chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fall, Monoplegia, Peripheral swelling, Vaccination site erythema
Clinical narrative: Could not move her legs; Swollen Left Arm post second vaccine; Hard to the touch Injection Site; Red Injection Site Spreading 6"; Spent 17 hours laying on the floor; Chills; A spontaneous report was received from a consumer concerning herself. She is a 77-years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Swollen Left Arm/peripheral swelling, Could not move her legs/ Monoplegia, Hard to the touch Injection Site/Vaccination site induration, Red Injection Site Spreading 6"/Vaccination site erythema, Spent 17 hours laying on the floor .  The patient's medical history was not reported. Concomitant medications were not listed.  On 25 JAN 2021, prior to the onset of events the patient received first of their two planned doses of mRNA-1273 (Batch N0: unknown)intramuscularly in the left arm for prophylaxis of covid 19 infection, and Her Arm swelled up, and she had chills for 3 days.  On 22 Feb 2021, prior to the onset of events the patient received second of their two planned doses of mRNA-1273 (Batch N0:016M20A )intramuscularly in the left arm for prophylaxis of covid 19 infection. on 22 Feb 2021, Her Arm Swelled Up again, Red, Hard, Spreading 6" and at 2AM could not move her legs. She fell on the floor when tried to get up. She was on the floor For 17 hours until help arrived. She was Hospitalized for 2 days. Discharged 24 FEB 2021, released to a Home Health Care Facility. They started physical therapy.  Action taken with mRNA-1273 in response to the events not applicable.  The outcome of events, Swollen Left Arm/peripheral swelling, Hard to the touch Injection Site/Vaccination site induration, Red Injection Site Spreading 6"/Vaccination site erythema were considered recovering/ resolving by 24 Feb 2021, Spent 17 hours laying on the floor, Could not move her legs/ Monoplegia considered recovering or resolving by 3 mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: Could not move her legs; Swollen Left Arm post second vaccine; Hard to the touch Injection Site; Red Injection Site Spreading 6"; Spent 17 hours laying on the floor; Chills; A spontaneous report was received from a consumer concerning herself. She is a 77-years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Swollen Left Arm/peripheral swelling, Could not move her legs/ Monoplegia, Hard to the touch Injection Site/Vaccination site induration, Red Injection Site Spreading 6"/Vaccination site erythema, Spent 17 hours laying on the floor .  The patient's medical history was not reported. Concomitant medications were not listed.  On 25 JAN 2021, prior to the onset of events the patient received first of their two planned doses of mRNA-1273 (Batch N0: unknown)intramuscularly in the left arm for prophylaxis of covid 19 infection, and Her Arm swelled up, and she had chills for 3 days.  On 22 Feb 2021, prior to the onset of events the patient received second of their two planned doses of mRNA-1273 (Batch N0:016M20A )intramuscularly in the left arm for prophylaxis of covid 19 infection. on 22 Feb 2021, Her Arm Swelled Up again, Red, Hard, Spreading 6" and at 2AM could not move her legs. She fell on the floor when tried to get up. She was on the floor For 17 hours until help arrived. She was Hospitalized for 2 days. Discharged 24 FEB 2021, released to a Home Health Care Facility. They started physical therapy.  Action taken with mRNA-1273 in response to the events not applicable.  The outcome of events, Swollen Left Arm/peripheral swelling, Hard to the touch Injection Site/Vaccination site induration, Red Injection Site Spreading 6"/Vaccination site erythema were considered recovering/ resolving by 24 Feb 2021, Spent 17 hours laying on the floor, Could not move her legs/ Monoplegia considered recovering or resolving by 3 mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Renal stone removal
Clinical narrative: Suffered 2 strokes; kidney stone surgery; A spontaneous report was received from a consumer concerning a 62 year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cerebrovascular accident,and renal stone surgery.   The patient's medical history was not provided., included allergy to cefaclor and hereditary hemorrhagic telangiectasia.Concomitant medications reported included Atrovastin, Aspirin, Clopidogrel, Olicolic oil.  On 21 Jan 2021 , approximately 28 days  prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 032120A) via unknown route in an unknown site for prophylaxis of COVID-19 infection. Before the scheduled second dose of Moderna Vaccination patient developed adverse events.  On 16 Feb 2021, patient had surgery for kidney stone. On 17 Feb 2021 she developed a stroke and again on 26 Feb 2021 she developed second stroke.The event stroke was considered serious and medically significant.  The treatment taken for the events was reported as unknown. Action taken with mRNA-1273 in response to the events was unknown..  The outcomes of the events were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram, Cough, Dyspnoea, Fatigue
Clinical narrative: pneumonia; bad breathing; cough; runny nose; hives on chin and eyelid; fever; fatigue; A spontaneous report was received from a consumer who was also a 77-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pneumonia, bad breathing, fever, fatigue, cough, runny nose and hives on her chin and eyelid.  The patient's medical history included heart condition and severe asthma. No relevant concomitant medications were reported.  The patient received her first of the two planned doses of mRNA-1273 on 04-FEB-2021 (Batch# 030M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 05-FEB-2021, she experienced bad breathing, fever, fatigue, cough, runny nose and hives on her chin and eyelid. Patient  went to the ER on 10-FEB-2021 where she had a chest X-ray and CAT scan done and pneumonia was diagnosed. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Urticaria
Clinical narrative: pneumonia; bad breathing; cough; runny nose; hives on chin and eyelid; fever; fatigue; A spontaneous report was received from a consumer who was also a 77-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pneumonia, bad breathing, fever, fatigue, cough, runny nose and hives on her chin and eyelid.  The patient's medical history included heart condition and severe asthma. No relevant concomitant medications were reported.  The patient received her first of the two planned doses of mRNA-1273 on 04-FEB-2021 (Batch# 030M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 05-FEB-2021, she experienced bad breathing, fever, fatigue, cough, runny nose and hives on her chin and eyelid. Patient  went to the ER on 10-FEB-2021 where she had a chest X-ray and CAT scan done and pneumonia was diagnosed. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Fatigue, Feeling abnormal
Clinical narrative: Feeling terrible; Feeling tired; Bloot clot in knee; A spontaneous report was received from a nurse who was a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a blood clot in her knee, feeling terrible and feeling tired..   The patient's medical history was not provided by the reporter. No relevant concomitant medications were reported.  On 25 Feb 2021, the patient received her second of two planned doses of mRNA-1273 (Lot number: 031M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 04 Mar 2021, a week after vaccination, the patient was seen at the hospital and was diagnosed with a blood clot in her knee of unknown origin.  She also reported that she has continued feeling terrible and feeling tired.  Lab details were not provided by the reporter.  Treatment for the events were unknown.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, blood clot in her knee, feeling terrible and feeling tired, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea haemorrhagic, Feeling abnormal, Feeling jittery
Clinical narrative: Jittery; Feels worse today than last Saturday and Sunday; nervous; Teeth, head, & ears hurt, headache; Nauseated; Body aches; Bloody mucusy diarrhea; Stomach cramps; Low-grade fever (100F); Bad chills during the night; Could not sleep; A spontaneous report was received from a consumer concerning a female patient who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Stomach cramps, Bloody mucusy diarrhea, Bad chills during the night, Could not sleep, Low-grade fever (100F), Body aches,nauseated, Teeth, head, & ears hurt, Jittery, Felt worse,nervous and headache.   The patients medical history was not provided.No relevant Concomitant medications were reported.  On 03 mar 2021,prior to the onset of events, the patient received her first of two planned dose of mRNA-1273(Lot number: 014M20A) vaccine intramuscularly in the upper left non-dominant arm for prophylaxis of COVID-19 infection.   On 05 mar 2021, about 48 hours later, patient developed stomach cramps and bloody mucusy for 24 hours then stopped. Had chills, during the night, could not sleep, and a low grade fever (100F)  at about 11:30 am.  On 09 mar 2021,patient had low grade fever of 99.8F with body aches and headache,nauseated, teeth, head, and ears hurt. Patient reports feeling jittery and nervous and felt worse.Treatment for the event included Extra Strength Tylenol and Probiotics.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The events Stomach cramps,  Bloody mucusy diarrhea, chills, fever,and could not sleep were considered resolved.  The outcome of the event Low-grade fever (99.8), Body aches,nauseated, Teeth, head, & ears hurt, Jittery, Felt worse ,nervous,headache was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Myalgia, Nausea, Nervousness
Clinical narrative: Jittery; Feels worse today than last Saturday and Sunday; nervous; Teeth, head, & ears hurt, headache; Nauseated; Body aches; Bloody mucusy diarrhea; Stomach cramps; Low-grade fever (100F); Bad chills during the night; Could not sleep; A spontaneous report was received from a consumer concerning a female patient who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Stomach cramps, Bloody mucusy diarrhea, Bad chills during the night, Could not sleep, Low-grade fever (100F), Body aches,nauseated, Teeth, head, & ears hurt, Jittery, Felt worse,nervous and headache.   The patients medical history was not provided.No relevant Concomitant medications were reported.  On 03 mar 2021,prior to the onset of events, the patient received her first of two planned dose of mRNA-1273(Lot number: 014M20A) vaccine intramuscularly in the upper left non-dominant arm for prophylaxis of COVID-19 infection.   On 05 mar 2021, about 48 hours later, patient developed stomach cramps and bloody mucusy for 24 hours then stopped. Had chills, during the night, could not sleep, and a low grade fever (100F)  at about 11:30 am.  On 09 mar 2021,patient had low grade fever of 99.8F with body aches and headache,nauseated, teeth, head, and ears hurt. Patient reports feeling jittery and nervous and felt worse.Treatment for the event included Extra Strength Tylenol and Probiotics.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The events Stomach cramps,  Bloody mucusy diarrhea, chills, fever,and could not sleep were considered resolved.  The outcome of the event Low-grade fever (99.8), Body aches,nauseated, Teeth, head, & ears hurt, Jittery, Felt worse ,nervous,headache was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Jittery; Feels worse today than last Saturday and Sunday; nervous; Teeth, head, & ears hurt, headache; Nauseated; Body aches; Bloody mucusy diarrhea; Stomach cramps; Low-grade fever (100F); Bad chills during the night; Could not sleep; A spontaneous report was received from a consumer concerning a female patient who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Stomach cramps, Bloody mucusy diarrhea, Bad chills during the night, Could not sleep, Low-grade fever (100F), Body aches,nauseated, Teeth, head, & ears hurt, Jittery, Felt worse,nervous and headache.   The patients medical history was not provided.No relevant Concomitant medications were reported.  On 03 mar 2021,prior to the onset of events, the patient received her first of two planned dose of mRNA-1273(Lot number: 014M20A) vaccine intramuscularly in the upper left non-dominant arm for prophylaxis of COVID-19 infection.   On 05 mar 2021, about 48 hours later, patient developed stomach cramps and bloody mucusy for 24 hours then stopped. Had chills, during the night, could not sleep, and a low grade fever (100F)  at about 11:30 am.  On 09 mar 2021,patient had low grade fever of 99.8F with body aches and headache,nauseated, teeth, head, and ears hurt. Patient reports feeling jittery and nervous and felt worse.Treatment for the event included Extra Strength Tylenol and Probiotics.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The events Stomach cramps,  Bloody mucusy diarrhea, chills, fever,and could not sleep were considered resolved.  The outcome of the event Low-grade fever (99.8), Body aches,nauseated, Teeth, head, & ears hurt, Jittery, Felt worse ,nervous,headache was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysuria, Insomnia, Mucocutaneous disorder, Pain
Clinical narrative: mucocutaneous disorder NEC; MD thinks it a viral thing; possibly mono; screaming every time she had to pee; so painful; open ulcer/lesions in the vagina with severe burning; couldn't sleep; pain was effecting the nervous system; no energy; sore arm after the shot with ache and pain; A spontaneous report was received from a consumer concerning a 22 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm after the shot with mucocutaneous disorder NEC.  The patient's medical history was not provided. Recent (Aug 2020) STD profile  was clear and not having unprotected sex.   Concomitant medication included anti muscle relaxer and antidepressants.  On 02 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 02 Mar 2021, the patient immediately experienced sore arm after the shot. On 03 Mar 2021, the patient developed rash on the face and in the mouth and vaginal area and was painful, feeling week, unable to sleep and had painful urination. The patient visited GP, urgent care, ER and dermatology consult who cold not come to an exact diagnosis and suspected a vial infection. The herpes test was negative. She was treated symptomatic locally with lidocaine for vaginal lesions, and generally with anti viral drug, tylenol, Ibuprofen, morphine and oxycontin. She stayed overnight in the hospital and was discharged on 08 Mar 2021.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events secondary to rash were considered as resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Viral infection, Vulvovaginal burning sensation
Clinical narrative: mucocutaneous disorder NEC; MD thinks it a viral thing; possibly mono; screaming every time she had to pee; so painful; open ulcer/lesions in the vagina with severe burning; couldn't sleep; pain was effecting the nervous system; no energy; sore arm after the shot with ache and pain; A spontaneous report was received from a consumer concerning a 22 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm after the shot with mucocutaneous disorder NEC.  The patient's medical history was not provided. Recent (Aug 2020) STD profile  was clear and not having unprotected sex.   Concomitant medication included anti muscle relaxer and antidepressants.  On 02 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 02 Mar 2021, the patient immediately experienced sore arm after the shot. On 03 Mar 2021, the patient developed rash on the face and in the mouth and vaginal area and was painful, feeling week, unable to sleep and had painful urination. The patient visited GP, urgent care, ER and dermatology consult who cold not come to an exact diagnosis and suspected a vial infection. The herpes test was negative. She was treated symptomatic locally with lidocaine for vaginal lesions, and generally with anti viral drug, tylenol, Ibuprofen, morphine and oxycontin. She stayed overnight in the hospital and was discharged on 08 Mar 2021.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events secondary to rash were considered as resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Pneumonia
Clinical narrative: Pneumonia; A spontaneous report was received from a male patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed pneumonia.  The patient's medical history included a sinus infection. The concomitant medications were not reported.  On 03-MAR-2021, 7 days prior to the onset of the event, the patient received his first of two planned doses of mRNA-1273 (lot#: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On 09-MAR-2021, the patient was tested positive for pneumonia which the patient believed was from a previous sinus infection. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, pneumonia, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer, Infection
Clinical narrative: Infection; Breast cancer; A spontaneous report was received from a female consumer (demographics not provided) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events breast cancer and infection.  The patient's medical history was not provided. Concomitant product use was not provided.  On 09 Feb 2021, prior to the onset of the events the consumer received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient was diagnosed with breast cancer. The patient developed an infection and inquired if the antibiotics would affect efficacy of the vaccine. No treatment information details were provided.  There was no change planned to the dosing schedule of mRNA-1273 in response to the events.   The outcome of the events was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested. Causality of both events is assessed as unlikely related to mRNA-1273.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Hyperhidrosis, Pyrexia, Urinary tract infection
Clinical narrative: UTI  after second dose; Sweats; Unable to walk; Fever; This spontaneous report was received from a consumer concerning a 73-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced Urinary Tract Infection, fever (pyrexia), sweats (hyperhidrosis), and unable to walk (gait inability).  The patient's medical history and concomitant medications were not reported.  The patient received the first of two planned doses of mRNA-1273 (Lot/Batch number: 007MZ0A) on 30 Jan 2021.  On 27 Feb 2021, prior to onset of symptoms, the patient received the second of two planned doses of mRNA-1273 (Lot/Batch number:  013A21A) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, after first dose of vaccine, the patient felt sick with fever, had sweats and was unable to walk.   Post second vaccination administration, the patient experienced same symptoms of feeling sick with fever, had sweats and was unable to walk. After second dose, the patient also experienced Urinary Tract Infection (UTI) and was hospitalized for three days. The patient reported that the people at facility were not wearing gloves when she received both doses.  Treatment for the events was not reported.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome for the events, Urinary Tract Infection, fever, sweats, and unable to walk was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Fatigue
Clinical narrative: lymph node under left arm down to the left breast was swollen and painful; body aches; weak; lymph node under left arm down to the left breast was swollen and painful; temp of 99.4 to 99.9; chills; joints ached; fatigued; With in 3 hours of injection, I got hot and flushed in my face; This is a spontaneous report from a contactable nurse (patient). A 57-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not available) via intramuscular on right arm on 13Jan2021 14:15 (02:15 PM) (at the age of 57-years-old) at single dose for COVID-19 immunisation at Workplace clinic. The patient's medical history included Asthma and Arthritis. The patient had allergies to medications, food, or other products (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. Historical vaccine included first dose of influenza vaccine at the age of 57 years in nasal on 02Dec2020 which was given within 4 weeks prior to the COVID vaccine and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown via intramuscular on left arm on 23Dec2020 14:15 (02:15 PM) (at the age of 57-years-old) at single dose for COVID-19 immunisation. On 13Jan2021 at 17:00 (05:00 PM), within 3 hours of injection, the patient got hot and flushed in her face. The next morning on 14Jan2021, she woke up and her lymph node under left arm down to the left breast was swollen and painful. The patient also had a temperature of 99.4 to 99.9 and had chills and body aches enough to keep her home from work. The patient had joints ache and felt weak and fatigued. This lasted for about twenty-four hours. The reporter assessed the events as non-serious. The outcome of the events was recovered in Jan 2021.  Information regarding lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: lymph node under left arm down to the left breast was swollen and painful; body aches; weak; lymph node under left arm down to the left breast was swollen and painful; temp of 99.4 to 99.9; chills; joints ached; fatigued; With in 3 hours of injection, I got hot and flushed in my face; This is a spontaneous report from a contactable nurse (patient). A 57-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not available) via intramuscular on right arm on 13Jan2021 14:15 (02:15 PM) (at the age of 57-years-old) at single dose for COVID-19 immunisation at Workplace clinic. The patient's medical history included Asthma and Arthritis. The patient had allergies to medications, food, or other products (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. Historical vaccine included first dose of influenza vaccine at the age of 57 years in nasal on 02Dec2020 which was given within 4 weeks prior to the COVID vaccine and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown via intramuscular on left arm on 23Dec2020 14:15 (02:15 PM) (at the age of 57-years-old) at single dose for COVID-19 immunisation. On 13Jan2021 at 17:00 (05:00 PM), within 3 hours of injection, the patient got hot and flushed in her face. The next morning on 14Jan2021, she woke up and her lymph node under left arm down to the left breast was swollen and painful. The patient also had a temperature of 99.4 to 99.9 and had chills and body aches enough to keep her home from work. The patient had joints ache and felt weak and fatigued. This lasted for about twenty-four hours. The reporter assessed the events as non-serious. The outcome of the events was recovered in Jan 2021.  Information regarding lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Headache, Migraine, SARS-CoV-2 test, Taste disorder
Clinical narrative: Headache; taste was more impacted/ food didn't taste right/ too bitter/taste horrible; very bad migraines; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot/batch number: unknown), via an unspecified route of administration in left arm on 14Jan2021 at 07:30AM at single dose for COVID-19 immunization in hospital. Medical history included tested positive for COVID-19 on 09Sep2020. She had loss of taste and smell; next day horrible diarrhea; third day she had a headache for two days; then on day four or five she got a slight fever. The whole time starting on day three her heart was racing and she couldn't sleep. States her rapid heart rate was resolved about two weeks before the vaccine. She is still recovering her sense of taste. Mentions she saw a cardiologist and had an echocardiogram that was normal in 2020. She has continued to experience the episodes of resting tachycardia but not so often now. Maybe once every two weeks. Concomitant medications were none. No vaccines were administered on same date of the Pfizer suspect. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 34-year-old on 22Dec2020 at 10:00AM in the left arm for COVID-19 immunization. She had a headache and rapid heart rate that night and was up all night. It seemed like some of her COVID symptoms came back that first night. Added her arm hurt but she felt like that was related to the administration of the shot. Adds that is not how to give a shot. Adds her COVID symptoms had all gone away and then they came back but only for that first night after the first dose. Physical therapist reported that she received part two of the vaccine two weeks ago and ever since then she has had very bad migraines in Jan2021. She felt like she had recovered from the previous vaccine then she noticed her taste was more impacted on 15Jan2021. Her taste and smell was coming back from her COVID infection but after the second dose it seems like food didn't taste right. Mentions she loves Cilantro but now she can't eat it or anything citrus because it seems too bitter and Coke products taste horrible. Now she has a headache that started again on 16Jan2021. Adds normally she doesn't get headaches. She has tried rehydrating, tried drinking water and gatorade but the only thing that is helping is taking ibuprofen or Tylenol. She is rotating taking these products every other day and it is helping. Headaches come back when the medication has worn off. Patient does not require a visit to physician or ER for events. The outcome of events migraines, taste was more impacted was not recovered; unknown for another event.  Information about lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: 102.5 fever; Body aches; fatigue; This is a spontaneous report from a contactable Other Health Professional. A 41-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 27Jan2021 15:00 (Batch/Lot Number: EL9262) as single dose for covid-19 immunization.  Medical history included anxiety. The patient's concomitant medications were not reported. The past drug included bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 06Jan2021 15:00. The patient experienced 102.5 fever, body aches, fatigue on 27Jan2021 03:00 with outcome of not recovered. No treatment was given for the events. The facility type vaccine was Public Health Clinic/Veterans Administration facility. The patient reported that her fever got high (102.5) and was unwell for several days. The patient underwent lab tests and procedures which included body temperature: 102.5 on 27Jan2021.The outcome of the events was not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: symptoms started that night and then I tested positive for covid; This is a spontaneous report from a contactable Nurse (patient) via Medical Information Team.  A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EK9231, NDC number and Expiry Date: unknown), via an unknown route of administration in Deltoid, Left on 08Jan2021 at 16:00 (04:00 PM) the facility she works for Covid-19 immunization. Patient medical history reported as no and also reported that she had a lot of past medical history, but nothing that she thinks is relevant to her COVID19 Virus diagnosis. No other concomitant products. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect, prior vaccinations (within 4 weeks) were reported none. Adverse events prior vaccinations was none. Family medical history relevant to adverse event was included Positive COVID-19 Virus Test (test type unknown). COVID-19 vaccine was a Pfizer product. COVID-19 vaccine manufacturer was unspecified. The patient was given her first COVID-19 Vaccine on Friday, 08Jan2021 by the facility she works at. As per her apparently she already had the COVID-19 Virus prior to receiving her first dose of the COVID-19 Vaccine because she started with symptoms on 08Jan2021 (the night of the day she got her first COVID-19 Vaccine dose). She said she was now recovering from the COVID-19 Virus, and should have been re-vaccinated today, 29Jan2021. Her doctor told her it is too soon for her to receive the second dose of the COVID-19 Vaccine since she was positive for the COVID-19 Virus. She is in the 3rd week after receiving her first dose of the COVID19 Vaccine. She was tested for the COVID19 Virus on Monday, 11Jan2021. She didn't know what COVID-19 Virus test was used, but she knew the facility where she works (who performed the test) does not use the COVID-19 Virus rapid test. She said she received the positive COVID19 Virus test result on Wednesday, 13Jan2021. She went to the Emergency Room on 15Jan2021-stated she was not admitted to the hospital), and was given IV fluids and a 1-time infusion of "mono-something", and was discharged home. She can't remember the name of the infusion, and does not have the NDC, Lot and Expiration Dates for the infusion and IV fluids. No Physician office visit was reported. Outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: swelling in her right knee, not sore or hurt, just swelling.; This is a spontaneous report from a contactable consumer (patient reported herself) via sponsored Program . A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown, NDC number: Unknown) via an unspecified route of administration on 14Jan2021 at single dose to avoid COVID 19. The patient's medical history and concomitant medications were not reported. It was reported that, "caller received the first dose of the Pfizer vaccine on 14Jan2021. Caller reports swelling in her right knee, not sore or hurt, just swelling. Caller wanted to know if that was anything she needed to be concerned about. Caller already reported to DSU. Potential duplicate AE. A little bit of swelling in knee after she had first dose of the Covid-19 vaccine". She has had swelling in her right knee. "Caller is calling about Pfizer shot. She got it about two weeks ago and she was waiting for the second shot 04Feb2021. She has had swelling in the right knee and she was wondering if that would be anything she should be concerned about. Later on today she could answer some questions. She said she could answer some now if it did not take too long. She thinks it was on 14Jan2021. When she got her first dose. She noticed her right knee was swollen about a week ago. It was slightly swollen, just a little bit, it was not hurting, just swollen. It had improved since it began. Product details: She confirmed she got the Pfizer COVID-19 vaccine. All she had was a doctors office card that had a date and time for her to be back. She saw her name and the date and time she was supposed to be there. It was just the name of her primary care doctor then it had their name and address and the phone number and they told to her to bring it back with her. She did not see any NDC, lot number, or expiration date. She said it was just a doctors office card like they use to write you an appointment reminder. History and investigations: She did not think there was anything that needs to be added. There was nothing that she had not been taking all along". Outcome of the event was recovering. No PQC present.  Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain in extremity, Sleep disorder due to a general medical condition
Clinical narrative: Severe joint pain especially in feet, ankles, knees; Severe joint pain especially in feet, ankles, knees; chills; headache; Pain was severe enough as to interfere with sleep; This is a spontaneous report received from a contactable consumer (patient herself). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL1283) via an unspecified route of administration to left arm on 18Jan2021 13:00 at single dose for COVID-19 immunization. Patient medical history included high blood pressure and Allergy to tomatoes/walnuts. Concomitant medications included Lisinopril, Metropolol and Hydrochlorothiozide. On 26Jan2021 patient experienced with severe joint pain especially in feet, ankles, knees; chills, headache. Pain was severe enough as to interfere with sleep. Patient did not receive any treatment for the events. Seriousness was reported as non-serious. Outcome of events was not recovered.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Exposure to SARS-CoV-2, Hypogeusia, Hyposmia
Clinical narrative: her husband could have been exposed or contracted COVID-19 on that Friday before receiving his vaccine; He has a little stuffiness, and coughs up a little phlegm when clearing his throat; He still has his sense of taste and smell, although he feels his smell is diminished; He still has his sense of taste and smell, although he feels his smell is diminished; received his first dose last Friday and has tested positive for covid; This is a spontaneous report from a contactable Consumer. This Consumer (Patient's wife) reported for a male patient that. A 60-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Jan2021 (Batch/Lot number was not reported) intramuscular on arm left at single dose for covid-19 immunisation. Medical history included She woke up that Friday, 22Jan2021 feeling very ill with a headache. The patient's concomitant medications were not reported. It was reported that The caller's husband received his first Pfizer COVID-19 vaccine last Friday, 22Jan2021. That Sunday, her daughter tested positive for COVID. Her husband went and got tested and was positive. If he was positive and is due to having second shot, should he be getting it reporter questioned. He technically could have had COVID when he received his first vaccine. She did not know. She explains he did not have any symptoms, she clarifies further he has mild symptoms. Caller clarifies further her daughter does not live with them. She came home on her birthday on 21Jan2021. Her daughter works from home. She has no idea where she contracted COVID-19. She has gone nowhere. It's all a mystery. She woke up that Friday, 22Jan2021 feeling very ill with a headache. Her daughter tested positive on Sunday, 24Jan2021. Therefore, her husband could have been exposed or contracted COVID-19 on that Friday before receiving his vaccine. Obviously, they are not certain. He has mild symptoms. She clarifies her husband has been stuffy for months. He has a little stuffiness and coughs up a little phlegm when clearing his throat. He still has his sense of taste and smell, although he feels his smell is diminished. When attempting to confirm when these symptoms began, she states its unknown. It was just been chronic. He feels fine. He would never say he has COVID based on how he is feeling. He was due to get the second shot and she is just trying to determine if he should get it or if should wait questioned. They both went through a drive-thru clinic on 27Jan2021 and had the nasal swab. They got the results yesterday, 28Jan2021, and her husband tested positive. Outcome of the events was unknown.   No further information was provided or obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: her husband could have been exposed or contracted COVID-19 on that Friday before receiving his vaccine; He has a little stuffiness, and coughs up a little phlegm when clearing his throat; He still has his sense of taste and smell, although he feels his smell is diminished; He still has his sense of taste and smell, although he feels his smell is diminished; received his first dose last Friday and has tested positive for covid; This is a spontaneous report from a contactable Consumer. This Consumer (Patient's wife) reported for a male patient that. A 60-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Jan2021 (Batch/Lot number was not reported) intramuscular on arm left at single dose for covid-19 immunisation. Medical history included She woke up that Friday, 22Jan2021 feeling very ill with a headache. The patient's concomitant medications were not reported. It was reported that The caller's husband received his first Pfizer COVID-19 vaccine last Friday, 22Jan2021. That Sunday, her daughter tested positive for COVID. Her husband went and got tested and was positive. If he was positive and is due to having second shot, should he be getting it reporter questioned. He technically could have had COVID when he received his first vaccine. She did not know. She explains he did not have any symptoms, she clarifies further he has mild symptoms. Caller clarifies further her daughter does not live with them. She came home on her birthday on 21Jan2021. Her daughter works from home. She has no idea where she contracted COVID-19. She has gone nowhere. It's all a mystery. She woke up that Friday, 22Jan2021 feeling very ill with a headache. Her daughter tested positive on Sunday, 24Jan2021. Therefore, her husband could have been exposed or contracted COVID-19 on that Friday before receiving his vaccine. Obviously, they are not certain. He has mild symptoms. She clarifies her husband has been stuffy for months. He has a little stuffiness and coughs up a little phlegm when clearing his throat. He still has his sense of taste and smell, although he feels his smell is diminished. When attempting to confirm when these symptoms began, she states its unknown. It was just been chronic. He feels fine. He would never say he has COVID based on how he is feeling. He was due to get the second shot and she is just trying to determine if he should get it or if should wait questioned. They both went through a drive-thru clinic on 27Jan2021 and had the nasal swab. They got the results yesterday, 28Jan2021, and her husband tested positive. Outcome of the events was unknown.   No further information was provided or obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: she developed shingles on the opposite arm of the vaccine arm; she is in a lot of nerve pain.; This is a spontaneous report from a contactable consumer via medical information. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number : EK9231; expiry date : Apr2021) via an unspecified route of administration, in Arm Right on 05Jan2021 10:00 as single dose for protect against covid. The patient medical history and concomitant medications. The patient previously took mortin and had allergy ongoing, influenza vaccine (Flu shot) and had pain (She got a Flu shot 3 years ago in her left arm and the pain didn't go away for 9 months. States that for the next 2 years she got her flu shot in the right arm). Patient had the 1st dose on 05Jan2021, and was due next Friday for her 2nd dose, but she has come down with shingles on her opposite arm on 11Jan2021. She doesn't know if it has anything to do with the vaccine. Has it been reported before, and can she get the 2nd dose. Shingles was reported as worsened. She has shingles on the left arm, hand, wrist, and fingers; she was in a lot of nerve pain in Jan2021. The pain started 6 days after she got the vaccine; pain and tingling. Then 2-3 days later, she noticed some red marks by her elbow. She went to a clinic and was diagnosed with Shingles and was started on Valacyclovir 1gm tablet, 1 tablet 3 times daily for 7 days. The next day she called the doctor, and had a tele-visit and the doctor was able to see some lesions. She told the doctor how much pain she was in, so the doctor prescribed Gabapentin 100mg. She was told to start off with 1 daily at night to help with sleep because she wasn't sleeping because the pain was so bad, then after 5 days she can take 1 twice daily as needed. States that it hasn't been 5 days yet, so she was still only taking it once at night, and she was able to sleep over 4 hours at a time, which was great. She wishes she could jump ahead and start taking it twice a day already because she was in pain all day long, but she was following the directions. States that the pharmacist said she could take Tylenol in between, so that was what she is doing. States that she was getting more lesions, but they are faint and are mostly on the palms of her hands and in between her fingers. The outcome of the event Shingles was recovered 11Jan2021; for Nerve pain was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Caller stated he tested positive for covid 19 yesterday on 28Jan2021 after his first dose of the pfizer covid 19 vaccine on 14Jan2021; Caller stated he tested positive for covid 19 yesterday on 28Jan2021 after his first dose of the pfizer covid 19 vaccine on 14Jan2021/ runny nose; This is a spontaneous report from a contactable consumer (patient himself). An unspecified aged male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient stated he tested positive for COVID 19 yesterday on 28Jan2021 after his first dose of the Pfizer COVID 19 vaccine on 14Jan2021. Caller stated his second dose is on 04Feb2021 and caller wants to make sure he can get the second dose as long as he is not feverish or sick. He took the first dose of the COVID vaccine on 14Jan2021. He is supposed to take the second on 04Feb. About two days ago he developed a regular classic cold that he gets this time of year. He went to the MD now and they suggested he get a COVID test and he has COVID. He has no COVID symptoms except a bit of a runny nose and that is it. The data came back and said COVID19 results from (site name). Caller began reading the lab test. "It says latest test 1 out of range 1. Most recent results positive for COVID19. COVID19 is under emergency use. Outcome of events was unknown.  Information about lot/batch number has been requested.