chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: LEG SWOLLEN; CANNOT PUT PRESSURE ON FOOT,  WALKS ON TIP TOES; TENDERNESS ON OUTSIDE OF LEFT  LEG; PAINFUL KNEE/LEG; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure abnormal, knee disorder, and hand arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included methotrexate for hand arthritis, and acetylsalicylic acid.  On 10-APR-2021, the subject experienced leg swollen. On 10-APR-2021, the subject experienced cannot put pressure on foot, walks on tip toes. On 10-APR-2021, the subject experienced tenderness on outside of left leg. On 10-APR-2021, the subject experienced painful knee/leg. On 14-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No blood clots. On 20-APR-2021, Laboratory data included: Blood test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tenderness on outside of left leg, painful knee/leg, leg swollen, and cannot put pressure on foot, walks on tip toes. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Asthenia, Fatigue, Gait inability
Clinical narrative: UNABLE TO WALK; LOSS OF TASTE; LOSS OF SMELL; WEAKNESS GENERALIZED; FATIGUE; HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 Company is unable to perform follow-up to request batch/lot numbers .No concomitant medications were reported. On an unspecified date, the subject experienced unable to walk, loss of taste, loss of smell, weakness generalized, fatigue, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of fatigue, headache, weakness generalized, loss of taste, loss of smell and unable to walk was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: UNABLE TO WALK; LOSS OF TASTE; LOSS OF SMELL; WEAKNESS GENERALIZED; FATIGUE; HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 Company is unable to perform follow-up to request batch/lot numbers .No concomitant medications were reported. On an unspecified date, the subject experienced unable to walk, loss of taste, loss of smell, weakness generalized, fatigue, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of fatigue, headache, weakness generalized, loss of taste, loss of smell and unable to walk was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE/TIREDNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not 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 25-APR-2021 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 25-APR-2021, the subject experienced fatigue/tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue/tiredness on 26-APR-2021. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: SWEATY; CHILLS; FEVERISH; REALLY TIRED; This spontaneous report received from a consumer concerned a 51 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021 19:00, the subject experienced chills. On 08-MAR-2021 19:00, the subject experienced feverish. On 08-MAR-2021 19:00, the subject experienced really tired. On 09-MAR-2021 05:00, the subject experienced sweaty. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty, chills, feverish, and really tired on 09-MAR-2021 18:30. This report was non-serious. This case, from the same reporter is linked to.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Insomnia, Pain, Pain in extremity
Clinical narrative: BAD BODY ACHES ALL OVER; COULD NOT SLEEP; DISCOMFORT; SORENESS IN ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced soreness in arm. On 12-APR-2021, the subject experienced bad body aches all over. On 12-APR-2021, the subject experienced could not sleep. On 12-APR-2021, the subject experienced discomfort. Treatment medications included: naproxen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad body aches all over, could not sleep, and discomfort on APR-2021, and had not recovered from soreness in arm. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tremor
Clinical narrative: SHAKING; HEADACHE; This spontaneous report received from a patient concerned a 26 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-APR-2021, the subject experienced shaking. On 26-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shaking, and had not recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hair colour changes, Therapeutic response unexpected
Clinical narrative: NOW BREATH OUT OF BOTH NOSTRILS FREELY; GREY HAIR; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight, height, and medical history were not 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. No concomitant medications were reported. On an unspecified date, the subject experienced now breath out of both nostrils freely, and grey hair. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the now breath out of both nostrils freely and grey hair was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Pain
Clinical narrative: SWOLLEN KNEE; PAIN; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not 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 swollen knee, and pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen knee and pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: PAIN IN MOUTH WENT AWAY AND AFTER 2 WEEKS HAS STILL NOT COME BACK; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not 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 subject experienced pain in mouth went away and after 2 weeks has still not come back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in mouth went away and after 2 weeks has still not come back was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUED; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigued. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: SMOKING CIGARETTE SMELL ONLY; This spontaneous report received from a consumer concerned a 60 year old female. The patient's weight, height, and medical history were not 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 06-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced smoking cigarette smell only. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from smoking cigarette smell only on APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Migraine, Rhinorrhoea
Clinical narrative: MIGRAINE HEADACHES; CHILLS; FLUCTUATIONS IN HOT AND COLD FEELING; SNIFFLING AND RUNNY NOSE; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes type 1, and undisclosed autoimmune disorder.  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 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced fluctuations in hot and cold feeling. On 20-MAR-2021, the subject experienced sniffling and runny nose. On 20-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced migraine headaches. Treatment medications (dates unspecified) included: sumatriptan. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fluctuations in hot and cold feeling, sniffling and runny nose, and chills on 21-MAR-2021, and migraine headaches on APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Medication error, Off label use
Clinical narrative: MEDICATION ERROR; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) .5 ml, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-APR-2021, the subject experienced medication error. On 27-APR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and medication error was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Pruritus, Urticaria
Clinical narrative: Dose 2: pruritus after doses 2 and 5; mild facial angioedema; chest and neck urticaria; This literature-non-study case was reported in a literature article and describes the occurrence of ANGIOEDEMA (mild facial angioedema) in a 39-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.   LITERATURE REFERENCE:  Administration of a Second Dose of the Moderna COVID-19.    Concurrent medical conditions included Allergic rhinitis.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced ANGIOEDEMA (mild facial angioedema) (seriousness criterion medically significant). 05-Jan-2021, the patient experienced URTICARIA (chest and neck urticaria). On an unknown date, the patient experienced PRURITUS (Dose 2: pruritus after doses 2 and 5). On 05-Jan-2021, ANGIOEDEMA (mild facial angioedema) had resolved. At the time of the report, URTICARIA (chest and neck urticaria) and PRURITUS (Dose 2: pruritus after doses 2 and 5) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   For dose #1 Medical personnel at vaccination site treated patient's urticaria with 25 mg of oral diphenhydramine.  For dose #1 ER treated patient's angioedema with 20 mg of intravenous famotidine and 125 mg of methylprednisolone. For dose #2 Allergy physician administered graduated dosing of vaccine every 15 minutes. Event of pruritic developed after dose 2 and 5 but no treatment was required. No concomitant medications were reported.  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 MOD-2021-085104 (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. MOD-2021-085104:2nd patient
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Feeling abnormal, Laboratory test, Loss of consciousness
Clinical narrative: passed out at vaccination facility.was taken by ambulance to the ER; started to feel strange and tried to flag someone after 10 minutes of  first dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out at vaccination facility.was taken by ambulance to the ER) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.     On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out at vaccination facility.was taken by ambulance to the ER) (seriousness criterion medically significant) and FEELING ABNORMAL (started to feel strange and tried to flag someone after 10 minutes of  first dose). At the time of the report, LOSS OF CONSCIOUSNESS (passed out at vaccination facility.was taken by ambulance to the ER) and FEELING ABNORMAL (started to feel strange and tried to flag someone after 10 minutes of  first dose) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal. On an unknown date, Electrocardiogram: normal. On an unknown date, Laboratory test: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was taken to ER after the patient passed out.  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-2021-089511 (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-2021-089511:Case for patient
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Lip swelling, Oral discomfort
Clinical narrative: Bell's Palsy, face twisted; Burning in the mouth; Lips swelling; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy, face twisted) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes mellitus. Concomitant products included METFORMIN for Diabetes mellitus. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy, face twisted) (seriousness criterion medically significant), ORAL DISCOMFORT (Burning in the mouth) and LIP SWELLING (Lips swelling). At the time of the report, FACIAL PARALYSIS (Bell's Palsy, face twisted), ORAL DISCOMFORT (Burning in the mouth) and LIP SWELLING (Lips swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Basedow's disease, Chills, Hyperthyroidism, Influenza like illness, Migraine
Clinical narrative: Migraine headache; Flu like symptoms; Body aches; Fever; Chills; Hyperthyroidism; Graves' disease; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTHYROIDISM (Hyperthyroidism) and BASEDOW'S DISEASE (Graves' disease) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced HYPERTHYROIDISM (Hyperthyroidism) (seriousness criterion medically significant) and BASEDOW'S DISEASE (Graves' disease) (seriousness criterion medically significant). On 23-Mar-2021, the patient experienced MIGRAINE (Migraine headache), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches), PYREXIA (Fever) and CHILLS (Chills). On 17-Apr-2021, MIGRAINE (Migraine headache), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, HYPERTHYROIDISM (Hyperthyroidism) and BASEDOW'S DISEASE (Graves' disease) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that the symptoms were mostly in the night. No concomitant medications were provided by the reporter.   Treatment medications included tylenol and metron.  Company comment: 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.; 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.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Migraine headache; Flu like symptoms; Body aches; Fever; Chills; Hyperthyroidism; Graves' disease; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTHYROIDISM (Hyperthyroidism) and BASEDOW'S DISEASE (Graves' disease) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced HYPERTHYROIDISM (Hyperthyroidism) (seriousness criterion medically significant) and BASEDOW'S DISEASE (Graves' disease) (seriousness criterion medically significant). On 23-Mar-2021, the patient experienced MIGRAINE (Migraine headache), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches), PYREXIA (Fever) and CHILLS (Chills). On 17-Apr-2021, MIGRAINE (Migraine headache), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, HYPERTHYROIDISM (Hyperthyroidism) and BASEDOW'S DISEASE (Graves' disease) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that the symptoms were mostly in the night. No concomitant medications were provided by the reporter.   Treatment medications included tylenol and metron.  Company comment: 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.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Eye contusion, Eye haemorrhage, Ocular hyperaemia
Clinical narrative: rupture in blood vessels; one eye is black; blood shot; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (rupture in blood vessels) 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 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced EYE HAEMORRHAGE (rupture in blood vessels) (seriousness criterion medically significant), EYE CONTUSION (one eye is black) and OCULAR HYPERAEMIA (blood shot). At the time of the report, EYE HAEMORRHAGE (rupture in blood vessels), EYE CONTUSION (one eye is black) and OCULAR HYPERAEMIA (blood shot) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.  No concomitant medication was provided.  Company Comment  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.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Euphoric mood, Feeling abnormal, Hallucination, Headache
Clinical narrative: feel weird, objects looked distorted,; could not sleep; felt hyperactive with her eyes popping out of her head; bone pain; muscle soreness; Headache; hallucinations; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinations) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN for Peripheral neuropathy, CLONAZEPAM (CLONAZEPAM AUDEN) for Seizures, METOPROLOL, DROXIDOPA and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced HALLUCINATION (hallucinations) (seriousness criterion medically significant) and HEADACHE (Headache). On an unknown date, the patient experienced FEELING ABNORMAL (feel weird, objects looked distorted,), SLEEP DISORDER (could not sleep), EUPHORIC MOOD (felt hyperactive with her eyes popping out of her head), BONE PAIN (bone pain) and MYALGIA (muscle soreness). On 11-Apr-2021, HALLUCINATION (hallucinations) had resolved. At the time of the report, FEELING ABNORMAL (feel weird, objects looked distorted,), SLEEP DISORDER (could not sleep), EUPHORIC MOOD (felt hyperactive with her eyes popping out of her head), BONE PAIN (bone pain), MYALGIA (muscle soreness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment given included Naproxen.  Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache and myalgia are consistent with the product safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache and myalgia are consistent with the product safety profile.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Sleep disorder
Clinical narrative: feel weird, objects looked distorted,; could not sleep; felt hyperactive with her eyes popping out of her head; bone pain; muscle soreness; Headache; hallucinations; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinations) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN for Peripheral neuropathy, CLONAZEPAM (CLONAZEPAM AUDEN) for Seizures, METOPROLOL, DROXIDOPA and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced HALLUCINATION (hallucinations) (seriousness criterion medically significant) and HEADACHE (Headache). On an unknown date, the patient experienced FEELING ABNORMAL (feel weird, objects looked distorted,), SLEEP DISORDER (could not sleep), EUPHORIC MOOD (felt hyperactive with her eyes popping out of her head), BONE PAIN (bone pain) and MYALGIA (muscle soreness). On 11-Apr-2021, HALLUCINATION (hallucinations) had resolved. At the time of the report, FEELING ABNORMAL (feel weird, objects looked distorted,), SLEEP DISORDER (could not sleep), EUPHORIC MOOD (felt hyperactive with her eyes popping out of her head), BONE PAIN (bone pain), MYALGIA (muscle soreness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment given included Naproxen.  Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache and myalgia are consistent with the product safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache and myalgia are consistent with the product safety profile.
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, Computerised tomogram
Clinical narrative: Abdominal Pain; This spontaneous case was reported by a health care professional and describes the occurrence of APPENDICITIS (Abdominal Pain) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was reported.     On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced APPENDICITIS (Abdominal Pain) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 24-Apr-2021 due to APPENDICITIS. The patient was treated with Surgery (Appendectomy) for Appendicitis. At the time of the report, APPENDICITIS (Abdominal Pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Computerised tomogram: abnormal (abnormal) Acute Appendicitis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment: 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; 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
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chest discomfort, Chest pain, Chills
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: body shaking, body sweats and chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe, Additional Details: pt experienced severe fatigue that has not resolved. she experienced breakouts in chills and shakiness
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dysphagia, Dyspnoea, Fatigue
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: body shaking, body sweats and chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe, Additional Details: pt experienced severe fatigue that has not resolved. she experienced breakouts in chills and shakiness
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Hyperhidrosis, Hypersensitivity, Injection site pain
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: body shaking, body sweats and chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe, Additional Details: pt experienced severe fatigue that has not resolved. she experienced breakouts in chills and shakiness
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Lethargy, Nausea, Paraesthesia, Pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: body shaking, body sweats and chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe, Additional Details: pt experienced severe fatigue that has not resolved. she experienced breakouts in chills and shakiness
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Throat tightness, Tremor, Visual impairment
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: body shaking, body sweats and chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe, Additional Details: pt experienced severe fatigue that has not resolved. she experienced breakouts in chills and shakiness
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, muscle ache, headache, extreme fatigue
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Hypotension, Presyncope, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: PT HAD VASOVAGAL REACTION AFTER RECIEVING COVID IM VACCINE
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: PT HAD VASOVAGAL REACTION AFTER RECIEVING COVID IM VACCINE
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Cough, Dizziness, Fatigue, Limb discomfort
Clinical narrative: 1/28 1st Pfizer > 1/29 Onset, dizziness, nausea, h/a, eye pressure, "heaviness" in legs, altered taste 2/3 Cough, mild congestion Seen in ER on 2/5 for evaluation of cough.  Reports 3 days of upper respiratory congestion, mild nonproductive cough.  Diffuse body aches.  Mild nausea associated with coughing, however no emesis.  Denies chest pain/abdominal pain.  ROS positive for: fatigue, congestion, cough, myalgias.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Ocular discomfort, Pain, Pneumonia
Clinical narrative: 1/28 1st Pfizer > 1/29 Onset, dizziness, nausea, h/a, eye pressure, "heaviness" in legs, altered taste 2/3 Cough, mild congestion Seen in ER on 2/5 for evaluation of cough.  Reports 3 days of upper respiratory congestion, mild nonproductive cough.  Diffuse body aches.  Mild nausea associated with coughing, however no emesis.  Denies chest pain/abdominal pain.  ROS positive for: fatigue, congestion, cough, myalgias.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test negative, Taste disorder, Upper respiratory tract congestion
Clinical narrative: 1/28 1st Pfizer > 1/29 Onset, dizziness, nausea, h/a, eye pressure, "heaviness" in legs, altered taste 2/3 Cough, mild congestion Seen in ER on 2/5 for evaluation of cough.  Reports 3 days of upper respiratory congestion, mild nonproductive cough.  Diffuse body aches.  Mild nausea associated with coughing, however no emesis.  Denies chest pain/abdominal pain.  ROS positive for: fatigue, congestion, cough, myalgias.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Fever developed overnight, slight nausea and headache with continued light fever in morning.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Limb injury, Pain in extremity, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: PATIENT VACCINE WAS GIVEN TOO HIGH ON ARM AND CAUSED SHOULDER PAIN AND SORE ARM
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Site: Pain at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: PATIENT VACCINE WAS GIVEN TOO HIGH ON ARM AND CAUSED SHOULDER PAIN AND SORE ARM
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams
Clinical narrative: Since i got the vaccine 2 weeks ago, almost every night since I have had significant dreams, much more so than I would normally. Normally I would have vivid dreams a couple times a month. This isn't a problem as I like the fact I'm getting deep sleep but I just wanted to report it. Thanks.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Additional Details: PATIENT STATES THAT THEY TESTED POSITIVE AFTER RECEIVING COVID-19 VACCINATION.  STATES THEY HAD A COVID-19 TEST DONE PRIOR TO THE VACCINATION THAT WAS NEGATIVE, THEN 2 DAYS LATER THEY HAD A POSITIVE COVID TEST AFTER EXPERIENCING SYMPTOMS.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Lymphadenopathy, Oropharyngeal pain, Pain in extremity
Clinical narrative: Severe arm pain for 12 hours, Tylenol for treatment, severe pain subsided after 12 hours, mild to moderate pain persists   Fever for 24 hours, subsided after 24hrs  Chills for 24 hours, subsided after 24hrs  Lightheadedness, lasted 24 hours, subsided after 24  Swollen lymph node and sore throat, began 24 hours after vaccine and is persisting.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe arm pain for 12 hours, Tylenol for treatment, severe pain subsided after 12 hours, mild to moderate pain persists   Fever for 24 hours, subsided after 24hrs  Chills for 24 hours, subsided after 24hrs  Lightheadedness, lasted 24 hours, subsided after 24  Swollen lymph node and sore throat, began 24 hours after vaccine and is persisting.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Lymphadenopathy, Pruritus
Clinical narrative: COVID arm:  4"x4" red patch on arm around injection site; itching spread across chest and in lymph nodes; lasted about 5 days
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Head injury, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient experienced dizziness and proceeded to faint and fall off her seat. She regained consciousness within approximately 20 seconds. Patient also got a cut above her eye due to the fall.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: High fever, chills and headache
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus left ear
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Dizziness, Fatigue, Hypertension, Pain
Clinical narrative: Day of injection:fever over 100, body aches, fatigue Day 2-same as day 1 plus dizziness, extreme high blood pressure and a seizure Day 3&4-all symptoms continue except the seizure Day 5&6-fever broke, now just dizzy and blood pressure spikes Day 7-most symptoms subsided, but blood pressure still spikes slightly and tinnitus began and continues
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Tinnitus
Clinical narrative: Day of injection:fever over 100, body aches, fatigue Day 2-same as day 1 plus dizziness, extreme high blood pressure and a seizure Day 3&4-all symptoms continue except the seizure Day 5&6-fever broke, now just dizzy and blood pressure spikes Day 7-most symptoms subsided, but blood pressure still spikes slightly and tinnitus began and continues
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Flushing, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: fever, headache, flushing on 4/27/21 starting at 7pm and continuing to 4/28/21 headache, joint ache, and signs of allergic reaction in right arm, around injection site. Redness, pain, slight itching, swelling, and heat. Symptoms of allergic reaction at site began 4/29/21. Had slight itching and redness with first vaccine, now second vaccine is more pronounced.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: fever, headache, flushing on 4/27/21 starting at 7pm and continuing to 4/28/21 headache, joint ache, and signs of allergic reaction in right arm, around injection site. Redness, pain, slight itching, swelling, and heat. Symptoms of allergic reaction at site began 4/29/21. Had slight itching and redness with first vaccine, now second vaccine is more pronounced.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot, Headache, Pain
Clinical narrative: redness, rash, hot, swelling, headache, achy, fatigue.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Vaccine positive rechallenge
Clinical narrative: redness, rash, hot, swelling, headache, achy, fatigue.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Nausea, Pain in extremity
Clinical narrative: Nausea for roughly 6 hours, arm extremely sore and stiff for about 24 hours, headache for about 8 hours.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed shingles three weeks after vaccine
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm soreness which came up within hours of injection, slightly limited range of motion , got slightly worse into the night but was gone by morning.  Pain would be described as minor.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Fever, body aches, arm stiffness. Lasted approximately 12-15 hours.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Nausea, Pain
Clinical narrative: Body aches and fever of about 99.5 the next day.  General fatigue and some nausea.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Vomiting
Clinical narrative: VIOLENT BOUTS OF VOMITING AND DIARRHEA. NOT ABLE TO EAT OR DRINK ANYTHING (SOLID OR LIQUID) FOR 72 HRS AFTER SHOT.  SEVERE STOMACH CRAMPING AND EXCESSIVE BLOATING AFTER EATING OR DRINKING ANYTHING.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Contraception, Erythema, Fatigue, Headache
Clinical narrative: After 1st dose on 3/25 lot# 008B21A I had a patch of redness on my right arm 2 days after the shot. I no longer get my period due to continuous birth control but started break through bleeding for 2 days.   After the 2nd dose on 4/24- I experienced arm pain and that evening. The next day I had fever, increased heart rate, body aches, headache, nausea, and fatigue.  That afternoon of 4/25 I started to get a rash on my arms. The next morning Monday 4/26 I woke up at 5am with a rash all over my body that itched and burned. This lasted for the next 12 hours.  I continued to have nausea, fatigue and headaches for the next 2 days.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Intermenstrual bleeding, Nausea, Pain, Pain in extremity
Clinical narrative: After 1st dose on 3/25 lot# 008B21A I had a patch of redness on my right arm 2 days after the shot. I no longer get my period due to continuous birth control but started break through bleeding for 2 days.   After the 2nd dose on 4/24- I experienced arm pain and that evening. The next day I had fever, increased heart rate, body aches, headache, nausea, and fatigue.  That afternoon of 4/25 I started to get a rash on my arms. The next morning Monday 4/26 I woke up at 5am with a rash all over my body that itched and burned. This lasted for the next 12 hours.  I continued to have nausea, fatigue and headaches for the next 2 days.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Pyrexia, Rash, Sleep disorder
Clinical narrative: After 1st dose on 3/25 lot# 008B21A I had a patch of redness on my right arm 2 days after the shot. I no longer get my period due to continuous birth control but started break through bleeding for 2 days.   After the 2nd dose on 4/24- I experienced arm pain and that evening. The next day I had fever, increased heart rate, body aches, headache, nausea, and fatigue.  That afternoon of 4/25 I started to get a rash on my arms. The next morning Monday 4/26 I woke up at 5am with a rash all over my body that itched and burned. This lasted for the next 12 hours.  I continued to have nausea, fatigue and headaches for the next 2 days.