chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anaemia, Chest X-ray, Chest discomfort, Chest pain, Chills
Clinical narrative: First night (Sunday) fever, chills, fatigue (normal symptoms) On Monday, I was fatigued but nothing else.  On Tuesday, I noticed that I was dizzy but I explained it away as being unrelated. On Wednesday, I noticed heart palpitations and increased dizziness. I was having chest pains.  On Thursday, I went to the ER after I noticed that my heart was pounding whilst doing normal household chores. They discharged me with no diagnosis and did not catch the palpitations on the monitor.  Friday-Saturday, I noticed extreme fatigue and chest irritation. Increased palpitations.  Sunday morning (a week after the shot) I decided to go back to the ER because I had woken up early that morning with extreme chest pain. They caught a PVC on the monitor but nothing else.  I visited a cardiologist on Monday (day 8) and I believe he mistakenly diagnosed me with benign PVCs.  I have been dealing with chest pain, heart palpitations,  fatigue, and dizziness ever since. It's slightly better than it was, but I am not even close to recovered.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram, Dizziness, Fatigue, Feeling abnormal, Full blood count abnormal
Clinical narrative: First night (Sunday) fever, chills, fatigue (normal symptoms) On Monday, I was fatigued but nothing else.  On Tuesday, I noticed that I was dizzy but I explained it away as being unrelated. On Wednesday, I noticed heart palpitations and increased dizziness. I was having chest pains.  On Thursday, I went to the ER after I noticed that my heart was pounding whilst doing normal household chores. They discharged me with no diagnosis and did not catch the palpitations on the monitor.  Friday-Saturday, I noticed extreme fatigue and chest irritation. Increased palpitations.  Sunday morning (a week after the shot) I decided to go back to the ER because I had woken up early that morning with extreme chest pain. They caught a PVC on the monitor but nothing else.  I visited a cardiologist on Monday (day 8) and I believe he mistakenly diagnosed me with benign PVCs.  I have been dealing with chest pain, heart palpitations,  fatigue, and dizziness ever since. It's slightly better than it was, but I am not even close to recovered.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Gait disturbance, General physical health deterioration, Laboratory test normal, Palpitations, Pyrexia
Clinical narrative: First night (Sunday) fever, chills, fatigue (normal symptoms) On Monday, I was fatigued but nothing else.  On Tuesday, I noticed that I was dizzy but I explained it away as being unrelated. On Wednesday, I noticed heart palpitations and increased dizziness. I was having chest pains.  On Thursday, I went to the ER after I noticed that my heart was pounding whilst doing normal household chores. They discharged me with no diagnosis and did not catch the palpitations on the monitor.  Friday-Saturday, I noticed extreme fatigue and chest irritation. Increased palpitations.  Sunday morning (a week after the shot) I decided to go back to the ER because I had woken up early that morning with extreme chest pain. They caught a PVC on the monitor but nothing else.  I visited a cardiologist on Monday (day 8) and I believe he mistakenly diagnosed me with benign PVCs.  I have been dealing with chest pain, heart palpitations,  fatigue, and dizziness ever since. It's slightly better than it was, but I am not even close to recovered.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Troponin
Clinical narrative: First night (Sunday) fever, chills, fatigue (normal symptoms) On Monday, I was fatigued but nothing else.  On Tuesday, I noticed that I was dizzy but I explained it away as being unrelated. On Wednesday, I noticed heart palpitations and increased dizziness. I was having chest pains.  On Thursday, I went to the ER after I noticed that my heart was pounding whilst doing normal household chores. They discharged me with no diagnosis and did not catch the palpitations on the monitor.  Friday-Saturday, I noticed extreme fatigue and chest irritation. Increased palpitations.  Sunday morning (a week after the shot) I decided to go back to the ER because I had woken up early that morning with extreme chest pain. They caught a PVC on the monitor but nothing else.  I visited a cardiologist on Monday (day 8) and I believe he mistakenly diagnosed me with benign PVCs.  I have been dealing with chest pain, heart palpitations,  fatigue, and dizziness ever since. It's slightly better than it was, but I am not even close to recovered.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Influenza like illness, Peripheral swelling
Clinical narrative: Pt reporting shortness of breath all night after vaccine, accompanied by flu-like symptoms and arm swelling.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient requested a flu vaccine, but a Tdap (boostrix) was administered instead. The administering pharmacist grabbed the wrong vaccine. Fluarix and Boostrix vaccines were next to each other with the same looking boxes. Patient was contacted immediately upon discovering the error. She did not report any adverse reactions or issues.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash on left lower extremity 7 days after administration of vaccines, then noticed four more on Bilateral leg. Seen in clinic as f/u rash on 8/12/2023
Age: 68.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: PATIENT WAS ADMINISTERED EXPIRED PREVNAR-13 VACCINE. EXPIRATION DATE 6/30/2023. PATIENT WAS MONITORED FOR 30 MINUTES BY MD AND RN. NO ADVERSE REACTIONS NOTED. MANUFACTURE OF THE VACCINE CONTACTED FOR POSSIBLE RECOMMENDATIONS AND FOLLOW UP.
Age: 68.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Expired product administered
Clinical narrative: PATIENT WAS ADMINISTERED EXPIRED PREVNAR-13 VACCINE. EXPIRATION DATE 6/30/2023. PATIENT WAS MONITORED FOR 30 MINUTES BY MD AND RN. NO ADVERSE REACTIONS NOTED. MANUFACTURE OF THE VACCINE CONTACTED FOR POSSIBLE RECOMMENDATIONS AND FOLLOW UP.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Malaise, Nausea
Clinical narrative: Nausea, headache, uneasy stomach, diarrhea, general malaise.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pain, Unresponsive to stimuli
Clinical narrative: Tdap was given to R deltoid Medquadfi was given second. After Menquadfi, patient stated "Ah, that like stings" I watched patient and talked with him and his mother for 90 seconds. He was standing independently. Patient and his mother were dismissed. I proceeded out of the room. Mother stated "Help me! Help me!" when I entered the room, patient was laying prone with his chin facing right shoulder. Patient was unresponsive for approximately 10-15 seconds. His pulse was regular and strong. Ice was applied to the back of his
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Pain in extremity, Pain in jaw
Clinical narrative: Pt experienced left arm, jaw and chest pain  x4 days.  Pain moderate to severe in  severity. Pt treated the pain with OTC Tylenol.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient's arm is red, swollen, and warm to the touch. Patient reports pain.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm is red, swollen, and warm to the touch. Patient reports pain.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC13, VARCEL, UNK, UNK, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: My son was given 2 doses of  the chickenpox vaccine! Nobody knows what the outcome is and he already started getting spots on his body I took him to urgent care and they said there is nothing I can do but wait and see
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC13, VARCEL, UNK, UNK, MMRV, VARCEL
Symptoms: Rash
Clinical narrative: My son was given 2 doses of  the chickenpox vaccine! Nobody knows what the outcome is and he already started getting spots on his body I took him to urgent care and they said there is nothing I can do but wait and see
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC13, VARCEL, UNK, UNK, MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: My son was given 2 doses of  the chickenpox vaccine! Nobody knows what the outcome is and he already started getting spots on his body I took him to urgent care and they said there is nothing I can do but wait and see
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report t/e on VARIVAX, administered. T/E case: 02431749. No additional AE/No PQC.   Vaccine: VARIVAX Temperature:  -3.6c Time frame: 0hours 6minutes 0seconds Lot(s) & expiration date: w016746 exp 05/23/2024 No previous Excursion; No additional AE/No PQC.; This spontaneous report as received from a physician refers to a patient of unknown age and gender.     No information was provided regarding the patient´s medical history, concurrent condition, drug and allergy history or concomitant medications.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # W016746, expiration date 23-MAY-2024). It was reported that the vaccine was stored during 6 minutes under a temperature of  -3.6 °C (product storage error). Not adverse event was reported.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: During temperature excursion evaluation customer reported that a patient had been given a vaccine after it was improperly stored. No PQC. No additional information.          ?    Names of vaccines involved (including lot/exp) MMR II W035041 5/24/20; This spontaneous report was received from a medical assistant and refer to a 5-year-old male patient. There was no information about patient's concurrent conditions or pertinent medical history.  Concomitant therapies included diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid(QUADRACEL) and varicella virus vaccine live (oka/merck)(VARIVAX).     On 20-JUL-2023, the patient was vaccinated with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) in the right deltoid, lot # W035041 with expiration date 24-MAY-2024 (dose was not reported) for prophylaxis (product storage error). The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was exposed to 1.4 degrees Fahrenheit for 8 hours and 2 minutes.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Product storage error
Clinical narrative: HCP reported administration of expired VARIVAX to a patient. No symptoms reported. VARIVAX previously experienced a TE (Case #02098347). New TE documented for escalation (Case #02432659). Obtained consent to contact HCP. No additional AE/PQC.  After; Expired vaccine used; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 20-JUL-2023, the patient was vaccinated  with an expired varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5ml dose, lot #U019906, expiration date: 24-JUN-2023 (strength, route of administration, and indication were not provided) (Expired vaccine used). No symptoms reported.  After the call, it was identified a miscommunication regarding information for expired administered products in which had a prior temperature excursion (Product storage error).  Unsuccessful call-back attempt was made.
Sex: U
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: HBP reported AE related to GARDASIL 9. Reported a 2-month-old patient received GARDASIL 9 at their previous pediatric office; patient is now at new pediatric clinic from which the HBP was calling from. Reporter unsure of when the patient received the; This spontaneous report was received from a physician, referring to a 2-month-old patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unspecified day the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate Schedule of Product Administered; Initial Report Received on 2-Jun-2023   A medical assistant reported that a 56-year-old female (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received a late second dose of HEPLISAV-B.  No relevant medical history was reported. No allergies or previous reactions to other vaccines were reported.  No relevant concomitant medications were reported.    On an 18-Apr-2023, the patient received the first dose of HEPLISAV-B (Lot #941587, expiration date of 31-Aug-2025, and NDC #43528-003-05) from a provider in the left deltoid with route of administration not provided.   On 01-Jun-2023, 44 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot #941592, expiration date of 31-Aug-2025, and NDC #43528-003-05) from a provider in the right deltoid with route of administration not provided. The patient did not experience any adverse effects.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: 5 Months Pregnant; Initial Report Received on 22-Jun-2023  A representative reported to the HEPLISAV-B pregnancy registry that a pregnant female patient resident (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while about 5 months pregnant.  No relevant medical history or concomitant medications were reported.   The last menstrual period date, estimated date of delivery, pregnancy history, and pregnancy risk factors were not reported.  On an unspecified date in Jun-2023, the patient who was about 5 months pregnant, received a dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not reported). No contact information or additional information was provided.  No further follow-up will be conducted by the Pregnancy Registry.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Nausea
Clinical narrative: Arm pain at site of injection; Flu like symptoms; Nausea; This non-serious case was reported by a lawyer and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31-JUL-2023, the patient received the 1st dose of Shingrix (left arm). On 01-AUG-2023, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: Arm pain at site of injection), influenza-like symptoms (Verbatim: Flu like symptoms) and nausea (Verbatim: Nausea). The outcome of the injection site pain, influenza-like symptoms and nausea were not reported.   The reporter considered the injection site pain, influenza-like symptoms and nausea to be related to Shingrix.     The company considered the injection site pain, influenza-like symptoms and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-AUG-2023 The patient age was reported as 6 decades. The patient reported that after received Shingrix vaccine he experienced flu like symptoms, arm pain at the site of injection and nausea.
Sex: U
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: two doses of PENTACEL were administered, only the HIB portion given, and it was thought to be reconstituted with sterile water with no reported adverse event; Initial information received on 14-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 patients who were administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)], only the HIB portion given, and it was thought to be reconstituted with sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ876AA) (with an unknown strength, dosage and expiry date) via unknown route in unknown administration site for Immunization, only the HIB portion given, and it was thought to be reconstituted with sterile water with no reported adverse event (product preparation error) (latency- same day).  Reportedly, Caller reporting two doses of PENTACEL were administered, only the HIB portion given, and it was thought to be reconstituted with sterile water. Caller reporting, they had 2 extra doses of the DTAP/IPV, which led them to believe 2 patients were given only the HIB. Caller reporting, they are unsure which patients affected, they have narrowed it down to 4, meaning 2 of the 4 receiving only HIB/sterile water and the other 2 patients received the full dose of PENTACEL. caller that the two patients who received the doses with HIB reconstituted with sterile water would not be counted as a valid dose. Caller then asked if they need to be repeated.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event
Clinical narrative: On 8/3/23 patient was brought to our office by a relative for a routine well child examination & immunization update. A health appraisal was requested & the child's immunization record was printed at approximately 1:30PM 8/3/23 from database, to attach to the form. I explained to the relative how to fill the form, we discussed the immunizations that were due indicated by the printed database record, how they would be administered, aftercare/possible side effects, & that I would hand write in the immunizations received on the printed record, which I initialed, signed, dated & stamped after the appointment. The patient was given Proquad (administered subcutaneously right thigh top) & Quadracel (administered intramuscular in the left vast lat) & tolerated it well. Once the visit was completed the relative & patient left the office. Around 2:30PM, the patient?s mother called from work & spoke with our receptionist & Dr., stating that she had taken the child to the Health Department that morning to have his immunizations. Once I was informed of this, I immediately called the immunization program coordinator at  Health Department to see what needed to be done & what the parent needed to watch for. She stated that the child should be fine, but to tell the mom to watch for fever, alternate Tylenol & Motrin, & if fever was not controlled by this method, she should take the child to the ER, & that I needed to make a VAERS report. Follow-up was completed with the patient 2 weeks later (08/17/23) & no adverse side effects were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Polyneuropathy, Symptom recurrence
Clinical narrative: DRUG INDUCED POLYNEUROPATHY 9/30/2022  &  3/21/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 18.0
Sex: F
Vaccine: PNC20
Symptoms: Urticaria
Clinical narrative: diffuses hives; recommended oral benadryl & she was instructed to go to the ED should she develop difficulty breathing
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Peripheral swelling, Skin warm, Vaccination site swelling, Vaccination site warmth
Clinical narrative: patient developed injection site reaction after receiving PNEUMOVAX 23; he patient's arm was swollen; warm to the touch; This spontaneous report was received from an other health professional and refers to a 38-year-old male patient. There was no information about the patient's concurrent conditions or medical history provided. Concomitant therapies included cobicistat (+) elvitegravir (+) emtricitabine (+) tenofovir alafenamide fumarate (GENVOYA), hydrochlorothiazide (HCTZ) and lisinopril.  On 02-AUG-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot #w007035 was valid, expiration date established as 20-OCT-2023 (exact dose, route of administration, anatomical location not provided) for prophylaxis.  On 03-AUG-2023, the patient experienced injection site reaction (vaccination site reaction). The patient's arm was swollen and warm to the touch (vaccination site warmth) (vaccination site swelling). The outcome of vaccination site reaction, vaccination site warmth and vaccination site swelling was reported as recovering/resolving. The patient was Sought Medical Attention, saw a physician and received doxycycline, diphenhydramine hydrochloride (BENADRYL) and prednisone as a treatment.  Causal relationship between events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Age: 1.08
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 13-month-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 27-APR-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, unk, lot #W024971, expiration date: 05-FEB-2024, administered for prophylaxis (anatomical location , and route of administration were not provided) (product storage error). Administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion were reported: 42.31 F for 36 hours and 35 minutes.  There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 3-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 27-APR-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, unk, lot #W024971, expiration date: 05-FEB-2024, administered for prophylaxis (anatomical location , and route of administration were not provided) (product storage error). Administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion were reported: 42.31 F for 36 hours and 35 minutes.  There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 4-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 05-JUN-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, unk, lot #W024971, expiration date: 05-FEB-2024, administered for prophylaxis (anatomical location , and route of administration were not provided) (product storage error). Administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion were reported: 42.31 F for 36 hours and 35 minutes.  There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 14-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 13-JUN-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, unk, lot #W024971, expiration date: 05-FEB-2024, administered for prophylaxis (anatomical location, and route of administration were not provided) (product storage error). Administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion was reported: 42.31 F for 36 hours and 35 minutes.  There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 1.08
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 13-month-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 10-JUL-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, unk, lot #W024971, expiration date: 05-FEB-2024, administered for prophylaxis (anatomical location, and route of administration were not provided) (product storage error). Administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion was reported: 42.31 F for 36 hours and 35 minutes.  There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 12.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 12-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 10-JUL-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, unk, lot #W024971, expiration date: 05-FEB-2024, administered for prophylaxis (anatomical location, and route of administration were not provided) (product storage error). Administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion was reported: 42.31 F for 36 hours and 35 minutes.  There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 4-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 13-JUL-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, unk, lot #W024971, expiration date: 05-FEB-2024, administered for prophylaxis (anatomical location, and route of administration were not provided) (product storage error). Administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion was reported: 42.31 F for 36 hours and 35 minutes.  There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 4-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 17-JUL-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, unk, lot #W024971, expiration date: 05-FEB-2024, administered for prophylaxis (anatomical location, and route of administration were not provided) (product storage error). Administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion was reported: 42.31 F for 36 hours and 35 minutes.  There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 1.83
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 22-month-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 17-JUL-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, unk, lot #W024971, expiration date: 05-FEB-2024, administered for prophylaxis (anatomical location, and route of administration were not provided) (product storage error). Administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion was reported: 42.31 F for 36 hours and 35 minutes.  There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Sex: M
Vaccine: PPV
Symptoms: Autoimmune haemolytic anaemia, Condition aggravated, Immunodeficiency common variable
Clinical narrative: poor response to immunization; This literature marketed report has been received from the authors of a published article titled as stated below and refers to a 23 year old male patient. The patient's concurrent conditions included autoimmune hemolytic anemia (AIHA), Non-Hodgkin Lymphoma and common variable immunodeficiency (CVID). Medical history was not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot#, expiration date, dose, route of administration and anatomical location were not reported) and only responded to 4 out of 11 serotypes unique to unconjugated ones, demonstrating poor response to immunization.  The outcome of the event was unknown. The authors considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  Literature report. A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report AE for ROTATEQ that experienced a temperature excursion and was administered.; No side effects reported.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On unknown day, the patients was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #W0291190 was not valid, expiration date was reported as 28-JAN-2024, exact dose and route of administration were not provided) for prophylaxis (Product storage error).  On unknown day, the suspect vaccine experienced a temperature excursion of 9.3 degrees Celsius (C) for 5 hours and 11 minutes. On unknown day, the vaccine experienced previous temperature excursion of 18.8 C for 2 hours and 55 minutes. No side effects reported (No adverse event). No product quality complaint (PQC).; Sender's Comments:  US-009507513-2308USA005205:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; HBP called to report inadvertent administration of PROQUAD after a temperature excursion. Limited patient demographics provided. See AE case #02451226 and #02451227. No additional AE/PQC.   ?    Names of vaccines involved (including lot/exp): PROQU; This spontaneous report was received from Other and refers to a patient of unknown gender and age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-AUG-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, lot #W016359, expiration date: 16-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 14-AUG-2023, HBP called to report inadvertent administration of PROQUAD after a temperature excursion. Temperature excursion occured for 30 minutes in 7.9 F degree and 30 minutes in 7.3 F degree. Limited patient demographics provided. See AE case #02451226 and #02451227. No additional AE/PQC.   Lot Number W016359 is valid for V221.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: significant fatigue after she received her second dose of shingrix vaccine; This serious case was reported by a physician via sales rep and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: significant fatigue after she received her second dose of shingrix vaccine) (serious criteria other: As per reporter). The outcome of the fatigue was not reported.   The reporter considered the fatigue to be related to Shingrix.     The company considered the fatigue to be related to Shingrix.   Additional Information: GSK Receipt date: 11-AUG-2023 A physician reported that his wife (patient) had significant fatigue after she received her second dose of Shingrix vaccine.  Physician believed it was related to immunization with Shingrix. The reporter did not agree to follow up from GSK.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Accidental overdose, Extra dose administered, Medication error, No adverse event
Clinical narrative: inadvertently administered both Pentacel and Pediarix instead of the ACT-HIB and Pediarix; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of accidental overdose in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included PENTACEL (batch number UJ844AB, expiry date 02-MAR-2024) for prophylaxis.   On 07-JUL-2023, the patient received Pediarix .5 ml and PENTACEL (intramuscular, right thigh). On 07-JUL-2023, an unknown time after receiving Pediarix, the patient experienced accidental overdose (Verbatim: inadvertently administered both Pentacel and Pediarix instead of the ACT-HIB and Pediarix). The outcome of the accidental overdose 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: 10-AUG-2023 The unsolicited valid non-serious case received from a Other Health Professional.  This case involved a patient who was inadvertently administered both Pentacel and Pediarix instead of the ACT-HIB and Pediarix with no reported adverse event and patient inadvertently received an extra dose of the dtap and ipv antigens with no reported adverse event.  The patient's past medical history, medical treatment, vaccination and family history were not provided.  The patient received 0.5 mL dose of suspect diphtheria/tetanus /5 hybrid AC vaccine via intramuscular route in the right thigh and unknown dose of suspect Pediarix not produced by Sanofi Pasteur (batch number, expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination, inadvertently instead of the Acthib and Pediarix and received an extra dose of the dtap and ipv antigens with no reported adverse event (latency same day).  This suspected adverse reaction report was 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 2001183/EC and Module VI of the Good Pharmacovigilance Practices.  The classification as a medical error was 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 was to be held liable for the occurrence of this medication error,  The suspect Pentacel, dose, batch number and expiry date added and text updated accordingly. The patient received inadvertently Pentacel and Pediarix instead of the ACT-HIB and Pediarix, which led to accidental overdose.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Rash
Clinical narrative: rash; severe joint pain; This non-serious case was reported by a nurse via sales rep and described the occurrence of rash in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 9372K) and (batch number XL7RB) for prophylaxis.   On an unknown date, the patient received Shingrix. On 29-JUN-2023, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: rash) and joint pain (Verbatim: severe joint pain). The outcome of the rash and joint pain were not resolved.   The reporter considered the rash and joint pain to be related to Shingrix.     The company considered the rash and joint pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-AUG-2023 It was reported that adverse reaction of rash and severe joint pain were currently ongoing. The patient believed that the events were related to the vaccine.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Immediate post-injection reaction, Injection site pain, Pain in extremity, Swelling
Clinical narrative: worsening pain in lower extreme ties; worsening pain in lower extreme ties; elevated CRP; injection pain; swelling; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) (batch number 432T3) for prophylaxis.   On 30-JUN-2023, the patient received Shingrix. On 30-JUN-2023, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection pain) and swelling (Verbatim: swelling). On an unknown date, the patient experienced pain of lower extremities (Verbatim: worsening pain in lower extreme ties), condition aggravated (Verbatim: worsening pain in lower extreme ties) and c-reactive protein increased (Verbatim: elevated CRP). The outcome of the injection site pain, swelling, pain of lower extremities, condition aggravated and c-reactive protein increased were not resolved.   It was unknown if the reporter considered the injection site pain, swelling, pain of lower extremities, condition aggravated and c-reactive protein increased to be related to Shingrix.     It was unknown if the company considered the injection site pain, swelling, pain of lower extremities, condition aggravated and c-reactive protein increased to be related to Shingrix.   Additional Information: GSK Receipt date: 10-AUG-2023 The patient received Shingrix vaccine and onset of symptoms immediately followed with injection pain, swelling and joint.  The patient first reported these symptoms to the office on 17th July 2023 after symptoms were not improving.  At the time of reporting, symptoms persisted and worsening pain in lower extremities.  The patient also experiencing elevated C-reactive protein increased (CRP) in bloodwork. The reporter agreed to follow up from GlaxoSmithKline (GSK).
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix late second doses; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix late second doses). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 09-AUG-2023 The physician assistant would like to know that if a patient received their first Shingrix vaccine and it had been years do they just get the second one or do they start over?   Also how much time is too long in between the two shots?     If they got shingles in between do they still finish the series? The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Overdose
Clinical narrative: supposed to receive the 2nd dose of Shingrix received two doses of the same vaccine on the same visit; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number Y227N, expiry date 25-OCT-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 09-AUG-2023, the patient received the 3rd dose of Shingrix. On 09-AUG-2023, an unknown time after receiving Shingrix and SHINGRIX, the patient experienced overdose (Verbatim: supposed to receive the 2nd dose of Shingrix received two doses of the same vaccine on the same visit). The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date:09-AUG-2023 The reporter informed that earlier that day, a patient that was supposed to receive the 2nd dose of Shingrix received two doses of the same vaccine on the same visit, which led to overdose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Needle issue, Underdose
Clinical narrative: less than 0.5mL administered; Some of the product leaked onto her arm; SSome of the product leaked onto her arm; This non-serious case was reported by a physician via call center representative and described the occurrence of underdose in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced underdose (Verbatim: less than 0.5mL administered), inadvertent exposure to vaccine (Verbatim: Some of the product leaked onto her arm) and exposure via skin contact (Verbatim: SSome of the product leaked onto her arm). The outcome of the underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 10-AUG-2023 The reporter reported that the patient received less than 0.5 ml of Shingrix vaccine during administration some of the product leaked onto her arm. The reporter stated that the lot number, expiration date and full patient demographics were not provided. The reporter did not provided additional details. The patient received less than 0.5 ml of Shingrix vaccine during administration some of the product leaked onto her, which led to underdose, exposure via skin contact and inadvertent exposure to vaccine. The reporter consented to follow up.