chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Sensitive skin
Clinical narrative: Swelling of arm and redness, pain in injection site . Now a dent , sunk in spot on left upper arm, numbness that comes and goes , as well as pain very sensitive spot in arm.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs, no PQCs; ROTATEQ was administered in a temperature excursion.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided.  On 08-MAR-2023, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered orally for prophylaxis (lot #1892784 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 03-DEC-2023) (dosage, vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported). The administered dose of the vaccine was stored at a temperature of 46.4 degrees Fahrenheit (F), for a time frame of 5 minutes, as recorded by a digital data logger. There was a previous temperature excursion reported as: 47.9 Fahrenheit (F),  There was no adverse effect reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Contracted COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Contracted COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076c21A) for COVID-19 prophylaxis.     The patient's past medical history included Lumpectomy in February 2020. Previously administered products included for COVID-19 vaccination: PFIZER/BIONTECH COVID-19 VACCINE (Time 11:00 am, Anatomical site of injection: right shoulder, lot number: ER2613, Dose 1) on 24-Mar-2021, PFIZER/BIONTECH COVID-19 VACCINE (Time 10:20 am, Anatomical site of injection: right shoulder, lot number: EL8729 and Dose 2) on 14-Apr-2021. Past adverse reactions to the above products included No adverse event with PFIZER/BIONTECH COVID-19 VACCINE and PFIZER/BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Hyperlipidemia, High cholesterol and Breast cancer female (Lumpectomy Feb 2020) in February 2020. Concomitant products included ATORVASTATIN for High cholesterol, ANASTROZOLE for Prophylaxis.    On 23-Oct-2021 at 9:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Contracted COVID-19). At the time of the report, COVID-19 (Contracted COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2023, SARS-CoV-2 test: positive, First negative test was 16 days after symptoms onset.         Anatomical site of injection was reported as right shoulder.  On 06-Apr-2022 at 10:30 AM, the patient received fourth dose of PFIZER/BIONTECH COVID-19 VACCINE of route intramuscular, anatomical site of injection right shoulder, lot number FK9893.  On unknown date, the patient received fifth dose of PFIZER bivalent booster for Covid prevention of route intramuscular injection, lot number GJ3277. The action taken, dechallenge and rechallenge was reported as not applicable.  On 06-Feb-2023, the patient experienced non-serious Cough, Congestion, Aches, Fever for two weeks which required Physician office visit. The patient was recovered/resolved from this. No treatment medication information was reported.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient was administered with the bivalent vaccine instead of the monovalent for their 1st dose of the primary series; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient was administered with the bivalent vaccine instead of the monovalent for their 1st dose of the primary series) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No relevant medical history or conditions, allergy,concomitant diseases and risk factor.     On 14-Feb-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (patient was administered with the bivalent vaccine instead of the monovalent for their 1st dose of the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient was administered with the bivalent vaccine instead of the monovalent for their 1st dose of the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient was administered with the bivalent vaccine instead of the monovalent for their 1st dose of the primary series).    No concomitant medications were reported. An administrator of an urgent care reports that they had an incident in one of their locations where a patient was administered with the bivalent vaccine instead of the monovalent for their 1st dose of the primary series. The patient was in their facility now for the supposed 2nd dose of the primary series. No treatment medications were reported.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; GIven the bivalent instead of a primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Given the bivalent instead of a primary series) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19.  The patient's past medical history included Transplant (patient had a transplant that wiped patient's entire immune system). Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (First dose of Moderna) on 18-Aug-2021 and Moderna COVID-19 Vaccine (Second dose of Moderna) on 15-Sep-2021; for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Booster) on 12-Jan-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and PFIZER BIONTECH COVID-19 VACCINE.    On 11-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Given the bivalent instead of a primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Given the bivalent instead of a primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Given the bivalent instead of a primary series).    No concomitant medications were reported.  The pharmacist stated that she had a patient that got the primary series when Moderna first came out. But then patient had a transplant that wiped patient's entire immune system. patient's doctor wanted patient to repeat the series. They initiated it back in 2Sep2022 and gave patient another first dose of Moderna. When patient came in on 11Oct2022, patient was given the bivalent instead of a second dose. The pharmacist stated that the patient did not report any adverse reactions.  No treatment medications were reported.   This case was linked to MOD-2023-715985 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Pain, Ultrasound abdomen, Wrong product administered
Clinical narrative: getting pain on my upper left side; Took the Booster by Pfizer on 05Jan2023/ Is bivalent=False; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2023 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "degenerative disk disease" (unspecified if ongoing); "osteoarthritis in hips" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Flagyl, reaction(s): "Allergy". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown, Route of administration: Unknown , Location of injection: Leg Right), administration date: 05Apr2022, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "prev dose vaccine location=Right leg"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown, Route of administration: Unknown , Location of injection: Leg left), administration date: 07Apr2022, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "prev dose administration date=07Apr2022", "prev dose vaccine location=Left leg". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 05Jan2023 at 12:00, outcome "unknown", described as "Took the Booster by Pfizer on 05Jan2023/ Is bivalent=False"; PAIN (non-serious) with onset 05Jan2023 at 12:30, outcome "not recovered", described as "getting pain on my upper left side". The event "getting pain on my upper left side" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain.  Additional Information: Patient was vaccinated with Pfizer booster dose and started getting pain on his upper left side. He visited ER twice where they couldn't figure it out. Then patient visited her gastroantologist and have done many tests but couldn't find the cause of pain. The pain comes and goes throughout the day until present. The pain was constant and the patient was sure that it was caused by booster shot. The patient didn't receive any other vaccine within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccine. Since vaccination, the patient hasn't been tested for COVID-19  The information on the batch/lot number for BNT162b2, BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300113635 same reporter, same patient, same product, different dose, different AE;US-PFIZER INC-202300111373 same reporter, same patient, same product, different dose, different AE;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: noticed metallic taste right away after they got it within a couple minutes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9266, Expiration Date: 31May2021) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "thyroid issues" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "her hair was falling out all the time" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM OXALATE taken for anxiety; LEVOTHYROXINE taken for blood parathyroid hormone decreased, alopecia. The following information was reported: DYSGEUSIA (non-serious) with onset 13Feb2021, outcome "recovered", described as "noticed metallic taste right away after they got it within a couple minutes".  Additional Information: It was reported that the patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient reported to pharmacist about the event and he said that was strange. She reported that the taste went away pretty quick within a couple days and doesn't recall when it went away. She also clarified that it didn't go into the next day.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300115041 same reporter/patient/product, different dose/event.;
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Vaccination failure, Weight
Clinical narrative: She still has symptoms of Covid; She still has symptoms of Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 74 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 03May2022 as dose 4 (booster), single (Lot number: FJY989) for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9266, Expiration Date: 31May2021), on 06Mar2021 as dose 2, single (Lot number: EN6205, Expiration Date: 30Jun2021) and on 03Nov2021 as dose 3 (booster), single (Lot number: 32030BD) for covid-19 immunisation. The patient's relevant medical history included: "borderline cholesterol" (unspecified if ongoing); "levels were really low" (unspecified if ongoing); "her hair was falling out all the time" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). The patient's medical history, reported also as family history included: "lot of heart problems" (unspecified if ongoing), notes: a lot of heart problems in the family and he wanted to be sure. Concomitant medication(s) included: ATORVASTATIN CALCIUM taken for blood cholesterol abnormal; LEVOTHYROXINE taken for blood parathyroid hormone decreased, alopecia (ongoing); ESCITALOPRAM OXALATE taken for anxiety; ALENDRONATE SODIUM oral taken for osteoporosis; VITAMIN D NOS; CALCIUM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "She still has symptoms of Covid". The patient underwent the following laboratory tests and procedures: Weight: lost a lot of weight. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID. It was also reported that her boys had aches, stated sore arms and aches with Covid vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300114979 same reporter/patient/product, different dose/event.;
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Hypoacusis, Jaw disorder, Tooth disorder
Clinical narrative: She still has symptoms of Covid; She still has symptoms of Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 74 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 03May2022 as dose 4 (booster), single (Lot number: FJY989) for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9266, Expiration Date: 31May2021), on 06Mar2021 as dose 2, single (Lot number: EN6205, Expiration Date: 30Jun2021) and on 03Nov2021 as dose 3 (booster), single (Lot number: 32030BD) for covid-19 immunisation. The patient's relevant medical history included: "borderline cholesterol" (unspecified if ongoing); "levels were really low" (unspecified if ongoing); "her hair was falling out all the time" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). The patient's medical history, reported also as family history included: "lot of heart problems" (unspecified if ongoing), notes: a lot of heart problems in the family and he wanted to be sure. Concomitant medication(s) included: ATORVASTATIN CALCIUM taken for blood cholesterol abnormal; LEVOTHYROXINE taken for blood parathyroid hormone decreased, alopecia (ongoing); ESCITALOPRAM OXALATE taken for anxiety; ALENDRONATE SODIUM oral taken for osteoporosis; VITAMIN D NOS; CALCIUM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "She still has symptoms of Covid". The patient underwent the following laboratory tests and procedures: Weight: lost a lot of weight. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID. It was also reported that her boys had aches, stated sore arms and aches with Covid vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300114979 same reporter/patient/product, different dose/event.;
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation, 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 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 16:00 as dose 5 (booster), single (Lot number: GHR693) at the age of 40 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER2613), in right arm, on 14Apr2021 as dose 2, single (Lot number: EW0158), in right arm, on 20Oct2021 as dose 3 (booster), single (Lot number: 320308D), in right arm and on 13May2022 at 17:00 as dose 4 (booster), single (Lot number: FM9992), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "asthma" (unspecified if ongoing); "chronic rhinitis" (unspecified if ongoing); "bronchial inflammation/infection" (unspecified if ongoing); "recently acquired arthritis or other autoimmune connective tissue d/o (disorder)" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "adenomyosis" (unspecified if ongoing); "Unclear autoimmune" (unspecified if ongoing); "immune compromised" (unspecified if ongoing); "Known allergies: Contrast dyes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Gabapentin, reaction(s): "Known allergies: gabapentin"; Nuvaring, reaction(s): "Known allergies: nuvaring"; Quafacine, reaction(s): "Known allergies: quafacine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Tested: (09Mar2023) Unknown results; SARS-CoV-2 test: (25Feb2023) positive, notes: Initial Covid positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Initial Covid positive test and significant symptoms; lasted 25Feb2023-09Mar2023. Paxlovid from 26Feb2023 pm to 04Mar2023 am. Remained symptomatic until 09Mar2023. Could not get in touch with medical providers.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Photophobia, Tinnitus
Clinical narrative: Tightening of the Chest; Harder to breath; sensitive to lights and sounds; for 2 years Iv'e been hearing voices; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: 33130BA), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Erb's Palsy" (unspecified if ongoing), notes: Erb's Palsy due to Birth Trauma. There were no concomitant medications. Past drug history included: Bnt162b2, start date: 02Apr2021, stop date: 02Apr2021, for COVID-19 immunization, notes: DOSE 1, SINGLE, Batch/Lot No: Pfizer ER8730, Location of injection: Arm Left; Bnt162b2, start date: 29Apr2021, stop date: 29Apr2021, for COVID-19 immunization, notes: DOSE 2, SINGLE, Batch/Lot No: Pfizer ER8735, Location of injection: Arm Left. The following information was reported: CHEST DISCOMFORT (disability, medically significant, life threatening), outcome "not recovered", described as "Tightening of the Chest"; DYSPNOEA (disability, medically significant, life threatening), outcome "not recovered", described as "Harder to breath"; PHOTOPHOBIA (disability, medically significant, life threatening), outcome "not recovered", described as "sensitive to lights and sounds"; TINNITUS (disability, medically significant, life threatening), outcome "not recovered", described as "for 2 years Iv'e been hearing voices". Therapeutic measures were taken as a result of chest discomfort, dyspnoea, photophobia, tinnitus.  Clinical Course: No Other medication in 2weeks. Today was 16Mar2023 and I am still having really bad symptoms. Tightening of the Chest, Harder to breath, Became more sensitive to lights and sounds and now for 2 years Iv'e been hearing voices and want to kill myself so Screw Pfizer for what they did to me. I'm serious these symptoms are not going away and now I just got prescribe Quetiapine ER (150 MG Tablets) to get ride of the voices. I mean it that lost shot messed my life up but this better not last even though it's 2 years in. Adverse event start date was 19Jan2021.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported events chest discomfort, dyspnoea, photophobia, tinnitus and suspect BNT162B2 cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300118031 same patient, different dose/AE;
Age: 52.0
Sex: M
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Lot number: gh9694) at the age of 52 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 was not reported. There were no concomitant medications. Past drug history included: Reglan, reaction(s): "known allergies: Reglan", notes: known allergies: Reglan. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: Tested negative 8 days after start of treatment; (Mar2023) Positive, notes: Tested positive 11 days after start of treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received antiviral treatment (paxlovid) from 04Mar2023 to 08Mar2023. The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID virus after COVID vaccines; COVID virus after COVID vaccines; 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 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 74 years intramuscular, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 25Feb2021 as dose 2, single (Lot number: EN6198), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FP4554), in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, stop date: 15Mar2023. No prior vaccinations (within 4 weeks). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Mar2023, outcome "unknown" and all described as "COVID virus after COVID vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Mar2023) Positive, notes: Tested positive at: 10AM. Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment included Paxlovid for Covid virus (Start of Drug: 16Mar2023, Stop: Ongoing, lot number: GF5570, Expiry Date: Apr2023) 3 tablets in morning and 3 tablets in evening. Also, Cepacol and Claritin D 12 hour for sore throat; and benzonatate from 16Mar2023 (Stop: Ongoing) for COVID and Cough (she asked her doctor for something for her cough; coughing like when she was six years old; also took Cepacol and felt much better) 200mg capsules three times a day). Clinical course: After all these vaccines, she still got the COVID virus. Just tested positive on 15Mar2023 (yesterday). While driving heard on the radio that if it had been two months since the last COVID vaccination that a person should get another vaccine. Would not give her another booster, after her last booster on 09Sep2022, because they had not received any specific guidance. Instructed by her doctor to stop taking atorvastatin (due to potential interaction with Paxlovid, stopping for 10 days). Clarified she did not take both Paxlovid and Atorvastatin together; took last dose of Atorvastatin 15Mar2023 (last night) and started Paxlovid 16Mar2023 (today). Tested positive at 10AM. Symptoms started on 14Mar2023 (a day before 14Mar2023), took Cepacol and Claritin D 12 hour for sore throat, and until she could call her physician, confirmed as over the counter. Adverse event required no emergency room no, and no physician office; spoke to her doctor.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 ( booster), single (Lot number: GH9694) at the age of 58 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxilovid for covid-19 from 07Mar2023 to 12Mar2023.
Sex: M
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9702), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Mar2023) Negative; (15Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received antiviral treatment (paxlovid) from 06Mar2023 to 10Mar2023. Other medication in 2weeks: No.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Wrong product administered
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine lot number=GJ6739/ vaccine dose number=1; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 1, single (Lot number: GJ6739) at the age of 59 years, in right arm for covid-19 immunisation.The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 05Oct2022, outcome "unknown", described as "vaccine lot number=GJ6739/ vaccine dose number=1"; 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: (unspecified date) Positive, notes: COVID 19 Treatment; (Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  clinical course: patient had no Known allergies reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2020 as dose 1, single (Lot number: 026B21A), in left arm, on 07May2021 as dose 2, single (Lot number: 002C21A), in left arm, on 17Dec2021 as dose 3 (booster), single (Lot number: 058H21A), in left arm and on 03May2022 as dose 4 (booster), single (Lot number: 056M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bipolar depression" (unspecified if ongoing); "Dementia" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "ADD" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: IRON; MIRTAZAPINE; BUPROPION HYDROCHLORIDE; OMEPRAZOLE; DEXAMPHETAMINE; LAMICTAL; GABAPENTIN; METFORMIN. Past drug history included: No, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Oct2022, outcome "unknown"; 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: (unspecified date) Positive; (10Mar2023) Negative; (14Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  Clinical Course: The patient was treated with paxilovid-19 for covid-19 from 04Mar2023to 09Mar2023.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 5 (booster), single (Lot number: EN6207) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Dermatomyositis" (unspecified if ongoing), notes: other medical history: Dermatomyositis. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid on 06Mar2023 to 11Mar2023. Clinical course: the patient had other medication within 2 weeks. She had sore throat, stuffiness, and her chest tightness returned.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 03Apr2021 as dose 2, single (Lot number: EP7533), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 28Mar2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient took Paxlovid to treat Covid 19 from 08Mar2023 through 12Mar2023. Symptoms resolved. Tested negative on 14Mar2023 and 15Mar2023. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Mar2023) Negative; (15Mar2023) Negative; (17Mar2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, FLUR3
Symptoms: Angioedema, Autoimmune thyroiditis, Investigation
Clinical narrative: angioedema; Hashimotos antibodies/ Chronic idiopathic hives/ abnormal thyroid levels; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 31 years, in left arm for covid-19 immunisation; influenza vaccine rha 3v (baculovirus) (FLUBLOK), on 07Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history (none until Oct2022). There were no concomitant medications. Patient had no COVID prior to vaccination. She has not been tested for COVID post-vaccination. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex". Vaccination history included: Covid-19 vaccine (primary immunization series and first booster dose completed, manufacturer unknown), for COVID-19 immunization. The following information was reported: AUTOIMMUNE THYROIDITIS (medically significant) with onset 21Oct2022, outcome "not recovered", described as "Hashimotos antibodies/ Chronic idiopathic hives/ abnormal thyroid levels"; ANGIOEDEMA (medically significant) with onset 27Oct2022, outcome "not recovered". The events "hashimotos antibodies/ chronic idiopathic hives/ abnormal thyroid levels" and "angioedema" required physician office visit. The patient underwent the following laboratory tests and procedures: follow-up tests: (unspecified date) confirmed Hashimotos antibodies; (21Oct2022) abnormal thyroid levels. Therapeutic measures were not taken as a result of autoimmune thyroiditis, angioedema. Clinical course: Chronic idiopathic hives and angioedema starting 27Oct2022 and lasting to present. Annual lab work done on 21Oct2022 showed abnormal thyroid levels. Follow-up tests confirmed Hashimotos antibodies.  No follow-up attempts are possible. No further information is expected.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Joint pain; Muscle pain; Tiredness; headaches; Nausea; arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 89-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Mar2023 as dose 4 (booster), single (Lot number: GL0446) at the age of 89 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (3rd dose, Intramuscular, Batch/Lot number: FL3197), administration date: 02Dec2021, when the patient was 87-year-old, for COVID-19 Immunization; BNT162b2 (2nd dose, Intramuscular, Batch/Lot number: EN6207), administration date: 23Mar2021, when the patient was 87-year-old, for COVID-19 Immunization; BNT162b2 (1st dose, Intramuscular, Batch/Lot number: EN6203), administration date: 02Mar2021, when the patient was 87-year-old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (medically significant) with onset 11Mar2023, outcome "not recovered", described as "Joint pain"; MYALGIA (medically significant) with onset 11Mar2023, outcome "not recovered", described as "Muscle pain"; NAUSEA (non-serious) with onset 11Mar2023, outcome "unknown"; FATIGUE (non-serious) with onset 11Mar2023, outcome "unknown", described as "Tiredness"; PAIN IN EXTREMITY (non-serious) with onset 11Mar2023, outcome "unknown", described as "arm pain"; HEADACHE (non-serious) with onset 11Mar2023, outcome "recovered", described as "headaches". Therapeutic measures were taken as a result of arthralgia, myalgia which included physical therapy. Clinical course: When asked for regarding his concomitant medications, the patient stated he is on about 6 regular drugs and 4 supplements and declines to go through the medications at the time of report. The patient received the 4th shot of the COVID shot that is the Bivalent last Thursday (09Mar2023). He is having several problems. He is reading in the book that says 5 days usually gone. He has tiredness, headaches, joint pain, muscle pain, nausea, and arm pain. He asked is there anything he can do. He stated the headaches are gone. He got the shot last Thursday (09Mar2023) and last Saturday (11Mar2023) started with symptoms, and the symptoms really kicked in on Saturday (11Mar2023), Sunday (12Mar2023), and Monday (13Mar2023). Joint pain and muscles are killing him. He had to go to therapy and do lower body. The physical therapy girl said the stretching and relief wouldn't last and therapy was not helping with this joint and muscle pain.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Joint pain; Muscle pain; Tiredness; headaches; Nausea; arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 89-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Mar2023 as dose 4 (booster), single (Lot number: GL0446) at the age of 89 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (3rd dose, Intramuscular, Batch/Lot number: FL3197), administration date: 02Dec2021, when the patient was 87-year-old, for COVID-19 Immunization; BNT162b2 (2nd dose, Intramuscular, Batch/Lot number: EN6207), administration date: 23Mar2021, when the patient was 87-year-old, for COVID-19 Immunization; BNT162b2 (1st dose, Intramuscular, Batch/Lot number: EN6203), administration date: 02Mar2021, when the patient was 87-year-old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (medically significant) with onset 11Mar2023, outcome "not recovered", described as "Joint pain"; MYALGIA (medically significant) with onset 11Mar2023, outcome "not recovered", described as "Muscle pain"; NAUSEA (non-serious) with onset 11Mar2023, outcome "unknown"; FATIGUE (non-serious) with onset 11Mar2023, outcome "unknown", described as "Tiredness"; PAIN IN EXTREMITY (non-serious) with onset 11Mar2023, outcome "unknown", described as "arm pain"; HEADACHE (non-serious) with onset 11Mar2023, outcome "recovered", described as "headaches". Therapeutic measures were taken as a result of arthralgia, myalgia which included physical therapy. Clinical course: When asked for regarding his concomitant medications, the patient stated he is on about 6 regular drugs and 4 supplements and declines to go through the medications at the time of report. The patient received the 4th shot of the COVID shot that is the Bivalent last Thursday (09Mar2023). He is having several problems. He is reading in the book that says 5 days usually gone. He has tiredness, headaches, joint pain, muscle pain, nausea, and arm pain. He asked is there anything he can do. He stated the headaches are gone. He got the shot last Thursday (09Mar2023) and last Saturday (11Mar2023) started with symptoms, and the symptoms really kicked in on Saturday (11Mar2023), Sunday (12Mar2023), and Monday (13Mar2023). Joint pain and muscles are killing him. He had to go to therapy and do lower body. The physical therapy girl said the stretching and relief wouldn't last and therapy was not helping with this joint and muscle pain.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: 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: Negative, notes: Rebound after 5 days of negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Have 2 vaccine and 2 boosters (Pfizer) prior to first time COVID diagnosis; Have 2 vaccine and 2 boosters (Pfizer) prior to first time COVID diagnosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Have 2 vaccine and 2 boosters (Pfizer) prior to first time COVID diagnosis".  Clinical information : Are you reporting any issues (side effects, complaints, etc.) with the product? Yes.Did the reported issue occur after use of the product? YesEvent information: Had to stop Paxlovid after 4 full days due to extreme diarrhea, Admission to hospital due to the event? NoAny treatment received? No, Still experiencing? Fine now.Are there any other product(s) that were taken together with those indicated above? No.Any additional information: Needed Imodium (word not legible) to stop diarrhea. Have 2 vaccines and 2 boosters (Pfizer) prior to first time COVID diagnosis.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.