chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Tested positive Oct. 7 with mild cold symptoms; Tested positive Oct. 7 with mild cold symptoms; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 14:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 47 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Jan2021 as dose 1, single (Lot number: 012L20A), on 09Feb2021 as dose 2, single (Lot number: 024M20A) and on 22Sep2021 as dose 3 (booster), single (Lot number: 045B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022 at 14:00, outcome "recovered" (12Oct2022); DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Oct2022, outcome "recovered" (12Oct2022) and all described as "Tested positive Oct. 7 with mild cold symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Oct2022) Positive, notes: Tested positive with mild cold symptoms and started Paxlovid; (12Oct2022) Negative, notes: negative and no symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: There was no other medication in 2 weeks. Patient received Paxlovid for COVID 19 Treatment started from 07Oct2022 to 12Oct2022. Patient was tested positive on 07Oct2022 with mild cold symptoms and started Paxlovid; negative on 12Oct2022 and no symptoms.    No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 28Sep2021, Pfizer / BioNTech; 19May2022, Moderna; 28Sep2022, Pfizer / BioNTech; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 1, single, in left arm and on 28Sep2022 as dose 3 (booster), single at the age of 59 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19May2022 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19May2022, outcome "unknown", described as "28Sep2021, Pfizer / BioNTech; 19May2022, Moderna; 28Sep2022, Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken with Paxlovid with start date 12Oct2022 and stop date 16Oct2022 as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 29Nov2021 as dose number unknown (booster), single (Lot number: EW0196) at the age of 23 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 06Apr2021 as dose number unknown, single (Lot number: 202A21A) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "SVT" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction: "Known allergies: Amoxicillin"; Augmentin, reaction: "Known alleries: Augmentin"; Tramadol, reaction: "Known allergies: Tramadol"; Hydrocodone, reaction: "Known allergies: Hydrocodone"; Codeine, reaction: "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Oct2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.; Sender's Comments: A contributory role of BNT162B2 to event COVID-19 cannot be excluded based on temporal association and available information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single, in right arm at age of 59 years old for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "overweight" (unspecified if ongoing); "irritable bowel syndrome" (unspecified if ongoing); "diverticulitis" (unspecified if ongoing); "first exposed at work" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: flu vaccine (at 5PM), administration date: 06Oct2022, for immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Oct2022 at 09:30, outcome "recovered" (16Oct2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2022) Positive, notes: tested positive at 9:30 PM; (16Oct2022) Negative, notes: tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. There was no other medication in 2 weeks. The patient was first exposed at work on 06Oct and 07Oct by someone who claimed they were recovering from the flu and had taken off work before. Patient received flu vaccine at 5PM on 06Oct. Patient first felt symptoms on 08Oct and tested positive at 9:30 PM on 08Oct. (Symptoms: fatigue, cough, headache). Patient began first dose of Paxlovid treatment at 6:00 PM on 09Oct2022 and finished in AM of 14Oct2022. Patient felt symptoms subside and tested negative on 16Oct. Patient returned to work 18Oct-21Oct.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 47 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies : Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Allergy". The patient had no other medical history. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 17Oct2022 to 19Oct2022 for treatment of COVID-19.; Sender's Comments: Based on the information currently available, a causal association between the reported event COVID-19 and BNT162b2 cannot be excluded.
Age: 36.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 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: "Type 1 diabetes" (unspecified if ongoing). The patient took concomitant medications. 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 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 10May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Minor damage to small airways" (unspecified if ongoing), notes: Minor damage to small airways after the first time I had Covid March 2020.; "I had Covid", start date: Mar2020 (unspecified if ongoing), notes: Minor damage to small airways after the first time I had Covid March 2020..; "Known allergies:  yes, all berries" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: I had no Covid rebound and the abbreviated dosage also resulted in a negative Covid test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  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: Patient likely caught COVID after vaccine; Patient likely caught COVID after vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  An adult male patient received 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 "Patient likely caught COVID after vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "autoimmune thyroid" (unspecified if ongoing); "migraines" (unspecified if ongoing); "allergies" (unspecified if ongoing); "raynauds" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; PRISTIQ; L-METHYLFOLATE.  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, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 12Oct2022 to 16Oct2022.  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: Nausea, Vomiting
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cardiac disorder" (unspecified if ongoing), notes: Caller also stated she has APS and is a cardiac patient too.; "APS" (unspecified if ongoing), notes: Caller also stated she has APS and is a cardiac patient too. Concomitant medication(s) included: INFLUENZA VACCINE. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot Number: Unknown), for COVID-19 Immunization, reaction(s): "nausea", "vomiting". The following information was reported: NAUSEA (non-serious), outcome "recovered"; VOMITING (non-serious), outcome "recovered".  Additional information: She mentioned she was vaccinated with the primary series and two boosters, all from Pfizer. She mentioned she got a reaction a couple of times, with nausea and vomiting all night, until 7:30 am. Last booster was in Jul. She mentioned she is concerned about getting the Omicron vaccine and that she is allergic to something vaccine. Caller asked if in stoppers or syringes may have latex. Caller also mentioned she just recently received a Flu shot and asked how long should she wait to get the new Omicron vaccine. Caller also stated she has APS and is a cardiac patient too. She asked if the Pfizer Product get into the valves of the heart. Caller also mentioned her last booster was in Jul2022 and asked when can she receive the bivalent vaccine. Caller mentioned she is vaccinated with the primary series and two boosters, all from Pfizer. She mentioned she got a reaction a couple of times, with nausea and vomiting all night, until 7:30 am. Last booster was in Jul. She mentioned she is concerned about getting the Omicron vaccine and that she is allergic to something vaccine. Caller asked if in stoppers or syringes may have latex.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Electric shock, Hyperhidrosis, Hyponatraemia
Clinical narrative: Insomnia; hyponatremia; stomach pain; sweaty palms; nerve pain (especially in vagus nerve); electric bolts; migraines; back pain; throat pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 14:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 47 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Cephalosporins, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: INSOMNIA (hospitalization) with onset 29Sep2022, outcome "not recovered"; BACK PAIN (hospitalization) with onset 29Sep2022, outcome "not recovered"; ELECTRIC SHOCK (hospitalization) with onset 29Sep2022, outcome "not recovered", described as "electric bolts"; HYPONATRAEMIA (hospitalization) with onset 29Sep2022, outcome "not recovered", described as "hyponatremia"; MIGRAINE (hospitalization) with onset 29Sep2022, outcome "not recovered", described as "migraines"; NEURALGIA (hospitalization) with onset 29Sep2022, outcome "not recovered", described as "nerve pain (especially in vagus nerve)"; ABDOMINAL PAIN UPPER (hospitalization) with onset 29Sep2022, outcome "not recovered", described as "stomach pain"; HYPERHIDROSIS (hospitalization) with onset 29Sep2022, outcome "not recovered", described as "sweaty palms"; OROPHARYNGEAL PAIN (hospitalization) with onset 29Sep2022, outcome "not recovered", described as "throat pain". The patient was hospitalized for insomnia, hyponatraemia, abdominal pain upper, hyperhidrosis, neuralgia, electric shock, migraine, back pain, oropharyngeal pain (hospitalization duration: 1 day(s)). The events "insomnia", "hyponatremia", "stomach pain", "sweaty palms", "nerve pain (especially in vagus nerve)", "electric bolts", "migraines", "back pain" and "throat pain" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Oct2022) Negative, notes: Nasal Swab. Therapeutic measures IV (intraveneous) saline, gabapentin, melatonin, protonix were taken as a result of insomnia, hyponatraemia, abdominal pain upper, hyperhidrosis, neuralgia, electric shock, migraine, back pain, oropharyngeal pain.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Migraine, Neuralgia, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Insomnia; hyponatremia; stomach pain; sweaty palms; nerve pain (especially in vagus nerve); electric bolts; migraines; back pain; throat pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 14:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 47 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Cephalosporins, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: INSOMNIA (hospitalization) with onset 29Sep2022, outcome "not recovered"; BACK PAIN (hospitalization) with onset 29Sep2022, outcome "not recovered"; ELECTRIC SHOCK (hospitalization) with onset 29Sep2022, outcome "not recovered", described as "electric bolts"; HYPONATRAEMIA (hospitalization) with onset 29Sep2022, outcome "not recovered", described as "hyponatremia"; MIGRAINE (hospitalization) with onset 29Sep2022, outcome "not recovered", described as "migraines"; NEURALGIA (hospitalization) with onset 29Sep2022, outcome "not recovered", described as "nerve pain (especially in vagus nerve)"; ABDOMINAL PAIN UPPER (hospitalization) with onset 29Sep2022, outcome "not recovered", described as "stomach pain"; HYPERHIDROSIS (hospitalization) with onset 29Sep2022, outcome "not recovered", described as "sweaty palms"; OROPHARYNGEAL PAIN (hospitalization) with onset 29Sep2022, outcome "not recovered", described as "throat pain". The patient was hospitalized for insomnia, hyponatraemia, abdominal pain upper, hyperhidrosis, neuralgia, electric shock, migraine, back pain, oropharyngeal pain (hospitalization duration: 1 day(s)). The events "insomnia", "hyponatremia", "stomach pain", "sweaty palms", "nerve pain (especially in vagus nerve)", "electric bolts", "migraines", "back pain" and "throat pain" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Oct2022) Negative, notes: Nasal Swab. Therapeutic measures IV (intraveneous) saline, gabapentin, melatonin, protonix were taken as a result of insomnia, hyponatraemia, abdominal pain upper, hyperhidrosis, neuralgia, electric shock, migraine, back pain, oropharyngeal pain.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he also had delta in December of last year; he also had delta in December of last year; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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 Dec2021, outcome "unknown" and all described as "he also had delta in December of last year". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2021) Positive. The report's brother had high fevers when he got his booster, but he also had delta in December of last year, right around , he got it because he travels for work.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202201252016 same patient, different AE;
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Myasthenia gravis
Clinical narrative: my son had a very serious reaction myasthenia gravis on second shot; her son has myasthenia gravis and got his 2nd shot on her birthday date and that day he ended up in the hospital; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "myasthenia gravis" (unspecified if ongoing), notes: under control. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: MYASTHENIA GRAVIS (hospitalization, life threatening), outcome "unknown", described as "my son had a very serious reaction myasthenia gravis on second shot"; CONDITION AGGRAVATED (hospitalization, life threatening), outcome "unknown", described as "her son has myasthenia gravis and got his 2nd shot on her birthday date and that day he ended up in the hospital". Clinical course: Caller also reports her son had a very serious reaction myasthenia gravis on second shot, admitted in medical crisis still suffering and this was also last year. Her son has myasthenia gravis and got his 2nd shot on her birthday date and that day he ended up in the hospital for the total of a month in a medical crisis. She is not sure if her son's vaccine was Moderna or Pfizer but he was at death's door. Her son had myasthenia gravis prior to the covid vaccine and it was under control but it was after the covid vaccine when he went into medical crisis. Her son had myasthenia gravis for about 6 years. The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix Administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 58-year-old female patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th June 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 16th June 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comments: The pharmacist called and wanted to know does expiration date move, how to proceed and would patient need to be revaccinated. The agency stated that they realized their Twinrix was expired and a few patients were administered. The agency reported that they inadvertently administered expired Twinrix doses to three separate patients.  All administered at their facility. The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used. This was 1 of the 3 cases reported by the same reporter.; Sender's Comments:  GSK-US2022150645:Same reporter GSK-US2022150647:Same reporter
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: obese. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 24-MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 47 years old. No concomitant medications were reported. On 26-SEP-2022, the patient tested positive for COVID-19 following with symptoms (confirmed covid-19 infection) which resulted to confirmed clinical vaccination failure for which the patient received Paxlovid (non company drug) (form of admin, route of admin, batch number were not reported) dose was not reported administered for covid-19 after which symptoms were resolved since patient took Paxlovid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221027458. This report was associated with product quality complaint: 90000256219.; Sender's Comments: V0: 20221039630-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Headache, Hypoaesthesia, Limb discomfort
Clinical narrative: had great difficulty using her left arm and fingers/Her hand is limp and feels like it is someone else's/seemingly no control over that arm; numbness; a headache for the past week; feels disoriented; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (had great difficulty using her left arm and fingers/Her hand is limp and feels like it is someone else's/seemingly no control over that arm), DISORIENTATION (feels disoriented), HYPOAESTHESIA (numbness) and HEADACHE (a headache for the past week) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced DISORIENTATION (feels disoriented). On 18-Oct-2022, the patient experienced LIMB DISCOMFORT (had great difficulty using her left arm and fingers/Her hand is limp and feels like it is someone else's/seemingly no control over that arm), HYPOAESTHESIA (numbness) and HEADACHE (a headache for the past week). The patient was treated with IBUPROFEN at an unspecified dose and frequency. In October 2022, HEADACHE (a headache for the past week) had resolved. At the time of the report, LIMB DISCOMFORT (had great difficulty using her left arm and fingers/Her hand is limp and feels like it is someone else's/seemingly no control over that arm), DISORIENTATION (feels disoriented) and HYPOAESTHESIA (numbness) outcome was unknown.            No concomitant medication was reported. On 29-JAN-2021, the patient received first Moderna dose with lot no. 041L20A, expiration date 31-JUN-2021. On 10-MAR-2021 the patient received Second Moderna dose with lot no.003A21A, expiration date unknown. On 24-NOV-2021 the patient received Third Moderna dose with lot no. FH802H,expiration date unknown. Patient not had any reactions with previous doses. Patient had broken glasses, cups, and a vase because of numbness and seemingly no control over that arm.   This case was linked to MOD-2022-662397 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: An hour after the second shot, she vomited and had nausea; An hour after the second shot, she vomited and had nausea; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (An hour after the second shot, she vomited and had nausea) and VOMITING (An hour after the second shot, she vomited and had nausea) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NAUSEA (An hour after the second shot, she vomited and had nausea). 2021, the patient experienced VOMITING (An hour after the second shot, she vomited and had nausea). In 2021, NAUSEA (An hour after the second shot, she vomited and had nausea) and VOMITING (An hour after the second shot, she vomited and had nausea) had resolved.            No concomitant medications were reported.  It was either March or April of last year, patient had her initial shots. Patient reported that an hour after the second shot, she vomited and had nausea and it  lasted for probably 24 hours.  No treatment medications were reported.   This case was linked to MOD-2022-662398, MOD-2022-662392 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: An hour after the second shot, she vomited and had nausea; An hour after the second shot, she vomited and had nausea; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (An hour after the second shot, she vomited and had nausea) and VOMITING (An hour after the second shot, she vomited and had nausea) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NAUSEA (An hour after the second shot, she vomited and had nausea). 2021, the patient experienced VOMITING (An hour after the second shot, she vomited and had nausea). In 2021, NAUSEA (An hour after the second shot, she vomited and had nausea) and VOMITING (An hour after the second shot, she vomited and had nausea) had resolved.            No concomitant medications were reported.  It was either March or April of last year, patient had her initial shots. Patient reported that an hour after the second shot, she vomited and had nausea and it  lasted for probably 24 hours.  No treatment medications were reported.   This case was linked to MOD-2022-662398, MOD-2022-662392 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nauseated; Tired; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (Nauseated) and FATIGUE (Tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced NAUSEA (Nauseated) and FATIGUE (Tired). At the time of the report, NAUSEA (Nauseated) and FATIGUE (Tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The concomitant medication was not reported by reporter. It was either March-2021 or April-2021, patient had her initial shots. Patient was nauseated and tired. The treatment medication was not reported by reporter.   This case was linked to MOD-2022-662396, MOD-2022-662392 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Nauseated; Tired; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (Nauseated) and FATIGUE (Tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced NAUSEA (Nauseated) and FATIGUE (Tired). At the time of the report, NAUSEA (Nauseated) and FATIGUE (Tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The concomitant medication was not reported by reporter. It was either March-2021 or April-2021, patient had her initial shots. Patient was nauseated and tired. The treatment medication was not reported by reporter.   This case was linked to MOD-2022-662396, MOD-2022-662392 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid yesterday; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid yesterday) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 and COVID-19.    On 18-Sep-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 22-Oct-2022, the patient experienced COVID-19 (tested positive for Covid yesterday). At the time of the report, COVID-19 (tested positive for Covid yesterday) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Oct-2022, SARS-CoV-2 test: (Positive) Positive and (Positive) Positive. On 23-Oct-2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant drugs were not reported. It was reported that patient had total 5 doses and all was of Moderna. It was also reported that for patient it was the third time of COVID infection, most recent being the second time in 5 months. Patient was isolating at home with chest tightness, sneezing, congestion, runny nose, headache, fatigue and dull sense of taste. Patient had two rapid tests and a PCR test on 22-Oct-2022.  Treatment medications were not provided.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Body aches; Chills; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Body aches) and CHILLS (Chills) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 033C21A and 032B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.            No concomitant information was provided. Patient had received 4 doses of the Moderna COVID-19 vaccines by intramuscular injection. Following the 3rd dose he had body aches and chills. No treatment information was provided.   This case was linked to MOD-2022-662424 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got Coronavirus; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got Coronavirus) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got Coronavirus). At the time of the report, COVID-19 (got Coronavirus) outcome was unknown.            No concomitant medications were reported.  On an unknown date, patient received the 1st dose of Moderna COVID-19 vaccine. On an unknown date, patient received the 2nd dose of Moderna COVID-19 vaccine. On an unknown date, patient received the 1st booster dose of Moderna COVID-19 vaccine. On an unknown date, patient received the 2nd booster dose of Moderna COVID-19 vaccine, Bivalent.  No treatment medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis
Clinical narrative: Inflamed lymph nodes under the left armpit; The initial case was missing the following minimum criteria: (unspecified product) Upon receipt of follow up information on (20Oct2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose number unknown, 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: LYMPHADENITIS (non-serious), outcome "unknown", described as "Inflamed lymph nodes under the left armpit".  Additional Information: On 20Oct2022, reporter reported that we were working together at a local food and she shared this information with me. I reported it in immediately after she informed me so the awareness date and reported date are the same. The medicine was Comirnaty. Any other questions please let me know.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: came down with covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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: COVID-19 (non-serious), 4 days after the suspect product(s) administration, outcome "unknown", described as "came down with covid".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: She had numbness in her temple for six months; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: HYPOAESTHESIA (non-serious), outcome "unknown", described as "She had numbness in her temple for six months". Additional information: The receptionist at my dentist office knows that reporter work for Pfizer and told me after her vaccine. The Pfizer COVID vaccine on. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Off label use, Pain in extremity, Product use issue
Clinical narrative: Got flu shot same day; Got flu shot same day; Sore arm; Felt tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (bivalent), single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Tdap (DOSE NUMBER UNKNOWN, SINGLE), for Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "Got flu shot same day"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "Felt tired".  Additional information: The patient reported that the event took place after use of product. Sore arm and felt tired after shot. Got flu shot the same day. Slept off any other side effects. Sore arm feels a little more painful than the flu shot in the other arm but more like a tdap feeling shot. Nothing strange.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin M, Blood immunoglobulin M increased, Coagulopathy
Clinical narrative: coagulation; after the first series the IgM went to 58; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003731 (Novavax).  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1), administration date: 14Mar2021, for COVID-19 Immunization. The following information was reported: BLOOD IMMUNOGLOBULIN M INCREASED (non-serious) with onset 2021, outcome "unknown", described as "after the first series the IgM went to 58"; COAGULOPATHY (non-serious), outcome "unknown", described as "coagulation". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported the patient experienced the following: after the first series the IgM went to 58, and after the 4th booster the IgM was at 94.5 and they reported it should be around 10. They reported the mRNA is causing coagulation. No further follow-up is anticipated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.