chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: covid five times; covid five times; shoulder pain; flu two or three times; illness; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4339039-00.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Apr2021 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. 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 "covid five times"; ARTHRALGIA (non-serious), outcome "unknown", described as "shoulder pain"; INFLUENZA (non-serious), outcome "unknown", described as "flu two or three times"; ILLNESS (non-serious), outcome "unknown", described as "illness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: patient experienced covid five times. The action taken for upadacitinib was dosage permanently withdrawn. Clinical information: she had nausea with the second covid vaccine with Rinvoq (Upadacitinib). She felt she had shoulder pain due to being off of her medication a lot due to illness. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for Rinvoq (Upadacitinib) The reporter's causality for the event(s) of covid five times, shoulder pain, flu two or three times, Headache, Nausea with the second covid vaccine unknown onset and Headache, nausea with the second covid vaccine unknown onset was not provided.  The reporter's assessment of the causal relationship of the [covid five times, shoulder pain, flu two or three times and illness] with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug Ineffective and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain in extremity, Rheumatoid arthritis, Vertigo
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4294724-00 (RA). A 73 year-old female patient received BNT162B2, intramuscular, administration date 26Jan2022 (Batch/Lot number: unknown, Expiry date: Unknown) at the age of 73 years as dose 3 (booster), single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown, Expiry date: Unknown) at CF for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Single, Route of Administration: Intra-muscular, Therapy Dates/Duration: 29Jun2021-29Jun2021), administration date: 29Jun2021, when the patient was 73 years old, for Covid-19 immunization; BNT162B2 (Dose 1, Single, Route of Administration: Intra-muscular, Therapy Dates/Duration: 08Jun2021 08Jun2021), administration date: 08Jun2021, when the patient was 73 years old, for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 04Feb2022, outcome "unknown", described as "Rheumatoid arthritis flare up"; VERTIGO (non-serious) with onset 2022, outcome "not recovered", described as "Vertigo"; CHILLS (non-serious) with onset 2022, outcome "recovered" (2022), described as "Chills"; VOMITING (non-serious) with onset Feb2022, outcome "recovering", described as "Vomiting"; DIZZINESS (non-serious) with onset Feb2022, outcome "recovering", described as "Dizziness"; PAIN IN EXTREMITY (non-serious) with onset 25Mar2022, outcome "not recovered", described as "Pain legs". The action taken for adalimumab was unknown. The reporter considered "rheumatoid arthritis flare up", "vertigo", "chills", "vomiting" and "dizziness" related to bnt162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the current available information, a possible contributory role of the suspect product bnt162b2 to the development of reported events rheumatoid arthritis, vertigo, chills, vomiting, dizziness and pain in extremity cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4294724-00 (RA). A 73 year-old female patient received BNT162B2, intramuscular, administration date 26Jan2022 (Batch/Lot number: unknown, Expiry date: Unknown) at the age of 73 years as dose 3 (booster), single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown, Expiry date: Unknown) at CF for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Single, Route of Administration: Intra-muscular, Therapy Dates/Duration: 29Jun2021-29Jun2021), administration date: 29Jun2021, when the patient was 73 years old, for Covid-19 immunization; BNT162B2 (Dose 1, Single, Route of Administration: Intra-muscular, Therapy Dates/Duration: 08Jun2021 08Jun2021), administration date: 08Jun2021, when the patient was 73 years old, for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 04Feb2022, outcome "unknown", described as "Rheumatoid arthritis flare up"; VERTIGO (non-serious) with onset 2022, outcome "not recovered", described as "Vertigo"; CHILLS (non-serious) with onset 2022, outcome "recovered" (2022), described as "Chills"; VOMITING (non-serious) with onset Feb2022, outcome "recovering", described as "Vomiting"; DIZZINESS (non-serious) with onset Feb2022, outcome "recovering", described as "Dizziness"; PAIN IN EXTREMITY (non-serious) with onset 25Mar2022, outcome "not recovered", described as "Pain legs". The action taken for adalimumab was unknown. The reporter considered "rheumatoid arthritis flare up", "vertigo", "chills", "vomiting" and "dizziness" related to bnt162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the current available information, a possible contributory role of the suspect product bnt162b2 to the development of reported events rheumatoid arthritis, vertigo, chills, vomiting, dizziness and pain in extremity cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pain, SARS-CoV-2 test, Swelling, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Swelling; Pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4336952-00 (RA).  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Aug2021 (Batch/Lot number: unknown) at the age of 57 years as dose 2, single and intramuscular, administration date 21Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at cf for ankylosing spondylitis, psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 01Mar2022, outcome "unknown", COVID-19 (medically significant) with onset 01Mar2022, outcome "recovered" (Mar2022) and all described as "COVID-19"; PAIN (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Pain"; SWELLING (non-serious) with onset Feb2022, outcome "not recovered", described as "Swelling". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Mar2022) positive. The action taken for adalimumab was unknown. Causality for humira(adalimumab): the reporter's causality for the event(s) of swelling and pain with humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of covid-19 with humira (adalimumab) was no reasonable possibility. Pfizer biontech covid-19 vaccine(tozinameran)(tozinameran), causality: causality as per reporter (drug/vaccine) given as not reported' for events swelling, covid-19, and pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the reported events: "Vaccination failure", "COVID-19", "Pain", "Swelling" and the suspect drug BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Thyroid disorder
Clinical narrative: abnormal thyroid; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Feb2021 11:30 (Lot number: EL9266) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Garlic/onion" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "Nuts" (unspecified if ongoing); "Citrus" (unspecified if ongoing); "Antibiotics" (unspecified if ongoing). Concomitant medication(s) included: THYROID. Past drug history included: Tylenol, reaction(s): "Allergy"; Parabens, reaction(s): "Allergy"; Raisins, reaction(s): "Allergy"; Rosemery, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (DOSE: 1, prev dose administration time=12:00 PM, prev_dose_vaccine_location=Right arm), administration date: 23Jan2021, for COVID-19 immunization. The following information was reported: THYROID DISORDER (non-serious), outcome "recovered" (Sep2021), described as "abnormal thyroid".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200461499 similar report from same reporter
Sex: U
Vaccine: UNK, YF
Symptoms: Product storage error
Clinical narrative: were out of range for an estimate of 72 hours and reached 35.38F(1.9C); Initial information received on 25-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced were out of range for an estimate of 72 hours and reached 35.38f(1.9c) while receiving vaccine YELLOW FEVER VACCINE [YF-VAX] and while treated with DUPILUMAB [DUPIXENT] via prefilled pen.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient started taking DUPIXENT (DUPILUMAB) via prefilled pen (lot - OF024A) (with an unknown dose, strength, form, route, frequency, indication and expiration date). On an unknown date, the patient received a  dose of suspect YELLOW FEVER VACCINE lot number not reported.  On an unknown date the patient developed a non-serious event were out of range for an estimate of 72 hours and reached 35.38f(1.9c) (product storage error) (unknown latency) following the first dose intake of DUPILUMAB. On an unknown date the patient developed a non-serious event were out of range for an estimate of 72 hours and reached 35.38f(1.9c) (product storage error) (unknown latency) following the administration of YELLOW FEVER VACCINE.  It was reported temperature excursion involving punctured and unopened YF-VAX, punctured and unopened sodium chloride diluent for YF- VAX and DUPIXENT. Cause of excursion is unknown. Products were out of range for an estimate of 72 hours and reached 35.38F(1.9C). Caller requesting stability information. DUPIXENT- Lot: OF024A This situation is reported as a medication error due to temperature excursion exceeded the stability data documented in the local labelling and additional supporting stability data and was due to human error. Caller requesting excursion information for Dupixent prefilled pen due to unknown reasons. Temperature was 35.38F for 72 hours over the weekend. Caller states excursion information is for administering Dupixent. Caller is not sure of the strength of the Dupixent. Additional Description of event Adverse events :Caller requesting excursion information for Dupixent prefilled pen due to unknown reasons.  Action taken with DUPILUMAB (DUPIXENT) and YELLOW FEVER VACCINE (YF-VAX) was not applicable.  Corrective treatment not reported.  At time of reporting, the outcome was Unknown for the event were out of range for an estimate of 72 hours and reached 35.38f(1.9c).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE occurred; a dose of PROQUAD was expired and administered; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 22-MAR-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (lot # t032150, expiration date reported as 20-MAR-2022; strength and route of administration were not reported) for prophylaxis (expired product administered). The reporter confirmed that no other adverse event (AE) occurred.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse events reported; seven doses of improperly stored GARDASIL 9 were administered to 7 different patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reaction or allergies were not reported.  On 08-MAR-2022, the patient was administered an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot # U008899 (presentation established upon internal validation as syringe), expiration date: 12-AUG-2023 (route of administration and anatomical location were not provided) for prophylaxis. The vaccine underwent temperature excursion of 33.4 degrees Fahrenheit for 2595 hours (product storage error). There was no previous temperature excursion. No further information provided. No other adverse events were reported.  This is one of multiple reports received from the same reporter, who reported seven doses of improperly stored suspect vaccine being administered to seven different patients. ; Sender's Comments:  US-009507513-2203USA007997: US-009507513-2203USA007825: US-009507513-2203USA007812: US-009507513-2203USA007915: US-009507513-2203USA008053: US-009507513-2203USA008063:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: only 1st dose administrated on 2020.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 20th September 2020 from batch number h552g with expiry date 20th September 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-Apr-2022 Reporter's comment: The patient was late for the second dose of Shingrix. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Skin ulcer
Clinical narrative: MULTIPLE SKIN ULCERS/ SORES ALL OVER BODY; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1141161 expiry: UNKNOWN) dose and frequency were not reported from an unspecified date to 14-MAR-2022 for moderate to severe rheumatoid arthritis.  No concomitant medications were reported.  On an unspecified date, the patient experienced multiple skin ulcers/ sores all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn on 14-MAR-2022. The patient was recovering from multiple skin ulcers/ sores all over body. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myasthenia gravis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYASTHENIA GRAVIS (Generalized myasthenia gravis exacerbated after the 2nd and 3rd shot of the vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036821A and 014M20A) for COVID-19 vaccination. The patient's past medical history included Ocular myasthenia (Prior getting Moderna COVID-19 vaccine, just about finishing treatment for Ocular Myasthenia). On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MYASTHENIA GRAVIS (Generalized myasthenia gravis exacerbated after the 2nd and 3rd shot of the vaccine) (seriousness criteria hospitalization and medically significant). At the time of the report, MYASTHENIA GRAVIS (Generalized myasthenia gravis exacerbated after the 2nd and 3rd shot of the vaccine) had not resolved. Concomitant medications were not reported. The patient had got monthly infusion treatment of IVIG. It was reported that generalized myasthenia gravis was then exacerbated after the 2nd and 3rd shot of the vaccine. The patient's doctor said they didn't had an idea if her symptoms were related to the vaccine. Patient's online reading suggested it might be due to the mRNA. The patient symptoms had worsened. Patient had not ever tested COVID positive test or had COVID-19 diagnosis. No other vaccination were given within 1 month prior to Moderna COVID-19 vaccine. Company Comment: This is a Spontaneous case concerning a 74-year-old female patient, with medical history of ocular myasthenia, who experienced the unexpected, serious (hospitalization and medically significant), and AESI of Myasthenia gravis. The event started approximately 3 weeks after the first dose of mRNA-1273 vaccine, and was exacerbated after second and third dose. She gets monthly infusion of immunoglobulin IV. Medical history of ocular myasthenia remains confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-529107, MOD-2022-529243 (Patient Link). Sender's Comments: This is a Spontaneous case concerning a 74-year-old female patient, with medical history of ocular myasthenia, who experienced the unexpected, serious (hospitalization and medically significant), and AESI of Myasthenia gravis. The event started approximately 3 weeks after the first dose of mRNA-1273 vaccine, and was exacerbated after second and third dose. She gets monthly infusion of immunoglobulin IV. Medical history of ocular myasthenia remains confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: An expired dose was administer to a patient; Dosing interval extended between 1st and 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired dose was administer to a patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing interval extended between 1st and 2nd dose) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 033H21A and 032H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired dose was administer to a patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing interval extended between 1st and 2nd dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (An expired dose was administer to a patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing interval extended between 1st and 2nd dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications was reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: pain at the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) and HEADACHE (headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 027A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-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 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site) and HEADACHE (headache). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) and HEADACHE (headache) outcome was unknown.            No concomitant and treatment information was provided.   This case was linked to MOD-2022-531854, MOD-2022-531858, MOD-2022-531856 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood immunoglobulin G, Cough, Dyspnoea
Clinical narrative: became very sick after vaccine; Cough; profound weakness; Marked SOB; Fever; joint pain; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (became very sick after vaccine), COUGH (Cough), ASTHENIA (profound weakness), DYSPNOEA (Marked SOB) and PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (RN diagnosed. Patient was very sick.) in March 2020.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (became very sick after vaccine), COUGH (Cough), ASTHENIA (profound weakness), DYSPNOEA (Marked SOB), PYREXIA (Fever) and ARTHRALGIA (joint pain). At the time of the report, ILLNESS (became very sick after vaccine), COUGH (Cough), ASTHENIA (profound weakness), DYSPNOEA (Marked SOB), PYREXIA (Fever) and ARTHRALGIA (joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin G: > 2500 (High) norm range >0.8, patient consistently had spiked antibodies. On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  Patient's cardiologist suggested not to take 2nd vaccine and to monitor antibodies and patient had done that for one year (every 3 months).   No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: became very sick after vaccine; Cough; profound weakness; Marked SOB; Fever; joint pain; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (became very sick after vaccine), COUGH (Cough), ASTHENIA (profound weakness), DYSPNOEA (Marked SOB) and PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (RN diagnosed. Patient was very sick.) in March 2020.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (became very sick after vaccine), COUGH (Cough), ASTHENIA (profound weakness), DYSPNOEA (Marked SOB), PYREXIA (Fever) and ARTHRALGIA (joint pain). At the time of the report, ILLNESS (became very sick after vaccine), COUGH (Cough), ASTHENIA (profound weakness), DYSPNOEA (Marked SOB), PYREXIA (Fever) and ARTHRALGIA (joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin G: > 2500 (High) norm range >0.8, patient consistently had spiked antibodies. On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  Patient's cardiologist suggested not to take 2nd vaccine and to monitor antibodies and patient had done that for one year (every 3 months).   No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine on 24-Sep-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 24-Sep-2022) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 24-Sep-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 24-Sep-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   This case was linked to MOD-2022-531880 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient had the full dose for 1st booster, though. That was before they said it was a half dose. This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patient had the full dose for 1st booster, though. That was before they said it was a half dose.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient had the full dose for 1st booster, though. That was before they said it was a half dose.). At the time of the report, ACCIDENTAL OVERDOSE (Patient had the full dose for 1st booster, though. That was before they said it was a half dose.) outcome was unknown.            No concomitant medications were reported. Patient took first and second dose of unknown vaccine and patient was not immunocompromised. No treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: Follow-up received contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Feeling hot, Malaise, Pain
Clinical narrative: had body aches; was sore at the injection site on left arm.; uncomfortable that night; I was ill feeling; felt hot; felt cold; This spontaneous case was reported by a patient and describes the occurrence of PAIN (had body aches), VACCINATION SITE PAIN (was sore at the injection site on left arm.), FEELING ABNORMAL (uncomfortable that night), MALAISE (I was ill feeling) and FEELING HOT (felt hot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (had body aches), VACCINATION SITE PAIN (was sore at the injection site on left arm.), FEELING ABNORMAL (uncomfortable that night), MALAISE (I was ill feeling), FEELING HOT (felt hot) and FEELING COLD (felt cold). At the time of the report, PAIN (had body aches), VACCINATION SITE PAIN (was sore at the injection site on left arm.), FEELING ABNORMAL (uncomfortable that night), MALAISE (I was ill feeling), FEELING HOT (felt hot) and FEELING COLD (felt cold) had resolved.            No concomitant medication was provided.  It was reported that, patient received vaccine a fewdays ago. Patient received second booster dose of moderna.  Patient had symptoms which was getting improved.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: Follow-up document received contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: had body aches; was sore at the injection site on left arm.; uncomfortable that night; I was ill feeling; felt hot; felt cold; This spontaneous case was reported by a patient and describes the occurrence of PAIN (had body aches), VACCINATION SITE PAIN (was sore at the injection site on left arm.), FEELING ABNORMAL (uncomfortable that night), MALAISE (I was ill feeling) and FEELING HOT (felt hot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (had body aches), VACCINATION SITE PAIN (was sore at the injection site on left arm.), FEELING ABNORMAL (uncomfortable that night), MALAISE (I was ill feeling), FEELING HOT (felt hot) and FEELING COLD (felt cold). At the time of the report, PAIN (had body aches), VACCINATION SITE PAIN (was sore at the injection site on left arm.), FEELING ABNORMAL (uncomfortable that night), MALAISE (I was ill feeling), FEELING HOT (felt hot) and FEELING COLD (felt cold) had resolved.            No concomitant medication was provided.  It was reported that, patient received vaccine a fewdays ago. Patient received second booster dose of moderna.  Patient had symptoms which was getting improved.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: Follow-up document received contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Mobility decreased, Myalgia, Pyrexia
Clinical narrative: Could not move; Fever with temperature 101.5F; Body was aching like crazy; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Could not move), PYREXIA (Fever with temperature 101.5F) and MYALGIA (Body was aching like crazy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (Could not move), PYREXIA (Fever with temperature 101.5F) and MYALGIA (Body was aching like crazy). At the time of the report, MOBILITY DECREASED (Could not move), PYREXIA (Fever with temperature 101.5F) and MYALGIA (Body was aching like crazy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, Body temperature: 101.5 (High) 101.5 Fahrenheit.         No concomitant medication was reported by reporter.  Patient took second booster of Moderna on 01-Apr-2022. Patient did not take any treatments for side effects.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus (ringing in right ear)
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Biopsy kidney abnormal, Blood creatinine increased, Glomerulonephritis acute, Kidney fibrosis
Clinical narrative: biopsy proven acute glomerulonephritis with marked nephrosis (over 10 grams proteinuria) and acute renal failure with Creatinine now at 1.5 mg/dl.  Had rash to shots 1 and 2.  On  third shot had rash and now nephrotic syndrome and renal failure.  Rash was immediate after each shot.  nephrosis was manifested several weeks after third shot
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Nephrotic syndrome, Proteinuria, Rash
Clinical narrative: biopsy proven acute glomerulonephritis with marked nephrosis (over 10 grams proteinuria) and acute renal failure with Creatinine now at 1.5 mg/dl.  Had rash to shots 1 and 2.  On  third shot had rash and now nephrotic syndrome and renal failure.  Rash was immediate after each shot.  nephrosis was manifested several weeks after third shot
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Patient said arm is very painful when moves & feels pain on back of shoulder/neck when moves his arm. no redness, bruising, or swelling observed. He said pain started later that evening
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Wrong Age for Vaccine Given-
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Additional Details: Patient stated that she noticed the bruise around injection site on that night she received a vaccine. She stated that she didn't notice any change in the size of bruise. Patient stated that she will follow up with the doctor on following Monday if symptom is not improving.
Age: 79.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Severe,
Age: 79.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Severe,
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient recieved Prevnar 20 on March 26, 2022. Patient came in to pharmacy to show she have developed redmess about 4 inches by 4 inches size also itchy. She stated that she has been watching it and it a bit better. I advice her to see her primary care doctor if she is not much better in a few days.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: PT SAYS AT INJECTION AREA IS WARM AT TOUCH AND REDNESS AND LITTLE SWOLLEN
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain
Clinical narrative: Chills, soreness at injection site, body ache
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Coronary arterial stent insertion
Clinical narrative: Started having angina that ended up having 3 Stents placed in my heart. Continue to have angina and taking medication for it.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Blood test normal, Cardiac disorder, Cardiac stress test normal
Clinical narrative: Burning at injection site in left arm.  Left shoulder pain, neck pain, left side chest pain and pressure developed 8 days later with panic and sense of doom.  Felt like heart problems.  Went to ER on day 9.  Chest x-ray, blood work, EKG  all negative.  Given nitro to alleviate pressure symptoms.  Scheduled for nuclear stress test.  Took nuclear stress test 2 months after symptoms developed.  Passed nuclear stress test.  MD diagnosis is costrochondritus.  Symptoms have lessoned over time but can be triggered by certain exertions or chest pressure.  Shoulder and neck pain still present 10 months after vaccine.  Suspect vaccine injection technique may have triggered adverse reaction in shoulder, neck and chest wall which may or may not be permanent.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Chest pain, Costochondritis, Electrocardiogram normal
Clinical narrative: Burning at injection site in left arm.  Left shoulder pain, neck pain, left side chest pain and pressure developed 8 days later with panic and sense of doom.  Felt like heart problems.  Went to ER on day 9.  Chest x-ray, blood work, EKG  all negative.  Given nitro to alleviate pressure symptoms.  Scheduled for nuclear stress test.  Took nuclear stress test 2 months after symptoms developed.  Passed nuclear stress test.  MD diagnosis is costrochondritus.  Symptoms have lessoned over time but can be triggered by certain exertions or chest pressure.  Shoulder and neck pain still present 10 months after vaccine.  Suspect vaccine injection technique may have triggered adverse reaction in shoulder, neck and chest wall which may or may not be permanent.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Neck pain, Panic reaction
Clinical narrative: Burning at injection site in left arm.  Left shoulder pain, neck pain, left side chest pain and pressure developed 8 days later with panic and sense of doom.  Felt like heart problems.  Went to ER on day 9.  Chest x-ray, blood work, EKG  all negative.  Given nitro to alleviate pressure symptoms.  Scheduled for nuclear stress test.  Took nuclear stress test 2 months after symptoms developed.  Passed nuclear stress test.  MD diagnosis is costrochondritus.  Symptoms have lessoned over time but can be triggered by certain exertions or chest pressure.  Shoulder and neck pain still present 10 months after vaccine.  Suspect vaccine injection technique may have triggered adverse reaction in shoulder, neck and chest wall which may or may not be permanent.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Urticaria
Clinical narrative: chronic hives
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone increased, Tinnitus
Clinical narrative: Tinnitus in both ears/ not improved or worse as of 04/06/22 Increase in thyroid tsh numbers after being stable for 10 years with no increase
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death
Clinical narrative: Information unavailable.  Patient died at home.  Covid 19 listed as a cause of death on death certificate.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Pain, Rhinorrhoea
Clinical narrative: Narrative: Patient was administered the vaccine and observed for 15 minutes without any issues. Two days later, on December 22, he contacted the clinic reporting that yesterday he had body aches, last night he started with a headache, nasal drainage and coughing, He was advised to monitor for worsening symptoms and to call back if no improvement in 48-72 hours. To date, 1/4/2022, there has not been any further communication from the patient. It would seem the reported ADE has resolved.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: writer did not dilute the vaccine as needed for peds dosing, pt got twice the amount of vaccine recomended
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, Inappropriate schedule of product administration
Clinical narrative: Information unavailable. Patient died at home. Covid 19 listed as a cause of death on death certificate.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Catheterisation cardiac abnormal, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: "Since receiving 1st Pfizer vaccine 8/21/21, episodes of anterior chest pain.   3 visits to Urgent Care/ ER within the first 3 weeks post vaccination with SOB.  Treated with steroids.       Since 9/21, still SOB particularly at night.   Daily bilateral constant anterior chest discomfort.   Episodes of right sided sharp chest pain, worse when reaching with right arm.  Poor stamina.   Sometimes, has epiosodes of thumping of the heartbeat.  Underwent cardiac cath 2/22.  Minimal irregularities.  Lipid medication recommended.  Rosuvastatin 10 mg started 2/22. "
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: "Since receiving 1st Pfizer vaccine 8/21/21, episodes of anterior chest pain.   3 visits to Urgent Care/ ER within the first 3 weeks post vaccination with SOB.  Treated with steroids.       Since 9/21, still SOB particularly at night.   Daily bilateral constant anterior chest discomfort.   Episodes of right sided sharp chest pain, worse when reaching with right arm.  Poor stamina.   Sometimes, has epiosodes of thumping of the heartbeat.  Underwent cardiac cath 2/22.  Minimal irregularities.  Lipid medication recommended.  Rosuvastatin 10 mg started 2/22. "
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza virus test, Nausea, Pain
Clinical narrative: fever, body aches, chills, headaches, nausea and vomiting.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccine positive rechallenge, Vomiting
Clinical narrative: fever, body aches, chills, headaches, nausea and vomiting.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Patient given vaccine that was not diluted per manufacturer direction, given undiluted vaccine, children's formulation (PEDS).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Hypoglycaemia, Intestinal obstruction, SARS-CoV-2 test positive, Urinary tract disorder
Clinical narrative: Patient with J+J COVID vaccine 03/23/21 who admitted with hypoglycemia, significant urinary tract issues, and bowel obstruction who incidentally tested detected during admission testing.  No s/s of COVID during stay, no hypoxia.  Discharged home.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient given undiluted vaccine, correct volume but not diluted so patient got more than recommended dose.