chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: N-terminal prohormone brain natriuretic peptide, Palpitations, SARS-CoV-2 test negative, Scan with contrast, Sinus tachycardia
Clinical narrative: Patient reported  symptomatic heart palpitations after receiving the 2nd dose of the Pfizer SARS-CoV2 mRNA vaccine on 5/11/2021 at 1pm which lasted a few hours. She then presented to her urgent care clinic around 3pm and was transferred to the Hospital ED. She was found to be in sinus tachycardia to HR 140s-150s. Work-up as described below was largely unrevealing. Plan for TTE on this hospital admission. Overall believe that severe anxiety is a the driving factor behind her sinus tachycardia, and that the SARS-CoV2 vaccination was just coincidental in time course.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin normal
Clinical narrative: Patient reported  symptomatic heart palpitations after receiving the 2nd dose of the Pfizer SARS-CoV2 mRNA vaccine on 5/11/2021 at 1pm which lasted a few hours. She then presented to her urgent care clinic around 3pm and was transferred to the Hospital ED. She was found to be in sinus tachycardia to HR 140s-150s. Work-up as described below was largely unrevealing. Plan for TTE on this hospital admission. Overall believe that severe anxiety is a the driving factor behind her sinus tachycardia, and that the SARS-CoV2 vaccination was just coincidental in time course.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Severe headaches immediately after vaccination, followed by dizziness and continued headaches
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash erythematous
Clinical narrative: Pain and red rash 1 week after injection
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache in the back of head with nausea
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: 8 days after first shot in The Pfizer Covid vaccine series, I developed very horrible tinnitus. Had not been around any loud sounds. Just woke up with it roaring in my ears. Never had COVID.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Sensitive skin, Tinnitus
Clinical narrative: 8 days after first shot in The Pfizer Covid vaccine series, I developed very horrible tinnitus. Had not been around any loud sounds. Just woke up with it roaring in my ears. Never had COVID.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus has become worse
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Muscle spasms
Clinical narrative: Menstrual irregularity. I cramped and bled for 15 days which has never before happened in my life.  Cycle is normally 5-7 days with 2-3 heavy flow days in the middle and intermittent cramping. Also experienced Mild nausea and sleepiness.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Nervousness
Clinical narrative: Client began to feel anxious and shaky after receiving the vaccine. Fire Rescue at the scene to evaluate client.  Clients BP was elevated but all other vitals stable.  Client states hx of high BP and did not take BP meds this morning.   Client began to feel much better and blood pressure came down.  Per Fire Rescue no further evaluation needed.  Client exited park at 2:30pm.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient had no reported side effects; an expired dose of ROTATEQ was administered; This spontaneous report was received from a nurse referring to a 4-month-old infant of unknown gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On 31-MAR-2021, the vaccine of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored in 46 degrees Fahrenheit for 6 hours. At 15:30, on 21-APR-2021, the patient was administered with the expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #: 1676327, expiration date: 19-APR-2021, dose: 2 milliliter (ml), strength was not reported) orally for prophylaxis. The patient had no reported side effects.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Confirmed with the caller no other AE; a 13 year old patiant inadvertently received a dose of PROQUAD; This spontaneous report was received from a medical assistant referring to a 13-year-old patient of unknown gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On 14-APR-2021, the patient was inadvertently vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (albumin status recombinant Human albumin (rHA) (lot #: t0281391, expiration date: 15-FEB-2022, 1 dosage form, strength and route were not reported) for prophylaxis (inappropriate age at vaccine administration). It was confirmed that no other adverse event reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: no further AEs reported; a patient was given an expired dose of MMR II vaccine; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 07-MAY-2021, the patient was vaccinated with an expired dose measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose was reported as 1 injection, lot# S013683, expiration date 05-MAY-2021; strength, route of administration, anatomical location were not reported) for prophylaxis (expired product administered). No further adverse events (AEs) were reported (no adverse event). No product quality complaint (PQC) was involved.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; Customer called to report that PROQUAD and V ARlV AX were inadvertently administered to a 12-month old female consumer; This spontaneous report was received from a consumer referring to a 12 months old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 10-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot# and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Product supply issue, Social problem
Clinical narrative: Took the first dose / right before they ran out / you irreponsibly ran out of vaccine; Took the first dose / about maybe 2 years ago / the pandemic hit before i got a chance to get the second; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about maybe 2 years ago from the time of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue and social problem. On an unknown date, the outcome of the product supply issue and social problem were unknown.  Additional details were provided as follows: The patient reported case for herself. The age at vaccination was not applicable for this report. The patient took the first dose of the Shingrix vaccine right before they ran out and the pandemic hit before the patient got a chance to get the second dose, which led to product supply issue and social problem. The patient enquired if the patient should just take one more shot. The patient was advised CDC (Centers for Disease Control and Prevention) provided guidance and was advise to talk to the healthcare provider about this guidance and on the individual situation.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR100456:Same reporter, Duplicate case.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pyrexia, Tremor
Clinical narrative: spiked fever of 102°F within hours; she didn't feel quite right; uncontrollable shaking; she felt burning shot down her arm; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   In March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than a day after receiving Shingrix, the patient experienced fever, feeling unwell, tremor and injection site burning. On an unknown date, the outcome of the fever, feeling unwell, tremor and injection site burning were recovered/resolved.   It was unknown if the reporter considered the fever, feeling unwell, tremor and injection site burning to be related to Shingrix.  Additional details were provided as follow: The age at the vaccination was not reported. The patient experienced severe reactions. A few seconds after she received the dose, she felt burning shot down her arm. Within hours she didn't feel quite right. There was uncontrollable shaking and spiked fever of 102 degree F within hours. The patient went in to emergency room because fever was not breaking.  At the time of the call no vaccine details were provided because the reporter was driving. The reporter did not consent to follow up nor declined.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Scar
Clinical narrative: fever blisters; causing scarring; This case was reported by a pharmacist via call center representative and described the occurrence of fever blister in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number Y37L9, expiry date 10th October 2022) for prophylaxis.   The patient's past medical history included fever blister.   On 27th February 2021, the patient received Shingrix. On 10th May 2021, 72 days after receiving Shingrix, the patient experienced fever blister and scar. On an unknown date, the outcome of the fever blister and scar were recovering/resolving.   It was unknown if the reporter considered the fever blister and scar to be related to Shingrix.  Additional details were provided as follow: The case was reported by the pharmacist. The patient received Shingrix and experienced fever blisters for 3 weeks and longer before healing and caused scarring. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose/in January 2020/ not received a second dose yet.; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The case was reported by patient's wife. The age at vaccination was not applicable for this report. The reporter declined to provide any demographic information. Till the time of report the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow up. This case has been linked with US2021101405 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021101405:wife´s case
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received a dose / only with the diluent component; Patient received a dose / only with the diluent component; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number P2J7E, expiry date 10th October 2022) for prophylaxis.   On 9th April 2021, the patient received Shingrix. On 9th April 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Pharmacist reported that a patient received a dose of Shingrix only with the diluent component (without the powder portion), which led to inappropriate dose of vaccine administered. The reporter consent to follow up.
Age: 0.17
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Havrix being given to a 2 month old; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 2-month-old patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   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 follows: The reporter reported that Havrix being given to a 2 month old patient, which led to inappropriate age at vaccine administration. No other details was given. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Angiogram, Blood cholesterol
Clinical narrative: STEMI HEART ATTACK; This spontaneous report received from a consumer concerned a 31 year old male. The patients height, and weight were not reported. The patients concurrent conditions included elevated cholesterol, and other pre-existing medical conditions included patient was not having a family history of heart issues.May be patient was genetically more prone to heart attacks. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, frequency 1 total, administered on APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021 in the morning, the patient experienced stemi heart attack (life-threatening), patient was rushed to Emergency Room at 3:00AM in morning and the patient was hospitalized. The patient experienced permanent heart damage and patient received angiogram and stent in artery was performed for the diagnosis. Laboratory data (dates unspecified) included: Angiogram (NR: not provided) not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stemi heart attack was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210504947-COVID-19 VACCINE AD26.COV2.S-STEMI Heart Attack . 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: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Body temperature, Headache, Malaise, Mucosal inflammation
Clinical narrative: SUSPECTED URETHRAL MUCOSITIS; CLOT; PENIS TIP GOT RED; PENIS PAIN; SAW ANGELS AND DEMONS IN BED; TERRIBLE MALAISE; HEADACHE; FEVER 40 DEGREE; This spontaneous report received from a patient concerned a 26-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: 204A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-MAY-2021 at night, the patient experienced some symptoms after vaccination including Fever of 40 degrees Celsius, headache, and a terrible malaise. The patient also reported seeing angels and demons in bed; Also, the patient noticed that the penis tip got red and experienced pain. On 05-MAY-2021, the patient continued with the symptoms, and it seemed as if a clot was generated. On 06-MAY-2021, the patient had an appointment with general physician who informed that he never saw an adverse reaction like this after vaccination and that it could be a urethral mucositis. On 10-May-2021, the patient would have an appointment with the urologist to inform the symptoms.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 40 degree Celsius, saw angels and demons in bed, headache, terrible malaise, penis tip got red, penis pain, clot and urethral mucositis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210513944-covid-19 vaccine ad26.cov2.s -thrombosis. 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: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Penile erythema, Penile pain, Pyrexia, Thrombosis
Clinical narrative: SUSPECTED URETHRAL MUCOSITIS; CLOT; PENIS TIP GOT RED; PENIS PAIN; SAW ANGELS AND DEMONS IN BED; TERRIBLE MALAISE; HEADACHE; FEVER 40 DEGREE; This spontaneous report received from a patient concerned a 26-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: 204A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-MAY-2021 at night, the patient experienced some symptoms after vaccination including Fever of 40 degrees Celsius, headache, and a terrible malaise. The patient also reported seeing angels and demons in bed; Also, the patient noticed that the penis tip got red and experienced pain. On 05-MAY-2021, the patient continued with the symptoms, and it seemed as if a clot was generated. On 06-MAY-2021, the patient had an appointment with general physician who informed that he never saw an adverse reaction like this after vaccination and that it could be a urethral mucositis. On 10-May-2021, the patient would have an appointment with the urologist to inform the symptoms.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 40 degree Celsius, saw angels and demons in bed, headache, terrible malaise, penis tip got red, penis pain, clot and urethral mucositis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210513944-covid-19 vaccine ad26.cov2.s -thrombosis. 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Mechanical ventilation, Suspected COVID-19
Clinical narrative: WAS ON  VENTILATOR; SUSPECTED COVID-19 INFECTION; DEATH; This spontaneous report received from a media article via a company representative concerned a 61 year old female of unspecified race and unspecified Ethnic origin. The patient's height, and weight were not reported.  The patient's concurrent conditions included exposure to covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered 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.   A day later of vaccination patient traveled extensively and returned home nine days later. On an unspecified date in MAR-2021, the patient was not feeling well and had difficulty in breathing. Later, patient's sister drove her to the hospital where she had ups and downs but was eventually put on a ventilator. On an unknown date in APR-2021, the patient died due to unknown cause of death. It was unspecified if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient died an APR-2021 and the outcome of was on ventilator and suspected covid-19 infection was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: 20210514186-covid-19 vaccine ad26.cov2.s-Death, was on ventilator, suspected covid-19 infection. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product
Clinical narrative: ACCIDENTALLY SPILLED SOME VACCINE IN THE EYE AS PHARMACIST WAS DRAWING IT UP; This spontaneous report received from a health care professional concerned a 45 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, ophthalmic, batch number: 052A21A, expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced accidentally spilled some vaccine in the eye as pharmacist was drawing it up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of accidentally spilled some vaccine in the eye as pharmacist was drawing it up was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 67 year old female. Initial information was processed along with the additional information received on 10-MAY-2021 and 11-MAY-2021. The patient's weight, height, and medical history were not reported. The patient was not pregnant at the time of reporting and had a family history of confirmed covid cases. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, 1 total administered to left arm on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAY-2021, the patient got tested for SARS-CoV-2 IgG antibody test (NR: not provided) which came out negative. The patient experienced  confirmed immunological vaccine failure. The patient had no adverse effects from the vaccine and would like to get the vaccine again if possible. The patient had her blood tested so that she could donate if she had antibodies. Per patient only 4 among them haven't been infected as they were the older ones, so maybe its just lifestyle. The patient inquired if she could get the second dose of the vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments:Covid-19 vaccine confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Atrial fibrillation, Body temperature, Feeling abnormal, Headache
Clinical narrative: STOMACH ACHES; GENERALIZED BODY PAIN; ATRIAL FIBRILLATION; HEARTBEAT SPED UP AND THEN SLOWED DOWN/IRREGULAR HEARTBEAT; BRAIN FOG; FEVER; HEADACHE; NAUSEA; This spontaneous report was received from a 71-year-old, White, not Hispanic or Latino female patient. The patient's height, and weight were not reported. The patient's concurrent conditions included Hashimoto thyroiditis, celiac disease, arthritis, autoimmune disease. The patient was diagnosed with atrial fibrillation (Afib) in JAN-2018 and seldom had an episode of Afib since then. The patient had no known allergies and was not pregnant at the time of report.  The patient received covid-19 vaccine ad26.cov2.s (JANSSEN COVID-19 VACCINE) (suspension for injection, route of administration was not reported, batch number: 1808978 and expiry: unknown) dose was not reported, 1 total, administered on 30-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, following vaccination, the patient had an episode of atrial fibrillation almost every day unlike the time before vaccination and her heartbeat sped up and then slowed down (irregular heartbeat). On the same day, the patient experienced brain fog, fever (axillary temperature of up to 100 degrees) and headache. Since the vaccination, the patient's nausea worsened. On 31-MAR-2021, the patient experienced stomach aches and generalized body pain. Due to the ongoing concern of reports of blood clots associated with the JANSSEN COVID-19 VACCINE, the patient's doctor put her on a blood thinner (unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach aches, and fever on 09-APR-2021, and headache on 04-MAY-2021, had not recovered from atrial fibrillation, generalized body pain, heartbeat sped up and then slowed down/irregular heartbeat, and brain fog, and the outcome of nausea was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210516760-COVID-19 VACCINE AD26.COV2.S- Atrial fibrillation. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Nausea, Pain, Pyrexia
Clinical narrative: STOMACH ACHES; GENERALIZED BODY PAIN; ATRIAL FIBRILLATION; HEARTBEAT SPED UP AND THEN SLOWED DOWN/IRREGULAR HEARTBEAT; BRAIN FOG; FEVER; HEADACHE; NAUSEA; This spontaneous report was received from a 71-year-old, White, not Hispanic or Latino female patient. The patient's height, and weight were not reported. The patient's concurrent conditions included Hashimoto thyroiditis, celiac disease, arthritis, autoimmune disease. The patient was diagnosed with atrial fibrillation (Afib) in JAN-2018 and seldom had an episode of Afib since then. The patient had no known allergies and was not pregnant at the time of report.  The patient received covid-19 vaccine ad26.cov2.s (JANSSEN COVID-19 VACCINE) (suspension for injection, route of administration was not reported, batch number: 1808978 and expiry: unknown) dose was not reported, 1 total, administered on 30-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, following vaccination, the patient had an episode of atrial fibrillation almost every day unlike the time before vaccination and her heartbeat sped up and then slowed down (irregular heartbeat). On the same day, the patient experienced brain fog, fever (axillary temperature of up to 100 degrees) and headache. Since the vaccination, the patient's nausea worsened. On 31-MAR-2021, the patient experienced stomach aches and generalized body pain. Due to the ongoing concern of reports of blood clots associated with the JANSSEN COVID-19 VACCINE, the patient's doctor put her on a blood thinner (unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach aches, and fever on 09-APR-2021, and headache on 04-MAY-2021, had not recovered from atrial fibrillation, generalized body pain, heartbeat sped up and then slowed down/irregular heartbeat, and brain fog, and the outcome of nausea was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210516760-COVID-19 VACCINE AD26.COV2.S- Atrial fibrillation. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Decreased appetite, Fatigue
Clinical narrative: TENDERNESS; LOSS OF APPETITE; PROFUSE SWEATING; BACK TIGHTENING; MUSCLE SPASM; SWELLING; BACK SORENESS; LACK OF SLEEP; HIP SORENESS; TIREDNESS; NAUSEOUS; FEVER; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included disabled. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced tenderness. On MAY-2021, the subject experienced loss of appetite. On MAY-2021, the subject experienced profuse sweating. On MAY-2021, the subject experienced back tightening. On MAY-2021, the subject experienced muscle spasm. On MAY-2021, the subject experienced swelling. On MAY-2021, the subject experienced back soreness. On MAY-2021, the subject experienced lack of sleep. On MAY-2021, the subject experienced hip soreness. On MAY-2021, the subject experienced tiredness. On MAY-2021, the subject experienced nauseous. On MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 98.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tenderness, loss of appetite, tiredness, profuse sweating, fever, hip soreness, nauseous, back tightening, muscle spasm, swelling, back soreness and lack of sleep was not reported. This report was non-serious.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Muscle spasms, Muscle tightness, Nausea
Clinical narrative: TENDERNESS; LOSS OF APPETITE; PROFUSE SWEATING; BACK TIGHTENING; MUSCLE SPASM; SWELLING; BACK SORENESS; LACK OF SLEEP; HIP SORENESS; TIREDNESS; NAUSEOUS; FEVER; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included disabled. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced tenderness. On MAY-2021, the subject experienced loss of appetite. On MAY-2021, the subject experienced profuse sweating. On MAY-2021, the subject experienced back tightening. On MAY-2021, the subject experienced muscle spasm. On MAY-2021, the subject experienced swelling. On MAY-2021, the subject experienced back soreness. On MAY-2021, the subject experienced lack of sleep. On MAY-2021, the subject experienced hip soreness. On MAY-2021, the subject experienced tiredness. On MAY-2021, the subject experienced nauseous. On MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 98.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tenderness, loss of appetite, tiredness, profuse sweating, fever, hip soreness, nauseous, back tightening, muscle spasm, swelling, back soreness and lack of sleep was not reported. This report was non-serious.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Tenderness
Clinical narrative: TENDERNESS; LOSS OF APPETITE; PROFUSE SWEATING; BACK TIGHTENING; MUSCLE SPASM; SWELLING; BACK SORENESS; LACK OF SLEEP; HIP SORENESS; TIREDNESS; NAUSEOUS; FEVER; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included disabled. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced tenderness. On MAY-2021, the subject experienced loss of appetite. On MAY-2021, the subject experienced profuse sweating. On MAY-2021, the subject experienced back tightening. On MAY-2021, the subject experienced muscle spasm. On MAY-2021, the subject experienced swelling. On MAY-2021, the subject experienced back soreness. On MAY-2021, the subject experienced lack of sleep. On MAY-2021, the subject experienced hip soreness. On MAY-2021, the subject experienced tiredness. On MAY-2021, the subject experienced nauseous. On MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 98.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tenderness, loss of appetite, tiredness, profuse sweating, fever, hip soreness, nauseous, back tightening, muscle spasm, swelling, back soreness and lack of sleep was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Depression, Fatigue, Headache, Injection site pain
Clinical narrative: DEPRESSIVE EPISODE; IRRITABLE; BODY ACHE; INSOMNIA; FEVER; HEADACHE; INJECTION SITE PAIN; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included granule storage platelet disorder, early-stage prostate cancer, itch, face peeled, and huge sunburn like reaction, and concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with morphine, and articaine hydrochloride/epinephrine bitartrate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-APR-2021, the subject experienced depressive episode. On 30-APR-2021, the subject experienced irritable. On 30-APR-2021, the subject experienced body ache. On 30-APR-2021, the subject experienced insomnia. On 30-APR-2021, the subject experienced fever. On 30-APR-2021, the subject experienced headache. On 30-APR-2021, the subject experienced injection site pain. On 30-APR-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5 F, running greater than 100 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache on 01-MAY-2021, and injection site pain on 02-MAY-2021, had not recovered from fever, headache, irritable, depressive episode, and insomnia, and the outcome of tired was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Irritability, Pain, Pyrexia
Clinical narrative: DEPRESSIVE EPISODE; IRRITABLE; BODY ACHE; INSOMNIA; FEVER; HEADACHE; INJECTION SITE PAIN; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included granule storage platelet disorder, early-stage prostate cancer, itch, face peeled, and huge sunburn like reaction, and concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with morphine, and articaine hydrochloride/epinephrine bitartrate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-APR-2021, the subject experienced depressive episode. On 30-APR-2021, the subject experienced irritable. On 30-APR-2021, the subject experienced body ache. On 30-APR-2021, the subject experienced insomnia. On 30-APR-2021, the subject experienced fever. On 30-APR-2021, the subject experienced headache. On 30-APR-2021, the subject experienced injection site pain. On 30-APR-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5 F, running greater than 100 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache on 01-MAY-2021, and injection site pain on 02-MAY-2021, had not recovered from fever, headache, irritable, depressive episode, and insomnia, and the outcome of tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Accidental exposure to product, Incorrect dose administered, Underdose
Clinical narrative: INAPPROPRIATE DOSE OF VACCINE ADMINISTERED; VACCINE UNDERDOSE; ACCIDENTAL EXPOSURE TO PRODUCT; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) .3 ml, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-MAY-2021, the subject experienced inappropriate dose of vaccine administered. On 10-MAY-2021, the subject experienced vaccine underdose. On 10-MAY-2021, the subject experienced accidental exposure to product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate dose of vaccine administered and vaccine underdose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hepatic pain, Malaise
Clinical narrative: DIZZY FOR 3 DAYS; FEELING SICK; LIVER PAIN; 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  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-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 APR-2021, the subject experienced liver pain. On APR-2021, the subject experienced feeling sick. On 09-APR-2021, the subject experienced dizzy for 3 days. The action taken with covid-19 vaccine  was not applicable. The patient recovered from dizzy for 3 days on 12-APR-2021, and the outcome of feeling sick and liver pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: NECK PAIN; SHOULDERS PAIN/ ANKLE PAIN/ POLYARTHRALGIA/ MIDDLE FINGER JOINT ISSUES; PAIN IN HANDS/ FOREARMS HURTING/ SHIN PAIN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included shin pain. The patient was previously treated with gabapentin for shin pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and 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 neck pain, shoulders pain/ ankle pain/ polyarthralgia/ middle finger joint issues, and pain in hands/ forearms hurting/ shin pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in hands/ forearms hurting/ shin pain, shoulders pain/ ankle pain/ polyarthralgia/ middle finger joint issues and neck pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: SHORTNESS OF BREATH AT NIGHT'; OXYGEN SATURATION DROPPED DURING SLEEP; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, frequency one total administered on 15-MAR-2021 for prophylactic vaccination .The batch number was not reported and has been requested. No concomitant medications were reported. On Apr-2021 (around five weeks after vaccination) patient experienced shortness of breath at night and oxygen saturation was decreased during sleep. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) 86 percentage The action taken with covid-19 vaccine  was not applicable. The outcome of the shortness of breath at night' and oxygen saturation dropped during sleep was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: covid-19 vaccine shortness of breath, oxygen saturation decreased to 86%. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Contusion, Dizziness, Head discomfort
Clinical narrative: DIZZINESS; DEBILITATING HEAD PRESSURE; STRUGGLES TO FALL ASLEEP; TERRIBLE THROBBING HEADACHE; BURNING IN LEGS VEINS; THROBBING IN LEGS VEINS; BRUISING IN LEGS; RADIATING PAIN THROUGH HIPS; INJECTION SITE BRUISING; INJECTION SITE KNOT; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's past medical history included migraines, and concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Blood test (NR: not provided) Did not find anything abnormal, and MRI (NR: not provided) Did not find anything abnormal. On 30-MAR-2021, the subject experienced injection site bruising. On 30-MAR-2021, the subject experienced injection site knot. On 04-APR-2021, the subject experienced radiating pain through hips. On 10-APR-2021, the subject experienced bruising in legs. On 12-APR-2021, the subject experienced burning in legs veins. On 12-APR-2021, the subject experienced throbbing in legs veins. On 26-APR-2021, the subject experienced dizziness. On 26-APR-2021, the subject experienced debilitating head pressure. On 26-APR-2021, the subject experienced struggles to fall asleep. On 26-APR-2021, the subject experienced terrible throbbing headache. Treatment medications (dates unspecified) included: pseudoephedrine hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site bruising on 13-APR-2021, injection site knot on 31-MAR-2021, bruising in legs on 11-APR-2021, burning in legs veins, and throbbing in legs veins on 19-APR-2021, and radiating pain through hips on 08-APR-2021, was recovering from terrible throbbing headache, and had not recovered from dizziness, debilitating head pressure, and struggles to fall asleep. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site bruising, Injection site mass, Insomnia, Magnetic resonance imaging
Clinical narrative: DIZZINESS; DEBILITATING HEAD PRESSURE; STRUGGLES TO FALL ASLEEP; TERRIBLE THROBBING HEADACHE; BURNING IN LEGS VEINS; THROBBING IN LEGS VEINS; BRUISING IN LEGS; RADIATING PAIN THROUGH HIPS; INJECTION SITE BRUISING; INJECTION SITE KNOT; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's past medical history included migraines, and concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Blood test (NR: not provided) Did not find anything abnormal, and MRI (NR: not provided) Did not find anything abnormal. On 30-MAR-2021, the subject experienced injection site bruising. On 30-MAR-2021, the subject experienced injection site knot. On 04-APR-2021, the subject experienced radiating pain through hips. On 10-APR-2021, the subject experienced bruising in legs. On 12-APR-2021, the subject experienced burning in legs veins. On 12-APR-2021, the subject experienced throbbing in legs veins. On 26-APR-2021, the subject experienced dizziness. On 26-APR-2021, the subject experienced debilitating head pressure. On 26-APR-2021, the subject experienced struggles to fall asleep. On 26-APR-2021, the subject experienced terrible throbbing headache. Treatment medications (dates unspecified) included: pseudoephedrine hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site bruising on 13-APR-2021, injection site knot on 31-MAR-2021, bruising in legs on 11-APR-2021, burning in legs veins, and throbbing in legs veins on 19-APR-2021, and radiating pain through hips on 08-APR-2021, was recovering from terrible throbbing headache, and had not recovered from dizziness, debilitating head pressure, and struggles to fall asleep. This report was non-serious.