chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 30 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: 211A21A expiry: 14-DEC-2021) 2.5 ml, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced received 2.5ml of the janssen covid-19 vaccine. On 14-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219731, 20211219686, 20211220537, 20211220233, 20211219807, 20211220948, 20211221158 and 20211221439.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ONLY THE NORMAL THINGS; This spontaneous report received from a parent concerned a male of unspecified age. 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, (Dose series number : 1) start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced only the normal things. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of only the normal things was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a health care professional concerned a 55 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: 211A21A, expiry: 14-DEC-2021) 2.5 ml, administered on 13-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-NOV-2021, the patient experienced received 2.5ml of the janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received 2.5ml of the janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220948, 20211221158, 20211221439, 20211221529, 20211219731, 20211219686, 20211220537, 20211220233 and 20211219807.
Sex: U
Vaccine: COVID19
Symptoms: Intracardiac thrombus, Pulmonary thrombosis
Clinical narrative: BLOOD CLOTS IN THE LUNGS; BLOOD CLOTS IN THE HEART; This spontaneous report received from a consumer via social media concerned multiple patients of unspecified age, sex, race and ethnicity. 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, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The dose number in series was 1. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced "blood clots in the lungs, and blood clots in the heart". On an unspecified date, the patient died from "blood clots in the lungs, and blood clots in the heart". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots in the lungs, and blood clots in the heart was fatal. This report was serious (Death).; Sender's Comments: V0:  20211222177-covid-19 vaccine ad26.cov2.s-blood clots in the lungs, and blood clots in the heart. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLOOD CLOTS IN THE LUNGS; BLOOD CLOTS IN THE HEART
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: TEMPERATURE EXCURSION FOR AN HOUR AND ADMINISTERED VIALS TO 5 PATIENTS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients. 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: 1822811, and expiry: 20-MAR-2022) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced temperature excursion for an hour and administered vials to 5 subjects, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion for an hour and administered vials to 5 patients and incorrect product storage was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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: Unknown) 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. No concomitant medications were reported.  On an unspecified date, the patient experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION ERROR/INCORRECTLY STORED VACCINE ADMINISTERED; VACCINE STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 35 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: 213D21A, and expiry: 11-APR-2022) dose was not reported, administered on 08-DEC-2021 15:27 for prophylactic vaccination. No concomitant medications were reported.  On 08-DEC-2021, the patient experienced administration error/incorrectly stored vaccine administered. On 08-DEC-2021, the patient experienced vaccine stored outside of the recommended storage conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error/incorrectly stored vaccine administered and vaccine stored outside of the recommended storage conditions was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: A LITTLE BIT OF FATIGUE/TIRED; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the patient experienced a little bit of fatigue/tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a little bit of fatigue/tired on 13-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cold sweat, Nausea, Pain, Pain in extremity
Clinical narrative: COLD SWEATS; SEVERE BODY ACHES; SORE ARM (LIKE PUNCH IN THE ARM); FEELING NAUSEA; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. 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: 1855835, and expiry: 27-APR-2022) dose was not reported, administered on 08-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-DEC-2021, the patient experienced cold sweats. On 08-DEC-2021, the patient experienced severe body aches. On 08-DEC-2021, the patient experienced sore arm (like punch in the arm). On 08-DEC-2021, the patient experienced feeling nausea. On 08-DEC-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) More than 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling nausea, cold sweats, sore arm (like punch in the arm), fever and severe body aches was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: COLD SWEATS; SEVERE BODY ACHES; SORE ARM (LIKE PUNCH IN THE ARM); FEELING NAUSEA; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. 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: 1855835, and expiry: 27-APR-2022) dose was not reported, administered on 08-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-DEC-2021, the patient experienced cold sweats. On 08-DEC-2021, the patient experienced severe body aches. On 08-DEC-2021, the patient experienced sore arm (like punch in the arm). On 08-DEC-2021, the patient experienced feeling nausea. On 08-DEC-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) More than 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling nausea, cold sweats, sore arm (like punch in the arm), fever and severe body aches was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: SIGNIFICANT ABDOMINAL PAIN FOR 3-4 DAYS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: polyethylene glycol allergy, and severe asthma attacks. 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. No concomitant medications were reported. On MAR-2021, the patient experienced significant abdominal pain for 3-4 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from significant abdominal pain for 3-4 days on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: General physical health deterioration, Hypokinesia, Laboratory test, Migraine, Pain
Clinical narrative: SEVERE CHRONIC PAIN; CAN BARELY MOVE; HEALTH SEVERELY DECLINED; SEVERE MIGRAINES; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: fibromyalgia. 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 MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the patient experienced health severely declined. On MAY-2021, the patient experienced severe migraines. On an unspecified date, the patient experienced severe chronic pain, and can barely move. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) Healthy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the health severely declined, severe migraines, severe chronic pain and can barely move was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of booster shot from vial punctured past 12 hours; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of booster shot from vial punctured past 12 hours) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia, Prediabetes and Schizoaffective disorder. Concomitant products included INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) for an unknown indication.    On 23-Nov-2021 at 10:35 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of booster shot from vial punctured past 12 hours). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of booster shot from vial punctured past 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.  HCP stated the vial was received and put in freezer on 5 Nov 2021 then was pulled out of freezer to thaw the day of being punctured at 11:30 AM on 22 Nov 2021. Total amount of time the vial was exposed to room temperature range is from 11:30AM 22 Nov 2021 then overnight and was administered 23 Nov 2021.  Patient had no side effects since the day of vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow-up received which contains primary source, patient demographics On 09-Dec-2021: Follow-up received on 09-DEC-2021 Updated Patient information, and Medical History and concomitant medication.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after second shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after second shot) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart disease, unspecified. Concomitant products included INSULIN GLARGINE (LANTUS), METFORMIN, LISINOPRIL, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, EMPAGLIFLOZIN (JARDIANCE), CARVEDILOL and MORPHINE SULFATE (MORPHINE SULPHATE) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm after second shot). At the time of the report, PAIN IN EXTREMITY (sore arm after second shot) outcome was unknown.            No treatment medications reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered Moderna COVID-19 first dose in an individual 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inadvertently administered Moderna COVID-19 first dose in an individual 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inadvertently administered Moderna COVID-19 first dose in an individual 17 year old). On 18-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inadvertently administered Moderna COVID-19 first dose in an individual 17 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No Treatment medication was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2021: Follow up information received added 2nd reporter, added dose number and updated event term.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced COVID-19 (tested positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (tested positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant product included Vitamins. Patient got monoclonal antibody treatment.  Patient got second dose from batch number either 048A21A or 098A21A. Patient was scheduled to get the booster on 22 Nov 2021 but did not get it and advised to wait for 4 months by HCP. This is a spontaneous case concerning a 71-year-old female patient with no medical history reported, who experienced the unexpected event of COVID-19 and drug ineffective. The event occurred approximately 254 days after the second dose of the mRNA- 1273 vaccine. Patient received monoclonal antibody as treatment. The reporter's assessment was not provided. The rechallenge is not applicable since there's no information about the first dose. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 71-year-old female patient with no medical history reported, who experienced the unexpected event of COVID-19 and drug ineffective. The event occurred approximately 254 days after the second dose of the mRNA- 1273 vaccine. Patient received monoclonal antibody as treatment. The reporter's assessment was not provided. The rechallenge is not applicable since there's no information about the first dose. The benefit-risk relationship of the vaccine is not affected by this report.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: delayed hives, 10 days later/hives all over the body/come and go in different parts of body; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (delayed hives, 10 days later/hives all over the body/come and go in different parts of body) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H2117) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced URTICARIA (delayed hives, 10 days later/hives all over the body/come and go in different parts of body). At the time of the report, URTICARIA (delayed hives, 10 days later/hives all over the body/come and go in different parts of body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient tried anti-histamines for 1 day as treatment medication and it worked. Patient was not under any concomitant medications.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: After 2nd unknown vaccine got + PCR test; This spontaneous case was reported by a nurse and describes the occurrence of SARS-COV-2 TEST POSITIVE (After 2nd unknown vaccine got + PCR test) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced SARS-COV-2 TEST POSITIVE (After 2nd unknown vaccine got + PCR test). At the time of the report, SARS-COV-2 TEST POSITIVE (After 2nd unknown vaccine got + PCR test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   Company Comment : This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected adverse event of special interest of SARS-CoV-2 test positive. It is unknown the timeframe between the event and the second dose of mRNA-1273 vaccine. The rechallenge was unknown since there's no information about the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected adverse event of special interest of SARS-CoV-2 test positive. It is unknown the timeframe between the event and the second dose of mRNA-1273 vaccine. The rechallenge was unknown since there's no information about the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: same thing in their back/back started itching; their back broke up all over; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (same thing in their back/back started itching) and RASH (their back broke up all over) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (same thing in their back/back started itching) and RASH (their back broke up all over). At the time of the report, PRURITUS (same thing in their back/back started itching) and RASH (their back broke up all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.  The patient had the same thing in their back and took Moderna   This case was linked to MOD-2021-406198, MOD-2021-406143 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 21st puncture dose administered as booster; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (21st puncture dose administered as booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (21st puncture dose administered as booster). On 06-Dec-2021, PRODUCT ADMINISTRATION ERROR (21st puncture dose administered as booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: total body hives/hives progressed down her trunk/hives a little on the top of her thighs/hives on feet/hives primarily on her trunk front and back; her neck started swelling with hives; her trunk will sometime go red like it is sunburned/arms turned red; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (total body hives/hives progressed down her trunk/hives a little on the top of her thighs/hives on feet/hives primarily on her trunk front and back), SWELLING (her neck started swelling with hives) and ERYTHEMA (her trunk will sometime go red like it is sunburned/arms turned red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051e21a, 048b21a and 038c21a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Insulin resistance. Concomitant products included LOSARTAN for Blood pressure high, METFORMIN HYDROCHLORIDE (GLUCOPHAGE) for Insulin resistance.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ERYTHEMA (her trunk will sometime go red like it is sunburned/arms turned red). On 03-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (total body hives/hives progressed down her trunk/hives a little on the top of her thighs/hives on feet/hives primarily on her trunk front and back) and SWELLING (her neck started swelling with hives). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (total body hives/hives progressed down her trunk/hives a little on the top of her thighs/hives on feet/hives primarily on her trunk front and back), SWELLING (her neck started swelling with hives) and ERYTHEMA (her trunk will sometime go red like it is sunburned/arms turned red) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's events come and go since 03-Dec-2021. When patient woke up on 07-Dec-2021 not itching and thought patient was ok but once  was up and walking patient's arms turned red, had hives on trunk. On 06-Dec-2021 patient visited doctor. Concomitant medication include birth control medication.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Influenza like illness
Clinical narrative: feeling like she has the flu; pain in shoulder; Middle of night felt tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feeling like she has the flu), ARTHRALGIA (pain in shoulder) and FATIGUE (Middle of night felt tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 030A21 and 013M207) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-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 INFLUENZA LIKE ILLNESS (feeling like she has the flu), ARTHRALGIA (pain in shoulder) and FATIGUE (Middle of night felt tired). At the time of the report, INFLUENZA LIKE ILLNESS (feeling like she has the flu), ARTHRALGIA (pain in shoulder) and FATIGUE (Middle of night felt tired) outcome was unknown.        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   This case was linked to MOD-2021-406405 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she was pretty sick with the other two; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she was pretty sick with the other two) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Shortness of breath (shortness of breath due to anxiety and deppresion). Concurrent medical conditions included Thyroid disorder NOS, Cholesterol, Fibromyalgia, Recurrent UTI, Irritable bowel syndrome (stomach ibs) and Arthritis. Concomitant products included CELECOXIB (CELEBREX) for Arthritis, VITAMINS NOS for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (she was pretty sick with the other two). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, ILLNESS (she was pretty sick with the other two) outcome was unknown.        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.   This case was linked to MOD-2021-406411, MOD-2021-035455 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Bed rest, Fatigue
Clinical narrative: Patient laid in bed all day after second dose; more fatigue after his second dose; This spontaneous case was reported by a consumer and describes the occurrence of BED REST (Patient laid in bed all day after second dose) and FATIGUE (more fatigue after his second dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004D21A and 009D21A) for COVID-19 vaccination.  No Medical History information was reported.  On 24-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 24-Jul-2021, the patient experienced BED REST (Patient laid in bed all day after second dose) and FATIGUE (more fatigue after his second dose). On 25-Jul-2021, BED REST (Patient laid in bed all day after second dose) and FATIGUE (more fatigue after his second dose) had resolved.     No concomitant medications were reported. Treatment information was not provided.  This case was linked to MOD-2021-406415 (Patient Link).
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects were more intense after the booster dose when compared to after receiving the 1st or 2nd doses of vaccine.; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (side effects were more intense after the booster dose when compared to after receiving the 1st or 2nd doses of vaccine.) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 VACCINATION COMPLICATION (side effects were more intense after the booster dose when compared to after receiving the 1st or 2nd doses of vaccine.). At the time of the report, VACCINATION COMPLICATION (side effects were more intense after the booster dose when compared to after receiving the 1st or 2nd doses of vaccine.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   This case was linked to MOD-2021-406419, MOD-2021-406421 (Patient Link).
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. Not Provided          No treatment and concomitant medications were provided.   This case was linked to MOD-2021-406420, MOD-2021-406419 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Eye disorder, Fatigue, Headache
Clinical narrative: Felt my face swollen; Felt my tongue swollen; Eyes tearing up; Feeling not well; Shaking; Eyes sensitivity; I couldn't sleep at Night; Fatigue; Headache,Slight headache; Couldn't breathe; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Couldn't breathe), SWELLING FACE (Felt my face swollen), SWOLLEN TONGUE (Felt my tongue swollen), LACRIMATION INCREASED (Eyes tearing up) and MALAISE (Feeling not well) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Milk allergy, Food allergy, Latex allergy and Fibromyalgia since 2009. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) from 2017 to an unknown date for Thyroid disorder NOS.    On 01-Mar-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DYSPNOEA (Couldn't breathe). On 01-Mar-2021 at 10:15 AM, the patient experienced HEADACHE (Headache,Slight headache). On an unknown date, the patient experienced SWELLING FACE (Felt my face swollen), SWOLLEN TONGUE (Felt my tongue swollen), LACRIMATION INCREASED (Eyes tearing up), MALAISE (Feeling not well), TREMOR (Shaking), EYE DISORDER (Eyes sensitivity), INSOMNIA (I couldn't sleep at Night), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Couldn't breathe), SWELLING FACE (Felt my face swollen), SWOLLEN TONGUE (Felt my tongue swollen), LACRIMATION INCREASED (Eyes tearing up), MALAISE (Feeling not well), TREMOR (Shaking), EYE DISORDER (Eyes sensitivity), INSOMNIA (I couldn't sleep at Night), HEADACHE (Headache,Slight headache), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient mentioned  there was good and bad days.   This case was linked to MOD-2021-404475, MOD-2021-406425 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Lacrimation increased, Malaise, Swelling face, Swollen tongue
Clinical narrative: Felt my face swollen; Felt my tongue swollen; Eyes tearing up; Feeling not well; Shaking; Eyes sensitivity; I couldn't sleep at Night; Fatigue; Headache,Slight headache; Couldn't breathe; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Couldn't breathe), SWELLING FACE (Felt my face swollen), SWOLLEN TONGUE (Felt my tongue swollen), LACRIMATION INCREASED (Eyes tearing up) and MALAISE (Feeling not well) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Milk allergy, Food allergy, Latex allergy and Fibromyalgia since 2009. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) from 2017 to an unknown date for Thyroid disorder NOS.    On 01-Mar-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DYSPNOEA (Couldn't breathe). On 01-Mar-2021 at 10:15 AM, the patient experienced HEADACHE (Headache,Slight headache). On an unknown date, the patient experienced SWELLING FACE (Felt my face swollen), SWOLLEN TONGUE (Felt my tongue swollen), LACRIMATION INCREASED (Eyes tearing up), MALAISE (Feeling not well), TREMOR (Shaking), EYE DISORDER (Eyes sensitivity), INSOMNIA (I couldn't sleep at Night), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Couldn't breathe), SWELLING FACE (Felt my face swollen), SWOLLEN TONGUE (Felt my tongue swollen), LACRIMATION INCREASED (Eyes tearing up), MALAISE (Feeling not well), TREMOR (Shaking), EYE DISORDER (Eyes sensitivity), INSOMNIA (I couldn't sleep at Night), HEADACHE (Headache,Slight headache), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient mentioned  there was good and bad days.   This case was linked to MOD-2021-404475, MOD-2021-406425 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Felt my face swollen; Felt my tongue swollen; Eyes tearing up; Feeling not well; Shaking; Eyes sensitivity; I couldn't sleep at Night; Fatigue; Headache,Slight headache; Couldn't breathe; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Couldn't breathe), SWELLING FACE (Felt my face swollen), SWOLLEN TONGUE (Felt my tongue swollen), LACRIMATION INCREASED (Eyes tearing up) and MALAISE (Feeling not well) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Milk allergy, Food allergy, Latex allergy and Fibromyalgia since 2009. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) from 2017 to an unknown date for Thyroid disorder NOS.    On 01-Mar-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DYSPNOEA (Couldn't breathe). On 01-Mar-2021 at 10:15 AM, the patient experienced HEADACHE (Headache,Slight headache). On an unknown date, the patient experienced SWELLING FACE (Felt my face swollen), SWOLLEN TONGUE (Felt my tongue swollen), LACRIMATION INCREASED (Eyes tearing up), MALAISE (Feeling not well), TREMOR (Shaking), EYE DISORDER (Eyes sensitivity), INSOMNIA (I couldn't sleep at Night), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Couldn't breathe), SWELLING FACE (Felt my face swollen), SWOLLEN TONGUE (Felt my tongue swollen), LACRIMATION INCREASED (Eyes tearing up), MALAISE (Feeling not well), TREMOR (Shaking), EYE DISORDER (Eyes sensitivity), INSOMNIA (I couldn't sleep at Night), HEADACHE (Headache,Slight headache), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient mentioned  there was good and bad days.   This case was linked to MOD-2021-404475, MOD-2021-406425 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Therapeutic response unexpected
Clinical narrative: Dizziness; slight boost of energy, started to feel better; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and THERAPEUTIC RESPONSE UNEXPECTED (slight boost of energy, started to feel better) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B12A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia since 2009, Thyroid disorder NOS, Penicillin allergy, Milk allergy, Food allergy and Latex allergy. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for Thyroid disorder NOS.   On 01-Mar-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021 at 10:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (slight boost of energy, started to feel better). On 29-Mar-2021 at 11:00 AM, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) and THERAPEUTIC RESPONSE UNEXPECTED (slight boost of energy, started to feel better) had resolved.             No treatment medications were reported.   This case was linked to MOD-2021-404475, MOD-2021-406423 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Fatigue, Gait disturbance, Hepatic enzyme increased
Clinical narrative: hard time getting out of the bed; hard time to sleep; hard time walking; hard time getting out of the bed; intense body aches; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (hard time getting out of the bed), INSOMNIA (hard time to sleep), GAIT DISTURBANCE (hard time walking), DISCOMFORT (hard time getting out of the bed) and MYALGIA (intense body aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H216, 026A21A and 026M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromatosis, Arthritis, Blood pressure high and Sacroiliitis.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-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 FATIGUE (hard time getting out of the bed), INSOMNIA (hard time to sleep), GAIT DISTURBANCE (hard time walking), DISCOMFORT (hard time getting out of the bed), MYALGIA (intense body aches) and ARTHRALGIA (joint pain). At the time of the report, FATIGUE (hard time getting out of the bed), INSOMNIA (hard time to sleep), GAIT DISTURBANCE (hard time walking), DISCOMFORT (hard time getting out of the bed), MYALGIA (intense body aches) and ARTHRALGIA (joint pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme increased: elevated (High) Elevated.         Concomitant medication was not reported.  Patient did not have any reaction from the 1 and 2 shots.  Treatment information was not reported.   This case was linked to MOD-2021-406482 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia
Clinical narrative: hard time getting out of the bed; hard time to sleep; hard time walking; hard time getting out of the bed; intense body aches; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (hard time getting out of the bed), INSOMNIA (hard time to sleep), GAIT DISTURBANCE (hard time walking), DISCOMFORT (hard time getting out of the bed) and MYALGIA (intense body aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H216, 026A21A and 026M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromatosis, Arthritis, Blood pressure high and Sacroiliitis.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-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 FATIGUE (hard time getting out of the bed), INSOMNIA (hard time to sleep), GAIT DISTURBANCE (hard time walking), DISCOMFORT (hard time getting out of the bed), MYALGIA (intense body aches) and ARTHRALGIA (joint pain). At the time of the report, FATIGUE (hard time getting out of the bed), INSOMNIA (hard time to sleep), GAIT DISTURBANCE (hard time walking), DISCOMFORT (hard time getting out of the bed), MYALGIA (intense body aches) and ARTHRALGIA (joint pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme increased: elevated (High) Elevated.         Concomitant medication was not reported.  Patient did not have any reaction from the 1 and 2 shots.  Treatment information was not reported.   This case was linked to MOD-2021-406482 (Patient Link).