chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEP, IPV
Symptoms: Extra dose administered
Clinical narrative: Incomplete course of vaccination; Kinrix with double polio dose same day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 5h95b, expiry date 16-FEB-2026) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Polio vaccine (batch number v1b891m) for prophylaxis.   Previously administered products included Polio vaccine (received 2 doses in 2020) and Hepatitis B vaccine (received 2 doses in 2020).   On 08-APR-2024, the patient received Kinrix. On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine. On 08-APR-2024, the patient received Polio vaccine. On 08-APR-2024, an unknown time after receiving Kinrix and not applicable after receiving Hepatitis B vaccine, the patient experienced overdose (Verbatim: Kinrix with double polio dose same day). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the overdose and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-APR-2024 The medical assistant called to report pediatric patient received Kinrix and a non gsk polio vaccine on the same day, which led to overdose. Till the time of reporting the patient did not receive the 3rd dose of Hepatitis B vaccine, which led to incomplete course of vaccination. The reporter consented to follow up. The follow up via email agreed. The patient 1 of 2 reported in the same phone call.; Sender's Comments:  US-GSK-US2024046335:Different patient
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine was administered after it had been reconstituted for about 24 hours; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number LL5C2, expiry date 18-APR-2026) for prophylaxis.   On 10-APR-2024, the patient received the 1st dose of Shingrix. On 10-APR-2024, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: vaccine was administered after it had been reconstituted for about 24 hours). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 11-APR-2024 The pharmacist reported that Shingrix vaccine was administered ta a patient after it had been reconstituted for about 24 hours which led to incorrect storage of drug. The vaccine was stored refrigerated after reconstitution.  At the time of reporting, no further doses had been administered.  The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow up but declined to provide last name.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient recived 3rd dose of Shingrix vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 14-MAR-2018) and Shingrix (2nd dose received on 16-MAY-2018). Concurrent medical conditions included diabetes.   On 24-MAR-2024, the patient received the 3rd dose of Shingrix. On 24-MAR-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: patient recived 3rd dose of Shingrix vaccine). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 11-APR-2024 The pharmacist reported that a patient who was not immunocompromised had received 3rd dose of Shingrix vaccine by error, which led to an extra dose administered. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter. It was reported that, a 52-year-old female reported 68 people die with that lot number (012L20A). "So, she dodged a bullet. No other details were provided. The treatment medication was not reported by reporter. This case contains information about 38th patient out of 68 patients. Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (due to medically significant), Fatal, unexpected, event of Death, which occurred on an unknown date and with unknown latency after a dose of mRNA-1273 vaccine. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. No further information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 38 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter. It was reported that, a 52-year-old female reported 68 people die with that lot number (012L20A). "So, she dodged a bullet. No other details were provided. The treatment medication was not reported by reporter. This case contains information about 46th patient out of 68 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact  Company comment: This spontaneous case concerns a patient of unknown age and gender, with no medical history information reported, who experienced the unexpected serious (death and medically significant) event of death. The event occurred on an unknown date after a dose of mRNA-1273. The event was reported by a female reporter who reported death of 68 people of unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) from the same batch as reporter. There is no other information like date of death, cause of death and any information about autopsy. No further information about the event was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 46 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment medication was reported. This case is reported for patient 64 out of 68 patients. Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (due to medically significant), Fatal, unexpected, event of Death, which occurred on an unknown date and with unknown latency after a dose of mRNA-1273 vaccine. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. No further information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 64 of total 68; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: to receiving 2nd dose of Menactra before 15 years of age with no adverse event; Initial information received on 11-Apr-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves Adolescent female patient who was receiving 2nd dose of Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra] before 15 years of age with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date In 2022, the patient received unknown dose of suspect Meningococcal A-C-Y-W135 (D CONJ) Vaccine (Solution for injection) before 15 years of age with no adverse event (product administered to patient of inappropriate age) (latency: same day) (lot number, route, administration site , expiry and strength not reported) for Immunization.Information regarding batch number will be requested in this case.  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: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: child received the DTaP/ IPV portion of the vaccine, but it was not mixed with the ActHIB portion prior to administration; Initial information received on 15-Apr-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 6-month-old male child received the dtap/ ipv portion of the vaccine, but it was not mixed with the acthib portion prior to administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine; and rotavirus vaccine for Prophylactic vaccination.  On 12-Apr-2024, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength, expiry date: unknown) (lot: UK017AA) via intramuscular route in unknown administration site for Immunization and child received the dtap/ ipv portion of the vaccine, but it was not mixed with the acthib portion prior to administration (single component of a two-component product administered) (latency: same day).  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: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: they had administered daptacel which was 9 days expired to a patient with no reported adverse event; Initial information received on 15-Apr-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 1 years old female patient who had administered Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] which was 9 days expired to a patient 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 15-Apr-2024, the patient received a dose 1 of 0.5 ml of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine (Suspension for injection) (lot C5980AB ,Expiry date:06-Apr-2024, strength was unknown)  via unknown route in unknown administration site for Prophylactic vaccination (Immunization) and had administered daptacel which was 9 days expired to a patient with no reported adverse event (expired product administered) (latency : same day).  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.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate schedule of vaccine; did not yet receive second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate Schedule of Vaccine) and incomplete course of vaccination (Verbatim: did not yet receive second dose). The outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt Date: 10-APR-2024 The pharmacist reported via chat that a female patient was administered first dose of Shingrix nearly two years ago and did not yet receive second dose.  The reporter did not have the exact date of dose, or the product lot number or expiration date at the time of reporting. The vaccine administration facility was the same as primary reporter. The patient received Shingrix 1st dose at inappropriate age which led to inappropriate age at vaccine administration. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter. It was reported that, a 52-year-old female reported 68 people die with that lot number (012L20A). "So, she dodged a bullet. No other details were provided. The treatment medication was not reported by reporter. This case contains information about 64 patient out of 68 patients. Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (due to medically significant), Fatal, unexpected, event of Death, which occurred on an unknown date and with unknown latency after a dose of mRNA-1273 vaccine. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. No further information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 64 of total 68; Reported Cause(s) of Death: Unknown cause of death
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Myalgia
Clinical narrative: Soreness in shoulder muscle and joint.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Pharmacist called to report that an expired MMR II vaccine was administered to a patient.   Diluent was not expired. No additional AE was reported.  No further information provided.  No pqc.; Pharmacist called to report that an expired MMR II vaccine was administered to a patient.   Diluent was not expired. No additional AE was reported.  No further information provided.  No pqc.; This spontaneous report was received from a pharmacist concerning to a patient of unspecified age and gender.  The patient's medical history, historical drugs, known allergies, and concurrent conditions were not reported. Concomitant medications included sterile diluent (DILUENT MRK).   On 11-APR-2024, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II) injection,  lot #W019428, expiration date: 07-JAN-2024, administered for prophylaxis (strength, exact dose, anatomical location, and route of administration were not provided), that was expired (Expired vaccine used), but that the sterile diluent (DILUENT MRK) was not expired. No additional adverse events of information were provided.
Age: 74.0
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no symptomatic adverse events were reported; temperature excursions that occurred for VAXNEUVANCE; This spontaneous report was received from a registered nurse and referred to a 74-year-old patient with unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 07-JUN-2023, pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), 0.5 milliliter injection (lot #W036242, expiration date: 01-OCT-2024) experienced temperature excursion with 33 degree Fahrenheit (F) for 3 hours 0 minutes 0 seconds; On 13-JUN-2023, the vaccine experienced temperature excursion with 60F for 4 hours 30 minutes 0 seconds; From 13-JUN-2023 to 23-JUN-2023, the vaccine experienced temperature excursion with 34.10F  for 240 hours 0 minutes; On 30-NOV-2023, the vaccine experienced temperature excursion with 52F for 5 hours 45 minutes; From 01-DEC-2023 to 09-DEC-2023, the vaccine experienced temperature excursion with 51.78F for 192 hours. There were previous temperature excursion and was not call because of a "data logger". On 11-OCT-2023, the patient was vaccinated with improper stored pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), 0.5 milliliter injection (product quantity:1, lot #W036242, expiration date: 01-OCT-2024, administered for prophylaxis, route of administration and anatomical site of administration were not provided) (product storage error) by health professional. Confirmed no symptomatic adverse events were reported (no adverse event).
Age: 21.0
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose of Engerix-B was given to adult; pediatric dose of Engerix-B was given to adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 21-year-old patient who received HBV (Engerix B pediatric) (batch number 4zn3h, expiry date 28-MAR-2025) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: pediatric dose of Engerix-B was given to adult) and adult use of a child product (Verbatim: pediatric dose of Engerix-B was given to adult). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-APR-2024 The nurse from vaccine service center reported that, when she was checking on lot and realized that a pediatric dose of Engerix-B was given to 20- and 21-year-old patient, which led to an underdose and adult use of a child product. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2024046336:Same reporter / different patient
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received extra dose despite receiving both dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 29th July 2020) and Shingrix (received 2nd dose on 29th September 2020).   On 27-FEB-2024, the patient received the 3rd dose of Shingrix. On 27-FEB-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received extra dose despite receiving both dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 12-APR-2024 The pharmacist reported that the patient received Shingrix series in 2020 and apparently forgot she received the series and came in to pharmacy requesting vaccine, and it was administered to her on 27th February 2024. The reporter did not have any of the dosing lot numbers available at the time of call. The vaccine administration facility was the same as primary reporter. The reporter did not have email address to provide. The reporter consented to follow up. The patient received 3rd dose of Shingrix, which led to extra dose administered.
Sex: U
Vaccine: COVID19
Symptoms: Idiopathic urticaria
Clinical narrative: Extreme idiopathic urticaria and I have sever major pain daily due to this; This spontaneous case was reported by a non-health professional and describes the occurrence of IDIOPATHIC URTICARIA (Extreme idiopathic urticaria and I have sever major pain daily due to this) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IDIOPATHIC URTICARIA (Extreme idiopathic urticaria and I have sever major pain daily due to this). At the time of the report, IDIOPATHIC URTICARIA (Extreme idiopathic urticaria and I have sever major pain daily due to this) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medications were not reported.  It was reported that patient had sever major pain daily due to extreme idiopathic urticaria.  Treatment information was not reported.
Age: 49.0
Sex: F
Vaccine: COVID19, FLUC4, PPV
Symptoms: Fall, Pain, Product administered at inappropriate site, Sleep disorder, Tremor
Clinical narrative: MY ARMS ARE DESTROYED. I HAVE HAD TWO BAD FALLS BECAUSE I USE A WALKER, MY ARMS ARE SHAKING AND PAINFUL TO MOVE, PROVIDER PUT THE NEEDLE IN NEAR MY UPPER SHOULDER ON BOTH SIDES. I WAS TOLD MY ARMS WOULD GET BETTER BUT THEY ARE GETTING MUCH, MUCH WORSE. I CANNOT EVEN SLEEP. THIS IS A VACCCINE INJURY.
Age: 49.0
Sex: F
Vaccine: COVID19, FLUC4, PPV
Symptoms: Walking aid user
Clinical narrative: MY ARMS ARE DESTROYED. I HAVE HAD TWO BAD FALLS BECAUSE I USE A WALKER, MY ARMS ARE SHAKING AND PAINFUL TO MOVE, PROVIDER PUT THE NEEDLE IN NEAR MY UPPER SHOULDER ON BOTH SIDES. I WAS TOLD MY ARMS WOULD GET BETTER BUT THEY ARE GETTING MUCH, MUCH WORSE. I CANNOT EVEN SLEEP. THIS IS A VACCCINE INJURY.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Skin abrasion, Skin laceration, Syncope
Clinical narrative: Patient had vago-syncope episode after 20 min of receiving HPV vaccine- fell and encountered abrasion R cheek and 3 mm laceration on midforehead. Pt. was taken back and observed for 20 min , VSS, Alert and oriented stated felt fine, and left clinic ambulating.
Age: 4.0
Sex: F
Vaccine: HIBV
Symptoms: Cheilitis, Hyperhidrosis, Lip swelling
Clinical narrative: swelling lip and inflamation as shown in the picture below, started 4 hours after the vaccine was taken, she was sweating a lot as well. mom reports that she had previous reaction from previous vaccine in January (Varicella and Influenza). PO intake is normal. mom reported problem breathing as well.
Age: 6.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Giving to early. No reaction reported from parents.
Age: 7.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: DTaP was given when the child was 7 years old
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Eating disorder, Fatigue, Gait disturbance, Pain in extremity
Clinical narrative: Reported pain in left arm predominantly but has spread to all over, imbalance, trouble walking, fatigue, trouble eating for a month
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: 12cm x 7cm redness, swelling, warmth, rash on 4/19/24 around injection site of the right thigh. Started with small red spot on the evening of 4/17/24.
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Vaqta peds dose administered
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: swelling, redness
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Very nausea and vomiting after the vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray abnormal, Chest pain, General physical health deterioration, Lung opacity
Clinical narrative: Ever since i had the Covid vaccine my health has declined and I've been in and out of the doctors fo the last 3 years now. I have opacities in both my lungs nd have been suffering from consistent chest pains.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Medication given too early for age range.  No treatment needed.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: The diluent for the Hib vaccine was not mixed into the Hib vial and was just given as straight diluent.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: VACCINE EXPIRED
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Symptoms started on the 19th an today he is feeling better
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Was provided wrong age covid for 12 and above
Age: 3.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: In the evening after receiving the vaccines the patients mother reported they noticed Patient's leg was swollen at the injection site, it was red and warm to touch. Patient was brought in to have the immunization site checked on 04/19/2024 we did note swelling to the injection site redness and warmth still but those were the only reactions the patient experienced.
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received COVID (6mos- 4 yrs) after the 12 hour beyond use time had been reached. Vaccine had been drawn on 04/18/2024 but was left in stock overnight and not discarded. Patient received the vaccine on 04/19/2024.  When writer spoke to parents, patient was not having any side effects to the vaccine. No signs or symptoms or concerns
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong patient
Clinical narrative: 10 year old patient received Pfizer 12+ COVID vaccine instead of the EUA product for 5-11 years. Patient and sibling receiving vaccines and the products were accidently switched and administered to the incorrect age. No adverse effects noted.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong patient
Clinical narrative: 12 year old patient received Pfizer EUA 5-11 yr COVID vaccine instead of the FDA approved product for 12+ years. Patient and sibling receiving vaccines and the products were accidently switched and administered to the incorrect age. Per CDC interim guidance, patient is recommended to receive correct COVID vaccine for his age to be considered as complete for the vaccination.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Condition aggravated, Dysphagia, Eating disorder, Facial paralysis, Gastrointestinal tube insertion
Clinical narrative: Brought back my myasthenia gravis. Was in total remission from 2019, Within 2 days of the vaccine I had droopy eyes. Within 1 month I had an inability to eat proper. I ended up in the hospital in January and February 2024. The first time for 1 week. the second time for 1 month. Both times I was put on a ventilator. The first time for 1 day, and the second time for 2 days. I had a feeding tube inserted the second time due to my inability to swallow. I think it is wrong that this vaccine is pushed like there is nothing wrong with it and with no disclaimers, such as if you have myasthenia or anything else that might be affected
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Mechanical ventilation, Myasthenia gravis
Clinical narrative: Brought back my myasthenia gravis. Was in total remission from 2019, Within 2 days of the vaccine I had droopy eyes. Within 1 month I had an inability to eat proper. I ended up in the hospital in January and February 2024. The first time for 1 week. the second time for 1 month. Both times I was put on a ventilator. The first time for 1 day, and the second time for 2 days. I had a feeding tube inserted the second time due to my inability to swallow. I think it is wrong that this vaccine is pushed like there is nothing wrong with it and with no disclaimers, such as if you have myasthenia or anything else that might be affected
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac stress test, Echocardiogram, Feeling abnormal, Hypertension, Laboratory test abnormal
Clinical narrative: Client reports the day after vaccination, 3/15/2024, he started feeling bad. He went to clinic to be examined and have kidneys checked. He reports that the nurse practitioner didn't find anything wrong. He reports that he still felt bad throughout the week and weekend, so on 3/18/2024, he checked your blood pressure at home, and it was 200/100. He called his PCP on 3/19/2024 and reported that his blood pressure had been high the previous night, and she collected some labwork. PCP did put him on blood pressure medicine that day (clonidine). About two weeks later, she put him on Bencar. He said that some labwork came back abnormal but he doesn't recall what it was. She also ordered a kidney sonogram. PCP referred him to cardiology, and Cardiologist performed an ECHO (3/18/2024) and stress test on 3/17/2024. He is waiting to hear results.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Ultrasound kidney
Clinical narrative: Client reports the day after vaccination, 3/15/2024, he started feeling bad. He went to clinic to be examined and have kidneys checked. He reports that the nurse practitioner didn't find anything wrong. He reports that he still felt bad throughout the week and weekend, so on 3/18/2024, he checked your blood pressure at home, and it was 200/100. He called his PCP on 3/19/2024 and reported that his blood pressure had been high the previous night, and she collected some labwork. PCP did put him on blood pressure medicine that day (clonidine). About two weeks later, she put him on Bencar. He said that some labwork came back abnormal but he doesn't recall what it was. She also ordered a kidney sonogram. PCP referred him to cardiology, and Cardiologist performed an ECHO (3/18/2024) and stress test on 3/17/2024. He is waiting to hear results.
Age: 72.0
Sex: U
Vaccine: COVID19, FLU4
Symptoms: Brain compression, Ruptured cerebral aneurysm, Subarachnoid haemorrhage
Clinical narrative: Brain Compression Subarachnoid Hemorrhage Ruptured Cerebral Aneurysm
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Vision blurred
Clinical narrative: Donor stated that after her first tetanus immunization on April 8, 2024, she began experiencing blurred vision for a couple of hours during the night. Donor stated experiencing this symptom with other immunizations, specifically tetanus. Donor denies any other symptoms.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Nausea, Vomiting
Clinical narrative: Approximately 5 minutes after administration of vaccine pt reported nausea and had emesis. Pt reported decreased nausea after emesis. Vitals stable throughout 15 minute post injection observation period.
Age: 1.58
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC20
Symptoms: Urticaria
Clinical narrative: Hives on arms and legs
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: On 12/8/23, This patient was administered a covid vaccine indicated for >12yo and the patient was 5 years old at time of administration. Mother of patient was contacted and denies any secondary effects after covid vaccine as given
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered was expired
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Blood glucose, Blood pressure increased, Chest X-ray normal, Dizziness, Electrocardiogram
Clinical narrative: Patient reported having dizziness, vertigo, elevated blood pressure, and nausea after the vaccine which prompted her to go to the ED at midnight. This prompted patient to go to the emergency room.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Full blood count, Metabolic function test, Nausea, Troponin, Urine analysis
Clinical narrative: Patient reported having dizziness, vertigo, elevated blood pressure, and nausea after the vaccine which prompted her to go to the ED at midnight. This prompted patient to go to the emergency room.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Vertigo
Clinical narrative: Patient reported having dizziness, vertigo, elevated blood pressure, and nausea after the vaccine which prompted her to go to the ED at midnight. This prompted patient to go to the emergency room.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: The vaccine that was administered was expired. No adverse effects noted.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, Tenderness and Redness at injection Site.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Administration site swelling, Chest discomfort, Dizziness, Dyspnoea, Hypersensitivity
Clinical narrative: Pt developed symptoms of allergic reaction 5-6 hrs after administration w itchy neck and lower face, dizziness, swelling/tenderness at admin site. Given benadryl and ibuprofen on arrival back at clinic. When pt began c/o chest tightness and difficulty breathing thru neck /back of throat was given epi 0.3 mg , NC oxygen, and EMS called for transport to ER.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Pruritus
Clinical narrative: Pt developed symptoms of allergic reaction 5-6 hrs after administration w itchy neck and lower face, dizziness, swelling/tenderness at admin site. Given benadryl and ibuprofen on arrival back at clinic. When pt began c/o chest tightness and difficulty breathing thru neck /back of throat was given epi 0.3 mg , NC oxygen, and EMS called for transport to ER.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse reaction ,vaccine was expired when given
Age: 0.17
Sex: M
Vaccine: PNC20, UNK, UNK
Symptoms: Diarrhoea, Discoloured vomit, Faeces discoloured, Infantile diarrhoea, Infantile vomiting
Clinical narrative: 5 days of diarrhea and 1 day of vomiting.  Stool has been watery and yellow with no blood and no foul smell.  Vomit had been yellow with no blood and no bilious appearance.  Diarrhea started on Tuesday night after he had received vaccines on Tuesday during the day.
Age: 0.17
Sex: M
Vaccine: PNC20, UNK, UNK
Symptoms: Rotavirus test positive
Clinical narrative: 5 days of diarrhea and 1 day of vomiting.  Stool has been watery and yellow with no blood and no foul smell.  Vomit had been yellow with no blood and no bilious appearance.  Diarrhea started on Tuesday night after he had received vaccines on Tuesday during the day.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Immunisation reaction, Laboratory test, Pericardial effusion
Clinical narrative: MODERNA #1 2/3/2021 MODERNA #2 3/2/2021  MODERNA #3 11/11/2021  DEVELOPED POLYMYALGIA RHEUMATICA WITH TERMPORAL INVOLVEMENT AND HAS BEEN TREATED BY A RHEUMATOLOGIST WITH PREDNISON, LEFLUNIMIDE, AND HYDROXYCHLOROQUINE.   HAS DEVELOPED LONG TERM STEROID CUSHINGOID SIDE EFFECTS.   APRIL 22 2024 WAS DISCOVERED TO HAVE A SMALL PERICARDIAL EFFUSION AND DIAGNOSIS OF VACCINE PERICARDITIS.  COLCHICINE WAS ADDED.  STARTED ON PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pericarditis, Polymyalgia rheumatica
Clinical narrative: MODERNA #1 2/3/2021 MODERNA #2 3/2/2021  MODERNA #3 11/11/2021  DEVELOPED POLYMYALGIA RHEUMATICA WITH TERMPORAL INVOLVEMENT AND HAS BEEN TREATED BY A RHEUMATOLOGIST WITH PREDNISON, LEFLUNIMIDE, AND HYDROXYCHLOROQUINE.   HAS DEVELOPED LONG TERM STEROID CUSHINGOID SIDE EFFECTS.   APRIL 22 2024 WAS DISCOVERED TO HAVE A SMALL PERICARDIAL EFFUSION AND DIAGNOSIS OF VACCINE PERICARDITIS.  COLCHICINE WAS ADDED.  STARTED ON PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient reported to pharmacy 4/22/24 stating that after vaccine admin in 10/2023 she was extremely sore, more so than usual and that to date soreness at the site of injection has not gone away and has continued to cause discomfort.  Pain has started radiating down her arm it is painful to lift and use.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: The dose administered was expired. No adverse effects noted.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Feeling abnormal
Clinical narrative: About 10 minutes after the vaccines were given the client became dizzy while exiting the clinic. He had just received the HPV vaccine. He was safely placed in a chair and remained conscious through the incident. He became warm and clammy but remained alert and oriented, and he answered all of the question appropriately. Safety was maintained throughout the incident. Vitals 99/66 B/P, 62 Pulse, 18 Resp, 97.2 Temp (Infared), and O2 98%. Client self-ambulated out of the clinic with his mother without incident.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Magnetic resonance imaging head abnormal, Multiple sclerosis, Muscular weakness
Clinical narrative: Spot showed on a brain mri I had done for Morlar pregnancy was clear from that and sent to a neurologist which then sent me to an MS specialist! Tired a lot of the time, weakness and jelly feeling in legs, with leg pain? now I will be starting MS medicine in the next week
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Spot showed on a brain mri I had done for Morlar pregnancy was clear from that and sent to a neurologist which then sent me to an MS specialist! Tired a lot of the time, weakness and jelly feeling in legs, with leg pain? now I will be starting MS medicine in the next week
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was expired. No adverse effects noted.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, X-ray normal
Clinical narrative: Patient came today 4/22/24 and says he has not been able to move his arm from the pain of the shingles vaccine given on 2/26/24
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: VACCINE ADMINISTED WAS EXPIRED, NO SYMPTOMS
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: RED, SWOLLEN, WARM TO TOUCH
Age: 33.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Blood creatine phosphokinase, Fibrin D dimer, Metabolic function test, Peripheral swelling, Urine analysis
Clinical narrative: On 4/19/24 patient was given 2nd dose of JYNNEOS vaccine in the back of the left arm subcutaneously.  Patient was observed fpr 15min with no signs of an allergic reaction or other complain.  The patient scheduled an appointment with a provider today and reported noticing generalized swelling to the L arm over the weekend,  Lab were ordered and ice pack for treatment given to student by clinician.  Lab tests ordered as well to rule out blood clot.
Age: 1.08
Sex: M
Vaccine: HEPA
Symptoms: Syringe issue, Underdose
Clinical narrative: Patient was being administered ped Hep A vaccination when pushing imm into leg contents of the inside shot out from the side of vaccine and none of the contents got into patient leg .
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Dizziness, Fatigue, Headache
Clinical narrative: Headache, chills, fatigue, dizziness, shivering
Age: 78.0
Sex: F
Vaccine: HEPAB, RSV
Symptoms: Injected limb mobility decreased, Injection site swelling
Clinical narrative: Patient received the Twinrix vaccination and the Arexvy vaccination in the right deltoid on 4/11/2024.   Patient presented around 9:30 AM on 4/22/24 with swelling in her right arm and she was unable to lift it up.  Area was inspected and the 2 vaccinations were given an inch apart and in the appropriate area of the arm.  It is unknown which injection or both injections caused the reaction as they were given in the same arm and the entire upper arm was swollen. Patient was instructed to go to the doctor and to ice the area and take ibuprofen until the doctor visit.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: VACCINE ADMINISTERED WAS EXPIRED. NO SYMPTOMS
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event, the vaccine was expired.
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Body temperature increased, Feeling hot, Pruritus, Urticaria
Clinical narrative: HIVES, ITCHING, FEELING HOT IN THE FACE, ELEVATED TEMP @ HOME UPON SHOWERING BETWEEN 5-5:30PM
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site warmth, Malaise, Vaccination site erythema
Clinical narrative: One day after vaccination with Moderna  Spikevax pt developed malaise and 4x6 cm area of erythema/warmth  and induration at vaccine site  The following day the reaction had increased to 6x9 cm area of dusky erythema and induration with central 1 cm ecchymosis. Palpable induration was minimally tender  to touch with mild warmth, no fluctuance or exudate. Pt remained afebrile.  Induration, tenderness and erythema gradually resolved by day 5 following immunization.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: One day after vaccination with Moderna  Spikevax pt developed malaise and 4x6 cm area of erythema/warmth  and induration at vaccine site  The following day the reaction had increased to 6x9 cm area of dusky erythema and induration with central 1 cm ecchymosis. Palpable induration was minimally tender  to touch with mild warmth, no fluctuance or exudate. Pt remained afebrile.  Induration, tenderness and erythema gradually resolved by day 5 following immunization.
Age: 38.0
Sex: M
Vaccine: HPV9
Symptoms: Arthralgia, Inflammation, Pain, Pain in extremity
Clinical narrative: Patient started to get pain and inflammation the next day after he got his vaccine. He was having pain and inflammatory in his arm/shoulder.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Product preparation error
Clinical narrative: Vaccine diluent and powder mismatch noted.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: VACCINE ADMINISTERED WAS EXPIRED. NO SYMPTOMS
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: VACCINE GIVEN WAS EXPIRED. NO SYMPTOMS
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Product preparation error
Clinical narrative: Varicella Powder/Diluent Mismatch
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: VACCINE GIVEN WAS EXPIRED.  NO SYMPTOMS
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Product preparation error
Clinical narrative: Varicella Powder/Diluent mismatch
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Product preparation error
Clinical narrative: Varicella powder/diluent mismatch
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given was expired, no symptoms
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: Product preparation error
Clinical narrative: Varicella Powder/Diluent mismatch
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Staring, Tonic clonic movements
Clinical narrative: 20 seconds after HPV injection occurred.  Blank stare for 10 seconds followed by clonic tonic upper extremity movement lasting 10 seconds. BP (88/62) glucose (88) performed. Evaluated by NP.  Referred to ER
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Myalgia
Clinical narrative: myalgia in patient's back, trouble taking deep breaths; symptoms started soon after receiving vaccine and continued for 2-3 days before resolving.