chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Rash, Renal disorder, Urine analysis
Clinical narrative: Rash, feet up to her thighs.; She has high blood pressure now.; how bad her kidneys are affected; has a high resting heart rate; diagnosed with HSP; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2022 as dose 2, single (Lot number: F51614) at the age of 12 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: number: 330368D, Expiration: Jun2022), administration date: 04Jan2022, when the patient was 12-year-old, for COVID-19 immunization. The following information was reported: HENOCH-SCHONLEIN PURPURA (non-serious) with onset Feb2022, outcome "not recovered", described as "diagnosed with HSP"; RASH (non-serious), outcome "not recovered", described as "Rash, feet up to her thighs."; HYPERTENSION (non-serious), outcome "unknown", described as "She has high blood pressure now."; RENAL DISORDER (non-serious), outcome "unknown", described as "how bad her kidneys are affected"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "has a high resting heart rate". The events "rash, feet up to her thighs." and "how bad her kidneys are affected" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, henoch-schonlein purpura, hypertension.  Additional information: Reporter reported for her daughter. Her and her daughter had adverse effects plus health problems. She wanted to report on her daughter first, since her daughter is worst. Her daughter's kidney specialist said it was from the vaccine. Less than a month after second covid vaccine her daughter got a really bad rash from her feet up to her thighs, and she was taken to the hospital and her doctor sent her to a kidney specialist. She was not admitted to the hospital. Did a lot of blood work and urine. She was diagnosed with HSP in late Feb2022, she does not know what HSP stands for. Treatment: she had to be put on steroids and another medication to get the rash to come down and antibiotics. Rash Outcome: Right now it is at an incline, the rash is not affecting her right now but giving her other problems. She has high blood pressure now and has to be on medication for that. She has a high resting heart rate, sometimes her heart rate goes between 150-160. Stated that the high blood pressure and high heartrate is from the HSP which she states is from the covid vaccine. Doctor did urinalysis and blood work and she is about to do a ultrasound on her kidneys. And will have to do a biopsy of her kidneys where she will have to stay overnight and be put to sleep, and see how bad her kidneys are affected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Weight
Clinical narrative: had a sore arm and was achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 30-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Diagnosed pre-2020 and reporter would say maybe in 2018 patient he was undiagnosed. Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, when the patient was 30 years old, for COVID-19 immunization, reaction(s): "had a sore arm and was achy". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had a sore arm and was achy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient's medical history was reported as: Hypothyroidism was diagnosed pre-2020 and reporter would say maybe in 2018 as patient was undiagnosed and after the fact he noted his hands were cold and put it together it may be the hypothyroidism and so was getting treatment by 2018 and this started to appear when the patient was in law school in 2016 and he was treated and they thought he was not just tired from law school but attributed some fatigue to being in school so was diagnosed in 2017 or 2018 for the hypothyroidism. Reporter further stated that the patient mounted a response and he had said his arms were a little sore; clarified the patient had a sore arm and was achy and was unremarkable.   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-202300249456 same reporter/patient/product, different dose/event;US-PFIZER INC-202300249538 same reporter/patient/product, different dose/event;
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Joint lock, Magnetic resonance imaging, Vaccination site joint movement impairment, Vaccination site pain
Clinical narrative: Our arms we can't hardly move them; Nothing but pain; I mean it hurts so bad you can hardly move your arms; Our arms we can't hardly move them; Nothing but pain; I mean it hurts so bad you can hardly move your arms; Shoulders are locking up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EW0158), administration date: 15Apr2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot/batch number not reported), administration date: 07May2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot/batch number not reported), administration date: 01Oct2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot/batch number not reported), administration date: 05Aug2022, when the patient was 58-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (non-serious) all with onset 11Nov2022, outcome "not recovered" and all described as "Our arms we can't hardly move them; Nothing but pain; I mean it hurts so bad you can hardly move your arms"; JOINT LOCK (non-serious) with onset 11Nov2022, outcome "not recovered", described as "Shoulders are locking up". The events "our arms we can't hardly move them; nothing but pain; i mean it hurts so bad you can hardly move your arms" and "shoulders are locking up" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, vaccination site joint movement impairment, joint lock.  Additional information: Reporter and his wife had taken vaccine and could not move their arms hardly. Nothing but pain, reporter stated that it hurt so bad and could hardly move arms and the shoulders were locking up. Patient took 5 shot of Pfizer vaccine. Fifth dose was taken on 11Nov2022 and lot number reported was GT25Z4 or 24 (not clear). Patient was given Advil 200mg a piece. Patient visited hospital and had neck and arm X ray and they could not find anything. He had an MRI because he thought it had something to do with his neck but it did not. Doctor could not find anything. Both reporter and his wife could not move left arm and it hurt constantly and there was no stop for it.  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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Our arms we can't hardly move them; Nothing but pain; I mean it hurts so bad you can hardly move your arms; Our arms we can't hardly move them; Nothing but pain; I mean it hurts so bad you can hardly move your arms; Shoulders are locking up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EW0158), administration date: 15Apr2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot/batch number not reported), administration date: 07May2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot/batch number not reported), administration date: 01Oct2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot/batch number not reported), administration date: 05Aug2022, when the patient was 58-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (non-serious) all with onset 11Nov2022, outcome "not recovered" and all described as "Our arms we can't hardly move them; Nothing but pain; I mean it hurts so bad you can hardly move your arms"; JOINT LOCK (non-serious) with onset 11Nov2022, outcome "not recovered", described as "Shoulders are locking up". The events "our arms we can't hardly move them; nothing but pain; i mean it hurts so bad you can hardly move your arms" and "shoulders are locking up" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, vaccination site joint movement impairment, joint lock.  Additional information: Reporter and his wife had taken vaccine and could not move their arms hardly. Nothing but pain, reporter stated that it hurt so bad and could hardly move arms and the shoulders were locking up. Patient took 5 shot of Pfizer vaccine. Fifth dose was taken on 11Nov2022 and lot number reported was GT25Z4 or 24 (not clear). Patient was given Advil 200mg a piece. Patient visited hospital and had neck and arm X ray and they could not find anything. He had an MRI because he thought it had something to do with his neck but it did not. Doctor could not find anything. Both reporter and his wife could not move left arm and it hurt constantly and there was no stop for it.  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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Joint lock, Magnetic resonance imaging, Vaccination site joint movement impairment, Vaccination site pain
Clinical narrative: Our arms we can't hardly move them/we hardly move our left arm; Nothing but pain; I mean it hurts so bad you can hardly move your arms; Our arms we can't hardly move them/we hardly move our left arm; Nothing but pain; I mean it hurts so bad you can hardly move your arms; Shoulders are locking up; hers was four Moderna (suspect captured as COVID-19 Moderna Vaccine) and one Pfizer. And the last one the fifth one was Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 60 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 moderna vaccine (DOSE 1, SINGLE, Lot number and expiration date not provided.), for COVID-19 immunization; Covid-19 moderna vaccine (DOSE 2, SINGLE, Lot number and expiration date not provided.), for COVID-19 immunization; Covid-19 moderna vaccine (DOSE 3, SINGLE, Lot number and expiration date not provided.), for COVID-19 immunization; Covid-19 moderna vaccine (DOSE 4, SINGLE, Lot number and expiration date not provided.), administration date: Aug2022, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 11Nov2022, outcome "unknown", described as "hers was four Moderna (suspect captured as COVID-19 Moderna Vaccine) and one Pfizer. And the last one the fifth one was Pfizer"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (non-serious) all with onset Jan2023, outcome "not recovered" and all described as "Our arms we can't hardly move them/we hardly move our left arm; Nothing but pain; I mean it hurts so bad you can hardly move your arms"; JOINT LOCK (non-serious) with onset Jan2023, outcome "not recovered", described as "Shoulders are locking up". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, vaccination site joint movement impairment, joint lock.  Additional Information: Patient was given Advil 200mg a piece. The patient had tried everything and nothing was helping. Actually she had an MRI. It was still the same every morning and it was like ache and the patient could hardly move her left arm. Lot number of Moderna was 014M2OA (further not clarified). Fifth dose was taken on 11Nov2022 and lot number reported was GT25Z4 or 24 (not clear).   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-202300250768 same reporter/drug, different patient/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I have COVID; I have COVID; 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 patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Aug2022 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 following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have COVID". Clinical course: Patient wanted to know if she could still have another booster of covid-19. She already had 2 boosters. Caller mentioned that she started to take Pfizer vaccines because she was up in years and she was healthy. She had no lasting effects at all from Pfizer vaccines. They were wonderful and happy to take them. She also had 2 boosters in November and Aug2022. She was wondering if she needed to go for a new 4th booster. She has not had any booster since 2022. She had one in February. She mentioned that she is worried because half of 2023 was gone, and she needs to know if boosters were ready.  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-PV202300124294 same patient, different vaccine dose/event;
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Mutism
Clinical narrative: loss of sight and inability to speak.; loss of sight and inability to speak.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21May2021 as dose 2, single (Lot number: EW0186) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "anemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "dry eyes" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "gerd" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "migraines" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; MONTELUKAST; ADVAIR; NIFEDIPIN. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin". Vaccination history included: BNT162b2 (Dose 1, Single, Batch/lot number: EW0164, Anatomical Location: Left arm), administration date: 30Apr2021, for COVID-19 immunization. The following information was reported: BLINDNESS (hospitalization), MUTISM (hospitalization) all with onset 21Aug2021, outcome "not recovered" and all described as "loss of sight and inability to speak.". The patient was hospitalized for blindness, mutism (hospitalization duration: 10 day(s)). The events "loss of sight and inability to speak." required physician office visit and emergency room visit. Therapeutic measures were taken as a result of blindness, mutism.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events Blindness ,mutism and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300252274 same patient and different drug dose/events.;US-PFIZER INC-202300252275 same patient and different drug dose/events.;
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 72-year-old male patient received BNT162b2 multivalent nos (BNT162B2 MULTIVALENT NOS), on 14Jul2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 72 years intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE: 5), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 4), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 3), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 2), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 1), for COVID-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 14Jul2023, outcome "recovered", described as "Flu like symptoms". Therapeutic measures were not taken as a result of influenza like illness. Additional information: The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No other vaccine in four weeks. No COVID prior vaccination; No COVID tested post vaccination.  The information on the batch/lot number for BNT162b2 multivalent nos has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 at 17:00 as dose 5 (booster), single (Lot number: GS3275) at the age of 52 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Jan2021 at 15:30 as dose 1, single (Lot number: EL9261), in left arm, on 08Feb2021 at 09:30 as dose 2, single (Lot number: EM9810), in left arm, on 07Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 11Jun2022 at 11:30 as dose 4 (booster), single (Lot number: FM0173), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Tachycardia" (unspecified if ongoing); "massive bilateral pulmonary emboli" (unspecified if ongoing); "DVT from knee trauma, skiing" (unspecified if ongoing); "Allergic rhinitis" (unspecified if ongoing); "migraine (rare)" (unspecified if ongoing); "PENICILLINS ALLERGY" (unspecified if ongoing); "knee trauma" (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 Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 Treatment as Paxlovid with start date 30Jun2023 and stop date 05Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300122487 same reporter/patient, different product/AE;
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Neuropathy peripheral
Clinical narrative: I think it is an after effect in my knees it is like neuropathy of my knee; knees is very sore; My whole leg feels almost dead; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 2023, outcome "unknown", described as "I think it is an after effect in my knees it is like neuropathy of my knee"; HYPOAESTHESIA (medically significant) with onset 2023, outcome "unknown", described as "My whole leg feels almost dead"; ARTHRALGIA (medically significant) with onset 2023, outcome "unknown", described as "knees is very sore". Therapeutic measures were taken as a result of neuropathy peripheral, arthralgia. Clinical course: Reporter stated that lot of people started with the product. The reporter had two of the vaccines (Clarified as Pfizer Covid-19 Vaccine) that was first coming out and then talked about boosters and had two boosters (Pfizer COVID-19 Booster). The last booster administered to reporter was in September of last year and got COVID in March of the current year and she thought it was an after effect in her knees it was like neuropathy of the knee, whole leg feels almost dead, but the knees is very sore, nervous nerve wise. For the pain the patient took Tylenol; she mentioned her knee but she was also having everyday it did not go away neuropathy in her Achilles tendons on the same leg  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-202300251724 same patient, different dose/event;
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I think it is an after effect in my knees it is like neuropathy of my knee; knees is very sore; My whole leg feels almost dead; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 2023, outcome "unknown", described as "I think it is an after effect in my knees it is like neuropathy of my knee"; HYPOAESTHESIA (medically significant) with onset 2023, outcome "unknown", described as "My whole leg feels almost dead"; ARTHRALGIA (medically significant) with onset 2023, outcome "unknown", described as "knees is very sore". Therapeutic measures were taken as a result of neuropathy peripheral, arthralgia. Clinical course: Reporter stated that lot of people started with the product. The reporter had two of the vaccines (Clarified as Pfizer Covid-19 Vaccine) that was first coming out and then talked about boosters and had two boosters (Pfizer COVID-19 Booster). The last booster administered to reporter was in September of last year and got COVID in March of the current year and she thought it was an after effect in her knees it was like neuropathy of the knee, whole leg feels almost dead, but the knees is very sore, nervous nerve wise. For the pain the patient took Tylenol; she mentioned her knee but she was also having everyday it did not go away neuropathy in her Achilles tendons on the same leg  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-202300251724 same patient, different dose/event;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Neuropathy peripheral
Clinical narrative: I have the COVID in March; I have the COVID in March; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm 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), SUSPECTED COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "I have the COVID in March". Clinical course: The last booster patient had was September of last year and she got COVID in March of this year. Patient was just afraid to have another booster. So, she had the COVID in March and she wonder should she wait six months from having COVID to have the next booster.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300251712 same patient, different dose/event;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I have the COVID in March; I have the COVID in March; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm 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), SUSPECTED COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "I have the COVID in March". Clinical course: The last booster patient had was September of last year and she got COVID in March of this year. Patient was just afraid to have another booster. So, she had the COVID in March and she wonder should she wait six months from having COVID to have the next booster.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300251712 same patient, different dose/event;
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: pronounced swelling and redness; pronounced swelling and redness; This is a spontaneous report received from non-contactable reporter(s) (Nurse) from a sales representative.  An 82-year-old female patient (not pregnant) received pneumococcal 20-valent conjugate vacccine (diphtheria CRM197 protein) (PREVNAR 20), on 05Jul2023 at 03:00 as dose 1, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history included: "Hyperlipemia" (unspecified if ongoing); "DM" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 06Jul2023, outcome "recovering" and all described as "pronounced swelling and redness".  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Age: 72.0
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 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Oct2021 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 06Apr2022 at 13:00 as dose 4 (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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure controlled" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "mild asthma" (unspecified if ongoing); "Known allergies: All penicillin types" (unspecified if ongoing). Concomitant medication(s) included: VALSART, start date: 01Feb2017. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300251633 same patient, different drug/AE.;
Age: 58.0
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 a 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 26Oct2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 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: "Hashimoto's hypothyroidism" (unspecified if ongoing); "Known allergies: sulfa drug" (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 2023, outcome "not recovered" and all described as "COVID 19 Treatment.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Treatment of Covid-19. Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300251666 same patient, different drug/AE.;
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 73-year-old male patient 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 following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "not recovered" 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 08Jul2023 to 12Jul2023 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300251667 Same patient, different drug/ AE;
Age: 66.0
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 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 20Apr2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 66 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IPF" (unspecified if ongoing); "COPD" (unspecified if ongoing); "HIV" (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 2023, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid Treatment from 01Jul2023 to 06Jul2023. Patient got COVID rebound about 5 days after she felt fine and finished Paxlovid. 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-202300251669 same patient, different drug/AE.;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID 19; 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 17May2023 at 16:00 as dose 5 (booster), single (Lot number: AS7165B), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Mar2021 at 14:00 as dose 1, single (Lot number: 04GA21A), in left arm, on 22Apr2021 at 13:00 as dose 2, single (Lot number: 039B21A), in left arm, on 12Nov2021 at 13:00 as dose 3 (booster), single (Lot number: 033F21A), in left arm and on 09Sep2022 at 16:00 as dose 4 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight 50 lbs" (unspecified if ongoing); "anxiety disorder" (unspecified if ongoing), notes: long term Lexapro generic; "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: nickel metal" (unspecified if ongoing); "in recovery alcoholic/addict sober since 1984", start date: 1984 (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: 02Oct2022, stop date: 08Jul2023; LEXAPRO taken for anxiety disorder. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown", described as "COVID 19"; VACCINATION FAILURE (medically significant) with onset 2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Day 12 since original onset of Covid symptoms still testing POSITIVE. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 07Jul2023 to 12Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300251995 same patient, different drug/event;
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Testing positive for covid; Testing positive for covid; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.   A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Lot number: GJ6665, Expiration Date: Jun2023) at the age of 60 years intramuscular, in left deltoid for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EW0162), in left deltoid, on 29Apr2021 as dose 2, single (Lot number: EW0176), in left deltoid, on 10Dec2021 as dose 3 (booster), single (Lot number: FH8030), in left deltoid and on 20May2022 as dose 4 (booster), single (Lot number: FM9992), in left deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Mild BPH" (ongoing), notes: Start: Before getting the covid vaccines; "increased cholesterol" (ongoing), notes: Start: Before getting the covid vaccines; "Hypertension" (ongoing), notes: Start: Before getting the covid vaccines; "Blood pressure abnormal" (unspecified if ongoing); "Non-smoker" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol increased (ongoing); VALSARTAN taken for blood pressure abnormal (ongoing); TAMSULOSIN taken for benign prostatic hyperplasia (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jul2023, outcome "unknown" and all described as "Testing positive for covid". The event "testing positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.Clinical course: Patient had mild to moderate symptoms and was treated with Lagvrio instead. Prescribed to take 2 tablets twice a day, started 12Jul2023. Patient had all the doses in the morning. Patient didn't visit emergency room and didn't get hospitalized. He did not display clinical signs at rest. He monitored O2 Sats at home and it was always above 93%. Never had shortness of breath or difficulty breathing and didn't require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. Patient neither required the initiation of new medication nor any other treatment or procedure.; Sender's Comments: Based on the known the information available the Causal relation between the events VACCINATION FAILURE,  COVID-19 and suspect drug cannot be excluded completely,Linked Report(s) : US-PFIZER INC-202300252242 same reporter/vaccine, similar event and diff patient;US-PFIZER INC-202300251733 Same reporter/drug/events and different patient;US-PFIZER INC-202300252281 same product, different dose, different patient;US-PFIZER INC-202300251737 same product, different dose, different patient;
Age: 58.0
Sex: M
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). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6205), on 29Mar2021 as dose 2, single (Lot number: ER8733) and on 10Dec2021 as dose 3 (booster), single (Lot number: FJ8762) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "High Chlolestrol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetnus booster, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Paxlovid were taken as therapeutic measures as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid from 07Jul2023 to 11Jul2023.  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-202300251680 Same patient, different event/drug;
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid test result: Positive; covid test result: Positive; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Apr2021 as dose 1, single (Lot number: EW0164), in left arm, on 21May2021 as dose 2, single (Lot number: EW0186), in left arm and on 13Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Dry eyes" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "gerd" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "migraines" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; MONTELUKAST; ADVAIR; NIFEDIPIN. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11May2023, outcome "unknown" and all described as "covid test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2023) Positive, notes: Nasal Swab.; Sender's Comments: The contributory role of the suspect product to the reported event drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency. ,Linked Report(s) : US-PFIZER INC-202300251628 same patient and different drug dose/events.;US-PFIZER INC-202300252274 same patient and different drug dose/events.;
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1: Moderna/ Dose 2: Moderna/ Dose 3: Moderna/ Dose 4: Moderna/ Dose 5: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 12:00 as dose 5 (booster), single (Lot number: 6H9694) at the age of 61 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Feb2021 at 12:00 as dose 1, single (Lot number: 011M20A), in right arm, on 19Mar2021 at 12:00 as dose 2, single (Lot number: 029A21A), in right arm, on 29Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 076C21A), in right arm and on 19Apr2022 at 12:00 as dose 4 (booster), single (Lot number: 001M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Apr2022 at 12:00, outcome "unknown", described as "Dose 1: Moderna/ Dose 2: Moderna/ Dose 3: Moderna/ Dose 4: Moderna/ Dose 5: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 05Jul2023 to 09Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300252481 Same reporter/patient, different drug, different AE.;