chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, HIBV, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse events; Product storage error temperature too low; This spontaneous report was received from a licensed practical nurse and an office manager referring to a 7 months old female patient. The patient's pertinent medical history and drug reactions/ allergies were not reported. The concomitant medication and historical vaccine was reported as none.     The unit that had vaccine was making a noise. To prevent a loss of vaccine, all vaccine transformed to a unit that had intrinsic samples in it on 09-APR-2021. Due to the amount of product in the unit, the temperature got down to 35.2 Fahrenheit (F) for 480 hours and 0 minutes on one day. On 30-APR-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (the third dose, 2 ml, lot# 1707457, expiration date 23-FEB-2022, orally for prophylaxis; strength was not provided), haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# TF4EB is an invalid lot number, expiration date 26-SEP-2021, intramuscularly (IM) on left anterior thigh (LAT) for prophylaxis; strength was not reported), hib vaccine conj (tet tox) (HIBERIX) (dose, strength, route, indication, anatomical location, lot# and expiration date were not reported) and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (lot# DN4217, expiration date 30-DEC-2022, intramuscularly on right anterior thigh (RAT); dose, strength and indication were not reported were not reported) and diphtheria vaccine toxoid (+) hepatitis b vaccine rhbsag (yeast) (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (PEDIARIX) (lot# 4977T, expiration date 05-SEP-2022, intramuscularly on LAT; dose, strength and indication were not reported were not reported). There was no previous temperature excursion. A digital data logger was involved. When a new unit was available and temperature at acceptable level, vaccine was put in the new unit on 04-MAY-2021. The vaccine was not available for return due to single use. No additional adverse events reported.; Sender's Comments:  US-009507513-2105USA002859:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; M-M-R II that has experienced an ongoing temperature excursion; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions and allergies was not provided.  The reporter stated measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) experienced ongoing temperature excursion started on 13-MAY-2021 at 09:15 with highest temperature at 114. 8 Fahrenheit (F). On the same day after excursion started, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (dose, route of administration and anatomical location were not provided; lot # S039319 has been verified to be a valid lot number, expiration date was 04-DEC-2021) for prophylaxis (product storage error). The vaccine's temperature was not back in range, the temperature at time of administration was unknown. It was reported that there were no previous temperature excursions. The digital data logger was involved in recording excursion details. No additional adverse events (AEs) were reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; inadvertently administered an expired dose of MMRII to a patient on 5/26/2021 that had a labeled expiry of 5/23/2021; This spontaneous report has been received from a medical assistant referring to a 12-month-old patient of unknown gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 26-MAY-2021, the patient was inadvertently vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin (rHA)) (M-M-R II) 0.5 mL for prophylaxis (lot# S015962, expiration date was reported and validated as 23-MAY-2021; strength and route were not reported) (expired product administered). There were no temperature excursions involved. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse events have been reported since administration of PROQUAD/no additional information provided; an expired dose of PROQUAD was administered to a patient on 28MAY2021; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 28-MAY-2021, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) for prophylaxis (strength and route were not reported; lot# S035111, expiration date: 03-MAY-2021) (expired product administered). The vaccine did not experience any prior temperature excursions. The reporter did not have the information available for the sterile diluent used. No additional adverse event or information was reported since administration of the vaccine.
Age: 1.67
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional information provided. No AE/ PQC reported at this time.; improperly stored temperature excursion; This spontaneous report has been received from a physician referring to a 20 months years old patient of unknown gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On 18-MAY-2021, the patient was vaccinated with improperly stored hepatitis A vaccine, inactivated (VAQTA) (lot # T033304 has been verified to be a valid lot number for hepatitis A vaccine, inactivated (VAQTA), expiration date was reported as 02-APR-2022; dose detail and route were not reported)  for prophylaxis (incorrect product storage).    The storage temperature of the vaccine was 36 degrees Fahrenheit to 46 degrees Fahrenheit (48.2 F) for a time frame of 15 minutes and 36 degrees Fahrenheit to 46 degrees Fahrenheit (48.2 F) for a time frame of 15 minutes. Previous temperature excursions were 36 degrees Fahrenheit to 46 degrees Fahrenheit (46.2 F) for a time frame of 15 minutes. The call was because of a data logger. No adverse event or product quality complaint was reported.   This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033304; expirationdate: 02-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA000757:01937560 US-009507513-2106USA000712:01937562 US-009507513-2106USA000591:01937623 US-009507513-2106USA000663:01937631 US-009507513-2106USA000775:01937641 US-009507513-2106USA000689:01937651 US-009507513-2106USA000988:01937598
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / 2 years ago (2019) / can I still get the second dose / it has been almost 2 years. I got the first dose in October 2019; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago in October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: This case was reported by the patient himself or herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient asked if he/she had exceeded the maximum interval between doses or could he/she still get the 2nd dose and had it been effective. The patient stated he/she had already read almost everything on the internet, and as soon as possible, was too vague and asked could we you address a 2-year interval as there was very little information on specific intervals beyond 6 months. The patient asked about adverse event and do he/she had to start over, or would the 2nd dose still be effective 2 years after the 1st dose. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Off label use, Rash
Clinical narrative: I had the shingles shot about 2-3 days after the shingles rash broke out; This case was reported by a consumer via  interactive digital media and described the occurrence of off label use in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (shingles rash broke out).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were provided as follows: The case was reported by the patient for herself/himself The age at vaccination was not reported. The patient received Shingles vaccine about 2 to 3 days after the shingles rash broke out, which led to off label use. The patient reported that without vaccine shingles can reappear again, usually in some other nerve group. No other information was reported.
Sex: M
Vaccine: UNK
Symptoms: Drug interaction
Clinical narrative: is taking Ilumya /received the flu shot, which is an inactive vaccine; This case was reported by a consumer via other manufacturer and described the occurrence of drug interaction in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included TILDRAKIZUMAB (ILUMYA) for immunosuppression.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and ILUMYA. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced drug interaction. On an unknown date, the outcome of the drug interaction was unknown.   It was unknown if the reporter considered the drug interaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The Patient was taking Ilumya and the patient had been asking reading the use of immunosuppressive can engage the effect of the Covid 19 vaccine as patient had took the Johnson and Johnson vaccine and enquired about the studies on the efficacy of the vaccine in Ilumya treated patients. The patient had concerned about "inactive vaccines" as he had received the flu shot, which was an inactive vaccine. It was unknown if the reporter considered the drug interaction to be related to ILUMYA. No other information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot and still got shingles/Suspect vaccination failure; I had the shot and still got shingles!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the Shingles shot and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Seizure, Vomiting
Clinical narrative: SEIZURE; VOMITING; DIAPHORESIS; TIRED; This spontaneous report received from a consumer concerned a 24 year old white, Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient no known drug allergies and no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 31-OCT-2021) dose was not reported, one total administered in Left arm on 03-JUN-2021 at 13.25 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021 (within 5 mins of the post-vaccination, 13.30), consumer reported that patient received the Janssen COVID-19 vaccine and began to seizure, of the post-vaccination and 20 mins later (13.45), patient vomited. Diaphoretic. EMS was called to assist the patient. Patient refused to go to ER (emergency room), but was given an ice pack. Patient was now fine, and was picked up to go home. Currently patient felt tired.  The patient recovered from seizure, vomiting, and diaphoresis on 03-JUN-2021, and was recovering from tired. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210607415-covid-19 vaccine ad26.cov2.s -seizure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: ADMINISTERING A VACCINE AFTER 6 HOUR PUNCTURED REFRIGERATED WINDOW; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 06-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUN-2021, the subject experienced administering a vaccine after 6 hour punctured refrigerated window. On 06-JUN-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administering a vaccine after 6 hour punctured refrigerated window and poor quality vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypotension, Syncope, Tachycardia
Clinical narrative: COLLAPSED; TACHYCARDIC; HYPOTENSIVE; DIAPHORETIC; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-MAR-2021, 6 minutes after vaccination, patient became tachycardic, hypotensive, diaphoretic and collapsed. Patient attended signature emergency room for clinical review and was later discharged that day. Patient stated, due to unexpected visit to emergency room, was unable to work and missed clinical shift due to illness.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tachycardic, hypotensive, diaphoretic and collapsed was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0. 20210612583-Covid-19 vaccine ad26.cov2.s -collapsed. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Dizziness, Headache, Ultrasound scan
Clinical narrative: BRUISING ON BACK OF LEFT KNEE; SEVERE PAIN ON LEFT LEG BEHIND KNEE; HEADACHE; DIZZINESS; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not had drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced dizziness. On 13-APR-2021, the subject experienced headache. On 26-APR-2021, the subject experienced bruising on back of left knee. On 26-APR-2021, the subject experienced severe pain on left leg behind knee. On 10-MAY-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and headache on 20-APR-2021, and had not recovered from severe pain on left leg behind knee, and bruising on back of left knee. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: HAD SEIZURE IMMEDIATELY  AFTER SHOT; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight, past medical history or concurrent conditions were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, with frequency1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had seizure immediately after shot and reporter thought that patient was going to die. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient had seizure immediately after shot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210614044-COVID-19 VACCINE AD26.COV2.S-had seizure immediately after shot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Diarrhoea, Headache, Hypoaesthesia
Clinical narrative: VOMITING; DIARRHEA; NUMBNESS FEELING IN BODY AND LEGS; ACHEY; RASH; CHILLS; FEVER FLUCTUATING UP AND DOWN; HEADACHE; A BRUISE; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included smoker, and concurrent conditions included alcoholic, and other pre-existing medical conditions included the patient did not have any history of drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAY-2021, the subject experienced a bruise. On 04-JUN-2021, the subject experienced vomiting. On 04-JUN-2021, the subject experienced diarrhea. On 04-JUN-2021, the subject experienced numbness feeling in body and legs. On 04-JUN-2021, the subject experienced achey. On 04-JUN-2021, the subject experienced rash. On 04-JUN-2021, the subject experienced chills. On 04-JUN-2021, the subject experienced fever fluctuating up and down. On 04-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a bruise, was recovering from rash, and numbness feeling in body and legs, had not recovered from fever fluctuating up and down, vomiting, chills, and headache, and the outcome of diarrhea and achey was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash, Vomiting
Clinical narrative: VOMITING; DIARRHEA; NUMBNESS FEELING IN BODY AND LEGS; ACHEY; RASH; CHILLS; FEVER FLUCTUATING UP AND DOWN; HEADACHE; A BRUISE; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included smoker, and concurrent conditions included alcoholic, and other pre-existing medical conditions included the patient did not have any history of drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAY-2021, the subject experienced a bruise. On 04-JUN-2021, the subject experienced vomiting. On 04-JUN-2021, the subject experienced diarrhea. On 04-JUN-2021, the subject experienced numbness feeling in body and legs. On 04-JUN-2021, the subject experienced achey. On 04-JUN-2021, the subject experienced rash. On 04-JUN-2021, the subject experienced chills. On 04-JUN-2021, the subject experienced fever fluctuating up and down. On 04-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a bruise, was recovering from rash, and numbness feeling in body and legs, had not recovered from fever fluctuating up and down, vomiting, chills, and headache, and the outcome of diarrhea and achey was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Headache, Nausea, Pyrexia
Clinical narrative: HEADACHE; NAUSEA; FEVER; STOMACH CRAMPS; VOMITING; REALLY BAD SHAKES; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's past medical history included laparoscopic surgery, and concurrent conditions included endometriosis, and factor v leiden carrier, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: 01-JUL-2021) dose was not reported, administered on 22-MAY-2021 10:30 to the left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced stomach cramps. On 22-MAY-2021, the subject experienced vomiting. On 22-MAY-2021, the subject experienced really bad shakes. On 22-MAY-2021, the subject experienced nausea. On 22-MAY-2021, the subject experienced fever. On 23-MAY-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 22-MAY-2021, and fever on 23-MAY-2021, was recovering from nausea, and stomach cramps, had not recovered from headache, and the outcome of really bad shakes was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: HEADACHE; NAUSEA; FEVER; STOMACH CRAMPS; VOMITING; REALLY BAD SHAKES; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's past medical history included laparoscopic surgery, and concurrent conditions included endometriosis, and factor v leiden carrier, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: 01-JUL-2021) dose was not reported, administered on 22-MAY-2021 10:30 to the left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced stomach cramps. On 22-MAY-2021, the subject experienced vomiting. On 22-MAY-2021, the subject experienced really bad shakes. On 22-MAY-2021, the subject experienced nausea. On 22-MAY-2021, the subject experienced fever. On 23-MAY-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 22-MAY-2021, and fever on 23-MAY-2021, was recovering from nausea, and stomach cramps, had not recovered from headache, and the outcome of really bad shakes was not reported. This report was non-serious.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: a patient was administered an expired dose of ACT-HIB vaccine/ No AE; a two years old patient was administered a second dose of ACT-HIB vaccine/ No AE; Initial information received on 21-May-2021 regarding an unsolicited valid non-serious case received from nurse via phone via Medical Information (Reference number- 00611667).  This case involves a two years old female patient who was administered an expired 0.5 ml second dose of suspect vaccine HIB (PRP/T) VACCINE [ACT-HIB] Frequency: Once, Strength: Standard [lot UJ207AA, expiry date 30-Apr-2021] via intramuscular route in the right thigh on 21-May-2021 for prophylactic vaccination (expired product administered and inappropriate schedule of product administration).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [PEDIARIX], PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)) [PCV13] and INFLUENZA VACCINE [FLU] vaccine for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used and drug dose administration interval too long (latency: same day).  Potential Product Technique Complain: No, Caller stated that she gave and expired ACT-HIB vaccine to patient. Caller would like to know what to do at this point. Confirmed nurse question about an expired dose of ACTHIB that was given. Nurse explained what happened and provider told her to repeat the ACT-HIB dose. Patient was in late with her vaccines. No further information was provided.   At the time of reporting, no adverse event was reported.  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 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Moderna COVID-19 Vaccine EUA  -   First,  arms swelled up at the my wrists/forearm. Second,  feet swelled up that I had to elevate them and couldn't walk.  Third, feeling  sharp jolts of pain in my feet toward my toes
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hot flush, Menopausal symptoms, Oligomenorrhoea
Clinical narrative: End of menopause hot flashes days after dose and return on menstrual cycle after 8 months, cycle to date has been 25 days in length and heavy
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood culture, CSF cell count, Mechanical ventilation, Seizure
Clinical narrative: Seizure treated with anti-seizure medications, antibiotics, and mechanical ventilation for airway support
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, Headache, Magnetic resonance imaging head abnormal, Posterior reversible encephalopathy syndrome, Postictal state
Clinical narrative: Seizure treated with anti-seizure medications, antibiotics, and mechanical ventilation for airway support
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product prescribing issue, Seizure, Treatment noncompliance
Clinical narrative: Seizure treated with anti-seizure medications, antibiotics, and mechanical ventilation for airway support
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary normal, Anti-islet cell antibody negative, Beta haemolytic streptococcal infection, Blood creatinine increased, Blood culture positive
Clinical narrative: Pt rec'd 2 doses Pfizer/BioNTech, 2nd dose May 9,2021 at outside facility. Presented to hospital on 06/08/21 after cardiac arrest, sudden collapse at home, refractory PEA with ongoing CPR >4hrs, cardiogenic shock (EF20%), refractory DIC, MOSF and coma. Uncertain antecedent history, pt had tolerated vaccine well w/o untoward reactions, was possibly "sick" in the 2 days prior to admission 06/08, but limited history available. SARS2 PCR and resp path PCR panels negative, no clear bacterial source of shock/collapse initially identified, thus concern for primary myocarditis resulting in refractory shock (perhaps also with ischemic CVA); Tpn not c/w type I ACS/MI. Workup negative for PE, hemorrhagic stroke, PTX/tamponade, etc. 6hrs after death (in evening 06/08/21) BCx x2 resulted Grp A strep, thus pt may have had TSS at home then collapsed in PEA, however source of TSS is uncertain.  Notably patient usually healthy, active, no medications, favorable lipid panel, no illicits; + EtOH binge-drinking last several months but no cirrhosis/ESLD previously doubt primarily Etoh-related process.  Pt had ongoing PEA arrests with brief ROSC for approx 7 hrs in field -> ED > ICU until death declared.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood gases, Blood glucose normal, Blood lactic acid, Blood phosphorus increased, Blood potassium increased
Clinical narrative: Pt rec'd 2 doses Pfizer/BioNTech, 2nd dose May 9,2021 at outside facility. Presented to hospital on 06/08/21 after cardiac arrest, sudden collapse at home, refractory PEA with ongoing CPR >4hrs, cardiogenic shock (EF20%), refractory DIC, MOSF and coma. Uncertain antecedent history, pt had tolerated vaccine well w/o untoward reactions, was possibly "sick" in the 2 days prior to admission 06/08, but limited history available. SARS2 PCR and resp path PCR panels negative, no clear bacterial source of shock/collapse initially identified, thus concern for primary myocarditis resulting in refractory shock (perhaps also with ischemic CVA); Tpn not c/w type I ACS/MI. Workup negative for PE, hemorrhagic stroke, PTX/tamponade, etc. 6hrs after death (in evening 06/08/21) BCx x2 resulted Grp A strep, thus pt may have had TSS at home then collapsed in PEA, however source of TSS is uncertain.  Notably patient usually healthy, active, no medications, favorable lipid panel, no illicits; + EtOH binge-drinking last several months but no cirrhosis/ESLD previously doubt primarily Etoh-related process.  Pt had ongoing PEA arrests with brief ROSC for approx 7 hrs in field -> ED > ICU until death declared.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium decreased, Blood urea increased, Brain natriuretic peptide increased, Calcium ionised decreased, Cardiac arrest
Clinical narrative: Pt rec'd 2 doses Pfizer/BioNTech, 2nd dose May 9,2021 at outside facility. Presented to hospital on 06/08/21 after cardiac arrest, sudden collapse at home, refractory PEA with ongoing CPR >4hrs, cardiogenic shock (EF20%), refractory DIC, MOSF and coma. Uncertain antecedent history, pt had tolerated vaccine well w/o untoward reactions, was possibly "sick" in the 2 days prior to admission 06/08, but limited history available. SARS2 PCR and resp path PCR panels negative, no clear bacterial source of shock/collapse initially identified, thus concern for primary myocarditis resulting in refractory shock (perhaps also with ischemic CVA); Tpn not c/w type I ACS/MI. Workup negative for PE, hemorrhagic stroke, PTX/tamponade, etc. 6hrs after death (in evening 06/08/21) BCx x2 resulted Grp A strep, thus pt may have had TSS at home then collapsed in PEA, however source of TSS is uncertain.  Notably patient usually healthy, active, no medications, favorable lipid panel, no illicits; + EtOH binge-drinking last several months but no cirrhosis/ESLD previously doubt primarily Etoh-related process.  Pt had ongoing PEA arrests with brief ROSC for approx 7 hrs in field -> ED > ICU until death declared.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiogenic shock, Coma, Computerised tomogram head abnormal, Computerised tomogram normal, Death
Clinical narrative: Pt rec'd 2 doses Pfizer/BioNTech, 2nd dose May 9,2021 at outside facility. Presented to hospital on 06/08/21 after cardiac arrest, sudden collapse at home, refractory PEA with ongoing CPR >4hrs, cardiogenic shock (EF20%), refractory DIC, MOSF and coma. Uncertain antecedent history, pt had tolerated vaccine well w/o untoward reactions, was possibly "sick" in the 2 days prior to admission 06/08, but limited history available. SARS2 PCR and resp path PCR panels negative, no clear bacterial source of shock/collapse initially identified, thus concern for primary myocarditis resulting in refractory shock (perhaps also with ischemic CVA); Tpn not c/w type I ACS/MI. Workup negative for PE, hemorrhagic stroke, PTX/tamponade, etc. 6hrs after death (in evening 06/08/21) BCx x2 resulted Grp A strep, thus pt may have had TSS at home then collapsed in PEA, however source of TSS is uncertain.  Notably patient usually healthy, active, no medications, favorable lipid panel, no illicits; + EtOH binge-drinking last several months but no cirrhosis/ESLD previously doubt primarily Etoh-related process.  Pt had ongoing PEA arrests with brief ROSC for approx 7 hrs in field -> ED > ICU until death declared.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Disseminated intravascular coagulation, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram ST segment elevation, Haematocrit decreased
Clinical narrative: Pt rec'd 2 doses Pfizer/BioNTech, 2nd dose May 9,2021 at outside facility. Presented to hospital on 06/08/21 after cardiac arrest, sudden collapse at home, refractory PEA with ongoing CPR >4hrs, cardiogenic shock (EF20%), refractory DIC, MOSF and coma. Uncertain antecedent history, pt had tolerated vaccine well w/o untoward reactions, was possibly "sick" in the 2 days prior to admission 06/08, but limited history available. SARS2 PCR and resp path PCR panels negative, no clear bacterial source of shock/collapse initially identified, thus concern for primary myocarditis resulting in refractory shock (perhaps also with ischemic CVA); Tpn not c/w type I ACS/MI. Workup negative for PE, hemorrhagic stroke, PTX/tamponade, etc. 6hrs after death (in evening 06/08/21) BCx x2 resulted Grp A strep, thus pt may have had TSS at home then collapsed in PEA, however source of TSS is uncertain.  Notably patient usually healthy, active, no medications, favorable lipid panel, no illicits; + EtOH binge-drinking last several months but no cirrhosis/ESLD previously doubt primarily Etoh-related process.  Pt had ongoing PEA arrests with brief ROSC for approx 7 hrs in field -> ED > ICU until death declared.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Intensive care, Multiple organ dysfunction syndrome, Platelet count decreased, Pulseless electrical activity, Respiratory viral panel
Clinical narrative: Pt rec'd 2 doses Pfizer/BioNTech, 2nd dose May 9,2021 at outside facility. Presented to hospital on 06/08/21 after cardiac arrest, sudden collapse at home, refractory PEA with ongoing CPR >4hrs, cardiogenic shock (EF20%), refractory DIC, MOSF and coma. Uncertain antecedent history, pt had tolerated vaccine well w/o untoward reactions, was possibly "sick" in the 2 days prior to admission 06/08, but limited history available. SARS2 PCR and resp path PCR panels negative, no clear bacterial source of shock/collapse initially identified, thus concern for primary myocarditis resulting in refractory shock (perhaps also with ischemic CVA); Tpn not c/w type I ACS/MI. Workup negative for PE, hemorrhagic stroke, PTX/tamponade, etc. 6hrs after death (in evening 06/08/21) BCx x2 resulted Grp A strep, thus pt may have had TSS at home then collapsed in PEA, however source of TSS is uncertain.  Notably patient usually healthy, active, no medications, favorable lipid panel, no illicits; + EtOH binge-drinking last several months but no cirrhosis/ESLD previously doubt primarily Etoh-related process.  Pt had ongoing PEA arrests with brief ROSC for approx 7 hrs in field -> ED > ICU until death declared.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Resuscitation, SARS-CoV-2 test negative, Syncope, Toxic shock syndrome, Troponin increased
Clinical narrative: Pt rec'd 2 doses Pfizer/BioNTech, 2nd dose May 9,2021 at outside facility. Presented to hospital on 06/08/21 after cardiac arrest, sudden collapse at home, refractory PEA with ongoing CPR >4hrs, cardiogenic shock (EF20%), refractory DIC, MOSF and coma. Uncertain antecedent history, pt had tolerated vaccine well w/o untoward reactions, was possibly "sick" in the 2 days prior to admission 06/08, but limited history available. SARS2 PCR and resp path PCR panels negative, no clear bacterial source of shock/collapse initially identified, thus concern for primary myocarditis resulting in refractory shock (perhaps also with ischemic CVA); Tpn not c/w type I ACS/MI. Workup negative for PE, hemorrhagic stroke, PTX/tamponade, etc. 6hrs after death (in evening 06/08/21) BCx x2 resulted Grp A strep, thus pt may have had TSS at home then collapsed in PEA, however source of TSS is uncertain.  Notably patient usually healthy, active, no medications, favorable lipid panel, no illicits; + EtOH binge-drinking last several months but no cirrhosis/ESLD previously doubt primarily Etoh-related process.  Pt had ongoing PEA arrests with brief ROSC for approx 7 hrs in field -> ED > ICU until death declared.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Venous oxygen saturation, Ventricular hypokinesia, White blood cell count normal
Clinical narrative: Pt rec'd 2 doses Pfizer/BioNTech, 2nd dose May 9,2021 at outside facility. Presented to hospital on 06/08/21 after cardiac arrest, sudden collapse at home, refractory PEA with ongoing CPR >4hrs, cardiogenic shock (EF20%), refractory DIC, MOSF and coma. Uncertain antecedent history, pt had tolerated vaccine well w/o untoward reactions, was possibly "sick" in the 2 days prior to admission 06/08, but limited history available. SARS2 PCR and resp path PCR panels negative, no clear bacterial source of shock/collapse initially identified, thus concern for primary myocarditis resulting in refractory shock (perhaps also with ischemic CVA); Tpn not c/w type I ACS/MI. Workup negative for PE, hemorrhagic stroke, PTX/tamponade, etc. 6hrs after death (in evening 06/08/21) BCx x2 resulted Grp A strep, thus pt may have had TSS at home then collapsed in PEA, however source of TSS is uncertain.  Notably patient usually healthy, active, no medications, favorable lipid panel, no illicits; + EtOH binge-drinking last several months but no cirrhosis/ESLD previously doubt primarily Etoh-related process.  Pt had ongoing PEA arrests with brief ROSC for approx 7 hrs in field -> ED > ICU until death declared.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Pre-existing condition improved
Clinical narrative: It is not an adverse effect, but an effect that both my husband and I experienced days after vaccination.  My "positive" effect happened after my first dose; his happened after his second dose.  I have a bone spur under my rotator cuff which has for many years been wearing out my rotator cuff.  For about a year I have had significant pain and wanted to get vaccinated so I could start treating for this pain.  After the first dose, my pain has gone away.  I still have limited range of motion, but my pain went from a 9 to a 1.  My husband had an acute onset of shoulder pain about 3 months before his second dose.  After his second dose, his pain (which was more scapular pain) disappeared.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Patient became lightheaded, with a head ache and patient stated he was about to faint.  Patient received fluids.  Patient states that symptoms no longer present.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Flushing, Hyperhidrosis, Nausea
Clinical narrative: Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Neck pain, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fever-Medium, Systemic: neck pain-Medium
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Muscle tightness, Muscle twitching, Poor quality sleep
Clinical narrative: Twitching in both legs, (calves, thighs, quads) beginning approx 3 weeks after second done.  Seems to be worsening /progressing.  The twitching is now preventing restful sleep.  Present all the time now.  Causing anxiety.   Leading to tense muscles and fatigue.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: we elevated his legs and he sat down and rested. wiped his face with a cold paper towel. he was fine. he also drank some juice before he left.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Patient reports feeling light headed with headache. denied shortness of breath, dyspnea, hives or itchiness. Patient educated to lay flat with feet up. Also encouraged to drink water to stay hydrated. after few minutes symptoms subsided.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Flushing, Hyperhidrosis, Lethargy
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Severe, Additional Details: Patient started to feel dizzy and lightheaded and sweaty within 1 minute after getting the vaccine.   We informed the clinic nurse who took over care. Patient drank some cold water and after about 15 minutes, patient started to feel better.  Patient is going home with her mom.   Patient is feeling much better now
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Epistaxis, Eye irritation, Ocular hyperaemia, Rhinorrhoea
Clinical narrative: 3:10pm Pt. developed a reaction to 2nd dose of COVID-19 EW0164.  Pt. verbalize feels burning sensation in eyes, throat and nose.  I've observed red eyes and runny nose.  Pt. refused to get hospital care.  She wants to call her doctor later to notify about the reaction.  Pt. left still feeling symptoms.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: 3:10pm Pt. developed a reaction to 2nd dose of COVID-19 EW0164.  Pt. verbalize feels burning sensation in eyes, throat and nose.  I've observed red eyes and runny nose.  Pt. refused to get hospital care.  She wants to call her doctor later to notify about the reaction.  Pt. left still feeling symptoms.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Vomiting
Clinical narrative: Systemic: vomited x 2-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Vomiting-Mild
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: pt would like a follow up call
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High