chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Menveo 2 vials presentation instead of MMR vaccine; Inappropriate age at vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: Menveo 2 vials presentation instead of MMR vaccine) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt date: 14-SEP-2023 Medical Assistant reported that a 4 year old patient received by mistake Menveo 2 vials presentation instead of MMR vaccine which led to wrong vaccine administered and Inappropriate age at vaccine administered.  The reporter consented to follow up by e mail.
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 73 year old received a dose of Bexsero; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 73-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included splenectomy.   On 15-JUL-2023, the patient received the 1st dose of Bexsero. On 15-JUL-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: 73 year old received a dose of Bexsero).  The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-SEP-2023 The pharmacist stated that she had a 73 year old female patient who has had a splenectomy requested a dose of Bexsero as ordered by her physician. She stated that the patient already had 1 dose of Bexsero given on 15 July 2023 at a different location. Pharmacist did not have the lot number / expiration date of the dose and did not have the patient initials. At the time of reporting, a second dose had not been administered. 73 year old female patient received Bexsero Inappropriate age at vaccine administration The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: malaise lasting 3 days upon receipt of last dose (5th total dose, reported receiving in Jan/Feb 2023); This spontaneous case was reported by a patient and describes the occurrence of MALAISE (malaise lasting 3 days upon receipt of last dose (5th total dose, reported receiving in Jan/Feb 2023)) in an 83-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2023, the patient experienced MALAISE (malaise lasting 3 days upon receipt of last dose (5th total dose, reported receiving in Jan/Feb 2023)). In 2023, MALAISE (malaise lasting 3 days upon receipt of last dose (5th total dose, reported receiving in Jan/Feb 2023)) had resolved. Not Provided      For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pulse abnormal, Pyrexia
Clinical narrative: very sharp pains in chest and going up into their throat; very sharp pains in chest and going up into their throat; Pulse went up to 101; fever; chills; Arm is extremely sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm is extremely sore), CHEST PAIN (very sharp pains in chest and going up into their throat), PYREXIA (fever), CHILLS (chills) and OROPHARYNGEAL PAIN (very sharp pains in chest and going up into their throat) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had no known allergies, no previous health conditions and no previous heart or blood pressure concerns. It was unknown whether the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Pfizer (dose 1), Pfizer (dose 3) and Pfizer (dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 18-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 18-Sep-2023, the patient experienced PAIN IN EXTREMITY (Arm is extremely sore), PYREXIA (fever), CHILLS (chills) and PULSE ABNORMAL (Pulse went up to 101). On 20-Sep-2023, the patient experienced CHEST PAIN (very sharp pains in chest and going up into their throat) and OROPHARYNGEAL PAIN (very sharp pains in chest and going up into their throat). The patient was treated with ACETAMINOPHEN on 19-Sep-2023 at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm is extremely sore), CHEST PAIN (very sharp pains in chest and going up into their throat), PYREXIA (fever), CHILLS (chills), OROPHARYNGEAL PAIN (very sharp pains in chest and going up into their throat) and PULSE ABNORMAL (Pulse went up to 101) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2023, Blood pressure measurement: normal. On 18-Sep-2023, Body temperature: temperature went up to 101 degrees.    At night, temperature went from 101.7 to 102. On 18-Sep-2023, Heart rate: 100 and Pulse went up to 101.         No concomitant medication was reported. The patient had received the most recent Moderna Spikevax vaccine a couple of days ago. It didn't happen immediate but later in the day temperature went up to 101 degrees which isn't super serious. The pulse went up to 101 and it was normally above 60. The patient was left-handed and was given the shot in left arm. Arm was extremely sore. Two days later on 20th Sep, the patient got a very sharp pains in chest and going up into the throat. The patient's arm was sore right after the shot on 18th Sep, but as the day went on the arm pain got worse and worse and then got fever and chills. This was at night, late evening. The patient took temperature, it was 101.7 to 102. The heart rate was about 100 and blood pressure was normal.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 female patient received bnt162b2 (BNT162B2), on 25Oct2021 as dose 1, single (Batch/Lot number: unknown) and on 12Jun2022 as dose 2, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. 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 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid received).  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-202300302805 Same patient, different vaccine dose and different event;
Age: 62.0
Sex: F
Vaccine: 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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 01Nov2022 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "asthma", start date: 01Nov2022, stop date: 01Nov2022; "hypothyroidism" (unspecified if ongoing); "hyperlipodemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "Known Allergies: Demerol"; Codeine, reaction(s): "known Allergies: codiene". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" 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 (Paxlovid received).  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 58-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 01:00 as dose 5 (booster), single (Lot number: Fk9m9693) at the age of 57 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 15Mar2021 at 10:00 as dose 1, single (Lot number: En6203), in left arm, on 05Apr2021 at 12:00 as dose 2, single (Lot number: Ep6955), in left arm, on 09Nov2021 as dose 3 (booster), single (Lot number: Fg3527), in left arm and on 27Apr2022 at 12:00 as dose 4 (booster), single (Lot number: Fk9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer survivor" (unspecified if ongoing), notes: Breast cancer survivor. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid received). Additional information: No known allergy.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Infection, Sinus headache
Clinical narrative: Headache since time of infection that still persists; Headache since time of infection that still persists; sinus headache; Extremely fatigue; DOSE 6 (BOOSTER); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2023 at 11:00 as dose 6 (booster), single (Lot number: HH4595) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies:Pcn" (unspecified if ongoing). Concomitant medication(s) included: NIACINAMIDE; ATORVASTIN; METOPROLOL. Vaccination history included: Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Sep2023 at 11:00, outcome "unknown", described as "DOSE 6 (BOOSTER)"; FATIGUE (non-serious) with onset 16Sep2023 at 11:00, outcome "not recovered", described as "Extremely fatigue"; INFECTION (non-serious), HEADACHE (non-serious) all with onset 16Sep2023 at 11:00, outcome "not recovered" and all described as "Headache since time of infection that still persists"; SINUS HEADACHE (non-serious) with onset 16Sep2023 at 11:00, outcome "not recovered". Therapeutic measures were not taken as a result of infection, headache, sinus headache, fatigue.
Sex: M
Vaccine: MENB
Symptoms: Headache, Incomplete course of vaccination, Malaise, Pyrexia
Clinical narrative: not feeling well; headache; fever; It was supposed to be two parts but he only did 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the parent.  A 16-year-old male patient received meningococcal group b rlp2086 (TRUMENBA), in 2018 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well"; HEADACHE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; INCOMPLETE COURSE OF VACCINATION (non-serious), outcome "unknown", described as "It was supposed to be two parts but he only did 1".  Additional information: It was supposed to be two parts, but he only did 1 part. Caregiver was asking for medical information about Trumenba. Caregiver's son was supposed to be a 2-part series but he only did one part because he had side effects: fever, headache, and not feeling well. His doctor said these were common. Now fast forward 5 years, he is 21 years old and going to a dorm and needs to get vaccinated. Reporter wanted to know did he have immunity from the first shot after 5 years and did he complete it now or did he need to start series over and can it be done with Bexsero.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Amnesia, Depression, Headache, Illness
Clinical narrative: Trouble sleeping; It hurts when he walks; Losing weight/ Weight loss; Short term memory loss; Suffers mental health; Depression; Loss of hair; Non-stop headaches; Got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and legal division. The reporter is the parent.  A 15-year-old male patient received bnt162b2 (BNT162B2), on 31Aug2021 as dose 2, single (Lot number: FD8448) at the age of 15 years for covid-19 immunisation. The patient's relevant medical history included: "disabled" (unspecified if ongoing), notes: We are disabled. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot number: FA7485), administration date: 10Aug2021, for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Got sick"; INSOMNIA (non-serious), outcome "unknown", described as "Trouble sleeping"; PAIN (non-serious), outcome "unknown", described as "It hurts when he walks"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Losing weight/ Weight loss"; AMNESIA (non-serious), outcome "unknown", described as "Short term memory loss"; MENTAL DISORDER (non-serious), outcome "unknown", described as "Suffers mental health"; DEPRESSION (non-serious), outcome "unknown"; ALOPECIA (non-serious), outcome "unknown", described as "Loss of hair"; HEADACHE (non-serious), outcome "unknown", described as "Non-stop headaches". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter and her son had a sickness, weight loss, Loss of hair, depression, pain when walking and non-stop headaches.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300304578 same reporter/product, different event/patient;
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Mental disorder, Pain, Weight, Weight decreased
Clinical narrative: Trouble sleeping; It hurts when he walks; Losing weight/ Weight loss; Short term memory loss; Suffers mental health; Depression; Loss of hair; Non-stop headaches; Got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and legal division. The reporter is the parent.  A 15-year-old male patient received bnt162b2 (BNT162B2), on 31Aug2021 as dose 2, single (Lot number: FD8448) at the age of 15 years for covid-19 immunisation. The patient's relevant medical history included: "disabled" (unspecified if ongoing), notes: We are disabled. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot number: FA7485), administration date: 10Aug2021, for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Got sick"; INSOMNIA (non-serious), outcome "unknown", described as "Trouble sleeping"; PAIN (non-serious), outcome "unknown", described as "It hurts when he walks"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Losing weight/ Weight loss"; AMNESIA (non-serious), outcome "unknown", described as "Short term memory loss"; MENTAL DISORDER (non-serious), outcome "unknown", described as "Suffers mental health"; DEPRESSION (non-serious), outcome "unknown"; ALOPECIA (non-serious), outcome "unknown", described as "Loss of hair"; HEADACHE (non-serious), outcome "unknown", described as "Non-stop headaches". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter and her son had a sickness, weight loss, Loss of hair, depression, pain when walking and non-stop headaches.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300304578 same reporter/product, different event/patient;
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) (Other HCP). The reporter is the patient.  A 78-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown). The patient's relevant medical history included: "Shortness of breath when walking" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, 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 05Sep2023 to 09Sep2023.   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 the information provided in the narrative and known drug safety profile, a causal association between the events and the suspect drug cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300305506 same patient, same product, different dose/events;
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bedridden, Interchange of vaccine products, Joint range of motion decreased, Pain in extremity
Clinical narrative: she couldn't move her left arm at all/ her right arm was also extremely painful and could not move this one either; her back was extremely painful and the pain radiated into right arm; right arm was extremely painful and she couldn't move it either; She had to stay in bed.; her first two Covid vaccines were the J&J; injection it was a little sore for a couple of days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), on 10May2022 as dose 3 (initial pfizer dose), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Johnson and johnson covid vaccine (DOSE 1, SINGLE, The first two Covid shots were Johnson and Johnson), for COVID-19 Immunization; Johnson and johnson covid vaccine (DOSE 2, SINGLE, The first two Covid shots were Johnson and Johnson), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 10May2022, outcome "unknown", described as "her first two Covid vaccines were the J&J"; BEDRIDDEN (non-serious) with onset 11May2022, outcome "recovered" (May2022), described as "She had to stay in bed."; BACK PAIN (non-serious) with onset 11May2022, outcome "recovered" (May2022), described as "her back was extremely painful and the pain radiated into right arm"; PAIN IN EXTREMITY (non-serious) with onset 11May2022, outcome "recovered" (May2022), described as "right arm was extremely painful and she couldn't move it either"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 11May2022, outcome "recovered" (May2022), described as "she couldn't move her left arm at all/ her right arm was also extremely painful and could not move this one either"; VACCINATION SITE PAIN (non-serious) with onset May2022, outcome "recovered" (May2022), described as "injection it was a little sore for a couple of days".  Additional information: Caller states her first two Covid vaccines were the J and J and then she got her first Pfizer Covid vaccine on 10May2022. The next morning, she couldn't move her left arm at all, across her back was extremely painful and the pain radiated into right arm. So, her right arm was also extremely painful and could not move this one either. She had to stay in bed. The day after that it was gone. On this injection it was a little sore for a couple of days but nothing like the last time. This report was not related to a study or programmer.  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-202300306015 same patient, different dose/AE;
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: she couldn't move her left arm at all/ her right arm was also extremely painful and could not move this one either; her back was extremely painful and the pain radiated into right arm; right arm was extremely painful and she couldn't move it either; She had to stay in bed.; her first two Covid vaccines were the J&J; injection it was a little sore for a couple of days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), on 10May2022 as dose 3 (initial pfizer dose), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Johnson and johnson covid vaccine (DOSE 1, SINGLE, The first two Covid shots were Johnson and Johnson), for COVID-19 Immunization; Johnson and johnson covid vaccine (DOSE 2, SINGLE, The first two Covid shots were Johnson and Johnson), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 10May2022, outcome "unknown", described as "her first two Covid vaccines were the J&J"; BEDRIDDEN (non-serious) with onset 11May2022, outcome "recovered" (May2022), described as "She had to stay in bed."; BACK PAIN (non-serious) with onset 11May2022, outcome "recovered" (May2022), described as "her back was extremely painful and the pain radiated into right arm"; PAIN IN EXTREMITY (non-serious) with onset 11May2022, outcome "recovered" (May2022), described as "right arm was extremely painful and she couldn't move it either"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 11May2022, outcome "recovered" (May2022), described as "she couldn't move her left arm at all/ her right arm was also extremely painful and could not move this one either"; VACCINATION SITE PAIN (non-serious) with onset May2022, outcome "recovered" (May2022), described as "injection it was a little sore for a couple of days".  Additional information: Caller states her first two Covid vaccines were the J and J and then she got her first Pfizer Covid vaccine on 10May2022. The next morning, she couldn't move her left arm at all, across her back was extremely painful and the pain radiated into right arm. So, her right arm was also extremely painful and could not move this one either. She had to stay in bed. The day after that it was gone. On this injection it was a little sore for a couple of days but nothing like the last time. This report was not related to a study or programmer.  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-202300306015 same patient, different dose/AE;
Age: 18.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old male patient received bnt162b2 (BNT162B2), on 18Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 18 years 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's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other vaccine received, No Other medication in 2 weeks. Anti-viral details: Product: COVID 19 Treatment, Treatment start date: 11Sep2023, Treatment stop date: 16Sep2023, Indication: Treatment of COVID-19,   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), 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's relevant medical history included: "High blood pressure" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, 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 08Sep2023 to 12Sep2023.  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-202300305693 Same patient, different product, different event;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Intense body aches; headache; muscle pain; arm pain; tiredness; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2023 as dose 6 (booster), single (Lot number: HH7595) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ceclor, reaction(s): "Allergy: Ceclor"; Lisinopril, reaction(s): "Allergy: Lisinopril"; Topamax, reaction(s): "Allergy: Topamax". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (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 5 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 16Sep2023, outcome "recovered" (17Sep2023), described as "Intense body aches"; PAIN IN EXTREMITY (non-serious) with onset 16Sep2023, outcome "recovered" (17Sep2023), described as "arm pain"; HEADACHE (non-serious) with onset 16Sep2023, outcome "recovered" (17Sep2023); ARTHRALGIA (non-serious) with onset 16Sep2023, outcome "recovered" (17Sep2023), described as "joint pain"; MYALGIA (non-serious) with onset 16Sep2023, outcome "recovered" (17Sep2023), described as "muscle pain"; FATIGUE (non-serious) with onset 16Sep2023, outcome "recovered" (17Sep2023), described as "tiredness". Therapeutic measures were not taken as a result of pain, headache, myalgia, pain in extremity, fatigue, arthralgia.  Additional information: Patient did not received other vaccine in four weeks. Patient had received other medications in two weeks. The patient experienced intense body aches, headache, muscle pain, arm pain, tiredness, joint pain for two days. Patient had no covid prior vaccination and not tested covid post vaccination.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Intense body aches; headache; muscle pain; arm pain; tiredness; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2023 as dose 6 (booster), single (Lot number: HH7595) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ceclor, reaction(s): "Allergy: Ceclor"; Lisinopril, reaction(s): "Allergy: Lisinopril"; Topamax, reaction(s): "Allergy: Topamax". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (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 5 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 16Sep2023, outcome "recovered" (17Sep2023), described as "Intense body aches"; PAIN IN EXTREMITY (non-serious) with onset 16Sep2023, outcome "recovered" (17Sep2023), described as "arm pain"; HEADACHE (non-serious) with onset 16Sep2023, outcome "recovered" (17Sep2023); ARTHRALGIA (non-serious) with onset 16Sep2023, outcome "recovered" (17Sep2023), described as "joint pain"; MYALGIA (non-serious) with onset 16Sep2023, outcome "recovered" (17Sep2023), described as "muscle pain"; FATIGUE (non-serious) with onset 16Sep2023, outcome "recovered" (17Sep2023), described as "tiredness". Therapeutic measures were not taken as a result of pain, headache, myalgia, pain in extremity, fatigue, arthralgia.  Additional information: Patient did not received other vaccine in four weeks. Patient had received other medications in two weeks. The patient experienced intense body aches, headache, muscle pain, arm pain, tiredness, joint pain for two days. Patient had no covid prior vaccination and not tested covid post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Postural orthostatic tachycardia syndrome
Clinical narrative: POTS syndrome; gastrointestinal disease; This is a spontaneous report received from non-contactable reporter(s) (Nurse).  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single; manufacturer unknown, batch/lot number: unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Single; manufacturer unknown, batch/lot number: unknown), for Covid-19 immunization. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "recovering", described as "POTS syndrome"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "gastrointestinal disease". The events "pots syndrome" and "gastrointestinal disease" required physician office visit. It was unknown if therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome.  Additional information: Nurse reported that family member had received COVID vaccine and was diagnosed with POTS syndrome and gastrointestinal disease.  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: 37.0
Sex: M
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 38-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose 5 (booster), single (Lot number: GL0446) at the age of 37 years 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 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), outcome "not 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; (13Sep2023) Negative, notes: was testing negative 13Sep; (Sep2023) Positive, notes: then positive again a couple days later. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks: yes. Patient received COVID 19 Treatment with Paxlovid. Treatment start date was 08Sep2023 and Treatment stop date was 12Sep2023. Patient had no known allergies.
Age: 54.0
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) (Physician). The reporter is the patient.  A 55-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 54 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: "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: TERIPARATIDE, start date: 06Jul2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid from 12Sep2023 to 17Sep2023, for the treatment of covid-19. 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: Based on the information provided and temporal association, a causal relationship between  bnt162b2  and the reported events covid 19, drug ineffective cannot be excluded.
Sex: M
Vaccine: 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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pancreatitis" (unspecified if ongoing); "Allergy to sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Sep2023 to 13Sep2023.  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-202300305786 Same patient, Different product and events;
Age: 60.0
Sex: F
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 61-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 60 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: "Ankylosing spondylitis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received other medication in 2 weeks. Patient received COVID 19 Treatment with Paxlovid. Treatment start date was 12Sep2023 and Treatment stop date was 17Sep2023.   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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 66-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 3 (booster), single (Lot number: 9M9693) at the age of 65 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: 030A21A), in left arm and on 07Nov2021 as dose 2, single (Lot number: FH8020), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL, start date: 14Sep2018; LISINOPRIL, start date: 14Sep2018; SIMVASTATIN, start date: 14Sep1992. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures included Paxlovid from 10Sep2023 to 14Sep2023 were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300306423 same patient/drug, different dose/event;
Age: 35.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 35 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing); "Overweight" (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 "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 12Sep2023 from 16Sep2023.
Sex: F
Vaccine: COVID19, 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 36-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 08Sep2023 to 12Sep2023.  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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got the vaccine last year and tested positive; got the vaccine last year and tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got the vaccine last year and tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The caller claims that she experienced COVID symptoms a year ago. She had received all of her Pfizer COVID-19 shots by that time. The patient was prescribed Paxlovid and fine after that. Caller would like to know if the vaccine is still effective.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm (Nothing surprising, but reporting it anyway); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2023 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization Series Completed, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Sep2023 at 16:00, outcome "not recovered", described as "Sore arm (Nothing surprising, but reporting it anyway)". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: No covid prior vaccination. No covid tested post vaccination. No known allergies.  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-202101291962 Same patient/vaccine, different vaccine dose/event;US-PFIZER INC-2021238603 Same patient/vaccine, different vaccine dose/event;