chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: fever; body still sore; arm still hurts; Back pain; Neck pain; This case was reported by a consumer via and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th August 2021, the patient received the 1st dose of Shingles vaccine. In August 2021, less than a day after receiving Shingles vaccine, the patient experienced fever, general body pain, pain in arm, back pain and neck pain. On an unknown date, the outcome of the fever, general body pain, pain in arm, back pain and neck pain were unknown.   It was unknown if the reporter considered the fever, general body pain, pain in arm, back pain and neck pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient stated that, he/she got first Shingles shot a day before reporting date. The patient woke up at 3:00 with a fever, his/her body was still sore from it, including neck and back. The patient arm still hurts, but the patient guess it was better than getting the shingles. The patient would get his/her next shot in October.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got shingles after each inlection; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional case details were reported as follows: Age at vaccination was not reported. The reporter knew the patient who got shingles after 1st injection. No contact details were reported. For tolerance in 2nd dose refer case US2021AMR178318.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178318:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: I got the shot and got shingles/ suspected vaccination failure; shingles; still burns; itch; hurts off and on; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation, pruritus and pain. On an unknown date, the outcome of the vaccination failure and pruritus were unknown and the outcome of the shingles, burning sensation and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, pruritus and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shot and got shingles and it would been two years this Christmas and the patient still had a spot of shingles on the right side. The patient reported that it was still burns, itch and hurts off and on. The doctor told the patient that it could last up to 2 years. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Sensory disturbance, Stress, Vaccination failure
Clinical narrative: I had both of the shots. I came down shingles/suspected vaccination failure; shingles; It was just a horrible sensation; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feels awful. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and feels awful were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had both of the shots, then, right before the patient had the 1st Covid shot, the patient came down with shingles.  The patient did not get the rash, for which he\she so grateful.  It was just a horrible sensation where the rash would have been.  The patient got medication from physician and it went away in a few days. The patient said it was might be the stress of getting the Covid shot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; still get them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingles vaccine years ago from the date of reporting. After receiving Shingles vaccine, the patient still got shingles. The patient reported that, if you were one of those unlucky folks who got the Shingles vaccine multiple times, the shot only minimized their chance of getting it again. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; got Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. This case had been linked with case US2021AMR178176, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178176:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The age at vaccination was not applicable. The reporter stated that, it was not a guarantee that you would not get shingles just because you got the shots. People did get shingles inspite of having gotten the Shingle shots. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. This case had been linked with case US2021AMR175872, reported by the same reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 61 year old female, race and unknown ethnicity. The patient's weight was 130 pounds, and height was 60 inches. The patient's concurrent conditions included: thyroid problem, seasonal allergies, penicillin allergy, non alcoholic, and smoker (Half a packet per day). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: Unknown) dose was not reported, administered on 18-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for thyroid problem.  On 28-AUG-2021, the patient performed antibody test in order to check presence of antibody after vaccination and  the result was negative. Laboratory data included: Antibody test (NR: not provided) Negative (finger prick test with results within 15minutes). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210858647-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: have not received the 2nd shot. It has been 4 months since the first.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (have not received the 2nd shot. It has been 4 months since the first.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (have not received the 2nd shot. It has been 4 months since the first.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (have not received the 2nd shot. It has been 4 months since the first.) had resolved.            No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Myasthenia gravis
Clinical narrative: The patient was diagnosed with Myasthenia Gravis 1 month after receiving the second dose of the Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of MYASTHENIA GRAVIS (The patient was diagnosed with Myasthenia Gravis 1 month after receiving the second dose of the Moderna Covid-19 vaccine.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYASTHENIA GRAVIS (The patient was diagnosed with Myasthenia Gravis 1 month after receiving the second dose of the Moderna Covid-19 vaccine.) (seriousness criterion medically significant). At the time of the report, MYASTHENIA GRAVIS (The patient was diagnosed with Myasthenia Gravis 1 month after receiving the second dose of the Moderna Covid-19 vaccine.) outcome was unknown.            No concomitant medications were provided. Treatment for the event was not provided.  Company comment Very limited information regarding this event has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-008664 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Large, hard, red lump at injection site and armpit pain starting 6 days post 1st dose of Moderna. Currently still monitoring symptoms.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal tenderness, Blood test abnormal, Diarrhoea, Flatulence
Clinical narrative: Lasting several days:  Distended abdomen; slowed or improper motility in intestines; tenderness below sternum; very loud stomach gurgles  Lasting about 3 months: Loose stools, loud stomach gurgles, occasional tenderness on surface of abdomen, burping
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal hypermotility, Laboratory test
Clinical narrative: Lasting several days:  Distended abdomen; slowed or improper motility in intestines; tenderness below sternum; very loud stomach gurgles  Lasting about 3 months: Loose stools, loud stomach gurgles, occasional tenderness on surface of abdomen, burping
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: continuous headache, continuous tinnitus in left ear
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Tenderness
Clinical narrative: Large swollen armpit lymph node on the same arm that received the shot. Size of baseball. Painful/tender.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: slight sore throat at around 8pm on 08/30/2021, worsening overnight and combining with a runny nose at around 4am on 08/31/2021.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pain in extremity, Vomiting
Clinical narrative: Severe migraine and nausea. Vomiting. Sore arm.  Got my 1st shot about 15 hours ago and have had side affixes for about 13 hours.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Upper respiratory tract infection bacterial
Clinical narrative: Upper respiratory bacterial infection 4 months after vaccine.  Duration of illness, 1 month.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate abnormal
Clinical narrative: Irregular Heart Rate fluctuations ranging from as low as 50 to as high as 100 BPM; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE ABNORMAL (Irregular Heart Rate fluctuations ranging from as low as 50 to as high as 100 BPM) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Penicillin , gabapentin).    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced HEART RATE ABNORMAL (Irregular Heart Rate fluctuations ranging from as low as 50 to as high as 100 BPM). At the time of the report, HEART RATE ABNORMAL (Irregular Heart Rate fluctuations ranging from as low as 50 to as high as 100 BPM) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Heart rate: abnormal (abnormal) Abnormal (Irregular Heart Rate fluctuations ranging from as low as 50 to as high as 100 BPM).     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported.   No treatment history was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Follow-up received on 24 Aug 2021 included no new information.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: it was only one shot; This case was reported by a consumer via  interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (in 2011). Previously administered products included Shingles vaccine (received 1st dose on an unknown date and had troble with the dose than the shingles).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows The patient had reported for himself/herself. The age at vaccination was not applicable for this report. The patient stated that he/she only had one shot and knock on wood had not had it again.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The patient suggested that, it was highly contagious, so you must really careful around someone who had it. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: Small scabs rear calf / shines; This case was reported by a consumer via call center representative and described the occurrence of scab in a 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 scab. On an unknown date, the outcome of the scab was unknown.  It was unknown if the reporter considered the scab to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient received shingrix vaccine and developed small scabs rear calf,shines.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got INWARD SHINGLES ended at  for 3 weeks; They were just as painful; Suspected Vaccination failure; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles (serious criteria hospitalization) and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingles vaccine at least two years before the date of reporting and then doctors told the patient that the patient had inward shingles and ended at hospital for 3 weeks and it was just painful. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got fully vaccinated and developed shingles/ Suspected vaccination failure; Developed shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Shingles on her left foot).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient reported the case for herself. The age at vaccination was not reported. After previous shingles on left foot resolved, the patient got 2 doses of Shingrix and then developed shingles on her right foot. This case was considered to be a suspected vaccination failure case, as the details regarding time to onset and laboratory confirmation for shingles were unknown. The reporter did not consented to follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: COLITIS ATTACK; CONFIRMED CLOT IN EACH OF HER TWO LUNG'S LOWER LOBES (1 CLOT IN EACH LUNG); DEEP VEIN THROMBOSIS IN THE RIGHT ARM; DIZZINESS; PAIN IN THE RIGHT ELBOW; PAIN IN THE RIGHT ARM; SWELLING IN THE RIGHT ARM; SWELLING IN THE RIGHT ELBOW; FEELING COLD; This spontaneous report received from a patient concerned a 53 year old white female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 15-JUL-2021, the patient experienced swelling in the right arm, swelling in the right elbow, pain in the right elbow, pain in the right arm. On 14-AUG-2021, the patient experienced feeling cold due to the thin blood due to the Eliquis treatment. Laboratory data on 14-AUG-2021 included: Sonogram (NR: not provided) Confirmed blood clot in the right arm. On 16-AUG-2021, the patient experienced confirmed clot in each of her two lung's lower lobes (1 clot in each lung), deep vein thrombosis in the right arm and dizziness. The patient stated she went to emergency room on 13-AUG-2021, 14-AUG-2021, 16-AUG-2021 and 21-AUG-2021. On 21-AUG-2021, computed tomography of the chest confirmed blood clot in each lung in each of the lower lobes and patient was admitted in hospital due to colitis attack and because of the severity of the clots and got discharged on 26-AUG-2021. The patient was hospitalized for 6 days.  The patient was treated with an injection in the hospital (unknown medication) and Eliquis for blood clots after discharge. Eliquis was given orally at 10 mg in the morning and 10 mg in the evening and after 7 days switched to 5mg in the morning and 5 mg in the evening. The patient was on a special diet as per Gastroenterologist. The action taken with covid-19 vaccine was not applicable. The patient was recovering from pain in the right arm, pain in the right elbow, swelling in the right arm, swelling in the right elbow, confirmed clot in each of her two lung's lower lobes (1 clot in each lung), colitis attack, and deep vein thrombosis in the right arm, and had not recovered from dizziness, and feeling cold. This report was serious (Hospitalization Caused / Prolonged). Sender's Comments: V0: 20210857614-Covid-19 vaccine-Confirmed clot in each of her two lung's lower lobes (1 clot in each lung), Colitis attack, Deep vein thrombosis in the right arm, Swelling in the right arm, Swelling in the right elbow, Dizziness. 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).  20210857614-Covid-19 vaccine- Pain in the right arm, Pain in the right elbow. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 55 year old white and not Hispanic or Latino male. 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, route of admin not reported, batch number: 201A21A, and expiry: unknown) dose was not reported, 1 total, administered on 12-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  The patient had no problems after initial receipt. On 28-AUG-2021, the patient tested positive for Covid (suspected covid-19 infection) (suspected clinical vaccination failure). Patient went to the hospital and received Regeneron and another unspecified medication and was discharged. Number of days of hospitalization was not reported. On 28-AUG-2021, laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000191386.; Sender's Comments: V0: 20210858502 -covid-19 vaccine ad26.cov2.s- suspected covid-19 infection. 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).  V0: 20210858502 - covid-19 vaccine ad26.cov2.s -Suspected clinical vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 28-AUG-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from covid-19 test positive. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned an unspecified age female. The patient's race and ethnicity were unknown. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 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 patient was hospitalized for Covid (suspected covid-19 infection) confirms suspected clinical vaccination failure and the patient was in home at the time of reporting, discharge dates were not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210858457.; Sender's Comments: V0 - 20210858737- covid-19 vaccine ad26.cov2.s-Suspected Covid-19 infection. 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). 20210858737- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced tired. The action taken with covid-19 vaccine was not applicable. The patient recovered from tired. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: INDIVIDUAL MAGNETIZED; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced individual magnetized. The action taken with covid-19 vaccine was not applicable. The outcome of individual magnetized was not reported.  This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling; numbness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness). At the time of the report, PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment information was provided by the reporter.  Company Comment: Very limited information regarding these events have been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow-up information included the addition of an additional serious event which initially indicated that the case should be upgraded, however, AI confirmed to remove the serious event. Narrative updated accordingly.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Pruritus, Rash, Urticaria
Clinical narrative: had full body itching/the itching was still there/The itching comes, then hives, rash and it goes away few minutes later/It has gotten better but she is still itching; experienced an allergic reaction/had a delayed allergic reaction after the first dose; hives/She itches, she gets hives; was breaking out in rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (had full body itching/the itching was still there/The itching comes, then hives, rash and it goes away few minutes later/It has gotten better but she is still itching), ALLERGY TO VACCINE (experienced an allergic reaction/had a delayed allergic reaction after the first dose), URTICARIA (hives/She itches, she gets hives) and RASH (was breaking out in rash) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Smoker.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced PRURITUS (had full body itching/the itching was still there/The itching comes, then hives, rash and it goes away few minutes later/It has gotten better but she is still itching), ALLERGY TO VACCINE (experienced an allergic reaction/had a delayed allergic reaction after the first dose), URTICARIA (hives/She itches, she gets hives) and RASH (was breaking out in rash). The patient was treated with PREDNISONE at an unspecified dose and frequency; ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) at an unspecified dose and frequency and CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL [CAMPHOR;DIPHENHYDRAMINE HYDROCHLORIDE;ZINC OXIDE]) at an unspecified dose and frequency. In 2021, URTICARIA (hives/She itches, she gets hives) and RASH (was breaking out in rash) had resolved. At the time of the report, PRURITUS (had full body itching/the itching was still there/The itching comes, then hives, rash and it goes away few minutes later/It has gotten better but she is still itching) had not resolved and ALLERGY TO VACCINE (experienced an allergic reaction/had a delayed allergic reaction after the first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Reporter went to the ER on the 27th and they confirmed it was an allergic reaction   She takes Tagamet for heart burn as needed Patient is a little overweight.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Fall, Feeling of body temperature change, Hyperhidrosis
Clinical narrative: diagnosed with a blood clot in her leg; got really sick.; was hot and cold; had sweating episodes; had a tumble over a board where she hit her leg and it bruised.; she hit her leg and it bruised.; A  week and a half after the fall her  leg was swelling.; missed several days from work; Every single joint on her body ached; had a fever; This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOSIS (diagnosed with a blood clot in her leg) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (diagnosed with a blood clot in her leg) (seriousness criterion medically significant), ILLNESS (got really sick.), FEELING OF BODY TEMPERATURE CHANGE (was hot and cold), HYPERHIDROSIS (had sweating episodes), FALL (had a tumble over a board where she hit her leg and it bruised.), CONTUSION (she hit her leg and it bruised.), PERIPHERAL SWELLING (A  week and a half after the fall her  leg was swelling.), IMPAIRED WORK ABILITY (missed several days from work), ARTHRALGIA (Every single joint on her body ached) and PYREXIA (had a fever). At the time of the report, THROMBOSIS (diagnosed with a blood clot in her leg), ILLNESS (got really sick.), FEELING OF BODY TEMPERATURE CHANGE (was hot and cold), HYPERHIDROSIS (had sweating episodes), FALL (had a tumble over a board where she hit her leg and it bruised.), CONTUSION (she hit her leg and it bruised.), PERIPHERAL SWELLING (A  week and a half after the fall her  leg was swelling.), IMPAIRED WORK ABILITY (missed several days from work), ARTHRALGIA (Every single joint on her body ached) and PYREXIA (had a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There was no concomitant medication reported. There was no treatment medication reported. Also reported information included, 25th is the due date for second dose.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Impaired work ability, Peripheral swelling, Pyrexia, Thrombosis
Clinical narrative: diagnosed with a blood clot in her leg; got really sick.; was hot and cold; had sweating episodes; had a tumble over a board where she hit her leg and it bruised.; she hit her leg and it bruised.; A  week and a half after the fall her  leg was swelling.; missed several days from work; Every single joint on her body ached; had a fever; This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOSIS (diagnosed with a blood clot in her leg) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (diagnosed with a blood clot in her leg) (seriousness criterion medically significant), ILLNESS (got really sick.), FEELING OF BODY TEMPERATURE CHANGE (was hot and cold), HYPERHIDROSIS (had sweating episodes), FALL (had a tumble over a board where she hit her leg and it bruised.), CONTUSION (she hit her leg and it bruised.), PERIPHERAL SWELLING (A  week and a half after the fall her  leg was swelling.), IMPAIRED WORK ABILITY (missed several days from work), ARTHRALGIA (Every single joint on her body ached) and PYREXIA (had a fever). At the time of the report, THROMBOSIS (diagnosed with a blood clot in her leg), ILLNESS (got really sick.), FEELING OF BODY TEMPERATURE CHANGE (was hot and cold), HYPERHIDROSIS (had sweating episodes), FALL (had a tumble over a board where she hit her leg and it bruised.), CONTUSION (she hit her leg and it bruised.), PERIPHERAL SWELLING (A  week and a half after the fall her  leg was swelling.), IMPAIRED WORK ABILITY (missed several days from work), ARTHRALGIA (Every single joint on her body ached) and PYREXIA (had a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There was no concomitant medication reported. There was no treatment medication reported. Also reported information included, 25th is the due date for second dose.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Product dose omission issue, Tinnitus
Clinical narrative: severe Case of tinnitus; I felt a general weakness; patient didnt recieve the second dose of Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (severe Case of tinnitus), ASTHENIA (I felt a general weakness) and PRODUCT DOSE OMISSION ISSUE (patient didnt recieve the second dose of Moderna COVID-19 Vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (severe Case of tinnitus), ASTHENIA (I felt a general weakness) and PRODUCT DOSE OMISSION ISSUE (patient didnt recieve the second dose of Moderna COVID-19 Vaccine). At the time of the report, TINNITUS (severe Case of tinnitus), ASTHENIA (I felt a general weakness) and PRODUCT DOSE OMISSION ISSUE (patient didnt recieve the second dose of Moderna COVID-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications was not provided.  Company Comment: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown,  with associated AEs (Tinnitus and Asthenia). Very limited information regarding this events has been provided at this time. The date of onset of events has not been reported. Further information has been requested.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown,  with associated AEs (Tinnitus and Asthenia). Very limited information regarding this events has been provided at this time. The date of onset of events has not been reported. Further information has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: she had sweating in the back; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (she had sweating in the back) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A, 012L20A and 051C2(Q)1A) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus (Autoimmune disorder, with positive ANA, diagnosed with prior to receiving the vaccine a few years) and Joint pain. Concomitant products included PARACETAMOL (TYLENOL) for Joint pain.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (she had sweating in the back). At the time of the report, HYPERHIDROSIS (she had sweating in the back) outcome was unknown.            Treatment medication was not provided by the reporter.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-294521 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery thrombosis, Fatigue, Myocardial infarction, Thrombectomy
Clinical narrative: I had a blood clot that blocked my right anterior descending artery causing me to have a heart attack.  I was air lifted to the hospital where the clot was removed.  The surgeon had no explanation for the clotting and I had no other heart issues aside from high blood pressure.  No symptoms except I was very tired after second shot.  Plaque was not the cause.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain 3 min. Went away after 10 min.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Nausea, extreme fatigue, headache, muscle aches, backache,  All ongoing since  Aug 27
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Palpitations
Clinical narrative: heart palpitations, arrhythmia
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Sleep disorder
Clinical narrative: I have had three significant nosebleeds following my 3rd Pfizer COVID vaccine, two occurring on Friday August 27 and one on Sunday August 29 . The first nosebleed occurred during my sleep and woke me up during the night. All of the nosebleeds took between 20-45 minutes to stop after pinching my nose. I have not had significant nosebleeds in over 15 years so this was highly unusual. I saw an ENT doctor who said it was very unusual to get such nosebleeds during the night, as this is far more likely to happen during the winter.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site bruising, Pyrexia
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Headache-Mild