chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling cold, Gait inability, Pain, Pyrexia
Clinical narrative: very bad pain in her spinal cord; bad back ache in spinal cord; she cannot even use the restroom has to walk on her hands and knees/she is not able to walk; shaking; super cold; fever; severe pain since 1 hour ago and she is some how walking but is still in so much pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (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 johnson (she first got the Johnson shot, Dose number: Unknown, Dose- 2), for COVID-19 Immunization, reaction(s): "no adverse event"; Covid-19 vaccine johnson (she first got the Johnson shot, Dose number: Unknown, Dose-1), for COVID-19 Immunization, reaction(s): "no adverse event". The following information was reported: SPINAL CORD DISORDER (non-serious), outcome "unknown", described as "very bad pain in her spinal cord"; BACK PAIN (non-serious), outcome "not recovered", described as "bad back ache in spinal cord"; GAIT INABILITY (non-serious), outcome "not recovered", described as "she cannot even use the restroom has to walk on her hands and knees/she is not able to walk"; TREMOR (non-serious), outcome "unknown", described as "shaking"; FEELING COLD (non-serious), outcome "unknown", described as "super cold"; PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "severe pain since 1 hour ago and she is some how walking but is still in so much pain". Clinical information: Patient stated that she had the booster two days ago, since yesterday she has a very bad pain in her spinal cord, states she cannot even use the restroom has to walk on her hands and knees, wants to know what is wrong with her, what medication can she take. Patient stated that she first got the Johnson shot, and had no side effects with that one, states she got this booster from Pfizer and the first night was super cold and shaking and had a fever states the next day she felt okay until 12PM and slowly after 2PM she got a very bad back ache in spinal cord and she is not able to walk, and she has been in severe pain since 1 hour ago and she is some how walking but is still in so much pain, wants to know what medication to take  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Spinal cord disorder, Tremor
Clinical narrative: very bad pain in her spinal cord; bad back ache in spinal cord; she cannot even use the restroom has to walk on her hands and knees/she is not able to walk; shaking; super cold; fever; severe pain since 1 hour ago and she is some how walking but is still in so much pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (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 johnson (she first got the Johnson shot, Dose number: Unknown, Dose- 2), for COVID-19 Immunization, reaction(s): "no adverse event"; Covid-19 vaccine johnson (she first got the Johnson shot, Dose number: Unknown, Dose-1), for COVID-19 Immunization, reaction(s): "no adverse event". The following information was reported: SPINAL CORD DISORDER (non-serious), outcome "unknown", described as "very bad pain in her spinal cord"; BACK PAIN (non-serious), outcome "not recovered", described as "bad back ache in spinal cord"; GAIT INABILITY (non-serious), outcome "not recovered", described as "she cannot even use the restroom has to walk on her hands and knees/she is not able to walk"; TREMOR (non-serious), outcome "unknown", described as "shaking"; FEELING COLD (non-serious), outcome "unknown", described as "super cold"; PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "severe pain since 1 hour ago and she is some how walking but is still in so much pain". Clinical information: Patient stated that she had the booster two days ago, since yesterday she has a very bad pain in her spinal cord, states she cannot even use the restroom has to walk on her hands and knees, wants to know what is wrong with her, what medication can she take. Patient stated that she first got the Johnson shot, and had no side effects with that one, states she got this booster from Pfizer and the first night was super cold and shaking and had a fever states the next day she felt okay until 12PM and slowly after 2PM she got a very bad back ache in spinal cord and she is not able to walk, and she has been in severe pain since 1 hour ago and she is some how walking but is still in so much pain, wants to know what medication to take  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: after the first two COVID-19 shots and the 1st booster shot, caller started having atrial fibrillation and that is when caller started taking Eliquis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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: Bnt162b2 (Dose: 2), for Covid-19 Immunization; Moderna covid-19 vaccine (Dose: 1), for Covid-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "after the first two COVID-19 shots and the 1st booster shot, caller started having atrial fibrillation and that is when caller started taking Eliquis". Therapeutic measures were taken as a result of atrial fibrillation.  Clinical course: Patient was supposed to take the Pfizer 2nd booster shot today but took the medication Eliquis and was asking for recommendations. She was referring to the Pfizer COVID-19 vaccine 2nd booster shot. Patient started taking Eliquis after receiving the 1st booster shot, however, caller was told when she had her 1st vaccine shot, which was the Moderna COVID- 19 vaccine, and then switched to the Pfizer COVID-19 vaccine for her 2nd shot and her 1st booster shot, caller was told when she got the 1st dose of the Moderna COVID-19 vaccine, not to take Aspirin. After the first two COVID-19 shots and the 1st booster shot, patient started having atrial fibrillation and that was when caller started taking Eliquis. The atrial fibrillation started after patient received the first two COVID-19 vaccine shots and her 1st booster shot. Started taking Eliquis about 2 months ago for this condition, the irregular heartbeat. Patient's first two shots were the Moderna COVID-19 vaccine and only her booster shot, which was caller's 3rd dose, was the Pfizer COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Laboratory test, Pain in extremity, Ultrasound scan
Clinical narrative: arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), 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: "wasn't feeling good and and shoveling snow" (unspecified if ongoing), notes: wasn't feeling good and and shoveling snow; "chest pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "Chills", "DVT", "arm pain", "blood clot". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Negative; (Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: No. Did you/the patient previously receive a COVID-19 Vaccine?: Yes. Reported Event: Took Paxlovid got a negative test-5 days later symptoms returned-tested positive AGAIN-remained positive for another 5 days-struggling with dizziness and nausea ever since-same thing happened to spouse  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Headache, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: tested positive 07May2022; tested positive 07May2022; sx 07May HA achey; sx 07May HA achey; URI; fever; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 40-year-old patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 26Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. If COVID prior vaccination was unknown. If Other vaccine in four weeks was unknown. The following information was reported: UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 07May2022, outcome "unknown", described as "URI"; PYREXIA (non-serious) with onset 07May2022, outcome "unknown", described as "fever"; PAIN (non-serious) with onset 07May2022, outcome "unknown", HEADACHE (non-serious) with onset 07May2022, outcome "unknown" and all described as "sx 07May achey"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07May2022, outcome "unknown" and all described as "tested positive 07May2022". If COVID tested post vaccination was yes, The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive, notes: COVID test post vaccination COVID test type post vaccination=Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, pain, headache, upper respiratory tract infection, pyrexia. Adverse event: sx 07May achey URI cold sx fever 0May2022 son tested positive 07May2022, then he did PCR 5/9 and just back now positive  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Upper respiratory tract infection, Vaccination failure
Clinical narrative: tested positive 07May2022; tested positive 07May2022; sx 07May HA achey; sx 07May HA achey; URI; fever; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 40-year-old patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 26Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. If COVID prior vaccination was unknown. If Other vaccine in four weeks was unknown. The following information was reported: UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 07May2022, outcome "unknown", described as "URI"; PYREXIA (non-serious) with onset 07May2022, outcome "unknown", described as "fever"; PAIN (non-serious) with onset 07May2022, outcome "unknown", HEADACHE (non-serious) with onset 07May2022, outcome "unknown" and all described as "sx 07May achey"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07May2022, outcome "unknown" and all described as "tested positive 07May2022". If COVID tested post vaccination was yes, The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive, notes: COVID test post vaccination COVID test type post vaccination=Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, pain, headache, upper respiratory tract infection, pyrexia. Adverse event: sx 07May achey URI cold sx fever 0May2022 son tested positive 07May2022, then he did PCR 5/9 and just back now positive  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Soreness following COVID vaccine; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4384720-00.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, on 05Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 12Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown) oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare up"; PAIN (non-serious), outcome "unknown", described as "Soreness following COVID vaccine". On unknown dates, the patient experienced rheumatoid arthritis flare up and soreness following COVID vaccine. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect.  Patient had rheumatoid arthritis flare and soreness followed by COVID vaccination. It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  The action taken for upadacitinib was unknown.  The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up" and "soreness following covid vaccine" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.    Seq.No. : 1  Drug : Rinvoq (Upadacitinib)   Causality  1) Rheumatoid arthritis flare up (Rheumatoid arthritis) Action(s) taken with drug : Unknown  Causality as per reporter (Drug/Vaccine) : Not Reported  Dechallenge : N/A   2) Pain (Pain)  Action(s) taken with drug : Unknown  Causality as per reporter (Drug/Vaccine) : Not Reported  Dechallenge : N/A   Seq.No. : 2  Drug : Pfizer BioNTech COVID-19 Vaccine (Tozinameran) (Tozinameran), Unknown, Unknown, Unknown  1) Rheumatoid arthritis flare up (Rheumatoid arthritis) Action(s) taken with drug : Unknown  Causality as per reporter (Drug/Vaccine) : Not Reported  Dechallenge : N/A   2) Pain (Pain)  Action(s) taken with drug : Unknown  Causality as per reporter (Drug/Vaccine) : Not Reported  Dechallenge : N/A  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Confusional state, Muscular weakness
Clinical narrative: muscle weakness; confusion; balance/falling related issues; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 70-year-old male patient received BNT162b2 (BNT162B2), 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 on 26Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "muscle weakness"; CONFUSIONAL STATE (non-serious), outcome "not recovered", described as "confusion"; BALANCE DISORDER (non-serious), outcome "not recovered", described as "balance/falling related issues".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11May2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 25Sep2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 23Mar2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis for 37 yrs" (unspecified if ongoing), notes: Rheumatoid arthritis for 37 yrs; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: SIMPONI, start date: 14Apr2022, stop date: 14Apr2022; VITAMIN C; VITAMIN D. Past drug history included: Avelox reaction(s): "Known allergies: Avelox", notes: Known allergies: Avelox. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Negative; (11May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The patient received other medication in 2weeks. The patient received treatment with Paxlovid on 30Apr2022 and stop date: 05May2022, it is used for Indication as treatment of COVID-19. she took the Paxlovid as prescribed. Felt better after 2 full doses. Completed the medication after 5 days and was well. Tested negative on day 8. Not feeling well on day 10. Tested and was positive today (day 11) and not well. before taking Paxlovid the COVID was like a bad flu. Now with the rebound it is mostly like a bad head cold so far. Adverse event start date: 10May2022. The outcome of event recovered. she was not received treatment with medication.  The information on the batch/lot number for (BNT162B2) has been requested and will be submitted if and when received
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Dec2021 at 12:00 as dose 1, single (Lot number: Fh8028) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: seafood" (unspecified if ongoing), notes: Known allergies: seafood. Concomitant medication(s) included: VERAPAMIL. Past drug history included: Sulfur, reaction(s): "known allergy: Sulfur", notes: Known allergies: Sulfur. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Repeated antigen test and it positive; (07May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid: start date: 02May2022, stop date: 6May2022, Indication: Treatment of COVID-19. The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. Device Date : 11May2022.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3249), in left arm, on 09Feb2021 as dose 2, single (Lot number: EM9810), in left arm and on 25Nov2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "cardiac arrhythmia" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "mild hypertension" (unspecified if ongoing); "mild scoliosis" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS, start date: Nov2021; TRIAMTERENE/HCTZ, start date: Jan2007; RECLAST, start date: 02Mar2021; GLUCOSAMINE CHONDROITIN SULFATE, start date: Apr2021; BOSMERIC SR, start date: Nov2015; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D3, start date: Jan2009; VITAMIN C [ASCORBIC ACID], start date: 11Apr2022, stop date: 19Apr2022; CENTRUM SILVER WOMEN 50+, start date: 13Apr2022. Past drug history included: Tetracycline, reaction(s): "known allergies: Tetracycline"; Xarelto, reaction(s): "known allergies: Xarelto". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) Positive; (26Apr2022) Positive. Therapeutic measures were taken as a result of covid-19.  If vaccine received Yes, other medication in 2 weeks: Yes; Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: Yes; Did you/the patient previously receive a COVID-19 Vaccine?: Yes. Adverse event: My initial covid symptoms began 11Apr2022. PCR Test + on 12Apr. All symptoms disappeared 18Apr2022. On Apr2022 new symptoms began - extreme runny nose and sneezing, with slight sore throat, no fever. PCR test + on 26Apr. On 28Apr, the extreme runny nose was over, however, slight cough and nose blowing 3-4x /day persisted through 10May.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body height, Musculoskeletal stiffness, Pain, Weight
Clinical narrative: hard time moving her fingers; painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (002591).  An 88-year-old female patient received tofacitinib citrate (XELJANZ XR), (Lot number: EH9981, Expiration Date: Jan2023) at 11 mg 1x/day, oral for rheumatoid arthritis; BNT162b2 (BNT162B2), as unk unk, single (dose 1, single) (Batch/Lot number: unknown), as unk unk, single (dose 2, single) (Batch/Lot number: unknown) and as unk, single ((dose 3 single) (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "neuropathy" (unspecified if ongoing); "Weight loss" (unspecified if ongoing); "not being able to walk" (unspecified if ongoing). Concomitant medication(s) included: FOLIC ACID; ATENOL. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "hard time moving her fingers"; PAIN (non-serious), outcome "unknown", described as "painful". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for tofacitinib citrate was unknown. Additional information:  Patient stated her height has been shrunk. she lost a lot of weight, and she was real good at the time and ended up not being able to walk.   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, SARS-CoV-2 test
Clinical narrative: well i hope it works. but right after i got the 3rd shot  i got COVID; well i hope it works. but right after i got the 3rd shot  i got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 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 "well i hope it works. but right after i got the 3rd shot  i got COVID".  The patient wanted to know what makes the Pfizer-BioNTech COVID-19 vaccine unique and different from other COVID-19 vaccines. He wanted to be as specific as possible. The patient wanted to know why he got COVID right after 3rd shot.The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood pressure" (unspecified if ongoing); "emphysema" (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". Therapeutic measures were taken as a result of covid-19.  Clinical Course: Anti viral details product COVID 19 Treatment brand Pfizer treatment start date on 28Apr2022 and treatment stop date on 02May2022 indication treatment of COVID-19, adverse event return of symptoms cough, runny nose, sore throat, congestion. Fatigue  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Feb2021 as dose 1, single (Lot number: 015m20A), on 25Mar2021 as dose 2, single (Lot number: 018B21A) and on 23Oct2021 as dose 3, single (Lot number: 058e21A) for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR; LOSARTAN; LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of covid-19.  Clinical Course: Anti viral details: Product COVID 19 Treatment, brand Pfizer, treatment start date on 01May2022, treatment stop date on 06May2022, indication, treatment of COVID-19. The patient was prescribed Paxlovid as for 5 days it worked to help with the symptoms. On day 9 of infection he was finally tested totally negative on home antigen test then day 10 tested strong positive and all symptoms came back stronger than before still testing positive on day 11.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Drug ineffective
Clinical narrative: COVID-19 infection; COVID-19 infection; feeling a little tightness in chest; 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 male patient received BNT162b2 (BNT162B2), 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), outcome "unknown" and all described as "COVID-19 infection"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "feeling a little tightness in chest". Reporter stating events as non serious.  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: Anorectal disorder, Drug ineffective, Gastrointestinal motility disorder, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Light burning and redness at the rectal sight with inflammation; tan in color loose bowl movements; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Nov2021 as dose 2, single (Lot number: FG3527) at the age of 57 years, in right arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 05Mar2021 as dose 1, single (Lot number: 1802068), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthama" (unspecified if ongoing), notes: energy induced asthma. Concomitant medication(s) (other medications in 2 weeks) included: SINGULAIR; VITAMIN D3; VITAMIN B12 & FOLIC ACID; ZINC CHLORIDE; CITALOPRAM; VITAMIN C [ASCORBIC ACID]. The following information was reported: ANORECTAL DISORDER (non-serious) with onset 14Apr2022, outcome "recovered" (Apr2022), described as "Light burning and redness at the rectal sight with inflammation"; GASTROINTESTINAL MOTILITY DISORDER (non-serious) with onset 14Apr2022, outcome "recovered" (Apr2022), described as "tan in color loose bowl movements"; SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were not taken as a result of anorectal disorder, gastrointestinal motility disorder. Clinical course includes tan in color loose bowl movements, light burning and redness at the rectal sight with inflammation. Patient had no known allergies.  Follow up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
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 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: en6201), in left arm, on 04Mar2021 as dose 2, single (Lot number: en6205), in left arm and on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 01May2022, outcome "unknown", DRUG INEFFECTIVE (medically significant) with onset 11May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Negative, notes: testing negative at the end of paxlovid treatment on Friday 06May2022; (11May2022) Positive, notes: I tested highly positive today again today 11May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 antibody test, Suspected COVID-19
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 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 as dose 1, single (Lot number: ER8736) and on 17May2021 as dose 2, single (Lot number: EW0168) at the age of 37 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZOLOFT, start date: Jan2022, stop date: May2022; NYQUIL, start date: 04May2022, stop date: 05May2022; DAYQUIL, start date: 04May2022, stop date: 05May2022.Known allergies are none.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. Therapeutic measures were taken as a result of suspected covid-19.Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 06May2022, Treatment stop date: 10May2022, Lot number: FY9909, Indication: Treatment of COVID-19.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: PCR testing for SARS-CoV-2 that was positive 16 days after the third vaccine/ Breakthrough infection after three doses of COVID-19 mRNA vaccine; PCR testing for SARS-CoV-2 that was positive 16 days after the third vaccine/ Breakthrough infection after three doses of COVID-19 mRNA vaccine; This is a literature report.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Batch/Lot number: unknown), on 11Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 25Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "seropositive rheumatoid arthritis" (unspecified if ongoing), notes: 14 years duration; "hypertension" (unspecified if ongoing); "hyperlipidaemia" (unspecified if ongoing); "obesity" (unspecified if ongoing); "obstructive sleep apnoea" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Certolizumab pegol for rheumatoid arthritis, notes: 200mg SC every other week; Gabapentin for obstructive sleep apnoea; Olmesartan/hydrochlorothiazide for obstructive sleep apnoea; Rosuvastatin for obstructive sleep apnoea; Finasteride. The following information was reported: VACCINATION FAILURE (medically significant), 16 days after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant), 16 days after the suspect product(s) administration, outcome "recovered" and all described as "PCR testing for SARS-CoV-2 that was positive 16 days after the third vaccine/ Breakthrough infection after three doses of COVID-19 mRNA vaccine". The patient underwent the following laboratory tests and procedures: Body mass index: (10Sep2021) 35.6, notes: Units kg/m2; SARS-CoV-2 test: (10Sep2021) Postive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162b2.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (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 was not reported. 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". Therapeutic measures were taken as a result of covid-19.  Clinical course: COVID 19 Treatment included Paxlovid (Treatment start date: 04May2022 Treatment stop date: 06May2022)   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6205), on 26Mar2021 as dose 2, single (Lot number: ER8727) and on 30Oct2021 as dose 3 (booster), single (Lot number: EW0185) for covid-19 immunisation. The patient's relevant medical history included: "Bicuspid aortic valve" (unspecified if ongoing), notes: Other medical history: Bicuspid aortic valve; "Beta blockers" (unspecified if ongoing), notes: Known allergies: Beta blockers. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 includes Paxlovid.   Clinical course:Patient felt better and was rapiding negative as of 07May22. On 11May22 (day 4 after Stopping paxlovid, and day 9 since I tested positive) patient developed a mild Sore throat, runny nose, and felt off. Patient took a rapid in the morning when she only had a mild sore throat and it was Negative. Patient then took a rapid around 3pm when her runny nose was more present and the rapid turned positive within a minute or two.Patient antiviral details include Covid 19 treatment which was started on 03May2022 and was stopped on 07May2022
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dermatomyositis, Rash erythematous, Vaccination site erythema
Clinical narrative: have been diagnosed with Dermatomyositis; had red rashing everywhere; I also had a red ring around the injection site for 4.5 months; I began to lose strength in my arms and legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FH8027) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: hypothyroidism" (unspecified if ongoing), notes: Other medical history: hypothyroidism; "Other medical history: hashimotos" (unspecified if ongoing), notes: Other medical history: hashimotos; "Other medical history: vitiligo" (unspecified if ongoing), notes: Other medical history: vitiligo; "Known allergies: pollen" (unspecified if ongoing), notes: Known allergies: pollen. Concomitant medication(s) included: PANTOPRAZOLE; LEVOTHYROXINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6202, Route of Administration: Intramuscular), administration date: 08Mar2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Route of Administration: Intramuscular), administration date: 12Feb2021, when the patient was 65-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (disability) with onset 13Aug2021, outcome "not recovered", described as "I also had a red ring around the injection site for 4.5 months"; ASTHENIA (disability) with onset 13Aug2021, outcome "not recovered", described as "I began to lose strength in my arms and legs"; RASH ERYTHEMATOUS (disability) with onset 13Aug2021, outcome "not recovered", described as "had red rashing everywhere"; DERMATOMYOSITIS (disability, medically significant) with onset 13Aug2021, outcome "not recovered", described as "have been diagnosed with Dermatomyositis". The events "have been diagnosed with dermatomyositis", "had red rashing everywhere", "i also had a red ring around the injection site for 4.5 months" and "i began to lose strength in my arms and legs" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of dermatomyositis, rash erythematous, vaccination site erythema, asthenia included lots of medical care.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a literature report for the following literature source(s). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis". In another study, anaphylaxis was confirmed after the first dose in 7 patients who received BNT-162b2 vaccine and 9 patients who received mRNA-1273 vaccine. The CDC had reported a rate of 2.5 cases per million doses.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, Anaphylactic reaction cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200681973 Same article/ drug/event and different patient: