chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Bone pain, Dizziness, Flank pain
Clinical narrative: Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with severe ocular pressure; palpitations; dizziness; Tingling and numbness to hands and feet; Tingling and numbness to hands and feet; Vein engorgement and swelling of left leg; Vein engorgement and swelling of left leg; right abdominal and flank pain; right abdominal and flank pain; crushing headache with severe ocular pressure; This is a spontaneous report from a contactable  health care professional nurse, the patient (patient).   A 47-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: El3249), via an unspecified route of administration  in the left arm on 19Jan2021 at 15:30 as a single dose, for COVID-19 vaccination.  The vaccine was administered in a Nursing Home/Senior Living Facility.  Medical history included asthma and known allergies (details not provided).  Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 at 15:30, the patient experienced Profound weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure. The events resulted in an emergency room visit and physician office visit.  No treatment was  given for the events. The clinical outcome of weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure was not recovered.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Myalgia, Ocular discomfort, Palpitations
Clinical narrative: Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with severe ocular pressure; palpitations; dizziness; Tingling and numbness to hands and feet; Tingling and numbness to hands and feet; Vein engorgement and swelling of left leg; Vein engorgement and swelling of left leg; right abdominal and flank pain; right abdominal and flank pain; crushing headache with severe ocular pressure; This is a spontaneous report from a contactable  health care professional nurse, the patient (patient).   A 47-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: El3249), via an unspecified route of administration  in the left arm on 19Jan2021 at 15:30 as a single dose, for COVID-19 vaccination.  The vaccine was administered in a Nursing Home/Senior Living Facility.  Medical history included asthma and known allergies (details not provided).  Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 at 15:30, the patient experienced Profound weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure. The events resulted in an emergency room visit and physician office visit.  No treatment was  given for the events. The clinical outcome of weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure was not recovered.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling, Peripheral venous disease
Clinical narrative: Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with severe ocular pressure; palpitations; dizziness; Tingling and numbness to hands and feet; Tingling and numbness to hands and feet; Vein engorgement and swelling of left leg; Vein engorgement and swelling of left leg; right abdominal and flank pain; right abdominal and flank pain; crushing headache with severe ocular pressure; This is a spontaneous report from a contactable  health care professional nurse, the patient (patient).   A 47-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: El3249), via an unspecified route of administration  in the left arm on 19Jan2021 at 15:30 as a single dose, for COVID-19 vaccination.  The vaccine was administered in a Nursing Home/Senior Living Facility.  Medical history included asthma and known allergies (details not provided).  Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 at 15:30, the patient experienced Profound weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure. The events resulted in an emergency room visit and physician office visit.  No treatment was  given for the events. The clinical outcome of weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure was not recovered.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature decreased, Chills, Discomfort, Dizziness
Clinical narrative: chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm is killing her; pain was in her body/whole body was killing her; not able to walk; whole body joint pain; feeling cold and warm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date not reported), intramuscular on the left arm on 19Jan2021 10:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiry date not reported), intramuscular on the left arm on 29Dec2020 10:15 for COVID-19 immunization and experienced arm was sore and hurting. The patient reported that she just got the second dose of the vaccine yesterday (19Jan2021). She had a really bad side effects. With the first dose only her arm was sore and hurting, states it was nothing, she did not have side effects. With the second dose her left arm is killing her on 19Jan2021. She clarifies the side effects that she is experiencing are whole body joint pain and muscle pain on 19Jan2021, chills on an unspecified date, nausea on 20Jan2021, headache on an unspecified date, and she is very, very tired on 19Jan2021. She received the second dose of the vaccine around 10:15 am yesterday and she went to work and she was ok. About 12 hours later on 19Jan2021 she started feeling bad, by 10-10:30pm her whole body was killing her and she was not able to walk. Around 11:15pm she had to talk to her supervisor since she was not able to work. She was experiencing the whole body pain and muscle pain. She did not have nausea or dizziness last night. She could not sleep last night, she was not comfortable in bed since she was in pain, her pain was in her body. She started feeling dizzy and nauseous this morning (20Jan2021) when she was getting out bed. States she could not even drive, she wish she had someone that could have picked her up from work since it was horrible. She reported all night she was feeling cold and warm, yesterday she felt warm and she thought she had a fever and when she checked her temperature she did not have a fever. Her temperature this morning was 97.5. Right now she feels freezing, the chills. The patient underwent lab tests and procedures which included body temperature: 97.5 on 20Jan2021. The patient did not recover from her left arm is killing her, whole body joint pain, feeling cold and warm, muscle pain, nausea, very tired, and dizziness while the outcome of the rest of the events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling of body temperature change, Gait inability, Headache
Clinical narrative: chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm is killing her; pain was in her body/whole body was killing her; not able to walk; whole body joint pain; feeling cold and warm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date not reported), intramuscular on the left arm on 19Jan2021 10:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiry date not reported), intramuscular on the left arm on 29Dec2020 10:15 for COVID-19 immunization and experienced arm was sore and hurting. The patient reported that she just got the second dose of the vaccine yesterday (19Jan2021). She had a really bad side effects. With the first dose only her arm was sore and hurting, states it was nothing, she did not have side effects. With the second dose her left arm is killing her on 19Jan2021. She clarifies the side effects that she is experiencing are whole body joint pain and muscle pain on 19Jan2021, chills on an unspecified date, nausea on 20Jan2021, headache on an unspecified date, and she is very, very tired on 19Jan2021. She received the second dose of the vaccine around 10:15 am yesterday and she went to work and she was ok. About 12 hours later on 19Jan2021 she started feeling bad, by 10-10:30pm her whole body was killing her and she was not able to walk. Around 11:15pm she had to talk to her supervisor since she was not able to work. She was experiencing the whole body pain and muscle pain. She did not have nausea or dizziness last night. She could not sleep last night, she was not comfortable in bed since she was in pain, her pain was in her body. She started feeling dizzy and nauseous this morning (20Jan2021) when she was getting out bed. States she could not even drive, she wish she had someone that could have picked her up from work since it was horrible. She reported all night she was feeling cold and warm, yesterday she felt warm and she thought she had a fever and when she checked her temperature she did not have a fever. Her temperature this morning was 97.5. Right now she feels freezing, the chills. The patient underwent lab tests and procedures which included body temperature: 97.5 on 20Jan2021. The patient did not recover from her left arm is killing her, whole body joint pain, feeling cold and warm, muscle pain, nausea, very tired, and dizziness while the outcome of the rest of the events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Impaired work ability, Insomnia, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm is killing her; pain was in her body/whole body was killing her; not able to walk; whole body joint pain; feeling cold and warm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date not reported), intramuscular on the left arm on 19Jan2021 10:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiry date not reported), intramuscular on the left arm on 29Dec2020 10:15 for COVID-19 immunization and experienced arm was sore and hurting. The patient reported that she just got the second dose of the vaccine yesterday (19Jan2021). She had a really bad side effects. With the first dose only her arm was sore and hurting, states it was nothing, she did not have side effects. With the second dose her left arm is killing her on 19Jan2021. She clarifies the side effects that she is experiencing are whole body joint pain and muscle pain on 19Jan2021, chills on an unspecified date, nausea on 20Jan2021, headache on an unspecified date, and she is very, very tired on 19Jan2021. She received the second dose of the vaccine around 10:15 am yesterday and she went to work and she was ok. About 12 hours later on 19Jan2021 she started feeling bad, by 10-10:30pm her whole body was killing her and she was not able to walk. Around 11:15pm she had to talk to her supervisor since she was not able to work. She was experiencing the whole body pain and muscle pain. She did not have nausea or dizziness last night. She could not sleep last night, she was not comfortable in bed since she was in pain, her pain was in her body. She started feeling dizzy and nauseous this morning (20Jan2021) when she was getting out bed. States she could not even drive, she wish she had someone that could have picked her up from work since it was horrible. She reported all night she was feeling cold and warm, yesterday she felt warm and she thought she had a fever and when she checked her temperature she did not have a fever. Her temperature this morning was 97.5. Right now she feels freezing, the chills. The patient underwent lab tests and procedures which included body temperature: 97.5 on 20Jan2021. The patient did not recover from her left arm is killing her, whole body joint pain, feeling cold and warm, muscle pain, nausea, very tired, and dizziness while the outcome of the rest of the events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm is killing her; pain was in her body/whole body was killing her; not able to walk; whole body joint pain; feeling cold and warm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date not reported), intramuscular on the left arm on 19Jan2021 10:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiry date not reported), intramuscular on the left arm on 29Dec2020 10:15 for COVID-19 immunization and experienced arm was sore and hurting. The patient reported that she just got the second dose of the vaccine yesterday (19Jan2021). She had a really bad side effects. With the first dose only her arm was sore and hurting, states it was nothing, she did not have side effects. With the second dose her left arm is killing her on 19Jan2021. She clarifies the side effects that she is experiencing are whole body joint pain and muscle pain on 19Jan2021, chills on an unspecified date, nausea on 20Jan2021, headache on an unspecified date, and she is very, very tired on 19Jan2021. She received the second dose of the vaccine around 10:15 am yesterday and she went to work and she was ok. About 12 hours later on 19Jan2021 she started feeling bad, by 10-10:30pm her whole body was killing her and she was not able to walk. Around 11:15pm she had to talk to her supervisor since she was not able to work. She was experiencing the whole body pain and muscle pain. She did not have nausea or dizziness last night. She could not sleep last night, she was not comfortable in bed since she was in pain, her pain was in her body. She started feeling dizzy and nauseous this morning (20Jan2021) when she was getting out bed. States she could not even drive, she wish she had someone that could have picked her up from work since it was horrible. She reported all night she was feeling cold and warm, yesterday she felt warm and she thought she had a fever and when she checked her temperature she did not have a fever. Her temperature this morning was 97.5. Right now she feels freezing, the chills. The patient underwent lab tests and procedures which included body temperature: 97.5 on 20Jan2021. The patient did not recover from her left arm is killing her, whole body joint pain, feeling cold and warm, muscle pain, nausea, very tired, and dizziness while the outcome of the rest of the events was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Caller had the second shot 16Jan2021 and was tested today 20Jan2021 and now she is back positive.; Caller had the second shot 16Jan2021 and was tested today 20Jan2021 and now she is back positive.; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on 26Dec2020 (first dose; Batch/lot number: EL5738) at single dose into right arm and on 16Jan2021 (second dose LOT EL3248) at single dose into left arm. Medical history was none.  Concomitant medication included gummy bear vitamins, no further details provided. Patient did her first COVID test on 16Dec2020, prior to getting the vaccination, and was negative. Patient got the first dose of the vaccine on 26Dec2020 and on 30Dec2020 tested positive (via COVID-19 PCR test) for Covid. She was tested negative on 03Jan2021 and 04Jan2021 (both COVID-19 PCR tests). Patient had the second shot on 16Jan2021 and COVID-19 PCR test on 20Jan2021 was back positive. Patient clarified she got the injection twice, and each time she has gotten it and gotten tested after, each test was showing positive. She clarified that she went to a nursing home and was tested every 14 days when she went to see her mom and all times prior to getting the vaccine doses she was negative. She said her first dose of the vaccine was on 26Dec2020, then four days after that it was time to go get tested to go see her mom and the test was positive within no time it lights up. She said as a medical worker (she was a patient registration clerk at the emergency room- ER) she can wait 5 days after that for it to come up after being positive and after that if it was showing up negative she had to wait 24 hours to confirm negative test and repeated the test within 24 hours, which was negative too. She got the second dose on 16Jan2021 and then she went to go get tested to go back to the nursing home and again it came back positive. Outcome of the event was unknown. Patient wanted to know if this was a herd immunity vaccine and if the vaccine had covid in it.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021051224 same patient, different dose
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature increased, Chills, Faeces discoloured, Fatigue
Clinical narrative: white mucous stools with blood; abdominal pain; tenesmus; white mucous stools with blood; fatigue; chills; headache; temp 99.5; This is a spontaneous report from a contactable nurse. This 58-year-old female Nurse (Patient) reported that A 36-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19 pfizer, Lot#: EL3246), via an unspecified route of administration on 11Jan2021 01:00 PM on Right arm at single dose for COVID-19 immunisation. She is not pregnant. Medical history was none. Known allergies: NKA. Facility type vaccine was other. No other vaccine in four weeks. Concomitant medications included thyroid (ARMOUR THYROID), estrogens conjugated/medroxyprogesterone acetate (PREMPRO), Regular vitamin.  4:00 am on 20Jan2021 woke with abdominal pain, tenesmus, white mucous stools with blood, fatigue, chills, headache, Temp 99.5 called physician told it sounds like reaction. Took Tylenol 500 mg for symptoms. 21Jan2021 feel better but still mucous blood stools dr wants to see me monday 25Jan2021 if still having blood. AE resulted in: Doctor or other healthcare professional office/clinic visit.  The outcome of the events was recovered with lasting effects. Treatment received. No COVID prior vaccination. No COVID tested post vaccination.; Sender's Comments: Based on the information currently available and in absence of strong confounding factors, a possible contributory role of the suspect BNT162B2 in triggering the onset of blood stool cannot be 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Haematochezia, Headache, Mucous stools, Rectal tenesmus
Clinical narrative: white mucous stools with blood; abdominal pain; tenesmus; white mucous stools with blood; fatigue; chills; headache; temp 99.5; This is a spontaneous report from a contactable nurse. This 58-year-old female Nurse (Patient) reported that A 36-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19 pfizer, Lot#: EL3246), via an unspecified route of administration on 11Jan2021 01:00 PM on Right arm at single dose for COVID-19 immunisation. She is not pregnant. Medical history was none. Known allergies: NKA. Facility type vaccine was other. No other vaccine in four weeks. Concomitant medications included thyroid (ARMOUR THYROID), estrogens conjugated/medroxyprogesterone acetate (PREMPRO), Regular vitamin.  4:00 am on 20Jan2021 woke with abdominal pain, tenesmus, white mucous stools with blood, fatigue, chills, headache, Temp 99.5 called physician told it sounds like reaction. Took Tylenol 500 mg for symptoms. 21Jan2021 feel better but still mucous blood stools dr wants to see me monday 25Jan2021 if still having blood. AE resulted in: Doctor or other healthcare professional office/clinic visit.  The outcome of the events was recovered with lasting effects. Treatment received. No COVID prior vaccination. No COVID tested post vaccination.; Sender's Comments: Based on the information currently available and in absence of strong confounding factors, a possible contributory role of the suspect BNT162B2 in triggering the onset of blood stool cannot be 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.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Neck pain, Odynophagia
Clinical narrative: tired; head feels fuzzy; throat and neck pain; throat and neck pain; hurts to swallow; Low grade fever/low grade temp of 99.4; Headache; body aches; This is a spontaneous report from a contactable Nurse (patient). A 26-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left deltoid on 20Jan2021 11:00 at 0.3 mL, single for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient received her first dose yesterday at 11:00am. She was talking to someone and all of a sudden she got throat to neck pain that was intense that lasted two minutes on 21Jan2021. It has been about 10-15minutes since and if she hold her neck straight she is fine, but if she looks up it hurts. She can breathe fine. It hurts to swallow all of a sudden on 21Jan2021. Asking if it is normal to experience this. She had a low grade fever/low grade temp of 99.4, body aches, and a headache that started today 21Jan2021. She received Tylenol as treatment. States she is a nurse and she is tired. Her head feels fuzzy, she has not taken her temperature recently and it still hurts to swallow. The events did not require a visit to emergency room or physician office. Relatedness of drug to events from reporter for throat and neck pain, hurts to swallow, low grade fever, headache, body aches was reported as related. Reporter seriousness for throat and neck pain and hurts to swallow was medically significant. Event outcome of throat and neck pain was recovered, of hurts to swallow was not recovered, of others was unknown.   Information on the lot/ batch number has been requested.; Sender's Comments: The reported events were likely causally related to the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship.  However, it is worth noting that the reporter/user of the vaccine was nurse, and her tiredness from job could have confounded with the events.  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.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: tired; head feels fuzzy; throat and neck pain; throat and neck pain; hurts to swallow; Low grade fever/low grade temp of 99.4; Headache; body aches; This is a spontaneous report from a contactable Nurse (patient). A 26-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left deltoid on 20Jan2021 11:00 at 0.3 mL, single for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient received her first dose yesterday at 11:00am. She was talking to someone and all of a sudden she got throat to neck pain that was intense that lasted two minutes on 21Jan2021. It has been about 10-15minutes since and if she hold her neck straight she is fine, but if she looks up it hurts. She can breathe fine. It hurts to swallow all of a sudden on 21Jan2021. Asking if it is normal to experience this. She had a low grade fever/low grade temp of 99.4, body aches, and a headache that started today 21Jan2021. She received Tylenol as treatment. States she is a nurse and she is tired. Her head feels fuzzy, she has not taken her temperature recently and it still hurts to swallow. The events did not require a visit to emergency room or physician office. Relatedness of drug to events from reporter for throat and neck pain, hurts to swallow, low grade fever, headache, body aches was reported as related. Reporter seriousness for throat and neck pain and hurts to swallow was medically significant. Event outcome of throat and neck pain was recovered, of hurts to swallow was not recovered, of others was unknown.   Information on the lot/ batch number has been requested.; Sender's Comments: The reported events were likely causally related to the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship.  However, it is worth noting that the reporter/user of the vaccine was nurse, and her tiredness from job could have confounded with the events.  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.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: fever of 100.6; chills; fatigue that lasted 36 hours.; This is a spontaneous report from a contactable consumer. This 34-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: Unknown), second dose, via an unspecified route of administration on 19Jan2021 at 10:30 (at the age of 34-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was not reported. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication was reported as none and no other medications were received within 2 weeks of the vaccination. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EK9231), dose #1, via an unspecified route of administration on 30Dec2020 as a single dose for COVID-19 vaccination. On 20Jan2021, the patient received her second dose and experienced fever of 100.6 degrees Fahrenheit, chills and fatigue that lasted 36 hours. No therapeutic measures were taken as a result of the events. The clinical outcomes of the fever of 100.6 degrees Fahrenheit, chills and fatigue were resolved on unspecified dates in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Gastrooesophageal reflux disease
Clinical narrative: Had heartburn like she was going to have a heart attack; Intense GERD; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose BNT162B2 via an unspecified route of administration on 21Jan2021 12:50 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had first COVID shot today (21Jan2021) at 12:50. Was doing fine, arm wasn't even sore. While eating dinner started having intense GERD on 21Jan2021. Had heartburn like she was going to have a heart attack. Took a Famotidine, but it didn't do anything. Took one of a Pepto Bismol Ultra at about 5:30PM. Starting to get some relief, but just didn't know whether she is going to be relieved throughout the night. Wants to know whether she should go to an urgent care facility to give her something to quiet it down. Events outcome was recovering.  Information on the Lot/Batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for having the Covid Virus; Tested positive for having the Covid Virus; This is a spontaneous report from a Pfizer-sponsored Program. A contactable consumer reported that a 20-year-old female patient (reporter's daughter) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration in Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received the first dose on 04Jan2021 or 05Jan2021 and was tested positive for having the COVID-19 virus. They want to know when and if she can get the second dose. She returned to school and she took the spit swab that the university was requiring for all students. She took it on Saturday or Sunday (unspecified dates in Jan2021) and she got the result yesterday morning and it was positive. It was reported that she was currently isolated, she went home, she was fine and everything. It was also stated that she is asymptomatic and she really has no signs. Outcome of the events was unknown.  Information on the Batch/Lot number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Endotracheal intubation, Resuscitation, Ventricular fibrillation
Clinical narrative: Cardiac Arrest; Ventricular Fibrillation; This is a spontaneous report from a contactable physician reporting for a patient. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN), hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) in two weeks. It was unknown if the patient received Other vaccine in four weeks, if patient had Covid prior vaccination, if Covid was tested post vaccination. Patient went for Running after returning home suffered Cardiac Arrest, Ventricular Fibrillation on 28Jan2021, CPR (Cardiopulmonary resuscitation) by Wife, Intubated by EMS (Emergency Medical Service) brought to the Hospital. The adverse events resulted in visiting Emergency room/department or urgent care and Life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of cardiac arrest and ventricular fibrillation which included CPR and Intubated. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cardiac arrest and ventricular fibrillation cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Pain in extremity, Vaccination site pain
Clinical narrative: Headache; Horrible calf pain bilaterally; I could barely walk; Horrible calf pain bilaterally; I could barely walk; Major injection site soreness; my arm started getting super sore; Major injection site soreness; my arm started getting super sore; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) at left deltoid on 18Jan2021 12:45 PM at single dose for COVID-19 immunisation in Hospital. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]), just the Vitamins and supplements. Patient was just calling to report the side effects to the Covid 19 vaccine, major injection site soreness, she was having headache today (19Jan2021) and horrible calf pain bilaterally. the first dose was 18Jan2021 and due date of second dose was 08Feb2021. As of causality, nurse practitioner stated Yes, yesterday (18Jan2021) her arm started getting super sore and it kept getting worse and then she woke up this morning and she could barely walk because her calf pain is so bad, in both of her legs. Treatment include she have taken Advil, she took 600 mg today and she took 400 mg last night. As Results of Lab work, she stated she don't have it. She asked if anyone had the calf pain with it. Patient was not recovered from the events. Event relatedness for Covid 19 vaccine with Major injection site soreness; my arm started getting super sore and Horrible calf pain bilaterally; I could barely walk were Related. Relatedness of drug to Major injection site soreness; my arm started getting super sore, Headache, Horrible calf pain bilaterally; I could barely walk per Source of assessment:  Source of assessment. Method of assessment: Global Introspection. Drug result: Related.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Malaise, Mobility decreased, Pain in extremity
Clinical narrative: Got tested and came positive after receiving first vaccine; Got tested and came positive after receiving first vaccine; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported similar events in two patients. This is the first of two reports.  A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not reported), intramuscular on 10Jan2021 at single dose for COVID-19 immunization. Medical history included asthma. Concomitant medication included vitamins nos. It was reported that both the patient and her husband received the Pfizer Vaccine on 10Jan2021; and they had reaction to it. They both both had bad arm swelling and pain. Her was worst she couldn't even lift or move her arm. At first, they just thought it was a reaction as they read reactions could be and then she started to get small cough but by Friday, her husband went and got tested and on Wednesday he was tested positive and this is after the vaccine and then he got the results and it said he was positive. So, Saturday, they both went and got tested, they did the rapid and they did what they call the PCR, and they both came positive for both of them and this was after they receive the first vaccine. So, she thought they need to know that they got sick and it was after the vaccine. The patient needed to ask a question as they were supposed to go for their second vaccine on 31Jan2021 and do they do it even though they got sick. They knew they were claiming that they can't get sick because of the vaccine but it's very ironic that they did get this. They had been following CBC guidelines, both her husband and the patient because they are older and they wear mask all the time and they did everything they needed to and they could not understand how they got this. The patient underwent lab tests and procedures which included Rapid and PCR: positive in Jan2021. Therapeutic measures were taken as a result of "bad arm swelling and pain; worst she couldn't even lift or move her arm" which included treatment with Tylenol. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092094 same reporter and drug, similar events in a different patient
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 test positive
Clinical narrative: Got tested and came positive after receiving first vaccine; Got tested and came positive after receiving first vaccine; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported similar events in two patients. This is the first of two reports.  A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not reported), intramuscular on 10Jan2021 at single dose for COVID-19 immunization. Medical history included asthma. Concomitant medication included vitamins nos. It was reported that both the patient and her husband received the Pfizer Vaccine on 10Jan2021; and they had reaction to it. They both both had bad arm swelling and pain. Her was worst she couldn't even lift or move her arm. At first, they just thought it was a reaction as they read reactions could be and then she started to get small cough but by Friday, her husband went and got tested and on Wednesday he was tested positive and this is after the vaccine and then he got the results and it said he was positive. So, Saturday, they both went and got tested, they did the rapid and they did what they call the PCR, and they both came positive for both of them and this was after they receive the first vaccine. So, she thought they need to know that they got sick and it was after the vaccine. The patient needed to ask a question as they were supposed to go for their second vaccine on 31Jan2021 and do they do it even though they got sick. They knew they were claiming that they can't get sick because of the vaccine but it's very ironic that they did get this. They had been following CBC guidelines, both her husband and the patient because they are older and they wear mask all the time and they did everything they needed to and they could not understand how they got this. The patient underwent lab tests and procedures which included Rapid and PCR: positive in Jan2021. Therapeutic measures were taken as a result of "bad arm swelling and pain; worst she couldn't even lift or move her arm" which included treatment with Tylenol. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092094 same reporter and drug, similar events in a different patient
Sex: M
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Cough, Malaise, Pain in extremity
Clinical narrative: Tested positive after receiving the vaccine; Tested positive after receiving the vaccine; bad arm swelling and pain; bad arm swelling and pain/leg pain; not feeling well having severe back pain; not feeling well; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events in two patients. This is the second of two reports. A 67-year-old male patient (reporter's husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included vitamins nos. It was reported that the patient as well as the reporter had bad arm swelling and pain. By Wednesday the patient was not feeling well he was having severe back pain and leg pain and what not. At first they just thought it was a reaction as they read reactions could be and then the reporter started to get small cough but by Friday the patient went and got tested and on Wednesday he was tested positive and this is after the vaccine and then he got the results and it said he was positive. So, Saturday they both went and got tested, they did the rapid and what they call the PCR, and they both came positive for both of them and this was after they receive the first vaccine. The patient underwent lab tests and procedures which included Rapid and PCR: positive on Jan2021. Therapeutic measures were taken as a result of bad arm swelling and pain, not feeling well having severe back pain and leg pain which included treatment with Tylenol. The outcome of the events was unknown.  Information on Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092066 same reporter and drug, similar events in a different patient
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 test positive
Clinical narrative: Tested positive after receiving the vaccine; Tested positive after receiving the vaccine; bad arm swelling and pain; bad arm swelling and pain/leg pain; not feeling well having severe back pain; not feeling well; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events in two patients. This is the second of two reports. A 67-year-old male patient (reporter's husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included vitamins nos. It was reported that the patient as well as the reporter had bad arm swelling and pain. By Wednesday the patient was not feeling well he was having severe back pain and leg pain and what not. At first they just thought it was a reaction as they read reactions could be and then the reporter started to get small cough but by Friday the patient went and got tested and on Wednesday he was tested positive and this is after the vaccine and then he got the results and it said he was positive. So, Saturday they both went and got tested, they did the rapid and what they call the PCR, and they both came positive for both of them and this was after they receive the first vaccine. The patient underwent lab tests and procedures which included Rapid and PCR: positive on Jan2021. Therapeutic measures were taken as a result of bad arm swelling and pain, not feeling well having severe back pain and leg pain which included treatment with Tylenol. The outcome of the events was unknown.  Information on Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092066 same reporter and drug, similar events in a different patient