chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Urinary incontinence
Clinical narrative: lost all their muscle strength; bladder incontinent; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (lost all their muscle strength) and URINARY INCONTINENCE (bladder incontinent) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 027A21A and 013M20A) for COVID-19 prophylaxis.     The patient's past medical history included Leukemia (had leukemia). Concurrent medical conditions included Diabetes.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (lost all their muscle strength) and URINARY INCONTINENCE (bladder incontinent). At the time of the report, MUSCULAR WEAKNESS (lost all their muscle strength) and URINARY INCONTINENCE (bladder incontinent) had resolved.            It was reported that patient took medication for diabetes.  It was reported that after booster patient had incontinence and loss muscle strength but it subsided in a few hours, was down and out for a couple of days. No treatment medication were provided.   This case was linked to MOD-2022-666049.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: No adverse event; Pediatric patient who was supposed to receive first dose received the second dose by mistake; This spontaneous case was reported by a consumer and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Pediatric patient who was supposed to receive first dose received the second dose by mistake) and NO ADVERSE EVENT (No adverse event) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010H22A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Oct-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Pediatric patient who was supposed to receive first dose received the second dose by mistake). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Pediatric patient who was supposed to receive first dose received the second dose by mistake) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      Concomitant medications details were not reported by the reporter.  Reportedly, Patient was not sure if she had received an incorrect product of Moderna.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2022: Follow-up document contains updated start date of vaccine administration and narrative updated accordingly.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain, SARS-CoV-2 test
Clinical narrative: Achiness; Tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID-19) and PAIN (Achiness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 010A21A and 032L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced PAIN (Achiness). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE (ANACIN [ACETYLSALICYLIC ACID;CAFFEINE]) for Ache, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID-19) and PAIN (Achiness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Positive.         No concomitant medications were reported.  It was reported that around approximately 30-May-2022, patient thought she had a cold, took a COVID test, and tested positive for COVID-19. Patient might had taken Anacin for achiness but did not remember.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; lower than authorized dose of Moderna bivalent vaccine administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) 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 ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients).    The concomitant and treatment medication was not reported. This case is reported for 13th patient out of 18 patients.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666280:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; lower than authorized dose of Moderna bivalent vaccine administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Oct-2022, the patient experienced UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) 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 UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients).    No concomitant medication details was reported. The patient had not reported any adverse reactions at that time. This case is reported for 15th patient out of 18 patients. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-666277, US-MODERNATX, INC.-MOD-2022-666284, US-MODERNATX, INC.-MOD-2022-666280 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666277:Patient 15 US-MODERNATX, INC.-MOD-2022-666284: US-MODERNATX, INC.-MOD-2022-666280:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Oct-2022, the patient experienced UNDERDOSE (patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine) 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 UNDERDOSE (patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine).    No concomitant drug was reported. The patient received 0.25 mL dose instead of 0.5 mL dose (Lot #: 061F22A, Expiration date: 16MAY2023) of  the Moderna COVID-19 bivalent vaccine The patient had not reported any adverse reactions at that time. No treatment drug was reported. This case contains information for the 17th of 18 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-666284 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666284:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Oct-2022, the patient experienced UNDERDOSE (patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine) 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 UNDERDOSE (patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine).    No concomitant drug was reported. The patient received 0.25 mL dose instead of 0.5 mL dose (Lot #: 061F22A, Expiration date: 16MAY2023) of  the Moderna COVID-19 bivalent vaccine The patient had not reported any adverse reactions at that time. No treatment drug was reported. This case contains information for the 8th of 18 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-666277, US-MODERNATX, INC.-MOD-2022-666284, US-MODERNATX, INC.-MOD-2022-666280 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666277: US-MODERNATX, INC.-MOD-2022-666284: US-MODERNATX, INC.-MOD-2022-666280:
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia, Blood pressure measurement, Cardiac monitoring, Cough, Dyspnoea
Clinical narrative: Arrhythmia; Small palpitations; Cough; Harder to breath; Tachycardia; Fatigue; This serious initial spontaneous safety report was received by Novavax on 31-OCT-2022 from a consumer via contact center.   A 76 year-old female of an unspecified race  was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose 1 on 19-SEP-2022 in the right side at a pharmacy.   The following medical history was reported: Polymers allergy, Drug hypersensitivity (sulfa allergy), Interstitial lung disease and Rubber sensitivity.  No concomitant medications were reported.  On 23-SEP-2022, reported as 5 days after vaccination, the individual experienced some small palpitations (PT: Palpitations) that went all the way until the 13th day. On 24-SEP-2022, reported as 6 days after vaccination, the individual reported that she experienced fatigue (PT: Fatigue), cough (PT: Cough) and it was harder to breath (PT: Dysponea). On 01-OCT-2022, reported as 13 days after vaccination, the individual experienced arrhythmia (PT: Arrhythmia) (Serious: Medically Significant) and tachycardia (PT: Tachycardia).   Treatment included: Individual checked with their doctor three weeks after. Reported as everything went away after about three week.  Relevant lab tests included: Cardiac monitoring (Result: No results available; Unspecified date in 2022) and Blood pressure measurement (Result: No results available; Unspecified date in 2022).  At the time of reporting, the event outcomes of Arrhythmia, Tachycardia, Fatigue, Cough and Dyspnoea were recovered/resolved and event stop date was on an unspecified date in 2022 (about 3 weeks from the onset date), Palpitations was recovered/resolved and event stop date was 01-OCT-2022.; Sender's Comments: This 76 year-old female experienced: Arrhythmia, Palpitations, Cough, Dyspnoea, Fatigue and Tachycardia after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Arrhythmia was assessed as serious. The events Palpitations, Cough, Dyspnoea, Fatigue and Tachycardia were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Palpitations, Tachycardia
Clinical narrative: Arrhythmia; Small palpitations; Cough; Harder to breath; Tachycardia; Fatigue; This serious initial spontaneous safety report was received by Novavax on 31-OCT-2022 from a consumer via contact center.   A 76 year-old female of an unspecified race  was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose 1 on 19-SEP-2022 in the right side at a pharmacy.   The following medical history was reported: Polymers allergy, Drug hypersensitivity (sulfa allergy), Interstitial lung disease and Rubber sensitivity.  No concomitant medications were reported.  On 23-SEP-2022, reported as 5 days after vaccination, the individual experienced some small palpitations (PT: Palpitations) that went all the way until the 13th day. On 24-SEP-2022, reported as 6 days after vaccination, the individual reported that she experienced fatigue (PT: Fatigue), cough (PT: Cough) and it was harder to breath (PT: Dysponea). On 01-OCT-2022, reported as 13 days after vaccination, the individual experienced arrhythmia (PT: Arrhythmia) (Serious: Medically Significant) and tachycardia (PT: Tachycardia).   Treatment included: Individual checked with their doctor three weeks after. Reported as everything went away after about three week.  Relevant lab tests included: Cardiac monitoring (Result: No results available; Unspecified date in 2022) and Blood pressure measurement (Result: No results available; Unspecified date in 2022).  At the time of reporting, the event outcomes of Arrhythmia, Tachycardia, Fatigue, Cough and Dyspnoea were recovered/resolved and event stop date was on an unspecified date in 2022 (about 3 weeks from the onset date), Palpitations was recovered/resolved and event stop date was 01-OCT-2022.; Sender's Comments: This 76 year-old female experienced: Arrhythmia, Palpitations, Cough, Dyspnoea, Fatigue and Tachycardia after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Arrhythmia was assessed as serious. The events Palpitations, Cough, Dyspnoea, Fatigue and Tachycardia were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: three different cancer at the same time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "a little vegan" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "three different cancer at the same time". Patient never had cancer before. She thought she might have gotten exposed while travelling but her parents were there too and didn't get it (pending clarification). The reporter stated there were increases in all kinds of cancer and its from the injection. Patient didn't believe it but reporter knew it's from the vaccine. Patient was going to see oncologists.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: normal fatigue; headache; 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 received BNT162b2 (BNT162B2), on 18Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT taken for asthma (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: unknown), for COVID-19 immunization, reaction(s): "normal fatigue", "headache"; Bnt162b2 (DOSE 2, SINGLE, Lot Number: unknown), for COVID-19 immunization, reaction(s): "normal fatigue", "headache"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot Number: unknown), for COVID-19 immunization, reaction(s): "normal fatigue", "headache". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "normal fatigue"; HEADACHE (non-serious), outcome "unknown".  Additional information: It was reported that, just normal fatigue, headache, sort of thing. Had that thing they were talking about with the period coming on sooner. Thought that was a normal event. Clarified that all occurred after Pfizer Covid vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial infection, Oral candidiasis, SARS-CoV-2 test
Clinical narrative: Bacterial infection on lips; thrush inside mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 11:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 82 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "chronic pain" (unspecified if ongoing); "known allergies : sulfa" (unspecified if ongoing); "known allergies : Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE HIGH DOSE, on 01Sep2022 as dose 1, single (Other vaccine 4weeks product: Flu zone High Dose); ADVAIR; AMLODIPINE BESYLATE; LEVOTHYROXIN (other medications in two weeks Advair Discus, Amlodipine Besylate, Levothyroxin, L). Past drug history included: Clindamycin, reaction(s): "Known allergies: Clindamycin". 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; Covid-19 vaccine (dose:4 (Booster), Unknown manufacturer), for Covid-19 immunization.  The following information was reported: BACTERIAL INFECTION (non-serious) with onset 15Sep2022, outcome "recovering", described as "Bacterial infection on lips"; ORAL CANDIDIASIS (non-serious) with onset 15Sep2022, outcome "recovering", described as "thrush inside mouth". The events "bacterial infection on lips" and "thrush inside mouth" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of bacterial infection, oral candidiasis.  Additional information: Adverse event treatment Nystatin for thrush, Mupirocin 2% for lips was given. No Covid prior vaccination and tested for Covid post vaccination.  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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 71-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: Gh9694) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Jun2022 as dose 4 (booster), single (Lot number: Fj4991), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Mar2021 as dose 1, single (Lot number: 006m20a), in left arm, on 30Mar2021 as dose 2, single (Lot number: 046a21a), in left arm and on 28Oct2021 as dose 3 (booster), single (Lot number: 076?z1a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "mesothelioma cancer" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: XYZAL. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "COVID 19 "; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Extremely drowsiness; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 at 16:30 as dose 4 (booster), single (Lot number: GH9697) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 21Oct2022 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Primary immunization was completed, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset 26Oct2022 at 19:00, outcome "recovering", described as "Extremely drowsiness"; FATIGUE (non-serious) with onset 26Oct2022 at 19:00, outcome "recovering", described as "Tiredness". Therapeutic measures were not taken as a result of somnolence, fatigue.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received flu vaccine within 4 weeks prior to the vaccination. The patient received other medications within 2 weeks. The patient had unspecified known allergies.  Follow-up (31Oct2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nasopharyngeal swab
Clinical narrative: Each time the lymph node under my armpit swelled up like a kiwi; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "Each time the lymph node under my armpit swelled up like a kiwi". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Each time the lymph node under my armpit swelled up like a kiwi". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient got flu shot 16Oct2022 in left arm no problem. Patient received 3 COVID shots 2 Pfizer 1 moderna. Each time the lymph node under armpit swelled up like a kiwi. On 21Oct2022, patient got the new COVID vaccine. Patient had never improving and never tested positive for COVID. The patient had never tested positive for COVID. Patient didn't received any vaccines within four weeks and tested positive post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in right 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anti-hypertensive" (unspecified if ongoing), notes: Other medication in 2weeks product=Anti-hypertensive (beta blocker), last dose day before Paxlovid ,. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tests strongly positive again; Positive, notes: tests strongly positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19; received Paxlovid as COVID 19 Treatment from 14Oct2022 to 18Oct2022.  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, 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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical information: Other medication in 2 weeks was none, patient was given Paxlovid as covid-19 treatment from 13Oct2022 to 18Oct2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Chills; Joint pain; muscle pain; headache; fatigue; lightheaded; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 15:00 as dose 4 (booster), single (Lot number: GJ6739) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 21Oct2022 as unk unk, single. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 25Oct2022 at 17:00, outcome "recovering"; ARTHRALGIA (non-serious) with onset 25Oct2022 at 17:00, outcome "recovering", described as "Joint pain"; FATIGUE (non-serious) with onset 25Oct2022 at 17:00, outcome "recovering"; HEADACHE (non-serious) with onset 25Oct2022 at 17:00, outcome "recovering"; DIZZINESS (non-serious) with onset 25Oct2022 at 17:00, outcome "recovering", described as "lightheaded"; MYALGIA (non-serious) with onset 25Oct2022 at 17:00, outcome "recovering", described as "muscle pain". Therapeutic measures were not taken as a result of chills, arthralgia, myalgia, headache, fatigue, dizziness. Additional information: Other vaccine in four weeks included Flu. Patient did not have covid prior to vaccination and did not covid tested post vaccination.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Chills; Joint pain; muscle pain; headache; fatigue; lightheaded; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 15:00 as dose 4 (booster), single (Lot number: GJ6739) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 21Oct2022 as unk unk, single. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 25Oct2022 at 17:00, outcome "recovering"; ARTHRALGIA (non-serious) with onset 25Oct2022 at 17:00, outcome "recovering", described as "Joint pain"; FATIGUE (non-serious) with onset 25Oct2022 at 17:00, outcome "recovering"; HEADACHE (non-serious) with onset 25Oct2022 at 17:00, outcome "recovering"; DIZZINESS (non-serious) with onset 25Oct2022 at 17:00, outcome "recovering", described as "lightheaded"; MYALGIA (non-serious) with onset 25Oct2022 at 17:00, outcome "recovering", described as "muscle pain". Therapeutic measures were not taken as a result of chills, arthralgia, myalgia, headache, fatigue, dizziness. Additional information: Other vaccine in four weeks included Flu. Patient did not have covid prior to vaccination and did not covid tested post vaccination.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER2613), in right arm, on 06May2021 as dose 2, single (Lot number: ER8731), in right arm and on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (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: (21Oct2022) Negative, notes: By day 6 he had recovered and tested negative consistently; (23Oct2022) Positive, notes: Day 8, mild symptoms reappeared and he again tested positive; (24Oct2022) Positive, notes: From days 8-11 he was experiencing escalating, but mild symptoms (sore throat, cough, runny nose) and continue to test positive; (25Oct2022) Positive, notes: From days 8-11 he was experiencing escalating, but mild symptoms (sore throat, cough, runny nose) and continue to test positive; (26Oct2022) Positive, notes: From days 8-11 I am experiencing escalating, but mild symptoms (sore throat, cough, runny nose) and continue to test positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: It was reported that, the patient did not receive any other medications in 2 weeks. Anti-viral details were Paxlovid from 16Oct2022 to 20Oct2022 for Covid-19 treatment. He took Paxlovid as soon as symptoms appeared, taking the standard 5-day course. Days 1-3 he was very unwell, with high fever, aches etc. By day 6 he had recovered and tested negative consistently. Day 8, mild symptoms reappeared, and he again tested positive. From days 8-11 I am experiencing escalating, but mild symptoms (sore throat, cough, runny nose) and continue to test positive. No Known allergies and no other medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Muscle twitching, Nausea, Nodule
Clinical narrative: Body aches; hot and cold; knot in arm; arm twitching; headache; nausea; This is a spontaneous report received from a 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 26Oct2022 at 14:00 as dose 5 (booster), single (Lot number: GJ6742) at the age of 53 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure, cholesterol, AFIB; "cholesterol" (unspecified if ongoing), notes: Other medical history: high blood pressure, cholesterol, AFIB; "AFIB" (unspecified if ongoing), notes: Other medical history: high blood pressure, cholesterol, AFIB; "Known allergies: bees" (unspecified if ongoing), notes: known allergies Cipro, sulfa, bees. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation as dose number unknown, single. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro", notes: Known allergies: Cipro, sulfa, bees; Sulfa, reaction(s): "Known allergies: sulfa", notes: known allergies Cipro, sulfa, bees. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 27Oct2022 at 03:00, outcome "recovering", described as "Body aches"; MUSCLE TWITCHING (non-serious) with onset 27Oct2022 at 03:00, outcome "recovering", described as "arm twitching"; HEADACHE (non-serious) with onset 27Oct2022 at 03:00, outcome "recovering"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 27Oct2022 at 03:00, outcome "recovering", described as "hot and cold"; NODULE (non-serious) with onset 27Oct2022 at 03:00, outcome "recovering", described as "knot in arm"; NAUSEA (non-serious) with onset 27Oct2022 at 03:00, outcome "recovering". Therapeutic measures were not taken as a result of pain, feeling of body temperature change, nodule, muscle twitching, headache, nausea.  Additional information: Reportedly, dose received were more than 3. For most recent dose details Facility type vaccine was Workplace clinic. No covid prior vaccination and no covid tested post vaccination.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches; hot and cold; knot in arm; arm twitching; headache; nausea; This is a spontaneous report received from a 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 26Oct2022 at 14:00 as dose 5 (booster), single (Lot number: GJ6742) at the age of 53 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure, cholesterol, AFIB; "cholesterol" (unspecified if ongoing), notes: Other medical history: high blood pressure, cholesterol, AFIB; "AFIB" (unspecified if ongoing), notes: Other medical history: high blood pressure, cholesterol, AFIB; "Known allergies: bees" (unspecified if ongoing), notes: known allergies Cipro, sulfa, bees. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation as dose number unknown, single. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro", notes: Known allergies: Cipro, sulfa, bees; Sulfa, reaction(s): "Known allergies: sulfa", notes: known allergies Cipro, sulfa, bees. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 27Oct2022 at 03:00, outcome "recovering", described as "Body aches"; MUSCLE TWITCHING (non-serious) with onset 27Oct2022 at 03:00, outcome "recovering", described as "arm twitching"; HEADACHE (non-serious) with onset 27Oct2022 at 03:00, outcome "recovering"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 27Oct2022 at 03:00, outcome "recovering", described as "hot and cold"; NODULE (non-serious) with onset 27Oct2022 at 03:00, outcome "recovering", described as "knot in arm"; NAUSEA (non-serious) with onset 27Oct2022 at 03:00, outcome "recovering". Therapeutic measures were not taken as a result of pain, feeling of body temperature change, nodule, muscle twitching, headache, nausea.  Additional information: Reportedly, dose received were more than 3. For most recent dose details Facility type vaccine was Workplace clinic. No covid prior vaccination and no covid tested post vaccination.
Age: 67.0
Sex: U
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 67 years, in left arm 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 included: "Copd" (unspecified if ongoing). Concomitant medication(s) included: ANORO. Past drug history included: Doxycycline, reaction(s): "known allergies: Doxycycline", notes: known allergies: Doxycycline. 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: (unspecified date) Positive, notes: COVID 19 Treatment; (Oct2022) Positive, notes: Still testing positive 14 days after initial symptoms; (20Oct2022) Positive, notes: Tested positive again 3 days after course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient vaccine received and other medication in 2weeks. Vaccine lot unknown reason was Not available/provided to reporter at the time of report completion.   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: Illness, Loss of personal independence in daily activities
Clinical narrative: Patient in apparently so ill that she cannot get out of the house for normal activities; Patient in apparently so ill that she cannot get out of the house for normal activities; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered" and all described as "Patient in apparently so ill that she cannot get out of the house for normal activities". It was unknown if therapeutic measures were taken as a result of illness, loss of personal independence in daily activities.  Additional information: Other vaccine in four weeks were reported as unknown. Other medications in two weeks were reported as unknown. Details were obscure. Patient in apparently so ill that she cannot get out of the house for normal activities. Had told others that she was going to sue Pfizer. If COVID prior vaccination reported as unknown. If COVID tested positive vaccination reported as unknown. Known allergies reported as unknown. Other medical history reported as unknown. Device time stamp reported as 27Oct2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: When I took my fourth Pfizer vaccine booster on 21Aug2022, I developed a new blood clot on 26Oct2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 21Aug2022 as dose 4 (booster), single (Lot number: FP7137) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OLMESARTAN. Vaccination history included: coviD-19 vaccine (DOSE 3 (BOOSTER), SINGLE ((manufacturer unknown), I developed a blood clot on my right calf on 28Jan2022.), administration date: 26Nov2021, when the patient was 60-year-old, for Covid-19 Immunization, reaction(s): "blood clot on my right calf"; Covid-19 vaccine (Primary immunization completed (manufacturer unknown)), for Covid-19 Immunization. The following information was reported: THROMBOSIS (medically significant) with onset 26Oct2022 at 08:00, outcome "recovered" (2022), described as "When I took my fourth Pfizer vaccine booster on 21Aug2022, I developed a new blood clot on 26Oct2022.". Therapeutic measures were taken as a result of thrombosis.  Clinical course: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. When I took my 3rd vaccine on 26Nov2021 I developed a blood clot on my right calf on 28Jan2022. I was clear of the blood clot in Sep2022. When I took my fourth Pfizer vaccine booster on 21Aug2022 developed a new blood clot on 26Oct2022. Treatment received for blood clot was Blood thinner Xarelto 20 MG. Covid prior vaccination was yes. Covid was not tested post vaccination. Known allergies was none. Other medical history was none. The vaccine was administered on Pharmacy or Drug Store.  Follow-up attempts are completed. No further information is expected.