chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick".  Additional information: A Caller is trying to get a hold of an office to make an appointment so they can give her a shot. She mentioned that she had to wait for 9 months to get a booster shot and now she got sick. Also, she wants to get a flu vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: elderly mother caught covid, was then vaccinated with Pfizers comirnaty, and then passed away a week later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "elderly mother caught covid, was then vaccinated with Pfizers comirnaty, and then passed away a week later". The date and cause of death for the patient were unknown.  Clinical information: On 08Jan2023, reporter took an Uber ride in (city withheld) and the Uber driver (who I do not know personally outside of this interaction) told me that his elderly mother caught covid, was then vaccinated with Pfizers comirnaty, and then passed away a week later (in that order). I do not have additional details.  The information on the batch/lot number for [Comirnaty] has been requested and will be submitted if and when received.; Reported Cause(s) of Death: elderly mother caught covid, was then vaccinated with Pfizers comirnaty, and then passed away a week later
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I did have the shot, and still got the flu; Initial information received on 06-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves a patient of unknown age and gender who reported i did have the shot, and still got the flu after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), concomitants and family history were not provided.   On an unknown date, the patient had received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, route, formulation, batch number and expiry date: unknown) in unknown administration site for flu (influenza).  On an unknown date, the patient reported i did have the shot, and still got the flu (influenza) (latency: unknown) following the administration of influenza vaccine.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: still got the flu; Initial information received on 06-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves a patient who still got the flu after receiving vaccine Influenza Vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On an unknown date the patient still got the flu (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (still got the flu).  Outcome was Unknown for the event still got the flu.
Sex: U
Vaccine: FLUX
Symptoms: Asthenia, Decreased appetite, Hypersomnia, Hypophagia, Illness
Clinical narrative: I slept for 4 days n hardly ate anything; I slept for 4 days n hardly ate anything; Been sick since I got the, Flu shot; I came down with a terrible cold n still have it; Got the flu shot, five hrs later I was so weak I could barely get to bed; Initial information was received on 06-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who  got the flu shot, five hrs later i was so weak i could barely get to bed, i slept for 4 days n hardly ate anything, i came down with a terrible cold n still have it and been sick since i got the, flu shot after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On 06-Dec-2022, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).  On 06-Dec-2022 the patient who got the flu shot, five hrs later i was so weak i could barely get to bed (asthenia)(latency: 5 hours) following the administration of influenza vaccine.  On 12-Dec-2022 the patient came down with a terrible cold n still have it (nasopharyngitis) (latency: 6 days) following the administration of influenza vaccine.  On an unknown date the patient been sick since i got the, flu shot (illness) and i slept for 4 days n hardly ate anything (hypersomnia), (Decreased appetite) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Not Recovered for the events i came down with a terrible cold n still have it and been sick since i got the, flu shot and Unknown for rest of the events.
Sex: U
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: I slept for 4 days n hardly ate anything; I slept for 4 days n hardly ate anything; Been sick since I got the, Flu shot; I came down with a terrible cold n still have it; Got the flu shot, five hrs later I was so weak I could barely get to bed; Initial information was received on 06-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who  got the flu shot, five hrs later i was so weak i could barely get to bed, i slept for 4 days n hardly ate anything, i came down with a terrible cold n still have it and been sick since i got the, flu shot after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On 06-Dec-2022, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).  On 06-Dec-2022 the patient who got the flu shot, five hrs later i was so weak i could barely get to bed (asthenia)(latency: 5 hours) following the administration of influenza vaccine.  On 12-Dec-2022 the patient came down with a terrible cold n still have it (nasopharyngitis) (latency: 6 days) following the administration of influenza vaccine.  On an unknown date the patient been sick since i got the, flu shot (illness) and i slept for 4 days n hardly ate anything (hypersomnia), (Decreased appetite) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Not Recovered for the events i came down with a terrible cold n still have it and been sick since i got the, flu shot and Unknown for rest of the events.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination failure
Clinical narrative: My flu vaccine didn't work with no reported adverse event; Initial information received on 05-Jan-2023 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient for whom influenza vaccine didn't work with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination which didn't work with no reported adverse event (vaccination failure).  Action taken with influenza vaccine was not applicable.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   At time of reporting, the outcome was Unknown for the event my flu vaccine didn't work with no reported adverse event.  Seriousness criteria: The event vaccination failure was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 10-Jan-2023: This case involves an unknown age and gender patient for whom influenza vaccine didn't work with no reported adverse event. Based on information provided, the causal role of company suspect vaccine cannot be excluded. Case will be re-evaluated post further update on information regarding underlying disease, risk precipitating factor, other concomitant medication, past medical history and patient lifestyle which will aid a comprehensive assessment of this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Nasopharyngitis
Clinical narrative: Got my flu shot and right nowI'm sick as a dog with a nasty cold; Got my flu shot and right nowI'm sick as a dog with a nasty cold; Initial information received on 06-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who got flu shot and right now developed sickness as a dog with a nasty cold after receiving vaccine Influenza Vaccine.   The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, strength, formulation and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient reported that "got my flu shot and right nowi'm sick as a dog with a nasty cold (nasopharyngitis)" and (illness) (unknown latency) following the administration of  Influenza Vaccine.  It was unknown if there were lab data/results available.   Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for both the events.    At time of reporting, the outcome was Unknown for both the events.
Sex: U
Vaccine: FLUX
Symptoms: Asthenia, Cough, Malaise
Clinical narrative: been sick off and on every since; Cough wont go away; no energy; feel like crap; Initial information received on 08-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who reported after receiving influenza vaccine, had been sick off and on ever since, cough won't go away, no energy and feel like crap.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, expiry date, lot number: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious events of been sick off and on ever since (illness), cough won't go away (cough), no energy (asthenia) and feel like crap (feeling abnormal) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events (been sick off and on ever since, Cough won't go away, no energy, feel like crap).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event cough won't go away and was Unknown for all the rest events (been sick off and on ever since, no energy and feel like crap).
Age: 0.33
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Ipol being administered post excursion with no reported adverse event; 1.8C for 15 minutes due to a refrigerator malfunction with no reported adverse event; Initial information was received on 16-Dec-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves 4 months old male patient who was administered  ipol  post excursion with no reported adverse event and the vaccine had excursion 1.8c for 15 minutes due to a refrigerator malfunction with no reported adverse event while receiving vaccine IPV (VERO) [Ipol].  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 (Daptacel) for Immunisation; HIB VACCINE CONJ (TET TOX) (Acthib) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (Rotateq) for Immunisation.   On 04-Oct-2022,  the reporter state that the vaccine was 1.8C for 15 minutes due to a refrigerator malfunction (not human error)(product storage error)  On 10-Oct-2022, the patient received a Once total  dose of suspect IPV (VERO) (lot V1B901M  and expiration date: 02-Jun-2024) at a dose of 0.5ml via intramuscular route in the right thigh for immunization.  On 10-Oct-2022, the patient developed a non-serious event of ipol being administered post excursion with no reported adverse event (poor quality product administered)(latency: same day) following the administration of ipv (VERO).  Action taken :not applicable  It was not reported if the patient received a corrective treatment for the events.   Outcome: unknown for both 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.
Sex: U
Vaccine: TDAP
Symptoms: Headache, Ocular discomfort, Surgery, Visual impairment
Clinical narrative: suffering visual disturbances; requiring emergent surgery due to pressure in eyes; headache; Initial information received on 05-Jan-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who experienced suffering visual disturbances, requiring emergent surgery due to pressure in eyes and headache while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (unknown strength, dose, frequency) lot U7561AA, expiry date: 09-11-2024 via unknown route in unknown administration site for prophylaxis.  On an unknown date the patient developed a non-serious suffering visual disturbances (visual impairment), requiring emergent surgery due to pressure in eyes (ocular discomfort), headache (unknown latency).  Lab data was not reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
Sex: U
Vaccine: UNK
Symptoms: Rash
Clinical narrative: rash; did not complete the 4 doses of the oral typhoid vaccine; Initial information received on 06-Jan-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who experienced rash and did not complete the 4 doses of the oral TYPHOID VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received total dose of suspect TYPHOID VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date: not reported) (Drug Treatment Duration: Not Applicable) via oral route in unknown administration site for Immunization.  On 06-Jan-2023, patient did not complete the 4 doses of the oral typhoid vaccine (incomplete course of vaccination) due to a rash (unknown latency), that may/may not have been caused by the oral typhoid and reporter wanted to know if the vaccine schedule could be completed with TYPHIM VI.  It was reported, caller was requesting information about TYPHIM VI and the safety of using it after an oral typhoid vaccine. Caller also requests product composition of TYPHIM VI. Caller encouraged to reach out to the manufacturer of said oral typhoid vaccine if she could get that information from the patient.  Action taken with TYPHOID VACCINE (TYPHOID VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (rash).  At time of reporting, the outcome was Unknown for both 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: 15.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok Quadrivalent was given to a 15 year with no reported adverse event; Initial information was received on 06-Jan-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 15 years old male patient who was treated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Jan-2023, the patient received total 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (product administered to patient of inappropriate age) (latency same day) (lot UJ903AA and expiry date 30-06-23) via intramuscular route in the right deltoid for immunization.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable.  At time of reporting, the outcome was Unknown for the event flublok quadrivalent was given to a 15 year 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 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: M
Vaccine: IPV
Symptoms: Extra dose administered, Medication error, No adverse event, Wrong product administered
Clinical narrative: an extra dose of IPOL was administered to a patient instead of the intended GARDASIL vaccine with no reported AE; Initial information received on 06-Jan-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12 years old male patient who was administered an extra dose of ipol instead of the intended gardasil vaccine with no reported AE (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 06-Jan-2023, the patient received a  dose of suspect poliomyelitis vaccine (inactivated) (Ipol) Suspension for injection at a dose of 0.5 ml with lot U1A601M and expiry date- 27-Feb-2023 via intramuscular route in the left deltoid for Immunization (strength unknown).  On 06-Jan-2023 the patient was administred an extra dose of ipol instead of the intended gardasil vaccine with no reported AE(wrong 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: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes, Vulvovaginal dryness, Vulvovaginal pruritus
Clinical narrative: Intense Vaginal dryness and severe itching- Dr. said it looked like a herpes outbreak.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cough, Foreign travel, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: I am responding due to a follow-up call left on my voice mail.  I am traveling and unable to respond by phone. I developed congestion and a dry cough in early December. I home tested twice for COVID and was negative both times. I did not have a fever or body aches. Prior to travel, I consulted by phone with my primary doc. He said he?d been seeing a lot of cases with my symptoms. Possibly RSV?? Based on the severity of my symptoms, and the fact I was improving, he prescribed a regimen of antibiotics and felt it was safe for mr to travel.
Age: 27.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral abnormal, Aphasia, Disorientation, Dizziness, Hallucination, olfactory
Clinical narrative: 05/09/2022-Two episodes of giddiness, nausea, aphasia; each episode lasted a few seconds (less than 5). 8/31/2022-Four episodes of giddiness, nausea, disorientation, aphasia (one episode); olfactory hallucination (two episodes).  Each episode lasted only a few seconds. No treatments as of this date.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Intracranial aneurysm, Magnetic resonance imaging head abnormal, Nausea, Scan with contrast abnormal
Clinical narrative: 05/09/2022-Two episodes of giddiness, nausea, aphasia; each episode lasted a few seconds (less than 5). 8/31/2022-Four episodes of giddiness, nausea, disorientation, aphasia (one episode); olfactory hallucination (two episodes).  Each episode lasted only a few seconds. No treatments as of this date.
Age: 40.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Induration, Pruritus, Skin discolouration, Skin hyperpigmentation
Clinical narrative: Day 1-7 post vaccine- erythema, induration, itching and recurrent hives with skin hyperpigmentation.  Week 2 resolution of induration and itching but persisting skin discoloration/hyperpigmentation until today now week 3. No change is hyperpigmentation from week 2-3.
Age: 40.0
Sex: F
Vaccine: PNC20
Symptoms: Urticaria
Clinical narrative: Day 1-7 post vaccine- erythema, induration, itching and recurrent hives with skin hyperpigmentation.  Week 2 resolution of induration and itching but persisting skin discoloration/hyperpigmentation until today now week 3. No change is hyperpigmentation from week 2-3.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient hadn't received the 2nd dose of Shingrix on time; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th Oct 2020).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 04-JAN-2022 Reporters comment: The pharmacist reported that patient did received the 2nd dose of Shingrix on time. First dose was received on 4th October 2020, and since then the scheme was not completed  The reporter consent to follow up  Details reported for 1st dose. Additional Supportive information: The patient received the first dose on 04th OCT 2020 and did not receive the second dose which led to incomplete course of vaccination; Sender's Comments:  US-GSK-US2023000767:Same reporter
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; a 20-year-old patient whom received a bivalent Moderna COVID-19 booster from a vial intended for Bivalent booster vaccination of 6M-5Y; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (a 20-year-old patient whom received a bivalent Moderna COVID-19 booster from a vial intended for Bivalent booster vaccination of 6M-5Y) and NO ADVERSE EVENT (No adverse event) in a 20-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 12-Apr-2021 and Moderna COVID-19 Vaccine on 10-May-2021; for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE on 23-Jan-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and PFIZER BIONTECH COVID-19 VACCINE.    On 06-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 06-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (a 20-year-old patient whom received a bivalent Moderna COVID-19 booster from a vial intended for Bivalent booster vaccination of 6M-5Y). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (a 20-year-old patient whom received a bivalent Moderna COVID-19 booster from a vial intended for Bivalent booster vaccination of 6M-5Y) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (a 20-year-old patient whom received a bivalent Moderna COVID-19 booster from a vial intended for Bivalent booster vaccination of 6M-5Y).    No concomitant medicine were reported. No treatment medicine were reported.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abnormal menstrual clots, Antibody test, Arthralgia, Asthenia, Blood test
Clinical narrative: Hospital: After 10 - 15 minutes I began to have symptoms of muscle hardness on the upper left part of my back. mialgia)( After 30 min. the pain was very strong and accompanied by a urticaria on my chest. (helped with intravenous medication) After 60 min. - cloudy vision. Home( incl. day of vaccine): Paresthesia (various types), asthenia, chest pain, hives, rashes (back), terrible Burning sensation (back), short of breath, tremors, joint pain (knee), tachicardia (POTS), Subacute Thyroiditis, Tinnitus, dizziness, permanent sensation of very cold ( specially on my back), menstrual pain ( almost constant for 5 months), Menstrual Clotting ( 2 times), lymphadenopathy,brain fog, tunel vision,general malaise, fever, sweats.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Chest pain, Dizziness, Dysmenorrhoea, Dyspnoea
Clinical narrative: Hospital: After 10 - 15 minutes I began to have symptoms of muscle hardness on the upper left part of my back. mialgia)( After 30 min. the pain was very strong and accompanied by a urticaria on my chest. (helped with intravenous medication) After 60 min. - cloudy vision. Home( incl. day of vaccine): Paresthesia (various types), asthenia, chest pain, hives, rashes (back), terrible Burning sensation (back), short of breath, tremors, joint pain (knee), tachicardia (POTS), Subacute Thyroiditis, Tinnitus, dizziness, permanent sensation of very cold ( specially on my back), menstrual pain ( almost constant for 5 months), Menstrual Clotting ( 2 times), lymphadenopathy,brain fog, tunel vision,general malaise, fever, sweats.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Feeling abnormal, Feeling cold
Clinical narrative: Hospital: After 10 - 15 minutes I began to have symptoms of muscle hardness on the upper left part of my back. mialgia)( After 30 min. the pain was very strong and accompanied by a urticaria on my chest. (helped with intravenous medication) After 60 min. - cloudy vision. Home( incl. day of vaccine): Paresthesia (various types), asthenia, chest pain, hives, rashes (back), terrible Burning sensation (back), short of breath, tremors, joint pain (knee), tachicardia (POTS), Subacute Thyroiditis, Tinnitus, dizziness, permanent sensation of very cold ( specially on my back), menstrual pain ( almost constant for 5 months), Menstrual Clotting ( 2 times), lymphadenopathy,brain fog, tunel vision,general malaise, fever, sweats.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Lymphadenopathy, Malaise, Myalgia, Myosclerosis
Clinical narrative: Hospital: After 10 - 15 minutes I began to have symptoms of muscle hardness on the upper left part of my back. mialgia)( After 30 min. the pain was very strong and accompanied by a urticaria on my chest. (helped with intravenous medication) After 60 min. - cloudy vision. Home( incl. day of vaccine): Paresthesia (various types), asthenia, chest pain, hives, rashes (back), terrible Burning sensation (back), short of breath, tremors, joint pain (knee), tachicardia (POTS), Subacute Thyroiditis, Tinnitus, dizziness, permanent sensation of very cold ( specially on my back), menstrual pain ( almost constant for 5 months), Menstrual Clotting ( 2 times), lymphadenopathy,brain fog, tunel vision,general malaise, fever, sweats.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Paraesthesia, Postural orthostatic tachycardia syndrome, Pyrexia, Rash
Clinical narrative: Hospital: After 10 - 15 minutes I began to have symptoms of muscle hardness on the upper left part of my back. mialgia)( After 30 min. the pain was very strong and accompanied by a urticaria on my chest. (helped with intravenous medication) After 60 min. - cloudy vision. Home( incl. day of vaccine): Paresthesia (various types), asthenia, chest pain, hives, rashes (back), terrible Burning sensation (back), short of breath, tremors, joint pain (knee), tachicardia (POTS), Subacute Thyroiditis, Tinnitus, dizziness, permanent sensation of very cold ( specially on my back), menstrual pain ( almost constant for 5 months), Menstrual Clotting ( 2 times), lymphadenopathy,brain fog, tunel vision,general malaise, fever, sweats.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Thyroiditis subacute, Tinnitus, Tremor, Tunnel vision
Clinical narrative: Hospital: After 10 - 15 minutes I began to have symptoms of muscle hardness on the upper left part of my back. mialgia)( After 30 min. the pain was very strong and accompanied by a urticaria on my chest. (helped with intravenous medication) After 60 min. - cloudy vision. Home( incl. day of vaccine): Paresthesia (various types), asthenia, chest pain, hives, rashes (back), terrible Burning sensation (back), short of breath, tremors, joint pain (knee), tachicardia (POTS), Subacute Thyroiditis, Tinnitus, dizziness, permanent sensation of very cold ( specially on my back), menstrual pain ( almost constant for 5 months), Menstrual Clotting ( 2 times), lymphadenopathy,brain fog, tunel vision,general malaise, fever, sweats.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria, Vision blurred, X-ray normal
Clinical narrative: Hospital: After 10 - 15 minutes I began to have symptoms of muscle hardness on the upper left part of my back. mialgia)( After 30 min. the pain was very strong and accompanied by a urticaria on my chest. (helped with intravenous medication) After 60 min. - cloudy vision. Home( incl. day of vaccine): Paresthesia (various types), asthenia, chest pain, hives, rashes (back), terrible Burning sensation (back), short of breath, tremors, joint pain (knee), tachicardia (POTS), Subacute Thyroiditis, Tinnitus, dizziness, permanent sensation of very cold ( specially on my back), menstrual pain ( almost constant for 5 months), Menstrual Clotting ( 2 times), lymphadenopathy,brain fog, tunel vision,general malaise, fever, sweats.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: No additional AE reported; Patient was administered a low MMRII Dose on 12/19/2022 due to Corresponding MMRII leaking outside of Corresponding Syringe Needle; Patient was administered a low MMRII Dose on 12/19/2022 due to Corresponding MMRII leaking outside of Corresponding Syringe Needle; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information of the patient's medical history, drug reactions/allergies, concomitant medication and concurrent condition was unknown.  On 19-DEC-2022, the patient was administrated with a low dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (therapy type: recombinant Human albumin (rHA), lot #U039549, expiration date: 14-DEC-2023, strength, anatomical location and route of administration were not reported) prophylaxis due to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) leaking outside of corresponding syringe needle (accidental underdose), (needle issue). Only the patient was exposed to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No additional adverse event (AE) reported (no adverse event).
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; TE case/PROQUAD was administered to 1 patient; This spontaneous report was received from a nurse referring to a 5-year-old female patient. The patient's medical histories, concomitant medications, concurrent conditions and drug reaction/allergies were not reported.  On 05-JAN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter, once, lot #W028564, expiration date: 06-MAR-2024, administered for prophylaxis (strength, route of administration and anatomical site of administration were not provided) which was improperly stored (product storage error). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Injection site mass, Urticaria
Clinical narrative: big lump at injection site; Hives on one foot; This case was reported by a consumer via interactive digital media and described the occurrence of injection site lump in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2023, the patient received Shingrix. On 4th January 2023, 2 days after receiving Shingrix, the patient experienced injection site lump and hives. On an unknown date, the outcome of the injection site lump and hives were unknown.   It was unknown if the reporter considered the injection site lump and hives to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment: The case was received by consumer via interactive digital media. The patient reported that he/she received Shingrix vaccine on Monday. The patient stated that yesterday (day before reporting) observed a very big lump in the place where he/she received vaccine and a little hives in one of his/her foot. Follow-up would not possible as no contact details were available.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient had received Kinrix vaccine on 28Nov2022 at a different facility when he was 4 months of age; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 04-JAN-2023 Reporter's Comments: The physician reported that she saw a 6 month old male patient in clinic today (on the day of reporting) as a new patient, and when she looked on his shot records, she noted that the patient had received Kinrix vaccine at a different facility when he was 4 months of age. The patient had no adverse effects noted and was doing well. The reporter did not had lot number and expiration date information. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Kinrix below the recommended age limit, which led to inappropriate age at vaccine administration. Note: The reporting system details captured as reported due to limited information.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 08-Jan-2023 regarding an unsolicited valid non-serious case received from a non-healthcare professional via social media.  This case involves a male patient of unknown age who experienced flu after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient had received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, route, formulation, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination (immunization).  On an unknown date, the patient developed flu (influenza) (latency: unknown) following the administration of influenza vaccine.  It was reported, "My boyfriend got the flu shot and it gave him the flu. And then he gave it to me."  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the outcome was Unknown for the event.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Underdose
Clinical narrative: pregnant patient was administered a less that half dose of adacel with no reported adverse event; Initial information received on 06-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 28 years old female patient who was pregnant and got the vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in context of pregnant patient was administered a less that half dose of adacel with no reported adverse event.   The gestation period at onset was not reported. The date of last menstrual period was not reported. The estimated due date is 18-Mar-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 06-Jan-2022, the patient received a dose 1 of suspect of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE for suspension for injection (lot no: 2CA24C1, expiry date: 02-Dec-2024, strength not reported) via intramuscular route in the left deltoid for immunization.  On an unknown date the pregnant patient got a less that half dose of adacel with no reported adverse event (exposure during pregnancy) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Relevant prenatal testing after exposure was not reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the pregnancy is still ongoing.
Sex: U
Vaccine: YF
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received an expired dose of YF-VAX (with no reported adverse event); Initial information received on 06-Jan-2023 regarding an unsolicited valid non-serious case received via physician.  This case involves an unknown age and unknown gender patient received an expired dose of yellow fever vaccine - [YF-VAX] (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect yellow fever vaccine - Solution for injection (strength: unknown) (batch number: UJ412AB) (expiry date: 25-Nov-2022) via unknown route in unknown administration site for immunization.  On an unknown date the patient received an expired dose of yf-vax (with no reported adverse event) (expired product administered) (unknown latency) following the administration of yellow fever vaccine.  Action taken with yellow fever vaccine (YF-VAX) was not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: HOSPITALIZATION
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: HOSPITALIZATION
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: HOSPITALIZATION
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: HOSPITALIZATION
Age: 70.0
Sex: U
Vaccine: COVID19-2
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Softball size Red, hot swelled area
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Bronchitis, Chest pain, Chills, Dyspnoea
Clinical narrative: Chills, body aches, chest conjestion/pain, fatigue, sore throat, headache, nausea ,short of breath  Sinusitis,  bronchitis  ,asthma shortness of breath. Now using nebulizer albuterolsul 2.5 mg/3 prn , wixela 2 x Da
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Chills, body aches, chest conjestion/pain, fatigue, sore throat, headache, nausea ,short of breath  Sinusitis,  bronchitis  ,asthma shortness of breath. Now using nebulizer albuterolsul 2.5 mg/3 prn , wixela 2 x Da
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Sinusitis, X-ray abnormal
Clinical narrative: Chills, body aches, chest conjestion/pain, fatigue, sore throat, headache, nausea ,short of breath  Sinusitis,  bronchitis  ,asthma shortness of breath. Now using nebulizer albuterolsul 2.5 mg/3 prn , wixela 2 x Da
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1 Moderna 2/12/21  025J20A dose 2 Moderna 3/12/21  006M20A
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case. Moderna 1/29/21 007M20A, 2/26/21 010A21A, 11/4/21 034F21A and 10/24/22 027E22A
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case. Moderna 3/7/21 015M20A, 4/5/21 025B21A, and boosted Pfizer 12/1/21 FJ1620
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest pain, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: 12/13/22 presents to ED for "chest pain, dyspnea". PMHx of "CAD s/p stents x3, HTN, HLD, type 2 diabetes mellitus"