chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6201), via an unspecified route of administration on Arm Left on 11Feb2021 as single dose for COVID-19 immunisation. The Patient's Medical history included asthma (since years ago) and lung cancer (but that is not a current condition, it was diagnosed Jan2017). The patient's concomitant medications were not reported. The patient historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL8982) and it was given on 21Jan2021 injected into her left arm for COVI-19 immunization at the age of 76-year-old. It was reported that, the consumer calling about the Pfizer COVID-19 vaccine who says she experienced dizziness for 11 days after her second shot in Feb2021. She says she saw the nurse practitioner one day at that office while she was having this problem. Caller says that on the 12th day her dizziness was gone, but she suffered 11 days with it. She says that she tried Antivert, different sized medication doses, it made her sleepy all day in addition to the vertigo and nauseousness, those were old pills in a pharmacy bottle without NDC/LOT/EXP on the label. She says she tried both 12.5mg dose and 25mg dose, one a day before sleep 24 hours apart. Caller says that the main reason she was calling is that she was concerned if there was a booster shot that might be required and she got it that this was gonna happen again if she has a booster shot in 6 months. Therapeutic measures were taken as a result of the event dizziness. The Outcome of the event was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: I was tested positive for Covid-19.; I was tested positive for Covid-19.; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: Not reported), via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient had the first shot on 11Feb2021 and scheduled to get the second dose on 04Mar2021. However, the patient was tested positive for Covid-19 in 2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 22Mar2021 (Lot number: EL9266) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nosebleeds in Mar 2021. The patient was scheduled for the second dose in 4 weeks. The clinical outcome of nosebleeds was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal pain, Oral herpes
Clinical narrative: intestinal issues - pain; diarrhea; fever blisters; This is a spontaneous report from a contactable consumer.   A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 17Feb2021 15:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that one week after intestinal issues pain and diarrhea plus fever blisters getting better after 6 days but not completely gone. Patient did not have Covid prior vaccination, Patient did not test Covid post vaccination. Patient did not receive any treatment. Patient did not receive any other vaccine in four weeks. Outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient got her 1st dose and then ended up getting Covid with serious complications; patient got her 1st dose and then ended up getting Covid with serious complications; 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, Solution for injection), dose 1, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got her 1st dose and then ended up getting Covid with serious complications on an unspecified date, and she now needs to get her 2nd dose and wanted to know if she should or not. The patient tested positive in COVID-19 on an unspecified date. The outcome of the events was unknown.  Batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, Malaise
Clinical narrative: COVID-19; COVID-19; yesterday marked 6 weeks from the date she got the 1st dose and she is yet to receive the 2nd dose; got very sick; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age (reported as Age:57; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 18Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient's medical history was and concomitant medications were not reported. The patient received the 1st dose of the Pfizer COVID vaccine 18Jan2021, and was scheduled to receive the 2nd dose 10Feb2021, however 5 days after the 1st dose she got very sick on 23Jan2021 and was diagnosed with COVID-19 on 31Jan2021. She was hospitalized for 6 days. She received Remdesivir, an antiviral. Yesterday marked 6 weeks from the date she got the 1st dose and she is yet to receive the 2nd dose. The patient would like to know if has to wait a certain amount of time before receiving the 2nd dose of the Pfizer COVID vaccine with her history of COVID infection or if she has to start the Pfizer COVID vaccine series all over again with her history of COVID infection. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received first dose of covid vaccine and got covid; received first dose of covid vaccine and got covid; This is a spontaneous report from a program. A male patient of an unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. on an unspecified date, patient who received first dose of COVID vaccine and got COVID. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tests positive for covid; Tests positive for COVID; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported that a patient of unspecified age and gender received BNT162B2, dose 1 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse stated that patient received first dose on 12Feb2021 and now, on an unspecified date, tests positive for COVID. The nurse wanted to know if it is okay to administer second dose. The outcome of the event was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective / COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: Received 1st dose of covid vaccine is due for 2nd dose next week. Pretty sure in between she had covid virus.; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient had received first dose of COVID vaccine and was due for second dose next week. The patient was pretty sure that she had COVID virus in between. The patient had clarified that she was not underwent testing. The patient wanted to know if she should get second dose of COVID vaccine. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: who received her 1st shot of our vaccine last 19Feb but was tested COVID-19 27Feb; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), via an unspecified route of administration on 19Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received her 1st shot of our vaccine BNT162B2 on 19Feb2021 and was tested COVID-19 on 27Feb2021. The patient was scheduled for shot of our vaccine BNT162B2 on 12Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Headache, Neoplasm
Clinical narrative: I was tired; headache on the left side of his head/stroke-like headache on left side of his head (in the temple)/headache, a throbbing the size of a quarter on the left side of my head; He feels a slight pressure with his headache; I have been experiencing a little lumps, it feels like a little lumps inside like "hard" (not clarified) in my head just one side of the head is stopped.; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 65 years of age), dose 1 via an unspecified route of administration on 05Mar2021 11:30 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the first Pfizer COVID-19 vaccine on Friday (05Mar2021) and on 10Mar2021 he had a stroke-like headache on the left side of his head (in the temple). He felt a slight pressure with his headache and he was not sure whether this was a sinus pressure. He wanted to know if this had been reported with the Pfizer COVID-19 vaccine. He also wanted to know if stroke was an AE related to the Pfizer COVID-19 vaccine. He wanted to know if he could take Tylenol after getting the vaccine. Two weeks after the vaccine, the patient had been experiencing a little lumps, it felt like a little lumps inside like "hard" (not clarified) in his head just one side of the head was stopped. He queried if it was a side effects with Pfizer shot. He clarified that he had it on 05Mar2021, he got it all in the March. He queried if that was part of side effects from the shot he had, a sort of side effects part in his head. It was reaction he believed, he doesn't think it was nothing else, he didn't have it before, he didn't have before the 5Mar2021. He didn't have by initially by all 8-9 days, going on 2 weeks now. He just wanted to know if these are one of the side effects. The one, he wanted to know if the sort of side effects inside of his head. The events are reported non-serious. On 26Mar2021, it was reported that patient was supposed to get his 2nd dose today. He added that on 13Mar2021, he was tired, but also had a headache, a throbbing the size of a quarter on the left side of his head, it did not increase in pain it was moderate in pain and it was on and off, which he still have. He asked if it was common. He mentioned that he saw his doctor and was prescribed Naprosyn 500mg which he takes 4-5 times and it didn't do anything, it might went away but came back again. He was supposed to have an ultrasound in April 2021. He asked if he had sinus issue, will that be a problem to get his second dose. Therapeutic measures were taken as a result of headache. The outcome of headache was not recovered while unknown for other events.   Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she's been tested positive 6 days after her first dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient herself) reported that an unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On unspecified date it was reported as patient got the first dose. The second dose of the vaccine is scheduled tomorrow (05Mar2021). She has been tested positive 6 days after her first dose. She would like to confirm if she can take the second dose scheduled for tomorrow. Outcome of event was unknown.  No follow up attempts are possible; information about Lot/batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia
Clinical narrative: Had double vision for the rest of the day/evening. Was fine the following morning.; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (BNT162B2), at vaccination age of 68-year-old via an unspecified route of administration in the left arm on 08Mar2021 14:30 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not diagnosed with covid-19 prior vaccination. Concomitant medications included lisinopril; montelukast sodium (SINGULAIR) and amlodipine, indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient previously took acetylsalicylic acid (aspirin), ibuprofen and fexofenadine hydrochloride (ALLEGRA) but had allergies. On 08Mar2021 03:30 PM, the patient had double vision for the rest of the day/evening and was fine the following morning. The patient did not receive treatment for the adverse events. The patient was not covid tested post vaccination. The outcome of the event was recovered on 09Mar2021.  Information about lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: I started feeling fatigued, and my joints started aching Having arthritis; I started feeling fatigued, and my joints started aching Having arthritis; This is a spontaneous report from contactable consumer (patient) reported for herself. A 81-year-old non-pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6202), via an unspecified route of administration in the left arm on 17FEB2021 10:00 as a SINGLE DOSE and previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9265), via an unspecified route of administration in the left arm on 01FEB2021 13:00 for COVID-19 immunization. Medical history reported as penicillin allergy. Prior to the 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. Patient's medications received within 2 weeks of vaccination olmesartan 40mg, multivitamin, Omega 3, D3, Tumeri. On day after second shot patient started feeling fatigued and joints started aching. Having arthritis used to some joint discomfort, but this went beyond want was normal to patient. The fatigue was so encompassing that patient lay on the couch and watch tv most of the day, interspersed with naps. The pain and fatigue lasted from 25Mar2021 until 10Mar2021 when it has begun to ease. Patient still nor back to where she was but feel better. Not being sure why reaction was so bad and glad she had the vaccine and would repeat it even knowing how I would react. The patient did not receive any treatment for the events. The clinical outcome of the events was recovering. Information on the lot/batch number is requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Positive Covid-19 Test; This is a spontaneous report from a contactable other healthcare professional (reporting for herself). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jan2021 13:15 (Batch/Lot Number: El1283) as SINGLE DOSE for covid-19 immunisation (66-year age at Vaccination). The patient medical history was none. The patient had no previous allergies. The patient's concomitant medications include metformin for unknown indication. It was reported that patient received first dose of Pfizer covid vaccine on 25Jan2021. Patient received second dose on 17Feb2021 (Lot no: EN6200) on right arm. on 01Feb2021 11:30 AM patient experienced Positive Covid-19 Test. covid test name post vaccination was aegis and type were Nasal swab. The patient did not receive any treatment for the event. The patient did not receive any other vaccines in four weeks. Patient received other medications in two weeks was Metformin. Outcome of the event was recovered on unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Glossodynia, Headache, Oral fungal infection, Tongue disorder
Clinical narrative: Said it felt sore until today; His tongue is really red and it is stinging; Lost his taste; His tongue started to hurt; Bad headache; Tongue turned bright red; His doctor believes that his tongue has a yeast infection; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6206 and expiration date: Not available), via an unspecified route of administration in the right upper arm on 08Mar2021 as a single dose for COVID-19 immunisation. The patients medical history included heart problems, cirrhosis of the liver, has less than 50% of his lung capacity, high blood pressure and high cholesterol, cancer and 3 heart attacks and he is on pace maker. The patients family history included heart attack, cancer, heart failures, lung cancer, heavy smokers, acute respiratory failure, his sister died undergoing a cardio test, his brother had rheumatic fever and everything. The patient had no prior vaccine in 4 weeks. On 08Mar2021, the patient experienced slight headache on the day of vaccination and on 09Mar2021, he had a bad headache. On 11Mar2021, the patients tongue started to hurt and on 12Mar2021, his tongue is really red, and it is stinging. In 2021, his doctor believes that his tongue has a yeast infection. The events did not result in a visit to Emergency Room or Physician Office. The clinical outcome of the event bad headache was Recovered/Resolved, the patients tongue started to hurt, and his tongue is really red and it is stinging was Not Recovered/Not Resolved, whereas for other events it was unknown. The patient wanted to know if this is a normal reaction to the vaccine or if the vaccine interacted with some of the medications he is currently taking. Consumer said that some of his medications give him a dry mouth, so he wants to know if the vaccine somehow interacted with his medications. He has been through pandemics before, he remembers the swine flu. He had to see a doctor over there and he was asked if he had ever had any problems with vaccines before and he said that when he took the swine flu vaccine, shortly after he doze out, he didn't ever pass out, but he did run off the road because he was dizzy.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Tongue erythema
Clinical narrative: Said it felt sore until today; His tongue is really red and it is stinging; Lost his taste; His tongue started to hurt; Bad headache; Tongue turned bright red; His doctor believes that his tongue has a yeast infection; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6206 and expiration date: Not available), via an unspecified route of administration in the right upper arm on 08Mar2021 as a single dose for COVID-19 immunisation. The patients medical history included heart problems, cirrhosis of the liver, has less than 50% of his lung capacity, high blood pressure and high cholesterol, cancer and 3 heart attacks and he is on pace maker. The patients family history included heart attack, cancer, heart failures, lung cancer, heavy smokers, acute respiratory failure, his sister died undergoing a cardio test, his brother had rheumatic fever and everything. The patient had no prior vaccine in 4 weeks. On 08Mar2021, the patient experienced slight headache on the day of vaccination and on 09Mar2021, he had a bad headache. On 11Mar2021, the patients tongue started to hurt and on 12Mar2021, his tongue is really red, and it is stinging. In 2021, his doctor believes that his tongue has a yeast infection. The events did not result in a visit to Emergency Room or Physician Office. The clinical outcome of the event bad headache was Recovered/Resolved, the patients tongue started to hurt, and his tongue is really red and it is stinging was Not Recovered/Not Resolved, whereas for other events it was unknown. The patient wanted to know if this is a normal reaction to the vaccine or if the vaccine interacted with some of the medications he is currently taking. Consumer said that some of his medications give him a dry mouth, so he wants to know if the vaccine somehow interacted with his medications. He has been through pandemics before, he remembers the swine flu. He had to see a doctor over there and he was asked if he had ever had any problems with vaccines before and he said that when he took the swine flu vaccine, shortly after he doze out, he didn't ever pass out, but he did run off the road because he was dizzy.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombophlebitis superficial
Clinical narrative: diagnosed with a superficial venous thrombosis in my lower extremity; This is a spontaneous report from a contactable Nurse (patient). A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Jan2021 (Batch/Lot Number: EL0142) as SINGLE DOSE for covid-19 immunisation, at 32 years old. The patient's other medical history was not reported. Patient has no known allergies. The patient is not pregnant. The patient previously received the first dose of bnt162b2 on 18Dec2020, administered in left arm (Lot number LH9899) for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. Patient has no COVID prior vaccination. Patient was not tested for COVID post vaccination. There were no concomitant medications. The patient was diagnosed with a superficial venous thrombosis in the lower extremity on 19Feb2021. The patient has no known risk factor for the event. Therapeutic measures were taken which included ELIQUIS. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of the event was recovered with sequelae (recovered with lasting effects) on an unspecified date.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site pruritus, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: rash was bigger, swollen, itchy, and extremely painful; Extreme fatigue and a lot of pain on the arm where the vaccine was given; Extreme fatigue and a lot of pain on the arm where the vaccine was given; itching, hot, small rash in the area of where the vaccine was given; itching, hot, small rash in the area of where the vaccine was given; itching, hot, small rash in the area of where the vaccine was given; This is a spontaneous report received from a contactable consumer or other non hcp. A 32-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 09:00 as single dose for COVID-19 immunization. Medical history included asthma and allergies (Penicillin), COVID-19, drug hypersensitivity, hypersensitivity and thyroid disorder (had thyroid issues about 7 years ago but that was resolved and have not had problems with thyroid for years now) from an unknown date and unknown if ongoing. Probiotics were given on every other day. The patient had COVID-19 prior vaccination. On 11Mar2021 patient experienced extreme fatigue and a lot of pain on the arm where the vaccine was given (fatigue and vaccination site pain), itching, hot, small rash in the area of where the vaccine was given (injection site pruritus, vaccination site warmth and vaccination site rash). On 12Mar2021 rash was bigger, swollen, itchy, and extremely painful. The patient visited Urgent case. Treatment was given with Steroid shot, antibiotics and an ointment. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site warmth
Clinical narrative: rash was bigger, swollen, itchy, and extremely painful; Extreme fatigue and a lot of pain on the arm where the vaccine was given; Extreme fatigue and a lot of pain on the arm where the vaccine was given; itching, hot, small rash in the area of where the vaccine was given; itching, hot, small rash in the area of where the vaccine was given; itching, hot, small rash in the area of where the vaccine was given; This is a spontaneous report received from a contactable consumer or other non hcp. A 32-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 09:00 as single dose for COVID-19 immunization. Medical history included asthma and allergies (Penicillin), COVID-19, drug hypersensitivity, hypersensitivity and thyroid disorder (had thyroid issues about 7 years ago but that was resolved and have not had problems with thyroid for years now) from an unknown date and unknown if ongoing. Probiotics were given on every other day. The patient had COVID-19 prior vaccination. On 11Mar2021 patient experienced extreme fatigue and a lot of pain on the arm where the vaccine was given (fatigue and vaccination site pain), itching, hot, small rash in the area of where the vaccine was given (injection site pruritus, vaccination site warmth and vaccination site rash). On 12Mar2021 rash was bigger, swollen, itchy, and extremely painful. The patient visited Urgent case. Treatment was given with Steroid shot, antibiotics and an ointment. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Pain
Clinical narrative: rash was bigger, swollen, itchy, and extremely painful; Extreme fatigue and a lot of pain on the arm where the vaccine was given; Extreme fatigue and a lot of pain on the arm where the vaccine was given; itching, hot, small rash in the area of where the vaccine was given; itching, hot, small rash in the area of where the vaccine was given; itching, hot, small rash in the area of where the vaccine was given; This is a spontaneous report received from a contactable consumer or other non hcp. A 32-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 09:00 as single dose for COVID-19 immunization. Medical history included asthma and allergies (Penicillin), COVID-19, drug hypersensitivity, hypersensitivity and thyroid disorder (had thyroid issues about 7 years ago but that was resolved and have not had problems with thyroid for years now) from an unknown date and unknown if ongoing. Probiotics were given on every other day. The patient had COVID-19 prior vaccination. On 11Mar2021 patient experienced extreme fatigue and a lot of pain on the arm where the vaccine was given (fatigue and vaccination site pain), itching, hot, small rash in the area of where the vaccine was given (injection site pruritus, vaccination site warmth and vaccination site rash). On 12Mar2021 rash was bigger, swollen, itchy, and extremely painful. The patient visited Urgent case. Treatment was given with Steroid shot, antibiotics and an ointment. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 87.0
Sex: U
Vaccine: COVID19
Symptoms: Joint swelling, Pain, Pyrexia
Clinical narrative: Soreness; Fever; Right elbow swelled up like a sac of fluid is in my elbow; It is quite a large lump and and size is more closer to a tennis ball; It is three-quarter of size of a tennis ball and it is full of fluid; This is a spontaneous report from a contactable consumer. An 87-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in Arm Left on an unspecified date,single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included atenolol, other medicines were itch medicine, thinks it is 'Hydrocortisone', patient doesn't remember the name of it (consumer was not sure) and patient uses inhaler, it is 'Dulera', twice a day and  'Hydroxyzine' or whatever it is , it is also twice a day (not clarified). Patient had soreness and fever or whatever and all of a sudden, patient thinks on March 6th (not clarified), patient's right elbow swelled up like a sac of fluid is in my elbow. Patient doesn't know if it is related. After two days, patient started getting swelling in my right elbow. Patient got the shot in left arm but the swelling is in my right elbow. It is just unusual patient never had anything like this. It is almost like I don't know like there is  water inside or whatever it is, it is quite a large lump and and size is more closer to a tennis ball but it is not that large. It is like the size of a tennis ball and it is on my right elbow. Patient tried to see doctor today but patient never experienced anything like so patient doesn't know what is going to happen. It is persisting, it just swelled up like its not large as of tennis ball but it is three-quarter of size of a tennis ball and it is full of fluid. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Tendonitis
Clinical narrative: swelling in my elbow, like tendonitis, red and painful. It is not related to the vaccine. I get this tendonitis sometimes; swelling in my elbow, like tendonitis, red and painful. It is not related to the vaccine. I get this tendonitis sometimes; swelling in my elbow, like tendonitis, red and painful. It is not related to the vaccine. I get this tendonitis sometimes; This is a spontaneous report from contactable consumer (Patient) via Pfizer sponsored program COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced swelling in her elbow was not related to the Pfizer vaccine she received. Also experienced swelling in my elbow, like tendonitis, red and painful. It is not related to the vaccine. I get this tendonitis sometimes." She is due for her 2nd Pfizer vaccine dose on 23Mar2021. The outcome of event was unknown.  Information on product lot/batch is requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Vision blurred
Clinical narrative: is seeing double; left eye was really blurry; This is a spontaneous report from  contactable consumer (patient). A 74-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202) on 09Mar2021 at 12:00 (at the age of 74 years) at a single dose in the arm right for COVID-19 immunization. Medical history included ongoing high blood pressure diagnosed 5-6 months ago. Concomitant medication included amlodipine taken for high blood pressure from an unspecified start date and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on an unspecified date, patient was driving to get kids from school and all of a sudden he is seeing double. Also, on 10Mar2021 at 13:30, patient's left eye was really blurry. Stated blurriness had kind of cleared up before went to bed and woke up and it was still blurry. Stated it happens from a distance. Stated that if he covers his left eye that it goes away. The outcome of the events was not recovered.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatic enzyme, Hepatic enzyme increased
Clinical narrative: elevation of liver enzymes; This is a spontaneous report from a contactable physician. A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 08Jan2021 (at the age of 71years) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an 19Jan2021, the patient experienced elevation of liver enzymes in the absence of other contributing factors which then normalized on further check on 22Feb2021. The outcome of event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia, SARS-CoV-2 test, Swollen tongue
Clinical narrative: Loss of taste; a metallic taste; Swollen tongue; This is a spontaneous report from a contactable pharmacist. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 26Feb2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient developed loss of taste and swollen tongue that has persisted post first dose of the vaccine on 26Feb2021. The loss of taste started as a metallic taste and couple of days later progressed to a loss of taste. The patient has been tested twice and both negative for COVID-19 on unspecified dates in 2021. As of 14Mar2021, the symptoms have started improving, which is about 3 weeks post dose and it is mostly gone now. The clinical outcomes of swollen tongue loss of taste and a metallic taste were resolving.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: next day, my wife went to the hospital and found out she had covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Husband) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via an unspecified route of administration on 25Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The next day, the reporter stated that my wife went to the hospital and found out she had covid on 26Jan2021. The outcome of event was unknown.   No follow up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Pain
Clinical narrative: Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) second dose via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 was unknown. The patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise on same day of second shot. It was reported that No treatment was given to patient. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; Patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) second dose via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 was unknown. The patient experienced sore arm, fatigue, fever (99.9), chills, headache, body ache, and generalized malaise on same day of second shot. It was reported that No treatment was given to patient. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Ear infection
Clinical narrative: I have gotten an ear infections hours after both shots; This is a spontaneous report received from a contactable consumer (Patient himself) via Pfizer sponsored program.  A patient of unspecified age and gender received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number: UNKNOWN), via unspecified route on 12Feb2021 as a SINGLE DOSE for COVID-19 immunisation and on 12Mar2021, the patient received second dose of BNT162B2 (COMIRNATY, Lot number: unknown), via unspecified route as a SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient gotten an ear infections hours after both shots and reported that just interesting data and would take busters but really hate having the infection. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Ear infection
Clinical narrative: I have gotten an ear infections hours after both shots; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on 12Mar2021 as single dose and was previously administered the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 12Feb2021 as single dose for Covid-19 immunization. Patients medical history and concomitant medications were not reported. Patient had both the COVID vaccination. Patient experienced ear infections hours after both shots. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: throat itching; This is a spontaneous report from a contactable physician.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Mar2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced throat itching on 17Mar2021. Patient had reaction about 15 minutes after getting the shot. The patient had throat itching and systematic stuff. Reporter stated his question is if the patient is allergic to what is in the base of vaccine. The outcome of the event was unknown.   No follow-up attempts are possible. Information regarding batch/lot number could not be requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Influenza, Malaise, Nausea, Pain
Clinical narrative: achy; not feeling well, overall feeling unwell; flu symptoms; nausea; joint pain; arm is a little sore; This is a spontaneous report from a contactable consumer, the patient. This 70-year-old female patient of received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration on 15Mar2021 "between 12:20 - 12:30" (at the age of 70-year-old) as single dose for COVID-19 immunization. Medical history included thyroid removal due to thyroid cancer when she was 32-34 years old, shingles, broken rib on chest X-ray, and hearing problem. The patient also stated that she doesn't have a spleen, so she is very sensitive to ASPIRIN (acetylsalicylic acid). Concomitant medications included valaciclovir hydrochloride (VALTREX S) 7 days treatment for shingles, and levothyroxine (manufacturer unknown). The patient previously took the influenza vaccine on 28Nov2020, then 9 days later (Dec2020) she thought she was having a heart attack and went by EMS to the hospital where they checked her for a heart attack but it was negative and she also got an echocardiogram that was negative. She was diagnosed with costochondritis ten days after getting the Flu shot. She took ibuprofen (MOTRIN) about a month for costochondritis and it made her blood pressure go up, so she was off it. On 15Mar2021, the patient reported that she was feeling fine after her first dose of COVID vaccine. She stated even her arm is a little sore (in Mar2021). Until 14:00 on 17Mar2021, the patient reported not feeling well, experiencing overall feeling unwell, flu symptoms, nausea and joint pain. Later, she also stated feels like she is coming down with the flu now and has joint pain, though she doesn't have a fever, and she is achy. The clinical outcomes of the feeling unwell, flu symptoms, nausea, joint pain, achy and arm is a little sore were not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: achy; not feeling well, overall feeling unwell; flu symptoms; nausea; joint pain; arm is a little sore; This is a spontaneous report from a contactable consumer, the patient. This 70-year-old female patient of received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration on 15Mar2021 "between 12:20 - 12:30" (at the age of 70-year-old) as single dose for COVID-19 immunization. Medical history included thyroid removal due to thyroid cancer when she was 32-34 years old, shingles, broken rib on chest X-ray, and hearing problem. The patient also stated that she doesn't have a spleen, so she is very sensitive to ASPIRIN (acetylsalicylic acid). Concomitant medications included valaciclovir hydrochloride (VALTREX S) 7 days treatment for shingles, and levothyroxine (manufacturer unknown). The patient previously took the influenza vaccine on 28Nov2020, then 9 days later (Dec2020) she thought she was having a heart attack and went by EMS to the hospital where they checked her for a heart attack but it was negative and she also got an echocardiogram that was negative. She was diagnosed with costochondritis ten days after getting the Flu shot. She took ibuprofen (MOTRIN) about a month for costochondritis and it made her blood pressure go up, so she was off it. On 15Mar2021, the patient reported that she was feeling fine after her first dose of COVID vaccine. She stated even her arm is a little sore (in Mar2021). Until 14:00 on 17Mar2021, the patient reported not feeling well, experiencing overall feeling unwell, flu symptoms, nausea and joint pain. Later, she also stated feels like she is coming down with the flu now and has joint pain, though she doesn't have a fever, and she is achy. The clinical outcomes of the feeling unwell, flu symptoms, nausea, joint pain, achy and arm is a little sore were not reported.