chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: temperature excursion for IPOL as fridge door opened for long, temperature reached: 46.6f for a duration of 2 minutes, with no reported adverse event; administration of IPOL after temperature excursion with no reported adverse event; Initial information received on 31-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA235694, 2023SA235058, 2023SA236046, 2023SA235023, 2023SA234814 and 2023SA235246.  This case involves 13 years old female patient and reporter reported temperature excursion for IPV (VERO) [IPOL] as fridge door opened for long, temperature reached: 46.6f for a duration of 2 minutes, with no reported adverse event and administration of IPOL after temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine (Varicella vaccine) for Prophylactic vaccination; HPV vaccine for Prophylactic vaccination; and hepatitis A vaccine (Hepatitis A) for Prophylactic vaccination.  On 11-Jul-2023, the patient received a Standard dose 5 of suspect IPV (VERO) Suspension for injection at a dose of 0.5mL total (lot W1A191M, expiry date- 16-FEB-2025) via subcutaneous route in the left arm for Immunization.  Caller reported temperature excursion for opened IPOL as fridge door opened for long, temperature reached: 46.6f for a duration of 2 minutes, with no reported adverse event (product storage error) (unknown latency) and administration of IPOL on 11-Jul-2023 after temperature excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, there were no previous excursions. Human error was involved. Caller is asking if they need to re-vaccinate the patient given the opened IPOL after temperature excursion.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Fridge door opened for long Max/Low temperature reached: 46.6F Duration of 2 minutes with no reported adverse event; ipol given after the temperature excursion with no reported adverse event; Initial information received on 31-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA235015, 2023SA235023, 2023SA235694, 2023SA235058, 2023SA236046 and 2023SA234814.  This case involves a 17 years old male patient to whom Ipol was given after the temperature excursion with no reported adverse event and the fridge door opened for long max/low temperature reached: 46.6f duration of 2 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine for Prophylactic vaccination; HPV vaccine for Prophylactic vaccination; Hepatitis A Vaccine (Hepatitis A) for Prophylactic vaccination; Meningococcal Vaccine B RFHBP/NADA/NHBA OMV (Bexsero) for Immunisation; and meningococcal vaccine A/C/Y/W CONJ (CRM197) (Menveo) for Immunisation.  On 12-Jul-2023, the patient received 0.5 ml (dose 3) of suspect IPV (VERO), Suspension for injection lot W1A191M, expiry date:16-Feb-2025 via subcutaneous route in the left arm for immunization (strength: unknown), was given after the temperature excursion with no reported adverse event (poor quality product administered) (latency same day).  On an unknown date the fridge door opened for long max/low temperature reached: 46.6f duration of 2 minutes with no reported adverse event (product storage error) (unknown latency).  This situation is due to human error.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events poor quality product administered and product storage error.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: patient received two doses of MenQuadfi about 5 weeks apart with no reported adverse event; Initial information was received  on 31-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 18 years old male patient who received two doses of meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] about 5 weeks apart with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Jun-2023, the patient received a dose 1 of suspect meningococcal a-c-y-w135 (t conj) vaccine (Solution for injection) (expiry date, lot number not reported) via unknown route in unknown administration site and On 28-Jul-2023 he also received a dose 2 of 0.5 ml of the same vaccine lot U7594AD (strength, expiry date unknown) via unknown route in the left arm for Immunization.  On 28-Jul-2023 the patient developed a non-serious event of patient received two doses of menquadfi about 5 weeks apart with no reported adverse event (inappropriate schedule of product administration) ( latency : same day) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  It was reported that "A medical assistant (MA) made error and administered MenQuadfi instead of the intended Gardasil. The result is that a patient received two doses of MenQuadfi about 5 weeks apart. The first and intended MenQuadfi dose was administered on 14Jun2023. The second and erroneous MenQuadfi dose was administered on 28Jul2023 in the left arm. The MA documented that the 28Jul2023 dose was administered subcutaneously (SC). The caller stated that she is not sure if the dose was actually given SC because the MA often makes a documentation error of SC when she means to document IM. The MA is not available today for the caller to check with her about the possible SC administration. No other vaccines were administered to the patient on 28Jul2023. The ordering provider is at the same address and phone as the caller. The lot and expiry in the template below are for the erroneous dose on 28Jul2023. "  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  At time of reporting, the outcome was Unknown for the event patient received two doses of menquadfi about 5 weeks apart with no reported adverse 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Open ipol stored total time out of range is 15 minutes with a maximum temperature of 47.34F reported with no reported adverse event; 3 patients received a dose from the open vial after a routine clinic activity caused a temperature excursion reported with no reported adverse event; Initial information received on 01-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and reporter reported temperature excursion for Poliomyelitis Vaccine (Inactivated) IPV (VERO) (IPOL)/open vaccine stored total time out of range is 15 minutes with a maximum temperature of 47.34f reported and 3 patients received a dose from the open vial after a routine clinic activity caused a temperature excursion reported 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 an unknown dose of suspect Poliomyelitis Vaccine (Inactivated) Suspension for injection (with an unknown expiry date, strength and lot number) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On 24-Jun-2023, the reporter reported temperature excursion for Poliomyelitis Vaccine (Inactivated) IPV (VERO) (IPOL)/open vaccine stored total time out of range is 15 minutes with a maximum temperature of 47.34f reported and 3 patients received a dose from the open vial after a routine clinic activity caused a temperature excursion reported with no reported adverse event. (product storage error) (unknown latency) (poor quality product administered) (latency: same day).  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received doses of menactra in 2017, 11NOV2020, extra dose vaccine menquadfi on 31JUL2023 with no reported AE; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old female patient who received doses of menactra in 2017, 11NOV2020, extra dose vaccine menquadfi on 31JUL2023 with no reported adverse event.  The patient's past vaccination(s) included menactra in 2017 and on 11-Nov-2020. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included meningococcal vaccine B RFHBP/NADA/NHBA OMV (Bexsero) for Immunisation.  On 31-Jul-2023, the patient received a dose 3  of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection lot U7675DC, expiry date:30-Sep-2025  via intramuscular route in the left deltoid for prophylactic vaccination (strength, dose: unknown), received doses of menactra in 2017, 11NOV2020, extra dose vaccine menquadfi on 31JUL2023 with no reported adverse event (extra dose administered) (latency same day).  Action taken: not applicable.  Reportedly, patient had previously received doses of MENACTRA in 2017 and on 11NOV2020. The patient received a third dose of MENQUADFI on 31JUL2023. The dose of MENQUADFI was administered 2 years and 8 months after the last dose of MENACTRA  At time of reporting, the outcome was Unknown for the event extra dose administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, UNK
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: patient received both PENTACEL and Pediarix on same day with no reported adverse event; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 months old female patient who received both Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] and Pediarix [Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid] on same day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine And Pneumococcal Vaccine Conj 13v (Crm197) (Prevnar 13) for Prophylactic vaccination.  On 01-Aug-2023, the patient received a unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine suspension for injection; Pediarix not produced by Sanofi Pasteur (strength, expiry date and lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination (immunization) and received both pentacel and pediarix on same day with no reported adverse event (extra dose administered) (latency: same day).  Information on the batch number was requested.  Reportedly: The nurse reports that the patient has not required any treatment for the event; reports that the patient has not required any ER/Dr. visits.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: F
Vaccine: RAB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: IMOVAX was administered to a patient/vaccine was out of its expiration date for 1 day, with no reported adverse event; Initial information was received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 60 years old female patient was received rabies (hdc) vaccine [Imovax rabies] and the vaccine was out of its expiration date for 1 day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 21-Jul-2023, the patient received a dose of suspect rabies (hdc) vaccine Powder and solvent for suspension for injection (strength: standard) at dose of 1 ml total once (lot number: U1D222M) vaccine was out of its expiration date for 1 day (expiration date: 20-Jul-2023) via unknown route in the right upper arm for Immunization (immunisation)  with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event imovax was administered to a patient/vaccine was out of its expiration date for 1 day, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the  authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received expired adacel with no reported adverse event; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 16 years old female patient who received expired diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine b rfhbp/nada/nhba omv (Bexsero) for Prophylactic vaccination.  On 01-Aug-2023, the patient received 0.5 ml (TOTAL) dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (lot U7117AA, expiration date- 15-Jul-2023) via unknown route in the left upper arm (strength: not provided) for Immunization and patient received expired adacel with no reported adverse event (expired product administered) (latency- same day).  Action taken- 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient inadvertently received an expired dose of acthib with no reported adverse event; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male patient who had inadvertently received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) for prophylactic vaccination (Immunization).   On 31-Jul-2023, the patient received 0.5 ml dose of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection)(Lot number- HIB: UJ679AA, DILUENT: U7261AA and expiry date: HIB: 28-May-2023, DILUENT: 07-Apr-2023) (Frequency: Once) (Strength: standard) via intramuscular route in the left thigh for Immunization.  On 31-Jul-2023, the patient had inadvertently received an expired dose of ACTHIB with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the regulatory agency. 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.
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient was administered tenivac 28Jun2023 but it expired the 24Jun2023 with no reported adverse event; Initial information received on 02-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Adult male patient who was administered tenivac 28jun2023, but it expired the 24jun2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Jun-2023, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection lot U7092AA, expiry date: 24-Jun-2023 via intramuscular route in the left deltoid for immunization (strength: unknown), but it expired the 24jun2023 with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Pateint received vaccine after BUD
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Pateint received vaccine after BUD
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Device occlusion, Disseminated intravascular coagulation, Right ventricular failure
Clinical narrative: Right ventricular heart failure, right ventricular outflow obstruction, pulmonary blood clot, disseminated intravascular coagulation, DEATH
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Adrenal disorder, Barium swallow, Blood test, Computerised tomogram, Gastric emptying study
Clinical narrative: Gastro paresis Adrenal failure
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired gastric emptying, Scan with contrast
Clinical narrative: Gastro paresis Adrenal failure
Age: 22.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness
Clinical narrative: Patient received their first dose of COVID-19 Pfizer Bivalent vaccine 08/01/23. After vaccination, the patient felt dizzy and sat down. Patient was alert and oriented x4 and did not fall or injure the head. 12:17: Initial BP 90/72 (12:17PM), 12:20PM BP 111/77, BG: 118 with physician on scene. The patient was given water and was able to ambulate. The patient was safely discharged and instructed to follow up with PCP in 48 hrs.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Lip swelling
Clinical narrative: Swollen upper lip present 1 day.
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: PATIENT CAME IN TO GET SECOND SHINGLES VACCINE, VACCINE WAS GIVEN. UPON ENTERING VACCINE IN REGISTRY IT WAS DISCOVERED PATIENT HAD ALREADY RECEIVED 2 DOSES.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: Patient displayed symptoms to syncope after receiving the vaccine. Patient regained consciousness within 10 seconds after passing out. Patient's mother and I monitored patient for about 35 minutes after regaining consciousness.
Age: 18.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Syncope
Clinical narrative: Fainted a couple minutes after receiving vaccines.
Age: 0.83
Sex: F
Vaccine: COVID19-2
Symptoms: Cafe au lait spots, Injection site discolouration
Clinical narrative: Patient developed discoloration- similar to cafe au lait spot over the injection site.  1x2cm. Mom estimates this occurs 2-4 weeks after. Not painful. Has not changed in 3 months since it developed. No other rashes or cafe au lait spots on body.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: The pharmacist administered the right vaccine but the vaccine was past expiration date (expiration date: 07/15/2023)
Age: 12.0
Sex: F
Vaccine: PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 year old given vaccine for children under 59 months.  This patient does not have underlying medical issues which would warrant administering the vaccine.
Age: 66.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient did not have any adverse events or effects from taking the shot.  The shot was expired-patient was contacted and they had no symptoms . They did not wish to come for a follow up shot as they were originally taking it for travel, but decided not to go.
Sex: U
Vaccine: HEPA, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report inadvertent administration of expired VAQTA and MMR-II to a patient. VAQTA expired on 07/13/2023 and MMR-II expired on 07/15/2023 and were both administered on 07/21/2023. No additional AE/PQC.; This spontaneous report was received from a medical assistant referring to a 14-month-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.     On 21-JUL-2023, the patient was vaccinated with an expired doses of hepatitis a vaccine, inactivated(VAQTA) expiration date reported as 13-JUL-2023 (dose, route of administration and lot number not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with an expiration date reported as 15-JUL-2023 (dose, route of administration and lot number not reported) both for prophylaxis (expired product administered). No adverse event was reported.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; HBP called to report administering PROQUAD to a patient after a temperature excursion.; This spontaneous report was received from ''HPB'' and refers to a 5-year-old patient of unknown gender. The patient's medical, concurrent conditions, and concomitant therapies were not reported.  On 27-JUL-2023, the patient was vaccinated with an improperly storage measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, valid lot #X007086, expiration date: 04-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). Temperature excursion occurred at 5.7F, for 8 hours. Previous temperature excursions were not reported.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Generalised tonic-clonic seizure, Syncope
Clinical narrative: syncopal episode; tonic/clonic seizure; This spontaneous report was received from a Clinical Medical Assistant, concerning a 12-year-old male patient.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 12-APR-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1st dose, administered for prophylaxis. Lot # reported as s021345, was determined to be not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as confirmed by lot verification team.  (dose, expiry date, route of administration, and anatomical location were not provided). It was reported that he also received other two unspecified vaccines (not manufactured by the company)   On the same date after vaccination, the patient experienced syncopal episode (syncope) and tonic/clonic seizure (generalised tonic-clonic seizure). Ambulance was called and patient was taken to emergency department and later discharged. On an unknown date in 2023, the patient recovered from these events. The patient had been seen in clinic after the episode and had no lasting effects.  The causal relationship between the events of syncope, generalised tonic-clonic seizure, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), and the other unspecified vaccines was unknown.   Upon internal review, the events the events of syncope and generalised tonic-clonic seizure were determined to be medically significant.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood calcium, Blood magnesium, Blood potassium, Dyskinesia, Full blood count
Clinical narrative: Mother described the patient making "jerking" motions with all of her limbs followed by tensing up of her whole  body for about 15 seconds. Afterward she soon began acting normal. About 1 hour later "her whole body stiffened up" again. Parents brough the patient to the ER. Labs were done as described below. Vital signs were WNL. Patient was observed in the ER for 2.5 hours and was acting normal for the duration of this observation period. Patient was discharged home with parents with instruction to follow up if symptoms return.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Metabolic function test, Musculoskeletal stiffness, White blood cell count
Clinical narrative: Mother described the patient making "jerking" motions with all of her limbs followed by tensing up of her whole  body for about 15 seconds. Afterward she soon began acting normal. About 1 hour later "her whole body stiffened up" again. Parents brough the patient to the ER. Labs were done as described below. Vital signs were WNL. Patient was observed in the ER for 2.5 hours and was acting normal for the duration of this observation period. Patient was discharged home with parents with instruction to follow up if symptoms return.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dyspnoea, Pain, Pyrexia
Clinical narrative: whole body aches, difficulty taking a deep breath, fever, blood pressure dropped to 98/68. onset "middle of the night" after receiving vaccine at 5pm
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: There was no adverse event.  The patient was given the first dose of another series of Shingrix even though the patient had already completed the 2 dose series in November 2019.  The report is being compiled due to mistakenly starting another series.  The pharmacy became aware of the mistake when the patient presented to the pharmacy on 8/4/23 for the second dose.  The patient had no adverse event due to receiving the 1 dose on 5/17/23.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Burning sensation, Musculoskeletal stiffness, Pain in extremity, Skin warm
Clinical narrative: Patient reports arm pain, stiffness, burning and hot to the touch starting the evening of adminstration and continuing into the following day.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Blood test, Scleroderma
Clinical narrative: Schleraderma Morphea rash noted 1/2023 still not cleared up
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure, Catheterisation cardiac, Dyspnoea, Ejection fraction decreased, Electrocardiogram abnormal
Clinical narrative: Started end of 04/2023 with increased breathing problems and pedal edema.   Made doctors appointment to find out I had significant EKG changes.  Was referred to a Cardiologist, and was sent for a stress test.   Results from test revealed that I was in cardiac heart failure.  Ejection Fraction was at 20%(normal for my age is about 70%).  I had an echocardiogram in 2019 with the results being normal.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oedema peripheral, Stress echocardiogram abnormal
Clinical narrative: Started end of 04/2023 with increased breathing problems and pedal edema.   Made doctors appointment to find out I had significant EKG changes.  Was referred to a Cardiologist, and was sent for a stress test.   Results from test revealed that I was in cardiac heart failure.  Ejection Fraction was at 20%(normal for my age is about 70%).  I had an echocardiogram in 2019 with the results being normal.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Chest pain, Hypoaesthesia, Pain in extremity
Clinical narrative: patient was given 3 Liter of oxygen via nasal cannula. patient complained of not being able to breathe. patient complained of severe lower back pain, severe thigh pain that was alternating back and forth. Denies shooting pain down legs . patient complained of chest pain. Vital were taken, 211/133 pulse 90. Attempted to get second B/p. patient took off b/p cuff stating is was hurting her non-dominate arm. Denies tingling in any extremities. After 20 minutes patient complained of numbness in her toes. Denies any pain radiating down or upward for local pain locations.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: vaccine was administered after BUD. The BUD date was 7/29/23
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Blood lactic acid, Computerised tomogram head, Differential white blood cell count, Drug screen
Clinical narrative: New on-set tonic-clonic seizures upon waking, two occurring within 24 hours of each other.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram, Full blood count, Generalised tonic-clonic seizure, Magnetic resonance imaging head, Metabolic function test
Clinical narrative: New on-set tonic-clonic seizures upon waking, two occurring within 24 hours of each other.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Scan with contrast, Sleep deficit
Clinical narrative: New on-set tonic-clonic seizures upon waking, two occurring within 24 hours of each other.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Cold sweat, Contusion, Electrocardiogram, Injection site bruising
Clinical narrative: About 2 hours after injection, I had extreme pain in left shoulder around joint and movement of left arm caused more intense pain.  I thought maybe I was having a heart attack so I put a nitroglycerin tablet under my tongue.  A few minutes later, my vision became blurry and I had a cold sweat (later learned these symptoms came from nitro tablet).  I had my wife call EMS,  Medics administered an EKG and the took my blood pressure.  Both were normal but medics said I should go to the ER.  ER doctor believed the pain was the result of the vaccine injection.  I was given a morphine injection prior to leaving the ER that reduced the pain by about 50%.  I was nauseated the following morning and vomited twice.  The nausea could have been caused by the morphine or the Shingrix injection.  I believe the pain was caused by the injection being given too high on my left arm and the vaccine got into the joint.  I had 2 bruises, one high up on the upper left arm and one on the shoulder.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Vision blurred, Vomiting
Clinical narrative: About 2 hours after injection, I had extreme pain in left shoulder around joint and movement of left arm caused more intense pain.  I thought maybe I was having a heart attack so I put a nitroglycerin tablet under my tongue.  A few minutes later, my vision became blurry and I had a cold sweat (later learned these symptoms came from nitro tablet).  I had my wife call EMS,  Medics administered an EKG and the took my blood pressure.  Both were normal but medics said I should go to the ER.  ER doctor believed the pain was the result of the vaccine injection.  I was given a morphine injection prior to leaving the ER that reduced the pain by about 50%.  I was nauseated the following morning and vomited twice.  The nausea could have been caused by the morphine or the Shingrix injection.  I believe the pain was caused by the injection being given too high on my left arm and the vaccine got into the joint.  I had 2 bruises, one high up on the upper left arm and one on the shoulder.
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient was unknowingly given the wrong vaccine she was given 0.3 mls of undiluted pfizer bilvalent age 5-11 and should have received pfizer bivalent age 12 +
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Asthenia, Confusional state, Depression, Dizziness
Clinical narrative: First dose: mild headache for two days Second dose: severe pressure in head, leading to headache dizziness and confusion. Approx. 10 days after 2nd dose, pt experienced significant mental deterioration, mostly in the form of severe depression and anxiety. Crippling depression made working difficult to impossible. Mental confusion accompanied the deterioration. Pt experienced bouts of weakness and emotional breakdown that affected his work environment and home life.  Pt was put on probation at work and was eventually fired for inability to perform job to satisfaction.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Emotional disorder, Head discomfort, Headache, Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: First dose: mild headache for two days Second dose: severe pressure in head, leading to headache dizziness and confusion. Approx. 10 days after 2nd dose, pt experienced significant mental deterioration, mostly in the form of severe depression and anxiety. Crippling depression made working difficult to impossible. Mental confusion accompanied the deterioration. Pt experienced bouts of weakness and emotional breakdown that affected his work environment and home life.  Pt was put on probation at work and was eventually fired for inability to perform job to satisfaction.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mental impairment
Clinical narrative: First dose: mild headache for two days Second dose: severe pressure in head, leading to headache dizziness and confusion. Approx. 10 days after 2nd dose, pt experienced significant mental deterioration, mostly in the form of severe depression and anxiety. Crippling depression made working difficult to impossible. Mental confusion accompanied the deterioration. Pt experienced bouts of weakness and emotional breakdown that affected his work environment and home life.  Pt was put on probation at work and was eventually fired for inability to perform job to satisfaction.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Shortly after the shingles short, I had fever, headache, swollen and sore arm,  and rashes on the arm. The fever and headache lasted < 2-day, while the swollen and sore arm and rashes lasted 5-day.  On the 5th day (7/17/23), I noticed a small bump in my right neck, which grew pretty fast.  I called my primary Dr. office on 7/20 and asked whether this may be duo to the vaccination. I was told that it could be vaccine related  and observed it for a couple more days. I ended up seeing the primary Dr. on 7/24, as the bump kept growing pretty fast. She diagnosed it as Thyroid Nodule, and thought this was unlikely related to the vaccination. It might be just coincident.  However, I am not convinced. I just had an annual exam on 4/21/23, ~2.5-month before the shingles short, when the Dr. concluded everything was normal. It is natural to relate the fast growing neck bump to the vaccination, as I didn't notice anything previously.  Now I am referred and scheduled to see an ENT doctor. I was told that I need to do an ultrasound and maybe biopsy for the thyroid nodule. I would like to know whether there were other people had similar adverse effect after shingles shot and got treated.  Also, I want to know if it is safe for me to get 2nd shingles shot. I asked my primary about 10-day ago, but she hasn't replied.  I would appreciate if you can refer me to some experts on shingles shot so that I can get more information or help. Thank you.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Thyroid mass
Clinical narrative: Shortly after the shingles short, I had fever, headache, swollen and sore arm,  and rashes on the arm. The fever and headache lasted < 2-day, while the swollen and sore arm and rashes lasted 5-day.  On the 5th day (7/17/23), I noticed a small bump in my right neck, which grew pretty fast.  I called my primary Dr. office on 7/20 and asked whether this may be duo to the vaccination. I was told that it could be vaccine related  and observed it for a couple more days. I ended up seeing the primary Dr. on 7/24, as the bump kept growing pretty fast. She diagnosed it as Thyroid Nodule, and thought this was unlikely related to the vaccination. It might be just coincident.  However, I am not convinced. I just had an annual exam on 4/21/23, ~2.5-month before the shingles short, when the Dr. concluded everything was normal. It is natural to relate the fast growing neck bump to the vaccination, as I didn't notice anything previously.  Now I am referred and scheduled to see an ENT doctor. I was told that I need to do an ultrasound and maybe biopsy for the thyroid nodule. I would like to know whether there were other people had similar adverse effect after shingles shot and got treated.  Also, I want to know if it is safe for me to get 2nd shingles shot. I asked my primary about 10-day ago, but she hasn't replied.  I would appreciate if you can refer me to some experts on shingles shot so that I can get more information or help. Thank you.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Pain in arm including upper arm and joint.  Patient complains of extreme pain continuing for 4 days at injection site and throughout arm, with inability to lift arm.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Malaise, Nausea, Sleep disorder
Clinical narrative: severe nausea, severe headache, disturbed sleep, general malaise ongoing 4+ days
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Arthralgia, Autoimmune disorder, Blood test abnormal, C-reactive protein increased
Clinical narrative: I had Moderna for my first vaccines. The fifth dose, booster was my first pfizer on 8/10/2022. A week later I could barely walk due to acute inflammation and pain. I struggled for months with overall joint, muscle, nerve pain throughout my body, particularly in my ankle, knees and legs. The inflammation and pain has seriously impacted my quality of life. I saw my primary physician for examination and bloodwork and she referred me to a rheumatologist due to the highly elevated inflammation markers in my blood and a positive RA factor which I have never had before. I could barely function at work as a teacher. My life consisted of managing pain with NSAIDS, joint braces, ice packs etc. It took over my life. Finally I got an appointment with the Rheumatology Clinic in November, 2022. I was then treated with 400 mg Plaquenil and naproxen as well as high doses of Vitamin D. Follow up 4 months later in March showed some improvement in symptoms. I then began  Physical Therapy for 12 weeks. Almost a year after my pfizer booster, i am still suffering with pain and inflammation, and the recent visit to Rheumatology clinic recommended that i remain on Plaquenil indefinitely. I may have to deal with Auto immunity Disease, RA, for the rest of my life. I walk with a noticable limp, as my righ leg is still the most impacted. Prior to this Vaccine Injury on 8/10/2022, I was perfectly healthy. I did not take any medications regularly, had no chronic health conditions, and enjoyed an active healthy lifestyle. This Covid 19 , pfizer vaccine Injury has not only stolen this past year of my life, but the future outcome and impact is still uncertain.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Impaired quality of life, Impaired work ability, Inflammation, Inflammatory marker increased
Clinical narrative: I had Moderna for my first vaccines. The fifth dose, booster was my first pfizer on 8/10/2022. A week later I could barely walk due to acute inflammation and pain. I struggled for months with overall joint, muscle, nerve pain throughout my body, particularly in my ankle, knees and legs. The inflammation and pain has seriously impacted my quality of life. I saw my primary physician for examination and bloodwork and she referred me to a rheumatologist due to the highly elevated inflammation markers in my blood and a positive RA factor which I have never had before. I could barely function at work as a teacher. My life consisted of managing pain with NSAIDS, joint braces, ice packs etc. It took over my life. Finally I got an appointment with the Rheumatology Clinic in November, 2022. I was then treated with 400 mg Plaquenil and naproxen as well as high doses of Vitamin D. Follow up 4 months later in March showed some improvement in symptoms. I then began  Physical Therapy for 12 weeks. Almost a year after my pfizer booster, i am still suffering with pain and inflammation, and the recent visit to Rheumatology clinic recommended that i remain on Plaquenil indefinitely. I may have to deal with Auto immunity Disease, RA, for the rest of my life. I walk with a noticable limp, as my righ leg is still the most impacted. Prior to this Vaccine Injury on 8/10/2022, I was perfectly healthy. I did not take any medications regularly, had no chronic health conditions, and enjoyed an active healthy lifestyle. This Covid 19 , pfizer vaccine Injury has not only stolen this past year of my life, but the future outcome and impact is still uncertain.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neuralgia, Orthosis user, Pain, Pain in extremity
Clinical narrative: I had Moderna for my first vaccines. The fifth dose, booster was my first pfizer on 8/10/2022. A week later I could barely walk due to acute inflammation and pain. I struggled for months with overall joint, muscle, nerve pain throughout my body, particularly in my ankle, knees and legs. The inflammation and pain has seriously impacted my quality of life. I saw my primary physician for examination and bloodwork and she referred me to a rheumatologist due to the highly elevated inflammation markers in my blood and a positive RA factor which I have never had before. I could barely function at work as a teacher. My life consisted of managing pain with NSAIDS, joint braces, ice packs etc. It took over my life. Finally I got an appointment with the Rheumatology Clinic in November, 2022. I was then treated with 400 mg Plaquenil and naproxen as well as high doses of Vitamin D. Follow up 4 months later in March showed some improvement in symptoms. I then began  Physical Therapy for 12 weeks. Almost a year after my pfizer booster, i am still suffering with pain and inflammation, and the recent visit to Rheumatology clinic recommended that i remain on Plaquenil indefinitely. I may have to deal with Auto immunity Disease, RA, for the rest of my life. I walk with a noticable limp, as my righ leg is still the most impacted. Prior to this Vaccine Injury on 8/10/2022, I was perfectly healthy. I did not take any medications regularly, had no chronic health conditions, and enjoyed an active healthy lifestyle. This Covid 19 , pfizer vaccine Injury has not only stolen this past year of my life, but the future outcome and impact is still uncertain.