chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Electromyogram, Laboratory test, Magnetic resonance imaging, Magnetic resonance imaging head
Clinical narrative: LUPUS; This spontaneous report received from a patient concerned a 69 year old white of unspecified sex and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Patient never had arthritis or lupus. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, 1 total, start therapy date were not reported to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had increased joint pain which got severe. They sent patient to neurologist and did Laboratory test MRI brain (NR: not provided) unknown and MRI (NR: not provided) diagnosed with lupus. When patient asked them could it be from vaccine. They said that they couldn't rule it out or say for sure. Patient was walking with a cane now. Patient used to run. Patient's ANA (Antinuclear antibody test) Laboratory test (NR: not provided) high (5120). Since APR-2021, the patient had increased difficulty to move joints and difficulty balancing. Patient had multiple evaluations from primary physician, cardiologist who ruled out heart and neurologist. Laboratory data (dates unspecified) included: Blood test (NR: not provided) normal, Electromyography (EMG) (NR: not provided) abnormal (EMG with neuropathy that looked like autoimmune). On 18-OCT-2021, Laboratory data included: EMG (NR: not provided) unknown. The patient visited to physician office. The action taken with covid-19 vaccine was not applicable. The outcome of lupus was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211036658--COVID-19 VACCINE - lupus. 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: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: LUPUS; This spontaneous report received from a patient concerned a 69 year old white of unspecified sex and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Patient never had arthritis or lupus. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, 1 total, start therapy date were not reported to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had increased joint pain which got severe. They sent patient to neurologist and did Laboratory test MRI brain (NR: not provided) unknown and MRI (NR: not provided) diagnosed with lupus. When patient asked them could it be from vaccine. They said that they couldn't rule it out or say for sure. Patient was walking with a cane now. Patient used to run. Patient's ANA (Antinuclear antibody test) Laboratory test (NR: not provided) high (5120). Since APR-2021, the patient had increased difficulty to move joints and difficulty balancing. Patient had multiple evaluations from primary physician, cardiologist who ruled out heart and neurologist. Laboratory data (dates unspecified) included: Blood test (NR: not provided) normal, Electromyography (EMG) (NR: not provided) abnormal (EMG with neuropathy that looked like autoimmune). On 18-OCT-2021, Laboratory data included: EMG (NR: not provided) unknown. The patient visited to physician office. The action taken with covid-19 vaccine was not applicable. The outcome of lupus was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211036658--COVID-19 VACCINE - lupus. 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: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEURITIS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of administration not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on 04-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had a neurologic complication diagnosed as peripheral neuritis concerned by primary care physician. She had arm pain, weakness with tingling and weakness in her legs. Her doctor told her to give it time and she was reporting improvement in strength but still had tingling mainly in her legs. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from peripheral neuritis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211036875-covid-19 vaccine -Peripheral neuritis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Condition aggravated, Psoriasis, Therapeutic response unexpected
Clinical narrative: PSORIASIS; FLARE UP; UNEXPECTED BENEFIT; SORE JOINTS AFTER COVID-19 VACCINE; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose and frequency were not reported from an unspecified date to 12-MAY-2021 for moderate to severe adult crohn's disease, and ankylosing spondylitis. No concomitant medications were reported. On an unspecified date, the patient experienced psoriasis, flare up, unexpected benefit, and sore joints after covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from psoriasis, and the outcome of flare up, unexpected benefit and sore joints after covid-19 vaccine was not reported. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a physician concerned a 78 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 14-OCT-2021 09:49 for prophylactic vaccination. No concomitant medications were reported. On 14-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Pain in extremity
Clinical narrative: PAIN IN ARM; HEADACHE; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 09-OCT-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for non-infectious intermediate posterior and panuveitis ankylosing spondylitis. No concomitant medications were reported. On 10-OCT-2021, the patient experienced pain in arm. On 10-OCT-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm, and headache on 11-OCT-2021. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 19 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, and expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211038507, 20211038614, 20211002617, 20211034734, 20211038664, 20211038411, 20211039749, 20211038442, 20211040433 and 20211039732.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211002617 and 20211038614.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Illness
Clinical narrative: SICKEST; CHILLS ALL NIGHT; TERRIBLE HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sickest, chills all night, and terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sickest, chills all night and terrible headache was not reported. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 21 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 201A21A expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211002617, 20211038507 and 20211038614.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Post-acute COVID-19 syndrome, Pyrexia, SARS-CoV-2 test
Clinical narrative: POST COVID ISSUES IN LUNGS; CONFIRMED CLINICAL VACCINATION FAILURE; BREAKTHROUGH COVID INFECTION; CHILLS; FEVER; This spontaneous report received from a consumer concerned a 20 year old not. Initial information was processed along with the additional information received on 19-OCT-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the reporter noted that the patient had fever and chills when having the vaccine initially, which was severe and lasted a few days. On AUG-2021, the patient experienced confirmed clinical vaccination failure. On AUG-2021, had a breakthrough covid infection. The patient received the positive test result in London while visiting her parents. Reporter was unsure of how severe the symptoms were, confirmed that the patient have covid symptoms. The patient did not get hospitalized, still has post-covid issues in terms of lungs. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breakthrough covid infection, and chills, and fever on APR-2021, had not recovered from post covid issues in lungs, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000198165.; Sender's Comments: V0; 20211038430-COVID-19 VACCINE AD26.COV2.S- confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: POST COVID ISSUES IN LUNGS; CONFIRMED CLINICAL VACCINATION FAILURE; BREAKTHROUGH COVID INFECTION; CHILLS; FEVER; This spontaneous report received from a consumer concerned a 20 year old not. Initial information was processed along with the additional information received on 19-OCT-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the reporter noted that the patient had fever and chills when having the vaccine initially, which was severe and lasted a few days. On AUG-2021, the patient experienced confirmed clinical vaccination failure. On AUG-2021, had a breakthrough covid infection. The patient received the positive test result in London while visiting her parents. Reporter was unsure of how severe the symptoms were, confirmed that the patient have covid symptoms. The patient did not get hospitalized, still has post-covid issues in terms of lungs. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breakthrough covid infection, and chills, and fever on APR-2021, had not recovered from post covid issues in lungs, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000198165.; Sender's Comments: V0; 20211038430-COVID-19 VACCINE AD26.COV2.S- confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned an 18 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, and expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211002617, 20211038507 and 20211038614.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned an 18 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211002617, 20211034734, 20211038269, 20211038411, 20211038664, 20211039749, 20211038614, 20211039732, 20211038269, 20211038442 and 20211040433.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 55 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211038507, 20211038269, 20211039749, 20211039732, 20211002617, 20211038442, 20211038411, 20211038664, 20211034734, 20211038276 and 20211038664.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned an 18 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211038507,20211002617, 20211034734, 20211038269, 20211038411,20211039749, 20211038614, 20211039732, 20211038269, 20211038442 and 20211040433.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Flushing, Malaise, Rash macular
Clinical narrative: QUARTER SIZE 6-8 INCHES REDNESS AROUND THE CENTER OF CHEST HEART AREA; FLUSHED CHEST; BLOTCHY CHEST AND AROUND NECK; FELT A LITTLE UNDER THE WEATHER; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, non-smoker, grass allergy, and animal allergy, and other pre-existing medical conditions included: The patient had no medical issues and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: UNKNOWN) dose was not reported, administered on 18-OCT-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 19-OCT-2021, the patient experienced felt a little under the weather.  On 20-OCT-2021, the patient experienced quarter size 6-8 inches redness around the center of chest heart area. On 20-OCT-2021, the patient experienced flushed chest. On 20-OCT-2021, the patient experienced blotchy chest and around neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt a little under the weather, and the outcome of quarter size 6-8 inches redness around the center of chest heart area, blotchy chest and around neck and flushed chest was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: A BIT OF SORENESS IN ARM; A STRANGE HEADACHE THE DAY AFTER VACCINATION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced a bit of soreness in arm, and a strange headache the day after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a bit of soreness in arm and a strange headache the day after vaccination was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: NON-SPECIFIC ISSUES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 patient experienced non-specific issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of non-specific issues was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Pain, Pyrexia, Splenomegaly
Clinical narrative: ENLARGED SPLEEN (VERY PRONOUNCED); ACHES; FEVER; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune disease, and seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included methotrexate for autoimmune disease. On 01-APR-2021, the patient experienced aches. On 01-APR-2021, the patient experienced fever. On 05-OCT-2021, the patient experienced enlarged spleen (very pronounced). Laboratory data included: CT scan (NR: not provided) enlarged spleen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, and fever on 02-APR-2021, and the outcome of enlarged spleen (very pronounced) was not reported. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered
Clinical narrative: ADMINISTRATION ERROR (ONE DOSE ADMINISTERED FROM A PUNCTURED VIAL); EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 07-MAR-2021) dose was not reported, administered on 20-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-OCT-2021, the patient experienced administration error (one dose administered from a punctured vial). On 20-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error (one dose administered from a punctured vial) and expired vaccine administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 53 year old male. The patient's weight was 175 pounds, and height was 70 inches. The patient's concurrent conditions included: hypertension, penicillin allergy, sulfa drug allergy, seafood allergy, fish allergy, seasonal allergies, alcohol user, and smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027 expiry: 29-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. Concomitant medications included apixaban for hypertension.  On 20-OCT-2021, the patient experienced confirmed covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection. This report was non-serious. This case, from the same reporter is linked to 20211039865.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 51 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: 21/SEP/2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211038507, 20211038614, 20211038664, 20211038269, 20211039749, 20211038442, 20211038411, 20211002617 and 20211034734.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 54 year old female. The patient's weight was 135 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, and expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211038507, 20211038614, 20211038664, 20211040433, 20211038442, 20211038411, 20211034734, 20211002617 and 20211038269.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 20-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Chills, Erythema, Headache, Injection site pain
Clinical narrative: SWOLLEN FACE; VERY RED FACE; TYPICAL SIDE EFFECTS; CHILLS; BIT OF NAUSEA; INJECTION SITE VERY SORE; HEADACHES; This spontaneous report received from a consumer concerned a 50 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: UNKNOWN) dose was not reported, administered on 19-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-OCT-2021, the patient experienced swollen face. On 19-OCT-2021, the patient experienced very red face. On 19-OCT-2021, the patient experienced typical side effects. On 19-OCT-2021, the patient experienced chills. On 19-OCT-2021, the patient experienced bit of nausea. On 19-OCT-2021, the patient experienced injection site very sore. On 19-OCT-2021, the patient experienced headaches. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bit of nausea, injection site very sore, chills, headaches, swollen face, and very red face, and the outcome of typical side effects was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Swelling face
Clinical narrative: SWOLLEN FACE; VERY RED FACE; TYPICAL SIDE EFFECTS; CHILLS; BIT OF NAUSEA; INJECTION SITE VERY SORE; HEADACHES; This spontaneous report received from a consumer concerned a 50 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: UNKNOWN) dose was not reported, administered on 19-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-OCT-2021, the patient experienced swollen face. On 19-OCT-2021, the patient experienced very red face. On 19-OCT-2021, the patient experienced typical side effects. On 19-OCT-2021, the patient experienced chills. On 19-OCT-2021, the patient experienced bit of nausea. On 19-OCT-2021, the patient experienced injection site very sore. On 19-OCT-2021, the patient experienced headaches. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bit of nausea, injection site very sore, chills, headaches, swollen face, and very red face, and the outcome of typical side effects was not reported. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Limb deformity, Skin discolouration, Skin indentation
Clinical narrative: RIGHT ARM DEFORM; SKIN INDENTATION LOOKS LIKE HOLE IN ARM; SKIN TURNING WHITE; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the patient experienced right arm deform. On MAY-2021, the patient experienced skin indentation looks like hole in arm. On MAY-2021, the patient experienced skin turning . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm deform, skin indentation looks like hole in arm, and skin turning . This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Feeling abnormal, Pain assessment, Renal pain
Clinical narrative: EXCRUCIATING ABDOMINAL PAIN; EXCRUCIATING BACK PAIN; EXCRUCIATING KIDNEY PAIN; EXCRUCIATING SPINE PAIN (ACROSS ENTIRE SPINE); SENSATION OF BUBBLE TO HEAD; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included: lost eyesight, and anaphylactic reaction, and concurrent conditions included: chronic regional pain syndrome, latex allergy, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with codeine, hydromorphone hydrochloride, fentanyl, gabapentin, oxycodone, oxycodone hydrochloride, and pseudoephedrine hydrochloride for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288 and expiry: 30-OCT-2021) dose was not reported, administered on 19-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-OCT-2021, the patient experienced excruciating abdominal pain. On 19-OCT-2021, the patient experienced excruciating back pain. On 19-OCT-2021, the patient experienced excruciating kidney pain. On 19-OCT-2021, the patient experienced excruciating spine pain (across entire spine). On 19-OCT-2021, the patient experienced sensation of bubble to head. Laboratory data included: Pain scale (NR: not provided) 10. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensation of bubble to head on 19-OCT-2021, and had not recovered from excruciating abdominal pain, excruciating back pain, excruciating kidney pain, and excruciating spine pain (across entire spine). This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain
Clinical narrative: EXCRUCIATING ABDOMINAL PAIN; EXCRUCIATING BACK PAIN; EXCRUCIATING KIDNEY PAIN; EXCRUCIATING SPINE PAIN (ACROSS ENTIRE SPINE); SENSATION OF BUBBLE TO HEAD; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included: lost eyesight, and anaphylactic reaction, and concurrent conditions included: chronic regional pain syndrome, latex allergy, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with codeine, hydromorphone hydrochloride, fentanyl, gabapentin, oxycodone, oxycodone hydrochloride, and pseudoephedrine hydrochloride for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288 and expiry: 30-OCT-2021) dose was not reported, administered on 19-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-OCT-2021, the patient experienced excruciating abdominal pain. On 19-OCT-2021, the patient experienced excruciating back pain. On 19-OCT-2021, the patient experienced excruciating kidney pain. On 19-OCT-2021, the patient experienced excruciating spine pain (across entire spine). On 19-OCT-2021, the patient experienced sensation of bubble to head. Laboratory data included: Pain scale (NR: not provided) 10. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensation of bubble to head on 19-OCT-2021, and had not recovered from excruciating abdominal pain, excruciating back pain, excruciating kidney pain, and excruciating spine pain (across entire spine). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced fever. Laboratory data (dates unspecified) included: Body temperature (: not provided) 37-39. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: 11-DEC-2021) dose was not reported, administered on 19-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-OCT-2021, the patient experienced incorrect product storage. On 19-OCT-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and out of specification product use was not reported. This report was non-serious.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pruritus, Secretion discharge, Sinus disorder, Vaccination site pruritus
Clinical narrative: sinus issues, occasional sneezing; Mucus that is discolored; tickle in one side of nostril; after receiving the 3rd dose she has sinus issues; A few days later the itching moved down to her left hand then went away.; Just below the injection site she had itching; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (sinus issues, occasional sneezing), SECRETION DISCHARGE (Mucus that is discolored), FEELING ABNORMAL (tickle in one side of nostril), SINUS DISORDER (after receiving the 3rd dose she has sinus issues) and PRURITUS (A few days later the itching moved down to her left hand then went away.) in an 82-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.     Concurrent medical conditions included Anxiety (due to the pandemic, she did not think it was related to the vaccine).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUS DISORDER (sinus issues, occasional sneezing), SECRETION DISCHARGE (Mucus that is discolored), FEELING ABNORMAL (tickle in one side of nostril), SINUS DISORDER (after receiving the 3rd dose she has sinus issues), PRURITUS (A few days later the itching moved down to her left hand then went away.) and VACCINATION SITE PRURITUS (Just below the injection site she had itching). At the time of the report, SINUS DISORDER (sinus issues, occasional sneezing), SECRETION DISCHARGE (Mucus that is discolored), FEELING ABNORMAL (tickle in one side of nostril), SINUS DISORDER (after receiving the 3rd dose she has sinus issues), PRURITUS (A few days later the itching moved down to her left hand then went away.) and VACCINATION SITE PRURITUS (Just below the injection site she had itching) outcome was unknown.            No concomitant medication was provided. No treatment information was provided.  On 24-Sep-2021 she had a physical and the blood work showed she had very low antibodies that waned.  Second dose events were updated in follow-up source document   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Followup received on 13OC2021. New events were added
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Product dose omission issue
Clinical narrative: missed second dose; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and PRODUCT DOSE OMISSION ISSUE (missed second dose) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced NAUSEA (Nausea). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second dose). At the time of the report, NAUSEA (Nausea) and PRODUCT DOSE OMISSION ISSUE (missed second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Patient reported that no treatment medication was taken for the event.   This case was linked to MOD-2021-347607, MOD-2021-347368 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: shaking; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (shaking). At the time of the report, TREMOR (shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment reported.   This case was linked to MOD21-151493 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm after third dose; extremely tired after third dose/was tired for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after third dose) and FATIGUE (extremely tired after third dose/was tired for 2 days) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0273-98, 031M2DA and 038K2DA) for COVID-19 vaccination.     No medical history for patient was reported.  Concomitant products included VITAMINS NOS for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced PAIN IN EXTREMITY (sore arm after third dose) and FATIGUE (extremely tired after third dose/was tired for 2 days). On 20-Aug-2021, FATIGUE (extremely tired after third dose/was tired for 2 days) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm after third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was not sure of the 3rd dose lot number. Patient had events on the same night of the dose. Patient took good sleep and hot water bottle to sore arm.  No treatment medications were reported.   This case was linked to MOD-2021-350343, MOD-2021-350385 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow up document received on 12 Oct 2021.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injection site arm after first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm after first vaccination) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore injection site arm after first vaccination). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm after first vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment medications were reported.   This case was linked to MOD-2021-350471 (Patient Link).