chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 16 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. 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 inappropriate age at vaccine administration, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Arthralgia, Blood test, Burning sensation, Chest X-ray
Clinical narrative: LUNG INFLAMMATION/ SEEMS LIKE LUNG INFECTION; SHORTNESS OF BREATH/HARD TIME BREATHING; CHEST PAIN/BURNING IN THE CHEST; SINUS INFLAMMATION; THROAT INFLAMMATION; INTERNAL BURNING DOWN HER ARM TO THE WRIST; SHOULDER BLADE AREA PAIN; ARM PAIN; INTERNAL BURNING AT THE  INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid -19 infection. 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 17:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included meloxicam for drug used for unknown indication. On 12-MAR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 09-APR-2021, Laboratory data included: Antibody test (NR: not provided) Positive. On 13-APR-2021, the subject experienced lung inflammation. On 13-APR-2021, the subject experienced shortness of breath/hard time breathing. On 13-APR-2021, the subject experienced chest pain/burning in the chest. On 13-APR-2021, the subject experienced sinus inflammation. On 13-APR-2021, the subject experienced throat inflammation. On 13-APR-2021, the subject experienced internal burning down her arm to the wrist. On 13-APR-2021, the subject experienced shoulder blade area pain. On 13-APR-2021, the subject experienced arm pain. On 13-APR-2021, the subject experienced internal burning at the injection site. On 15-APR-2021, Laboratory data included: Blood test (NR: not provided) Unknown, Chest X-ray (NR: not provided) Unknown, and EKG (NR: not provided) Unknown. Treatment medications included: ibuprofen. On 29-APR-2021, Laboratory data included: Blood test (NR: not provided) Lymphocytes and Eosinophil numbers changed. On MAY-2021, treatment medications included: omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath/hard time breathing, lung inflammation, chest pain/burning in the chest, internal burning at the injection site, shoulder blade area pain, sinus inflammation, throat inflammation, internal burning down her arm to the wrist, and arm pain. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Injection site pain, Pain in extremity
Clinical narrative: LUNG INFLAMMATION/ SEEMS LIKE LUNG INFECTION; SHORTNESS OF BREATH/HARD TIME BREATHING; CHEST PAIN/BURNING IN THE CHEST; SINUS INFLAMMATION; THROAT INFLAMMATION; INTERNAL BURNING DOWN HER ARM TO THE WRIST; SHOULDER BLADE AREA PAIN; ARM PAIN; INTERNAL BURNING AT THE  INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid -19 infection. 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 17:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included meloxicam for drug used for unknown indication. On 12-MAR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 09-APR-2021, Laboratory data included: Antibody test (NR: not provided) Positive. On 13-APR-2021, the subject experienced lung inflammation. On 13-APR-2021, the subject experienced shortness of breath/hard time breathing. On 13-APR-2021, the subject experienced chest pain/burning in the chest. On 13-APR-2021, the subject experienced sinus inflammation. On 13-APR-2021, the subject experienced throat inflammation. On 13-APR-2021, the subject experienced internal burning down her arm to the wrist. On 13-APR-2021, the subject experienced shoulder blade area pain. On 13-APR-2021, the subject experienced arm pain. On 13-APR-2021, the subject experienced internal burning at the injection site. On 15-APR-2021, Laboratory data included: Blood test (NR: not provided) Unknown, Chest X-ray (NR: not provided) Unknown, and EKG (NR: not provided) Unknown. Treatment medications included: ibuprofen. On 29-APR-2021, Laboratory data included: Blood test (NR: not provided) Lymphocytes and Eosinophil numbers changed. On MAY-2021, treatment medications included: omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath/hard time breathing, lung inflammation, chest pain/burning in the chest, internal burning at the injection site, shoulder blade area pain, sinus inflammation, throat inflammation, internal burning down her arm to the wrist, and arm pain. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngitis, Pneumonitis, SARS-CoV-2 test, Sinusitis
Clinical narrative: LUNG INFLAMMATION/ SEEMS LIKE LUNG INFECTION; SHORTNESS OF BREATH/HARD TIME BREATHING; CHEST PAIN/BURNING IN THE CHEST; SINUS INFLAMMATION; THROAT INFLAMMATION; INTERNAL BURNING DOWN HER ARM TO THE WRIST; SHOULDER BLADE AREA PAIN; ARM PAIN; INTERNAL BURNING AT THE  INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid -19 infection. 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 17:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included meloxicam for drug used for unknown indication. On 12-MAR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 09-APR-2021, Laboratory data included: Antibody test (NR: not provided) Positive. On 13-APR-2021, the subject experienced lung inflammation. On 13-APR-2021, the subject experienced shortness of breath/hard time breathing. On 13-APR-2021, the subject experienced chest pain/burning in the chest. On 13-APR-2021, the subject experienced sinus inflammation. On 13-APR-2021, the subject experienced throat inflammation. On 13-APR-2021, the subject experienced internal burning down her arm to the wrist. On 13-APR-2021, the subject experienced shoulder blade area pain. On 13-APR-2021, the subject experienced arm pain. On 13-APR-2021, the subject experienced internal burning at the injection site. On 15-APR-2021, Laboratory data included: Blood test (NR: not provided) Unknown, Chest X-ray (NR: not provided) Unknown, and EKG (NR: not provided) Unknown. Treatment medications included: ibuprofen. On 29-APR-2021, Laboratory data included: Blood test (NR: not provided) Lymphocytes and Eosinophil numbers changed. On MAY-2021, treatment medications included: omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath/hard time breathing, lung inflammation, chest pain/burning in the chest, internal burning at the injection site, shoulder blade area pain, sinus inflammation, throat inflammation, internal burning down her arm to the wrist, and arm pain. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Lyme disease, Rocky mountain spotted fever
Clinical narrative: RECURRENCE OF LYME DISEASE/FLARE OF LYME DISEASE POST VACCINE; RECURRENCE OF ROCKY MOUNTAIN SPOTTED FEVER/FLARE OF ROCKY MOUNTAIN SPOTTED FEVER POST VACCINE; This spontaneous report received from a patient concerned a 42 year old white, hispanic or latino male. The patient's height, and weight were not reported. The patient's past medical history included rocky mountain spotted fever, lyme disease, hernia repair surgery, esophageal stricture repair, hives and left ventricular hypertrophy and concurrent conditions included non alcohol user, non smoker, poison ivy, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient was previously treated with levofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 vaccination at left arm 12:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the patient experienced nerve pain in extremities, numbness to arms/extremities. On 17-APR-2021, the patient experienced recurrence of lyme disease/flare of lyme disease post vaccine, recurrence of rocky mountain spotted fever/flare of rocky mountain spotted fever and generalized muscle aches. On 19-APR-2021, the patient experienced tingling in bilateral hands/arm and fatigue. On 20-APR-2021, the patient experienced generalized joint pain throughout body, shoulder, arms, hands, legs. Laboratory data (dates unspecified) included: CBC (complete blood count) (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from recurrence of lyme disease/flare of lyme disease post vaccine and recurrence of rocky mountain spotted fever/flare of rocky mountain spotted fever post vaccine. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210505559-COVID-19 VACCINE AD26.COV2.S- recurrence of lyme disease/flare of lyme disease post vaccine and  recurrence of rocky mountain spotted fever/flare of rocky mountain spotted fever post vaccine. 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: MEDICAL HISTORY
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Platelet count, Platelet count decreased
Clinical narrative: LOW PLATELET COUNT; FLU LIKE SYMPTOMS; This spontaneous report was received from a health care professional and concerned a 50-year old female. The patient's height, weight, past medical history and concurrent conditions were not reported.  The patient received COVID-19 Vaccine Ad26.COV2.S (suspension for injection, route of admin not reported, batch number: Unknown) dose/anatomical site unspecified, and start therapy date were not reported (reported as a few weeks ago, the Friday right before it was paused) for the prevention of SARS-COV-2-virus infection. The batch number was not reported and has been requested. No concomitant medications were reported.  Post vaccination, the patient presented with "normal" flu-like symptoms.    On an unspecified date (reported as last Wednesday),  the subject experienced low platelet count. The reporter indicated that the patient's last platelet count (NR: not provided) was 136 K and dropped again to 107 K the following Monday. At reporting, the patient consulted with a hematologist. A platelet antibody test was pending. The action taken with COVID-19 Vaccine Ad26.COV2.S was not applicable. The outcome of the low platelet count and flu like symptoms was not reported. This report was non-serious..; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Gastrooesophageal reflux disease, Influenza like illness, Investigation, Nausea
Clinical narrative: BOTH LEG PAIN; HIVES / WORSENING HIVES; GASTROESOPHAGEAL REFLUX DISEASE; FELT LIKE HAVING HEART ATTACK; SLEEP INTERRUPTIONS; FLU-LIKE SYMPTOMS; ACHES; NAUSEA; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included neuropathy. 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 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Investigation (NR: not provided) blood clots which were negative. On 24-MAR-2021, the subject experienced flu-like symptoms. On 24-MAR-2021, the subject experienced aches. On 24-MAR-2021, the subject experienced sleep interruptions. On 24-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced felt like having heart attack. On 27-MAR-2021, the subject experienced gastroesophageal reflux disease. On 30-MAR-2021, the subject experienced hives / worsening hives. On 04-APR-2021, the subject experienced both leg pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, aches, felt like having heart attack, sleep interruptions, gastroesophageal reflux disease, hives / worsening hives, and nausea on 2021, and both leg pain on APR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Sleep disorder, Urticaria
Clinical narrative: BOTH LEG PAIN; HIVES / WORSENING HIVES; GASTROESOPHAGEAL REFLUX DISEASE; FELT LIKE HAVING HEART ATTACK; SLEEP INTERRUPTIONS; FLU-LIKE SYMPTOMS; ACHES; NAUSEA; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included neuropathy. 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 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Investigation (NR: not provided) blood clots which were negative. On 24-MAR-2021, the subject experienced flu-like symptoms. On 24-MAR-2021, the subject experienced aches. On 24-MAR-2021, the subject experienced sleep interruptions. On 24-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced felt like having heart attack. On 27-MAR-2021, the subject experienced gastroesophageal reflux disease. On 30-MAR-2021, the subject experienced hives / worsening hives. On 04-APR-2021, the subject experienced both leg pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, aches, felt like having heart attack, sleep interruptions, gastroesophageal reflux disease, hives / worsening hives, and nausea on 2021, and both leg pain on APR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a pharmacist concerned a 68 year old White Not Hispanic or Latino 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: 25-MAY-2021) dose was not reported, frequency once total, administered on 10-MAR-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported. The pharmacist reported that the patient had a negative antibody test (coded as suspected immunological vaccine failure). It was not clear what antibody test the patient had. It was unknown what laboratory patient had antibody done through. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210507313- 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
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Heart rate, Heart rate increased, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: INCREASED HEART RATE; FEVER; OXYGEN SATURATION 91%; This spontaneous report received from a consumer concerned a 75 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: 202A21A expiry: Unknown) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced oxygen saturation 91%. Laboratory data included: Heart rate (NR: not provided) 91 bpm, and Oxygen saturation (NR: not provided) 91 %. On 04-MAY-2021, the subject experienced increased heart rate. On 04-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.0 F, and Heart rate (NR: not provided) increased to 130. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the increased heart rate, fever and oxygen saturation 91% was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: INCREASED HEART RATE; FEVER; OXYGEN SATURATION 91%; This spontaneous report received from a consumer concerned a 75 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: 202A21A expiry: Unknown) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced oxygen saturation 91%. Laboratory data included: Heart rate (NR: not provided) 91 bpm, and Oxygen saturation (NR: not provided) 91 %. On 04-MAY-2021, the subject experienced increased heart rate. On 04-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.0 F, and Heart rate (NR: not provided) increased to 130. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the increased heart rate, fever and oxygen saturation 91% was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE DRAWN UP IN SYRINGE POSSIBLY ADMINISTERED PAST THE 6 HOUR EXPIRATION; This spontaneous report received from a pharmacist . 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 and has been requested. No concomitant medications were reported.  On 04-MAY-2021, the subject experienced vaccine drawn up in syringe possibly administered past the 6 hour expiration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine drawn up in syringe possibly administered past the 6 hour expiration was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: BELLS PALSY; This spontaneous report received from a patient concerned a Male of unspecified age. The patients weight, height, and medical history were not reported. On 08-APR-2021, the patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered 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 APR-2021, the patient experienced Bells Palsy after receiving Janssen vaccine and went to the Doctor but waiting for the diagnosis. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of Bells Palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210508205-covid-19 vaccine ad26.cov2.s -bell's palsy- This event(s) is considered unassessable . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Erythema, Feeling abnormal
Clinical narrative: VERY BAD DIARRHEA; UNABLE TO TO MOVE HER ARM; FELT COLD; BODY ACHES; CRAWLING SKIN SENSATION; SWEATING; FELT SICK; HEADACHE; SORE ARM; DIZZINESS; RED FACE; FLUSHING OF FACE; ITCHY FACE; DID NOT FEEL GREAT; BURNING PAIN IN UPPER LEFT ABDOMEN; NODE/SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ehlers-danlos syndrome, and other pre-existing medical conditions included no breastfeeding.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 17:00 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced burning pain in upper left abdomen. On MAY-2021, the subject experienced node/swelling at injection site. On 03-MAY-2021, the subject experienced dizziness. On 03-MAY-2021, the subject experienced red face. On 03-MAY-2021, the subject experienced flushing of face. On 03-MAY-2021, the subject experienced itchy face. On 03-MAY-2021, the subject experienced did not feel great. On 03-MAY-2021, the subject experienced sore arm. On 04-MAY-2021, the subject experienced body aches. On 04-MAY-2021, the subject experienced crawling skin sensation. On 04-MAY-2021, the subject experienced sweating. On 04-MAY-2021, the subject experienced unable to to move her arm. On 04-MAY-2021, the subject experienced felt cold. On 04-MAY-2021, the subject experienced felt sick. On 04-MAY-2021, the subject experienced headache. Laboratory data included: Pain scale (NR: not provided) 4/10. On 05-MAY-2021, the subject experienced very bad diarrhea. Laboratory data included: Pain scale (NR: not provided) 6/10 (headache worsened). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red face, flushing of face, and itchy face on 03-MAY-2021, and crawling skin sensation on 05-MAY-2021, was recovering from unable to to move her arm, had not recovered from dizziness, sore arm, felt sick, body aches, headache, burning pain in upper left abdomen, very bad diarrhea, and node/swelling at injection site, and the outcome of sweating, felt cold and did not feel great was not reported. This report was non-serious. This case, from the same reporter is linked to 20210509350.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Flushing, Formication, Headache, Hyperhidrosis
Clinical narrative: VERY BAD DIARRHEA; UNABLE TO TO MOVE HER ARM; FELT COLD; BODY ACHES; CRAWLING SKIN SENSATION; SWEATING; FELT SICK; HEADACHE; SORE ARM; DIZZINESS; RED FACE; FLUSHING OF FACE; ITCHY FACE; DID NOT FEEL GREAT; BURNING PAIN IN UPPER LEFT ABDOMEN; NODE/SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ehlers-danlos syndrome, and other pre-existing medical conditions included no breastfeeding.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 17:00 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced burning pain in upper left abdomen. On MAY-2021, the subject experienced node/swelling at injection site. On 03-MAY-2021, the subject experienced dizziness. On 03-MAY-2021, the subject experienced red face. On 03-MAY-2021, the subject experienced flushing of face. On 03-MAY-2021, the subject experienced itchy face. On 03-MAY-2021, the subject experienced did not feel great. On 03-MAY-2021, the subject experienced sore arm. On 04-MAY-2021, the subject experienced body aches. On 04-MAY-2021, the subject experienced crawling skin sensation. On 04-MAY-2021, the subject experienced sweating. On 04-MAY-2021, the subject experienced unable to to move her arm. On 04-MAY-2021, the subject experienced felt cold. On 04-MAY-2021, the subject experienced felt sick. On 04-MAY-2021, the subject experienced headache. Laboratory data included: Pain scale (NR: not provided) 4/10. On 05-MAY-2021, the subject experienced very bad diarrhea. Laboratory data included: Pain scale (NR: not provided) 6/10 (headache worsened). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red face, flushing of face, and itchy face on 03-MAY-2021, and crawling skin sensation on 05-MAY-2021, was recovering from unable to to move her arm, had not recovered from dizziness, sore arm, felt sick, body aches, headache, burning pain in upper left abdomen, very bad diarrhea, and node/swelling at injection site, and the outcome of sweating, felt cold and did not feel great was not reported. This report was non-serious. This case, from the same reporter is linked to 20210509350.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Malaise, Mobility decreased, Pain, Pain assessment
Clinical narrative: VERY BAD DIARRHEA; UNABLE TO TO MOVE HER ARM; FELT COLD; BODY ACHES; CRAWLING SKIN SENSATION; SWEATING; FELT SICK; HEADACHE; SORE ARM; DIZZINESS; RED FACE; FLUSHING OF FACE; ITCHY FACE; DID NOT FEEL GREAT; BURNING PAIN IN UPPER LEFT ABDOMEN; NODE/SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ehlers-danlos syndrome, and other pre-existing medical conditions included no breastfeeding.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 17:00 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced burning pain in upper left abdomen. On MAY-2021, the subject experienced node/swelling at injection site. On 03-MAY-2021, the subject experienced dizziness. On 03-MAY-2021, the subject experienced red face. On 03-MAY-2021, the subject experienced flushing of face. On 03-MAY-2021, the subject experienced itchy face. On 03-MAY-2021, the subject experienced did not feel great. On 03-MAY-2021, the subject experienced sore arm. On 04-MAY-2021, the subject experienced body aches. On 04-MAY-2021, the subject experienced crawling skin sensation. On 04-MAY-2021, the subject experienced sweating. On 04-MAY-2021, the subject experienced unable to to move her arm. On 04-MAY-2021, the subject experienced felt cold. On 04-MAY-2021, the subject experienced felt sick. On 04-MAY-2021, the subject experienced headache. Laboratory data included: Pain scale (NR: not provided) 4/10. On 05-MAY-2021, the subject experienced very bad diarrhea. Laboratory data included: Pain scale (NR: not provided) 6/10 (headache worsened). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red face, flushing of face, and itchy face on 03-MAY-2021, and crawling skin sensation on 05-MAY-2021, was recovering from unable to to move her arm, had not recovered from dizziness, sore arm, felt sick, body aches, headache, burning pain in upper left abdomen, very bad diarrhea, and node/swelling at injection site, and the outcome of sweating, felt cold and did not feel great was not reported. This report was non-serious. This case, from the same reporter is linked to 20210509350.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: VERY BAD DIARRHEA; UNABLE TO TO MOVE HER ARM; FELT COLD; BODY ACHES; CRAWLING SKIN SENSATION; SWEATING; FELT SICK; HEADACHE; SORE ARM; DIZZINESS; RED FACE; FLUSHING OF FACE; ITCHY FACE; DID NOT FEEL GREAT; BURNING PAIN IN UPPER LEFT ABDOMEN; NODE/SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ehlers-danlos syndrome, and other pre-existing medical conditions included no breastfeeding.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 17:00 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced burning pain in upper left abdomen. On MAY-2021, the subject experienced node/swelling at injection site. On 03-MAY-2021, the subject experienced dizziness. On 03-MAY-2021, the subject experienced red face. On 03-MAY-2021, the subject experienced flushing of face. On 03-MAY-2021, the subject experienced itchy face. On 03-MAY-2021, the subject experienced did not feel great. On 03-MAY-2021, the subject experienced sore arm. On 04-MAY-2021, the subject experienced body aches. On 04-MAY-2021, the subject experienced crawling skin sensation. On 04-MAY-2021, the subject experienced sweating. On 04-MAY-2021, the subject experienced unable to to move her arm. On 04-MAY-2021, the subject experienced felt cold. On 04-MAY-2021, the subject experienced felt sick. On 04-MAY-2021, the subject experienced headache. Laboratory data included: Pain scale (NR: not provided) 4/10. On 05-MAY-2021, the subject experienced very bad diarrhea. Laboratory data included: Pain scale (NR: not provided) 6/10 (headache worsened). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red face, flushing of face, and itchy face on 03-MAY-2021, and crawling skin sensation on 05-MAY-2021, was recovering from unable to to move her arm, had not recovered from dizziness, sore arm, felt sick, body aches, headache, burning pain in upper left abdomen, very bad diarrhea, and node/swelling at injection site, and the outcome of sweating, felt cold and did not feel great was not reported. This report was non-serious. This case, from the same reporter is linked to 20210509350.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dizziness, Feeling abnormal, Lower respiratory tract infection
Clinical narrative: CHEST COLD; FEELING SICK; FEVER; PRESSURE IN CHEST; COUGHING ON AND OFF; DIZZINESS; NOT FEELING GREAT; SORE ARM; This spontaneous report received from a consumer concerned a 27 year old white, hispanic or latino 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: 203A21A, expiry: 23/JUN/2021) dose was not reported,1 total administered administered on 03-MAY-2021, 17:00 for prophylactic vaccination. No concomitant medications were reported.  On 03-MAY-2021, after 30 to 50 minutes of vaccination, the patient started feeling not sober, dizzy, not feeling great and sore arm. On 04-MAY-2021, (Tuesday), the patient woke up feeling really sick, feeling feverish then felt better during the afternoon (around 5 pm). The patient felt like he had a chest cold, he was clearing his throat more often, feels a kind of pressure in his chest (but no shortness of breath) and was coughing on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, feeling sick, and fever on 04-MAY-2021, had not recovered from cough, and pressure in chest, and the outcome of sore arm, chest cold and feeling bad was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210509097 (same reporter).; Sender's Comments: V0;20210509350-covid-19 vaccine ad26.cov2.s-Chest Cold. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: CHEST COLD; FEELING SICK; FEVER; PRESSURE IN CHEST; COUGHING ON AND OFF; DIZZINESS; NOT FEELING GREAT; SORE ARM; This spontaneous report received from a consumer concerned a 27 year old white, hispanic or latino 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: 203A21A, expiry: 23/JUN/2021) dose was not reported,1 total administered administered on 03-MAY-2021, 17:00 for prophylactic vaccination. No concomitant medications were reported.  On 03-MAY-2021, after 30 to 50 minutes of vaccination, the patient started feeling not sober, dizzy, not feeling great and sore arm. On 04-MAY-2021, (Tuesday), the patient woke up feeling really sick, feeling feverish then felt better during the afternoon (around 5 pm). The patient felt like he had a chest cold, he was clearing his throat more often, feels a kind of pressure in his chest (but no shortness of breath) and was coughing on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, feeling sick, and fever on 04-MAY-2021, had not recovered from cough, and pressure in chest, and the outcome of sore arm, chest cold and feeling bad was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210509097 (same reporter).; Sender's Comments: V0;20210509350-covid-19 vaccine ad26.cov2.s-Chest Cold. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Chills, Dehydration, Pyrexia, Rash
Clinical narrative: DEHYDRATION; RASH; CHILLS; HIGH FEVER; ANAPHYLACTIC SHOCK; This spontaneous report received from a patient concerned a female 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 not reported) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-APR-2021, (after she had vaccine) patient had experienced the anaphylactic shock. She had a high fever and chills the same day she received the vaccine. On 15-APR-2021, she had a rash covering the entirety of her body. She called her PCP (Primary care physician) and was told to went to the emergency room but refused because of covid rates in her city. She had gone to urgent care instead and was given a benadryl shot and a prescription for steroid. The same day, the rash cleared up so she had not started the prescription again. On 17-APR-2021 the rashes were back, so she started the prescription again and she went to hospital and she was diagnosed with dehydration. She was given a new dose of benadryl, pepcid, and solumedrol for the treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anaphylactic shock, dehydration, rash, high fever and chills was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210509845- covid-19 vaccine ad26.cov2.s -Anaphylactic shock, Dehydration This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210509845- covid-19 vaccine ad26.cov2.s -Rash. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Computerised tomogram, Fibrin D dimer, Muscular weakness
Clinical narrative: CHEST PAIN; RIGHT HAND/WRIST WEAKNESS; REDUCED HAND/GRIP STRENGTH; PLEURISY; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, non alcohol user, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced pleurisy. Laboratory data included: Computerised tomogram (NR: not provided) It was clear, and Fibrin D dimer (NR: not provided) Elevated. On APR-2021, the subject experienced reduced hand/grip strength. On 20-APR-2021, the subject experienced chest pain. On 20-APR-2021, the subject experienced right hand/wrist weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 30-APR-2021, had not recovered from right hand/wrist weakness, and the outcome of reduced hand/grip strength and pleurisy was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pleurisy
Clinical narrative: CHEST PAIN; RIGHT HAND/WRIST WEAKNESS; REDUCED HAND/GRIP STRENGTH; PLEURISY; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, non alcohol user, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced pleurisy. Laboratory data included: Computerised tomogram (NR: not provided) It was clear, and Fibrin D dimer (NR: not provided) Elevated. On APR-2021, the subject experienced reduced hand/grip strength. On 20-APR-2021, the subject experienced chest pain. On 20-APR-2021, the subject experienced right hand/wrist weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 30-APR-2021, had not recovered from right hand/wrist weakness, and the outcome of reduced hand/grip strength and pleurisy was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED  TO PATIENT PAST ITS TEMPERATURE  EXCURSION; INCORRECT STORAGE OF DRUG; This spontaneous report received from a patient concerned a female 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 06-MAY-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 06-MAY-2021, the subject experienced vaccine administered to subject past its temperature excursion. On 06-MAY-2021, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to patient past its temperature excursion and incorrect storage of drug was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FELT BAD; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (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 felt bad. The action taken with covid-19 vaccine was not applicable. The outcome of felt bad was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Eye pain, Headache, Laboratory test
Clinical narrative: EYE PAIN; SEVERE HEADACHE; FEVER; FEELING THIRSTY; FELT MASSIVE PAIN RADIATING IN BODY AND PAIN IN LEGS AND ARMS; BLURRY VISION AND WHITE CLOUD OVER EYES; FELT LIKE LOSING SIGHT; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient did have no known drug allergies and no known health conditions and not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced felt like losing sight. On 2021, the subject experienced blurry vision and white cloud over eyes. On 2021, the subject experienced felt massive pain radiating in body and pain in legs and arms. Laboratory data included: CAT scan (NR: not provided) couldn't diagnose, Electrocardiogram (NR: not provided) couldn't diagnose, Eye exam (NR: not provided) couldn't diagnose, Lab test (NR: not provided) didn't see any blockage and couldn't figure out, and MRI (NR: not provided) couldn't diagnose. On 08-MAR-2021, the subject experienced feeling thirsty. On 09-MAR-2021, the subject experienced eye pain. On 09-MAR-2021, the subject experienced severe headache. On 09-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: macrogol 400/propylene glycol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eye pain, blurry vision and white cloud over eyes, and felt massive pain radiating in body and pain in legs and arms, and the outcome of feeling thirsty, severe headache, fever and felt like losing sight was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.