chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Rash, Rash papular, Urticaria
Clinical narrative: itchiness last night; eyes are begun swollen a little bit; some hives/red patches; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (Patient's mother) reported for her son. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), dose 1 via an unspecified route of administration on 25Apr2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that her son experienced itchiness last night and eyes were begun swollen a little bit, also experienced red patches/ some hives. The outcome of the events reported as unknown.   Follow-up received on 26Apr2021, no new information.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye swelling, Pruritus, Urticaria
Clinical narrative: itchiness last night; eyes are begun swollen a little bit; some hives/red patches; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (Patient's mother) reported for her son. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), dose 1 via an unspecified route of administration on 25Apr2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that her son experienced itchiness last night and eyes were begun swollen a little bit, also experienced red patches/ some hives. The outcome of the events reported as unknown.   Follow-up received on 26Apr2021, no new information.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Seizure
Clinical narrative: Went back to sleep and never woke up; Arm soreness; Feeling bad; very flushed/looked red; very tired/fatigue/nappy women taking a lot of naps; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Went back to sleep and never woke up) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C2117) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neurofibromatosis, type 2 (acoustic neurofibromatosis) (Diagnosed at age 11, had tumor on nerves and all over body.), Blindness (All blind in left eye), Allergy NOS (unspecified allergy), Walker user and Feeding tube user.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced DEATH (Went back to sleep and never woke up) (seriousness criterion death), PAIN IN EXTREMITY (Arm soreness), VACCINATION COMPLICATION (Feeling bad), FLUSHING (very flushed/looked red) and FATIGUE (very tired/fatigue/nappy women taking a lot of naps). The patient died on 23-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PAIN IN EXTREMITY (Arm soreness), VACCINATION COMPLICATION (Feeling bad), FLUSHING (very flushed/looked red) and FATIGUE (very tired/fatigue/nappy women taking a lot of naps) outcome was unknown.            The patient was on a feeding tube, lived independently but had a caretaker who came in every day. The patient had long list of medications for her conditions but concomitant medications were not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.  Regarding the events of Pain in extremity, Fatigue, Flushing, Vaccination related malaise, based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, regarding the event of Death,Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Regarding the events of Pain in extremity, Fatigue, Flushing, Vaccination related malaise, based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, regarding the event of Death,Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Fatigue, Flushing, Pain in extremity, Vaccination complication
Clinical narrative: Went back to sleep and never woke up; Arm soreness; Feeling bad; very flushed/looked red; very tired/fatigue/nappy women taking a lot of naps; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Went back to sleep and never woke up) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C2117) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neurofibromatosis, type 2 (acoustic neurofibromatosis) (Diagnosed at age 11, had tumor on nerves and all over body.), Blindness (All blind in left eye), Allergy NOS (unspecified allergy), Walker user and Feeding tube user.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced DEATH (Went back to sleep and never woke up) (seriousness criterion death), PAIN IN EXTREMITY (Arm soreness), VACCINATION COMPLICATION (Feeling bad), FLUSHING (very flushed/looked red) and FATIGUE (very tired/fatigue/nappy women taking a lot of naps). The patient died on 23-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PAIN IN EXTREMITY (Arm soreness), VACCINATION COMPLICATION (Feeling bad), FLUSHING (very flushed/looked red) and FATIGUE (very tired/fatigue/nappy women taking a lot of naps) outcome was unknown.            The patient was on a feeding tube, lived independently but had a caretaker who came in every day. The patient had long list of medications for her conditions but concomitant medications were not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.  Regarding the events of Pain in extremity, Fatigue, Flushing, Vaccination related malaise, based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, regarding the event of Death,Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Regarding the events of Pain in extremity, Fatigue, Flushing, Vaccination related malaise, based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, regarding the event of Death,Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Asthenia, Blood pressure increased, Chills, Dyspnoea
Clinical narrative: Not feeling well; Weak; Flu symptoms; Chills; Patient had a reaction; This is a spontaneous report from a contactable consumer (reporting herself).  A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 21Apr2021 as a single dose for COVID-19 immunization. The patients medical history and concomitant medication were not reported. The patient had a reaction and had to go to the ER (emergency room) twice. The patient was not feeling well and was wondering what she should do. The patient was weak and had flu symptoms. But sometimes they are ok. Today the patient was not. Sometimes the patient had chills. The patient told that to my PCP last Monday. The patient went to the ER and they checked kidney and heart and they were ok. The patient felt worse, and it was been 1 week already. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Insomnia, Musculoskeletal discomfort
Clinical narrative: Not feeling well; Weak; Flu symptoms; Chills; Patient had a reaction; This is a spontaneous report from a contactable consumer (reporting herself).  A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 21Apr2021 as a single dose for COVID-19 immunization. The patients medical history and concomitant medication were not reported. The patient had a reaction and had to go to the ER (emergency room) twice. The patient was not feeling well and was wondering what she should do. The patient was weak and had flu symptoms. But sometimes they are ok. Today the patient was not. Sometimes the patient had chills. The patient told that to my PCP last Monday. The patient went to the ER and they checked kidney and heart and they were ok. The patient felt worse, and it was been 1 week already. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chills, Influenza, Malaise, Nonspecific reaction
Clinical narrative: Not feeling well; Weak; Flu symptoms; Chills; Patient had a reaction; This is a spontaneous report from a contactable consumer (reporting herself).  A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 21Apr2021 as a single dose for COVID-19 immunization. The patients medical history and concomitant medication were not reported. The patient had a reaction and had to go to the ER (emergency room) twice. The patient was not feeling well and was wondering what she should do. The patient was weak and had flu symptoms. But sometimes they are ok. Today the patient was not. Sometimes the patient had chills. The patient told that to my PCP last Monday. The patient went to the ER and they checked kidney and heart and they were ok. The patient felt worse, and it was been 1 week already. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest discomfort, Cough, Dyspnoea, Erythema
Clinical narrative: hot , red face, dyspnea
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Throat tightness
Clinical narrative: hot , red face, dyspnea
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Dyspnoea, Erythema, Feeling hot
Clinical narrative: hot , red face, dyspnea
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Fatigue, Nasopharyngitis, Pruritus, Pyrexia
Clinical narrative: Her face started to swell; Developed a rash all over her body; This is a spontaneous report from a contactable consumer, the patient. A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced a rash all over her body, and her face started to swell abut had no difficulty breathing or shortness of breath.  She went to the emergency room on the 5th and 6th days after developing these symptoms and was given a 5day course of Prednisone and benadryl. The seriousness was reported as non-serious. The outcome of the event was reported as unknown.  Additional information is required.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Sneezing, Swelling face, Urticaria
Clinical narrative: Her face started to swell; Developed a rash all over her body; This is a spontaneous report from a contactable consumer, the patient. A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced a rash all over her body, and her face started to swell abut had no difficulty breathing or shortness of breath.  She went to the emergency room on the 5th and 6th days after developing these symptoms and was given a 5day course of Prednisone and benadryl. The seriousness was reported as non-serious. The outcome of the event was reported as unknown.  Additional information is required.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling face
Clinical narrative: Her face started to swell; Developed a rash all over her body; This is a spontaneous report from a contactable consumer, the patient. A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced a rash all over her body, and her face started to swell abut had no difficulty breathing or shortness of breath.  She went to the emergency room on the 5th and 6th days after developing these symptoms and was given a 5day course of Prednisone and benadryl. The seriousness was reported as non-serious. The outcome of the event was reported as unknown.  Additional information is required.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Loss of consciousness, vomiting.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Full blood count, Loss of consciousness, Metabolic function test, Vomiting
Clinical narrative: Loss of consciousness, vomiting.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling and numbness in left hand/fingertips; tingling and numbness in left hand/fingertips; This is a spontaneous report from a contactable consumer (Patient).   A 73-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 (Lot Number: EL3249) as SINGLE DOSE for covid-19 immunisation at age of 73 years old.  There was no medical history or concomitant medications. The patient previously received the first dose of BNT162B2 in Jan2021 for Covid-19 Immunization.The patient had tingling and numbness in her left hand and fingertips in mid Feb2021. No treatment was received. she did research to see if this was a side effect of vaccinations in general or Pfizer's or if she should call her doctor or if it was symptomatic or disease. she saw something about a needle could hit a nerve.The outcome of the events was resolving.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Arteriogram carotid abnormal, Blood thyroid stimulating hormone, Cerebrovascular accident, Computerised tomogram head abnormal
Clinical narrative: Patient reports she was in her regular state of health until the night prior to admission when she began having fevers and chills following her Johnson & Johnson vaccine.  She reports that she began feeling more more nauseous and got out of bed around 12 AM and crawled to the bathroom where she had episodes of emesis.Shortly after admitting the patient, the patient arrived on the floor where she was noted to have a new left-sided facial droop with worsening dysarthria. Called stroke code and neurology was gracious enough to assist.  Patient was transferred to CT where no evidence of any hemorrhage was identified.  tPA was administered per neurology recommendations and the patient was transferred to the neurosurgical ICU.#. Left facial droop, left side weakness, dysarthria and left hemineglect secondary to suspected ischemic stroke
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram neck, Echocardiogram, Full blood count, Glycosylated haemoglobin, International normalised ratio
Clinical narrative: Patient reports she was in her regular state of health until the night prior to admission when she began having fevers and chills following her Johnson & Johnson vaccine.  She reports that she began feeling more more nauseous and got out of bed around 12 AM and crawled to the bathroom where she had episodes of emesis.Shortly after admitting the patient, the patient arrived on the floor where she was noted to have a new left-sided facial droop with worsening dysarthria. Called stroke code and neurology was gracious enough to assist.  Patient was transferred to CT where no evidence of any hemorrhage was identified.  tPA was administered per neurology recommendations and the patient was transferred to the neurosurgical ICU.#. Left facial droop, left side weakness, dysarthria and left hemineglect secondary to suspected ischemic stroke
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lipids, Metabolic function test
Clinical narrative: Patient reports she was in her regular state of health until the night prior to admission when she began having fevers and chills following her Johnson & Johnson vaccine.  She reports that she began feeling more more nauseous and got out of bed around 12 AM and crawled to the bathroom where she had episodes of emesis.Shortly after admitting the patient, the patient arrived on the floor where she was noted to have a new left-sided facial droop with worsening dysarthria. Called stroke code and neurology was gracious enough to assist.  Patient was transferred to CT where no evidence of any hemorrhage was identified.  tPA was administered per neurology recommendations and the patient was transferred to the neurosurgical ICU.#. Left facial droop, left side weakness, dysarthria and left hemineglect secondary to suspected ischemic stroke
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Computerised tomogram head normal, Dysarthria, Facial paralysis, Hemiparesis
Clinical narrative: Patient reports she was in her regular state of health until the night prior to admission when she began having fevers and chills following her Johnson & Johnson vaccine.  She reports that she began feeling more more nauseous and got out of bed around 12 AM and crawled to the bathroom where she had episodes of emesis.Shortly after admitting the patient, the patient arrived on the floor where she was noted to have a new left-sided facial droop with worsening dysarthria. Called stroke code and neurology was gracious enough to assist.  Patient was transferred to CT where no evidence of any hemorrhage was identified.  tPA was administered per neurology recommendations and the patient was transferred to the neurosurgical ICU.#. Left facial droop, left side weakness, dysarthria and left hemineglect secondary to suspected ischemic stroke
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Ischaemic stroke, Nausea, Neurologic neglect syndrome, Pyrexia
Clinical narrative: Patient reports she was in her regular state of health until the night prior to admission when she began having fevers and chills following her Johnson & Johnson vaccine.  She reports that she began feeling more more nauseous and got out of bed around 12 AM and crawled to the bathroom where she had episodes of emesis.Shortly after admitting the patient, the patient arrived on the floor where she was noted to have a new left-sided facial droop with worsening dysarthria. Called stroke code and neurology was gracious enough to assist.  Patient was transferred to CT where no evidence of any hemorrhage was identified.  tPA was administered per neurology recommendations and the patient was transferred to the neurosurgical ICU.#. Left facial droop, left side weakness, dysarthria and left hemineglect secondary to suspected ischemic stroke
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Patient reports she was in her regular state of health until the night prior to admission when she began having fevers and chills following her Johnson & Johnson vaccine.  She reports that she began feeling more more nauseous and got out of bed around 12 AM and crawled to the bathroom where she had episodes of emesis.Shortly after admitting the patient, the patient arrived on the floor where she was noted to have a new left-sided facial droop with worsening dysarthria. Called stroke code and neurology was gracious enough to assist.  Patient was transferred to CT where no evidence of any hemorrhage was identified.  tPA was administered per neurology recommendations and the patient was transferred to the neurosurgical ICU.#. Left facial droop, left side weakness, dysarthria and left hemineglect secondary to suspected ischemic stroke
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: the injection site under her bandage was red and swollen; the injection site under her bandage was red and swollen; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 50-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via unspecified route of administration on 19Apr2021 as single dose for COVID-19 immunization. Patient was 50-years-old at the vaccination. Patients medical history and concomitant medications were not reported. Yesterday (20Apr2021) morning around 8:40am-9am the injection site under her bandage was red and swollen. Today her arm was a little better, and the swelling has gone down a little bit. The outcome of the events injection site under her bandage was red was unknown and swollen was recovering/resolving.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DEEP VEIN THROMBOSIS; This spontaneous report was received from 66-year-old, White, not Hispanic or Latino female patient.  The patient's height, and weight were not reported. The patient's past medical history included Factor 5 Leiden positive (no clot issues since 1998 and did not take any standard medication for it as per guidelines), and anaphylaxis due to drug and shellfish allergies. The patient underwent a surgery (unspecified) and was immobilized and developed multiple clots in her right leg. Concurrent condition included shellfish allergy. The patient drinks alcohol socially (rarely), does not smoke and had no drug abuse or illicit drug use. The patient experienced drug allergy when treated with Aspirin (acetylsalicylic acid), and ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1805022 and expiry: unknown) dose was not reported, 1 total, administered on left arm on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-APR-2021 (approximate date), the patient experienced persistent leg pains. On 29-APR-2021, the patient developed pitting edema, experienced ankle redness and ankle pain. On 01-May-2021, the patient saw a retired orthopedic surgeon who advised the patient to go to a doctor immediately. On 02-May-2021, the patient went to the primary care office, saw a nurse practitioner and was immediately sent to the Emergency room (ER). On the same day, many blood tests were done (including differential, routine chemistry and coagulation), all of which showed normal results and a computed tomography (CT) scan showed thrombus in left posterior tibial vein below the knee (blood clot in left calf) following which a diagnosis of deep vein thrombosis (DVT) was made. On 02-May-2021, the patient started with Xarelto (rivaroxaban) 15 mg twice daily for 21 days then decrease to once daily as part of treatment for DVT. The patient completed 6 doses of Xarelto at the time of report. Both the ER doctor and the primary care doctor stated that the cause of DVT was the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210509051- covid-19 vaccine ad26.cov2.s - Deep Vein Thrombosis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY,UNDERLYING DISEASE.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oedema, Pain, Swelling, Thrombosis, Ultrasound scan
Clinical narrative: DEEP VEIN THROMBOSIS; This spontaneous report was received from 66-year-old, White, not Hispanic or Latino female patient.  The patient's height, and weight were not reported. The patient's past medical history included Factor 5 Leiden positive (no clot issues since 1998 and did not take any standard medication for it as per guidelines), and anaphylaxis due to drug and shellfish allergies. The patient underwent a surgery (unspecified) and was immobilized and developed multiple clots in her right leg. Concurrent condition included shellfish allergy. The patient drinks alcohol socially (rarely), does not smoke and had no drug abuse or illicit drug use. The patient experienced drug allergy when treated with Aspirin (acetylsalicylic acid), and ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1805022 and expiry: unknown) dose was not reported, 1 total, administered on left arm on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-APR-2021 (approximate date), the patient experienced persistent leg pains. On 29-APR-2021, the patient developed pitting edema, experienced ankle redness and ankle pain. On 01-May-2021, the patient saw a retired orthopedic surgeon who advised the patient to go to a doctor immediately. On 02-May-2021, the patient went to the primary care office, saw a nurse practitioner and was immediately sent to the Emergency room (ER). On the same day, many blood tests were done (including differential, routine chemistry and coagulation), all of which showed normal results and a computed tomography (CT) scan showed thrombus in left posterior tibial vein below the knee (blood clot in left calf) following which a diagnosis of deep vein thrombosis (DVT) was made. On 02-May-2021, the patient started with Xarelto (rivaroxaban) 15 mg twice daily for 21 days then decrease to once daily as part of treatment for DVT. The patient completed 6 doses of Xarelto at the time of report. Both the ER doctor and the primary care doctor stated that the cause of DVT was the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210509051- covid-19 vaccine ad26.cov2.s - Deep Vein Thrombosis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY,UNDERLYING DISEASE.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Coagulation test, Computerised tomogram, Deep vein thrombosis, Full blood count
Clinical narrative: DEEP VEIN THROMBOSIS; This spontaneous report was received from 66-year-old, White, not Hispanic or Latino female patient.  The patient's height, and weight were not reported. The patient's past medical history included Factor 5 Leiden positive (no clot issues since 1998 and did not take any standard medication for it as per guidelines), and anaphylaxis due to drug and shellfish allergies. The patient underwent a surgery (unspecified) and was immobilized and developed multiple clots in her right leg. Concurrent condition included shellfish allergy. The patient drinks alcohol socially (rarely), does not smoke and had no drug abuse or illicit drug use. The patient experienced drug allergy when treated with Aspirin (acetylsalicylic acid), and ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1805022 and expiry: unknown) dose was not reported, 1 total, administered on left arm on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-APR-2021 (approximate date), the patient experienced persistent leg pains. On 29-APR-2021, the patient developed pitting edema, experienced ankle redness and ankle pain. On 01-May-2021, the patient saw a retired orthopedic surgeon who advised the patient to go to a doctor immediately. On 02-May-2021, the patient went to the primary care office, saw a nurse practitioner and was immediately sent to the Emergency room (ER). On the same day, many blood tests were done (including differential, routine chemistry and coagulation), all of which showed normal results and a computed tomography (CT) scan showed thrombus in left posterior tibial vein below the knee (blood clot in left calf) following which a diagnosis of deep vein thrombosis (DVT) was made. On 02-May-2021, the patient started with Xarelto (rivaroxaban) 15 mg twice daily for 21 days then decrease to once daily as part of treatment for DVT. The patient completed 6 doses of Xarelto at the time of report. Both the ER doctor and the primary care doctor stated that the cause of DVT was the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210509051- covid-19 vaccine ad26.cov2.s - Deep Vein Thrombosis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY,UNDERLYING DISEASE.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes simplex
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. A 103-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration, administered on the arm on 04Mar2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Feb2021 for COVID-19 immunisation. On 14Mar2021, patient experienced shingles (reported as approximately 7-10 days after vaccination). Therepeutic measurement was taken as a result of shingles included valacyclovir (VALTREX). The outcome of shingles was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021443579 Same reporter, drug, and event; different patient
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. A 103-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration, administered on the arm on 04Mar2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Feb2021 for COVID-19 immunisation. On 14Mar2021, patient experienced shingles (reported as approximately 7-10 days after vaccination). Therepeutic measurement was taken as a result of shingles included valacyclovir (VALTREX). The outcome of shingles was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021443579 Same reporter, drug, and event; different patient
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: 5 days after, she tested positive for the COVID19 virus; she has still no taste and smell; she has still no taste and smell; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female received first dose of BNT162B2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot number and expiration was not reported) .via an unspecified route of administration on an unknown date, as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. Patient had already finished her first dose of the PFIZER-BIONTECH COVID-19 VACCINE and 5 days after, she tested positive for the COVID19 virus. She wanted to know the efficacy of the vaccine even with prior/current COVID19 infection. She wanted to know on how she should proceed in getting the second dose of the vaccine. She also would like to know as to how long does she need to wait to get the second dose. Also, caller mentioned that she has still no taste and smell and was initially told to wait up until her isolation was finished. She was quite concerned as she had told that some people would need to wait up until 5 months to have their sense of taste and smell back. She also had this reported to safety already. Patient underwent lab test and procedure which included COVID 19 test positive on unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, COVID-19, SARS-CoV-2 test positive
Clinical narrative: 5 days after, she tested positive for the COVID19 virus; she has still no taste and smell; she has still no taste and smell; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female received first dose of BNT162B2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot number and expiration was not reported) .via an unspecified route of administration on an unknown date, as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. Patient had already finished her first dose of the PFIZER-BIONTECH COVID-19 VACCINE and 5 days after, she tested positive for the COVID19 virus. She wanted to know the efficacy of the vaccine even with prior/current COVID19 infection. She wanted to know on how she should proceed in getting the second dose of the vaccine. She also would like to know as to how long does she need to wait to get the second dose. Also, caller mentioned that she has still no taste and smell and was initially told to wait up until her isolation was finished. She was quite concerned as she had told that some people would need to wait up until 5 months to have their sense of taste and smell back. She also had this reported to safety already. Patient underwent lab test and procedure which included COVID 19 test positive on unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Pneumonia, Renal failure, Sepsis
Clinical narrative: Pt experienced severe generalized pain day after getting vaccine, symptoms worsened with additional symptoms of chest pain, shortness of breath, painful inspiration over the 7 days following vaccine.  Sent to ER from office day 8 and was admitted with diagnosis of sepsis, pneumonia, ground glass appearance on cxr, cardiomegaly, delirium, new onset atrial fibrillation, acute renal failure.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: Pt experienced severe generalized pain day after getting vaccine, symptoms worsened with additional symptoms of chest pain, shortness of breath, painful inspiration over the 7 days following vaccine.  Sent to ER from office day 8 and was admitted with diagnosis of sepsis, pneumonia, ground glass appearance on cxr, cardiomegaly, delirium, new onset atrial fibrillation, acute renal failure.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Atrial fibrillation, Cardiomegaly, Chest X-ray abnormal, Chest pain
Clinical narrative: Pt experienced severe generalized pain day after getting vaccine, symptoms worsened with additional symptoms of chest pain, shortness of breath, painful inspiration over the 7 days following vaccine.  Sent to ER from office day 8 and was admitted with diagnosis of sepsis, pneumonia, ground glass appearance on cxr, cardiomegaly, delirium, new onset atrial fibrillation, acute renal failure.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Delirium, Dyspnoea, Electrocardiogram abnormal, Endotracheal intubation, Lung opacity
Clinical narrative: Pt experienced severe generalized pain day after getting vaccine, symptoms worsened with additional symptoms of chest pain, shortness of breath, painful inspiration over the 7 days following vaccine.  Sent to ER from office day 8 and was admitted with diagnosis of sepsis, pneumonia, ground glass appearance on cxr, cardiomegaly, delirium, new onset atrial fibrillation, acute renal failure.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Painful respiration, Pneumonia, Sepsis
Clinical narrative: Pt experienced severe generalized pain day after getting vaccine, symptoms worsened with additional symptoms of chest pain, shortness of breath, painful inspiration over the 7 days following vaccine.  Sent to ER from office day 8 and was admitted with diagnosis of sepsis, pneumonia, ground glass appearance on cxr, cardiomegaly, delirium, new onset atrial fibrillation, acute renal failure.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure during pregnancy, Facial paresis, Guillain-Barre syndrome, Lumbar puncture abnormal, Neurological symptom
Clinical narrative: I was diagnosed with Guillain-Barre syndrome as a result of taking the J&J vaccine. Symptoms started about two weeks after the shot. I first felt tingling in the arms and legs as well as loss of taste on the tongue and then, a few days later, the left side of my face became numb and immobile. A few days after I was diagnosed with Bell's Palsy (after hours spent in the emergency room) and prescribed Prednisone and Valtrax to improve the symptoms, the symptoms got worse and spread to the right side of my face, as well. My entire face was immobile and numb (along with the tingling in my arms and legs). The neurologist I saw, who had originally diagnosed me with Bell's Palsy saw me in his office that same day (when the right side of my face became immobile) and sent me back to the emergency room to get treatment and help. He believed that I had Guillain-Barre syndrome, which is what it turned out to be. I was sent in an ambulance up to Hospital where I sat in the ER for five hours waiting to be seen before they performed a spinal tap to see if I had elevated protein in my spinal fluid. I did have elevated proteins in my spinal fluid, which led the neurology team to believe that I had Guillain-Barre syndrome. I was then admitted to to the hospital for six days during which I would undergo five days of IVIG treatment (ALL OF WHICH, WHILE 28-weeks PREGNANT!!!! which also added a HUGE layer of stress to the situation). I stayed in the hospital from Monday through Saturday to undergo the treatment. It is extremely discouraging and sad what happened as a result of me taking the J&J vaccine. This diagnosis has been extremely scary and I have no idea what kind of effect the treatment that I have had to undergo has had on my baby. This is extremely upsetting and demoralizing. I went through a terrible experience as a result of taking the J&J vaccine and I also have terrible lingering effects - I still have facial immobility and partial paralysis, I have complete loss of taste in my mouth/on my tongue, and I have the worst headaches known to mankind - all as a result of the nerve damage I have suffered as a result of the vaccine giving me GB syndrome. The J&J vaccine has really turned my life upside down. I am due to deliver my baby on July 29th, 2021 and sure hope that everything is okay with the baby after this horrific experience. This is my first pregnancy, so you can imagine how this event as a result of the J&J vaccine has affected me. It's been awful.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Rash
Clinical narrative: I was diagnosed with Guillain-Barre syndrome as a result of taking the J&J vaccine. Symptoms started about two weeks after the shot. I first felt tingling in the arms and legs as well as loss of taste on the tongue and then, a few days later, the left side of my face became numb and immobile. A few days after I was diagnosed with Bell's Palsy (after hours spent in the emergency room) and prescribed Prednisone and Valtrax to improve the symptoms, the symptoms got worse and spread to the right side of my face, as well. My entire face was immobile and numb (along with the tingling in my arms and legs). The neurologist I saw, who had originally diagnosed me with Bell's Palsy saw me in his office that same day (when the right side of my face became immobile) and sent me back to the emergency room to get treatment and help. He believed that I had Guillain-Barre syndrome, which is what it turned out to be. I was sent in an ambulance up to Hospital where I sat in the ER for five hours waiting to be seen before they performed a spinal tap to see if I had elevated protein in my spinal fluid. I did have elevated proteins in my spinal fluid, which led the neurology team to believe that I had Guillain-Barre syndrome. I was then admitted to to the hospital for six days during which I would undergo five days of IVIG treatment (ALL OF WHICH, WHILE 28-weeks PREGNANT!!!! which also added a HUGE layer of stress to the situation). I stayed in the hospital from Monday through Saturday to undergo the treatment. It is extremely discouraging and sad what happened as a result of me taking the J&J vaccine. This diagnosis has been extremely scary and I have no idea what kind of effect the treatment that I have had to undergo has had on my baby. This is extremely upsetting and demoralizing. I went through a terrible experience as a result of taking the J&J vaccine and I also have terrible lingering effects - I still have facial immobility and partial paralysis, I have complete loss of taste in my mouth/on my tongue, and I have the worst headaches known to mankind - all as a result of the nerve damage I have suffered as a result of the vaccine giving me GB syndrome. The J&J vaccine has really turned my life upside down. I am due to deliver my baby on July 29th, 2021 and sure hope that everything is okay with the baby after this horrific experience. This is my first pregnancy, so you can imagine how this event as a result of the J&J vaccine has affected me. It's been awful.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Bell's palsy, CSF protein increased, Exposure during pregnancy, Facial paralysis
Clinical narrative: I was diagnosed with Guillain-Barre syndrome as a result of taking the J&J vaccine. Symptoms started about two weeks after the shot. I first felt tingling in the arms and legs as well as loss of taste on the tongue and then, a few days later, the left side of my face became numb and immobile. A few days after I was diagnosed with Bell's Palsy (after hours spent in the emergency room) and prescribed Prednisone and Valtrax to improve the symptoms, the symptoms got worse and spread to the right side of my face, as well. My entire face was immobile and numb (along with the tingling in my arms and legs). The neurologist I saw, who had originally diagnosed me with Bell's Palsy saw me in his office that same day (when the right side of my face became immobile) and sent me back to the emergency room to get treatment and help. He believed that I had Guillain-Barre syndrome, which is what it turned out to be. I was sent in an ambulance up to Hospital where I sat in the ER for five hours waiting to be seen before they performed a spinal tap to see if I had elevated protein in my spinal fluid. I did have elevated proteins in my spinal fluid, which led the neurology team to believe that I had Guillain-Barre syndrome. I was then admitted to to the hospital for six days during which I would undergo five days of IVIG treatment (ALL OF WHICH, WHILE 28-weeks PREGNANT!!!! which also added a HUGE layer of stress to the situation). I stayed in the hospital from Monday through Saturday to undergo the treatment. It is extremely discouraging and sad what happened as a result of me taking the J&J vaccine. This diagnosis has been extremely scary and I have no idea what kind of effect the treatment that I have had to undergo has had on my baby. This is extremely upsetting and demoralizing. I went through a terrible experience as a result of taking the J&J vaccine and I also have terrible lingering effects - I still have facial immobility and partial paralysis, I have complete loss of taste in my mouth/on my tongue, and I have the worst headaches known to mankind - all as a result of the nerve damage I have suffered as a result of the vaccine giving me GB syndrome. The J&J vaccine has really turned my life upside down. I am due to deliver my baby on July 29th, 2021 and sure hope that everything is okay with the baby after this horrific experience. This is my first pregnancy, so you can imagine how this event as a result of the J&J vaccine has affected me. It's been awful.