chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received 2nd Dose of Heplisav-B 21 Days After The First Dose; Initial report received on 24-Aug-2023  A registered nurse reported that a 48-year-old female patient (race and ethnicity not provided) received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization 21 days after the first dose.  Medical history at the time of vaccination was reported as unknown. The patient had allergies to penicillin, Bactrim (sulfamethoxazole-trimethoprim), erythromycin, "Spirofloxan," iodine, latex, pineapple, and shellfish (all reactions were unknown).   Concomitant medications at the time of vaccination were not reported.   On 01-Aug-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not reported).   On 22 Aug-2023, 21 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot # 940486, expiration date 10-Nov-2024, and NDC # 43528 003 01) intramuscularly (injection site not reported). The patient did not report any side effects.   No other information was available.  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 of Heplisav-B; Initial report received on 12-Sep-2023  A registered pharmacist reported that a 29-year-old female patient (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant medications at the time of vaccination were not reported. The patient had no allergies or previous reactions to other vaccines.  On 12-Sep-2023, the patient received an expired dose of HEPLISAV-B (Lot # 937228, expiration date 30 Aug-2023, NDC # 43528-003-05; route not reported) in the left shoulder by the registered pharmacist.   No additional 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: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received Heplisav-B on 85 then 2nd Dose was Engerix on 9/5; Initial report received on 12-Oct-2023  A pharmacist reported that a 49-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient received a second dose of Engerix-B 31 days later.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On a 05-Aug-2023, the patient received the first dose of HEPLISAV-B (Lot #937780, expiration date 14-Sep-2023, and NDC # 43528-003-05) intramuscularly in the right arm. On 05-Sep-2023 the patient received a dose of Engerix-B (Lot #4H297, expiration date 06-Apr-2025; NDC number not reported) in the right arm.  On 05-Sep-2023, 31 days after having been vaccinated with HEPLISAV-B, the patient received Engerix-B. No adverse effects or pregnancy reported.   No additional information was reported.   Company Comment:  The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: First Dose Given With Heplisav-B and Second Dose Given With Engerix; Initial report received on 16-Oct-2023  A company sales representative on behalf of a licensed practical nurse reported that a 48-year-old female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and Engerix-B as the second dose.  Allergies, previous reactions to other vaccines, or medications were reported as unknown.  On 13-Sep-2023, the patient received the first dose of HEPLISAV-B (Lot # 941590, expiration date 31 Aug 2025, NDC # 43528-002-01; route of administration not reported) in the left deltoid.   On 13-Oct-2023, 30 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received Engerix-B (no details provided) as the second dose. No adverse reactions were reported.  No additional information was provided.  Company Comment: The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received First Dose with Heplisav-B and Second Dose with Engerix; Initial Report Received on 26-Oct-2023  A nurse reported that a 20-year-old male patient (race, and ethnicity not provided) received first dose with HEPLISAV-B and second dose with ENGERIX-B.  Medical history and allergies at the time of vaccination were not reported. Medications at the time of vaccination were not reported.  On 21-Jul-2023, the patient received HEPLISAV-B (NDC # 043528-003-01, lot # 935844, and expiration date of 04-Nov-2022; route and site of administration not reported) for hepatitis B immunization.   On 20-Oct-2023, the patient received ENGERIX-B(Lot #, expiration date, NDC #, route and site of administration not reported) as the second dose for hepatitis B immunization. No adverse reactions reported.  No additional information was reported.   Company Comment:  The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain
Clinical narrative: developed chest pain; This non-serious case was reported by a other health professional via call center representative and described the occurrence of chest pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-NOV-2023, the patient received the 2nd dose of Shingrix (left deltoid). On 14-NOV-2023, less than a day after receiving Shingrix, the patient experienced chest pain (Verbatim: developed chest pain). The outcome of the chest pain was resolved.   It was unknown if the reporter considered the chest pain to be related to Shingrix.     It was unknown if the company considered the chest pain to be related to Shingrix.   Additional Information: GSK receipt date: 21-NOV-2023 The reporter (office manager) stated that a patient received Shingrix, on the same day she developed chest pain. According to the reporter the patient went to the urgent care, and it was discharged the same day. The patient was doing okay. She was seen by the healthcare professional (HCP) at the medical office on the day of reporting and the pain was gone. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Malaise, Pain, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive; achy; dry cough; No temperature but does not feel right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 71-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Feb2023 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset Nov2023, outcome "unknown", described as "No temperature but does not feel right"; PAIN (non-serious) with onset Nov2023, outcome "unknown", described as "achy"; COUGH (non-serious) with onset Nov2023, outcome "unknown", described as "dry cough"; SARS-COV-2 TEST POSITIVE (non-serious) with onset 17Nov2023, outcome "unknown", described as "tested positive". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter said she got vaccinated yesterday with the Covid-19 vaccine and she feels achy and has a dry cough and she allegedly tested positive again this morning. She wants to know if it is normal. She is inquiring about the Pfizer Covid-19 vaccine for adults. Caller states this is the 5th one, and she never had a reaction. She used an old test, she has another test from the state/government that they sent her, she will try it later. She does not have a temperature but does not feel right, she is achy. She had Covid in February but it was not bad, she was okay after 2 days.  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Musculoskeletal stiffness, Vision blurred
Clinical narrative: stiff neck; blurred vision; throbbing head pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 13-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) at the age of 13 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "recovered", described as "stiff neck"; VISION BLURRED (non-serious), outcome "recovered", described as "blurred vision"; HEADACHE (non-serious), outcome "recovered", described as "throbbing head pain". Additional information included: Reporter stated that their regular doctor was telling them, her children experienced an allergic reaction to the vaccine, while the school doctor was stating that their reactions were not an allergic reaction. The school doctor provided that an allergist would have to prove it in which they tried to go to an allergist, and the allergist stated they don't do that. The reporter's son and daughter (patient), who were both 13 years old at the time of their reactions, had an adverse response to the meningitis vaccine that Pfizer manufactured. The patient had an adverse response, not as severe, that included two days of a stiff neck, blurred vision, and throbbing head pain at the base of the bottom of the head. It was reported that one child received the vaccine in 2013 and another child received the vaccine in 2019. Reporter stated, "if they're not having an allergic response according to the school doctor, what type of reaction was it? Is this vaccine poison?" Their regular doctor is stating they had an allergic reaction to the vaccine and is exempt from taking the booster. The school was saying they need to take the vaccine as there is no such thing as an allergic response.  The information on the batch/lot number for meningococcal group b rlp2086 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 73-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Keflex Allergy" (unspecified if ongoing); "Coronary Artery Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 13Nov2023 to 18Nov2023  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events Vaccination failure and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300396937 Same reporter/patient, different drug, different event.;
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 14Nov2023 to 18Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300396703 Same reporter/patient, different drug, different event.;
Sex: M
Vaccine: MENB
Symptoms: Epilepsy, Seizure
Clinical narrative: seizured; Epilepsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 13-year-old male patient received meningococcal group b rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation, meningitis; for immunisation, meningitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "seizured"; EPILEPSY (medically significant), outcome "unknown". Additional information: the patient's parent was inquiring about the "meningitis vaccine that Pfizer manufactures, does not know the name of the vaccine and stated that she is getting mixed messages from two different doctors on recommendations. The  regular doctor told them, her children experienced an allergic reaction to the vaccine, while the school doctor stated that their reactions were not an allergic reaction. Reporter stated the "school doctor provided that an allergist would have to prove it in which they tried to go to an allergist, and the allergist stated they don't do that. The parent provided that her "son and daughter, who were both 13 years old at the time of their reactions, had an adverse response to the meningitis vaccine that Pfizer manufactured. The son never got the booster for it, as a result, he has epilepsy and he seizured from it. The daughter had an adverse response, not as severe, that included two days of a stiff neck, blurred vision, and throbbing head pain at the base of the bottom of the head. Parent provided that one child received the vaccine in 2013 and another child received the vaccine in 2019. Parent added that her son had the same thing happen to him when he was 6, however doesn't known which vaccine, if it was meningitis, or a Pfizer vaccine. Parent provided that she had a history 50 years ago that resulted in encephalitis acute apoxia, inflammation of the brain, all neurological responses. Parent stated that their regular doctor stated they had an allergic reaction to the vaccine and is exempt from taking the booster, however the school was saying they need to take the vaccine as there is no such thing as an allergic response.   The information on the batch/lot number for meningococcal group b rlp2086, meningococcal group b rlp2086  has been requested and will be submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "OCD" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 09Jun2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of Covid-19; (14Sep2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 10Nov2023 to 14Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300396819 Same reporter/patient, different drug/AE;
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Jul2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 16Nov2023 to 20Nov2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300396864 same  patient/reporter, different drug/AE;
Age: 78.0
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) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 78-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 12:00 as dose 1, single (Lot number: HG4677) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rectal prolapse" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "IDS-C" (unspecified if ongoing); "known allergies: sulpha drugs" (unspecified if ongoing); "known allergies: lactose" (unspecified if ongoing); "known allergies: perfume" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, bnt162b2 omi ba.4-5 (Dose 5 (BOOSTER), SINGLE, vaccine administration time: 02:00 PM, vaccine lot number: GJ3277, vaccine location: Left arm), for COVID-19 immunization; Bnt162b2 (Dose 4 (BOOSTER), SINGLE, vaccine administration time: 02:00 PM, vaccine lot number: FP4554, vaccine location: Left arm), for COVID-19 immunization; Bnt162b2 (Dose 3 (BOOSTER), SINGLE, vaccine administration time: 02:00 PM, vaccine lot number: EW9217, vaccine location: Left arm), for COVID-19 immunization; Bnt162b2 (Dose 2, SINGLE, vaccine administration time: 02:00 PM, vaccine lot number: EN5318 , vaccine location: Left arm), for COVID-19 immunization; Bnt162b2 (Dose 1, SINGLE, vaccine administration time: 02:00 PM, vaccine lot number: EL9261, vaccine location: Left arm), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: COVID-19 Treatment with Paxlovid on 15Nov2023 till 19Nov2023, lot number: GH2641. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Balance disorder, Chills, Cough, Hypersomnia
Clinical narrative: fluid in ears/ still feels a little squishy in one ear; very weak/had no energy; constantly sleeping; Fever; Chills; Blurred vision; balance was off; coughing for hours; Sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 16Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for immunisation. The patient's relevant medical history included: "moderate COPD", start date: 2010 (ongoing), notes: probably from 2010. There were no concomitant medications. The following information was reported: VISION BLURRED (non-serious) with onset 17Nov2023, outcome "recovered" (17Nov2023), described as "Blurred vision"; CHILLS (non-serious) with onset 17Nov2023, outcome "recovered" (17Nov2023); PYREXIA (non-serious) with onset 17Nov2023, outcome "recovered" (18Nov2023), described as "Fever"; OROPHARYNGEAL PAIN (non-serious) with onset 17Nov2023, outcome "recovered" (17Nov2023), described as "Sore throat"; BALANCE DISORDER (non-serious) with onset 17Nov2023, outcome "recovered" (17Nov2023), described as "balance was off"; SOMNOLENCE (non-serious) with onset 17Nov2023, outcome "recovered" (18Nov2023), described as "constantly sleeping"; COUGH (non-serious) with onset 17Nov2023, outcome "not recovered", described as "coughing for hours"; ASTHENIA (non-serious) with onset 17Nov2023, outcome "not recovered", described as "very weak/had no energy"; EAR DISORDER (non-serious) with onset 18Nov2023, outcome "not recovered", described as "fluid in ears/ still feels a little squishy in one ear".  Additional information: The caller at first stated no prior vaccinations (within 4 weeks), then stated caller may have gotten a flu vaccine a week or 2 weeks before Abrysvo vaccine, went to doctor for check up, has so much going on, cannot recall for sure. There is no related family medical history. Because of age and has moderate COPD, the patient had vaccination. Caller clarified the side effects caller experienced were fever, chills, blurred vision which started very later on in the day 17Nov2023, balance was off, coughing for hours, sore throat, felt like had fluid in ears and still feels a little squishy in one ear, very weak stayed in bed for a like a day and a half so most of the day on Saturday because caller had no energy. Constantly sleeping, only got up to go to bathroom or get something to drink. Most of the side effects started early in the morning on 17Nov2023. Caller did not disclose any of this information to caller's doctor because felt like wouldn't do any good, doctor would just say stay home and rest and take this or that or go to a walk in.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Middle ear effusion, Oropharyngeal pain, Pyrexia, Vision blurred
Clinical narrative: fluid in ears/ still feels a little squishy in one ear; very weak/had no energy; constantly sleeping; Fever; Chills; Blurred vision; balance was off; coughing for hours; Sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 16Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for immunisation. The patient's relevant medical history included: "moderate COPD", start date: 2010 (ongoing), notes: probably from 2010. There were no concomitant medications. The following information was reported: VISION BLURRED (non-serious) with onset 17Nov2023, outcome "recovered" (17Nov2023), described as "Blurred vision"; CHILLS (non-serious) with onset 17Nov2023, outcome "recovered" (17Nov2023); PYREXIA (non-serious) with onset 17Nov2023, outcome "recovered" (18Nov2023), described as "Fever"; OROPHARYNGEAL PAIN (non-serious) with onset 17Nov2023, outcome "recovered" (17Nov2023), described as "Sore throat"; BALANCE DISORDER (non-serious) with onset 17Nov2023, outcome "recovered" (17Nov2023), described as "balance was off"; SOMNOLENCE (non-serious) with onset 17Nov2023, outcome "recovered" (18Nov2023), described as "constantly sleeping"; COUGH (non-serious) with onset 17Nov2023, outcome "not recovered", described as "coughing for hours"; ASTHENIA (non-serious) with onset 17Nov2023, outcome "not recovered", described as "very weak/had no energy"; EAR DISORDER (non-serious) with onset 18Nov2023, outcome "not recovered", described as "fluid in ears/ still feels a little squishy in one ear".  Additional information: The caller at first stated no prior vaccinations (within 4 weeks), then stated caller may have gotten a flu vaccine a week or 2 weeks before Abrysvo vaccine, went to doctor for check up, has so much going on, cannot recall for sure. There is no related family medical history. Because of age and has moderate COPD, the patient had vaccination. Caller clarified the side effects caller experienced were fever, chills, blurred vision which started very later on in the day 17Nov2023, balance was off, coughing for hours, sore throat, felt like had fluid in ears and still feels a little squishy in one ear, very weak stayed in bed for a like a day and a half so most of the day on Saturday because caller had no energy. Constantly sleeping, only got up to go to bathroom or get something to drink. Most of the side effects started early in the morning on 17Nov2023. Caller did not disclose any of this information to caller's doctor because felt like wouldn't do any good, doctor would just say stay home and rest and take this or that or go to a walk in.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Nov2023, outcome "recovered" (08Nov2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Nov2023) Positive; (08Nov2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient took Paxlovid from 03Nov2023 to 07Nov2023. Tested positive for Covid on 02Nov2023, started Paxlovid on 03Nov2023, tested negative on 08Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events Vaccination failure and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300400546 Same patient, different drug/event;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she rescheduled that because she got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient received bnt162b2 (BNT162B2), in Apr2021 as dose 1, single (Lot number: ER8733) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: diagnosed around age 30; "Hypothyroidism" (ongoing); "Blood pressure abnormal" (ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing); MONTELUKAST taken for asthma (ongoing); METOPROLOL SUCCINATE taken for blood pressure abnormal (ongoing). The following information was reported: COVID-19 (non-serious) with onset 2021, outcome "unknown", described as "she rescheduled that because she got Covid". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Synthroid: had been on Synthroid for thirty something years. Montelukast: been on it about 30-35 years. Metoprolol Succ ER: been on it probably 6-8 years. Height: she was shrinking and turning into her mother. Caller confirmed shrinking was before getting the Covid19 vaccine. She was talking like her mom and her hair was turning gray. Got first Covid vaccine at withheld Hospital and was sick at 2 o'clock in the morning. She reported that to CDC because she thought it was an adverse reaction and wanted them to know that she was in the waiting room with 50 people and was positive for Covid. That was on a Thursday and then grandson tested positive and her daughter tested positive on Saturday. Caller could not say if it the symptoms she had were Covid or the Covid vaccine because she had Covid when she got the vaccine. Caller clarified she is not sure if she had Covid and did not know it when she got the first Covid vaccine. She got the vaccine on Thursday and had symptoms of not feeling well, but did not get positive diagnosis from testing until Saturday. She tested positive on Saturday, but had the vaccine on Thursday. She was tested for Covid after her grandson tested positive for Covid on Saturday.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300400722 same patient/reporter, different doses/AE;US-PFIZER INC-202300400408 same patient/reporter, different doses/AE;
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Jan2023 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 13Nov2023 to 18Nov2023. Patient had No Known allergies.  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: Linked Report(s) : US-PFIZER INC-202300400754 Same patient, different drug and event;
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 as dose 1, single (Lot number: HG2282) at the age of 67 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 6 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 7 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 8 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 9 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 10 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 11 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 12 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 13 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 14 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 11Nov2023 to 15Nov2023. Clinical course: Patient had no known allergies  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300400753 Same patient, different drug and event;
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dermatitis allergic, Pain, Peripheral swelling, Rash
Clinical narrative: Rash; Allergic skin reaction; Arthralgia symptoms; Pain in UE and LE/ increased pain to WB; swelling of left foot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received bnt162b2 (BNT162B2), on 30Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Chocolate" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH (medically significant), outcome "unknown"; DERMATITIS ALLERGIC (medically significant), outcome "unknown", described as "Allergic skin reaction"; ARTHRALGIA (non-serious), outcome "unknown", described as "Arthralgia symptoms"; PAIN (non-serious), outcome "unknown", described as "Pain in UE and LE/ increased pain to WB"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling of left foot ". Clinical course: Family History: Mother: hypertension, Father: hypertension and had Angioplasty, Uncle: Cancer. Stated the rash appeared after having her first COVID vaccine injection, had swelling of left foot that appeared with the rash which caused increased pain to WB.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300400946 Same patient and product, Different dose and events;
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 09:30 as dose 1, single (Lot number: HG4677) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Drug Allergy", notes: known allergies: codeine. Vaccination history included: Covid-19 vaccine (dose 5 (booster), single; manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (dose 4 (booster), single; manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (dose 3 (booster), single; manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (dose 2, single; manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (dose 1, single; manufacturer unknown), for Covid-19 immunization.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: I keep testing positive but have practically no symptoms and no fever. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included PAXLOVID from 14Nov2023 to 19Nov2023.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 14:00 as dose 1, single (Lot number: CVS3940), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (19Nov2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Nov2023) Negative, notes: Tested negative 7 days after beginning symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from  13Nov2023 to 17Nov2023. Clinical course: Patient had no Known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300404830 same patient different drug/event;
Age: 40.0
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) (Nurse) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 20Oct2023 as dose 1, single (Lot number: Hg4677) at the age of 40 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Systemic lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Allergy: Bactrim"; Flagyl, reaction(s): "Drug allergies: flagyl"; Gabapentin, reaction(s): "Drug Allergy: gabapentin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information : The patient received paxlovid, since 14Nov2023 till 19Nov2023 for COVID-19. The patient received other medication in 2 weeks are Benlysta (start date : 01Feb2023), Plaquenil, Metoprolol , Methylprednisolone,  Memantine, Doxycycline, Dexilant and Qulipta  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.; 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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "known allergies: IV dye" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Anatomical location: Left arm), administration date: 10Feb2021, when the patient was 66-year-old, for Covid-19 immunisation; bnt162b2 (DOSE 2, SINGLE, Anatomical location: Left arm), administration date: 03Mar2021, when the patient was 66-year-old, for Covid-19 immunisation; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Left arm), administration date: 16Aug2021, when the patient was 67-year-old, for Covid-19 immunisation; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Anatomical location: Left arm), administration date: 14Apr2022, when the patient was 67-year-old, for Covid-19 immunisation; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Anatomical location: Left arm), administration date: 14Sep2022, when the patient was 68-year-old, for Covid-19 immunisation; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE, Anatomical location: Left arm), administration date: 11May2023, when the patient was 68-year-old, for Covid-19 immunisation. The following information was reported: VACCINATION FAILURE (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: (2023) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 13Nov2023 to 18Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300400983 Same reporter/ patient; different drug/event;
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 Nov2023, outcome "unknown" and all described as "COVID-19 Treatment". 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 : No other medication in 2 weeks. The patient received paxlovid treatment since 14Nov2023 till 19Nov2023 for COVID-19.  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: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient.  A 53-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Paxlovid was taken as therapeutic measures as a result of drug ineffective, covid-19 from 12Nov2023 to 16Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300404840 Same patient, different drug/events;