chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: UNK, UNK
Symptoms: Full blood count, Gait disturbance, Hypoaesthesia, Impaired driving ability, Laboratory test abnormal
Clinical narrative: After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01; Unknown manufacturer, Lot number: unknown), for Covid-19 immunization.  The following information was reported: MULTIPLE SCLEROSIS (medically significant), CEREBROVASCULAR ACCIDENT (medically significant), CHEST PAIN (non-serious), outcome "unknown" and all described as "After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.". The event "after 2nd vaccine, chest pain felt like stroke while driving. er. redid lab work. bad. ms." required emergency room visit. The patient underwent the following laboratory tests and procedures: Lab test: Unknown results, notes: Redid lab work.  Clinical course: Patient injured by 2nd Pfizer vaccine, needed for employment. Super healthy 58 years; only go to doctor for annual physical. After lab work each year my doctor says, "You are the healthiest person I have ever seen in my life!" After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS. Now, 5 years to live and ruined Patient's life.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK, UNK
Symptoms: Lichenoid keratosis, Loss of personal independence in daily activities, Metabolic function test, Muscular weakness, Pain
Clinical narrative: After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01; Unknown manufacturer, Lot number: unknown), for Covid-19 immunization.  The following information was reported: MULTIPLE SCLEROSIS (medically significant), CEREBROVASCULAR ACCIDENT (medically significant), CHEST PAIN (non-serious), outcome "unknown" and all described as "After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.". The event "after 2nd vaccine, chest pain felt like stroke while driving. er. redid lab work. bad. ms." required emergency room visit. The patient underwent the following laboratory tests and procedures: Lab test: Unknown results, notes: Redid lab work.  Clinical course: Patient injured by 2nd Pfizer vaccine, needed for employment. Super healthy 58 years; only go to doctor for annual physical. After lab work each year my doctor says, "You are the healthiest person I have ever seen in my life!" After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS. Now, 5 years to live and ruined Patient's life.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK, UNK
Symptoms: Pain in extremity, Paraesthesia, Periodic limb movement disorder, Rash, Rash pruritic
Clinical narrative: After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01; Unknown manufacturer, Lot number: unknown), for Covid-19 immunization.  The following information was reported: MULTIPLE SCLEROSIS (medically significant), CEREBROVASCULAR ACCIDENT (medically significant), CHEST PAIN (non-serious), outcome "unknown" and all described as "After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.". The event "after 2nd vaccine, chest pain felt like stroke while driving. er. redid lab work. bad. ms." required emergency room visit. The patient underwent the following laboratory tests and procedures: Lab test: Unknown results, notes: Redid lab work.  Clinical course: Patient injured by 2nd Pfizer vaccine, needed for employment. Super healthy 58 years; only go to doctor for annual physical. After lab work each year my doctor says, "You are the healthiest person I have ever seen in my life!" After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS. Now, 5 years to live and ruined Patient's life.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK, UNK
Symptoms: Troponin
Clinical narrative: After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01; Unknown manufacturer, Lot number: unknown), for Covid-19 immunization.  The following information was reported: MULTIPLE SCLEROSIS (medically significant), CEREBROVASCULAR ACCIDENT (medically significant), CHEST PAIN (non-serious), outcome "unknown" and all described as "After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.". The event "after 2nd vaccine, chest pain felt like stroke while driving. er. redid lab work. bad. ms." required emergency room visit. The patient underwent the following laboratory tests and procedures: Lab test: Unknown results, notes: Redid lab work.  Clinical course: Patient injured by 2nd Pfizer vaccine, needed for employment. Super healthy 58 years; only go to doctor for annual physical. After lab work each year my doctor says, "You are the healthiest person I have ever seen in my life!" After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS. Now, 5 years to live and ruined Patient's life.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she feels like she has Covid and the caller already took 5 doses of the Pfizer Covid Vaccine; she feels like she has Covid and the caller already took 5 doses of the Pfizer Covid Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she feels like she has Covid and the caller already took 5 doses of the Pfizer Covid Vaccine".  Clinical course: Caller is going to have the covid vaccine on Thursday 26Jan and right now she feels like she does have a covid and wants to know if she can take the vaccine on Thursday. It will be her 6th dose. The caller also wanted to know what would be the side effects if she will take the covid vaccine on Thursday. Created Manual AE form because the caller said she feels like she has Covid and the caller already took 5 doses of the Pfizer Covid Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: UNK
Symptoms: Death
Clinical narrative: Died 2 weeks after getting it; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died 2 weeks after getting it". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical Course: Her father died 2 weeks after getting the vaccine. She do not really support any type of vaccines for COVID (I do support most other vaccinations though) as her dad died 2 weeks after getting it and also there is proof you can still get COVID after being vaccinated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died 2 weeks after getting it
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporters (HCP and Consumer). A 21-year-old female patient received BNT162b2 (BNT162B2), on 05Aug2021 at 15:20 as dose 1, single (Lot number: EW0183), in left deltoid and on 26Aug2021 at 09:05 as dose 2, single (Lot number: EW0183) at the age of 20 years, in left deltoid, all intramuscular for covid-19 immunization. Relevant medical history included depression (ongoing); migraine (ongoing); allergies. Concomitant medications included duloxetine hydrochloride (CYMBALTA) oral taken for depression, start date: 2019 (ongoing); topiramate (TOPAMAX) oral taken for migraine, start date: 2020 (ongoing); buspirone hydrochloride (BUSPAR) oral taken for depression, start date: 2017 (ongoing); montelukast sodium (SINGULAIR) oral taken for allergies, start date: 2016, stop date: 2022. The patient did not receive prior vaccinations (within 4 weeks).  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Nov2021, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Nov2021) Positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "vaccination failure", "COVID-19".
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness, Seizure
Clinical narrative: passed out 3 separate times and had 3 seizures right on their floor; passed out 3 separate times and had 3 seizures right on their floor; Initial information received on 17-Jan-2023 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional.  This case involves a 16 years old male patient who passed out 3 separate times and had 3 seizures right on their floor after receiving vaccine Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a Booster dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection (with dose, strength, expiry date and lot number not reported) via unknown route in unknown administration site for prophylaxis.  In JUL-2022 the patient developed serious events of passed out 3 separate times and had 3 seizures right on their floor (loss of consciousness) (seizure) (unknown latency) following the administration of Meningococcal A-C-Y-W135 (T Conj) Vaccine. This event was assessed as medically significant.  No relevant lab data was reported.  Action taken : Not Applicable.  It was not reported if the patient received a corrective treatment for the events (passed out 3 separate times and had 3 seizures right on their floor, passed out 3 separate times and had 3 seizures right on their floor).  Outcome: Unknown.  Seriousness Criteria: Medically Significant; Sender's Comments: Sanofi Company Comment dated 21-Jan-2023: This case involves a 16 years old male patient who passed out 3 separate times and had 3 seizures right on their floor after receiving vaccine Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi]. Based on the limited information provided, the causal role of the company suspect product cannot be excluded in occurrence of the events. However, lack of information regarding, medical history, past and concomitant medication, any concurrent conditions, any family history of cancer precludes the comprehensive case assessment.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: gotten the flu everytime i got the shot; Initial information received on 17-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who gotten the flu everytime i got the shot after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose,  batch number and expiry date: unknown) via subcutaneous route in unknown administration site for prophylactic vaccination.  On an unknown date the patient gotten the flu everytime i got the shot (influenza) (unknown latency). It was reported that patient got the flu everytime  he got the shot... so no thanks. He is not falling for that trick again.   It is unknown if there were lab data/results available.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (gotten the flu everytime i got the shot).  At time of reporting, the outcome was Unknown for the event gotten the flu everytime i got the shot.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 17-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed flu (influenza) (unknown latency). It was reported that I got the vaccine but I just got over the flu.  Action taken :  not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information was received on 17-Jan-2023 regarding an unsolicited valid social media non-serious case received from a consumer via global digital media.  This case involves an unknown demographics patient who got the flu while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, route, batch number and expiry date: unknown in unknown administration site for prophylactic vaccination.  On an unknown date the patient had got the flu (influenza) (latency: unknown) following the administration of influenza vaccine.  No lab data was reported.  Action taken: not applicable.  Corrective treatment: not reported  Outcome: unknown
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: a dose of PENTACEL was administered and only the liquid component was administered, with no reported adverse event; whether the powdered portion consist of only the HIB portion of the vaccine and what diluent it now needs to be reconstituted with, wit no reported adverse event; Initial information received on 17-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who received a dose of pentacel was administered and only the liquid component was administered, with no reported adverse event and whether the powdered portion consist of only the hib portion of the vaccine and what diluent it now needs to be reconstituted with, wit no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On 06-Jan-2023, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ684AAA, U7331AA (DILUENT) via unknown route in unknown administration site.  On an unknown date the patient recieved a dose of pentacel was administered and only the liquid component was administered, with no reported adverse event (single component of a two-component product administered) and whether the powdered portion consist of only the hib portion of the vaccine and what diluent it now needs to be reconstituted with, wit no reported adverse event (product preparation error)  (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: Patient received a dose of IPOL that was no longer viable due to a temperature excursion with on reported AE; Initial information received on 18-Jan-2023 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 16-year-old female patient who experienced patient received a dose of ipol that was no longer viable due to a temperature excursion with on reported adverse event (AE) while receiving vaccine IPV (VERO) [IMOVAX POLIO].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included Hepatitis B Vaccine, Hepatitis A Vaccine, meningococcal vaccine measles vaccine, mumps vaccine, rubella vaccine (MMR), varicella zoster vaccine (Varicella Vaccine) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) all for prophylactic vaccination (Immunisation).  On 03-Jan-2023, the patient received suspect IPV (VERO) at a dose of 0.5 ml once (lot U1A451M, expiry date: 20-Feb-2023) via unknown route in the right deltoid for Immunization.  On 03-Jan-2023 the patient received a dose of ipol that was no longer viable due to a temperature excursion with on reported ae (poor quality product administered)  same day following the administration of IPV (VERO).  Action taken: Not applicable.   Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Monovalent vaccine incorrectly administered for a booster dose (if bivalent booster indicated) Dose not repeated. No adverse event
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menopause
Clinical narrative: Heavy menstrual bleeding twenty days per month for six months after the vaccine,  and I had previously been almost in menopause. Previous to vaccine I bled for one day every two months only.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Coordination abnormal, Dysarthria, Fall, Mobility decreased, Muscle spasms
Clinical narrative: Sore arm and pain with 2 hours of inject. Muscle spasms in legs. Tingling in feet. The next morning I could not get out of bed and needed assistance. Legs would not go and I had slurred speech. I was falling over. I sent my doctor an email letting him know I had the vaccine and this happened after. I was given no treatment. Pain meds for the pain. Husband was my caregiver for everything for 5 weeks. Could not move right hand, loss of coordination.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal disorder, Pain in extremity, Paraesthesia
Clinical narrative: Sore arm and pain with 2 hours of inject. Muscle spasms in legs. Tingling in feet. The next morning I could not get out of bed and needed assistance. Legs would not go and I had slurred speech. I was falling over. I sent my doctor an email letting him know I had the vaccine and this happened after. I was given no treatment. Pain meds for the pain. Husband was my caregiver for everything for 5 weeks. Could not move right hand, loss of coordination.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia
Clinical narrative: Bilateral arm numbness for days. Week of uncontrolled right arm numbness
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site laceration, Autopsy, Death, Diarrhoea, Electrolyte imbalance
Clinical narrative: On 7/30/2022 my mother received a shingles vaccination from the Pharmacy. On 8/3/2022 she passed away.  An autopsy was performed and the pathologist's report includes the following for cause of death: "Active enteritis with diarrhea and probable electrolyte imbalance: complications of intravenous vaccine administration with laceration, left cephalic vein."
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Enteritis, Pathology test, Vaccination complication, Vascular injury
Clinical narrative: On 7/30/2022 my mother received a shingles vaccination from the Pharmacy. On 8/3/2022 she passed away.  An autopsy was performed and the pathologist's report includes the following for cause of death: "Active enteritis with diarrhea and probable electrolyte imbalance: complications of intravenous vaccine administration with laceration, left cephalic vein."
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Ankylosing spondylitis, Autoimmune disorder, Condition aggravated, Neurological symptom
Clinical narrative: Stroke like symptoms day after second dose. Went to ER sent me home. I have had worse problems with my autoimmune disease since
Age: 25.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Bursitis, Immediate post-injection reaction, Incorrect route of product administration, Injected limb mobility decreased, Injection site pain
Clinical narrative: Vaccines were administered into right shoulder joint, not deltoid muscle. Each vaccine was given independently and both were given too high, missing the deltoid muscle. Immediate severe pain presented in my right shoulder and I could not move my own arm without assistance for 48 hours. 7 days later severe pain and reduced mobility persisted. Visited doctor and was advised to take ibuprofen to reduce swelling. 21 days later, pain still present with reduced mobility.
Age: 25.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Product administered at inappropriate site, Swelling
Clinical narrative: Vaccines were administered into right shoulder joint, not deltoid muscle. Each vaccine was given independently and both were given too high, missing the deltoid muscle. Immediate severe pain presented in my right shoulder and I could not move my own arm without assistance for 48 hours. 7 days later severe pain and reduced mobility persisted. Visited doctor and was advised to take ibuprofen to reduce swelling. 21 days later, pain still present with reduced mobility.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: patient inadvertently received three doses of Fluarix within the same season; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 19-month-old male patient who received Flu Seasonal QIV (Fluarix Quadrivalent 2022-2023 season) (batch number 953Y2, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included FLUARIX QUADRIVALENT (1st dose of Fluarix Quadrivalent 2022-2023 season received on 16th September 2022 with batch number 9XL7N and expiration date 30th June 2023). Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT).   On 19th December 2022, the patient received the 3rd dose of Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 19th December 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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: 17-JAN-2023 Reporter's Comments: The pediatrician reported that, the patient inadvertently received three doses of Fluarix within the same season.  The reporter consented to follow up. Additional Supportive Information: The patient received additional 3rd dose of Fluarix Quadrivalent, which led to extra dose administered.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Continuous muscle pain at 30 days; This case was reported by a consumer and described the occurrence of muscle pain in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 2459T, expiry date unknown) for muscle pain.   On 14th December 2022, the patient received Shingrix. On 14th December 2022, less than a day after receiving Shingrix, the patient experienced muscle pain. In January 2023, the outcome of the muscle pain was recovered/resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-JAN-2023 Reporter's comments: This report was submitted via reporting system.  This report was submitted by site.  The patient had stated that, he had continuous muscle pain for 30 days after injection.  The symptoms were not treated. The reporter consented to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 17 patients were administered expired doses of the Moderna COVID-19 vaccine bivalent as booster doses; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients were administered expired doses of the Moderna COVID-19 vaccine bivalent as booster doses) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients were administered expired doses of the Moderna COVID-19 vaccine bivalent as booster doses) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients were administered expired doses of the Moderna COVID-19 vaccine bivalent as booster doses) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (17 patients were administered expired doses of the Moderna COVID-19 vaccine bivalent as booster doses).    Concomitant and treatment medications were not reported.  17 patients were administered expired doses of the Moderna COVID-19 vaccine bivalent as booster doses.  This case included information for patient 11 out of 17.   This case was linked to MODERNATX, INC.-MOD-2023-698998 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: Non significant information received. Sender's Comments:  MODERNATX, INC.-MOD-2023-698998:master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; 17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date).    This case included information for 15 patient  out of 17. Concomitant and treatment medications were not reported.   This case was linked to MODERNATX, INC.-MOD-2023-698998 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: Live follow up received with non significant information.; Sender's Comments:  MODERNATX, INC.-MOD-2023-698998:master case
Age: 1.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Quadracel being administered to a patient under 4 years of age with no reported adverse event; Initial information received  on 18-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 months old male patient, quadracel being administered to a patient under 4 years of age with no reported adverse event while receiving vaccine diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  Concomitant medications included Hepatitis A vaccine (Hepatitis A) for Immunisation.  On 17-Jan-2023, the patient received 0.5ml dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (lot: C5970AA) via intramuscular route in unknown administration site.  On 17-Jan-2023 the patient had a non-serious event of quadracel being administered to a patient under 4 years of age with no reported adverse event (product administered to patient of inappropriate age) following the administration of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine.  Action taken with diphtheria, tetanus, AC pertussis and IPV vaccine (Quadracel) was not applicable.  Outcome: unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, RV5
Symptoms: Abdominal X-ray, Blood test, Intussusception, Lethargy, Ultrasound abdomen abnormal
Clinical narrative: Began vomiting around 9:30pm on 9 Jan. Became lethargic. Vomited  5 times in a  one hour period.  Was taken to a local Hospital ER. Abdominal Ultrasound preformed which showed intussusception. Fluid enema performed under XRay which reversed the intussusception. Patient was monitored in hospital for next 48 hours.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Began vomiting around 9:30pm on 9 Jan. Became lethargic. Vomited  5 times in a  one hour period.  Was taken to a local Hospital ER. Abdominal Ultrasound preformed which showed intussusception. Fluid enema performed under XRay which reversed the intussusception. Patient was monitored in hospital for next 48 hours.
Age: 8.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Patient received a dose of IPOL that was no longer viable due to a temperature excursion with no reported adverse event; Initial information received on 18-Jan-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 8-year-old male patient who received a dose of IPV (VERO) [IPOL] that was no longer viable due to a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 06-Jan-2023, the patient received a 0.5 ml Total dose of suspect IPV (VERO) Suspension for injection (lot: U1A451M) (strength, expiry date: unknown) via unknown route in unknown administration site for immunization.  On 06-Jan-2023 the patient had a non-serious event of patient received a dose of ipol that was no longer viable due to a temperature excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of IPV (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  Outcome: Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Cardiovascular symptom, Chest pain, Condition aggravated, Dyspnoea
Clinical narrative: This was first doze administered 4/7/21.  None after first dose other than soreness at injection site.  After 2nd dose on 5/4/21, started having intermittent heart fluttering, shortness of breath at times, cheat pains, afib-like symptoms.  Occasionally at first, now so frequent (as of 1/23/2023) I have scheduled a cardiologist visit to schedule a full workup.   I had a previous history of Afib that was in 100% remission for 5 years prior to vaccination.  I'm part of an at-risk group that should have been precluded from receiving this vaccine.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: This was first doze administered 4/7/21.  None after first dose other than soreness at injection site.  After 2nd dose on 5/4/21, started having intermittent heart fluttering, shortness of breath at times, cheat pains, afib-like symptoms.  Occasionally at first, now so frequent (as of 1/23/2023) I have scheduled a cardiologist visit to schedule a full workup.   I had a previous history of Afib that was in 100% remission for 5 years prior to vaccination.  I'm part of an at-risk group that should have been precluded from receiving this vaccine.
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Chest X-ray abnormal, Feeding disorder, Lymphoma
Clinical narrative: clear chest xray sept 22, chest xray on 01-13-23 shows MASSIVE Lymphoma, hospitalized, cant eat, 2nd biopsy today
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Chest X-ray abnormal, Chest tube insertion, Cough
Clinical narrative: DATE OF ADMISSION:  01/13/2023 DATE OF DISCHARGE:  01/19/2023 COVID positive date: 1/13/2023 HOSPITAL COURSE The patient is an 84-year-old female with past medical history significant for CLL, atrial fibrillation, hypertension, hyperlipidemia, anxiety, and recent pleural effusion and pneumonia.  The patient was admitted in December for pneumonia and treated with Zithromax and Ceftin with treatment through 01/05/2023.  She was discharged to subacute rehab where she resided until readmission.  She started eating less and feeling weak the previous weekend and developed cough.  She also developed low-grade fever on Monday.  She tested positive for COVID on Monday, 01/08/2023.  She has been afebrile since that time.  She has no history of COVID and is fully vaccinated.  She was hypoxic per EMS, 85% on evaluation.  She was given 2 L per nasal cannula, improved, but was again hypoxic at 80% in the ER.  Chest x-ray showed only tiny pleural effusion, moderate interstitial edema, pneumonitis.  Recent left upper lobe pneumonia appeared resolved.  She was admitted for respiratory failure and hypoxia.    The patient was admitted and started on remdesivir and dexamethasone for her COVID-19.  Pulmonology was consulted and followed for her thoracostomy tube that was placed by Dr. in December.  They recommended holding drainage for a week and attempting draining on 01/17.  If no output, they could pull the drain.  Her drain was removed during hospitalization on 01/18/2023.  The patient received electrolyte replacement during hospitalization as needed.  Per Dr. plan was to hold ibrutinib for another 4 weeks and reconsider based on clinical course of the patient.  The patient had repeat echocardiogram on 01/14/2023 that showed ejection fraction of 71% with small pericardial effusion without evidence of tamponade.  As patient was stable, plans were made to discharge the patient to subacute rehab.  She was discharged to a different facility than she was at previously as she was unhappy with the care there.   CONDITION ON DISCHARGE Stable.
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Echocardiogram abnormal, Ejection fraction normal, Electrolyte substitution therapy, Hypophagia, Hypoxia
Clinical narrative: DATE OF ADMISSION:  01/13/2023 DATE OF DISCHARGE:  01/19/2023 COVID positive date: 1/13/2023 HOSPITAL COURSE The patient is an 84-year-old female with past medical history significant for CLL, atrial fibrillation, hypertension, hyperlipidemia, anxiety, and recent pleural effusion and pneumonia.  The patient was admitted in December for pneumonia and treated with Zithromax and Ceftin with treatment through 01/05/2023.  She was discharged to subacute rehab where she resided until readmission.  She started eating less and feeling weak the previous weekend and developed cough.  She also developed low-grade fever on Monday.  She tested positive for COVID on Monday, 01/08/2023.  She has been afebrile since that time.  She has no history of COVID and is fully vaccinated.  She was hypoxic per EMS, 85% on evaluation.  She was given 2 L per nasal cannula, improved, but was again hypoxic at 80% in the ER.  Chest x-ray showed only tiny pleural effusion, moderate interstitial edema, pneumonitis.  Recent left upper lobe pneumonia appeared resolved.  She was admitted for respiratory failure and hypoxia.    The patient was admitted and started on remdesivir and dexamethasone for her COVID-19.  Pulmonology was consulted and followed for her thoracostomy tube that was placed by Dr. in December.  They recommended holding drainage for a week and attempting draining on 01/17.  If no output, they could pull the drain.  Her drain was removed during hospitalization on 01/18/2023.  The patient received electrolyte replacement during hospitalization as needed.  Per Dr. plan was to hold ibrutinib for another 4 weeks and reconsider based on clinical course of the patient.  The patient had repeat echocardiogram on 01/14/2023 that showed ejection fraction of 71% with small pericardial effusion without evidence of tamponade.  As patient was stable, plans were made to discharge the patient to subacute rehab.  She was discharged to a different facility than she was at previously as she was unhappy with the care there.   CONDITION ON DISCHARGE Stable.
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pleural effusion, Pneumonia, Pulmonary oedema, Pyrexia, Respiratory failure
Clinical narrative: DATE OF ADMISSION:  01/13/2023 DATE OF DISCHARGE:  01/19/2023 COVID positive date: 1/13/2023 HOSPITAL COURSE The patient is an 84-year-old female with past medical history significant for CLL, atrial fibrillation, hypertension, hyperlipidemia, anxiety, and recent pleural effusion and pneumonia.  The patient was admitted in December for pneumonia and treated with Zithromax and Ceftin with treatment through 01/05/2023.  She was discharged to subacute rehab where she resided until readmission.  She started eating less and feeling weak the previous weekend and developed cough.  She also developed low-grade fever on Monday.  She tested positive for COVID on Monday, 01/08/2023.  She has been afebrile since that time.  She has no history of COVID and is fully vaccinated.  She was hypoxic per EMS, 85% on evaluation.  She was given 2 L per nasal cannula, improved, but was again hypoxic at 80% in the ER.  Chest x-ray showed only tiny pleural effusion, moderate interstitial edema, pneumonitis.  Recent left upper lobe pneumonia appeared resolved.  She was admitted for respiratory failure and hypoxia.    The patient was admitted and started on remdesivir and dexamethasone for her COVID-19.  Pulmonology was consulted and followed for her thoracostomy tube that was placed by Dr. in December.  They recommended holding drainage for a week and attempting draining on 01/17.  If no output, they could pull the drain.  Her drain was removed during hospitalization on 01/18/2023.  The patient received electrolyte replacement during hospitalization as needed.  Per Dr. plan was to hold ibrutinib for another 4 weeks and reconsider based on clinical course of the patient.  The patient had repeat echocardiogram on 01/14/2023 that showed ejection fraction of 71% with small pericardial effusion without evidence of tamponade.  As patient was stable, plans were made to discharge the patient to subacute rehab.  She was discharged to a different facility than she was at previously as she was unhappy with the care there.   CONDITION ON DISCHARGE Stable.