chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature, Chills, Feeling abnormal, Feeling drunk
Clinical narrative: sweats; it is affecting his equilibrium; he staggers around like he is drunk; chills; fever usually less than a 100 [units unspecified]; heart rate goes up to 112-115; stomach muscle hurts; head is foggy; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE and also reported as Covid-19 vaccine; lot number: EL0142; expiration date: unknown), intramuscular left arm on 07Jan2021 09:15 at a single dose for covid-19 prophylaxis. Medical history included ongoing diabetic since 2020. The patient's concomitant medications were not reported. The patient did not receive any vaccination within the last 4 weeks. The patient mentioned that he got his first shot of the Covid-19 vaccine last week, Thursday (07Jan2021) in a mobile set up clinic in a gymnasium. He reported that every night after midnight, he gets the chills and runs a fever until he sweats and his fever breaks. He said that his fever was usually less than a 100 [units unspecified] and his heart rate goes up between 112-115 [units unspecified]. He also reported that his stomach muscles hurt really bad like he has been doing sit-ups. He said that his head is always foggy, and it is affecting his equilibrium and said that he staggers around like he is drunk. The patient further stated that all of his symptoms started on 07Jan2021. He said that he gets the chills and the fever at the same time. He said that his wife would take his temperature and it would show his temperature and heart rate. He said that this will start around midnight. He said that his symptoms will start around midnight every night. He said that his next dose is supposed to be the 28Jan2021. The patient inquired as to how long he will experience this or persist. The adverse events did not require an emergency room or physician's office visit. The outcome of the events affecting his equilibrium, sweats and staggers around like he is drunk were unknown while the outcome of the other events was not recovered.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: sweats; it is affecting his equilibrium; he staggers around like he is drunk; chills; fever usually less than a 100 [units unspecified]; heart rate goes up to 112-115; stomach muscle hurts; head is foggy; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE and also reported as Covid-19 vaccine; lot number: EL0142; expiration date: unknown), intramuscular left arm on 07Jan2021 09:15 at a single dose for covid-19 prophylaxis. Medical history included ongoing diabetic since 2020. The patient's concomitant medications were not reported. The patient did not receive any vaccination within the last 4 weeks. The patient mentioned that he got his first shot of the Covid-19 vaccine last week, Thursday (07Jan2021) in a mobile set up clinic in a gymnasium. He reported that every night after midnight, he gets the chills and runs a fever until he sweats and his fever breaks. He said that his fever was usually less than a 100 [units unspecified] and his heart rate goes up between 112-115 [units unspecified]. He also reported that his stomach muscles hurt really bad like he has been doing sit-ups. He said that his head is always foggy, and it is affecting his equilibrium and said that he staggers around like he is drunk. The patient further stated that all of his symptoms started on 07Jan2021. He said that he gets the chills and the fever at the same time. He said that his wife would take his temperature and it would show his temperature and heart rate. He said that this will start around midnight. He said that his symptoms will start around midnight every night. He said that his next dose is supposed to be the 28Jan2021. The patient inquired as to how long he will experience this or persist. The adverse events did not require an emergency room or physician's office visit. The outcome of the events affecting his equilibrium, sweats and staggers around like he is drunk were unknown while the outcome of the other events was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rhinorrhoea, Throat tightness
Clinical narrative: Throat, ears and nose itching; Nose running; Throat tightening; This is a spontaneous report from a contactable consumer. A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730/expiration date) dose number 1 via an unspecified route of administration on 22Dec2020 17:00 at a single dose on the right arm for COVID-19 immunization. Medical history included allergy to NSAIDs. The patient previously took buproprion and experienced allergies. No other vaccine was received within 4 weeks. Concomitant medications included sertraline hydrochloride (ZOLOFT), lisdexamfetamine mesilate (VYVANSE), and clarithromycin (CLARITIN). The patient experienced throat, ears and nose itching, nose running, and throat tightening on 23Dec2020 01:00. The patient received Benedryl and Prevacid taken at home for the events. The outcome of the events was recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Inappropriate schedule of product administration, Nausea
Clinical narrative: Body aches; chills; nausea; headache; arm pain; fatigue; received second dose of BNT162B2 on 09Jan2021; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received second single dose of BNT162B2 (Pfizer, solution for injection, batch/lot number and exp date not reported), intramuscular (left arm) on 09Jan2021 11:00 for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included migraines. The patient was not pregnant. There were no concomitant medications. No other vaccine was received in four weeks. No other medication within two weeks. The patient previously took acetylsalicylic acid (ASPIRIN) wherein patient had known allergies and anaphylaxis. The patient received the first single dose of BNT162B2 on 22Dec2020 15:00, Intramuscular (left arm). The patient received second dose of BNT162B2 on 09Jan2021 11:00. The patient experienced body aches, chills, nausea, headache, arm pain, and fatigue on 09Jan2021 21:00 (09:00 pm). The patient did not have COVID prior vaccination. Patient was not Covid tested post vaccination. Treatment for AE included paracetamol (TYLENOL) OTC every 4 hours x 24 hours. The patient recovered from the events body aches, chills, nausea, headache, arm pain, and fatigue on an unspecified date in Jan2021.  Information about lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Body aches; chills; nausea; headache; arm pain; fatigue; received second dose of BNT162B2 on 09Jan2021; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received second single dose of BNT162B2 (Pfizer, solution for injection, batch/lot number and exp date not reported), intramuscular (left arm) on 09Jan2021 11:00 for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included migraines. The patient was not pregnant. There were no concomitant medications. No other vaccine was received in four weeks. No other medication within two weeks. The patient previously took acetylsalicylic acid (ASPIRIN) wherein patient had known allergies and anaphylaxis. The patient received the first single dose of BNT162B2 on 22Dec2020 15:00, Intramuscular (left arm). The patient received second dose of BNT162B2 on 09Jan2021 11:00. The patient experienced body aches, chills, nausea, headache, arm pain, and fatigue on 09Jan2021 21:00 (09:00 pm). The patient did not have COVID prior vaccination. Patient was not Covid tested post vaccination. Treatment for AE included paracetamol (TYLENOL) OTC every 4 hours x 24 hours. The patient recovered from the events body aches, chills, nausea, headache, arm pain, and fatigue on an unspecified date in Jan2021.  Information about lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Headache, Impaired driving ability
Clinical narrative: Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; Swelling; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included ibuprofen and paracetamol (TYLENOL). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.  The patient previously took first dose of bnt162b2 (lot number: Ek5730, expiry date not reported) in the right arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 08Jan2021 at 18:00, the patient experienced brain fog, headache, muscle spasm at injection site, severe fatigue, joint pain, driving difficult and swelling. It was unknown if treatment was received for the adverse events. Clinical outcome of the events was not recovered.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Swelling
Clinical narrative: Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; Swelling; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included ibuprofen and paracetamol (TYLENOL). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.  The patient previously took first dose of bnt162b2 (lot number: Ek5730, expiry date not reported) in the right arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 08Jan2021 at 18:00, the patient experienced brain fog, headache, muscle spasm at injection site, severe fatigue, joint pain, driving difficult and swelling. It was unknown if treatment was received for the adverse events. Clinical outcome of the events was not recovered.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19 per COVID-19 PCR test; tested positive for COVID-19 per COVID-19 PCR test; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect, received from a contactable consumer (patient). A 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 15Dec2020 at a single dose (left arm) for COVID-19 immunization. There were no medical history and concomitant medications. The patient was given no new medications or received no other vaccines at that time. The patient was due to get the second dose of the vaccine last 04Jan2021 but was cancelled since he had tested positive for COVID-19 per COVID-19 PCR test on 02Jan2021. He wanted to know if he can get the second dose later than 21 days. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Confusional state, Dizziness, Headache
Clinical narrative: bloodshot left eye; injection site soreness/injection site soreness of L arm; Lack of energy; (time) confusion; lightheadedness; headache/slight headache; This is a spontaneous report from a contactable nurse, reporting for herself. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection lot number: EL1284), intramuscularly on the left arm on 05Jan2021 18:30 at a single dose for COVID-19 immunization. Medical history included received immunotherapy injections for environmental allergies from an unknown date and unknown if ongoing. Concomitant medication included diltiazem, spironolactone, trazodone, lorazepam, colecalciferol (VITAMIN D), zinc and fish oil. On 05Jan2021, the patient received Pfizer COVID-19 vaccine and experienced (time) confusion, and lightheadedness within one hour of receiving. Later that evening, the patient experienced headache. On 06Jan2021, the patient experienced injection site soreness x 2 days, continued with slight headache, lack of energy. On 08Jan2021, resolved injection site soreness of left arm, continue with slight headache. On 11Jan2021, The patient woke up with bloodshot left eye after having had headaches x 5 days which began the same evening of receiving the Pfizer COVID-19 vaccine. Blood pressure was 125/80. No headache or eye pain. BP was 128/89 on 10Jan2021, 11 PM. No headache. BP was 120/80 on 11Jan2021, 10 AM. The patient had never had a bloodshot eye before. The patient underwent lab tests and procedures which included Blood pressure:125/80 mmHg on an unspecified date, 128/89 mmHg on 10Jan2021 and 120/80 mmHg on 11Jan2021. The outcome of the event injection site soreness/injection site soreness of L arm was recovered on 08Jan2021 while the outcome of all other events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Vaccination site pain
Clinical narrative: bloodshot left eye; injection site soreness/injection site soreness of L arm; Lack of energy; (time) confusion; lightheadedness; headache/slight headache; This is a spontaneous report from a contactable nurse, reporting for herself. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection lot number: EL1284), intramuscularly on the left arm on 05Jan2021 18:30 at a single dose for COVID-19 immunization. Medical history included received immunotherapy injections for environmental allergies from an unknown date and unknown if ongoing. Concomitant medication included diltiazem, spironolactone, trazodone, lorazepam, colecalciferol (VITAMIN D), zinc and fish oil. On 05Jan2021, the patient received Pfizer COVID-19 vaccine and experienced (time) confusion, and lightheadedness within one hour of receiving. Later that evening, the patient experienced headache. On 06Jan2021, the patient experienced injection site soreness x 2 days, continued with slight headache, lack of energy. On 08Jan2021, resolved injection site soreness of left arm, continue with slight headache. On 11Jan2021, The patient woke up with bloodshot left eye after having had headaches x 5 days which began the same evening of receiving the Pfizer COVID-19 vaccine. Blood pressure was 125/80. No headache or eye pain. BP was 128/89 on 10Jan2021, 11 PM. No headache. BP was 120/80 on 11Jan2021, 10 AM. The patient had never had a bloodshot eye before. The patient underwent lab tests and procedures which included Blood pressure:125/80 mmHg on an unspecified date, 128/89 mmHg on 10Jan2021 and 120/80 mmHg on 11Jan2021. The outcome of the event injection site soreness/injection site soreness of L arm was recovered on 08Jan2021 while the outcome of all other events was unknown.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dehydration, Fatigue, Headache
Clinical narrative: Dose Number:1/ Date of start of drug:22Dec2020 / Dose Number:2/ Date of start of drug: 08Jan2021; Serious chills to the point of physical shaking; serious chills to the point of physical shaking; Nausea; Vomiting; Dry heaving; Significant body aches, especially pronounced in lower back region occurred; Significant body aches, especially pronounced in lower back region occurred; Headache; Having sweats; Possible fever (didn't have thermometer to accurately verify this though); My average HR is usually 70's. For about 36 hours, it ran 100-130's; Dehydration; Feeling fatigued/Excessive fatigue; Had some general arm soreness; This is a spontaneous report from a contactable nurse (patient).  A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EJ 1686, unknown expiration), intramuscular in right arm on 08Jan2021 at 13:30 at a single dose for COVID-19 immunization in a hospital.  The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ 1685, unknown expiration) via intramuscular in right arm on 22Dec2020 at 12:30 PM for COVID-19 immunization in a hospital. Concomitant medications included ibuprofen (MOTRIN) as needed and unspecified birth control. The patient has no known allergies. The patient started feeling fatigued about 1900 hours (07:00 PM) on 08Jan2021 and only had some general arm soreness. She woke up on 09Jan2021, with serious chills to the point of physical shaking; nausea started soon after and around 0300, began vomiting and dry heaving. The patient also experienced significant body aches, especially pronounced in lower back region occurred. Headache also present at this time (09Jan2021). She began having sweats and possible fever (didn't have thermometer to accurately verify this though). The patient's average HR is usually 70s. For about 36 hours (09Jan2021), it ran 100-130s. Vomiting episodes continued and for all of 09Jan2021, the patient did absolutely nothing. The patient described her body ached like it had been beaten by a baseball bat. On 10Jan2021, her HR at rest back in 70s, but with minimal exertion, will go to 110-120s. She had to call out of work from 11Jan2021 and 12Jan2021 due to continued nausea, dehydration and excessive fatigue. The patient did not receive other vaccine in four weeks.  The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient's symptoms still persisting at the time she is reporting this event. The patient did not receive treatment for the events. The outcome of the event "having sweats" was unknown, while the patient is recovering for the remaining events.; Sender's Comments: The reported serious chill was likely related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship and known safety profile of this product.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Impaired work ability, Nausea, Pain
Clinical narrative: Dose Number:1/ Date of start of drug:22Dec2020 / Dose Number:2/ Date of start of drug: 08Jan2021; Serious chills to the point of physical shaking; serious chills to the point of physical shaking; Nausea; Vomiting; Dry heaving; Significant body aches, especially pronounced in lower back region occurred; Significant body aches, especially pronounced in lower back region occurred; Headache; Having sweats; Possible fever (didn't have thermometer to accurately verify this though); My average HR is usually 70's. For about 36 hours, it ran 100-130's; Dehydration; Feeling fatigued/Excessive fatigue; Had some general arm soreness; This is a spontaneous report from a contactable nurse (patient).  A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EJ 1686, unknown expiration), intramuscular in right arm on 08Jan2021 at 13:30 at a single dose for COVID-19 immunization in a hospital.  The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ 1685, unknown expiration) via intramuscular in right arm on 22Dec2020 at 12:30 PM for COVID-19 immunization in a hospital. Concomitant medications included ibuprofen (MOTRIN) as needed and unspecified birth control. The patient has no known allergies. The patient started feeling fatigued about 1900 hours (07:00 PM) on 08Jan2021 and only had some general arm soreness. She woke up on 09Jan2021, with serious chills to the point of physical shaking; nausea started soon after and around 0300, began vomiting and dry heaving. The patient also experienced significant body aches, especially pronounced in lower back region occurred. Headache also present at this time (09Jan2021). She began having sweats and possible fever (didn't have thermometer to accurately verify this though). The patient's average HR is usually 70s. For about 36 hours (09Jan2021), it ran 100-130s. Vomiting episodes continued and for all of 09Jan2021, the patient did absolutely nothing. The patient described her body ached like it had been beaten by a baseball bat. On 10Jan2021, her HR at rest back in 70s, but with minimal exertion, will go to 110-120s. She had to call out of work from 11Jan2021 and 12Jan2021 due to continued nausea, dehydration and excessive fatigue. The patient did not receive other vaccine in four weeks.  The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient's symptoms still persisting at the time she is reporting this event. The patient did not receive treatment for the events. The outcome of the event "having sweats" was unknown, while the patient is recovering for the remaining events.; Sender's Comments: The reported serious chill was likely related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship and known safety profile of this product.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Retching, Tremor, Vomiting
Clinical narrative: Dose Number:1/ Date of start of drug:22Dec2020 / Dose Number:2/ Date of start of drug: 08Jan2021; Serious chills to the point of physical shaking; serious chills to the point of physical shaking; Nausea; Vomiting; Dry heaving; Significant body aches, especially pronounced in lower back region occurred; Significant body aches, especially pronounced in lower back region occurred; Headache; Having sweats; Possible fever (didn't have thermometer to accurately verify this though); My average HR is usually 70's. For about 36 hours, it ran 100-130's; Dehydration; Feeling fatigued/Excessive fatigue; Had some general arm soreness; This is a spontaneous report from a contactable nurse (patient).  A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EJ 1686, unknown expiration), intramuscular in right arm on 08Jan2021 at 13:30 at a single dose for COVID-19 immunization in a hospital.  The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ 1685, unknown expiration) via intramuscular in right arm on 22Dec2020 at 12:30 PM for COVID-19 immunization in a hospital. Concomitant medications included ibuprofen (MOTRIN) as needed and unspecified birth control. The patient has no known allergies. The patient started feeling fatigued about 1900 hours (07:00 PM) on 08Jan2021 and only had some general arm soreness. She woke up on 09Jan2021, with serious chills to the point of physical shaking; nausea started soon after and around 0300, began vomiting and dry heaving. The patient also experienced significant body aches, especially pronounced in lower back region occurred. Headache also present at this time (09Jan2021). She began having sweats and possible fever (didn't have thermometer to accurately verify this though). The patient's average HR is usually 70s. For about 36 hours (09Jan2021), it ran 100-130s. Vomiting episodes continued and for all of 09Jan2021, the patient did absolutely nothing. The patient described her body ached like it had been beaten by a baseball bat. On 10Jan2021, her HR at rest back in 70s, but with minimal exertion, will go to 110-120s. She had to call out of work from 11Jan2021 and 12Jan2021 due to continued nausea, dehydration and excessive fatigue. The patient did not receive other vaccine in four weeks.  The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient's symptoms still persisting at the time she is reporting this event. The patient did not receive treatment for the events. The outcome of the event "having sweats" was unknown, while the patient is recovering for the remaining events.; Sender's Comments: The reported serious chill was likely related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship and known safety profile of this product.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Ear disorder, Feeling abnormal
Clinical narrative: Lightheaded; Fogginess in head; Fluid behind ears; This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration in the left arm on 28Dec2020 08:30 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced lightheaded, fogginess in head, and fluid behind ears with no infection on 05Jan2021 19:00. Therapeutic measures were taken as a result of the adverse events and included treatment with methylprednisolone dose pack. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Ecchymosis, Headache, Malaise, Pyrexia
Clinical narrative: Now have ecchymosis on R Lower extremity, measuring 10x15cm. Area not warm to touch; Malaise; Headache; Fever; Stomach upset started 10 Jan (expected these effects.); This is a spontaneous report from a contactable physician (patient). A 68-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3240, expiration date unspecified), via an unspecified route of administration on 07Jan2021 00:30 at single dose (left arm) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took the first dose of bnt162b2 on 18Dec2020, at 12:00pm, left arm (lot EJ1685) for COVID-19 immunization. On 10Jan2021, at 12:00, the patient experienced malaise, headache, fever, and stomach upset. On an unspecified date, the patient now have ecchymosis on right lower extremity, measuring 10x15cm. Area was not warm to touch. There were no therapy for the events. There were no other vaccine in four weeks. The patient had no Covid prior to vaccination but was Covid tested post vaccinated.  The patient underwent lab tests and procedures which included nasal swab which was negative on 04Jan2021 post vaccination. Outcome of events was not recovered.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Now have ecchymosis on R Lower extremity, measuring 10x15cm. Area not warm to touch; Malaise; Headache; Fever; Stomach upset started 10 Jan (expected these effects.); This is a spontaneous report from a contactable physician (patient). A 68-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3240, expiration date unspecified), via an unspecified route of administration on 07Jan2021 00:30 at single dose (left arm) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took the first dose of bnt162b2 on 18Dec2020, at 12:00pm, left arm (lot EJ1685) for COVID-19 immunization. On 10Jan2021, at 12:00, the patient experienced malaise, headache, fever, and stomach upset. On an unspecified date, the patient now have ecchymosis on right lower extremity, measuring 10x15cm. Area was not warm to touch. There were no therapy for the events. There were no other vaccine in four weeks. The patient had no Covid prior to vaccination but was Covid tested post vaccinated.  The patient underwent lab tests and procedures which included nasal swab which was negative on 04Jan2021 post vaccination. Outcome of events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: patient passed away with in 90 minutes of getting vaccine; This is a spontaneous report from three non-contactable consumer reporting on behalf of the patient via a Pfizer sponsored program, Corporate (Pfizer) Social Media Platforms. A 90 (unspecified unit) old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL0142, unknown expiration), via an unspecified route of administration in right arm (reported as AR) on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was a nursing home patient and received the first dose of COVID vaccine on 30Dec2020. The patient was monitored for 15 minutes after getting shot. Staff reported that the patient was 15 days post COVID. The patient passed away with in 90 minutes of getting vaccine on 30Dec2020.  The patient did not require office/ ER visit.  An autopsy was not performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Patient passed away with in 90 minutes of getting vaccine
Sex: U
Vaccine: COVID19
Symptoms: Death, Diarrhoea
Clinical narrative: Reported causes of death: Diarrhoea; This is a spontaneous report from a contactable healthcare professional via agency and a non-contactable consumer via a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. An elderly patient of an unspecified age (also reported as were in their early to mid-60's) and gender received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 10Dec2020 at a single dose for COVID-19 immunisation. Medical history included pseudomembranous colitis (broad), gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), and noninfectious diarrhoea (narrow) . The patient's concomitant medications were not reported. The patient experienced diarrhoea on an unspecified date in 2020. It was reported that most of the deaths after the COVID-19 vaccine occurred within 24-48 hours after the shot. The write-ups that accompanied the reports furnished details about these sad fatalities, including the astonishing fact that some of the decreased had actually experienced and recovered from COVID-19 (raising questions about why they were vaccinated). It was also reported that the event was not life-threatening, did not result to a birth defect or permanent disability, did not require any office/ER/doctor visit, and did not require any hospitalization. The patient died on 10Dec2020. It was not reported if an autopsy was performed. The reported cause of death: diarrhoea.  No follow up attempts are possible, information about the lot/batch number cannot be obtained.; Sender's Comments: Based on the available information the event diarrhea resulting in death is attributed to patients preexisting medical conditions including pseudomembranous colitis, gastrointestinal nonspecific symptoms and therapeutic procedures, and noninfectious diarrhea. However, based on a close chronological association (same day) contributory role of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine) to event exacerbation cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Reported causes of death: Diarrhoea
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia eye, Hypoaesthesia oral, Lip pruritus, Pharyngeal hypoaesthesia
Clinical narrative: numbness in half of my body/starting by facial nerve then upper limb going back to face and eyes area/felt numbness in different areas including chest; numbness in half of my body/starting by facial nerve then upper limb going back to face and eyes area; felt numbness in different areas including chest and throat (it was itchy); felt numbness in different areas including chest and throat (it was itchy); felt numbness in different areas including chest and throat (it was itchy), by lips as well were itchy.; felt numbness in different areas including chest and throat (it was itchy), by lips as well were itchy.; This is a spontaneous report from a contactable physician (patient) reported that a patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got numbness in half of his/her body, starting by facial nerve then upper limb going back to face and eyes area, which decreased over one hour, then he/she felt numbness in different areas including chest and throat (it was itchy), by lips as well were itchy. Numbness stayed for two days. The patient asked what he/she should do to take his/her second dose. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: numbness in half of my body/starting by facial nerve then upper limb going back to face and eyes area/felt numbness in different areas including chest; numbness in half of my body/starting by facial nerve then upper limb going back to face and eyes area; felt numbness in different areas including chest and throat (it was itchy); felt numbness in different areas including chest and throat (it was itchy); felt numbness in different areas including chest and throat (it was itchy), by lips as well were itchy.; felt numbness in different areas including chest and throat (it was itchy), by lips as well were itchy.; This is a spontaneous report from a contactable physician (patient) reported that a patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got numbness in half of his/her body, starting by facial nerve then upper limb going back to face and eyes area, which decreased over one hour, then he/she felt numbness in different areas including chest and throat (it was itchy), by lips as well were itchy. Numbness stayed for two days. The patient asked what he/she should do to take his/her second dose. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Enlarged, sore lymph node right mid clavicle. 0.8mm; sore lymph node right mid clavicle. 0.8mm; This is Spontaneous report from a contactable Nurse (patient).  A 61-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EL1238, intramuscular in arm right on 09Jan2021 13:00 at single dose for covid-19 immunisation.  The patient previously received the first dose of BNT162B2 on 19Dec2020 at 10:00 AM,  lot number: EH9899, Intramuscular in arm left for covid-19 immunisation. The patient did not receive other vaccine in four weeks. The patient medical history was not reported.  The patient did not have covid prior vaccination, and she was not tested for covid post vaccination. There were not known allergies. Concomitant medication included acetylsalicylic acid (ASPIRIN), and colecalciferol (VITAMIN D).  The patient experienced enlarged, sore lymph node right mid clavicle. 0.8mm on 11Jan2021 18:00. The patient did not receive treatment. The outcome was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle spasms
Clinical narrative: muscle spasms; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on 19Dec2020 for the first dose (lot number and expiry date unknown), and on 09Jan2021 for the second dose (lot number: E11685, expiry date: May2021) both at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first shot on 19Dec2020 and had some muscle spasms on Dec2020, but it was gone after two (2) days. On Saturday (09Jan2021), she got her second shot and she was in a giant muscle spasm from head to toe. It was like a whole-body Charlie horse that won't quit, and it hurts. It started three (3) hours after the shot and is not going away. It hurts and worked her up. The patient called to ask what she can request to treat the muscle spasm; a muscle relaxer? Patient didn't want to take anything that will counteract the vaccine. The event was reported as Non-serious. The patient recovered from muscle spasms on an unspecified date in Dec2020.  information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: muscle spasms; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on 19Dec2020 for the first dose (lot number and expiry date unknown), and on 09Jan2021 for the second dose (lot number: E11685, expiry date: May2021) both at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first shot on 19Dec2020 and had some muscle spasms on Dec2020, but it was gone after two (2) days. On Saturday (09Jan2021), she got her second shot and she was in a giant muscle spasm from head to toe. It was like a whole-body Charlie horse that won't quit, and it hurts. It started three (3) hours after the shot and is not going away. It hurts and worked her up. The patient called to ask what she can request to treat the muscle spasm; a muscle relaxer? Patient didn't want to take anything that will counteract the vaccine. The event was reported as Non-serious. The patient recovered from muscle spasms on an unspecified date in Dec2020.  information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: muscle spasms; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on 19Dec2020 for the first dose (lot number and expiry date unknown), and on 09Jan2021 for the second dose (lot number: E11685, expiry date: May2021) both at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first shot on 19Dec2020 and had some muscle spasms on Dec2020, but it was gone after two (2) days. On Saturday (09Jan2021), she got her second shot and she was in a giant muscle spasm from head to toe. It was like a whole-body Charlie horse that won't quit, and it hurts. It started three (3) hours after the shot and is not going away. It hurts and worked her up. The patient called to ask what she can request to treat the muscle spasm; a muscle relaxer? Patient didn't want to take anything that will counteract the vaccine. The event was reported as Non-serious. The patient recovered from muscle spasms on an unspecified date in Dec2020.  information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site erythema, Vaccination site nodule, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: had a knot on her arm where the shot was administered; where the shot was administered that was itching; where the shot was administered that was redness; where the shot was administered that was swelling; This is a spontaneous report from a contactable consumer (patient herself). A 56-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on left arm, via unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. Medical history included she was exposed to Covid from a patient she was working with that came back positive on 05Jan2021 which exposed to Covid was prior to taking the shot. Concomitant medications were reported as none. Reporter stated that she came in last week and took Pfizer shot. Stated before the shot that she was exposed to Covid from a patient she was working with that came back positive. Wanted to know if she took Covid test would it come back positive automatically. Wanted to know if she was allowed to take the Covid test. She had on all of her PPE gear and N95 mask. She screened the patient but the patient had a mask on, she worked in dental, for a time period he that the patient had his mask off for a short time period. Stated that this was for the Pfizer Covid 19 shot, it was her first shot and she would take the second shot on 26Jan. Reporter was a dental assistant and calling on behalf of herself. Stated that she had a knot on her arm where the shot was administered that was swelling, red and itching on 06Jan2021. Stated that the knot was almost not there. Later stated that the knot was gone Saturday 09Jan. The outcome of event "where the shot was administered that was itching" was resolving while outcome of other events were resolved on 09Jan2021.  Information about lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Daily headaches; This is a spontaneous report from a non-contactable consumer.   A 57-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Lot # EK9231) at single dose at left arm on 05Jan2021 for Covid-19 immunisation.  Medical history included long QT syndrome, depression, anxiety. The patient had not experienced Covid-19 prior vaccination. Concomitant medication included duloxetine hydrochloride (CYMBALTA), nadolol (NADOLOL), doxycycline (ORACEA). The patient previously took bacitracin and experienced allergy. Patient vaccine history included the 1st dose of bnt162b2 (BNT162B2, Lot # EH9899) at single dose at left arm on 15Dec2020 for Covid-19 immunisation, administered at hospital. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine.  The patient experienced daily headaches on 06Jan2021. No treatment received. Covid was not tested post vaccination. The outcome of event was not recovered.   No follow-up attempts are possible. No furhter information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Rash
Clinical narrative: Rash on face that looked like she broke out in pimples; Rash on face that looked like she broke out in pimples; This is a spontaneous report from a contactable nurse (patient).   A 49-year-old non pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EH9899) in the left arm, on 22Dec2020 at 09:00, at single dose, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included hypothyroidism. No known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) and bupropion hydrochloride (WELLBUTRIN). On 24Dec2020, the patient experienced rash on face that looked like she broke out in pimples. No treatment was received. The patient recovered from the adverse event on an unspecified date. The patient had not experienced Covid-19 prior vaccination. Post the vaccination, the patient has not been tested for COVID-19.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Muscle fatigue
Clinical narrative: joint pain; muscle fatigue; chills; headache; fatigue; This is a spontaneous report from a contactable healthcare professional (patient herself). A 25-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EH9899), via an unspecified route of administration in the right arm on 21Dec2020 16:00 at a single dose for COVID-19 immunization. The patient is vaccinated in a hospital facility. Medical history included Nail-patella syndrome. Concomitant medications included ethinylestradiol, levonorgestrel (LESSINA) and escitalopram. The patient previously had known allergies with amoxicillin. First dose came with moderate muscle fatigue and joint pain, chills, headache, and fatigue. Events occurred on 28Dec2020, 7 days post vaccination. The patient did not receive any treatment for the reported events. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Cough, Fatigue, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid, loss of smell, fatigue, congestion and she was coughing for a few days; tested positive for Covid, loss of smell, fatigue, congestion and she was coughing for a few days; This is a spontaneous report from a contactable pharmacist for self. This 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140, Expiration Date 31Mar2021) via unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant mediations not provided. The pharmacist got her first dose on 23Dec2020. On 01Jan2021, the patient developed symptoms: loss of smell, fatigue, congestion and she was coughing for a few days. She tested positive for COVID on 04Jan2021. She was cleared to go back to work and is mostly symptom free except for the loss of smell.  She is supposed to get her second vaccine tomorrow on 13Jan2021. The pharmacist asked if she can get it. The outcome of event was resolving.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: she tested positive for COVID; PCR test that was positive for COVID; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, Expiry Date of COVID 19 vaccine: 31Mar2021), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included thyroid taken out. Concomitant medication included levothyroxine sodium (SYNTHROID) from Sep2019 and ongoing for thyroid taken out. On 05Jan2021, she tested positive for COVID. Her workplace told her to get the 2nd vaccine, she was due for the second dose on 11Jan2021, she needed to wait 10 days after the onset of symptoms to get it. Then, the health department called her and told her that with the Pfizer vaccine the caller needed to wait 90 days to get the second dose. She was scheduled this upcoming Friday to get the second dose so she was trying to figure out what to do. The reporter didn't have a prescribing doctor. She got the vaccine at work. She began to have Sars-Cov-2 symptoms 01Jan2021. Then on 02Jan2021, she had a rapid test that was negative. So on 05Jan2021 she had a PCR test that was positive. Her department was prioritized to get the vaccine. The outcome of events was unknown.