chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: itching more; but the right is still painful to walk especially in the heel area; hives on both palms and bottom of both feet; itching more; body aches; Headache; Fatigue; This is spontaneous report from a contactable consumer. This 24-year-old female consumer reported that who received bnt162b2 (BNT162B2) solution for injection, dose 1 (Lot Number: EN6206 expiry date was unknown) via an unspecified route of administration at arm right on 26Mar2021 05:PM (at the age of 24-years-old) as dose 1 single for covid-19 immunisation. Medical history was not reported. Concomitant medication(s) included desogestrel, ethinylestradiol (ENSKYCE) taken for contraception from an unspecified start date and ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Patient did not AE(s) require a visit to Emergency Room physician Office. She took the Pfizer COVID19 Vaccine first dose on Friday (26Mar2021). She was completely fine with slight fatigue on Friday. Saturday morning, she was completely fine, but in the evening, she started getting body aches (From: 27Mar2021 to: 27Mar2021), extreme fatigue (26Mar2021 to: Ongoing), and headaches (27Mar2021 to: 27Mar2021). She read that happens for some people with first dose. Sunday, she woke up with hives on both palms and on the bottom of both feet (From: 28Mar2021 to: Ongoing). It was around 9AM when she noticed them. Throughout the day they stated itching more. She tried to go to store on Sunday in the evening to get some psoriasis or eczema cream or any type of anti-itch cream. She thinks it was called Cortisone. She had never used it before. When she got back home from store the sores were so bad, she couldn't walk, especially on the right foot. This morning they are a little better. She can walk, but the right is still painful to walk especially in the heel area. The hives on right palm have gone down some and on the left they are still iffy. She just wanted to make sure it is a side effect, and her main question was about getting the second dose. HCP: (name) was a physician assistant, and reporter doesn't know her last name. reporter doesn't have the address or email to provide. Body aches: she woke up yesterday and did not have body aches. She is not sure if she took the vaccine kind of late. She got it at 5PM on 26Mar2021. Her mother says she is limping not walking. Reporter clarified that she was able to get the cortisone cream to treat the itch from store. It was when she got home that her feet started hurting really bad. Outcome of the events fatigue was recovering, general body pain and headache was recovered on 27Mar2021, Urticaria was recovering, Pruritus was not recovered,     No follow up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Varicella
Clinical narrative: It looks like I have chicken pox or something; Inside of her legs broke out with a rash/ Her hands did break out; This is a spontaneous report from a contactable consumer (patient). A 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in right deltoid on 25Mar2021 11:15 (at the age of 86-year-old) (Lot Number: EN6206) as dose 1, single for COVID-19 immunization. Medical history included contusion from and infection (patient ran into the bed post with her ankle and skinned it and it bruised and got infected and it was not healing). Concomitant medication(s) included cephalexin (CEPHALEXIN) taken for contusion, infection, start and stop date were not reported. The patient previously took flu vaccine. The patient did not take any other vaccine within 4 weeks prior to COVID vaccine. The patient reported that inside of her legs broke out with a rash and broke out on her hands on 27Mar2021. The patient reported that it looks like she had chicken pox or something on an unspecified date. The outcome of legs broke out with a rash and broke out on her hands was not reported and the outcome of other event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Malaise, Pyrexia
Clinical narrative: temperature of 103.6/experiencing 101 F temperature or fever; not feeling well; cough; fatigue; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 28Mar2021 at 17:00, dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient was running 103.6 temperature. The patient stated she was not feeling well. The patient further stated that she was experiencing 101 Fahrenheit temperature or fever, cough, and fatigue. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: low grade fever; body aches (right arm and back/neck); headache; painful swollen lymph node; painful swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP6955, patient was 48-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 30Mar2021 at 11:15 AM as DOSE 2, SINGLE for covid-19 immunisation. Medical history included chronic migraines, sarcoidosis. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EF3247), via an unspecified route of administration, administered in Arm Right on 09Mar2021 at 11:15 AM as DOSE 1, SINGLE for covid-19 immunisation. No known allergies to medications, food, or other products reported, the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine, no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient was not tested for COVID-19. On 30Mar2021 at 04:30 PM, the patient experienced low grade fever, body aches (right arm and back/neck), headache, painful swollen lymph node. The outcomes of events were recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever/fever never surpassed 102 degrees, it was primarily low-grade over a 20 hour period; chills; Fatigue; Pain at injection site was present but considered mild to moderate; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 3248), via an unspecified route of administration in right arm on 30Mar2021 at 11:30 AM (at the age of 50 years old) as single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications in two weeks included atorvastatin 10mg; levocetirizine dihydrochloride (XYZAL) 5mg; vardenafil 5mg. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3248), via an unspecified route of administration in right arm on 09Mar2021 at 02:30 PM (at the age of 50 years old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 30Mar2021 at 23:30 approximately 12 hours post dose patient experienced spiked a fever that started with extreme chills. The fever never surpassed 102 degrees; it was primarily low-grade over a 20 hour period. The chills lasted several hours. Fatigue still presents going on 48 hours post-dose. Pain at injection site was present but considered mild to moderate. These symptoms persisted throughout the day on Wednesday, 31Mar2021. The specific fever referenced did not subside until approximately 20 hours later, the late evening of Wednesday, 30Mar2021. He was symptomatic with immediate chills and fever sometime around midnight on Wednesday, 01Apr2021 and the fever persisted throughout the day on Wednesday, April 1st. After the fever subsided late evening on Wednesday, 31Mar2021 immediately went to sleep (at approximately 9pm). The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal swab): negative on 01Dec2020, sars-cov-2 test (Nasal swab): negative on 17Feb2021. No hospitalization required. The reporter considered events as non-serious. Therapeutic measures were taken as a result of all events and included treatment with Prednisone/Atarax. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: fever/fever never surpassed 102 degrees, it was primarily low-grade over a 20 hour period; chills; Fatigue; Pain at injection site was present but considered mild to moderate; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 3248), via an unspecified route of administration in right arm on 30Mar2021 at 11:30 AM (at the age of 50 years old) as single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications in two weeks included atorvastatin 10mg; levocetirizine dihydrochloride (XYZAL) 5mg; vardenafil 5mg. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3248), via an unspecified route of administration in right arm on 09Mar2021 at 02:30 PM (at the age of 50 years old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 30Mar2021 at 23:30 approximately 12 hours post dose patient experienced spiked a fever that started with extreme chills. The fever never surpassed 102 degrees; it was primarily low-grade over a 20 hour period. The chills lasted several hours. Fatigue still presents going on 48 hours post-dose. Pain at injection site was present but considered mild to moderate. These symptoms persisted throughout the day on Wednesday, 31Mar2021. The specific fever referenced did not subside until approximately 20 hours later, the late evening of Wednesday, 30Mar2021. He was symptomatic with immediate chills and fever sometime around midnight on Wednesday, 01Apr2021 and the fever persisted throughout the day on Wednesday, April 1st. After the fever subsided late evening on Wednesday, 31Mar2021 immediately went to sleep (at approximately 9pm). The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal swab): negative on 01Dec2020, sars-cov-2 test (Nasal swab): negative on 17Feb2021. No hospitalization required. The reporter considered events as non-serious. Therapeutic measures were taken as a result of all events and included treatment with Prednisone/Atarax. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: With 2nd dose experienced fever; chills; headache; diarrhea; nausea; This is a spontaneous report from contactable consumer (patient). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and batch no: not reported/lot number: EP6955) via an unspecified route of administration, in left arm on 30Mar2021 10:30 AM as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included as patient received her first dose of bnt162b2 (PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection, batch no: not reported/lot number: EL3247) via an unspecified route of administration, in left arm on 09Mar2021 10:30 AM as dose 1, single for covid-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, the patient has not been tested for covid-19. On 31Mar2021 02:00 AM, patient experienced fever, chills, headache, diarrhea and nausea. Outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Electric shock sensation, Energy increased, Fatigue
Clinical narrative: Lightheadedness; It increased the severity of the hay fever for probably 3 or 4 times; It increased the severity of the hay fever for probably 3 or 4 times; Things have starting to pop so my allergy hit me but I think this virus caused my allergy to be far more intense; Malaise; I don't sleep well it feels like my body is electric, like there is current going on through my body, so I have tossing turning sleeping; I don't sleep well it feels like my body is electric, like there is current going on through my body, so I have tossing turning sleeping; I am slightly nauseous in the stomach; I'm so exhausted; Had itchy throat and throat was closing so, clearly it was a reaction to the peanuts; Had itchy throat and throat was closing so, clearly it was a reaction to the peanuts; Had itchy throat and throat was closing so, clearly it was a reaction to the peanuts; Every cell on my body feels like it's energized and that's why I can't sleep; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199, Expiration date: Not reported), via an unspecified route of administration on 08Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Mar2021, the patient experienced very minor side effects with slight lightheadedness. After having the shot, the patient had hay fever and allergies, and obviously the things had started to pop out, so the allergy hit the patient but the patient thought that this virus caused the allergy to be far more intense. The hay fever comes along anyway, it increased the severity of the hay fever for probably 3 or 4 times. The patient literally went to four large boxes of tissues in 48 hours. So, the other thing is that the patient had extreme malaise in this reported week and the patient didn't sleep well as it feels like the body is electric, like there is current going on through the body, so the patient have tossing turning sleeping. The patient was slightly nauseous in the stomach and have been forced to try and take naps during the day just because the patient was so exhausted. The patient was definitely nauseous but not in extreme. The first 2 days of this reported week, the patient had itchy throat and throat was closing. So, clearly it was a reaction to the peanuts and never had the allergy before in the entire life and also reported that something was going on with the body. Every cell in the body feels like it's energized and that's why the patient can't sleep. The patient was wondering if they had heard any side effects which were hitting 2 weeks later. The outcome of the events was unknown at the time of report.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Food allergy, Hypersensitivity, Malaise, Nausea, Seasonal allergy
Clinical narrative: Lightheadedness; It increased the severity of the hay fever for probably 3 or 4 times; It increased the severity of the hay fever for probably 3 or 4 times; Things have starting to pop so my allergy hit me but I think this virus caused my allergy to be far more intense; Malaise; I don't sleep well it feels like my body is electric, like there is current going on through my body, so I have tossing turning sleeping; I don't sleep well it feels like my body is electric, like there is current going on through my body, so I have tossing turning sleeping; I am slightly nauseous in the stomach; I'm so exhausted; Had itchy throat and throat was closing so, clearly it was a reaction to the peanuts; Had itchy throat and throat was closing so, clearly it was a reaction to the peanuts; Had itchy throat and throat was closing so, clearly it was a reaction to the peanuts; Every cell on my body feels like it's energized and that's why I can't sleep; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199, Expiration date: Not reported), via an unspecified route of administration on 08Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Mar2021, the patient experienced very minor side effects with slight lightheadedness. After having the shot, the patient had hay fever and allergies, and obviously the things had started to pop out, so the allergy hit the patient but the patient thought that this virus caused the allergy to be far more intense. The hay fever comes along anyway, it increased the severity of the hay fever for probably 3 or 4 times. The patient literally went to four large boxes of tissues in 48 hours. So, the other thing is that the patient had extreme malaise in this reported week and the patient didn't sleep well as it feels like the body is electric, like there is current going on through the body, so the patient have tossing turning sleeping. The patient was slightly nauseous in the stomach and have been forced to try and take naps during the day just because the patient was so exhausted. The patient was definitely nauseous but not in extreme. The first 2 days of this reported week, the patient had itchy throat and throat was closing. So, clearly it was a reaction to the peanuts and never had the allergy before in the entire life and also reported that something was going on with the body. Every cell in the body feels like it's energized and that's why the patient can't sleep. The patient was wondering if they had heard any side effects which were hitting 2 weeks later. The outcome of the events was unknown at the time of report.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Sleep disorder, Throat irritation, Throat tightness
Clinical narrative: Lightheadedness; It increased the severity of the hay fever for probably 3 or 4 times; It increased the severity of the hay fever for probably 3 or 4 times; Things have starting to pop so my allergy hit me but I think this virus caused my allergy to be far more intense; Malaise; I don't sleep well it feels like my body is electric, like there is current going on through my body, so I have tossing turning sleeping; I don't sleep well it feels like my body is electric, like there is current going on through my body, so I have tossing turning sleeping; I am slightly nauseous in the stomach; I'm so exhausted; Had itchy throat and throat was closing so, clearly it was a reaction to the peanuts; Had itchy throat and throat was closing so, clearly it was a reaction to the peanuts; Had itchy throat and throat was closing so, clearly it was a reaction to the peanuts; Every cell on my body feels like it's energized and that's why I can't sleep; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199, Expiration date: Not reported), via an unspecified route of administration on 08Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Mar2021, the patient experienced very minor side effects with slight lightheadedness. After having the shot, the patient had hay fever and allergies, and obviously the things had started to pop out, so the allergy hit the patient but the patient thought that this virus caused the allergy to be far more intense. The hay fever comes along anyway, it increased the severity of the hay fever for probably 3 or 4 times. The patient literally went to four large boxes of tissues in 48 hours. So, the other thing is that the patient had extreme malaise in this reported week and the patient didn't sleep well as it feels like the body is electric, like there is current going on through the body, so the patient have tossing turning sleeping. The patient was slightly nauseous in the stomach and have been forced to try and take naps during the day just because the patient was so exhausted. The patient was definitely nauseous but not in extreme. The first 2 days of this reported week, the patient had itchy throat and throat was closing. So, clearly it was a reaction to the peanuts and never had the allergy before in the entire life and also reported that something was going on with the body. Every cell in the body feels like it's energized and that's why the patient can't sleep. The patient was wondering if they had heard any side effects which were hitting 2 weeks later. The outcome of the events was unknown at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Headache, Migraine, Pain in extremity, Poor quality sleep
Clinical narrative: fever; bad migraine; arm was a little sore; did not sleep well through the night; head feels like it is splitting wide open; her joints feel, head feels like it is splitting; This is a spontaneous report from a contactable consumer or other non hcp (patient's husband). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955), dose 2 via an unspecified route of administration on 31Mar2021 (at the age of 62-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included migraine. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199), dose 1 via an unspecified route of administration on 01Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient received her second dose shot of Pfizer BioNTech COVID-19 Vaccine 31Mar2021. After the second dose shot, unspecified date in 2021, she developed a fever last night and bad migraine. She has a past medical history of migraines. After the second dose shot her arm was a little sore which was expected, she did not sleep well through the night, her joints feel, head feels like it was splitting wide open although she does tend to get migraines. She asked can she take an over-the-counter product like Excedrin or Tylenol for the migraine after having been administered the Pfizer BioNTech COVID-19 Vaccine. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; bad migraine; arm was a little sore; did not sleep well through the night; head feels like it is splitting wide open; her joints feel, head feels like it is splitting; This is a spontaneous report from a contactable consumer or other non hcp (patient's husband). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955), dose 2 via an unspecified route of administration on 31Mar2021 (at the age of 62-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included migraine. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199), dose 1 via an unspecified route of administration on 01Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient received her second dose shot of Pfizer BioNTech COVID-19 Vaccine 31Mar2021. After the second dose shot, unspecified date in 2021, she developed a fever last night and bad migraine. She has a past medical history of migraines. After the second dose shot her arm was a little sore which was expected, she did not sleep well through the night, her joints feel, head feels like it was splitting wide open although she does tend to get migraines. She asked can she take an over-the-counter product like Excedrin or Tylenol for the migraine after having been administered the Pfizer BioNTech COVID-19 Vaccine. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eating disorder, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Sweating; Tired; Chills; Not sleeping very well; Uncomfortable/Feels like she's not well; Headache off and on; Arm hurt; Nausea; Fever on an off low grade; Hasn't been eating much; This is a spontaneous report received from a contactable consumer or other non hcp. A 56-years-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot Number: ER8727),via an unspecified route of administration,administered in Arm Right on 29Mar2021 11:00,at the age of 56 years old,as Dose 1,single for covid-19 immunization.Medical history included type 2 diabetes mellitus from 1994 and ongoing Type 2 since 1994 , hypertension from 1994 and ongoing Since 1994 and ongoing renal disorder Since the last 2 years.Concomitant medication(s) included metformin taken for diabetes mellitus from an unspecified start date and ongoing; carvedilol taken for hypertension from an unspecified start date and ongoing.The patient experienced fever on an off low grade on Mar2021,nausea on 29Mar2021,sweating on 30Mar2021,headache off and on on 29Mar2021,arm hurt on 29Mar2021, tired on 30Mar2021,chills on 30Mar2021,not sleeping very well on 30Mar2021,uncomfortable/feels like she's not well on 30Mar2021, hasn't been eating much on Mar2021.Therapeutic measures were taken as a result of headache off and on.Treatment received was Tylenol Rapid Release 500mg take 2 every 6 hours as needed NDC/Lot/Expiry not known.The adverse event didn't result in emergency room visit and physician office visit.The outcome of the event nausea,sweating,headache chills was not recovered and pain in extremity was recovered while other event was unknown.The patient received no other vaccination within 4 weeks.  Follow-up (01Apr2021): This is a follow up-spontaneous report received from a contactable consumer. This 56-year-old female consumer (patient) reported for herself that Vaccination Facility.  No follow-up attempts are needed. No further information is expected
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Sweating; Tired; Chills; Not sleeping very well; Uncomfortable/Feels like she's not well; Headache off and on; Arm hurt; Nausea; Fever on an off low grade; Hasn't been eating much; This is a spontaneous report received from a contactable consumer or other non hcp. A 56-years-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot Number: ER8727),via an unspecified route of administration,administered in Arm Right on 29Mar2021 11:00,at the age of 56 years old,as Dose 1,single for covid-19 immunization.Medical history included type 2 diabetes mellitus from 1994 and ongoing Type 2 since 1994 , hypertension from 1994 and ongoing Since 1994 and ongoing renal disorder Since the last 2 years.Concomitant medication(s) included metformin taken for diabetes mellitus from an unspecified start date and ongoing; carvedilol taken for hypertension from an unspecified start date and ongoing.The patient experienced fever on an off low grade on Mar2021,nausea on 29Mar2021,sweating on 30Mar2021,headache off and on on 29Mar2021,arm hurt on 29Mar2021, tired on 30Mar2021,chills on 30Mar2021,not sleeping very well on 30Mar2021,uncomfortable/feels like she's not well on 30Mar2021, hasn't been eating much on Mar2021.Therapeutic measures were taken as a result of headache off and on.Treatment received was Tylenol Rapid Release 500mg take 2 every 6 hours as needed NDC/Lot/Expiry not known.The adverse event didn't result in emergency room visit and physician office visit.The outcome of the event nausea,sweating,headache chills was not recovered and pain in extremity was recovered while other event was unknown.The patient received no other vaccination within 4 weeks.  Follow-up (01Apr2021): This is a follow up-spontaneous report received from a contactable consumer. This 56-year-old female consumer (patient) reported for herself that Vaccination Facility.  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: She said that she also experienced leg cramps and fever last night but it also started before she had the vaccine; She said that she also experienced leg cramps and fever last night but it also started before she had the vaccine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced leg cramps and fever last night but it also started before she had the vaccine. Outcome of the event was unknown, at the time of this report. No follow-up attempts are possible; information about lot/batch cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Have fever for last 14-15 hours, 102, 103, 101 like that; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 25Mar2021 as single dose for covid-19 immunisation. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 04Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that she got the second shot yesterday of the Pfizer COVID Vaccine and she was having fever since yesterday night, so she wanted to see if she can take Tylenol. She had fever for last 14-15 hours, 102, 103, 101 like that. She questioned if she can tylenol from medicine to bring the fever down. The patient underwent lab tests and procedures which included body temperature which was 102, 103 and 101. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cough, Nasopharyngitis, Rhinorrhoea
Clinical narrative: cold symptoms/ Starting to feel like he has a cold; Occasional coughing; Runny nose; This is a spontaneous report from a Pfizer. This is a spontaneous report from a contactable consumer (patient's daughter). A 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: CN6208 and earlier provided as NC201), via an unspecified route of administration, administered in left arm on 16Mar2021 (at the age of 83-year-old) as dose 2, single for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease, sinus allergies. Concomitant medications included pantoprazole; memantine; vitamin D; donepezil; tamsulosin and tamsulosin hydrochloride (FLOMAX).  The patient previously took fexofenadine hydrochloride (ALLEGRA) 180 mg daily for allergic sinusitis. On 27Mar2021, the patient experienced cold symptoms, mentioned as starting to feel like he had a cold, occasional coughing, and runny nose. The patient underwent lab tests and procedures which included blood test with unknown results on 05Nov2020. As the therapeutic measure the patient took cough drops and throat lozenges for the reported events. The outcome was recovering for occasional cough and not recovered for rest of the events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained; no further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Headache, Malaise, Nausea
Clinical narrative: Nausea; Head is very fuzzy and it's hurting; Body ache; He had a fever of 100.5; Head is very fuzzy and it's hurting; Feeling unwell; This is a spontaneous report from a contactable consumer (reporter's father) from a Pfizer sponsored program. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205 and expiration date was not reported), via an unspecified route of administration on 25Mar2021 (at the age of 62-years-old) at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. After vaccination patient felt a little unwell on 26Mar2021 but overall okay just kind of started up side effects probably. He was just fine on 27Mar2021 but when he woke up on 28Mar2021, he had nausea in the morning and then when he came home from  work, he said that his head was very fuzzy and it was hurting, he was not feeling well and he had some like body ache and when he took his temperature. He had a fever of 100.5 and the package that was given when he got the vaccine, had all of those side effects. But it says it should go away after a couple of days and they were just wondering because reporter's dad does have to work out with the public. No treatment was given for the events. The outcome of the events was unknown. .  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Nausea; Head is very fuzzy and it's hurting; Body ache; He had a fever of 100.5; Head is very fuzzy and it's hurting; Feeling unwell; This is a spontaneous report from a contactable consumer (reporter's father) from a Pfizer sponsored program. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205 and expiration date was not reported), via an unspecified route of administration on 25Mar2021 (at the age of 62-years-old) at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. After vaccination patient felt a little unwell on 26Mar2021 but overall okay just kind of started up side effects probably. He was just fine on 27Mar2021 but when he woke up on 28Mar2021, he had nausea in the morning and then when he came home from  work, he said that his head was very fuzzy and it was hurting, he was not feeling well and he had some like body ache and when he took his temperature. He had a fever of 100.5 and the package that was given when he got the vaccine, had all of those side effects. But it says it should go away after a couple of days and they were just wondering because reporter's dad does have to work out with the public. No treatment was given for the events. The outcome of the events was unknown. .  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Skin warm
Clinical narrative: She got after the vaccination low grade fever; she was feeling tired; the skin on her face and back warm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age of vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After the vaccination, on an unspecified date, the patient experienced low grade fever, she was feeling tired and also got the skin on her face and back warm. The patient wanted to know if the weight was factor for the dosage of the vaccine. She was worried she might get too much of the vaccine since she stated that she was very reactive to medications. The patient asked if there was a study being done for the Pfizer-BioNTech COVID-19 Vaccine in children less than 16 years of age and if the same volume (0.3 ml) was administered to children. The patient wanted to know what would happen if she does not get the second dose and whether one dose will be efficacious. The patient wanted to know if she could get the second dose of the vaccine after 21 days and it would be better in order to have less side effects. The patient wanted to know what would be the advise to those patients that got a severe allergic reaction to the first dose of the vaccine. The patient asked if she could cut the second dose in half due to her size. She wanted to get two doses of half dose each time for the second. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: The patient had flu-like symptoms on 03/25/2021 with 103 degrees Fahrenheit; The patient had flu-like symptoms on 03/25/2021 with 103 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (patient) from Pfizer sponsored program. A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on 24Mar2021 (at the age of 58-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 24Mar2021, patient wife experienced migraine the whole day while patient had flu-like symptoms on 25Mar2021 with 103 degrees Fahrenheit.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: head itching on right side; This is a spontaneous report from a non-contactable health care professional. A 65-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (lot number was not reported) (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a mild reaction to the first COVID vaccine which included head itching on right side which resolved without medication. The outcome of the event was recovered on an unknown date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: fever; waking up sweating; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support. A contactable female consumer (patient) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history concomitant medications were not reported. Historical vaccine includes BNT162B2 on an unspecified date for covid-19 immunisation. The patient reported took the second dose of the vaccine and got symptoms last night, having fever and waking up sweating on an unspecified date, and asked if she can take Tylenol. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: chills; fatigue/tired; body aches; joints hurt; right arm hurts; This is a spontaneous report from a Pfizer Sponsored Program via a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 26Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills, fatigue/tired, body aches, joints hurt and right arm hurts in Mar2021. The patient wanted to know if she can take a pain reliever. The outcome of the events was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Chills, Diarrhoea, Headache
Clinical narrative: diarrhea; joint pain; normally 182 pounds, but he has lost weight during these episodes; chills; a headache kind of pain; This is a spontaneous report from a contactable consumer or other non hcp.  A 65-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, Caller clarifies he has had continuous diarrhea problems. He states he had the two shots. About two weeks after the first shot, he experienced the diarrhea problem but he thought the problem would go away. Then he had the second shot and this problem has persisted for about 3 weeks. Caller clarified he had diarrhea after the first vaccine and the diarrhea continued after the second vaccine. He was reading that roughly 10 percent of patients may have similar issues. Right now, he is calling to see if there might be any clues to help relieve his symptoms. He has done blood work and stool samples and those results are coming back fine. He is also taking Imodium, and is toughing it out. NDC, Lot and expiry date not provided.So, he thought with 10 percent of the population maybe having similar problems and he is just trying to learn a little bit more if they were things that happened shortly after the shot and then diminished. He states he is looking for any clues, or any additional data if this is a common side effect, and what the reporting might be. The outcome of the events diarrhoea was not recovered. The outcome of the other events are unknown. Therapeutic measures were taken as a result of diarrhoea (diarrhoea).  Follow up #2 and 3 (06Apr2021): This is follow up a spontaneous report from a contactable consumer. This 65-year-old male consumer (patient) reported information included. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Stool analysis, Weight decreased
Clinical narrative: diarrhea; joint pain; normally 182 pounds, but he has lost weight during these episodes; chills; a headache kind of pain; This is a spontaneous report from a contactable consumer or other non hcp.  A 65-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, Caller clarifies he has had continuous diarrhea problems. He states he had the two shots. About two weeks after the first shot, he experienced the diarrhea problem but he thought the problem would go away. Then he had the second shot and this problem has persisted for about 3 weeks. Caller clarified he had diarrhea after the first vaccine and the diarrhea continued after the second vaccine. He was reading that roughly 10 percent of patients may have similar issues. Right now, he is calling to see if there might be any clues to help relieve his symptoms. He has done blood work and stool samples and those results are coming back fine. He is also taking Imodium, and is toughing it out. NDC, Lot and expiry date not provided.So, he thought with 10 percent of the population maybe having similar problems and he is just trying to learn a little bit more if they were things that happened shortly after the shot and then diminished. He states he is looking for any clues, or any additional data if this is a common side effect, and what the reporting might be. The outcome of the events diarrhoea was not recovered. The outcome of the other events are unknown. Therapeutic measures were taken as a result of diarrhoea (diarrhoea).  Follow up #2 and 3 (06Apr2021): This is follow up a spontaneous report from a contactable consumer. This 65-year-old male consumer (patient) reported information included. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia, Rash, SARS-CoV-1 test
Clinical narrative: running fever of 102 degree F; horrible nausea; vomiting; rash on her left arm; This is a spontaneous report from a Pfizer-sponsored program by contactable consumer reported herself. A female patient of an unknown age and gender received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unknown), via an unknown route of administration on 11Mar2021 (Thursday) as dose 1, single for COVID-19 immunization. She was scheduled to return for her second shot on 01Apr2021. The patient's medical history and concomitant mediation were not reported. On an unknown date in Mar2021, after she took the first shot, the patient had a running fever of 102 degree F, had horrible nausea and vomiting. She also developed a rash on her left arm and was on bed rest for days. She mentioned she tested positive for COVID-19 last Jun2020. Any unaddressed medical questions were not referred or forwarded to Medical Information. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.