chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. No concomitant medication was provided. The vaccine was administered after 19 days from  time from first puncture.   This case was linked to MOD-2021-332638 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received with no new information, but action reassessed and updated to not applicable because only event in case is medication error.
Age: 1.08
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event
Clinical narrative: No additional adverse events reported.; MA states a dose of MMRlI was given on 09/07/2021 and a dose of V ARlVAX was administered too early today, 09/30/2021, less than the recommendation of a months time.; This spontaneous report was received from a certified medical assistant referring to a 13-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 07-SEP-2021, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection, 0.5 milliliters (ml) "once" (lot number S035356 which has been verified to be valid, expiration date 05-NOV-2021). On 30-SEP-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 ml "once" (lot number T022313 which has been verified to be valid, expiration date 30-JUN-2022) (routes of administration and anatomical sites of injection were not reported for any of them); both for prophylaxis (inappropriate schedule of product administration). No additional adverse events were reported.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Cough, Injection site swelling, Nasal congestion, Pyrexia
Clinical narrative: Stuffy nose; Dry cough; Slight fever; small bump on the injection site; This case was reported by a physician via call center representative and described the occurrence of fever in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number T4Y35, expiry date 28th November 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th September 2021, the patient received the 2nd dose of Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 25th September 2021, 8 hrs after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced fever and injection site swelling. On 28th September 2021, the patient experienced nasal stuffiness and dry cough. On 26th September 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site swelling was recovered/resolved and the outcome of the nasal stuffiness and dry cough were not recovered/not resolved.   It was unknown if the reporter considered the fever, nasal stuffiness and dry cough to be related to Pediarix and Pediarix Pre-Filled Syringe Device. The reporter considered the injection site swelling to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by the physician. The physician reported that the patient received his Pediarix vaccine. The physician reported that the patient experienced a slight fever of 99.5 degree F approximately 8 hours after receiving the injection. The physician also reported that there was a small bump on the right thigh at the injection site. The physician reported that the mother of the patient texted him that the patient, as of this morning  had a stuffy nose and a dry cough, but otherwise doing well. The reporter consented to follow- up. This case is linked to the case US2021203776, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021203776:same reporter
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes simplex, Rash
Clinical narrative: breakout Herpes Simplex; Rash; This case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LC3P, expiry date 15th November 2022) for prophylaxis.   The patient's past medical history included herpes simplex.   On 16th July 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In July 2021, 7 days after receiving Shingrix, the patient experienced herpes simplex and rash. On an unknown date, the outcome of the herpes simplex and rash were recovered/resolved.   It was unknown if the reporter considered the herpes simplex and rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The patient reported that she received Shingrix vaccine and 7 days later developed rash that she descried as a breakout herpes simplex rash on her right side. No additional information was provided. The patient consented to follow-up. For tolerance of second dose refer linked case US2021AMR206123, reported for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR206123:same patient
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: Suspected Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 67 year old  male. The patient's height, and weight were not reported. The patient's concurrent conditions included: cardiac problems. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced suspected immunological vaccination failure. On an unspecified date, Laboratory data included: Antibody test (NR: not provided) with result negative. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from suspected immunological vaccine failure.  This report was serious (Other Medically Important Condition). The report is associated with Product quality complaint.; Sender's Comments: V0: 20211006505-COVID-19 VACCINE -suspected immunological vaccine failure. This event(s) is considered not related. 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
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: RECEIVED MODERNA AS A SECOND DOSE; This spontaneous report received from a health care professional concerned a 56 year old male. 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 not reported, batch number: 041A21A,expiry: 21-JUN-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination.  On 14-SEP-2021, the patient experienced received moderna as a second dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received moderna as a second dose was not reported. This report was non-serious. This case, from the same reporter is linked to 20211006342.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 24-AUG-2021) dose was not reported, 1 total administered on 16-MAR-2021 to left arm around 1300 hours in the afternoon for prophylactic vaccination. No concomitant medications were reported. On 03-OCT-2021, patient had a confirmed positive breakthrough covid infection by  rapid test. The test was done at an urgent care at 0900 hours and he received the test results in the morning. They confirmed that he was positive for covid (suspected covid-19 infection) and hence also experienced a suspected clinical vaccination failure. The action taken with covid-19 vaccine was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  20211006768-Covid-19 vaccine - suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-thyroid antibody, Differential white blood cell count, Full blood count, Hypoaesthesia, Insomnia
Clinical narrative: NO SLEEP; TINGLING IN HANDS, FACE AND LEGS; NUMBNESS; CHRONIC URTICARIA  ALL OVER BODY; THROAT FELT LIKE COLD COMING SORE-CLOSING UP; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no history of asthma, eczema or food allergies. Patient never had hives or angioedema before receiving vaccine. The patient experienced palpitation when treated with levofloxacin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021, the patient experienced chronic urticaria all over body. On 07-AUG-2021, the patient experienced throat felt like cold coming sore-closing up. On 07-AUG-2021, the patient experienced tingling in hands, face and legs. On 07-AUG-2021, the patient experienced numbness. On 28-SEP-2021, Laboratory data included: Complete blood count (NR: not provided) not reported, Differential WBC count (NR: not provided) not reported, Erythrocyte sedimentation rate (NR: not provided) not reported, Liver function test (NR: not provided) not reported, Platelet count (NR: not provided) not reported, Thyroglobulin antibody (NR: not provided) not reported, Thyroid peroxidase antibody (NR: not provided) not reported, and Tryptase (NR: not provided) not reported. On an unspecified date, the patient experienced no sleep. Treatment medications (dates unspecified) included: cetirizine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chronic urticaria all over body, numbness, and tingling in hands, face and legs, and the outcome of throat felt like cold coming sore-closing up and no sleep was not reported. This report was non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Liver function test, Oropharyngeal pain, Paraesthesia, Platelet count, Red blood cell sedimentation rate
Clinical narrative: NO SLEEP; TINGLING IN HANDS, FACE AND LEGS; NUMBNESS; CHRONIC URTICARIA  ALL OVER BODY; THROAT FELT LIKE COLD COMING SORE-CLOSING UP; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no history of asthma, eczema or food allergies. Patient never had hives or angioedema before receiving vaccine. The patient experienced palpitation when treated with levofloxacin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021, the patient experienced chronic urticaria all over body. On 07-AUG-2021, the patient experienced throat felt like cold coming sore-closing up. On 07-AUG-2021, the patient experienced tingling in hands, face and legs. On 07-AUG-2021, the patient experienced numbness. On 28-SEP-2021, Laboratory data included: Complete blood count (NR: not provided) not reported, Differential WBC count (NR: not provided) not reported, Erythrocyte sedimentation rate (NR: not provided) not reported, Liver function test (NR: not provided) not reported, Platelet count (NR: not provided) not reported, Thyroglobulin antibody (NR: not provided) not reported, Thyroid peroxidase antibody (NR: not provided) not reported, and Tryptase (NR: not provided) not reported. On an unspecified date, the patient experienced no sleep. Treatment medications (dates unspecified) included: cetirizine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chronic urticaria all over body, numbness, and tingling in hands, face and legs, and the outcome of throat felt like cold coming sore-closing up and no sleep was not reported. This report was non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Tryptase, Urticaria chronic
Clinical narrative: NO SLEEP; TINGLING IN HANDS, FACE AND LEGS; NUMBNESS; CHRONIC URTICARIA  ALL OVER BODY; THROAT FELT LIKE COLD COMING SORE-CLOSING UP; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no history of asthma, eczema or food allergies. Patient never had hives or angioedema before receiving vaccine. The patient experienced palpitation when treated with levofloxacin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021, the patient experienced chronic urticaria all over body. On 07-AUG-2021, the patient experienced throat felt like cold coming sore-closing up. On 07-AUG-2021, the patient experienced tingling in hands, face and legs. On 07-AUG-2021, the patient experienced numbness. On 28-SEP-2021, Laboratory data included: Complete blood count (NR: not provided) not reported, Differential WBC count (NR: not provided) not reported, Erythrocyte sedimentation rate (NR: not provided) not reported, Liver function test (NR: not provided) not reported, Platelet count (NR: not provided) not reported, Thyroglobulin antibody (NR: not provided) not reported, Thyroid peroxidase antibody (NR: not provided) not reported, and Tryptase (NR: not provided) not reported. On an unspecified date, the patient experienced no sleep. Treatment medications (dates unspecified) included: cetirizine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chronic urticaria all over body, numbness, and tingling in hands, face and legs, and the outcome of throat felt like cold coming sore-closing up and no sleep was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 67 year old female. 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 not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 03-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: MEDICATION ERROR; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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 was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162 for prophylactic vaccination. On 08-SEP-2021, the patient experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of medication error was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Extra dose administered
Clinical narrative: SECOND DOSE OF VACCINE ADMINISTERED; ADVERSE REACTIONS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 not reported, batch number: 1805022, expiry: unknown, and batch number: 205A21A expiry: unknown) dose was not reported, administered on 05-APR-2021, and dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, the patient experienced adverse reactions. On 09-SEP-2021, the patient experienced second dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the second dose of vaccine administered and adverse reactions was not reported. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Vomiting
Clinical narrative: BODY ACHES; CHILLS; VOMITING; FEVER; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-OCT-2021 10:30 for prophylactic vaccination. No concomitant medications were reported.  On 05-OCT-2021, the patient experienced body aches. On 05-OCT-2021, the patient experienced chills. On 05-OCT-2021, the patient experienced vomiting. On 05-OCT-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine was not applicable. The outcome of the chills, vomiting, fever and body aches was not reported. This report was non-serious.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered BUD (on day 32); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)). On 16-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant product were reported. No treatment information was provided.   This case was linked to MOD21-127424, MOD21-128279 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: Follow up was received on 04-OCT-2021. Contains Dose 1 administration date.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Malaise, Myalgia
Clinical narrative: was really sick; doesn't feel good; body aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (was really sick), MALAISE (doesn't feel good) and MYALGIA (body aches) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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 an unknown date, the patient experienced ILLNESS (was really sick), MALAISE (doesn't feel good) and MYALGIA (body aches). At the time of the report, ILLNESS (was really sick), MALAISE (doesn't feel good) and MYALGIA (body aches) outcome was unknown.            patient has MS so he got the third shot earlier.  Concomitant medications were not provided. Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anaemia, Decreased appetite, Gait inability, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis or poli rheumatoid poli maquia; Was diagnosed whit anemia; Amost could not walk; Loss appetite; Upset stomach; Lost weight; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis or poli rheumatoid poli maquia) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis or poli rheumatoid poli maquia) (seriousness criterion medically significant), ANAEMIA (Was diagnosed whit anemia), GAIT INABILITY (Amost could not walk), DECREASED APPETITE (Loss appetite), ABDOMINAL DISCOMFORT (Upset stomach) and WEIGHT DECREASED (Lost weight). The patient was treated with IRON for Anaemia, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis or poli rheumatoid poli maquia), ANAEMIA (Was diagnosed whit anemia), GAIT INABILITY (Amost could not walk), DECREASED APPETITE (Loss appetite), ABDOMINAL DISCOMFORT (Upset stomach) and WEIGHT DECREASED (Lost weight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Weight: decreased (Low) Decreased. In 2021, White blood cell count: increased (High) Risen in recent studies.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment -This case concerns a 75-year-old, female patient with no relevant medical history, who experienced the serious unexpected event of Rheumatoid arthritis, unexpected non-serious events anaemia, gait instability, decreased appetite, abdominal discomfort and weight decreased. The events occurred on an unknown date after the second dose of Spikevax. The rechallenge was not applicable since only information about one dose was disclosed. The benefit-risk relationship of Spikevax in not affected by this report.; Sender's Comments: This case concerns a 75-year-old, female patient with no relevant medical history, who experienced the serious unexpected event of Rheumatoid arthritis, unexpected non-serious events anaemia, gait instability, decreased appetite, abdominal discomfort and weight decreased. The events occurred on an unknown date after the second dose of Spikevax. The rechallenge was not applicable since only information about one dose was disclosed. The benefit-risk relationship of Spikevax in not affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased, White blood cell count
Clinical narrative: Rheumatoid arthritis or poli rheumatoid poli maquia; Was diagnosed whit anemia; Amost could not walk; Loss appetite; Upset stomach; Lost weight; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis or poli rheumatoid poli maquia) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis or poli rheumatoid poli maquia) (seriousness criterion medically significant), ANAEMIA (Was diagnosed whit anemia), GAIT INABILITY (Amost could not walk), DECREASED APPETITE (Loss appetite), ABDOMINAL DISCOMFORT (Upset stomach) and WEIGHT DECREASED (Lost weight). The patient was treated with IRON for Anaemia, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis or poli rheumatoid poli maquia), ANAEMIA (Was diagnosed whit anemia), GAIT INABILITY (Amost could not walk), DECREASED APPETITE (Loss appetite), ABDOMINAL DISCOMFORT (Upset stomach) and WEIGHT DECREASED (Lost weight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Weight: decreased (Low) Decreased. In 2021, White blood cell count: increased (High) Risen in recent studies.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment -This case concerns a 75-year-old, female patient with no relevant medical history, who experienced the serious unexpected event of Rheumatoid arthritis, unexpected non-serious events anaemia, gait instability, decreased appetite, abdominal discomfort and weight decreased. The events occurred on an unknown date after the second dose of Spikevax. The rechallenge was not applicable since only information about one dose was disclosed. The benefit-risk relationship of Spikevax in not affected by this report.; Sender's Comments: This case concerns a 75-year-old, female patient with no relevant medical history, who experienced the serious unexpected event of Rheumatoid arthritis, unexpected non-serious events anaemia, gait instability, decreased appetite, abdominal discomfort and weight decreased. The events occurred on an unknown date after the second dose of Spikevax. The rechallenge was not applicable since only information about one dose was disclosed. The benefit-risk relationship of Spikevax in not affected by this report.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered 6 days after 1st punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 6 days after 1st punctured) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 6 days after 1st punctured). On 31-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 6 days after 1st punctured) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.    This case was linked to MOD-2021-333903 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received: included no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 23-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      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.  The vaccine was administered after 2 days of first puncture.  The Moderna vaccine was used as though it had preservative, just like flu multi-dose vials.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: As it had preservative just like flu multi-dose vials; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (As it had preservative just like flu multi-dose vials) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (As it had preservative just like flu multi-dose vials). On 23-Jul-2021, EXPIRED PRODUCT ADMINISTERED (As it had preservative just like flu multi-dose vials) had resolved.        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.  The vaccine was administered after 2 days of first puncture.   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow-up was received and included no new information.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine administered 5 DAYS after 1st punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered 5 DAYS after 1st punctured) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered 5 DAYS after 1st punctured). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered 5 DAYS after 1st punctured) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Source document contains no new information.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported  The vaccine was administered after 6 days from  time from first puncture.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up contains no new information.
Age: 87.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 87-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment medication reported.    This case was linked to MOD-2021-332638 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up contains non-significant information.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Arm tingling; Arm numb/hand numb; Arm throbbing; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Arm tingling), HYPOAESTHESIA (Arm numb/hand numb) and PAIN (Arm throbbing) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037T21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-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 PARAESTHESIA (Arm tingling), HYPOAESTHESIA (Arm numb/hand numb) and PAIN (Arm throbbing). At the time of the report, PARAESTHESIA (Arm tingling), HYPOAESTHESIA (Arm numb/hand numb) and PAIN (Arm throbbing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. No treatment information was provided.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        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. The vaccine was administered after 2 days from  time from first puncture.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up information included no new information.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after 2 days of puncturing the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 2 days of puncturing the vial) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 2 days of puncturing the vial). On 15-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 2 days of puncturing the vial) had resolved.        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.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up contains updated event verbatim.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: itchy rashes; rashes; hives; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (hives), RASH PRURITIC (itchy rashes) and RASH (rashes) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced URTICARIA (hives) and RASH (rashes). On 19-Sep-2021, the patient experienced RASH PRURITIC (itchy rashes). In September 2021, URTICARIA (hives), RASH PRURITIC (itchy rashes) and RASH (rashes) had resolved.        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 medications were reported. No treatment medications were reported.  On 19-Sep-2021, the patient had itchy rash all over the body.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Swelling
Clinical narrative: Swelling and bumps; Double stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Double stroke) in a 79-year-old male patient 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 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Double stroke) (seriousness criteria death and medically significant). On an unknown date, the patient experienced SWELLING (Swelling and bumps). The patient died on 20-Jul-2021. The reported cause of death was double stroke. It is unknown if an autopsy was performed. At the time of death, SWELLING (Swelling and bumps) outcome was unknown.            Patient passed away after getting Moderna COVID-19 Vaccine. No relevant concomitant medications were reported. No treatment information was reported.; Sender's Comments: This case concerns a 75 year old male with no relevant medical history who experienced serious unexpected fatal event of CVA approximately 2 months after the first dose of the vaccine. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.; Reported Cause(s) of Death: Double Stroke
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Scar
Clinical narrative: his feet started getting scars/arm has scars/back of his neck looks like rainworm but it's not rainworm.; This spontaneous case was reported by a consumer and describes the occurrence of SCAR (his feet started getting scars/arm has scars/back of his neck looks like rainworm but it's not rainworm.) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer in 2002. Concurrent medical conditions included Diabetes (Patient has been diabetic for 4 years).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SCAR (his feet started getting scars/arm has scars/back of his neck looks like rainworm but it's not rainworm.). The patient was treated with TRIAMCINOLONE ACETONIDE for Adverse event, at an unspecified dose and frequency and PRAMOXINE HCL for Adverse event, at an unspecified dose and frequency. At the time of the report, SCAR (his feet started getting scars/arm has scars/back of his neck looks like rainworm but it's not rainworm.) had not resolved.    No relevant concomitant medications were reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced MYALGIA (Arm sore). At the time of the report, MYALGIA (Arm sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.   Reporter did not allow further contact
Age: 89.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Incorrect product formulation administered
Clinical narrative: Expired vaccine used; Vaccine administered as if it had a preservative; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and INCORRECT PRODUCT FORMULATION ADMINISTERED (Vaccine administered as if it had a preservative) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and INCORRECT PRODUCT FORMULATION ADMINISTERED (Vaccine administered as if it had a preservative). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and INCORRECT PRODUCT FORMULATION ADMINISTERED (Vaccine administered as if it had a preservative) had resolved. Not Provided          vaccine was administered after 7 days from the punctured vial  vaccine administered as if it had a preservative  No treatment and concomitant medications was reported   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up document contains no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-332638:Cluster case same reporter
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Interchange of vaccine product; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided. No treatment information was provided.