chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Seizure, Speech disorder
Clinical narrative: seizure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 2, single (Lot number: FJ1611) and on 15May2022 as dose 3 (booster), single (Lot number: EM9222) at the age of 63 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, LOT: EW0150 , NDC/EXPIRY: Unknown, reading information from Vaccine Card, not on Vaccine Card for any of the doses.), administration date: 30Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "booster hurt way more than any of the shots she had previously". The following information was reported: SEIZURE (hospitalization, medically significant), outcome "recovered with sequelae". The patient was hospitalized for seizure (start date: 30May2022, discharge date: 30Jun2022, hospitalization duration: 31 day(s)). The patient underwent the following laboratory tests and procedures: Testing: Unknown, notes: Had major testing done for seizure; SARS-CoV-2 test: Unknown results, notes: Checked for her COVID.  Clinical information: Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. Dose/Dosage Form: Gray cap, Original (Monovalent), greater than or equal to 12 years, minus 30 mcg/dose, Do not dilute. Reporter reported that 63-year-old female patient and states that she had a seizure after receiving the Pfizer COVID-19 booster vaccine. The patient was in hospital for Severe Seizure from 30May2022 to 30Jun2022. The patient had the booster on 15May2022 and two weeks later on 30May2022 she had a very, very severe seizure that she believes was directly related to the booster shot. Put her out for two weeks, has no memory of those two weeks. Was out in the hospital. Had another two weeks in hospital for rehab. Took her shot and her boosters regularly. The fact that this seizure was so close to the booster she doesn't believe it was caused by anything other than the booster shot. The patient was so upset that she can't express herself, has almost has no walking ability, problems with speaking ability, and other problems as well as a result from the seizure. The patient clarified she thought she had 4 doses total, but she only had three doses. Confirmed seizure was caused by second dose and third booster. Had major testing done for seizure. HCPs don't know what caused it. Checked her for COVID, relevant injuries, checked for a lot of things. Unknown test names or test results. Declined vaccine supplemental form.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201118303 same reporter/patient, different dose/events;
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Investigation, SARS-CoV-2 test, Seizure
Clinical narrative: After the third booster she had a lot of pain in her arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old female patient received BNT162b2 (BNT162B2), on 15May2022 as dose 3 (booster), single (Lot number: EM9222) at the age of 63 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EW0150), administration date: 30Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "Booster hurt way more than any of the shots she had previously"; BNT162b2 (DOSE 2, SINGLE; Lot number: FJ1611), administration date: 20Apr2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "Booster hurt way more than any of the shots she had previously". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15May2022, outcome "recovered" (May2022), described as "After the third booster she had a lot of pain in her arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Lot of pain in her arm: Stop date: Lasted 5 to 7 days. Recovered completely. After the third booster she had a lot of pain in her arm, booster hurt way more than any of the shots she had previously. Had the booster 15May2022 and two weeks later on 30May2022 she had a very, very severe seizure that she believes was directly related to the booster shot. Put her out for two weeks, has no memory of those two weeks. Was out in the hospital. Had another two weeks in hospital for rehab. Took her shot and her boosters regularly. The fact that this seizure was so close to the booster she doesn't believe it was caused by anything other than the booster shot. So upset that she can't express herself, has almost has no walking ability, problems with speaking ability, and other problems as well as a result from the seizure. Had major testing done for seizure. She only had three doses. Confirmed seizure was caused by third dose, second booster.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201118303 same reporter/patient/event, different dose;
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Gait disturbance, Ill-defined disorder, Laboratory test, Language disorder
Clinical narrative: After the third booster she had a lot of pain in her arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old female patient received BNT162b2 (BNT162B2), on 15May2022 as dose 3 (booster), single (Lot number: EM9222) at the age of 63 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EW0150), administration date: 30Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "Booster hurt way more than any of the shots she had previously"; BNT162b2 (DOSE 2, SINGLE; Lot number: FJ1611), administration date: 20Apr2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "Booster hurt way more than any of the shots she had previously". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15May2022, outcome "recovered" (May2022), described as "After the third booster she had a lot of pain in her arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Lot of pain in her arm: Stop date: Lasted 5 to 7 days. Recovered completely. After the third booster she had a lot of pain in her arm, booster hurt way more than any of the shots she had previously. Had the booster 15May2022 and two weeks later on 30May2022 she had a very, very severe seizure that she believes was directly related to the booster shot. Put her out for two weeks, has no memory of those two weeks. Was out in the hospital. Had another two weeks in hospital for rehab. Took her shot and her boosters regularly. The fact that this seizure was so close to the booster she doesn't believe it was caused by anything other than the booster shot. So upset that she can't express herself, has almost has no walking ability, problems with speaking ability, and other problems as well as a result from the seizure. Had major testing done for seizure. She only had three doses. Confirmed seizure was caused by third dose, second booster.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201118303 same reporter/patient/event, different dose;
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Seizure, Speech disorder
Clinical narrative: After the third booster she had a lot of pain in her arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old female patient received BNT162b2 (BNT162B2), on 15May2022 as dose 3 (booster), single (Lot number: EM9222) at the age of 63 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EW0150), administration date: 30Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "Booster hurt way more than any of the shots she had previously"; BNT162b2 (DOSE 2, SINGLE; Lot number: FJ1611), administration date: 20Apr2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "Booster hurt way more than any of the shots she had previously". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15May2022, outcome "recovered" (May2022), described as "After the third booster she had a lot of pain in her arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Lot of pain in her arm: Stop date: Lasted 5 to 7 days. Recovered completely. After the third booster she had a lot of pain in her arm, booster hurt way more than any of the shots she had previously. Had the booster 15May2022 and two weeks later on 30May2022 she had a very, very severe seizure that she believes was directly related to the booster shot. Put her out for two weeks, has no memory of those two weeks. Was out in the hospital. Had another two weeks in hospital for rehab. Took her shot and her boosters regularly. The fact that this seizure was so close to the booster she doesn't believe it was caused by anything other than the booster shot. So upset that she can't express herself, has almost has no walking ability, problems with speaking ability, and other problems as well as a result from the seizure. Had major testing done for seizure. She only had three doses. Confirmed seizure was caused by third dose, second booster.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201118303 same reporter/patient/event, different dose;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high", start date: 2010 (unspecified if ongoing), notes: doctor prescribed beta blockers for the first time to help with high blood pressure symptoms; "Five valve open heart surgery", start date: 2021 (unspecified if ongoing); "Headache" (unspecified if ongoing), notes: his body got headaches if he did not take beta blockers. The patient's concomitant medications were not reported. Past drug history included: Metoprolol succinate, start date: 2010, for pain, reaction(s): "interferes with erections", notes: beta-blocker, capsules. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "unknown", described as "COVID-19 / mucous in his chest and nose"; DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", described as "Drug ineffective ". Therapeutic measures were taken as a result of drug ineffective, covid-19 (mucus medicine, unspecified). It was specified that the patient got COVID-19 for the first time one month before this report after having 2 additional doses of the Pfizer COVID-19 vaccine after the primary series. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19, 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 78-year-old female patient received BNT162b2 (BNT162B2), on 28Feb2022 at 11:00 as dose 4 (booster), single (Lot number: FE3590) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Nitrofurantoin, reaction(s): "Known allergies: Nitrofurantoin". 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.The patient was received Paxlovid with lot number FK9894 via oral route of administration from 23Aug2022 to 28Aug2022 for the treatment of Covid- 19.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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: "MS" (unspecified if ongoing); "drug Allergy" (unspecified if ongoing), notes: Name of Drug as Reported: No. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 27Aug2022, outcome "recovering", described as "Rebound case. I have now been sick for 15 days". Therapeutic measures were taken as a result of drug ineffective, covid-19 from 21Aug2022 to 25Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 51-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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid as Anti-viral treatment for COVID-19 from 24Aug022 to 29Aug2022. Covid vaccine lot number was unknown since it was misplaced/discarded. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Device Date was 04Sep2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on available information, the events Covid-19 and drug ineffective is assessed as related to the suspect drug BNT162b2.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Maternal exposure timing unspecified
Clinical narrative: pregnant; miscarried; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 47-year-old female patient (pregnant) 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: MATERNAL EXPOSURE TIMING UNSPECIFIED (prolonged hospitalization, medically significant), outcome "unknown", described as "pregnant"; ABORTION SPONTANEOUS (prolonged hospitalization, medically significant), outcome "unknown", described as "miscarried". Patient miscarried after her Pfizer vaccine (1st shot). Patient thought that was the reason why. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Congenital anomaly or birth defect. The events "pregnant" and "miscarried" required physician office visit and emergency room visit. The pregnancy resulted in spontaneous abortion.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had no reactions to shots other than sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL3302) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; CALCIUM; IRON; D3. Vaccination history included: Shingrix, administration date: 2018, for immunisation, reaction(s): "flu", "feverish". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had no reactions to shots other than sore arm".  Additional information: The patient also received multiple vitamins as concomitant drug.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: EW0158), in right arm, on 05May2021 as dose 2, single (Lot number: EW0173), in right arm, on 09Nov2021 as dose 3 (booster), single (Lot number: FH8027), in right arm and on 21May2022 as dose 4 (booster), single (Lot number: PM9992) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Irritable bowel syndrome" (unspecified if ongoing); "tension headaches" (unspecified if ongoing); "Pacemaker implant due to bradycardia" (unspecified if ongoing), notes: Pacemaker implant due to bradycardia; "seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: Latex" (unspecified if ongoing); "pacemaker implant due to bradycardia" (unspecified if ongoing), notes: pacemaker implant due to bradycardia. Concomitant medication(s) included: Cetirizine; Fluticasone; Azelastine; Magnesium Citrate; Metamucil [Plantago Ovata]. The following information was reported: VACCINATION FAILURE (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: (Aug2022) Positive, notes: within 12 hours of symptom onset and positive antigen test; (unspecified date) Positive, notes: COVID 19 Treatment; (28Aug2022) Positive, notes: Began testing daily on day 6-9, never testing negative; (29Aug2022) Positive, notes: Began testing daily on day 6-9, never testing negative; (30Aug2022) Positive, notes: Began testing daily on day 6-9, never testing negative; (31Aug2022) Positive, notes: Began testing daily on day 6-9, never testing negative. Therapeutic measures were taken as a result of covid-19. Clinical course: Began 5-day course of Paxlovid within 12 hours of symptom onset and positive antigen test. Symptoms were mild-to moderate headache, mild sore throat, slight sinus congestion and no post-nasal drip. Began testing daily on day 6-9, never testing negative. On Day 10, headache became worse and sinus congestion and post-nasal drip increased. On Day 11, symptoms included fever, chills, cough, body aches, significant sinus congestion and post-nasal drip, fatigue. Fever and chills resolved during Day 12 but returned that evening. Other medication in 2 weeks. Patient received Anti-viral treatment for COVID-19 with Paxlovid from 23Aug2022 to 27Aug2022.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had no reactions to shots other than sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 2, single (Lot number: EN5318) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure measurement; CALCIUM; IRON; D3. Vaccination history included: BNT162b2 (Dose number: 1, Lot: EL3302.), administration date: 01Feb2021, when the patient was 73-year-old, for Covid-19 Immunization, reaction(s): "had no reactions to shots other than sore arm"; Shingrix (Vaccine/Brand Name: Shingles Shot; Shingrix; , 2 shots before COVID so 2018 Vaccination Date: long time ago), for Immunization, reaction(s): "flu"; Shingrix (Vaccine/Brand Name: Shingles Shot; Shingrix; , 2 shots before COVID so 2018 Vaccination Date: long time ago), for immunization, reaction(s): "feverish". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had no reactions to shots other than sore arm".
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had no reactions to shots other than sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 09Oct2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure measurement; CALCIUM; IRON; D3. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , Lot number: EL3302), administration date: 01Feb2021, when the patient was 72-year-old, for Covid-19 immunization, reaction(s): "had no reactions to shots other than sore arm"; BNT162b2 (DOSE 2, SINGLE , Lot number: EN5318), administration date: 01Mar2021, when the patient was 73-year-old, for Covid-19 immunization, reaction(s): "had no reactions to shots other than sore"; Shingrix (Vaccine/Brand Name: Shingles Shot; Shingrix; , 2 shots before COVID so 2018 Vaccination Date: long time ago), administration date: 2008, for Immunization, reaction(s): "flu", "feverish". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had no reactions to shots other than sore arm".
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jun2021 as dose 1, single (Lot number: EWO180), in left arm, on 07Jul2021 as dose 2, single (Lot number: EYO0584) and on 14Jan2022 as dose 3 (booster), single (Lot number: FJ6369) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's syndrome" (unspecified if ongoing); "ANA-anti nuclear antibodies" (unspecified if ongoing), notes: ANA-anti nuclear antibodies; "Known Allergies: Penicillin" (unspecified if ongoing), notes: Known Allergies: Penicillin. The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Known Allergies: Aspirin", notes: Known Allergies: Aspirin; NSAIDS, reaction(s): "Known Allergies: NSAIDS", notes: Known Allergies: NSAIDS; Ampicillin, reaction(s): "Known Allergies: Ampicillin", notes: Known Allergies: Ampicillin; Sublimaze (fentanyl) anesthesia, reaction(s): "Known Allergies: Sublimaze (Fentanyl) anesthesia", notes: Known Allergies: Sublimaze (Fentanyl) anesthesia. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: anti viral details: product COVID 19 Treatment, brand Paxlovid by Pfizer, treatment start date 02Sep2022, lot number GE1600, indication Treatment of COVID-19.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 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 22Jan2021 as dose 1, single (Lot number: EL1283), in right arm, on 12Feb2021 as dose 2, single (Lot number: EN5318), in right arm and on 02Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "SVT" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: 01Jan2020. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 03Sep2022 at 12:00, outcome "not recovered", described as "Rebound case of Covid with all the Covid symptoms"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (03Sep2022) Unknown results, notes: Rebound case of Covid with all the Covid symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. Patient took Paxlovid for COVID-19 treatment from 25Aug2022 to 31Aug2022. Patient had rebound case of Covid with all the Covid symptoms. Other medication received in 2weeks. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, SARS-CoV-2 test, Surgery, Tympanic membrane perforation
Clinical narrative: had surgery on my ear 01Sep2022; Not too long after the shot I had a metallic taste that lasted 7 days.; right ear ruptured a week later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CRPS" (unspecified if ongoing), notes: Other medical history: CRPS. The patient took concomitant medications. The following information was reported: DYSGEUSIA (non-serious) with onset 02Nov2021, outcome "recovered" (Nov2021), described as "Not too long after the shot I had a metallic taste that lasted 7 days."; TYMPANIC MEMBRANE PERFORATION (medically significant) with onset 02Nov2021, outcome "not recovered", described as "right ear ruptured a week later"; SURGERY (medically significant) with onset 01Sep2022, outcome "unknown", described as "had surgery on my ear 01Sep2022". The event "right ear ruptured a week later" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Aug2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of tympanic membrane perforation.  Clinical Course: Not too long after the shot patient had a metallic taste that lasted 7 days. Patient was told that was rare but would go away. On, 08Nov2021, patient went to the ENT because her right ear ruptured a week later. Patient just had surgery on her ear 01Sep2022 so hopefully the surgery was a success. The patient was in perfectly good health was forced by employer (Name withheld). No other vaccine in four weeks. Patient had Thyroid medication in two weeks of vaccination. Patient had no COVID prior to vaccination. Patient tested COVID post vaccination. There were no known allergies.   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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient. An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Gastrooesophageal reflux disease" (unspecified if ongoing), notes: other medical history: GERD. Concomitant medication(s) included: CLARITIN [LORATADINE], start date: 22Aug2022, stop date: 02Sep2022. The following information was reported: VACCINATION FAILURE (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: Negative, notes: after testing negative for three days in a row; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Patient received Paxlovid as a treatment of COVID-19 from 23Aug2022 to 28Aug2022. It was reported that on 02Sep2022 worsening symptoms 4 days after finishing Paxlovid and after testing negative for three days in a row. Patient had no known allergies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information in the case narrative, a causal association between reported events vaccination failure, Covid 19 and suspect BNT162B2 cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: R8733), in left arm, on 20Apr2021 as dose 2, single (Lot number: EU0170), in left arm and on 22Dec2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Pre-Diabetes" (unspecified if ongoing). Concomitant medication(s) included: Levothyroxine; Liothyronine; Labetalol; Hydrochlorothiazide; Tramadol; Diclofenac; Gabapentin; Acetaminophen; Vitamin D [Colecalciferol]; Zinc. Past drug history included: Lovenox, reaction(s): "Known allergies: Lovenox". 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, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 include COVID 19 Treatment from 22Aug2022 to 26Aug2022. Clinical information: Patient took other medication in 2 weeks. On 3rd day of treatment, symptoms markedly improved. Only symptom at end of treatment was fatigue. Remained in isolation for full 10days. 7 days post treatment felt congested. 8 days post treatment had congestion, myalgias, fatigue, loss of appetite, dry cough and headache No fever, though taking Tylenol for arthritis pain. Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2022 as dose 4 (booster), single (Lot number: fj9943) at the age of 35 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "crohn's" (unspecified if ongoing). Concomitant medication(s) included: REMICADE. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 31Aug2022, outcome "not recovered", described as "Rebound of symptoms and positive test"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 treatment: Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 treatment: Paxlovid; (31Aug2022) positive, notes: Rebound of symptoms and positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical information: Antiviral details: COVID 19 treatment was Paxlovid, treatment started on 22Aug2022, and treatment stopped on 27Aug2022. Other medication in 2 weeks was Remicade. Adverse event was rebound of symptoms and positive test. Adverse event started on 31Aug2022. No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Myalgia
Clinical narrative: Weird tearing pain in center of left armpit when i lift my left arm (arm i got booster shot in) a couple days after getting the 1st covid pfizer booster.; Also feel pain in left lat muscle that feels related to main pain described above.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old male patient received BNT162b2 (BNT162B2), on 02Aug2022 at 15:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization completed , Unknown Manufacturer), for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: MYALGIA (non-serious) with onset 04Aug2022 at 17:00, outcome "not recovered", described as "Also feel pain in left lat muscle that feels related to main pain described above."; AXILLARY PAIN (non-serious) with onset 04Aug2022 at 17:00, outcome "not recovered", described as "Weird tearing pain in center of left armpit when i lift my left arm (arm i got booster shot in) a couple days after getting the 1st covid pfizer booster.". Therapeutic measures were not taken as a result of axillary pain, myalgia.  Additional Information: The patient was 21 years old as reported. It was reported that other vaccine in four weeks and other medications in two weeks was reported as none and the patient had no known allergies. COVID prior vaccination and COVID tested post vaccination was reported as none. The patient stated that weird tearing pain in center of left armpit when he lift his left arm (arm he got booster shot in) a couple days after getting the 1st covid pfizer booster. Had pain for few days thinking it must be from booster shot so just wanted to tell. Also feel pain in left lat muscle that feels related to main pain described above.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 02Sep2022 at 12:00, outcome "unknown", described as "Rebound symptoms and positive test 2 days after completing dose pack". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Sep2022) Positive, notes: at 12:00 PM. Rebound symptoms and positive test 2 days after completing dose pack. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course: Patient was treated for covid-19 with antivirals from 25Aug2022 to 30Aug2022. Patient experienced terrible taste, there was rebound symptoms and positive test 2 days after completing dose pack. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19 treatment; Covid-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 08Apr2021 as dose 2, single (Lot number: ER8737), in left arm, on 24Nov2021 as dose 3 (booster), single (Lot number: FF3590), in left arm and on 13Jun2022 as dose 4 (booster), single (Lot number: FL3198), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing). Concomitant medication(s) included: GLUCOPHAGE, start date: 01Oct2018; LIPITOR, start date: 01Oct2019, stop date: 11Aug2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 02Sep2022 at 10:00, outcome "unknown", COVID-19 (medically significant) with onset 02Sep2022 at 10:00, outcome "recovering" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Sep2022) Positive, notes: Rebound positive test for Covid today. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Dec2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine nRVV ad26 (JANSSEN COVID-19 VACCINE), on 08Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing), notes: Other medical history: obesity; "depression" (unspecified if ongoing), notes: Other medical history: depression. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was not pregnant, No other medications in two weeks. No other medications in two weeks. If treatment AE, no. No known allergies. 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, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) 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: "RA" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "controlled high cholesterol" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "known allergies: codeine". The following information was reported: DISEASE RECURRENCE (medically significant) with onset 04Sep2022, outcome "not recovered", described as "tested negative for 5 days using a home test starting 27Aug2022/ took a home test twice, both positive"; 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: (unspecified date) Positive, notes: COVID 19 Treatment; (27Aug2022) Negative, notes: I tested negative for 5 days using a home test starting 27Aug; (28Aug2022) Negative, notes: I tested negative for 5 days using a home test starting 27Aug; (29Aug2022) Negative, notes: I tested negative for 5 days using a home test starting 27Aug; (30Aug2022) Negative, notes: I tested negative for 5 days using a home test starting 27Aug; (31Aug2022) Negative, notes: I tested negative for 5 days using a home test starting 27Aug; (04Sep2022) Positive, notes: Took a home test twice, both positive; (04Sep2022) Positive, notes: Took a home test twice, both positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Paxlovid was given as treatment for covid-19 starting on 24Aug2022 till 28Aug2022. Other medication were given in 2 weeks. It was reported that only adverse event was that the patient tested negative for 5 days using a home test starting 27Aug. Started feeling a little sick at her stomach on 04Sep. Took a home test twice, both positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Palpitations, Paraesthesia
Clinical narrative: I have had numbness and tingling in my left arm every morning; my arm is just going to sleep but it happens every morning; I have had numbness and tingling in my left arm every morning; my arm is just going to sleep but it happens every morning; I have heart palpitations sometimes; I am starting to have difficulty in walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 62 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, ), for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious), outcome "not recovered" and all described as "I have had numbness and tingling in my left arm every morning; my arm is just going to sleep but it happens every morning"; PALPITATIONS (non-serious), outcome "unknown", described as "I have heart palpitations sometimes"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I am starting to have difficulty in walking". Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia, palpitations, gait disturbance.  Additional Information: The patient stated that she was wondering if having a side effect from the Pfizer vaccine booster or whatever she had the first and second shot last year. The patient  had the booster but there was things going on usually she was extremely healthy but lately had numbness and tingling in left arm every morning and also had heart palpitations. The patient stated,  thinking it's possible that was a side effect that she was having. The patient  do have a doctor appointment on 25Oct to talk to doctor about the numbness and tingling in left arm which she  told him once before and he saw that it was that arm was just going to sleep but it happens every morning and the patient concerned about it. Well, it's actually happening now so the numbness and tingling in arm are concern of  patient and then had heart palpitations sometimes. The patient started to have difficulty in walking. Now, that's another reason patient going to doctor on 25Oct. The patient hope it was not anything but maybe it could be that hips going out on me she don't know, it could be knee. The patient don't know but  having difficulty in walking lately. So, that was the concern of patient but you know she may not have nothing to do with anything other than the normal aging process but we can just, the patient just thought she  should report it just in case.