chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Lethargy
Clinical narrative: Had pain at the injection site; Lethargy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in the past).   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain and lethargy. On an unknown date, the outcome of the injection site pain and lethargy were recovered/resolved.   It was unknown if the reporter considered the injection site pain and lethargy to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in her left arm and had pain at the injection site and lethargy.  The reporter stated she received the COVID 19 vaccine, sometime after between the 1st and 2nd dose of the Shingrix vaccine. The reporter consent to follow up. For tolerance of 2nd dose refer case US2021AMR088731.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088731:Same reporter. 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose in 2018. Late for the 2nd dose.; This case was reported by a other health professional and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The reporter stated that the patient received the first dose but did not receive the second dose till the time of reporting which led to incomplete course of vaccination. The reporter wanted to know if the series needs to be restarted. The reporter consented to follow up. No further information was reported.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Feeling cold, Musculoskeletal chest pain, Tremor
Clinical narrative: SHAKINESS (LIKE SEIZURE); CHEST AND RIBS BEING PAINFUL; FELLING COLD; FEELING AWFUL; This spontaneous report received from a patient and concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: 25/MAY/2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The vaccination site was left arm. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced shakiness (like seizure), chest and ribs being painful, felling cold and feeling awful. The patient felt "gassed out", but not as "offal as yesterday". The action taken with COVID-19 vaccine ad26.cov2.s was not reported. The patient recovered from shakiness (like seizure) on 06-MAR-2021, and chest and ribs being painful on 07-MAR-2021, and was recovering from felling cold, and feeling awful. This report was serious (Other Medically Important Condition).; Sender's Comments: Shakiness (like seizure), chest and ribs being painful, felling cold and feeling awful. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are no other factors more likely to be associated with the event(s) than the drug.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Feeling abnormal, Feeling cold, Musculoskeletal chest pain, Seizure like phenomena
Clinical narrative: SHAKINESS (LIKE SEIZURE); CHEST AND RIBS BEING PAINFUL; FELLING COLD; FEELING AWFUL; This spontaneous report received from a patient and concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: 25/MAY/2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The vaccination site was left arm. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced shakiness (like seizure), chest and ribs being painful, felling cold and feeling awful. The patient felt "gassed out", but not as "offal as yesterday". The action taken with COVID-19 vaccine ad26.cov2.s was not reported. The patient recovered from shakiness (like seizure) on 06-MAR-2021, and chest and ribs being painful on 07-MAR-2021, and was recovering from felling cold, and feeling awful. This report was serious (Other Medically Important Condition).; Sender's Comments: Shakiness (like seizure), chest and ribs being painful, felling cold and feeling awful. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are no other factors more likely to be associated with the event(s) than the drug.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: SHAKINESS (LIKE SEIZURE); CHEST AND RIBS BEING PAINFUL; FELLING COLD; FEELING AWFUL; This spontaneous report received from a patient and concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: 25/MAY/2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The vaccination site was left arm. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced shakiness (like seizure), chest and ribs being painful, felling cold and feeling awful. The patient felt "gassed out", but not as "offal as yesterday". The action taken with COVID-19 vaccine ad26.cov2.s was not reported. The patient recovered from shakiness (like seizure) on 06-MAR-2021, and chest and ribs being painful on 07-MAR-2021, and was recovering from felling cold, and feeling awful. This report was serious (Other Medically Important Condition).; Sender's Comments: Shakiness (like seizure), chest and ribs being painful, felling cold and feeling awful. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are no other factors more likely to be associated with the event(s) than the drug.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: UNDER DOSE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced under dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of under dose was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: PARTIAL ADMINISTRATION OF THE  VACCINE DOSE DUE TO A FAULTY  SYRINGE; PARTIAL ADMINISTRATION OF THE  VACCINE DOSE DUE TO A FAULTY  SYRINGE  (PRODUCT QUALITY ISSUE); This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. Batch number was not reported has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced partial administration of the vaccine dose due to a faulty syringe. On 05-MAR-2021, the subject experienced partial administration of the vaccine dose due to a faulty syringe (product quality issue). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the partial administration of the vaccine dose due to a faulty syringe and partial administration of the vaccine dose due to a faulty syringe (product quality issue) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Pyrexia
Clinical narrative: JOINT PAIN; CHILLS; FEVER 103.1; HEADACHE; 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, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 05-MAR-2021, the subject experienced joint pain. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced fever 103.1. On 05-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103.1 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, chills, fever 103.1, and headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: CHILLS; FEVER OF 100.7; This spontaneous report received from a patient concerned a 39 year old White (Not Hispanic/Latino) male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, high cholesterol, acid reflux, sleep apnea, sulfa allergy, alcohol use, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and  expiry: not reported) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever of 100.7. Laboratory data included: Body temperature (NR: not provided) 100.7 (not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and fever of 100.7. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Influenza like illness
Clinical narrative: DECREASED APPETITE; FLU LIKE SYMPTOMS; COLD CHILLS; TIREDNESS; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight was 170 pounds, and height was 165.1 centimeters. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included no medical history. The patient did not have any history of vaccine allergy, drug abuse and did not have acute illness 30 days prior to vaccination. The patient did not have significant family history of diseases or hospitalizations. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 13:08 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced cold chills. On 11-MAR-2021, the subject experienced tiredness. On 11-MAR-2021, the subject experienced injection site pain. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021 20:00, the subject experienced flu like symptoms. On 12-MAR-2021, the subject experienced decreased appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 12-MAR-2021, was recovering from cold chills, and flu like symptoms, and had not recovered from decreased appetite, tiredness, and injection site pain. 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: DECREASED APPETITE; FLU LIKE SYMPTOMS; COLD CHILLS; TIREDNESS; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight was 170 pounds, and height was 165.1 centimeters. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included no medical history. The patient did not have any history of vaccine allergy, drug abuse and did not have acute illness 30 days prior to vaccination. The patient did not have significant family history of diseases or hospitalizations. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 13:08 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced cold chills. On 11-MAR-2021, the subject experienced tiredness. On 11-MAR-2021, the subject experienced injection site pain. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021 20:00, the subject experienced flu like symptoms. On 12-MAR-2021, the subject experienced decreased appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 12-MAR-2021, was recovering from cold chills, and flu like symptoms, and had not recovered from decreased appetite, tiredness, and injection site pain. 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: FATIGUE; FELT HORRIBLE; SKIN BURNING AND HURTS TO TOUCH/SKIN ON FIRE/PAINFUL SKIN; NAUSEA; CHILLS; DIARRHEA; VOMITTING; LEG HEAVINESS; LEG PAIN/INTERMITTENT PAIN IN HIPS, BACK, DOWN TO MY KNEES; WEAKNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection, double lung pneumonia, leg pain, and leg heaviness, and concurrent conditions included arthritis, and fatigue, and other pre-existing medical conditions included patient second shingles shot begins in february. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced leg heaviness. On 2021, the subject experienced leg pain/intermittent pain in hips, back, down to my knees. On 2021, the subject experienced weakness. On 19-MAR-2021, the subject experienced diarrhea. On 19-MAR-2021, the subject experienced vomitting. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021 16:00, the subject experienced nausea. On 19-MAR-2021 23:00, the subject experienced skin burning and hurts to touch/skin on fire/painful skin. On 20-MAR-2021, the subject experienced felt horrible. On 25-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No clots found. On an unspecified date, the subject experienced fatigue. Treatment medications (dates unspecified) included: calcium chloride dihydrate/fructooligosaccharides/glucose/magnesium chloride hexahydrate/potassium chloride/sodium chloride/sodium lactate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomitting, and nausea on 20-MAR-2021, was recovering from diarrhea, had not recovered from chills, skin burning and hurts to touch/skin on fire/painful skin, leg pain/intermittent pain in hips, back, down to my knees, weakness, fatigue, and leg heaviness, and the outcome of felt horrible was not reported. This report was non-serious.; Sender's Comments: V1:Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Nausea, Pain in extremity, Skin burning sensation, Ultrasound scan
Clinical narrative: FATIGUE; FELT HORRIBLE; SKIN BURNING AND HURTS TO TOUCH/SKIN ON FIRE/PAINFUL SKIN; NAUSEA; CHILLS; DIARRHEA; VOMITTING; LEG HEAVINESS; LEG PAIN/INTERMITTENT PAIN IN HIPS, BACK, DOWN TO MY KNEES; WEAKNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection, double lung pneumonia, leg pain, and leg heaviness, and concurrent conditions included arthritis, and fatigue, and other pre-existing medical conditions included patient second shingles shot begins in february. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced leg heaviness. On 2021, the subject experienced leg pain/intermittent pain in hips, back, down to my knees. On 2021, the subject experienced weakness. On 19-MAR-2021, the subject experienced diarrhea. On 19-MAR-2021, the subject experienced vomitting. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021 16:00, the subject experienced nausea. On 19-MAR-2021 23:00, the subject experienced skin burning and hurts to touch/skin on fire/painful skin. On 20-MAR-2021, the subject experienced felt horrible. On 25-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No clots found. On an unspecified date, the subject experienced fatigue. Treatment medications (dates unspecified) included: calcium chloride dihydrate/fructooligosaccharides/glucose/magnesium chloride hexahydrate/potassium chloride/sodium chloride/sodium lactate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomitting, and nausea on 20-MAR-2021, was recovering from diarrhea, had not recovered from chills, skin burning and hurts to touch/skin on fire/painful skin, leg pain/intermittent pain in hips, back, down to my knees, weakness, fatigue, and leg heaviness, and the outcome of felt horrible was not reported. This report was non-serious.; Sender's Comments: V1:Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: FATIGUE; FELT HORRIBLE; SKIN BURNING AND HURTS TO TOUCH/SKIN ON FIRE/PAINFUL SKIN; NAUSEA; CHILLS; DIARRHEA; VOMITTING; LEG HEAVINESS; LEG PAIN/INTERMITTENT PAIN IN HIPS, BACK, DOWN TO MY KNEES; WEAKNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection, double lung pneumonia, leg pain, and leg heaviness, and concurrent conditions included arthritis, and fatigue, and other pre-existing medical conditions included patient second shingles shot begins in february. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced leg heaviness. On 2021, the subject experienced leg pain/intermittent pain in hips, back, down to my knees. On 2021, the subject experienced weakness. On 19-MAR-2021, the subject experienced diarrhea. On 19-MAR-2021, the subject experienced vomitting. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021 16:00, the subject experienced nausea. On 19-MAR-2021 23:00, the subject experienced skin burning and hurts to touch/skin on fire/painful skin. On 20-MAR-2021, the subject experienced felt horrible. On 25-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No clots found. On an unspecified date, the subject experienced fatigue. Treatment medications (dates unspecified) included: calcium chloride dihydrate/fructooligosaccharides/glucose/magnesium chloride hexahydrate/potassium chloride/sodium chloride/sodium lactate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomitting, and nausea on 20-MAR-2021, was recovering from diarrhea, had not recovered from chills, skin burning and hurts to touch/skin on fire/painful skin, leg pain/intermittent pain in hips, back, down to my knees, weakness, fatigue, and leg heaviness, and the outcome of felt horrible was not reported. This report was non-serious.; Sender's Comments: V1:Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Peripheral swelling, Pyrexia
Clinical narrative: SWOLLEN ARM; RED ARMS; SLIGHT FEVER; SORENESS AT THE SITE OF INJECTION; This spontaneous report received from a patient concerned a 78 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the subject experienced soreness at the site of injection. On 02-APR-2021, the subject experienced slight fever. On 02-APR-2021, the subject experienced swollen arm. On 02-APR-2021, the subject experienced red arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at the site of injection, slight fever, swollen arm, and red arms on 02-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Delusion, Nightmare
Clinical narrative: NIGHTTIME DELUSIONS; NIGHTMARES; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) on 02-APR-2021 was received on 02-APR-2021 and 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, 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 nighttime delusions, and nightmares. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nighttime delusions and nightmares was not reported. 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Headache, Laboratory test, Nausea, Pharyngeal swelling
Clinical narrative: THROAT SWELLED UP; STOMACH AND ABDOMINAL AREA SWELLED; HEADACHE; NAUSEA; 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 past medical history included 3.4 to 4.4 aneurysm in the aorta, and aneurysm in the blood vessels in the left side of the brain, and concurrent conditions included allergic to citric acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: 05/APR/2021) dose was not reported, administered on 05-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Lab test (NR: not provided) negative (units unspecified). On 05-APR-2021, the subject experienced throat swelled up. On 05-APR-2021, the subject experienced stomach and abdominal area swelled. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, throat swelled up, and stomach and abdominal area swelled, and the outcome of nausea was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Fatigue, Gastric disorder
Clinical narrative: NAUSEA; FELT ROUGH IN HER STOMACH; TIRED; COLD CHILLS; TEMPERATURE ABOVE 100.1; FEELING OF HAVING FLU; HEADACHE MIDDLE OF FORHEAD; BODY ACHE; This spontaneous report was received from a patient and concerned a female patient with Other race (Not Hispanic/Latino) of an 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: 1808980 and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced body ache.  On 04-APR-2021, the subject experienced cold chills.  On 04-APR-2021, the subject experienced temperature above 100.1.  On 04-APR-2021, the subject experienced feeling of having flu.  On 04-APR-2021, the subject experienced headache middle of forhead.  On 05-APR-2021, the subject experienced tired. On 06-APR-2021, the subject experienced nausea.  On 06-APR-2021, the subject experienced felt rough in her stomach. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) ABOVE 100.1 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the body ache, cold chills, temperature above 100.1, feeling of having flu, tired, headache middle of forhead, nausea and felt rough in her stomach was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Nausea, Pain
Clinical narrative: NAUSEA; FELT ROUGH IN HER STOMACH; TIRED; COLD CHILLS; TEMPERATURE ABOVE 100.1; FEELING OF HAVING FLU; HEADACHE MIDDLE OF FORHEAD; BODY ACHE; This spontaneous report was received from a patient and concerned a female patient with Other race (Not Hispanic/Latino) of an 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: 1808980 and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced body ache.  On 04-APR-2021, the subject experienced cold chills.  On 04-APR-2021, the subject experienced temperature above 100.1.  On 04-APR-2021, the subject experienced feeling of having flu.  On 04-APR-2021, the subject experienced headache middle of forhead.  On 05-APR-2021, the subject experienced tired. On 06-APR-2021, the subject experienced nausea.  On 06-APR-2021, the subject experienced felt rough in her stomach. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) ABOVE 100.1 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the body ache, cold chills, temperature above 100.1, feeling of having flu, tired, headache middle of forhead, nausea and felt rough in her stomach was not reported. This report was non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 19 INFECTION; This spontaneous report received from a patient concerned a 27 year old. 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: 1802072 and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced 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 outcome of covid 19 infection was not reported. 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: Blood test, Confusional state, Dyspnoea, Electrocardiogram, Inflammation
Clinical narrative: NECK PAIN (WITH RADIATION); SHORTNESS OF BREATH; BLURRED VISION; CONFUSION; BULGE IN NECK ON LEFT SIDE/NECK SWELLING; WHOLE LEFT SIDE OF BODY IS  SWOLLEN; SEVERE INFLAMMATION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was 240 pounds, and height was not reported. The patient's concurrent conditions included ankylosing spondylitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 12:05 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Electrocardiogram (NR: not provided) Electrocardiogram (units unspecified). On 03-APR-2021, the subject experienced neck pain (with radiation). On 03-APR-2021, the subject experienced shortness of breath. On 03-APR-2021, the subject experienced blurred vision. On 03-APR-2021, the subject experienced confusion. On 03-APR-2021, the subject experienced bulge in neck on left side/neck swelling. On 03-APR-2021, the subject experienced whole left side of body is swollen. On 03-APR-2021, the subject experienced severe inflammation. On 08-APR-2021, Laboratory data included: Blood test (NR: not provided) blood work. Treatment medications included: diazepam, and prednisone. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) blood work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neck pain (with radiation), shortness of breath, blurred vision, confusion, bulge in neck on left side/neck swelling, whole left side of body is swollen, and severe inflammation. This report was non-serious.; Sender's Comments: V0:20210417102-Ccovid-19 vaccine ad26.cov2.s-Neck pain. 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, UNDERLYING DISEASE
Sex: M
Vaccine: COVID19
Symptoms: Neck mass, Neck pain, Swelling, Vision blurred
Clinical narrative: NECK PAIN (WITH RADIATION); SHORTNESS OF BREATH; BLURRED VISION; CONFUSION; BULGE IN NECK ON LEFT SIDE/NECK SWELLING; WHOLE LEFT SIDE OF BODY IS  SWOLLEN; SEVERE INFLAMMATION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was 240 pounds, and height was not reported. The patient's concurrent conditions included ankylosing spondylitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 12:05 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Electrocardiogram (NR: not provided) Electrocardiogram (units unspecified). On 03-APR-2021, the subject experienced neck pain (with radiation). On 03-APR-2021, the subject experienced shortness of breath. On 03-APR-2021, the subject experienced blurred vision. On 03-APR-2021, the subject experienced confusion. On 03-APR-2021, the subject experienced bulge in neck on left side/neck swelling. On 03-APR-2021, the subject experienced whole left side of body is swollen. On 03-APR-2021, the subject experienced severe inflammation. On 08-APR-2021, Laboratory data included: Blood test (NR: not provided) blood work. Treatment medications included: diazepam, and prednisone. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) blood work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neck pain (with radiation), shortness of breath, blurred vision, confusion, bulge in neck on left side/neck swelling, whole left side of body is swollen, and severe inflammation. This report was non-serious.; Sender's Comments: V0:20210417102-Ccovid-19 vaccine ad26.cov2.s-Neck pain. 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, UNDERLYING DISEASE
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dyspnoea, Fatigue
Clinical narrative: I am having extreme shortness of breath and sharp chest and right shoulder pains. I also feel congested and really exhausted.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching at injection site about one week after receiving vaccine
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I took my vaccination on 4/7/21 at 12:10PM. On 4/13/21 at approximately 2PM I started suffering from very strong headaches, the pain stretched from one side of my head (temple) to the other side of the head. In the evening of  4/13/21 the pain was so great that I was literally pounding my fist on the wall and seriously considered going to the emergency room. I started taking Advil to help deal with these intense headaches. The pain peaked on 4/14/21, this was a day that I spent in bed taking medication (Advil). On 4/15/21 the pain started to subside. By 04/17 I barely registered anymore pain.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Upper-airway cough syndrome
Clinical narrative: Nasal Drip, mostly in the evening.... Bothersome, but not extreme!    Started shortly after the first Moderna/COVID-19 Vaccination on March 16, 2021 & got better. Then started again shortly after the second Moderna/COVID-19 Vaccination of April 13, 2021.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms, chills, body aches, headache,  fever
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain lower, Flatulence, Headache
Clinical narrative: The day of the shot, felt little to no symptoms until developing a slight headache in the evening (around 6:30PM). Fell asleep early at 9PM. Had elevated temp overnight (99.7 at 3am) and chills, woke up with extreme headache that did not resolve until about 4:30PM following day. A few days later on Saturday, developed pain in lower left abdominal area ? felt like cramping or gas. Continued for the next 5 days on and off and is ongoing. Period is not expected for another 10 days and these are unusual symptoms. If pains continue, will seek medical advice.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever 101.4, severe headache
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Deep vein thrombosis, Pulmonary embolism, Subclavian vein thrombosis, Ultrasound Doppler
Clinical narrative: 6 weeks after administration of COVID-19 vaccine developed DVT in right subclavian vein which progressed to a subsegmental PE 2 days after confirmation by ultrasound despite being on Eliquis.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary vein thrombosis, Chest pain, Computerised tomogram thorax abnormal, Condition aggravated, Deep vein thrombosis
Clinical narrative: 6 weeks after administration of COVID-19 vaccine developed DVT in right subclavian vein which progressed to a subsegmental PE 2 days after confirmation by ultrasound despite being on Eliquis.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pain in extremity, Peripheral swelling, Pulmonary vascular disorder, Subclavian vein occlusion
Clinical narrative: 6 weeks after administration of COVID-19 vaccine developed DVT in right subclavian vein which progressed to a subsegmental PE 2 days after confirmation by ultrasound despite being on Eliquis.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Subclavian vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: 6 weeks after administration of COVID-19 vaccine developed DVT in right subclavian vein which progressed to a subsegmental PE 2 days after confirmation by ultrasound despite being on Eliquis.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Hallucination, Headache
Clinical narrative: HALLUCINATIONS; BODY ACHES; FELT LIKE I WENT TO HELL AND BACK; UNCONTROLLABLE CHILLS; FEVER (101.1); HEADACHE; SWELLING IN AXILLA (ARM PIT) ON THE SIDE OF THE INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included COVID-19 on an unspecified date in JUN-2020. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 14:00 p.m. for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced swelling in axilla (arm pit) on the side of the injection site. On 08-APR-2021, by 19:00 p.m. the patient experienced hallucinations, body aches, felt like I went to heck and back, uncontrollable chills, fever (101.1 F) and headache. Laboratory data included: Body temperature (NR: not provided) 101.1 F. The patient reported that, the experience with the COVID vaccine was far worse than having the actual virus. The patient was a critical care nurse caring for COVID patients and this experience was horrible because the patient felt like went to heck and back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the uncontrollable chills, body aches, hallucinations, fever (101.1F), headache, felt like I went to hell and back and swelling in axilla (arm pit) on the side of the injection site was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210417701-COVID-19 VACCINE AD26.COV2.S -HALLUCINATIONS. 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: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: HALLUCINATIONS; BODY ACHES; FELT LIKE I WENT TO HELL AND BACK; UNCONTROLLABLE CHILLS; FEVER (101.1); HEADACHE; SWELLING IN AXILLA (ARM PIT) ON THE SIDE OF THE INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included COVID-19 on an unspecified date in JUN-2020. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 14:00 p.m. for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced swelling in axilla (arm pit) on the side of the injection site. On 08-APR-2021, by 19:00 p.m. the patient experienced hallucinations, body aches, felt like I went to heck and back, uncontrollable chills, fever (101.1 F) and headache. Laboratory data included: Body temperature (NR: not provided) 101.1 F. The patient reported that, the experience with the COVID vaccine was far worse than having the actual virus. The patient was a critical care nurse caring for COVID patients and this experience was horrible because the patient felt like went to heck and back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the uncontrollable chills, body aches, hallucinations, fever (101.1F), headache, felt like I went to hell and back and swelling in axilla (arm pit) on the side of the injection site was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210417701-COVID-19 VACCINE AD26.COV2.S -HALLUCINATIONS. 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Feeling abnormal, Hypertension, Loss of consciousness
Clinical narrative: PT MENTIONED SHE WAS NERVOUS ABOUT GETTING THE SHOT.  AFTER SHE RECEIVED THE SHOT, SHE WENT INTO THE WAITING ROOM AND A FEW MINS LATER, FELT LIKE SHE WAS GOING TO PASS OUT. WE HAD HER LAY ON THE FLOOR AND ELEVATED HER FEET.  SHE PROCEEDED TO PASS OUT.  WE ADMINISTERED THE SMELLING SALTS, SHE WAS SLIGHTLY AWAKE BUT OUT OF IT AND SAID SHE DIDN'T SMELL ANYTHING.  WE LIFTED HER MASK AND DID ANOTHER SMELLING SALT AND SHE "WOKE UP" BUT STILL REMAINDED ON THE FLOOR. SHE FELT WEIRD, EYES REMAINDED CLOSED AND SHE WAS SLIGHTLY CRYING AN SCARED.  WE ASKED HER PARTNER IF THIS HAS EVERY HAPPENED BEFORE AND HE SAID SHE HAS ONLY PASSED OUT B/C OF PAIN NOT ANXIETY.  WE TOOK HER PRESSURE/HEART RATE EVERY 5 MIN FOR 15 MIN.  IT WAS ELEVATED 165/110 (HR 69) AND STAYED AROUND THAT EACH READING.  WE ASKED HER IF SHE WANTED US TO CALL EMT AFTER THE FIRST 5-10 MIN AND SHE WASN'T SURE.  15-20 MIN LATER WE CALLED EMT AND THEY CAME TO ASSIST.  THEY TOOK HER VITALS AND THEN EVENTUALLY HELPED HER SIT UP AND EVENTUALLY SHE WALKED OUT ON HER OWN.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on torso
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: I felt an nodule on my left collarbone its was moving while I moved my neck , It is not painful and pea sized I didn?t get it checked by a doctor yet
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Feeling abnormal, Feeling hot, Injection site reaction
Clinical narrative: DIZZINESS (HEAD RUSH); BRAIN FOGGINESS; FELT HOT; FEVER; PULSING IN THE PLACE OF THE SHOT; This spontaneous report received from a consumer. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 98.9 F. On 08-APR-2021, treatment medications included: ibuprofen. On 08-APR-2021 18:00, the subject experienced dizziness (head rush). On 08-APR-2021 18:00, the subject experienced brain fogginess. On 08-APR-2021 18:00, the subject experienced felt hot. On 08-APR-2021 18:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from dizziness (head rush), pulsing in the place of the shot, brain fogginess, and felt hot. 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: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: DIZZINESS (HEAD RUSH); BRAIN FOGGINESS; FELT HOT; FEVER; PULSING IN THE PLACE OF THE SHOT; This spontaneous report received from a consumer. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 98.9 F. On 08-APR-2021, treatment medications included: ibuprofen. On 08-APR-2021 18:00, the subject experienced dizziness (head rush). On 08-APR-2021 18:00, the subject experienced brain fogginess. On 08-APR-2021 18:00, the subject experienced felt hot. On 08-APR-2021 18:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from dizziness (head rush), pulsing in the place of the shot, brain fogginess, and felt hot. 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: U
Vaccine: COVID19
Symptoms: Pain in extremity, Seizure
Clinical narrative: SEIZURE-LIKE ACTIVITY; PAIN IN ARM; This spontaneous report received from a health care professional concerned multiple patients of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: unknown) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patients experienced seizure-like activity and pain in arm. It was reported that, while the patients sat in the observation area, seizure-like activity was noted for 5 seconds. The patients complained of dizziness (subsumed under seizure-like activity), and pain in arm. The patients were observed for 2 hours and discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure-like activity and pain in arm was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210417256, 20210417209 and 20210417456.; Reporter's Comments: The case is a multiple patient case.; Sender's Comments: V0: 20210418457-covid-19 vaccine ad26.cov2.s-seizure-like activity. 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).