chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Herpes zoster, Pain, Pain in extremity
Clinical narrative: Notice rash on left shoulder 10 days post vaccine  appears consistent with herpes zoster Had chills, body aches, left arm pain Followed by cough right after vaccine
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Notice rash on left shoulder 10 days post vaccine  appears consistent with herpes zoster Had chills, body aches, left arm pain Followed by cough right after vaccine
Age: 15.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Confusional state, Dizziness, Fatigue, Hyporesponsive to stimuli, Increased bronchial secretion
Clinical narrative: Pt in office with mom, rec'd vaccines. Per mom, she left after 10 minutes because she had to pick up another child, felt he had no previous issue with vaccines so he'd be fine. Upon driving with patient she noted his hands start to curl, he started making some gurgling noises and he wasn't responding appropriately to her so she brought him back to office. Assisted in w/c up to Pedi Dept. Patient palor and confused. Pt seemed post ictal,tired but answered questions.Pt assisted to exam table cool compress applied. Over next 45 min, he remained light headed,pale, then fell asleep for about 10 minutes and after this he seemed much improved and more talkative. Throughout this he was able to answer questions ,was coherent and oriented. He remembered questions asked of him and facts given to him to remember, CV and resp exam ,as well as neuro exam was otherwise normal throughout this time. Pupils equal and reactive symmetrically. Vital signs monitored throughout. Zofran 4mg by mouth given at 6:10pm. Pt able to stand upright and walk without nausea or dizziness and assisted out to car via w/c with mom and nurse at 6:40pm.
Age: 15.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Muscle contracture, Neurological examination normal, Pallor, Postictal state
Clinical narrative: Pt in office with mom, rec'd vaccines. Per mom, she left after 10 minutes because she had to pick up another child, felt he had no previous issue with vaccines so he'd be fine. Upon driving with patient she noted his hands start to curl, he started making some gurgling noises and he wasn't responding appropriately to her so she brought him back to office. Assisted in w/c up to Pedi Dept. Patient palor and confused. Pt seemed post ictal,tired but answered questions.Pt assisted to exam table cool compress applied. Over next 45 min, he remained light headed,pale, then fell asleep for about 10 minutes and after this he seemed much improved and more talkative. Throughout this he was able to answer questions ,was coherent and oriented. He remembered questions asked of him and facts given to him to remember, CV and resp exam ,as well as neuro exam was otherwise normal throughout this time. Pupils equal and reactive symmetrically. Vital signs monitored throughout. Zofran 4mg by mouth given at 6:10pm. Pt able to stand upright and walk without nausea or dizziness and assisted out to car via w/c with mom and nurse at 6:40pm.
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain after injection left deltoid
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Angiogram pulmonary normal, Chest X-ray abnormal, Chest pain, Computerised tomogram head normal, Dizziness
Clinical narrative: Dizziness, pain in chest, bodyaches recurring from late Friday afternoon to Monday morning, when symptoms began to subside.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Pain
Clinical narrative: Dizziness, pain in chest, bodyaches recurring from late Friday afternoon to Monday morning, when symptoms began to subside.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Mobility decreased, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: States next am woke up with "pins and needle" sensation in both legs waist down . bottom of feet no sensation. walking deliberately , slowly and stiff. Monday 4/12- slight improvement remained stiff, slight improvement with numbness. 4/15- states 80 % improvement with ability to ambulate , decreased sensation now focused in the hip and groin area. Tylenol and Ibuprofen taken 1 day post vaccination.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory loss
Clinical narrative: States next am woke up with "pins and needle" sensation in both legs waist down . bottom of feet no sensation. walking deliberately , slowly and stiff. Monday 4/12- slight improvement remained stiff, slight improvement with numbness. 4/15- states 80 % improvement with ability to ambulate , decreased sensation now focused in the hip and groin area. Tylenol and Ibuprofen taken 1 day post vaccination.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: No adverse event
Clinical narrative: No adverse event noted at office visit.
Age: 78.0
Sex: F
Vaccine: COVID19-2, HEPA, YF
Symptoms: No adverse event, Product use issue
Clinical narrative: No adverse event client is fine Talked with her 4/18/2023 - she had no problems. Event is being reported because I gave live Yellow Fever when client was Receiving Dupixent - every 2 weeks - she called her Dr and Dupixent treatment did not need to be delayed
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received a dosage of 0.2 ml of the bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a dosage of 0.2 ml of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Rotavirus (Rota tec), Pediarix, ACT Hib and PCV 13. Past adverse reactions to the above products included No adverse event with ACT Hib, PCV 13, Pediarix and Rotavirus (Rota tec). Concurrent medical conditions included Lactose intolerant and Milk allergy (Allergic to cow milk protein).    On 19-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a dosage of 0.2 ml of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a dosage of 0.2 ml of the bivalent vaccine) 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), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received a dosage of 0.2 ml of the bivalent vaccine).    No concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-720512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720512:Infant Patient - 1 (master case)
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Laboratory test abnormal, Tinnitus
Clinical narrative: PT CALLED AND SPOKE TO PHARMACIST ON DUTY, ON 5/19/2021 AND SAID HE'S BEEN TIRED AND WEAK SINCE HIS SHOTS A MONTH AGO OR MORE. SEEN DR AND THEY RAN TESTS NOTHING COMING BACK AS WRONG WITH HIM. JUST WANTED TO LET US KNOW... ON 4/25/23 I GOT A CALL FROM COORDINATOR, INDICATING THAT PATIENT HAS BEEN COMPLAINING OF RINGING IN EARS SINCE HE GOT THE COVID SHOTS.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use
Clinical narrative: RECEIVED ONLY HALF A DOSE DUE TO A MISTAKE AND RECEIVED REMAINING HALF DOSE OF THE VACCINE ON THE FOLLOWING DAY; RECEIVED THIRD DOSE OF THE J AND J VACCINE; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 135 pounds, and height was 66 inches. The patient's concurrent conditions included: polyethylene glycol allergy, and other pre-existing medical conditions included: No allergies or side effects after previous vaccinations. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on unspecified date for COVID-19 prophylaxis.  It was reported that patient had no adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient previously received second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on unspecified date for COVID-19 prophylaxis.  It was reported that patient had no adverse events following vaccination with second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2). The patient additionally received third dose of covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin not reported, batch number: 1855140, expiry: unknown) dose was not reported, 1 total administered to left arm on 21-JUN-2022 for covid-19 prophylaxis which was Off label use (Off label dosing frequency) (dose number in series 3). The drug was associated with Medication error and Off label use (dose number in series 3). Age at time of vaccination 64 years old. No concomitant medications were reported.  On 21-JUN-2022, the patient received third dose of J and J vaccine. Patient only received half a dose (due to a mistake made by the person delivering the vaccine). She returned the following day on 22-JUN-2022 and was given the remaining half dose of the J and J vaccine (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received only half a dose due to a mistake and received remaining half dose of the vaccine on the following day and received third dose of the j and j vaccine was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin abnormal, Systemic lupus erythematosus
Clinical narrative: Diagnosed with lupus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Cerebyx for allergies Cerebyx; Morphine for allergies morphine. Vaccination history included: Bnt162b2 (Dose No: 1, Batch/Lot No:Unk., Unable to locate or read the details), administration date: Feb2021, when the patient was 37 years old, for COVID-19 immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant) with onset Jan2023, outcome "not recovered", described as "Diagnosed with lupus". The event "diagnosed with lupus" required physician office visit. Therapeutic measures were taken as a result of systemic lupus erythematosus.  Clinical Course:No other vaccine in four weeks.No Other medications in two weeks. AE treatment was Cream. No covid prior vaccination.If covid tested post vaccination was Unknown  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: Diagnosed with lupus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Cerebyx for allergies Cerebyx; Morphine for allergies morphine. Vaccination history included: Bnt162b2 (Dose No: 1, Batch/Lot No:Unk., Unable to locate or read the details), administration date: Feb2021, when the patient was 37 years old, for COVID-19 immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant) with onset Jan2023, outcome "not recovered", described as "Diagnosed with lupus". The event "diagnosed with lupus" required physician office visit. Therapeutic measures were taken as a result of systemic lupus erythematosus.  Clinical Course:No other vaccine in four weeks.No Other medications in two weeks. AE treatment was Cream. No covid prior vaccination.If covid tested post vaccination was Unknown  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 14.0
Sex: M
Vaccine: FLUC4, HPV9, FLUC4
Symptoms: Death
Clinical narrative: Patient came in office for well child exam, got vaccines given according to patients age and what was due.  No signs noted at the time administered.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Autoimmune thyroiditis, Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: : years later she completed 2 dose series with Gardasil 9 successfully; after the first dose of Gardasil in 2015. Years later she completed 2 dose series with Gardasil 9 successfully.; Email received inbox on 19APR2023 at 2013 ET with an adverse event report for GARDASIL and GARDASIL 9. Report verbatim: "A HCP  reported she developed hashimoto after the first dose of Gardasil in 2015. Years later she; Information has been received from a female patient of unknown age, referring on herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date in 2015, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), 0.05 milliliter (lot number, expiration date and anatomical location were not reported).  On an unspecified date in 2015, she developed Hashimoto (autoimmune thyroiditis) after the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL).   On an unknown date (reported as "years later"), she completed the two dose series with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot number, expiration date and anatomical location were not reported), successfully (interchange of vaccine products, inappropriate schedule of product administration).  The outcome of autoimmune thyroiditis and the causality assessment between the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and the event were unknown.     Upon internal review, the autoimmune thyroiditis was considered as medically significant event.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received an Expired Dose of Heplisav-B; Initial Report Received on 08-FEB-2023 and 09-FEB-2023.  A supervisor reported that a 58 year-old male (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 06-FEB-2023, the patient received a dose of HEPLISAV-B (Lot #935849, expiration date 13-JAN-2023 and NDC # 43528-003-01) intramuscularly in the right deltoid from a nurse.   On 06-FEB-2023, the patient received an expired dose of HEPLISAV-B. No adverse effects were reported by patient.   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Received an Expired Dose; Initial Report Received on 08-FEB-2023 and 09-FEB-2023.  A supervisor reported that a 56 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 06-FEB-2023, the patient received a dose of HEPLISAV-B (Lot #935849, expiration date 13-JAN-2023 and NDC # 43528-003-01) intramuscularly in the left deltoid from a nurse.   On 06-FEB-2023, the patient received an expired dose of HEPLISAV-B. No adverse effects were reported by patient.   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received First Dose on 02/06/2023 And a Second Dose on 02/07/2023; Initial Report Received on 10-Feb-2023.  A pharmacist reported that a 48-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and received a second dose HEPLISAV-B one day later.  Medical history and concomitant medications at the time of vaccination were not reported. The patient had no known allergies.  On 06-Feb-2023, the patient received the first dose of HEPLISAV-B vaccine (details not available) from another pharmacy location.   On 07-Feb-2023, one day after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot # 937234, expiration date 12-Sep-2023, NDC # 43528-003-05; route and injection site not reported) at this pharmacy. No adverse reactions were reported.  No further information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Therapy non-responder
Clinical narrative: First Dose Given on 3/14/2022 Second Dose Given on 12/05/2022; Patient Had Full Series of Heplisav-B and Did Not Respond; Initial Report Received on 13-Feb-2023  A registered nurse reported that a 63-year-old male patient (race and ethnicity unknown) received a full series of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and did not respond.  Medical history and concomitant medications at the time of vaccination were not reported. The patient has allergies to penicillin.  On 14-Mar-2022, the patient received the first dose of HEPLISAV-B vaccine (Lot # 935849, expiration date 13-Jan-2023; NDC # and route not reported) in the right deltoid.  On 05-Dec-2022, 267 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot # 940487, expiration date 14-Nov-2024; NDC # and route not reported) in the right deltoid. The patient had the full series of HEPLISAV-B and did not respond. The time to titer and the titer result was not specified.  No further information was provided.   Company Comment: The company assessed the events as non-serious. The event was considered non-immunologically confirmed due to dosing schedule and date and results of titer not specified.; Sender's Comments: The company assessed the events as non-serious. The event was considered non-immunologically confirmed due to dosing schedule and date and results of titer not specified.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Received the 1st Dose, Missed the 2nd Dose, and Then Received It a Year Later; Initial Report Received on 24-Feb-2023  A registered pharmacist reported that a 60-year-old female patient (race and ethnicity unknown) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the second dose of HEPLISAV-B a year later.  Medical history and allergies at the time of vaccination were not reported. Concomitant medications at the time of vaccination included levothyroxine.  On 28-May-2022, the patient received the first dose of HEPLISAV-B vaccine (Lot # 934975, expiration date 13-Aug-2022, and NDC # 43528-003-05) intramuscularly in the right deltoid. The patient missed the second dose of HEPLISAV-B.  On 16-Feb-2023, 265 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot # 939672, expiration date 14-May-2024, and NDC # 43528-003-05) intramuscularly in the right deltoid. The patient did not experience any adverse effects.  No further information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Received 2 Doses of Heplisav-B At The Same Time; Initial Report Received on 28-Feb-2023  A registered pharmacist reported that a 36-year-old male patient (race and ethnicity unknown) received two doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization at the same time in a combined dose.  Medical history was unknown and concomitant medications at the time of vaccination were not reported. The patient had no known drug allergies.  On an unknown date, the patient received two doses of HEPLISAV-B vaccine (Lot # 937230, expiration date Sep-2023, NDC # 4352800  305) at the same time in a combined dose intramuscularly (injection site unknown). The person administering the vaccines misread the prescription and combined two doses of HEPLISAV-B into one prefilled syringe and administered them to the patient. No adverse reactions were reported.  No further information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: An Expired Vaccine Was Administered; Patient received second dose of Heplisav-B four months after first dose; Initial Report Received on 02-Mar-2023.    A registered nurse reported that a 59-year-old male patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was expired.     Medical history and allergies were not reported at the time of vaccination. The patient was not on any concomitant medications.    On 01-Nov-2022, the patient received the first dose of HEPLISAV-B vaccine (no details were reported).    On 02-Mar-2023, the patient received the second dose of HEPLISAV-B vaccine (Lot # 937231, expiration date 30Jan-2023, NDC # 43528-003-05) intramuscularly in the right deltoid. The second dose of HEPLISAV-B vaccine that the patient received expired on 30-Jan-2023. The patient did not experience any adverse effects from the first or second dose of HEPLISAV-B.     Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Feeling hot, Thirst
Clinical narrative: high blood sugar above 200 mg/dl; warm; thirsty; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP).  An 85-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Organ-limited amyloidosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; Manufacturer unknown), for COVID-19 immunization. The following information was reported: BLOOD GLUCOSE INCREASED (medically significant), outcome "unknown", described as "high blood sugar above 200 mg/dl"; FEELING HOT (non-serious), outcome "unknown", described as "warm"; THIRST (non-serious), outcome "unknown", described as "thirsty". The patient underwent the following laboratory tests and procedures: Blood glucose: high blood sugar above 200. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of subject  vaccine cannot be excluded for the reported events, based on temporal relationship. There is limited information provided in this report.  This case will be reassessed upon receipt of follow-up information.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose #4: Pfizer/ Dose #5: Moderna; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Non-Hodgkin's lymphoma" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing); "Contrast dye allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Oct2022, outcome "unknown", described as "Dose #4: Pfizer/ Dose #5: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid as COVID-19 treatment from 10Apr2023 to 14Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded. Linked Report(s): US-PFIZER INC-202300161451 Same reporter/patient, different product/AE;
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: my period was delayed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 3 (booster), single (Lot number: GH9703) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Is bivalent: False, Prev dose lot number: EW0162, Prev dose lot unknown: False, Prev dose administration date: 20Apr2021, Prev dose dose number: 2, Prev dose vaccine location: Left arm), administration date: 20Apr2021, when the patient was 38-year-old, for COVID-19 immunization, reaction(s): "Drug ineffective", "Suspected COVID-19"; BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Is bivalent: False, Prev dose lot number: ER8733, Prev dose lot unknown: False, Prev dose administration date: 31Mar2021, Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 31Mar2021, when the patient was 38-year-old, for COVID-19 immunization, reaction(s): "Drug ineffective", "Suspected COVID-19". The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 09Oct2022, outcome "recovered", described as "my period was delayed". Therapeutic measures were not taken as a result of menstruation delayed.  Additional information: No other vaccine in four weeks. Other medications in two weeks included Zyrtec and multivitamin. After her booster shot in Sep2022, her period was delayed by 6 days. She used [Name withheld] to track her period and she was extremely regular 28 day cycle and have been for 3 years of tracking. After being delayed, then her cycle was right back on track. This was extremely concerning. She had covid prior vaccination and she was not covid tested post vaccination. Known allergies included penicillin and Other medical history: no.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300162028 same product, patient, different AEs, different dose;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID from 07Apr2023 to 10Apr2023 (lot number: GJ3474).   Clinical course: No known allergies. It was unknown whether other medication taken in 2 weeks or not.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 83 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arteriosclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient received Paxlovid for treatment of COVID-19 which stopped on. 13Apr2023. No known allergies were reported.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 12Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic urticaria" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: 01Sep2010; LORATADINE, start date: 01Dec1998; BUPROPION. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No Known allergies. The patient received Anti-Viral treatment with Paxlovid for Covid-19 started on 10Apr2023 and stopped on 14Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The contributory role of the suspect product to the reported drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.
Sex: M
Vaccine: PNC20
Symptoms: Cerebrovascular accident, Headache, Vision blurred
Clinical narrative: stroke; he had a headache and blurred vision the day of vaccination; he had a headache and blurred vision the day of vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; HEADACHE (non-serious), VISION BLURRED (non-serious), outcome "unknown" and all described as "he had a headache and blurred vision the day of vaccination". Additional information: Patients' wife stated that he had a headache and blurred vision the day of vaccination. Then a week later had a stroke.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Therapeutic response unexpected
Clinical narrative: the happy unexpected improvement; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 81-year-old female patient received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EL3246) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "vascular dementia alzheimers and parkinsons" (unspecified if ongoing); "vascular dementia alzheimers and parkinsons" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "the happy unexpected improvement".  Additional information: This is not an adverse negative reaction but rather a positive side effect. At both initial vaccines my mother experienced a (Illegible word) cognitive improvement. More alert and responsive as if to suggest an arresting of disease process. She has vascular dementia alzheimers and parkinsons. Both of which degrade overall awareness and interactive responsiveness. Beyond a pronounced general fatigue which is the understood effect of any vaccine on the body, the happy unexpected improvement which seems to occurred with any revaccination of Pfizer COVID vaccine. Caller report for the record that research may result. One or more of the chemicals or chemistry of this product could prove useful in the fight of both alzheimers and parkinsons.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Therapeutic response unexpected
Clinical narrative: The happy unexpected improvement; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 81-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 2, single (Lot number: EL3246) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "vascular dementia Alzheimer's and Parkinson's" (unspecified if ongoing); "vascular dementia Alzheimer's and Parkinson's" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 01, Dosage: Standard vaccine dose, Lot/Batch Number: EL3246), administration date: 07Jan2021, when the patient was 81-year-old, for COVID-19 immunization, reaction(s): "The happy unexpected improvement", "Fatigue". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "The happy unexpected improvement". Therapeutic measures were not taken as a result of fatigue.  Additional information: This is not an adverse negative reaction but rather a positive side effect. At both initial vaccines my mother experienced a (Illegible word) cognitive improvement. More alert and responsive as if to suggest an arresting of disease process. She has vascular dementia alzheimers and parkinsons. Both of which degrade overall awareness and interactive responsiveness. Beyond a pronounced general fatigue which is the understood effect of any vaccine on the body, the happy unexpected improvement which seems to occurred with any revaccination of Pfizer COVID vaccine. Caller report for the record that research may result. One or more of the chemicals or chemistry of this product could prove useful in the fight of both alzheimers and parkinsons.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Drug ineffective, Suspected COVID-19
Clinical narrative: The happy unexpected improvement; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 81-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 2, single (Lot number: EL3246) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "vascular dementia Alzheimer's and Parkinson's" (unspecified if ongoing); "vascular dementia Alzheimer's and Parkinson's" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 01, Dosage: Standard vaccine dose, Lot/Batch Number: EL3246), administration date: 07Jan2021, when the patient was 81-year-old, for COVID-19 immunization, reaction(s): "The happy unexpected improvement", "Fatigue". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "The happy unexpected improvement". Therapeutic measures were not taken as a result of fatigue.  Additional information: This is not an adverse negative reaction but rather a positive side effect. At both initial vaccines my mother experienced a (Illegible word) cognitive improvement. More alert and responsive as if to suggest an arresting of disease process. She has vascular dementia alzheimers and parkinsons. Both of which degrade overall awareness and interactive responsiveness. Beyond a pronounced general fatigue which is the understood effect of any vaccine on the body, the happy unexpected improvement which seems to occurred with any revaccination of Pfizer COVID vaccine. Caller report for the record that research may result. One or more of the chemicals or chemistry of this product could prove useful in the fight of both alzheimers and parkinsons.
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet disorder
Clinical narrative: she got her vaccine it affects her platelet; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), 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: PLATELET DISORDER (non-serious), outcome "unknown", described as "she got her vaccine it affects her platelet". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated that when she got vaccine it affected her platelet, she was not able to get any type of the vaccine and Pfizer never admit it and never dismissed the seriousness of it and added that the vaccine is stay and fall safe.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Patient had a mild case of Covid or reaction from Covid injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2023US075554_OS (Novartis).  A 73-year-old male patient received BNT162b2 (BNT162B2 NOS), 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: IMMUNISATION REACTION (non-serious), outcome "unknown", described as "Patient had a mild case of Covid or reaction from Covid injection".  Additional information: Patient had a mild case of Covid or reaction from Covid injection.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Myocardial infarction, Post-acute COVID-19 syndrome
Clinical narrative: got COVID; got COVID; heart attack due to a 100% blockage; long COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2 (COMIRNATY), as dose 1, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID"; MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack due to a 100% blockage"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long COVID". Clinical course: After initial dose patient got COVID and during long COVID he had a heart attack due to a 100% blockage that is has left him suspicious though not positive of the 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: Drug ineffective, Suspected COVID-19
Clinical narrative: Doesn't find the vaccine effective; Doesn't find the vaccine effective; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Doesn't find the vaccine effective".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective
Clinical narrative: The first two boosters didn't stop me from getting COVID; The first two boosters didn't stop me from getting COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "The first two boosters didn't stop me from getting COVID".  Additional information: The patient sated, "Don't need it, the first two boosters didn't stop me from getting COVID."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair is falling out; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2 NOS), 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: ALOPECIA (non-serious), outcome "unknown", described as "Hair is falling out". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: not effective; not effective; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "not effective". The doctor told the patient it was not effective against the most recent variant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.