), among other severe autoimmune injuries. The outcome of the events was unknown. The lawyer considered the events of POTS and autoimmune disorder to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  Upon internal review, the event of autoimmune disorder was determined to be medically significant.
Sex: U
Vaccine: UNK
Symptoms: Wrong technique in device usage process
Clinical narrative: Prepared w/needle attached on 10/12/22, given until 10/23/22; This case was reported by a nurse and described the occurrence of wrong technique in device usage process in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 23rd October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced wrong technique in device usage process. On an unknown date, the outcome of the wrong technique in device usage process was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's comment: The patient had given a dose of FluLaval Quadrivalent 2022-2023 season that had been prepared on 12th October 2022 but was not given until 23rd October 2022. The reporter was seeking information about how to proceed.  The reporter stated that a needle had been applied to the syringe on 12th October 2022. The syringe was stored in a temperature controlled refrigerator. The reporter consented to follow-up. Additional Supportive Information: The patient had been given a dose of FluLaval Quadrivalent 2022-2023 season that had been prepared on 12th October 2022 but was not given until 23rd October 2022, which led to wrong technique in device usage process. The case US2022161284 was identified as duplicate of this case. The case US2022161284 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient. This case had been linked with case US2022161279, reported by the same reporter.; Sender's Comments:  US-GSK-US2022161279:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: After 1st dose had Shingles 8 times; 1st dose 4 years ago, no 2nd dose yet; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included giant cell arteritis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK receipt date :04-NOV-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient had giant cell arteries before beigning treatment with actemra to received first dose of shingrix vaccine and experienced shingles,before had the second dose of shingrix. His/her rheumatologist suggested to wait. That was 4 years ago. The patient had light case of shingles 8 times since. The patient had been clear for almost year.   The doctor suggested patient to get shingrix again. The patient asked whether he/she should received the second dose only or series over again. Additional Supportive information:Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination