chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: ADMINISTRATION OF TWO DOSES OF JNJ VACCINE; This spontaneous report received from a health care professional concerned a female 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: 203A21A expiry: UNKNOWN, and batch number: 1816027 expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021, and dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-JUN-2021, the subject experienced administration of two doses of JNJ vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of two doses of JNJ vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210634981.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: ADMINISTRATION OF TWO DOSES OF JNJ VACCINE; This spontaneous report received from a health care professional concerned a female 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: 1816027, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021, and dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced administration of two doses of JNJ vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of two doses of JNJ vaccine was not reported. This report was non-serious. This case, from the same reporter.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: RUNNY NOSE; 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: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced runny nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from runny nose. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: CONSTANT LOW DEEP COUGH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included it was unknown if patient had drug abuse or illicit drug use or consume alcohol or smoke. 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. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced constant low deep cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of constant low deep cough was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: NEUROLOGICAL SYMPTOMS; This spontaneous report received from a consumer 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced neurological symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of neurological symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20210637243.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a health care professional concerned a 52 year old not Hispanic or Latino white male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypotension, seasonal allergies, alcohol use, and non-smoker. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) 1 total, dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUN-2021, the patient had antibody test which showed no antibodies (confirmed immunological vaccination failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with the Product Quality Complaint number: 90000183211 The suspected product quality complaint has been confirmed to be not voided (meets PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210637818-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccination 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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Pain in extremity, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; SORE ARM; This spontaneous report received from a patient concerned a 61 year old female of an unspecified race and ethnicity. The patient's weight was 265 pounds, and height was 69 inches. The patient's concurrent conditions included seasonal allergies, non-smoker, and non-alcoholic, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient was not pregnant at time of report. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, 1 total administered on 06-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced sore arm.  On an unspecified date patient underwent through laboratory test included: Antibody test revealed negative (suspected immunological vaccine failure) was reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 08-MAR-2021, and the outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210637750. This report was associated with product quality complaint: 90000183360.; Sender's Comments: V0 ; 20210637986- COVID-19 VACCINE AD26.COV2.S-SUSPECTED IMMUNOLOGICAL VACCINE 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
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient via a company representative 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a consumer concerned a female 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 was not reported, administered on 17-JUN-2021 11:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.0. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Condition aggravated, Pyrexia
Clinical narrative: BAD SYMPTOMS; HIGH FEVER; This spontaneous report received from a patient via a company representative 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be  requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced bad symptoms, and high fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever and bad symptoms was not reported. This report was non-serious.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Chest pain, Dyspnoea, Headache, Malaise
Clinical narrative: CHEST PAIN; SHORTNESS OF BREATH; VOMITING; BEDRIDDEN; FEELING OF SICKNESS; ARM SORENESS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and other pre-existing medical conditions included the patient had no known allergies. 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 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-MAY-2021, the subject experienced vomiting. On 21-MAY-2021, the subject experienced bedridden. On 21-MAY-2021, the subject experienced feeling of sickness. On 21-MAY-2021, the subject experienced arm soreness. On 21-MAY-2021, the subject experienced nausea. On 21-MAY-2021, the subject experienced headache. On 13-JUN-2021, the subject experienced shortness of breath. On 13-JUN-2021, the subject experienced chest pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, bedridden, and feeling of sickness on 24-MAY-2021, and arm soreness, had not recovered from nausea, and headache, and the outcome of shortness of breath and chest pain was not reported. This report was non-serious.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: CHEST PAIN; SHORTNESS OF BREATH; VOMITING; BEDRIDDEN; FEELING OF SICKNESS; ARM SORENESS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and other pre-existing medical conditions included the patient had no known allergies. 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 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-MAY-2021, the subject experienced vomiting. On 21-MAY-2021, the subject experienced bedridden. On 21-MAY-2021, the subject experienced feeling of sickness. On 21-MAY-2021, the subject experienced arm soreness. On 21-MAY-2021, the subject experienced nausea. On 21-MAY-2021, the subject experienced headache. On 13-JUN-2021, the subject experienced shortness of breath. On 13-JUN-2021, the subject experienced chest pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, bedridden, and feeling of sickness on 24-MAY-2021, and arm soreness, had not recovered from nausea, and headache, and the outcome of shortness of breath and chest pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECEIVED SECOND DOSE OF COVID VACCINE ACCIDENTLY; This spontaneous report received from a health care professional 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, start therapy date were not reported, and dose, 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 subject received second dose of covid vaccine accidently. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient received second dose of covid vaccine accidently was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: ACHES; CHILLS; TIREDNESS; DULL HEADACHE; This spontaneous report received from a patient concerned a 36 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: 1821286 expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced aches. On 19-JUN-2021, the subject experienced chills. On 19-JUN-2021, the subject experienced tiredness. On 19-JUN-2021, the subject experienced dull headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness, dull headache, chills and aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210643041.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Illness, Nausea
Clinical narrative: DIZZY; WORST BOUT OF DIARRHEA; HORRIBLY ILL FOR 3 DAYS; KILLER HEADACHE; SEVERE NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included crohn's. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced dizzy, worst bout of diarrhea, horribly ill for 3 days, killer headache, and severe nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the killer headache, severe nausea, dizzy, worst bout of diarrhea and horribly ill for 3 days was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: SEVERE SCIATICA; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included sciatica. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced severe sciatica. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe sciatica. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Rash pruritic
Clinical narrative: ITCHY RED SPOTS IN BOTH HANDS; PAINFUL INJECTION SITE; 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 (route of admin not reported, batch number: Unk) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-JUN-2021, the subject experienced itchy red spots in both hands. On 20-JUN-2021, the subject experienced painful injection site. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from painful injection site, and itchy red spots in both hands. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: TIRED; LITTLE HEADACHE; This spontaneous report received from a patient via a company representative 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced tired, and little headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired and little headache was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: BODY ACHES; HEADACHE; This spontaneous report received from a patient concerned a 53 year old male. The patient's weight was 285 pounds, and height was 72 inches. The patient's concurrent conditions included penicillin allergy, abstains from alcohol, and non smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced body aches. On 19-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 20-JUN-2021, and had not recovered from headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: HEADACHE; FEVER; This spontaneous report received from a consumer 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: Unk) dose was not reported, administered on 15-JUN-2021 20:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.7 F. Treatment medications included: ibuprofen. On 17-JUN-2021, Laboratory data included: Body temperature (NR: not provided) low grade, 100.4 F. On 18-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 18-JUN-2021, and had not recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Muscle tightness, Tremor
Clinical narrative: SENSATION OF COLD AND HOT AT THE SAME TIME; SHAKING BREASTS; BODY HURTS FROM MUSCLE TENSION; SHIVERING IN LEGS; This spontaneous report received from a patient concerned a female 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 and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 19-JUN-2021 17:30 for prophylactic vaccination. No concomitant medications were reported.  On 19-JUN-2021, the subject experienced sensation of cold and hot at the same time. On 19-JUN-2021, the subject experienced shaking breasts. On 19-JUN-2021, the subject experienced body hurts from muscle tension. On 19-JUN-2021, the subject experienced shivering in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shivering in legs, and the outcome of sensation of cold and hot at the same time, shaking breasts and body hurts from muscle tension was not reported. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site pain, Paraesthesia, Peripheral swelling
Clinical narrative: BRUISE ON TOP OF RT KNEE; TINGLING ON HAND AND LEGS; FEELS LIKE LEGS ARE SWELLING; ARM FROM INJECTION SITE FEELS LIKE A HEAVINESS AND PAIN; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808986, and batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the subject experienced bruise on top of rt knee. On 17-JUN-2021, the subject experienced tingling on hand and legs. On 17-JUN-2021, the subject experienced feels like legs are swelling. On 17-JUN-2021, the subject experienced arm from injection site feels like a heaviness and pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise on top of rt knee, tingling on hand and legs, feels like legs are swelling, and arm from injection site feels like a heaviness and pain. This report was non-serious.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase MB increased, Myocarditis, Troponin increased
Clinical narrative: Pt visit ER 3 days post 2nd Covid-19 vaccine on 6/18/21. SOB started following day, CP last night.  Diagnosed with Myocarditis during ER visit. Discharged.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, C-reactive protein increased, Chest pain, Dyspnoea, Echocardiogram normal
Clinical narrative: Pt visit ER 3 days post 2nd Covid-19 vaccine on 6/18/21. SOB started following day, CP last night.  Diagnosed with Myocarditis during ER visit. Discharged.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Myocarditis, SARS-CoV-2 test negative, Troponin increased
Clinical narrative: Pt visit ER 3 days post 2nd Covid-19 vaccine on 6/18/21. SOB started following day, CP last night.  Diagnosed with Myocarditis during ER visit. Discharged.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Headache, Heart rate increased, Heart rate variability test
Clinical narrative: Heart beats fasting, headache and dizziness
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Heart beats fasting, headache and dizziness
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Polymenorrhoea
Clinical narrative: Menstrual cycle changed and became shorter. It became shorter from 28 days to around 21 days which has never happened in my life.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: 3 days after the vaccine, I felt pain in the left leg; I thought I had torn my angle/foot (I have not kicked anything nor made a wrong step, but there was a bit of pain: since I hike a lot in the City and the country, I could have slightly sprayed my ankle without really recalling it), but I have never had such swelling: I could put my finger in the foot from the ankle down and it would leave a 1/3rd of an inch depression in a puffed-up skin/subcutis.  I am a pathologist myself and found it unnecessary to bother anyone with the trouble. So I took aspirin which controlled the swelling somewhat. It took a good 4 weeks for the swelling to fully subside, with a few occasional episodes of worsening. It is all good now.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Erythema, Pruritus, Rash
Clinical narrative: Redness/erythema; It does get itchy from time to time; broke out with no itching; red pimples on chest, neck, stomach (above belly button), arms (little); This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness/erythema) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Mar-2021 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021 at 1:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced DERMATITIS ACNEIFORM (red pimples on chest, neck, stomach (above belly button), arms (little)) and RASH (broke out with no itching). On an unknown date, the patient experienced ERYTHEMA (Redness/erythema) (seriousness criterion hospitalization) and PRURITUS (It does get itchy from time to time). The patient was hospitalized from 09-Apr-2021 to 22-Apr-2021 due to ERYTHEMA. The patient was treated with CLINDAMYCIN ongoing from 10-Apr-2021 for Acne, at a dose of 1 percent twice a day. At the time of the report, ERYTHEMA (Redness/erythema), DERMATITIS ACNEIFORM (red pimples on chest, neck, stomach (above belly button), arms (little)) and PRURITUS (It does get itchy from time to time) had not resolved and RASH (broke out with no itching) outcome was unknown.            Concomitant product use was not provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Outcome of event changed to not recovered. Event erythema and seriousness criterion (hospitalization) was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspnoea, Full blood count, Immediate post-injection reaction, Pain
Clinical narrative: Immediate pain & gastric burning sensation and shortness of breath
Sex: U
Vaccine: COVID19
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Immediate pain & gastric burning sensation and shortness of breath
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Injection site joint pain
Clinical narrative: Joint pain at the shoulder on injection site side
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives rash on arms, thighs , and legs
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Depression, Magnetic resonance imaging, Myoclonus
Clinical narrative: Developed Middle Ear Myoclonus in right ear.  One month later developed mild Tinnitus in left ear. I don?t have any of the normal characteristics for sudden onset of tinnitus or Middle Ear Myoclonus.  My hearing test was normal, I don?t smoke or drink, I don?t work around loud noises, Weight and blood pressure is normal etc.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Developed Middle Ear Myoclonus in right ear.  One month later developed mild Tinnitus in left ear. I don?t have any of the normal characteristics for sudden onset of tinnitus or Middle Ear Myoclonus.  My hearing test was normal, I don?t smoke or drink, I don?t work around loud noises, Weight and blood pressure is normal etc.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Peripheral neuropathy. May have started before vaccination. Did not know what it was and did not pay close attention to when it started.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram normal, Troponin increased
Clinical narrative: Chest pain
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Furuncle, Herpes virus infection, Hypoaesthesia, Palpitations
Clinical narrative: Boil that turned into herpes, face numbness, ear infection, heart palpitations
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of the left arm
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Seizure
Clinical narrative: CHILLS leading to SEIZURE
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Brain natriuretic peptide normal, Chest X-ray normal, Chest pain, Contusion
Clinical narrative: Bruising to bilateral legs, chest pain that radiates to left arm, and back pain.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Fibrin D dimer, Full blood count, Haematocrit normal, Haemoglobin normal
Clinical narrative: Bruising to bilateral legs, chest pain that radiates to left arm, and back pain.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Pain, Pain in extremity, Platelet count normal, Troponin I normal
Clinical narrative: Bruising to bilateral legs, chest pain that radiates to left arm, and back pain.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Small, itchy bumps on forearms and shins. Less severe on upper arms and thighs.  Leg rash ended after 5 days. Arms still affected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient died at home 3 weeks after receiving first dose of vaccine.
Age: 50.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain upper, Amnesia, Asthenia, Diarrhoea, Dizziness
Clinical narrative: I got Pneumococcal & Tetanus at around 5: PM on Thursday , June 15, and at around 11:00 PM of the same day, I got a severe vaccine reaction ended up to emergency. I had lot of headache, stomach, vomiting, diarrhea, dizziness, fatigue, weakness, loss of memory and shot breathing. I lost 10 pounds in two days
Age: 50.0
Sex: M
Vaccine: UNK
Symptoms: Dyspnoea, Fatigue, Headache, Vomiting, Weight decreased
Clinical narrative: I got Pneumococcal & Tetanus at around 5: PM on Thursday , June 15, and at around 11:00 PM of the same day, I got a severe vaccine reaction ended up to emergency. I had lot of headache, stomach, vomiting, diarrhea, dizziness, fatigue, weakness, loss of memory and shot breathing. I lost 10 pounds in two days
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Dysphagia, Hyporesponsive to stimuli, Lethargy
Clinical narrative: June 4, Became largic, could not speak aloud, but understood. could not swallow hardy even water shock head to answer, only last day, very little response Prior to that, was feeding self, carried on good conversation and was enjoyable to visit with
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Approximately 1 hour after 1st vaccine the arm vaccine was administered began to throb and ache, couldn't move it without extreme pain.  Fever began approximately 2 hours after 1st vaccine, my temperature went up to 102.5°F at it's highest.  Before fever started my head began to feel very strange, like I was motion sick, very dizzy and lightheaded, also felt I might pass out.  Then the headache started, I've suffered from migraines in the past and this headache was just as bad as my worst migraine. As soon as fever began so did the muscle pain and soreness and stiffness and bone and joint pains.  Took Tylenol, when that did nothing to provide enough relief for me to sleep, I tried Motrin which I still got little relief.  This went on for 7-8 days, each day I would feel slightly better than day before.  After 2nd vaccine approximately 3-4 hours after I had another fever, around 101.5°. Muscles have been sore and painful since then.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Eye pain, Headache, Nausea
Clinical narrative: Sore eyes, body chills, fever, headache after first dose lasting more than two days, sore body, dizzy, nausea
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Sore eyes, body chills, fever, headache after first dose lasting more than two days, sore body, dizzy, nausea
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Hot flush, Menstruation delayed
Clinical narrative: Hot flashes. Started suddenly, having zero before to having about one every hour or so, both day and night. Each one would last about 10-15 minutes. My temperature increased 2-3 degrees (from 96 to 99). As suddenly as the they started, they stopped on June 9, roughly. Also period went from regular to nothing during this time and it hasn?t returned even though hot flashes have subsided.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient had 2nd dose appointment for Pfizer vaccine, presented vaccine card revealing 1st dose Pfizer from Pharmacy on 5/19/21. Pharmacy assistant checked patient in, confirmed, and verified vaccine with customer. Pharmacist prepared Pfizer vaccine, reconfirmed vaccination card, and reconfirmed with patient, then administered Pfizer vaccine. When processing  administration paperwork,  insurance rejected that same manufacturer should be administed as 2nd dose. Upon investigation and due to same computer system, discovered that Moderna was administered as 1st dose. When other pharmacy was contacted, pharmacist said paperwork showed Moderna. When patient was contacted, patient states that originally he had asked for Moderna at other pharmacy, but they said due to "age restrictions," he had to get Pfizer vaccine. Other pharmacy gave him vaccination card with Pfizer information, and patient believed he received Pfizer as 1st dose, not Moderna. Consequently, he made appointment and received Pfizer at our pharmacy as 2nd dose.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Carpal tunnel syndrome, Musculoskeletal stiffness, Pain in extremity, Paraesthesia
Clinical narrative: Carpel tunnel like symptoms in left arm. Pain and tingling sensation down arm into finger tips. Muscle stiffness in shoulder and neck.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Vision blurred
Clinical narrative: Complained of being really dizzy; eyes became foggy with bright light; She collapsed on the kitchen floor; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (She collapsed on the kitchen floor) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (She collapsed on the kitchen floor) (seriousness criterion medically significant), DIZZINESS (Complained of being really dizzy) and VISION BLURRED (eyes became foggy with bright light). At the time of the report, LOSS OF CONSCIOUSNESS (She collapsed on the kitchen floor), DIZZINESS (Complained of being really dizzy) and VISION BLURRED (eyes became foggy with bright light) outcome was unknown.            No concomitant medications were reported  No treatment information was provided  The patient got the second vaccine and when she got home, she complained of being really dizzy when they were outside. Then her eyes became foggy with bright light and her husband hardly got her inside when she collapsed on the kitchen floor. She questioned if this is a normal side effect.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Death, Seizure
Clinical narrative: Passed away; Had seizures 2 days after receiving his first dose; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away) and SEIZURE (Had seizures 2 days after receiving his first dose) 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 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 DEATH (Passed away) (seriousness criteria death and medically significant) and SEIZURE (Had seizures 2 days after receiving his first dose) (seriousness criterion medically significant). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, SEIZURE (Had seizures 2 days after receiving his first dose) outcome was unknown.            No concomitant medication information was provided. No treatment medication information was provided. Reporter stated she knows of someone and is not totally sure which vaccine was taken, but says Moderna. Action taken with respect to mRNA-1273 was not applicable.  This is a case of a sudden death of a Male patient who reportedly had seizures 2 days after receiving his vaccine. Reporter is unsure of vaccine that patient received and this can be a confounding factor. Very limited information has been provided regarding these events.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Sender's Comments: This is a case of a sudden death of a Male patient who reportedly had seizures 2 days after receiving his vaccine. Reporter is unsure of vaccine that patient received and this can be a confounding factor. Very limited information has been provided regarding these events.; Reported Cause(s) of Death: unknown cause of death
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, Inflammation, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: High inflammation; Stiffness; Slight high temperature; Muscle pain; Rheumatoid arthritis flare up; Systemic lupus erythematosus syndrome aggravated; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus syndrome aggravated) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included COVID-19. Concurrent medical conditions included Migraine, Acid reflux (esophageal), Hypertension, Nerve pain and Drug allergy (Codeine allergy manifested by skin crawling and itching). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) for Hypertension, TOPIRAMATE for Migraine, GABAPENTIN for Nerve injury, TRAMADOL for Pain, FOLIC ACID for Supplementation therapy.   In August 2020, the patient started UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant) and SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus syndrome aggravated) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLAMMATION (High inflammation), MUSCULOSKELETAL STIFFNESS (Stiffness), PYREXIA (Slight high temperature) and MYALGIA (Muscle pain). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus syndrome aggravated), INFLAMMATION (High inflammation), MUSCULOSKELETAL STIFFNESS (Stiffness), PYREXIA (Slight high temperature) and MYALGIA (Muscle pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-213828 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-213828:Patient 1st Dose
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis, Systemic lupus erythematosus
Clinical narrative: High inflammation; Stiffness; Slight high temperature; Muscle pain; Rheumatoid arthritis flare up; Systemic lupus erythematosus syndrome aggravated; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus syndrome aggravated) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included COVID-19. Concurrent medical conditions included Migraine, Acid reflux (esophageal), Hypertension, Nerve pain and Drug allergy (Codeine allergy manifested by skin crawling and itching). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) for Hypertension, TOPIRAMATE for Migraine, GABAPENTIN for Nerve injury, TRAMADOL for Pain, FOLIC ACID for Supplementation therapy.   In August 2020, the patient started UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant) and SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus syndrome aggravated) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLAMMATION (High inflammation), MUSCULOSKELETAL STIFFNESS (Stiffness), PYREXIA (Slight high temperature) and MYALGIA (Muscle pain). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus syndrome aggravated), INFLAMMATION (High inflammation), MUSCULOSKELETAL STIFFNESS (Stiffness), PYREXIA (Slight high temperature) and MYALGIA (Muscle pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-213828 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-213828:Patient 1st Dose