chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: extra dose of MENACTRA was administered with no reported adverse event; Initial information received on 21-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old male patient who experienced extra dose of menactra was administered with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO); and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO).  On 18-Feb-2022, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U7140AA (expiry date 04-Nov-2022) via intramuscular route in the right deltoid for Immunization.  On 18-MAR-2022 the patient developed a non-serious event "extra dose of menactra was administered with no reported adverse event  "(extra dose administered) 1 month following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  It was not reported if the patient received a corrective treatment for the event (extra dose of MENACTRA was administered with no reported adverse event).  At time of reporting, the outcome was Unknown for the event extra dose of menactra was administered with no reported adverse event.     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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: product expired on 5Mar2022 and was administered to a patient on 18Mar2022, with no reported adverse event; Initial information received on 22-Mar-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves an unknown age and unknown gender patient who experienced product expired on 5mar2022 and was administered to a patient on 18mar2022, with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (Tenivac).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Mar-2022, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT with expiry date: 05-Mar-2022 (strength, dose, route, lot number and administration site) for Immunization (expired product administered) (latency: same day).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (product expired on 5Mar2022 and was administered to a patient on 18Mar2022, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event product expired on 5mar2022 and was administered to a patient on 18mar2022, with no reported adverse event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Age: 1.5
Sex: F
Vaccine: FLU4, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient inadvertently received an extra (third) dose of FLUZONE with no reported adverse event; Initial information  received on 22-Mar-2022 regarding an unsolicited valid  non-serious case received from an other health professional.  This case involves an 18 months old female patient who inadvertently received an extra (third) dose of Influenza quadrival A-B vaccine [Fluzone Quadrivalent] with no reported adverse event.  The patient's past vaccination(s) included Fluzone Quadrivalent on 30-NOV-2021 and 03-FEB-2022. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine RHBSAG (yeast) (Recombivax) for Prophylactic vaccination.  On 22-Mar-2022, the patient received a dose of suspect Influenza quadrival A-B vaccine (with an unknown formulation and strength) (lot number: UT7376NA and expiry date: 30-Jun-2022) at a dosage of 0.5 mL via intramuscular route in the left arm for prophylactic immunization.  On 22-MAR-2022 (latency: same day) the patient inadvertently received an extra (third) dose of Influenza quadrival A-B vaccine with no reported adverse event (extra dose administered).   Action taken was not applicable.  Outcome: Unknown    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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: made a mistake of vaccinating a patient with MENACTRA and later on they realized that the Lot number expired on 21FEB2022 with no reported adverse event; Initial information received on 22-Mar-2022 regarding an unsolicited valid non-serious case received by a health care professional via call center.  This case involves an 18 years old male patient who got mistakenly vaccinated with menactra and later on they realized that the lot number expired on 21feb2022 with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal Vaccine B (Menb) for Prophylactic vaccination; and HPV Vaccine (HPV Vaccine) for Prophylactic vaccination.  On 18-Mar-2022, the patient received 0.5 mL dose of Meningococcal A-C-Y-W135 (D Conj) Vaccine (form, strength, expiry date: Unknown; lot U6874AA) via intramuscular route in the right deltoid for Immunization.  On 18-MAR-2022 (Latency: same day), there was a mistake of vaccinating the patient with menactra and later on they realized that the lot number expired on 21feb2022 with no reported adverse event (expired product administered).  Action taken: Not applicable.  Event outcome: Unknown  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Age: 1.5
Sex: M
Vaccine: DTAP, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: child was given an expired dose of the DAPTACEL on 21-MAR-22 , with no reported adverse events; Initial information was received on 23-MAR-2022 regarding an unsolicited valid non-serious case received from a health care professional via call center.   This case involves a 18 months old male patient who experienced child was given an expired dose of the daptacel on 21-mar-22 , with no reported adverse events while receiving vaccine Diphtheria-15/tetanus/5 AC pertussis vaccine [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine for Prophylactic vaccination.  On 21-Mar-2022, the patient received a dose of suspect Diphtheria-15/tetanus/5 AC pertussis vaccine (dose, formulation, and strength: unknown) (batch number: C5706AA Expiry date- 11-MAR-2022) via Intramuscular route in left thigh for immunization.  On 21-MAR-2022 the patient developed a non-serious child was given an expired dose of the daptacel on 21-mar-22 , with no reported adverse events (expired product administered) (latency: same day) following the administration of Diphtheria-15/tetanus/5 AC pertussis vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event child was given an expired dose of the daptacel on 21-mar-22 , with no reported adverse events.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Chest pain, Dyspnoea, Hypertension
Clinical narrative: Unexplained chest pain and racing heartbeat when exercising. EKG normal, waiting on CT scan to rule out blockages. 02 normal. BP normal on stress echo but high in several incidents.  Rescue inhaler did not improve shortness of breath, pain or chest tightness. Will try to update if a cause is found. No indication that this is related to vaccine but felt important to note in case other cases pop up.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Stress echocardiogram
Clinical narrative: Unexplained chest pain and racing heartbeat when exercising. EKG normal, waiting on CT scan to rule out blockages. 02 normal. BP normal on stress echo but high in several incidents.  Rescue inhaler did not improve shortness of breath, pain or chest tightness. Will try to update if a cause is found. No indication that this is related to vaccine but felt important to note in case other cases pop up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pyrexia, Somnolence
Clinical narrative: The next day after my second dose shot of Moderna I felt so sleepy and Nausea that morning and later that night I felt dizziness and develop a fever of 105° I didn't take any medication for my fever it stayed for about 3 hours and finally went back to normal the third day I start to feeling much better
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Arthralgia, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Large swelling of the left arm, shoulder, pain and itchiness. Warm to the touch
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Chest pain, Computerised tomogram, Dyspnoea
Clinical narrative: Heart palpitations, chest pain, shortness of breath, very high heart rate. Went to hospital and was admitted in immediately. Can last up to 3 days after each episode. Treatment from hospital was beta blocker. Diagnosis was anxiety which lead to hydroxyzine medication.  But ended up the hospital again for very high heart rate again. Still having heart problems , chest pains and shortness of breath
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Heart rate increased, Palpitations
Clinical narrative: Heart palpitations, chest pain, shortness of breath, very high heart rate. Went to hospital and was admitted in immediately. Can last up to 3 days after each episode. Treatment from hospital was beta blocker. Diagnosis was anxiety which lead to hydroxyzine medication.  But ended up the hospital again for very high heart rate again. Still having heart problems , chest pains and shortness of breath
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood culture, Chest X-ray, Computerised tomogram abdomen, Fatigue, Full blood count
Clinical narrative: Body aches and fatigue for first 48 hrs, then acute onset nausea and profuse vomiting that lasted for 72 hrs, requiring 2 separate ER visits for IV fluids and aggressive anti-nausea therapy.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Nausea, Pain, Vomiting
Clinical narrative: Body aches and fatigue for first 48 hrs, then acute onset nausea and profuse vomiting that lasted for 72 hrs, requiring 2 separate ER visits for IV fluids and aggressive anti-nausea therapy.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: I suffered a stroke on the 22nd of January 2022. I was hospitalized in high care.
Sex: M
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: This spontaneous report received from a patient concerned an adult male of an unspecified race and ethnic origin. The patient's height and weight were not reported. The patient's concurrent conditions included non infectious intermediate posterior and Panuveitis. The patient previously received Spikevax (elasomeran) (dose number in series was 1) (form of administration was not reported, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, start therapy date were not reported for prophylactic vaccination for prophylactic vaccination. No adverse events were reported following vaccination with Spikevax (elasomeran). The patient received Covid-19 vaccine ad26.cov2.s (dose number in series was 2) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 01 total 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 number. No concomitant medications were reported. Non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for non-infectious intermediate posterior and Panuveitis. On an unspecified date, the patient experienced inflammation (dose number in series was 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inflammation was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Caller reported that a patient was given a dose of Moderna vaccine from a vial that had undergone a 2 and a half-hour temperature excursion.; Caller reported that a patient was given a dose of Moderna vaccine from a vial that had undergone a 2 and a half-hour temperature excursion.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Caller reported that a patient was given a dose of Moderna vaccine from a vial that had undergone a 2 and a half-hour temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (Caller reported that a patient was given a dose of Moderna vaccine from a vial that had undergone a 2 and a half-hour temperature excursion.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Caller reported that a patient was given a dose of Moderna vaccine from a vial that had undergone a 2 and a half-hour temperature excursion.). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Caller reported that a patient was given a dose of Moderna vaccine from a vial that had undergone a 2 and a half-hour temperature excursion.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Caller reported that a patient was given a dose of Moderna vaccine from a vial that had undergone a 2 and a half-hour temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (Caller reported that a patient was given a dose of Moderna vaccine from a vial that had undergone a 2 and a half-hour temperature excursion.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that vail stored at -10Deg C.  No treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: The recent follow up received on 24-MAR-2022.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: During my second dose, I had a reaction after ~ 1-2 mins after getting the shot. I had HBP (for the first time) and tachycardia, I felt like my body is going to experience an episode of syncope but I was able to ask for help prior.   On my third dose, did not had immediate reaction but have been developing a lot of unknown causes of itching hence hives-like rash.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: used sterile water to reconstitute the vaccine; used sterile water to reconstitute the vaccine; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 42CM4, expiry date 11th June 2023) for prophylaxis.   On 24th March 2022, the patient received the 2nd dose of Shingrix. On 24th March 2022, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-March-2022 Additional Supportive Information: The certified medical assistant (CMA) stated that the patient came for the 2nd dose of Shingrix and the health care professional used sterile water to reconstitute the vaccine and the dose was administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No further information reported. The reporter consented to follow-up via postal.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered to the left arm on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-Nov-2021, the patient received additional non-company suspect vaccine Moderna covid19 vaccine (elasomeran) (Dose number in series 2) (batch number: 013F21A, expiry: UNKNOWN, form of admin, route of admin, were not reported) dose was not reported, administered to the left arm for prophylactic vaccination.  On 14-MAR-2022, the patient experienced fever and cough (coded as suspected covid-19 infection) (Dose number in series 2). It was reported that patient recovered from cough on 15-MAR-2022 and fever on 17-MAR-2022 (Dose number in series 2). On 15-MAR-2022, Laboratory data included: COVID-19 antigen test (binax now) (NR: not provided) positive (coded as suspected clinical vaccination failure) (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from suspected covid-19 infection on 17-MAR-2022, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000222896.; Sender's Comments: V0-20220344998-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Thrombosis
Clinical narrative: BLOOD CLOTS; ADVERSE REACTIONS; This spontaneous report received from a patient via a company representative via social media concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient reported that "My youngest daughter's best friends mother died right in front of my daughter and her friend after getting the same one I got by J&J that's the main reason she refused and still refuses to be vaxxed. I'm okay with that as I had adverse reactions to it myself including blood clots". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and adverse reactions was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220349106.; Sender's Comments: V0: 20220349128-COVID-19 VACCINE AD26.COV2.S- blood clots. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Off label use
Clinical narrative: This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis, moderate to severe chronic plaque psoriasis, and moderate to severe ulcerative colitis, and other pre-existing medical conditions included: The patient had no known allergy, no concomitant drugs taken and no relevant medical history. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose, start therapy date were not reported, and 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: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis, moderate to severe chronic plaque, and moderate to severe ulcerative colitis. No concomitant medications were reported. On an unspecified date, the patient experienced Covid-19 infection, off label use, and inappropriate schedule of vaccine administered. The action taken with Covid-19 vaccine ad26.cov2.s, and upadacitinib was not applicable. The outcome of the off label use, Covid-19 infection and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220345561.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous report received from a consumer concerned a 53 year old female of an unspecified ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 20-DEC-2021) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 and was determined to be positive with an at home covid-19 virus test (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. On 11-DEC-2021, the patient received booster of Moderna vaccine (dose number in series: 2) (form of admin, route of admin not reported, and batch number: 014F21A, expiry: unknown) dose was not reported, administered for prophylactic vaccination. No adverse events were reported following Moderna vaccine (dose number in series: 2). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Overdose
Clinical narrative: Patient received a fourth full Moderna Covid-19 booster dose instead of the half dose booster dose after receiving 3 fill Moderna Covid-19 primary series dose. The booster I got was a full shot; Today I got the 4th shot. He has taken a whole 4th shot this morning; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (Patient received a fourth full Moderna Covid-19 booster dose instead of the half dose booster dose after receiving 3 fill Moderna Covid-19 primary series dose. The booster I got was a full shot) and EXTRA DOSE ADMINISTERED (Today I got the 4th shot. He has taken a whole 4th shot this morning) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   On 23-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2022, the patient experienced OVERDOSE (Patient received a fourth full Moderna Covid-19 booster dose instead of the half dose booster dose after receiving 3 fill Moderna Covid-19 primary series dose. The booster I got was a full shot). 23-Mar-2022, the patient experienced EXTRA DOSE ADMINISTERED (Today I got the 4th shot. He has taken a whole 4th shot this morning). At the time of the report, OVERDOSE (Patient received a fourth full Moderna Covid-19 booster dose instead of the half dose booster dose after receiving 3 fill Moderna Covid-19 primary series dose. The booster I got was a full shot) and EXTRA DOSE ADMINISTERED (Today I got the 4th shot. He has taken a whole 4th shot this morning) outcome was unknown.            No Concomitant Medications were provided by the Reporter. It was reported that the patient received third full dose Moderna COVID-19 vaccine a few months ago, as directed by his physician. It was also reported that the booster received was full dose as same as the first three doses No Treatment Medications were provided by the Reporter   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2022: Follow up received included reporter details and patient initials was updated.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of an expired vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 048B21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of an expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient didn´t have any allergies, acute or chronic illnesses at the time of vaccination, and no other vaccines were administered within 1 month prior to Moderna Covid-19 Vaccine. The patient was not tested positive for COVID-19. The expired dose administered was the booster dose. The reporter doesn´t know if the patient was on any concomitant medication. It was reported that the date the vial initially stored in refrigerator was unknown and the vial does not undergone any temperature excursion. The patient was not experiencing any symptoms after receiving the expired dose No treatment information was reported   This case was linked to MOD-2022-521623, MOD-2022-521636 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: Sore arm; Yucky feeling; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Yucky feeling) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine Allergy) and Parkinson's disease.    On 27-Mar-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 PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Yucky feeling). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Yucky feeling) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  Reporter stated that the events sore arm and yucky feeling didn't last very long.   This case was linked to MOD-2022-521546, MOD-2022-522741 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: he did the same with the first two, was like somebody punched them  in the arm for 2,3,4 days/The first two doses were given on 13-FEB-2021 and 15-MAR-2021 both given in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (he did the same with the first two, was like somebody punched them  in the arm for 2,3,4 days/The first two doses were given on 13-FEB-2021 and 15-MAR-2021 both given in left arm) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included Back injury, Kidney stones and Surgery (For ruptured disc, floating fragments, pinched nerve. Patient has been managing it with Gabapentin). Concurrent medical conditions included Gout and Charley horse (In his thigh.). Concomitant products included ALLOPURINOL for Gout and Kidney stones, LISINOPRIL, GABAPENTIN and SIMVASTATIN for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (he did the same with the first two, was like somebody punched them  in the arm for 2,3,4 days/The first two doses were given on 13-FEB-2021 and 15-MAR-2021 both given in left arm). At the time of the report, VACCINATION SITE PAIN (he did the same with the first two, was like somebody punched them  in the arm for 2,3,4 days/The first two doses were given on 13-FEB-2021 and 15-MAR-2021 both given in left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient was cleaning out his car and that pain started to re-occur and he started to have zaps in his leg. Patient does not know if that is associated with the shoulder because of the muscle part of it. Patient was taking gabapentin for zapping in leg, patient has never been tested, or have the symptoms of COVID. No treatment was provided by the reporter.   This case was linked to MOD-2022-522969, MOD-2022-522804, MOD-2022-523033 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Lot number, route updated from the follow-up source document.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: like somebody punched them in the arm/felt the same thing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (like somebody punched them in the arm/felt the same thing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-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 VACCINATION SITE DISCOMFORT (like somebody punched them in the arm/felt the same thing). At the time of the report, VACCINATION SITE DISCOMFORT (like somebody punched them in the arm/felt the same thing) had resolved.            No concomitant medications were reported.  After the booster patient felt the same thing like somebody punched them in the arm and it cleared up in 3 - 4 days.  No treatment medications were reported.   This case was linked to MOD-2022-522811, MOD-2022-523033 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: This is a spontaneous report received from a non-contactable healthcare professional. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), as unknown dose number, single for Covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The patient (PT) experienced myocarditis after COVID vaccine on an unspecified date, which was serious per hospitalization. Details were as follows: The reporting physician had a patient who had myocarditis. This was noted as vaccine related, and the patient was in the hospital for a couple of days. It was a nuisance, but the patient recovered fine, and a month later, everything was normal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: A possible contribution role of vaccination with BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to the onset of event myocarditis cannot be excluded. The case will be reassessed should additional information become available. 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain
Clinical narrative: Started after about 2 months after my third dose have chest pain. Also various roving joint pain, in my one knee and ankle and wrist. This is similar to what I had when I had an outbreak of Sarcoidosis, except not as severe. I am referring to the joint pain. I am hoping this goes away or I will visit my Doctor.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient received vaccine and was found non-responsive 4 days later
Age: 69.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Nystagmus, Vertigo
Clinical narrative: Noticed onset of vertigo when lying down, especially when laying on right side.  I searched the symptom, and it said this is a common, idiopathic problem.  However, I later read that hearing loss and vertigo were being reported as adverse events related to COVID vaccination.  The vertigo is mild to moderate, usucally noticed upon arising, and improving over the course of an hour or so.  However, I had all day vertigo (mild) on Friday, March 25, 2022.  That has since improved to a baseline of moderat symptoms when lying down and improvement to mild symptoms the rest of the day.  I noticed some nystagmus when lying on my right side, if the sensation of vertigo is more pronounced.  I take care with head movements and have not fallen as a result of the vertigo.  Vertigo seems to be slowly improving over all, but waxes and wanes without seeming precipitating cause.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Blood potassium decreased, COVID-19, Chest X-ray normal, Chronic obstructive pulmonary disease
Clinical narrative: Patient was initially presented on 3/8/2022 with a chief complaint of shortness of breath and he was informed that the COVID test is positive.  Patient was recently seen in the emergency room 5 days ago and was discharged the diagnosis of COPD exacerbation.  Subsequently COVID-19 PCR tested positive and patient was informed.  SpO2 87 in room air per EMS and patient received albuterol and Solu-Medrol prior to arrival.    Upon evaluation in the ED BP was 128/63 heart rate 88, afebrile and pulse ox was 86 in room air and subsequently improved to 96% on nasal cannula.  Chest x-ray unremarkable for any acute cardiac pulmonary process.  Lab work abnormal for elevated WBC of 19.6, potassium of 3.3 and the rest of the labs were unremarkable.   Patient was subsequently admitted for further evaluation and treatment under Hospital Medicine.  Patient continued to have significant wheezing bilaterally and he was started on dexamethasone 6 mg for 7 days.  Patient was treated with respiratory protocol and bronchodilators as well as Robitussin cough syrup.  Patient subsequently improved with acute component of the respiratory failure and is currently stable with his oxygenation.  Patient was evaluated by PT and OT and recommended for post-acute therapy.  Patient was going to be admitted to VA palliative care prior to admission.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Laboratory test normal, SARS-CoV-2 test positive, Wheezing
Clinical narrative: Patient was initially presented on 3/8/2022 with a chief complaint of shortness of breath and he was informed that the COVID test is positive.  Patient was recently seen in the emergency room 5 days ago and was discharged the diagnosis of COPD exacerbation.  Subsequently COVID-19 PCR tested positive and patient was informed.  SpO2 87 in room air per EMS and patient received albuterol and Solu-Medrol prior to arrival.    Upon evaluation in the ED BP was 128/63 heart rate 88, afebrile and pulse ox was 86 in room air and subsequently improved to 96% on nasal cannula.  Chest x-ray unremarkable for any acute cardiac pulmonary process.  Lab work abnormal for elevated WBC of 19.6, potassium of 3.3 and the rest of the labs were unremarkable.   Patient was subsequently admitted for further evaluation and treatment under Hospital Medicine.  Patient continued to have significant wheezing bilaterally and he was started on dexamethasone 6 mg for 7 days.  Patient was treated with respiratory protocol and bronchodilators as well as Robitussin cough syrup.  Patient subsequently improved with acute component of the respiratory failure and is currently stable with his oxygenation.  Patient was evaluated by PT and OT and recommended for post-acute therapy.  Patient was going to be admitted to VA palliative care prior to admission.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: Patient was initially presented on 3/8/2022 with a chief complaint of shortness of breath and he was informed that the COVID test is positive.  Patient was recently seen in the emergency room 5 days ago and was discharged the diagnosis of COPD exacerbation.  Subsequently COVID-19 PCR tested positive and patient was informed.  SpO2 87 in room air per EMS and patient received albuterol and Solu-Medrol prior to arrival.    Upon evaluation in the ED BP was 128/63 heart rate 88, afebrile and pulse ox was 86 in room air and subsequently improved to 96% on nasal cannula.  Chest x-ray unremarkable for any acute cardiac pulmonary process.  Lab work abnormal for elevated WBC of 19.6, potassium of 3.3 and the rest of the labs were unremarkable.   Patient was subsequently admitted for further evaluation and treatment under Hospital Medicine.  Patient continued to have significant wheezing bilaterally and he was started on dexamethasone 6 mg for 7 days.  Patient was treated with respiratory protocol and bronchodilators as well as Robitussin cough syrup.  Patient subsequently improved with acute component of the respiratory failure and is currently stable with his oxygenation.  Patient was evaluated by PT and OT and recommended for post-acute therapy.  Patient was going to be admitted to VA palliative care prior to admission.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Agitation, Choking, Cough, Crying, Decreased appetite
Clinical narrative: 9 hours after receiving the vaccination she vomited a very large amount 3 separate times. The third time she choked on the vomit. within 24 hours she developed congestion, loss of appetite and a cough. She had unconsolable crying and fussiness up to 3.28.2022 (still happening)
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Respiratory tract congestion, Vomiting
Clinical narrative: 9 hours after receiving the vaccination she vomited a very large amount 3 separate times. The third time she choked on the vomit. within 24 hours she developed congestion, loss of appetite and a cough. She had unconsolable crying and fussiness up to 3.28.2022 (still happening)
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Disturbance in attention, Headache, Insomnia, Neck pain
Clinical narrative: Severe Headache traveling done neck and into lower back.  Pain severe enough unable to rest/sleep, difficulty with vision on concentrating and being able to read
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Reading disorder, Visual impairment
Clinical narrative: Severe Headache traveling done neck and into lower back.  Pain severe enough unable to rest/sleep, difficulty with vision on concentrating and being able to read
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Chest X-ray normal, Cough, Malaise
Clinical narrative: Narrative:  COVID infection following COVID vaccine series 08/18 Janssen, dose #1 12/30 COVID swab, result: detected 12/29 pt cc:Fever, malaise, body aches (worst in lower back) and a dry cough exposure: unknown 12/30 pt admit ED cc: Fever, malaise, body aches (worst in lower back) and dry cough dx: COVID LOS: 1 day 12/30 CXR impression: Clear lungs and normal cardiac silhouette.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Narrative:  COVID infection following COVID vaccine series 08/18 Janssen, dose #1 12/30 COVID swab, result: detected 12/29 pt cc:Fever, malaise, body aches (worst in lower back) and a dry cough exposure: unknown 12/30 pt admit ED cc: Fever, malaise, body aches (worst in lower back) and dry cough dx: COVID LOS: 1 day 12/30 CXR impression: Clear lungs and normal cardiac silhouette.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray normal, Chest discomfort, Fibrin D dimer increased, Malaise
Clinical narrative: Narrative: COVID infection following COVID vaccine series 01/26, Pfizer, dose #1 02/12, Pfizer, dose #2 12/29 COVID swab, result: detected 12/29 pt cc: productive cough, yellow phlegm, chest tightness and malaise exposure: unknown 12/26 pt admit to ED cc: productive cough, yellow phlegm, chest tightness and malaise dx: cute Viral Syndrome, COVID-19 12/29 CXR impression: No acute cardiopulmonary process. 12/29 PROCALCITONIN: <0.05 12/29 ESR: 56 12/29 DDIMER: 0.46
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Procalcitonin, Productive cough, Red blood cell sedimentation rate increased, SARS-CoV-2 test positive, Sputum discoloured
Clinical narrative: Narrative: COVID infection following COVID vaccine series 01/26, Pfizer, dose #1 02/12, Pfizer, dose #2 12/29 COVID swab, result: detected 12/29 pt cc: productive cough, yellow phlegm, chest tightness and malaise exposure: unknown 12/26 pt admit to ED cc: productive cough, yellow phlegm, chest tightness and malaise dx: cute Viral Syndrome, COVID-19 12/29 CXR impression: No acute cardiopulmonary process. 12/29 PROCALCITONIN: <0.05 12/29 ESR: 56 12/29 DDIMER: 0.46
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative: Patient was tested positive for COVID-19 on 1/27/2022 while being an inpatient despite full vaccination. Pt did receive 2 doses of Pfizer and the booster on 11/30/2021
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, COVID-19, Chest X-ray, Chest pain, Cough
Clinical narrative: Narrative: COVID infection following COVID vaccine series 04/02, Pfizer, dose #1 04/23, Pfizer, dose #2 01/10 COVID swab, result: detected 01/01 cxr impression: No evidence of acute cardiopulmonary abnormality. 01/01 cta pe impression: 1. No acute pulmonary emboli. 2. Findings of mild pulmonary edema. Superimposed infectious/ inflammatory process possible. 01/01 pt admit ED cc: sob, chest pain 12/21 pt cc: cough, sob, chest pain exposure: unknown 01/06 clinically resolved
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary oedema, SARS-CoV-2 test positive
Clinical narrative: Narrative: COVID infection following COVID vaccine series 04/02, Pfizer, dose #1 04/23, Pfizer, dose #2 01/10 COVID swab, result: detected 01/01 cxr impression: No evidence of acute cardiopulmonary abnormality. 01/01 cta pe impression: 1. No acute pulmonary emboli. 2. Findings of mild pulmonary edema. Superimposed infectious/ inflammatory process possible. 01/01 pt admit ED cc: sob, chest pain 12/21 pt cc: cough, sob, chest pain exposure: unknown 01/06 clinically resolved
Age: 68.0
Sex: M
Vaccine: PNC20
Symptoms: Urticaria
Clinical narrative: Hives - abdomen, arms and legs