chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Feeling hot, Fibromyalgia
Clinical narrative: not being able to sleep last night/couldn't sleep very well; Dry and tired eyes; Dry and tired eyes; Pain around the neck/tight and tired in neck; Feels like her legs are tight/tired and painful in legs; Feet are hot; Trouble walking/hard to walk; Not breathing well/Short of breath; Her heart feels fast; Stomach and head "feel like there is a bump on them''; Stomach and head "feel like there is a bump on them''; Fibromyalgia worsened; Feeling tired; Feels nervous; She has anxiety; Wants to throw up; very weird the way she feels; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 10Feb2021 as dose 2 single for COVID-19 immunization. Medical history included fibromyalgia. Concomitant medications included atenolol, alprazolam (XANAX). The patient reported feeling worse after the second injection compared to after the first. After the second injection, the patient reported experiencing not being able to sleep last night, dry and tired eyes, pain around the neck, feels like her legs are tight, bottom of feet are hot, trouble walking, not breathing well, and like someone is pinching her hands with a nail. The patient reported her stomach and head feel like there is a bump on them and her heart feels fast, feeling tired, feels nervous, she has anxiety. The patient was worried her blood pressure might be high but it had not been measured. Patient was calling because she had her second vaccine yesterday. The first one, she had a little bit of side effects, but after the second one she felt terrible. She was wondering how long this will last in her body. What can she do when she feels like this. Clinical course included she had been feeling tired. She had fibromyalgia, and she thinks this had been worse for her. She felt tight and tired in her neck. Her legs were tired and painful. She feels like tired. She had to call out of work. She also felt very nervous. Last night she could not sleep very well. Her heart was beating very fast. Her head. She had anxiety. She is a custodian at school. She was working this morning, and felt short of breath. She had to stop working. She almost felt like if her blood pressure was up or something like that. It was like when someone feels nervous. It made her uncomfortable. It was very weird the way she feels. She needs to know does she need to do something or take something.  She had a prescription from the doctor for Atenolol. She mentioned her stomach and her heart, and so she took an Atenolol. She also took a half of a Xanax, and she is feeling a little better now. She just wanted to know if this is normal. Should she go to the ER. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Head discomfort, Limb discomfort, Nausea, Neck pain
Clinical narrative: not being able to sleep last night/couldn't sleep very well; Dry and tired eyes; Dry and tired eyes; Pain around the neck/tight and tired in neck; Feels like her legs are tight/tired and painful in legs; Feet are hot; Trouble walking/hard to walk; Not breathing well/Short of breath; Her heart feels fast; Stomach and head "feel like there is a bump on them''; Stomach and head "feel like there is a bump on them''; Fibromyalgia worsened; Feeling tired; Feels nervous; She has anxiety; Wants to throw up; very weird the way she feels; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 10Feb2021 as dose 2 single for COVID-19 immunization. Medical history included fibromyalgia. Concomitant medications included atenolol, alprazolam (XANAX). The patient reported feeling worse after the second injection compared to after the first. After the second injection, the patient reported experiencing not being able to sleep last night, dry and tired eyes, pain around the neck, feels like her legs are tight, bottom of feet are hot, trouble walking, not breathing well, and like someone is pinching her hands with a nail. The patient reported her stomach and head feel like there is a bump on them and her heart feels fast, feeling tired, feels nervous, she has anxiety. The patient was worried her blood pressure might be high but it had not been measured. Patient was calling because she had her second vaccine yesterday. The first one, she had a little bit of side effects, but after the second one she felt terrible. She was wondering how long this will last in her body. What can she do when she feels like this. Clinical course included she had been feeling tired. She had fibromyalgia, and she thinks this had been worse for her. She felt tight and tired in her neck. Her legs were tired and painful. She feels like tired. She had to call out of work. She also felt very nervous. Last night she could not sleep very well. Her heart was beating very fast. Her head. She had anxiety. She is a custodian at school. She was working this morning, and felt short of breath. She had to stop working. She almost felt like if her blood pressure was up or something like that. It was like when someone feels nervous. It made her uncomfortable. It was very weird the way she feels. She needs to know does she need to do something or take something.  She had a prescription from the doctor for Atenolol. She mentioned her stomach and her heart, and so she took an Atenolol. She also took a half of a Xanax, and she is feeling a little better now. She just wanted to know if this is normal. Should she go to the ER. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Sleep disorder
Clinical narrative: not being able to sleep last night/couldn't sleep very well; Dry and tired eyes; Dry and tired eyes; Pain around the neck/tight and tired in neck; Feels like her legs are tight/tired and painful in legs; Feet are hot; Trouble walking/hard to walk; Not breathing well/Short of breath; Her heart feels fast; Stomach and head "feel like there is a bump on them''; Stomach and head "feel like there is a bump on them''; Fibromyalgia worsened; Feeling tired; Feels nervous; She has anxiety; Wants to throw up; very weird the way she feels; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 10Feb2021 as dose 2 single for COVID-19 immunization. Medical history included fibromyalgia. Concomitant medications included atenolol, alprazolam (XANAX). The patient reported feeling worse after the second injection compared to after the first. After the second injection, the patient reported experiencing not being able to sleep last night, dry and tired eyes, pain around the neck, feels like her legs are tight, bottom of feet are hot, trouble walking, not breathing well, and like someone is pinching her hands with a nail. The patient reported her stomach and head feel like there is a bump on them and her heart feels fast, feeling tired, feels nervous, she has anxiety. The patient was worried her blood pressure might be high but it had not been measured. Patient was calling because she had her second vaccine yesterday. The first one, she had a little bit of side effects, but after the second one she felt terrible. She was wondering how long this will last in her body. What can she do when she feels like this. Clinical course included she had been feeling tired. She had fibromyalgia, and she thinks this had been worse for her. She felt tight and tired in her neck. Her legs were tired and painful. She feels like tired. She had to call out of work. She also felt very nervous. Last night she could not sleep very well. Her heart was beating very fast. Her head. She had anxiety. She is a custodian at school. She was working this morning, and felt short of breath. She had to stop working. She almost felt like if her blood pressure was up or something like that. It was like when someone feels nervous. It made her uncomfortable. It was very weird the way she feels. She needs to know does she need to do something or take something.  She had a prescription from the doctor for Atenolol. She mentioned her stomach and her heart, and so she took an Atenolol. She also took a half of a Xanax, and she is feeling a little better now. She just wanted to know if this is normal. Should she go to the ER. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Maternal exposure during pregnancy, Muscle spasms
Clinical narrative: pregnant/ She is pregnant. Her last menstrual period was in Aug2020.; lower and upper back aches all the way to [her] neck; lower and upper back aches all the way to [her] neck; chills; headache; body aches; cramps; This is a spontaneous report from a contactable consumer or other non hcp.   A 37-years-old pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EM9810), dose 2 intramuscularly administered in Arm Right on 10Feb2021 18:10 (at age of 37-years) as single dose for covid-19 immunisation. Vaccination Facility Type was hospital. The patient's medical history was not reported. There were no concomitant medications. Historical vaccine included first dose received on 20Jan2021 around 18:10, intramuscularly in upper right arm (Lot: EL3247, NDC: unknown, Expiration: unknown). With the first dose she was ok. The patient experienced pregnant/ she is pregnant. her last menstrual period was in Aug2020 (on an unspecified date. On 11Feb2021, patient experienced lower and upper back aches all the way to [her] neck, chills, headache, body aches and cramps. The mother reported she became pregnant while taking bnt162b2. She was 24 Weeks pregnant at the onset of the event. The mother was due to deliver on 28May2021. The patient reported estimated date of conception as labor day weekend but unsure of exact date. First dose received at 21 weeks and second dose received at 24 weeks. The patient did not smoke during this pregnancy nor drink alcohol during this pregnancy. She do not use illicit drugs during this pregnancy. No previous pregnancy reported. Paternal age was reported as 38 DOB with no relevant history. No drugs (e.g., OTC, medical prescription) taken by the father during the mother's pregnancy. Father did not smoke during the mother's pregnancy nor drink alcohol during the mother's pregnancy. He also did not use illicit drugs during the mother's pregnancy. She asked were these symptoms reported as side effects to the COVID-19 vaccine, how long will the symptoms last and how long did the reported side effects lasted. AE's did not require a visit to emergency room or physician office. No prior vaccinations (within 4 weeks) and no AE's following prior vaccinations reported. No additional vaccines administered on same date of the pfizer suspect. Her last menstrual period was in Aug2020Outcome of the events pregnant/ she is pregnant was reported as an unknown and lower and upper back aches all the way to [her] neck was unknown while for rest of the events it was not recovered.  Follow-up attempts have been completed and no further information is expected
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain
Clinical narrative: pregnant/ She is pregnant. Her last menstrual period was in Aug2020.; lower and upper back aches all the way to [her] neck; lower and upper back aches all the way to [her] neck; chills; headache; body aches; cramps; This is a spontaneous report from a contactable consumer or other non hcp.   A 37-years-old pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EM9810), dose 2 intramuscularly administered in Arm Right on 10Feb2021 18:10 (at age of 37-years) as single dose for covid-19 immunisation. Vaccination Facility Type was hospital. The patient's medical history was not reported. There were no concomitant medications. Historical vaccine included first dose received on 20Jan2021 around 18:10, intramuscularly in upper right arm (Lot: EL3247, NDC: unknown, Expiration: unknown). With the first dose she was ok. The patient experienced pregnant/ she is pregnant. her last menstrual period was in Aug2020 (on an unspecified date. On 11Feb2021, patient experienced lower and upper back aches all the way to [her] neck, chills, headache, body aches and cramps. The mother reported she became pregnant while taking bnt162b2. She was 24 Weeks pregnant at the onset of the event. The mother was due to deliver on 28May2021. The patient reported estimated date of conception as labor day weekend but unsure of exact date. First dose received at 21 weeks and second dose received at 24 weeks. The patient did not smoke during this pregnancy nor drink alcohol during this pregnancy. She do not use illicit drugs during this pregnancy. No previous pregnancy reported. Paternal age was reported as 38 DOB with no relevant history. No drugs (e.g., OTC, medical prescription) taken by the father during the mother's pregnancy. Father did not smoke during the mother's pregnancy nor drink alcohol during the mother's pregnancy. He also did not use illicit drugs during the mother's pregnancy. She asked were these symptoms reported as side effects to the COVID-19 vaccine, how long will the symptoms last and how long did the reported side effects lasted. AE's did not require a visit to emergency room or physician office. No prior vaccinations (within 4 weeks) and no AE's following prior vaccinations reported. No additional vaccines administered on same date of the pfizer suspect. Her last menstrual period was in Aug2020Outcome of the events pregnant/ she is pregnant was reported as an unknown and lower and upper back aches all the way to [her] neck was unknown while for rest of the events it was not recovered.  Follow-up attempts have been completed and no further information is expected
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: Progressive loss of memory; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 03Feb2021 at 14:00 (Lot Number: Pfizer EL 9264) at the age of 78-year-old as single dose for COVID-19 immunization. Medical history included COVID-19 (prior vaccination) and sulfa allergy. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication was not reported. On 09Feb2021, the patient experienced loss of memory. No treatment received for event. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: stomach ache; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 05Feb2021 at 09:00 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced stomach ache in Feb2021. The clinical course as follows: Reporter was saying she doesn't want to register this on the computer. Had first vaccine last Friday at 9am had a stomach ache at 4. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fall, Nausea, Pyrexia
Clinical narrative: he was weak; fever; chills; now has to use a walker; Nausea; throwing up; fell; This is a spontaneous report from a contactable consumer reported that. A 70s male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2 SINGLE for covid-19 immunizations. The patient medical history and concomitant medication was not reported. Patient had a lot of comorbidities and we dis not how he would react to it. He had Polychondritis, rheumatoid arthritis, diabetes. I did not know if it was worth the risk. He was on Xeljanz, autoimmune drug for this RA. Patient previously received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) for covid-19 immunizations. On an unspecified date when people get their second dose, they have horrible side effects of weak as a cat, fever and chills and now must use a walker, nausea, throwing up. Even his Physical Therapist he is in his 30s, he had terrible side effects after the 2nd round, and he was out for 3 days. The event outcome was Unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting, Walking aid user
Clinical narrative: he was weak; fever; chills; now has to use a walker; Nausea; throwing up; fell; This is a spontaneous report from a contactable consumer reported that. A 70s male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2 SINGLE for covid-19 immunizations. The patient medical history and concomitant medication was not reported. Patient had a lot of comorbidities and we dis not how he would react to it. He had Polychondritis, rheumatoid arthritis, diabetes. I did not know if it was worth the risk. He was on Xeljanz, autoimmune drug for this RA. Patient previously received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) for covid-19 immunizations. On an unspecified date when people get their second dose, they have horrible side effects of weak as a cat, fever and chills and now must use a walker, nausea, throwing up. Even his Physical Therapist he is in his 30s, he had terrible side effects after the 2nd round, and he was out for 3 days. The event outcome was Unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Difficulty breathing; Fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 11Feb2021 at 13:30 (Lot Number: El9265) at the age of 65-year-old as single dose for COVID-19 immunization. Medical history included sickle cell disease and diabetic. Allergies to medications, food, or other products was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received other medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication was not reported. On 12Feb2021 at 04:00 PM, the patient experienced difficulty breathing and fast heartbeat. No treatment was received for events. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: Difficulty breathing; Fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 11Feb2021 at 13:30 (Lot Number: El9265) at the age of 65-year-old as single dose for COVID-19 immunization. Medical history included sickle cell disease and diabetic. Allergies to medications, food, or other products was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received other medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication was not reported. On 12Feb2021 at 04:00 PM, the patient experienced difficulty breathing and fast heartbeat. No treatment was received for events. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: numbness of the tongue, lips and cheeks; numbness of the tongue, lips and cheeks; BP went down to 104; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had the first dose and experienced numbness of the tongue, lips and cheeks on an unknown date. She also mentioned BP went down to 104 on an unknown date. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Confusional state, Dizziness, Fatigue
Clinical narrative: Extreme Rapid Heartbeat; dizziness; Felt sick to my stomach; chill; Had fever the second day 101; headache; tired; have pins and needle feeling all over; Slight confusion; Ice cold feet and hands but was burning; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Feb2021 17:00 (at the age of 55-year-old) (Batch/Lot Number: EN6201) as dose 1, single for covid-19 immunization. The patient other medical history was reported none. Concomitant medications included valaciclovir hydrochloride (VALTREX); ascorbic acid (VITAMIN C ACID); zinc; nitric oxide (NITRIC OXIDE) taken for an unspecified indication, start and stop date were not reported. The patient previously took dexamethasone and experienced drug hypersensitivity. On 12Feb2021 17:00, the patient experienced extreme Rapid Heartbeat and dizziness immediately after injection. Had to empty my bowel right away. Hands and feet were freezing but my body was hot. Slight confusion. Felt sick to my stomach. Almost went to emergency room but decided to go home. Increase heart rate and chill lasted for a day. Ice cold feet and hands but was burning up. Heart rate slowed after a full 24 hours or so. Increased HR came back off and on for a day or two. Had fever the second day 101 and headache. Tired. Broke on the third day. Now on the third day, have pins and needle feeling all over mild. Cold hands and feet and extremely tired. The patient did not received treatment for AEs. The patient had other vaccine in four weeks. Other medications in two weeks are Valtrex, Vitamin C, Zinc, Nitric Oxide. The patient does not have covid prior vaccination. Covid tested post vaccination was reported as no. The outcome of event was reported as recovering.  Follow-up attempts completed. No further information expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Nausea, Paraesthesia
Clinical narrative: Extreme Rapid Heartbeat; dizziness; Felt sick to my stomach; chill; Had fever the second day 101; headache; tired; have pins and needle feeling all over; Slight confusion; Ice cold feet and hands but was burning; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Feb2021 17:00 (at the age of 55-year-old) (Batch/Lot Number: EN6201) as dose 1, single for covid-19 immunization. The patient other medical history was reported none. Concomitant medications included valaciclovir hydrochloride (VALTREX); ascorbic acid (VITAMIN C ACID); zinc; nitric oxide (NITRIC OXIDE) taken for an unspecified indication, start and stop date were not reported. The patient previously took dexamethasone and experienced drug hypersensitivity. On 12Feb2021 17:00, the patient experienced extreme Rapid Heartbeat and dizziness immediately after injection. Had to empty my bowel right away. Hands and feet were freezing but my body was hot. Slight confusion. Felt sick to my stomach. Almost went to emergency room but decided to go home. Increase heart rate and chill lasted for a day. Ice cold feet and hands but was burning up. Heart rate slowed after a full 24 hours or so. Increased HR came back off and on for a day or two. Had fever the second day 101 and headache. Tired. Broke on the third day. Now on the third day, have pins and needle feeling all over mild. Cold hands and feet and extremely tired. The patient did not received treatment for AEs. The patient had other vaccine in four weeks. Other medications in two weeks are Valtrex, Vitamin C, Zinc, Nitric Oxide. The patient does not have covid prior vaccination. Covid tested post vaccination was reported as no. The outcome of event was reported as recovering.  Follow-up attempts completed. No further information expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral coldness, Pyrexia
Clinical narrative: Extreme Rapid Heartbeat; dizziness; Felt sick to my stomach; chill; Had fever the second day 101; headache; tired; have pins and needle feeling all over; Slight confusion; Ice cold feet and hands but was burning; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Feb2021 17:00 (at the age of 55-year-old) (Batch/Lot Number: EN6201) as dose 1, single for covid-19 immunization. The patient other medical history was reported none. Concomitant medications included valaciclovir hydrochloride (VALTREX); ascorbic acid (VITAMIN C ACID); zinc; nitric oxide (NITRIC OXIDE) taken for an unspecified indication, start and stop date were not reported. The patient previously took dexamethasone and experienced drug hypersensitivity. On 12Feb2021 17:00, the patient experienced extreme Rapid Heartbeat and dizziness immediately after injection. Had to empty my bowel right away. Hands and feet were freezing but my body was hot. Slight confusion. Felt sick to my stomach. Almost went to emergency room but decided to go home. Increase heart rate and chill lasted for a day. Ice cold feet and hands but was burning up. Heart rate slowed after a full 24 hours or so. Increased HR came back off and on for a day or two. Had fever the second day 101 and headache. Tired. Broke on the third day. Now on the third day, have pins and needle feeling all over mild. Cold hands and feet and extremely tired. The patient did not received treatment for AEs. The patient had other vaccine in four weeks. Other medications in two weeks are Valtrex, Vitamin C, Zinc, Nitric Oxide. The patient does not have covid prior vaccination. Covid tested post vaccination was reported as no. The outcome of event was reported as recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: flushing on her cheeks; This is a spontaneous report from a contactable female Consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number: Not reported) via an unspecified route of administration, administered on 15Feb2021 as a single dose for covid-19 immunisation. The patient medical history included ongoing migraine, ongoing fibromyalgia. The patient concomitant medications were not reported. It was reported that she received the vaccine yesterday (15Feb2021) morning and experienced flushing on her cheeks after within an hour. It was persisting today (16feb2021). She was wondering if it was a common side effect of the vaccine as she had not seen it in the fact sheet. She also mentioned that she takes medication for migraines and fibromyalgia and was asking if it could have interactions with the vaccine that may have caused this. The patient was not recovered from the events.  Information on lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Depressed mood
Clinical narrative: Caller extremely confused and flustered; I am depressed; This is a spontaneous report from a non-contactable consumer (patient) via medical information team. A female patient of an unspecified age (reported as 78 without units) received bnt162b2 (Solution for injection) via an unspecified route of administration on 22Jan2021 as dose 1, single for COVID-19 immunisation.  Medical history included arthritis. The patient's concomitant medications were not reported. On an unknown date in 2021, it was reported that the patient was extremely confused and flustered while giving all kinds of dates and states. The patient stated, she took the first one 4 weeks ago. The patient provided Identification number on the white card she was provided at the vaccination site. The patient received the first shot of the Pfizer COVID vaccine on 22Jan2021. The patient was scheduled on 19Feb2021 at 3:12PM. The patient stated they texted her with the gate she was supposed to go in and then asked for her phone number, they told her it was the wrong number, and it was on the card as the right number.  The prompt said sorry we could not help. The patient was concerned that her appointment was cancelled. The patient stated that she was not angry but depressed on an unknown date in 2021 and was going to go take something. On top of everything else, the patient had arthritis and she got it when she moved down. She blamed her husband. Outcome of the events were unknown.   No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Maternal exposure during pregnancy, Neck pain, Pain in extremity
Clinical narrative: L arm soreness; neck/shoulder ache; neck/shoulder ache; fatigue; Pregnant at the time of vaccination? Yes; This is a spontaneous report from a contactable other Health care professional (patient). A 34-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3249), via an unspecified route of administration in left arm on 20Jan2021 at 10:15 (at the age of 34-year-old) as dose 1, single for COVID-19 immunisation in public health clinic. Medical history included fetal distress from an unknown date and unknown if ongoing (Hx of emergency c-section with 1st pregnancy due to fetal distress). Concomitant medications included PRENATAL VITAMINS [ASCORBIC ACID; BETACAROTENE; CALCIUM SULFATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL ACETATE; RIBOFLAVIN; THIAMINE MONONITRATE; TOCOPHERYL ACETATE; ZINC OXIDE] taken for an unspecified indication, start and stop date were not reported; calcium gummies taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have COVID prior vaccination and not COVID tested post vaccination The patient was pregnant on 20Jan2021 at the time of vaccination. On 20Jan2021 at 15:00, the patient experienced L arm soreness, neck/shoulder ache, fatigue on. The mother reported she became pregnant while taking bnt162b2. The patient was 9 Weeks pregnant at the onset of the event. The patient was due to deliver on 18Sep2021 and last menstrual date on 12Dec2020. The patient did not receive any treatment for the events. The outcome was events was reported as resolved on an unknown date.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Weakness; dizziness; This is a spontaneous report from a Contactable Consumer.  A 84-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in Left arm on 28Jan2021 16:00 (at the age of 84-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. Patient had not received other vaccines within 4 weeks. Patient had not received other medications in two weeks. Prior to vaccination, patient was not diagnosed with COVID-19. The patient was not tested for COVID-19. On 28Jan2021, the patient experienced weakness, dizziness. No treatment received for the events. The clinical outcome of events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Heart rate, Tachycardia
Clinical narrative: I had a little bit of tachycardia you know like heart rate little bit like 100 & 102 for about like 3 hours; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Batch/Lot Number: EL9269) via an unspecified route of administration on 12Feb2021 as dose number unknown, single at the age of 45-years-old for COVID-19 immunization.Medical history included headache and migraine. Concomitant medications included galcanezumab gnlm (EMGALITY [GALCANEZUMAB GNLM]) monthly taken for headache and migraine.On 12Feb2021, she experienced tachycardia 10 to 15 minutes ago, that lasted for 3 to 4 hours and wanted to know if she should get the second dose of vaccine and if there was any listed drug interactions listed when taking the vaccine. Patient reported that she had a little bit of tachycardia you know like heart rate little bit like 100 & 102 for about like 3 hours and asked if this is that normal. No treatment was received for event. The patient did take a drug Emgality, which was monoclonal antibodies injections that prevent taking once in month you know for prevention of headache or migraine. Reporter asked is there any interaction between this and vaccine because she have to take it like be safe. The patient underwent lab tests which included Complete Blood Count resulted as regular checkup labs nothing on an unspecified date and heart rate resulted as 100 & 102 on 12Feb2021. The patient recovered from event on unspecified date in 2021.  No Follow-up attempts are possible. Information about lot/batch cannot be obtained.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling drunk, Inappropriate schedule of product administration, Loss of personal independence in daily activities
Clinical narrative: He felt very weak and dizzy; He felt very weak and dizzy; I couldn't get out of the bed, I was struggling; Drowsiness; felt like a drunk; First dose administered 08Feb2021, second dose administered 17Feb2021; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9266, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 17Feb2021 as dose 2, single for covid-19 immunisation in pop up clinic. No prior vaccinations were given within 4 weeks and no other vaccinations was given within four weeks prior to the first administration date of the suspect vaccine. Medical history included allergy to penicillin. The patient's concomitant medications were not reported. The patient previously took indocin [indometacin] and experienced hypersensitivity. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 08Feb2021 as dose 1, single for covid-19 immunisation. The patient was administered with first dose on 08feb2021, second dose administered on 17feb2021 and experienced he felt very weak and dizzy, he couldn't get out of the bed, he was struggling, felt like a drunk and drowsiness on 18Feb2021. The events did not result in emergency room or physician office. Patient received the second dose of the Pfizer-BioNtech Covid-19 vaccine on 17feb2021, next morning he felt very weak and dizzy, this symptom disappeared 15 hours later, patient stated he felt like a drunk. He would like to know if this could be related to the vaccine. The outcome of the event felt like a drunk was unknown and recovered for other events on 18Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: He felt very weak and dizzy; He felt very weak and dizzy; I couldn't get out of the bed, I was struggling; Drowsiness; felt like a drunk; First dose administered 08Feb2021, second dose administered 17Feb2021; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9266, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 17Feb2021 as dose 2, single for covid-19 immunisation in pop up clinic. No prior vaccinations were given within 4 weeks and no other vaccinations was given within four weeks prior to the first administration date of the suspect vaccine. Medical history included allergy to penicillin. The patient's concomitant medications were not reported. The patient previously took indocin [indometacin] and experienced hypersensitivity. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 08Feb2021 as dose 1, single for covid-19 immunisation. The patient was administered with first dose on 08feb2021, second dose administered on 17feb2021 and experienced he felt very weak and dizzy, he couldn't get out of the bed, he was struggling, felt like a drunk and drowsiness on 18Feb2021. The events did not result in emergency room or physician office. Patient received the second dose of the Pfizer-BioNtech Covid-19 vaccine on 17feb2021, next morning he felt very weak and dizzy, this symptom disappeared 15 hours later, patient stated he felt like a drunk. He would like to know if this could be related to the vaccine. The outcome of the event felt like a drunk was unknown and recovered for other events on 18Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness
Clinical narrative: feeling general weakness which is new; dizziness worse than normal; Loose bowels; This is a spontaneous report from a contactable other hcp (Nurse).   A 87-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201, Expiration date: unknown), dose 1 via intramuscular, administered in Arm Right on 16Feb2021 14:00 as (Age at vaccination 87 years-old) dose 1, single for covid-19 immunisation. Medical history included atrial fibrillation episode, peripheral neuropathy, hyperlipidaemia-diet controlled vertigo, hypothyroid, bilateral mastectomy prophylactic, osteoarthritis and skin tape (known allergies: skin tape). Concomitant medication(s) included asa, gabapentin; levothyroxine and diazepam, all taken for unspecified indication start and stop date were not reported. The patient previously took bactrim (Bactrim Known allergies) and lovenox (Known allergies: Lovenox). On 18Feb2021 08:00 the patient experienced feeling general weakness which is new, dizziness worse than normal and loose bowels. Patient did not received any treatment for events. Facility type vaccine was administered at hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. The clinical outcome of all events were unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Muscular weakness, Tachycardia
Clinical narrative: Very dizzy; Heartbeat was beating fast; Muscles were weak; This is a spontaneous report from contactable female consumer (patient) via Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration on 11Feb2021 as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported that she had the Pfizer Covid vaccine shot on Thursday 11Feb late afternoon. On her way to home she felt very dizzy, and her heartbeat was beating fast, and her muscles were weak on unspecified date in Feb2021. How can she reschedule her second shot so her husband can drive her to the facility. The patient underwent lab tests and procedures which included heart rate: heartbeat was beating fast. The outcome of events was unknown.  Information about batch/lot number has been requested.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Heart rate irregular, Pyrexia
Clinical narrative: Headache, Fever,Joint pain, irregular heart beat; Headache; Fever; Joint pain; This is a spontaneous report from a contactable consumer or other non hcp. A 76-year-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: en6200), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 at 13:30 (age at vaccination was 67 years old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included atenolol (ATENOLOL) taken for an unspecified indication, start and stop date were not reported; pravastatin (PRAVASTATIN) taken for an unspecified indication, start and stop date were not reported. Patient didn't receive other vaccines within 4 weeks prior to vaccination. Patient previously received first dose bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: el9264,) via intramuscular in Left arm, on 28JAN2021 13:30 (age at vaccination was 67 years old) as DOSE 1, SINGLE for covid-19 immunisation. patient had no allergies patient didn't had covid prior to vaccination and patient was not tested for covid to post vaccination. The patient experienced headache, fever, joint pain, irregular heartbeat on 19Feb2021 at 04:00. The outcome of the events heart rate irregular, headache, pyrexia, arthralgia was recovered on unspecified date.  Follow-up attempts completed. No further information expected.  FUP#1 (13May2021): Follow-up activities closed: Follow-up attempts completed.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Asthenia, Body temperature, Pyrexia, Somnolence
Clinical narrative: Extreme weakness, especially of legs; ache in lower abdomen; vomiting and inability to hold even water down; diminution of vision; fever of 100.3; I slept almost full time from 9:00am until 6:30am the following day, with very brief waking periods.; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional. An 80-years-old female patient (non-pregnant) received the second dose bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection) via an unspecified route of administration, administered in Arm Left on 18Feb2021 16:30 (Lot Number: EN6201, Expiry date was not reported) (at the age of 80-years-old) as a single dose for COVID-19 immunization at the hospital. Medical history included mild allergy to dairy and some fruits. Other medical history was reported as none. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 16:30 Lot Number: F(E?) L3248, Expiry date was not reported) for COVID-19 immunization. The patient did not receive any other vaccine in 4 weeks of COVID vaccine. The patient did not have other medications in two weeks. The patient did not have COVID prior vaccination and COVID was not tested post vaccination. On 20Feb2021, 07:00 the patient experienced extreme weakness, especially of legs, ache in lower abdomen, vomiting and inability to hold even water down, diminution of vision, fever of 100.3, the patient slept almost full time from 9:00am until 6:30am the following day, with very brief waking periods. Laboratory tests on an unspecified date included body temperature: 100.3 (fever 100.3). There was no treatment received for the events. The clinical outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.