chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Thrombosis, Vaccination failure
Clinical narrative: BLOOD CLOT; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via telephone concerned a patient of an unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient tested positive for Covid-19 (suspected covid-19 infection, suspected clinical vaccination failure). On an unspecified date, the patient experienced blood clot. The patient was hospitalized (date unspecified) for 17 days and has been discharged with oxygen. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected Covid-19 infection, blood clot and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000183554.; Sender's Comments: V0- 20210642886-Covid-19 vaccine ad26.cov2.S  Suspected clinical vaccination 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  20210642886-Covid-19 vaccine ad26.cov2.S- Blood clot, Suspected Covid-19 infection. This event is considered unassessable. The event 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.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Therapy non-responder
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a parent via social media concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) start therapy date were not reported, 1 total administrated 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, patient had the Johnson and Johnson and just got over the virus, it did not stop patient from not getting it (suspected covid-19 infection and suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210644963-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 SITUATION
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Skin mass
Clinical narrative: BUMP ON UPPER LIP; ITCHINESS AROUND VACCINATION SITE (LEFT ARM); This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-JUN-2021, the subject experienced bump on upper lip. On 21-JUN-2021, the subject experienced itchiness around vaccination site (left arm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bump on upper lip, and itchiness around vaccination site (left arm). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Thrombosis
Clinical narrative: HEART ATTACK; MULTIPLE BLOOD CLOTS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported ,1 total administered 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. The reporter stated that, On an unspecified date her mother had multiple blood clots due to which she had heart attack. Patient was on blood thinners and did not survive. It was unknown if autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from heart attack and had not recovered from multiple blood clots. This report was serious (Death).; Sender's Comments: V0: 20210648060-covid-19 vaccine ad26.cov2.s -multiple blood clots , 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).; Reported Cause(s) of Death: HEART ATTACK
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue
Clinical narrative: LOW PLATELET COUNT; FATIGUE (NOT FELT GREAT); This spontaneous report received from a consumer concerned a 48-year-old female. The patient's weight was 155 pounds and height was 170 centimeters. The patient's concurrent conditions included non-smoker and abstains from alcohol. The patient had no underlying medical condition, no known allergies and had no drug abuse or illicit drug usage. Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: unknown) 1 total, dose was not reported, administered on 05-APR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  After vaccination, from an unspecified date in APR-2021, the patient's platelet count dropped dramatically to almost mid-20,000 (low platelet count) and visited physician's office for the same. Patient had no previous history of this condition. Patient did not experience any side effects except that, she did not feel great (fatigue) for few days, but, felt better afterwards. On 21-JUN-2021, patient had her routine physical and blood test and the test showed low platelet count (mid 20,000). On 25-JUN-2021, patient had appointment with hematologist. At the time of reporting, the reporter (patient's husband) did not have the vaccination card with him. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue (not felt great) on APR-2021 and had not recovered from low platelet count. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210648114-covid-19 vaccine ad26.cov2.s -Low platelet count. 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Limb mass, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: RIGHT FOOT SWELLING; CAN'T PUT WEIGHT ON IT WITHOUT  PAIN/FEEL LIKE CAN'T PUT WEIGHT ON FOOT; LUMP ON TOP OF RIGHT FOOT, SLIGHTLY TO THE SIDE; CAN'T WALK; RIGHT FOOT PAIN; FEVER; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient did not seek medical attention. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-JUN-2021, the subject experienced fever. On 22-JUN-2021, the subject experienced right foot swelling. On 22-JUN-2021, the subject experienced can't put weight on it without pain/feel like can't put weight on foot. On 22-JUN-2021, the subject experienced lump on top of right foot, slightly to the side. On 22-JUN-2021, the subject experienced can't walk. On 22-JUN-2021, the subject experienced right foot pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 21-JUN-2021, and had not recovered from right foot pain, right foot swelling, can't put weight on it without pain/feel like can't put weight on foot, lump on top of right foot, slightly to the side, and can't walk. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Weight bearing difficulty
Clinical narrative: RIGHT FOOT SWELLING; CAN'T PUT WEIGHT ON IT WITHOUT  PAIN/FEEL LIKE CAN'T PUT WEIGHT ON FOOT; LUMP ON TOP OF RIGHT FOOT, SLIGHTLY TO THE SIDE; CAN'T WALK; RIGHT FOOT PAIN; FEVER; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient did not seek medical attention. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-JUN-2021, the subject experienced fever. On 22-JUN-2021, the subject experienced right foot swelling. On 22-JUN-2021, the subject experienced can't put weight on it without pain/feel like can't put weight on foot. On 22-JUN-2021, the subject experienced lump on top of right foot, slightly to the side. On 22-JUN-2021, the subject experienced can't walk. On 22-JUN-2021, the subject experienced right foot pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 21-JUN-2021, and had not recovered from right foot pain, right foot swelling, can't put weight on it without pain/feel like can't put weight on foot, lump on top of right foot, slightly to the side, and can't walk. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative from social media concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, frequency 1 total, start therapy date were not reported administered for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient died. It was reported by consumer that his niece was died due to vaccine. No further information was provided. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210648251-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Hypersomnia, Injection site pain
Clinical narrative: The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced tiredness. On JUN-2021, the subject experienced fatigue. On JUN-2021, the subject experienced lack of energy. On 12-JUN-2021, the subject experienced headache. On 12-JUN-2021, the subject experienced soreness in right arm at injection site. On 12-JUN-2021, the subject experienced pain in the muscle in upper arm. On 16-JUN-2021, the subject experienced dark red blood in left eye. On 20-JUN-2021, the subject experienced slight blurred vision in left eye. On 20-JUN-2021, the subject experienced sleeping more than usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, dark red blood in left eye, tiredness, slight blurred vision in left eye, fatigue, lack of energy, sleeping more than usual, soreness in right arm at injection site and pain in the muscle in upper arm was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Ocular hyperaemia, Vision blurred
Clinical narrative: The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced tiredness. On JUN-2021, the subject experienced fatigue. On JUN-2021, the subject experienced lack of energy. On 12-JUN-2021, the subject experienced headache. On 12-JUN-2021, the subject experienced soreness in right arm at injection site. On 12-JUN-2021, the subject experienced pain in the muscle in upper arm. On 16-JUN-2021, the subject experienced dark red blood in left eye. On 20-JUN-2021, the subject experienced slight blurred vision in left eye. On 20-JUN-2021, the subject experienced sleeping more than usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, dark red blood in left eye, tiredness, slight blurred vision in left eye, fatigue, lack of energy, sleeping more than usual, soreness in right arm at injection site and pain in the muscle in upper arm was not reported. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Capillary fragility, Gait inability, Soft tissue necrosis, Thrombosis
Clinical narrative: BLOOD CLOT; TISSUES NECROSIS; UNABLE TO WALK; CAPILLARIES EXPLODED; This spontaneous report received from a 35 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN)  frequency one total, dose was not reported, administered on 07-APR-2021  in left arm for prophylactic vaccination. No concomitant medications were reported.  The patient reported about 3 weeks after vaccination his health problems started. He had been to numerous ERs, to primary neurologist, finally at 3rd hospital visit he was admitted and was in the ICU for 5 days. On 07-JUN-2021, they concluded a blood clot had formed in leg and traveled down to feet in toes where all capillaries exploded and tissues in toes necroded and died. The patient was unable to walk by self. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot, tissue necrosis, unable to walk and capillaries exploded was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210648314-covid-19 vaccine ad26.cov2.s-blood clot, tissue necrosis, unable to walk, capillaries exploded. 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: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: RECEIVED SECOND DOSE ACCIDENTALLY; This spontaneous report received from a health care professional concerned a 75 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient reported none medical history. the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041a21a, expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the subject experienced received second dose accidentally. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received second dose accidentally was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Electroencephalogram, Feeling abnormal
Clinical narrative: BRAIN FOG; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included got covid-19, and concurrent conditions included alcoholic, and non smoker. 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 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced brain fog. On 21-JUN-2021, Laboratory data included: Computerized tomography scan (NR: not provided) UNKNOWN, and Electroencephalogram (NR: not provided) UNKNOWN. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of brain fog was not reported. This report was non-serious. This case, from the same reporter is linked to 20210648429.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: PAIN RELIEF AFTER VACCINATION IN HANDS AND SHOULDER; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non-smoker, and other pre-existing medical conditions included the patient did not have any known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 07-AUG-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced pain relief after vaccination in hands and shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain relief after vaccination in hands and shoulder was not reported. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; FEVER; This spontaneous report was received from a 21-year-old female patient. 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 administration was not reported, batch number: 201A21A, and expiry: unknown) dose was not reported,1 total, administered on left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021 (12 hours post vaccination), the patient experienced fever and felt fine after 2 days. On 18-JUN-2021, the patient experienced cough and head cold. On 19-JUN-2021, the patient experienced loss of taste, and loss of smell. The patient then realized that it could be coronavirus disease (COVID-19) symptoms and took an 'at-home' covid test which came back positive (suspected clinical vaccination failure, suspected covid-19 infection). At the time of report, the patient still had some lingering cold and her loss of taste and smell did not return. She generally felt better at the time of report and had not consulted a health care provider as her symptoms were mild. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 10-APR-2021, was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint (PQC) number 90000183672 The suspected product quality complaint has been confirmed to be not void, based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210648767-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: Dyspnoea, Nausea
Clinical narrative: SHORTNESS OF BREATH; NAUSEA; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: YYZ24Z, expiry: 24-JUL-2021) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-JUN-2021, the subject experienced shortness of breath. On 23-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer via other manufacturer concerned a 46 year old female of unknown race and ethnic origin. The patient's height, and weight were not reported.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose once total, 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 16-APR-2021, the patient had antibodies test done which came back negative for antibodies (coded as suspected immunological vaccine failure). Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210649679-covid-19 vaccine ad26.cov2.s-Suspected immunological vaccination 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: Death, Hospitalisation
Clinical narrative: IN THE HOSPITAL 3 DAYS AFTER JANSSEN VACCINE; DEATH (LOST THE FIGHT 3 WEEKS LATER); This spontaneous report received from a consumer via a company representative concerned a female of unspecified age and unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, one total administered, 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.  it was reported that on an unspecified date, the patient was in the hospital fighting for her life 3 days after taking the vaccine. She lost the fight 3 weeks later (death). It was mentioned that the patient believed the propaganda and lost her life. The patient died due to unknown cause. It was unknown if autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20210650080-COVID-19 VACCINE AD26.COv2.S-In the Hospital 3 days after Jannsen vaccine, Death(Lost the Fight 3 weeks later). This event(s) is considered un-assessable. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain, SARS-CoV-2 test, Tinnitus
Clinical narrative: BODY ACHES; LETHARGY; TINNITUS ON THE LEFT EAR (LOW  PITCH AND HIGH PITCH); This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimoto's disease, abstains from alcohol, non smoker, and orange peel (has epi pen for) iodinated contrast. The patient experienced extreme bloating when treated with clarithromycin, and neurological side effects when treated with levofloxacin, and lips swelled up, rash and throat tightened up when treated with cortisone, high blood pressure when treated with prednisone, and rash when treated with methocarbamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAR-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) positive. On 02-JUN-2021, the subject experienced body aches. On 02-JUN-2021, the subject experienced lethargy. On 02-JUN-2021, the subject experienced tinnitus on the left ear (low pitch and high pitch). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and lethargy on 04-JUN-2021, and had not recovered from tinnitus on the left ear (low pitch and high pitch). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: MILD SIDE EFFECTS; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) on 18-JUN-2021 was received on 18-JUN-2021 and concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced mild side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild side effects was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizziness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Fibromyalgia, Pulmonary fibrosis
Clinical narrative: COVID PNEUMONIA; SCARRING OF LUNG TISSUE; BEGINNING OF FIBROMYALGIA; This spontaneous report received from a consumer concerned a female. The patient's concurrent condition included beginning stages of chronic obstructive pulmonary disease (COPD). 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 29-MAR-2021 on right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-APR-2021, the patient had a COVID pneumonia and was hospitalized. The patient was hospitalized for 9 days (also given as 8 days) till 23-APR-2021, and received a 5 day course of an unspecified medication. The patient was not ventilated, but due to preexisting COPD status, the patient followed up with pulmonologist on 23-APR-2021, who confirmed that the patient had scarring of lungs tissue due to COVID and the beginnings of fibromyalgia.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from COVID pneumonia on 23-APR-2021, and had not recovered from scarring of lung tissue, and beginning of fibromyalgia. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Disability Or Permanent Damage).; Sender's Comments: V0 20210651198-covid-19 vaccine ad26.cov2.s -COVID pneumonia, scarring of lungs tissue due to COVID and the beginnings of fibromyalgia. 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, NATURE OF EVENT
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: BILATERAL FOOT SWELLING; BILATERAL FOOT REDNESS; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient have no health conditions/medications. 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: 1805022, expiry: 09-JUL-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, treatment medications included: ibuprofen. On an unspecified date, the subject experienced bilateral foot swelling, and bilateral foot redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bilateral foot swelling, and bilateral foot redness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Pain, Pyrexia
Clinical narrative: TERRIBLE PAINS; SEVERE DIARRHEA; HEAVY FEVERS; This spontaneous report received from a consumer concerned multiple patients.  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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced terrible pains, severe diarrhea, and heavy fevers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe diarrhea, heavy fevers and terrible pains was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: OUT OF SPECIFICATION USE (VACCINE ADMINISTERED 1 DAY AFTER OPENED); This spontaneous report received from a health care professional concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the subject experienced out of specification use (vaccine administered 1 day after opened). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of specification use (vaccine administered 1 day after opened) was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: WARMTH; RIGHT ARM SWELLING LOCALIZED, HALF DOLLAR SIZED AND HARD TO CENTER; REDNESS; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with morphine, and hydrocodone bitartrate/paracetamol for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-JUN-2021 07:38 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-JUN-2021, the subject experienced warmth. On 18-JUN-2021, the subject experienced right arm swelling localized, half dollar sized and hard to center. On 18-JUN-2021, the subject experienced redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm swelling localized, half dollar sized and hard to center, redness, and warmth. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Headache, Pyrexia
Clinical narrative: DIZZINESS; HEADACHE; WEAKNESS; FEVER; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux, and rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. Concomitant medications included omeprazole for acid reflux, atorvastatin for drug used for unknown indication, buspirone for drug used for unknown indication, ergocalciferol for drug used for unknown indication, escitalopram oxalate for drug used for unknown indication, folic acid for drug used for unknown indication, and methotrexate for rheumatoid arthritis. On 22-JUN-2021, the subject experienced dizziness. On 22-JUN-2021, the subject experienced headache. On 22-JUN-2021, the subject experienced weakness. On 22-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.4 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, headache, weakness and fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) frequency 1 total, 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 died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210651615-COVID-19 VACCINE AD26.COV2.S -Death. This event is considered unassessable. The event 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Computerised tomogram, Headache, Hepatic enzyme
Clinical narrative: LOW PLATELET COUNT; LIVER ENZYMES HIGH; BODY ACHES; JOINT ACHES; SEVERE NAUSEA; HORRIBLE HEADACHE; This spontaneous report received from a patient (who is a Healthcare professional) concerned a 73 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, intramuscular, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total, administered to the left arm on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified day, the patient had a horrible headache for 4 weeks and went into the hospital and did bloodwork. She stated that her platelet count went down to 69,000 and liver enzymes were high. She also had a head computerized tomography (CT) scan done as well as went to the eye doctor. Two weeks later the patient went and had another platelet count done and it went up to low normal. She wondered if a month after the vaccine, it was possible to have the side effects. She also stated that she had severe nausea along with the headaches. She also had joint aches as well as body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low platelet count, and the outcome of liver enzymes high, horrible headache, severe nausea, joint aches and body aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210651622-covid-19 vaccine ad26.cov2.S-Low platelet count. This event is considered unassessable. The event 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme increased, Nausea, Pain, Platelet count, Platelet count decreased
Clinical narrative: LOW PLATELET COUNT; LIVER ENZYMES HIGH; BODY ACHES; JOINT ACHES; SEVERE NAUSEA; HORRIBLE HEADACHE; This spontaneous report received from a patient (who is a Healthcare professional) concerned a 73 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, intramuscular, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total, administered to the left arm on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified day, the patient had a horrible headache for 4 weeks and went into the hospital and did bloodwork. She stated that her platelet count went down to 69,000 and liver enzymes were high. She also had a head computerized tomography (CT) scan done as well as went to the eye doctor. Two weeks later the patient went and had another platelet count done and it went up to low normal. She wondered if a month after the vaccine, it was possible to have the side effects. She also stated that she had severe nausea along with the headaches. She also had joint aches as well as body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low platelet count, and the outcome of liver enzymes high, horrible headache, severe nausea, joint aches and body aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210651622-covid-19 vaccine ad26.cov2.S-Low platelet count. This event is considered unassessable. The event 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.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site reaction
Clinical narrative: REACTION TO VACCINE GIVEN IN TENDON; INAPPROPRIATE ROUTE OF VACCINATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced reaction to vaccine given in tendon, and inappropriate route of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the reaction to vaccine given in tendon and inappropriate route of vaccination was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: PERIOD LASTING APPROXIMATELY TWO WEEKS AND NOT STOPPED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-JUN-2021, the subject experienced period lasting approximately two weeks and not stopped. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from period lasting approximately two weeks and not stopped. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: NOT FEELING WELL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feeling well was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Headache, Pruritus
Clinical narrative: FELT PRETTY UNCOMFORTABLE; SKIN FELT REALLY ITCHY; BAD HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-JUN-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 23-JUN-2021, the subject experienced felt pretty uncomfortable. On 23-JUN-2021, the subject experienced skin felt really itchy. On 23-JUN-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt pretty uncomfortable, skin felt really itchy and bad headache was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal X-ray, Abdominal pain upper
Clinical narrative: BAD STOMACH ACHE; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced bad stomach ache. Laboratory data (dates unspecified) included: Abdominal X-ray (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad stomach ache. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.