chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Somnolence, Vaccine positive rechallenge
Clinical narrative: Body Aches; Tiredness; been having to take many naps during the day; headache; This case was reported by a consumer and described the occurrence of general body pain in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received on an unknown date and experience headache and fatigue,for the tolerance of 1st dose refer the case US2021AMR095072). Concomitant products included COVID 19 VACCINE.   On 13th April 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th April 2021, less than a day after receiving Shingrix, the patient experienced general body pain, tiredness and daytime sleepiness. In April 2021, the patient experienced headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain, tiredness and headache were not recovered/not resolved and the outcome of the daytime sleepiness was unknown.   The reporter considered the general body pain and tiredness to be related to Shingrix. It was unknown if the reporter considered the daytime sleepiness and headache to be related to Shingrix.   Additional details were provided as follows: The case was reported by the patient's wife and by the patient's Physician. After vaccination, later that same day, the patient experienced body aches and tiredness.  He had been taking many naps during the day since the vaccination.  These symptoms were ongoing and had not yet resolved. The reporter consented to follow up with their health care provider and provided phone number.  The patient's physician reported that, the patient experienced headache and fatigue after receiving Shingrix. The HCP did not have lot number or expiration date of doses of Shingrix. The HCP described the headache and fatigue had not gotten any better or worse since they began. The HCP noted 14 days before dose two of Shingrix, the patient received Covid vaccine.  No additional information was reported. The reporter did not consented to follow up. This is 1 of the 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094721:same reporter US-GLAXOSMITHKLINE-US2021094725:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product storage error
Clinical narrative: stored in freezer/It was not administered; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product storage error in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as an adult as per vaccine indication. The Shingrix vaccine was stored in the freezer by mistake but it was not administered to the patients, which led to intercepted product storage error. No lot number or expiration date provided and the reporter informed stability conditions. The reporter did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: received Shingrix second dose half of final volume; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 7F94C, expiry date 11th November 2022) for prophylaxis.   On 28th April 2021, the patient received the 2nd dose of Shingrix .25 ml. On 28th April 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The pharmacist reported that the patient received Shingrix 2nd dose half of final volume (0.25ml approximately) due to problem with needles which lead to accidental underdose. The reporter consented to follow up. The pharmacist asked to receive a follow-up on the patient to her private phone as soon as possible.
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Had injection site pain; Also had redness of the injected arm; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 14-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On an unknown date, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain and erythema of extremities. On an unknown date, the outcome of the injection site pain and erythema of extremities were recovered/resolved.   The reporter considered the injection site pain and erythema of extremities to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follow: The case was reported by a pediatrician via sales representative. The patient received 1st dose of Bexsero in an unspecified deltoid. The patient immediately after got home called the physician office and said that he had injection site pain. The patient also had redness of the injected arm which went from the shoulder all the way down to the hand and lasted 3 days. The physician stated that all events had resolved.  The physician stated that Bexsero was the only vaccination that patient received that day. No further information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Right arm injection site pain which started 11/1/2020 and has resolved; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2020, the patient received the 1st dose of Shingrix. On 1st November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. The action taken with Shingrix was unknown. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccination in her right arm and on the same day, she experienced injection site pain and had resolved. The patient also received 2 Covid vaccinations (unspecified) in 2021 and her 2nd Covid vaccination was in February 2021.  The reporter did not consent to follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ammonia, Antithrombin III decreased, Cataract, Chest pain, Eye pain
Clinical narrative: PALPITATIONS; CHEST PAIN; CATARACTS; BILATERAL EYE PAIN; INTERMITTENT HEADACHE/LIGHTHEADEDNESS; This spontaneous report received from a pharmacist concerned a Vietnamese female of unspecified age. The patient's weight, height, and medical history were not reported. The patient's concurrent conditions included high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and vaccination site not reported, batch number: Unknown) dose was not reported, 1 total, administered in APR-2021 (reported as approximately 2 weeks prior to the date of the report) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  In APR-2021, reported as 5 days ago, the patient experienced with intermittent headache, bilateral eye pain and blurry vision, in addition to chest pain and palpitations.  She was seen in the emergency Room on 26-APR-2021, and was subsequently diagnosed with acute cavernous venous thrombosis. Patient was hospitalized and number of days were unspecified. On an unspecified date, the patient experienced bilateral eye pain, blurry vision, cataracts, and intermittent headache/lightheadedness.  On 26-APR-2021, Laboratory data included: Magnetic resonance imaging (NR: not provided) grossly abnormal indicative of clot, and Platelet count (NR: not provided) 251000 on admission. On 27-APR-2021, Laboratory data included: Magnetic resonance imaging (NR: not provided) no evidence of thrombus, mild white matter (units unspecified), and platelet count (NR: not provided) 246,000. On 28-APR-2021, Laboratory data included: Anti-thrombin III decreased (NR: not provided) unknown, erythrocyte sedimentation rate (nr: not provided) 21 (normal), factor V leiden mutation (NR: not provided) unknown, Fibrin D dimer abnormal (NR: not provided) 0.29 (unit not reported) (normal 0-0.49), Platelet count (NR: not provided) 227,000, Protein C (NR: not provided) unknown, Protein S antigen (NR: not provided) unknown, and Serotonin syndrome (NR: not provided) unknown. Laboratory data (dates unspecified) included: Ammonia (NR: not provided) high ammonia level. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intermittent headache/lightheadedness on 28-APR-2021, and the outcome of chest pain, palpitations, bilateral eye pain and cataracts was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0.20210451865-covid-19 vaccine ad26.cov2.s-cataract,palpitations,chest pain. 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Factor V Leiden mutation, Fibrin D dimer increased, Headache, Magnetic resonance imaging, Palpitations
Clinical narrative: PALPITATIONS; CHEST PAIN; CATARACTS; BILATERAL EYE PAIN; INTERMITTENT HEADACHE/LIGHTHEADEDNESS; This spontaneous report received from a pharmacist concerned a Vietnamese female of unspecified age. The patient's weight, height, and medical history were not reported. The patient's concurrent conditions included high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and vaccination site not reported, batch number: Unknown) dose was not reported, 1 total, administered in APR-2021 (reported as approximately 2 weeks prior to the date of the report) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  In APR-2021, reported as 5 days ago, the patient experienced with intermittent headache, bilateral eye pain and blurry vision, in addition to chest pain and palpitations.  She was seen in the emergency Room on 26-APR-2021, and was subsequently diagnosed with acute cavernous venous thrombosis. Patient was hospitalized and number of days were unspecified. On an unspecified date, the patient experienced bilateral eye pain, blurry vision, cataracts, and intermittent headache/lightheadedness.  On 26-APR-2021, Laboratory data included: Magnetic resonance imaging (NR: not provided) grossly abnormal indicative of clot, and Platelet count (NR: not provided) 251000 on admission. On 27-APR-2021, Laboratory data included: Magnetic resonance imaging (NR: not provided) no evidence of thrombus, mild white matter (units unspecified), and platelet count (NR: not provided) 246,000. On 28-APR-2021, Laboratory data included: Anti-thrombin III decreased (NR: not provided) unknown, erythrocyte sedimentation rate (nr: not provided) 21 (normal), factor V leiden mutation (NR: not provided) unknown, Fibrin D dimer abnormal (NR: not provided) 0.29 (unit not reported) (normal 0-0.49), Platelet count (NR: not provided) 227,000, Protein C (NR: not provided) unknown, Protein S antigen (NR: not provided) unknown, and Serotonin syndrome (NR: not provided) unknown. Laboratory data (dates unspecified) included: Ammonia (NR: not provided) high ammonia level. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intermittent headache/lightheadedness on 28-APR-2021, and the outcome of chest pain, palpitations, bilateral eye pain and cataracts was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0.20210451865-covid-19 vaccine ad26.cov2.s-cataract,palpitations,chest pain. 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Protein C, Protein S, Red blood cell sedimentation rate, Serotonin syndrome
Clinical narrative: PALPITATIONS; CHEST PAIN; CATARACTS; BILATERAL EYE PAIN; INTERMITTENT HEADACHE/LIGHTHEADEDNESS; This spontaneous report received from a pharmacist concerned a Vietnamese female of unspecified age. The patient's weight, height, and medical history were not reported. The patient's concurrent conditions included high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and vaccination site not reported, batch number: Unknown) dose was not reported, 1 total, administered in APR-2021 (reported as approximately 2 weeks prior to the date of the report) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  In APR-2021, reported as 5 days ago, the patient experienced with intermittent headache, bilateral eye pain and blurry vision, in addition to chest pain and palpitations.  She was seen in the emergency Room on 26-APR-2021, and was subsequently diagnosed with acute cavernous venous thrombosis. Patient was hospitalized and number of days were unspecified. On an unspecified date, the patient experienced bilateral eye pain, blurry vision, cataracts, and intermittent headache/lightheadedness.  On 26-APR-2021, Laboratory data included: Magnetic resonance imaging (NR: not provided) grossly abnormal indicative of clot, and Platelet count (NR: not provided) 251000 on admission. On 27-APR-2021, Laboratory data included: Magnetic resonance imaging (NR: not provided) no evidence of thrombus, mild white matter (units unspecified), and platelet count (NR: not provided) 246,000. On 28-APR-2021, Laboratory data included: Anti-thrombin III decreased (NR: not provided) unknown, erythrocyte sedimentation rate (nr: not provided) 21 (normal), factor V leiden mutation (NR: not provided) unknown, Fibrin D dimer abnormal (NR: not provided) 0.29 (unit not reported) (normal 0-0.49), Platelet count (NR: not provided) 227,000, Protein C (NR: not provided) unknown, Protein S antigen (NR: not provided) unknown, and Serotonin syndrome (NR: not provided) unknown. Laboratory data (dates unspecified) included: Ammonia (NR: not provided) high ammonia level. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intermittent headache/lightheadedness on 28-APR-2021, and the outcome of chest pain, palpitations, bilateral eye pain and cataracts was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0.20210451865-covid-19 vaccine ad26.cov2.s-cataract,palpitations,chest pain. 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, COVID19, COVID19
Symptoms: Illness
Clinical narrative: ILLNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced illness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of illness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Agitation, Anion gap, Blood chloride, Blood creatinine, Blood glucose
Clinical narrative: ILLNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced illness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of illness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature
Clinical narrative: ILLNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced illness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of illness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain natriuretic peptide, Carbon dioxide, Chest pain, Coma scale, Cough
Clinical narrative: ILLNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced illness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of illness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Differential white blood cell count, Dizziness, Dysgeusia, Dyspnoea, Ear pain
Clinical narrative: ILLNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced illness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of illness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Factor II mutation, Factor V Leiden mutation, Fatigue, Feeling abnormal, Glomerular filtration rate
Clinical narrative: ILLNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced illness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of illness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haematocrit, Haemoglobin, Headache, Heart rate, Heart rate abnormal
Clinical narrative: ILLNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced illness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of illness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Illness, Laboratory test, Malaise, Mean cell volume, Myalgia
Clinical narrative: ILLNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced illness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of illness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nucleated red cells, Oropharyngeal pain, Oxygen saturation, Pain, Pain assessment
Clinical narrative: ILLNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced illness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of illness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count, Pollakiuria, Red blood cell count, Respiratory rate, SARS-CoV-2 test
Clinical narrative: ILLNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced illness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of illness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin I, White blood cell count, X-ray
Clinical narrative: ILLNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced illness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of illness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Chest pain, Cough, Dizziness, Dysgeusia
Clinical narrative: ILLNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced illness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of illness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram, Feeling abnormal, Glycosylated haemoglobin increased, Headache
Clinical narrative: ILLNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced illness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of illness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Impaired work ability, Malaise, Pyrexia, SARS-CoV-2 test negative, X-ray normal
Clinical narrative: ILLNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced illness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of illness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nausea
Clinical narrative: ACHING JOINTS; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced aching joints. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching joints, headache, and nausea. This report was non-serious. This case, from the same reporter is linked to 20210458817.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HIVES; This spontaneous report received from a patient concerned a 35 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: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Headache, Nausea, Pain assessment
Clinical narrative: DEHYDRATION; SEVERE HEADACHE; NAUSEA; MASSIVE CHILLS; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: 25-MAY-2021) dose was not reported, 1 total administered on 10-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. Right after Vaccine administration no side effects but the patient spent the next day at Emergency Room. On 11-MAR-2021, the patient was sicker than dog and had experienced dehydration, massive chills, severe headache, and nausea. On the same day PET scan was performed for headache and pain was 10/10. Patient was given cold medicine and 2 unspecified intravenous medication. After that patient was well enough to go home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dehydration, massive chills, severe headache, and nausea on 11-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210458937-COVID-19 VACCINE AD26.COV2.S-DEHYDRATION. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210458937-COVID-19 VACCINE AD26.COV2.S-20210458937-COVID-19 VACCINE AD26.COV2.S-SEVERE HEADACHE, NAUSEA, MASSIVE CHILLS. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Positron emission tomogram
Clinical narrative: DEHYDRATION; SEVERE HEADACHE; NAUSEA; MASSIVE CHILLS; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: 25-MAY-2021) dose was not reported, 1 total administered on 10-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. Right after Vaccine administration no side effects but the patient spent the next day at Emergency Room. On 11-MAR-2021, the patient was sicker than dog and had experienced dehydration, massive chills, severe headache, and nausea. On the same day PET scan was performed for headache and pain was 10/10. Patient was given cold medicine and 2 unspecified intravenous medication. After that patient was well enough to go home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dehydration, massive chills, severe headache, and nausea on 11-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210458937-COVID-19 VACCINE AD26.COV2.S-DEHYDRATION. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210458937-COVID-19 VACCINE AD26.COV2.S-20210458937-COVID-19 VACCINE AD26.COV2.S-SEVERE HEADACHE, NAUSEA, MASSIVE CHILLS. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Headache, Pyrexia
Clinical narrative: BONE PAIN; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and abstains from alcohol, and the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 11:00:00 for prophylactic vaccination. No concomitant medications were reported.  On 29-APR-2021, the subject experienced bone pain. On 29-APR-2021, the subject experienced fever. On 29-APR-2021, the subject experienced headache. Laboratory data (dates unspecified) included: Fever (NR: not provided) Not measured. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bone pain, fever, and headache. This report was non-serious. This case, from the same reporter is linked to 20210459729 and 20210459724.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: ACHES; STIFF NECK; SWELLING; GENERALIZED JOINT PAIN; MUSCLE PAIN9; INJECTION SITE PAIN; VERY FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 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 13-MAR-2021, the subject experienced aches. On 13-MAR-2021, the subject experienced stiff neck. On 13-MAR-2021, the subject experienced swelling. On 13-MAR-2021, the subject experienced generalized joint pain. On 13-MAR-2021, the subject experienced muscle pain9. On 13-MAR-2021, the subject experienced injection site pain. On 13-MAR-2021, the subject experienced very fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pain9, generalized joint pain, aches, stiff neck, swelling, injection site pain and very fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Swelling
Clinical narrative: ACHES; STIFF NECK; SWELLING; GENERALIZED JOINT PAIN; MUSCLE PAIN9; INJECTION SITE PAIN; VERY FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 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 13-MAR-2021, the subject experienced aches. On 13-MAR-2021, the subject experienced stiff neck. On 13-MAR-2021, the subject experienced swelling. On 13-MAR-2021, the subject experienced generalized joint pain. On 13-MAR-2021, the subject experienced muscle pain9. On 13-MAR-2021, the subject experienced injection site pain. On 13-MAR-2021, the subject experienced very fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pain9, generalized joint pain, aches, stiff neck, swelling, injection site pain and very fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Confusional state, Fatigue, Hypoaesthesia, Insomnia
Clinical narrative: ACHES; STIFF NECK; SWELLING; GENERALIZED JOINT PAIN; MUSCLE PAIN9; INJECTION SITE PAIN; VERY FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 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 13-MAR-2021, the subject experienced aches. On 13-MAR-2021, the subject experienced stiff neck. On 13-MAR-2021, the subject experienced swelling. On 13-MAR-2021, the subject experienced generalized joint pain. On 13-MAR-2021, the subject experienced muscle pain9. On 13-MAR-2021, the subject experienced injection site pain. On 13-MAR-2021, the subject experienced very fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pain9, generalized joint pain, aches, stiff neck, swelling, injection site pain and very fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Nodule, Pain, Pain in extremity
Clinical narrative: ACHES; STIFF NECK; SWELLING; GENERALIZED JOINT PAIN; MUSCLE PAIN9; INJECTION SITE PAIN; VERY FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 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 13-MAR-2021, the subject experienced aches. On 13-MAR-2021, the subject experienced stiff neck. On 13-MAR-2021, the subject experienced swelling. On 13-MAR-2021, the subject experienced generalized joint pain. On 13-MAR-2021, the subject experienced muscle pain9. On 13-MAR-2021, the subject experienced injection site pain. On 13-MAR-2021, the subject experienced very fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pain9, generalized joint pain, aches, stiff neck, swelling, injection site pain and very fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: ACHES; STIFF NECK; SWELLING; GENERALIZED JOINT PAIN; MUSCLE PAIN9; INJECTION SITE PAIN; VERY FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 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 13-MAR-2021, the subject experienced aches. On 13-MAR-2021, the subject experienced stiff neck. On 13-MAR-2021, the subject experienced swelling. On 13-MAR-2021, the subject experienced generalized joint pain. On 13-MAR-2021, the subject experienced muscle pain9. On 13-MAR-2021, the subject experienced injection site pain. On 13-MAR-2021, the subject experienced very fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pain9, generalized joint pain, aches, stiff neck, swelling, injection site pain and very fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a patient concerned an 86 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from unspecified side effects. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenopia, Eye swelling, Nausea, Pain in extremity
Clinical narrative: HEAVINESS IN EYE; ABDOMINAL PAIN / STRANGE SENSATIONS IN ABDOMEN; LEFT EYE SWOLLEN AND PUFFY; STRANGE SENSATIONS IN FACE; LEFT ARM PAINFUL; NAUSEA; This spontaneous report received from a parent concerned a 37 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced heaviness in eye, abdominal pain / strange sensations in abdomen, left eye swollen and puffy, strange sensations in face, left arm painful, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heaviness in eye, abdominal pain / strange sensations in abdomen, left arm painful, left eye swollen and puffy, strange sensations in face and nausea was not reported. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: HEAVINESS IN EYE; ABDOMINAL PAIN / STRANGE SENSATIONS IN ABDOMEN; LEFT EYE SWOLLEN AND PUFFY; STRANGE SENSATIONS IN FACE; LEFT ARM PAINFUL; NAUSEA; This spontaneous report received from a parent concerned a 37 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced heaviness in eye, abdominal pain / strange sensations in abdomen, left eye swollen and puffy, strange sensations in face, left arm painful, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heaviness in eye, abdominal pain / strange sensations in abdomen, left arm painful, left eye swollen and puffy, strange sensations in face and nausea was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Pain, Pyrexia
Clinical narrative: BODY ACHES; LOST TASTE; HIGH FEVER; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced body aches. On 2021, the subject experienced lost taste. On 2021, the subject experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, body aches and lost taste was not reported. This report was non-serious. This case, from the same reporter is linked to 20210500162.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site nodule
Clinical narrative: KNOT ON ARM INJECTION SITE; SORE ARM; RED ARM; CHILLS; MILD TIREDNESS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 40 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced chills. On 28-APR-2021, the subject experienced mild tiredness. On 28-APR-2021, the subject experienced fever. On 28-APR-2021, the subject experienced headache. On 29-APR-2021, the subject experienced knot on arm injection site. On 29-APR-2021, the subject experienced sore arm. On 29-APR-2021, the subject experienced red arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from knot on arm injection site, chills, mild tiredness, fever, headache, and red arm, and had not recovered from sore arm. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: KNOT ON ARM INJECTION SITE; SORE ARM; RED ARM; CHILLS; MILD TIREDNESS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 40 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced chills. On 28-APR-2021, the subject experienced mild tiredness. On 28-APR-2021, the subject experienced fever. On 28-APR-2021, the subject experienced headache. On 29-APR-2021, the subject experienced knot on arm injection site. On 29-APR-2021, the subject experienced sore arm. On 29-APR-2021, the subject experienced red arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from knot on arm injection site, chills, mild tiredness, fever, headache, and red arm, and had not recovered from sore arm. This report was non-serious.