chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pneumonia legionella
Clinical narrative: Dizzy; Legionnaire's disease; 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-163-4379945-00.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 64 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1159670) at unk (citrate free) and second regimen since Aug2021 (Lot number: 1159670), all subcutaneous for psoriasis. The patient's relevant medical history included: "Moderate to severe chronic plaque psoriasis " (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single via Intramuscular), administration date: 02Feb2021, for COVID-19 immunisation. The following information was reported: PNEUMONIA LEGIONELLA (medically significant) with onset Jun2021, outcome "unknown", described as "Legionnaire's disease"; DIZZINESS (non-serious), outcome "recovered", described as "Dizzy". On 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation  The reporter's assessment of the causal relationship of "legionnaire's disease" and "dizzy" 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.  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 events, Legionnaire's disease, dizzy 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.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 06Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 18Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IgA deficiency" (unspecified if ongoing); "Mixed connective tissue d/o nos" (unspecified if ongoing), notes: Mixed connective tissue d/o nos. The patient took concomitant medications. Past drug history included: Known allergies: keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex; Known allergies: terbinafine, reaction(s): "Known allergies: Terbinafine", notes: Known allergies: Terbinafine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Ae treatment: Dexamethasone.  Clinical course: Other medical history was reported. Patient received Other medication in 2weeks. Anti viral details reported as patient took Paxlovid orally for COVID 19 Treatment, Treatment start date: 15Apr2022, Treatment stop date: 20Apr2022. Adverse event: Took Paxlovid. Felt better next day. Then on day 11 of covid course which was 4-5 days after stopping Paxlovid symptoms rebounded. Event onset date, outcome and treatment was reported.   The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Vaccination failure and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: El9264), in left arm and on 05Mar2021 as dose 2, single (Lot number: Eng6206) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Nov2021 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Apr2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Apr2022) Positive, notes: positive PCR 16Apr; (17Apr2022) Positive, notes: Positive rapid antigen tests 17Apr and 19Apr; (19Apr2022) Positive, notes: Positive rapid antigen tests 17Apr and 19Apr; (22Apr2022) Positive, notes: Negative rapid antigen test 22Apr; (04May2022) Positive, notes: Positive rapid antigen tests 4May and 5May; (05May2022) Positive, notes: Positive rapid antigen tests 4May and 5May. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Muscle tightness, Myalgia, Neck pain
Clinical narrative: felt like a tingly nerve pain; had tightening of upper back and neck muscles; Sharp pain was experienced from back up the neck up to head.; Sharp pain was experienced from back up the neck up to head.; Muscle pain was unbearable for entire body for a few hours; Sharp pain was experienced from back up the neck up to head/Severe headache; 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 1, single (Batch/Lot number: unknown) and on 05Nov2021 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. Past drug history included: Codeine for Allergies: CODEINE. The patient did not receive other vaccine in four weeks and no other medications in two weeks. The patient did not had Covid prior vaccination and was tested for covid post vaccination. The following information was reported: MYALGIA (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "Muscle pain was unbearable for entire body for a few hours"; BACK PAIN (non-serious), NECK PAIN (non-serious) all with onset Nov2021, outcome "recovered with sequelae" and all described as "Sharp pain was experienced from back up the neck up to head."; HEADACHE (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "Sharp pain was experienced from back up the neck up to head/Severe headache"; NEURALGIA (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "felt like a tingly nerve pain"; MUSCLE TIGHTNESS (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "had tightening of upper back and neck muscles". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that after both the initial and 2nd dose the following occurred: 12hours from receiving vaccine shot, had tightening of upper back and neck muscles. Muscle pain was unbearable for entire body for a few hours. Sharp pain was experienced from back up the neck up to head. This lasted for 7 days. Severe headache lingered for 2 weeks. The headache experiences was abnormal. Usually I feel pressure or pounding headaches, this however felt like a tingly nerve pain. It was reported that the patient recovered with lasting effects. 2 months after receiving last dose, I then also got the virus and it was a severe to mild case. The patient underwent Nasal swab test post vaccination twice on unspecified dates in Feb2022 and the result was Positive and Negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, SARS-CoV-2 test
Clinical narrative: felt like a tingly nerve pain; had tightening of upper back and neck muscles; Sharp pain was experienced from back up the neck up to head.; Sharp pain was experienced from back up the neck up to head.; Muscle pain was unbearable for entire body for a few hours; Sharp pain was experienced from back up the neck up to head/Severe headache; 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 1, single (Batch/Lot number: unknown) and on 05Nov2021 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. Past drug history included: Codeine for Allergies: CODEINE. The patient did not receive other vaccine in four weeks and no other medications in two weeks. The patient did not had Covid prior vaccination and was tested for covid post vaccination. The following information was reported: MYALGIA (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "Muscle pain was unbearable for entire body for a few hours"; BACK PAIN (non-serious), NECK PAIN (non-serious) all with onset Nov2021, outcome "recovered with sequelae" and all described as "Sharp pain was experienced from back up the neck up to head."; HEADACHE (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "Sharp pain was experienced from back up the neck up to head/Severe headache"; NEURALGIA (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "felt like a tingly nerve pain"; MUSCLE TIGHTNESS (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "had tightening of upper back and neck muscles". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that after both the initial and 2nd dose the following occurred: 12hours from receiving vaccine shot, had tightening of upper back and neck muscles. Muscle pain was unbearable for entire body for a few hours. Sharp pain was experienced from back up the neck up to head. This lasted for 7 days. Severe headache lingered for 2 weeks. The headache experiences was abnormal. Usually I feel pressure or pounding headaches, this however felt like a tingly nerve pain. It was reported that the patient recovered with lasting effects. 2 months after receiving last dose, I then also got the virus and it was a severe to mild case. The patient underwent Nasal swab test post vaccination twice on unspecified dates in Feb2022 and the result was Positive and Negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfa" (unspecified if ongoing), notes: Known allergies : Sulfa. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of suspected covid-19.  Additional information: Other medication in 2weeks reported as no. It was reported that Paxlovid was used as treatment for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: 2 months after receiving last dose, I then also got the virus and it was a severe to mild case.; 2 months after receiving last dose, I then also got the virus and it was a severe to mild case.; 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 1, single (Batch/Lot number: unknown) and on 05Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codine for known allergies codine, notes: known allergies codine. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Feb2022, outcome "recovered" (2022) and all described as "2 months after receiving last dose, I then also got the virus and it was a severe to mild case.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) Positive, notes: Nasal Swab; (Feb2022) Negative, notes: Nasal Swab. Adverse event after both the initial and 2nd dose the following occurred 12hours from receiving vaccine shot, had tightening of upper back and neck muscles. Muscle pain was unbearable for entire body for a few hours. Sharp pain was experienced from back up the neck up to head. This lasted for 7 days. Severe headache lingered for 2 weeks. The headache experiences was abnormal. Usually patient feel pressure or pounding headaches, this however felt like a tingly nerve pain. 2 months after receiving last dose, she then also got the virus and it was a severe to mild case. Patient had not received any other vaccine in four weeks and not received other medications in two weeks. patient had not received any covid prior vaccination and received covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I'm still testing positive on the at-home test; I'm still testing positive on the at-home test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 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: "Depression" (unspecified if ongoing); "sleep anxiety" (unspecified if ongoing), notes: sleep anxiety; "Lymphoma" (unspecified if ongoing); "herniated discs" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "reflux" (unspecified if ongoing), notes: reflux; "migrain" (unspecified if ongoing); "penicillin" (unspecified if ongoing); "sulfa" (unspecified if ongoing). Concomitant medication(s) included: PROZAC; NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]; GABAPENTIN; KLONOPIN. Past drug history included: Quinalones/floxacins, reaction(s): "Allergies: Quinolones", notes: known allergies quinalones/floxacins; Floxacin, reaction(s): "Allergies: floxacins", notes: known allergies quinalones/floxacins.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "I'm still testing positive on the at-home test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: I'm still testing positive. 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: many unusual cloths in the menstrual blood.; Bleeding since ovulation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 at 16:00 as dose 3 (booster), single (Lot number: FK9895) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety/ depression" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Covid" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; LEVOTHYROXIN. Vaccination history included: covishield (Dose 1, Product: COVID 19, Brand: Covishield, Lot number: 215VCD126Z, Dose administration time: 04:00 PM, Vaccine location: Left arm), administration date: 08Jun2021, when the patient was 38-year-old, for Covid-19 immunization; covishield (Dose 2, Product: COVID 19, Brand: Covishield, Lot number: 217VCD243Z, Dose administration time: 12:00 PM, Vaccine location: Left arm), administration date: 31Aug2021, when the patient was 39-year-old, for Covid-19 immunization. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious) with onset 11Apr2022 at 08:00, outcome "not recovered", described as "Bleeding since ovulation"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 11Apr2022 at 08:00, outcome "not recovered", described as "many unusual cloths in the menstrual blood.". Therapeutic measures were not taken as a result of heavy menstrual bleeding, intermenstrual bleeding.  Additional information: The clinical course was reported as the patient had not other vaccine in four weeks. Patient had received other medications in two weeks with Zoloft and levothyroxine. The patient had covid prior vaccination and had not covid tested post vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: major vertigo issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EP6955) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset 21Mar2021, outcome "not recovered", described as "major vertigo issues". The event "major vertigo issues" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo.  Additional information: The Patient didn't taken other vaccine in four weeks and Other medications in two weeks.A week after 1st dose patient experienced major vertigo issues for no apparent reason. She went to ER to ensure she wasn't having a stroke. Patient was not taken Covid prior vaccination.Covid tested post vaccination. Patient didn't had known allergies.  . No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Has changed menstruation cycle permanently. Had normal menstruation cycles of 29-31 days prior to vaccine. After fully vaccinated has made cycles 45+ days or currently not menstruating at all. No life; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 27Apr2021 at 13:15 as dose 2, single (Batch/Lot number: unknown) at the age of 26 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 05Apr2021 at 12:00, outcome "not recovered", described as "Has changed menstruation cycle permanently. Had normal menstruation cycles of 29-31 days prior to vaccine. After fully vaccinated has made cycles 45+ days or currently not menstruating at all. No life". The event "has changed menstruation cycle permanently. had normal menstruation cycles of 29-31 days prior to vaccine. after fully vaccinated has made cycles 45+ days or currently not menstruating at all. no life" required physician office visit. Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: Has changed menstruation cycle permanently. Had normal menstruation cycles of 29-31 days prior to vaccine. After fully vaccinated has made cycles 45+ days or currently not menstruating at all. No life style changes have been made. No treatment received for AE. No covid symptoms prior to vaccination. No known allergies and no medical history was reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Magnetic resonance imaging, SARS-CoV-2 test, Vertigo
Clinical narrative: vertigo; ongoing headaches; brain fog; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 24Dec2020 at 20:00 as dose 1, single (Lot number: EL9231) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; OLMESARTAN; CRESTOR. The following information was reported: FEELING ABNORMAL (non-serious) with onset 28Dec2020 at 07:00, outcome "recovering", described as "brain fog"; HEADACHE (non-serious) with onset 28Dec2020 at 07:00, outcome "recovering", described as "ongoing headaches"; VERTIGO (non-serious) with onset 28Dec2020 at 07:00, outcome "recovering". The events "vertigo", "ongoing headaches" and "brain fog" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vertigo, headache, feeling abnormal.  Additional information: Previous dose details: Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose lot number: EL3249, Prev dose lot unknown: False, Prev dose administration date: 13Jan2022, Prev dose number: 2, Prev dose vaccine location: Right arm   Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Neuropathy peripheral, SARS-CoV-2 test
Clinical narrative: peripheral neuropathy; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 23Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 30125BA) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; OLMESARTAN; CRESTOR. Vaccination history included: BNT162b2 (Lot no: EL9231, time=08:00 PM, location=Left arm; 4 days after 1st dose vertigo and ongoing headaches and brain fog lasting 4 months), administration date: 24Dec2020, when the patient was 75-year-old, for Covid-19 immunization, reaction(s): "brain fog", "vertigo", "headaches"; BNT162b2 (Lot no: EL3249, vaccine location=Right arm), administration date: 13Jan2022, when the patient was 75-year-old, for Covid-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "recovering", described as "peripheral neuropathy". The event "peripheral neuropathy" required physician office visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (unspecified date) unknown result; SARS-CoV-2 test: (19Apr2022) Negative, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of neuropathy peripheral.  Clinical information: The patient was treated with MRIs and unspecified meds. The patient did not had any other vaccine in four weeks. No COVID prior vaccination. No known allergies.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2022 as dose 3 (booster), single (Lot number: FL3209) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04May2021 as dose 1, single (Lot number: 003C21A), in left arm and on 01Jun2021 as dose 2, single (Lot number: 049C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Clinical course: Other medication in 2 weeks was reported as no. No Known allergies.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, SARS-CoV-2 test
Clinical narrative: Extreme pain in left shoulder surfacing a few days after 1st injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EM9810) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "A1C slightly elevated" (unspecified if ongoing); "thyroid cancer" (unspecified if ongoing); "gall bladder removal" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; PRILOSEC [OMEPRAZOLE]. The following information was reported: ARTHRALGIA (non-serious), outcome "recovered", described as "Extreme pain in left shoulder surfacing a few days after 1st injection". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Extreme pain in left shoulder surfacing a few days after 1st injection that gradually subsided after a few weeks. Pain occurred when lifting left arm, reaching out or above head, placing arm behind back. Also experienced extreme pain in right shoulder day after 2nd dose. Felt lethargic, extremely weak, disoriented. Took a nap for about one hour and felt a little better. Pain disrupts sleep caused from pain when moving in bed. Difficulty lifting, reaching out and to the side. Went to Orthopedist and was diagnosed with adhesive capsulitis (shoulder freeze). Physician administered cortisone and provided stretching exercises. Worked out ok for a couple weeks and then slowly began to return to the same level as before the cortisone injection. Currently working with physical therapist to loosen encapsulation with minimal improvement.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2022 at 13:00 as dose 3 (booster), single (Lot number: FK9895) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (product: COVID 19,, prev_dose_brand: Pfizer,, prev_dose_lot_number: ER8735,, prev_dose_administration_date: 06A, pr2021, prev_dose_dose_number: 2,, prev_dose_vaccine_location: Left, arm), administration date: 06Apr2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (prev_dose_product: COVID 19,, prev_dose_brand: Pfizer,, Lot number: EP6955,, prev dose administration date:14M, ar2021, prev_dose_dose_number: 1,, prev_dose_vaccine_location: Left, arm}]), administration date: 14Mar2021, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "Major Vertigo issue". The following information was reported: TINNITUS (non-serious) with onset Mar2022, outcome "not recovered". The event "tinnitus" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus.  Additional information: It was reported that a week after 1st dose patient experienced major vertigo issues for no apparent reason. Patient went to ER to ensure she wasn't having a stroke. Within a week after her 3rd Dose, she has been experiencing Tinnitus in both ears, but primarily in her left (loudest there) 24/7. Patient had no Covid prior vaccination. Patient had tested Covid post vaccination. Known allergies: No.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
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 46-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP6955), on 09Apr2021 as dose 2, single (Lot number: EW0150) and on 22Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FF2593) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension." (ongoing). Concomitant medication(s) included: LOSARTAN; AMLODIPINE; ALEVE; TYLENOL.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; negative, notes: previously tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies. The patient received Paxlovid for COVID 19 treatment from 23Apr2022 to 27Apr2022.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: PAXAES report with Pfizer-BioNTech Vaccine administered; report with Pfizer-BioNTech Vaccine administered; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "Chronic Kidney Disease" (unspecified if ongoing); "thyroid cysts" (unspecified if ongoing). There were no concomitant medications, also reported as no other medication in 2weeks. Past drug history included: Soy, reaction(s): "known allergies: Soy"; Erythromycin, reaction(s): "known allergies: erythromycin"; Oxycontin, reaction(s): "known allergies: Oxycontin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "report with Pfizer-BioNTech Vaccine administered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (02May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 included anti-viral Paxlovid (Brand: Pfizer) started from 26Apr2022 and stopped on 30Apr2022. Clinical course was reported as, two days after completing treatment, and testing negative, patient's fever and symptoms returned on 02May2022 at 13:30. Patient was not recovered from symptoms and no treatment received for symptoms   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from 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 01Apr2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Apr2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Oct2021 at 15:00 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: "Ashthma" (unspecified if ongoing); "severe allergies" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "brain issues" (unspecified if ongoing), notes: brain issues treated with Lamotrigine.; "autoimmune thyroid" (unspecified if ongoing). No known allergies reported. Patient received other medications within two weeks of vaccination as concomitant medication(s) included: THYROID; ARMOUR THYROID, start date: 01Dec2018, stop date: 06May2022; LAMOTRIGINE, start date: 01Jun2021, stop date: 06May2022; DULERA, start date: 01Jul2020, stop date: 06May2022; XOLAIR, start date: 01Jul2021, stop date: 06May2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 26Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 26Apr2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive, notes: COVID infection confirm with both rapid and PCR; (26Apr2022) Positive, notes: COVID infection confirm with both rapid and PCR; (02May2022) Negative, notes: Rapid test Negative on Day 7; (06May2022) Positive, notes: today again on Day 11/ Slight line on positive rapid test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: patient took Paxlovid last around Day 2 of COVID infection confirm with both rapid and PCR. Felt wonderful after about a day, finished series. Rapid test Negative on Day 7. Started having symptoms today again on Day 11 that feel just like the beginning of the infection, chills, headache, nasal drips, slight sore throat. Slight line on positive rapid test. It feels like it was coming back, she have severe asthma and autoimmune thyroid and really scared.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 at 12:00 as dose 1, single (Lot number: EL9266), in right arm, on 01Apr2021 at 12:00 as dose 2, single (Lot number: ER8733), in left arm, on 13Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 26Mar2022 at 14:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 82 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Sjogren's syndrome" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing). Concomitant medication(s) (other medications in 2 weeks) included: ATORVASTATIN, stop date: 25Apr2022; AMITRIPTYLINE; AMLODIPINE; AREDS 2 VISUAL ADVANTAGE; ASPIRIN [ACETYLSALICYLIC ACID]; FOLIC ACID. Past drug history included: Advil, reaction(s): "known allergies: Advil". 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Developed minor Covid symptoms and tested positive on antigen test; Developed minor Covid symptoms and tested positive on antigen test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have survived cancer twice - 28 years ago and 7 years ago." (unspecified if ongoing), notes: I have survived cancer twice - 28 years, ago and 7 years ago.; "Had splenectomy as a result." (unspecified if ongoing), notes: Had splenectomy as a result; "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; ESCITALOPRAM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Apr2022, outcome "not recovered" and all described as "Developed minor Covid symptoms and tested positive on antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) Positive; (05May2022) Positive; (03May2022) Negative. Therapeutic measures were taken as a result of covid-19.Clinical Course: Adverse event: Developed minor Covid symptoms and tested positive on antigen test on 27Apr2022. Began Paxlovid the morning of 27Apr2022 and completed course evening of 01May2022. While taking Paxlovid, patient symptoms resolved and he felt fine. patient tested negative on an at-home antigen test on 03May2022. On 05May2022, Patient developed the same Covid symptoms as patient had started with runny nose, sinus pressure, low grade fever, sore throat, some body aches. Patient tested positive again on an antigen test and called to doctor the following morning, 06May2022 and pateint asked if he could retake Paxlovid, however, he was unsure if this was advised or not and has suggested he tough it out. Known allergies was reported as no.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Dec2021 as dose 3 (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 included: "Diabetic" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]; VITAMIN C [ASCORBIC ACID]; FARXIGA; OZEMPIC; ATORVASTATIN. Other medication in 2weeks was reported as yes. Past drug history included: Vicodin, reaction(s): "Known allergies: Vicodin". 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment with Paxlovid, treatment start date=25Apr2022, treatment stop date=29Apr2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID symptoms returned; COVID symptoms returned; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Mar2021 as dose 1, single (Lot number: 003A21A), in left arm, on 10Apr2021 as dose 2, single (Lot number: 036BZ1A), in left arm and on 12Apr2022 as dose 4 (booster), single (Lot number: 001M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "GERD" (unspecified if ongoing); "gastroparesis" (unspecified if ongoing); "PVC" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "Interchange of vaccines products" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; SINGULAIR; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ROSUVASTATIN; LOSARTAN; ASPIRIN [ACETYLSALICYLIC ACID]; METOPROLOL; MAGNESIUM; LANSOPRAZOLE; BREO ELLIPTA; B12 [CYANOCOBALAMIN]; D3; PROBIOTIC [BIFIDOBACTERIUM LACTIS]; ALBUTEROL [SALBUTAMOL]. No Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06May2022, outcome "not recovered" and all described as "COVID symptoms returned". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: I once again tested positive; negative, notes: having had a negative test shortly after finishing Paxlovid. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment/Tested positive on 26Apr2022; COVID 19 Treatment/Tested positive on 26Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 at 09:00 as dose 1, single (Lot number: EL0142), in left arm, on 03Feb2021 at 12:00 as dose 2, single (Lot number: EL9265), in right arm and on 17Dec2021 at 10:00 as dose 3 (booster), single (Lot number: 33130BA) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "arterial plaque" (unspecified if ongoing). Concomitant medication(s) included: IRON. The following information was reported: VACCINATION FAILURE (medically significant) with onset 26Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 26Apr2022, outcome "recovered" (04May2022) and all described as "COVID 19 Treatment/Tested positive on 26Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) Negative; (20Apr2022) Negative; (26Apr2022) Positive; (04May2022) Negative. Therapeutic measures were taken as a result of covid-19.  Clinical Course: Second vaccine dose caused gastric bloating and ultimately anemia. After seeing a half-dozen mds, convinced my GP to prescribe a steroid dose. Have been taking iron pills for a year. Blood levels after the steroid dose began climbing and are back to normal. Had Covid rebound. After negative tests on 17Apr2022 and 20Apr2022 felt a bad cold hit me on 25Apr2022. Tested positive on 26Apr2022. Began a steriod and antibiotic dose with minerals and vitamins. Tested negative 4May2022. Patient had no other medication in 2 weeks. AE treatment with Methypredisone, azithromyican, vc, vd3, Turmeric. No Known allergies. Other medical history includes High BP, arterial plaque.  Anti viral details: Product=COVID 19 Treatment; Treatment start date=13Apr2022; Treatment stop date=17Apr2022; Lot number=Didn't keep this information; Indication=Treatment of COVID-19.