chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cough, Dizziness, Fatigue, Headache
Clinical narrative: Fever; Cough; Backache; Headache; Nausea; dizziness; pain in the right hand; Tiredness; This is a spontaneous report from a Contactable Consumer (patient). A 58-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), at 58 years of age, via an unspecified route of administration on 24Feb2021 16:30 at single dose, in right arm for COVID-19 immunisation. The patient medical history included type 2 diabetes, high blood pressure, factor 5 leiden. Patient was had allergic reaction with cephalexin, tramadol, ibuprofin, peanuts. Concomitant medication included Bactrim (SULFAMETHOXAZOLE, TRIMETHOPRIM). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), at 58 years of age, via an unspecified route of administration on 03Feb2021 16:15 at single dose, in right arm for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 24Feb2021 19:00, the patient experienced fever, cough, backache, headache, nausea, dizziness, pain in the right hand and tiredness. The events were considered as non-serious. No treatment was given for the events. The outcome of all the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever; Cough; Backache; Headache; Nausea; dizziness; pain in the right hand; Tiredness; This is a spontaneous report from a Contactable Consumer (patient). A 58-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), at 58 years of age, via an unspecified route of administration on 24Feb2021 16:30 at single dose, in right arm for COVID-19 immunisation. The patient medical history included type 2 diabetes, high blood pressure, factor 5 leiden. Patient was had allergic reaction with cephalexin, tramadol, ibuprofin, peanuts. Concomitant medication included Bactrim (SULFAMETHOXAZOLE, TRIMETHOPRIM). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), at 58 years of age, via an unspecified route of administration on 03Feb2021 16:15 at single dose, in right arm for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 24Feb2021 19:00, the patient experienced fever, cough, backache, headache, nausea, dizziness, pain in the right hand and tiredness. The events were considered as non-serious. No treatment was given for the events. The outcome of all the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: COVID-19; This is a spontaneous report from a contactable consumer. A 55-year-old male patient 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 23-FEB-2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications wee not reported. Subsequently began feeling ill on Sunday and went in on Monday 01Mar2021 tested positive to COVID-19 and the patient was scheduled for second dose on 16 Mar 2021 and caller asked what should he do about second dose. The outcome of the events were unknown.   Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: I woke up the following morning and my eyesight was slightly blurry.  Need new glasses as a result.; This is a spontaneous report from a contactable consumer or other non hcp. A 66-year-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 17:45 as SINGLE DOSE for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing Known allergies: Tea tree oil. On 26Feb2021 08:00, the patient experienced i woke up the following morning and my eyesight was slightly blurry, need new glasses as a result. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was not recovered.  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: received the first dose of the pfizer covid 19 vaccine and then got covid 7-8 days after; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient received the first dose of the pfizer covid 19 vaccine and then got COVID 7-8 days after on an unspecified date. He and his wife received a viral cocktail. The caller wanted to know if it is recommended to wait 90 days for the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on got COVID 7-8 days after. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: Tested COVID Positive; Tested COVID Positive; got sick; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported for herself that:     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 09Feb2021  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 tested covid positive, tested covid positive on Feb2021  got sick on Feb2021   The patient underwent lab tests and procedures which included sars-cov-2 test: positive   on 2021 Received the first dose on 29Feb2021 then got sick after 5 days, caller took the rapid test and Tested COVID Positive. 2nd dose will be on 02Mar2021 (21st day). Caller is asking if the Vaccination date can be moved due to having a weak body for still being sick due to COVID.The events were assessed as serious (medically significant) by health authority and outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 25Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Mar2021 patient had sars-cov-2 test and she tested positive for COVID. She was positive that it was not from the vaccine. The event considered as medically significant. She was wondering if she can receive the second dose on 18Mar2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive rapid COVID test; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 25Feb2021 at about 10:30 AM (Batch/Lot number and expiry date were not reported) at the age of 61-years-old at a single dose for COVID-19 immunisation. The patient took COVID-19 vaccine because she has health conditions and didn't want to end up in the hospital. The vaccination facility type was pharmacy. Medical history included chronic obstructive pulmonary disease (COPD), thyroid issues, high blood pressure, atrial fibrillation (AFib), central origin vertigo, low potassium levels, chronic kidney disease, history of deep vein thrombosis (DVT) and pulmonary embolism. Other medical condition was also reported as "They have it down as Lupus, but it is really F Factor Five." Concomitant medications included pantoprazole sodium EC for an unspecified indication; lisdexamfetamine mesilate (VYVANSE) for an unspecified indication; apixaban (ELIQUIS) for history of DVT and pulmonary embolism that went to her lung, heart, and legs; potassium chloride ER for an unspecified indication; hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) for an unspecified indication; levothyroxine sodium for thyroid; acetylsalicylic acid (ASPIRIN) for an unspecified indication; amlodipine for high blood pressure; metoprolol succinate ER for blood pressure; furosemide as water pill; clonazepam for central origin vertigo; atorvastatin calcium for an unspecified indication; famotidine for stomach; fluticasone propionate, salmeterol xinafoate (ADVAIR) for COPD; all start and stop dates were not reported. The patient got her first Pfizer shot on 25Feb2021. She had a positive rapid COVID test on 02Mar2021. Second dose will be on 18Mar2021. She wanted to know if she should take that dose on 18Mar2021. She clarified the product as Pfizer COVID-19 vaccine. She didn't have a vaccination card to provide NDC, lot, and expiry. She didn't think she got COVID from the shot. She thinks it was from an exposure. She clarified that she wants information about second dose of COVID-19 vaccine after receiving the first dose and testing positive for COVID. There was no history of previous immunization with the Pfizer vaccine, no additional vaccines administered on same date and no prior vaccinations (within 4 weeks). The rapid test was done and also a sendoff COVID test. She doesn't have the results for the long one yet. The patient reported that she tested positive for COVID after receiving vaccine and she wanted to know if she should still get second dose at the appropriate time of 3 weeks after the first dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Diarrhea; Exhaustion; This is a spontaneous report from a contactable consumer.  A 84-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9809), via an unspecified route of administration on 10Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and Concomitant medications was not reported. the patient had vaccine on 10Feb202 and had minor symptoms 2 days after the shot and then had total exhaustion for 3 days now and had diarrhea. The outcome of event diarrhea was not recovered, whereas outcome of event exhaustion was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Peripheral coldness, Vomiting
Clinical narrative: Severe Dizziness; cold extremities; Nausea; vomiting; headache; This is a spontaneous report from a contactable consumer (patient).  A 73-years-old female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 vaccine), via an unspecified route of administration, administered in left arm on 28Feb2021 15:30 (Lot Number: Not reported) as single dose for COVID-19 immunization.  Medical history included medication for high blood pressure from an unknown date. Concomitant medication(s) included Verapamil, Fenofibrate; acetylsalicylic acid (ASPIRIN) and multi-vitamin. No known allergies had been reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Mar2021 23:00, the patient experienced severe dizziness, nausea, vomiting, headache and reported about cold extremities with sudden onset. The patient went to doctor or other healthcare professional office/clinic visit for these events. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID-19. No corrective measures were taken for the reported events. The event outcome was reported as unknown for the reported events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Injection site pain; Tiredness; Headache; Chills; Fever was 101.6; Injection site redness; Nausea; Not feeling well; Felt bad; Weakness; Soreness arm; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 21Feb2021 at single dose for COVID-19 immunisation. Medical history included Pulmonary hypertension and high blood pressure from an unknown date and unknown if ongoing. Patient previously took first dose of vaccine for Covid-19 immunisation. Concomitant medication not reported. When probed for the concern, consumer stated, "I was just calling to pass on my experience with the second vaccine. I ended up having all of the side effects that you had listed. I have injection site pain and redness and it still is as up today and I had the injection on Tuesday (23Feb2021). I had tiredness, headache, chills, fever and my fever was 101.6, injection site redness, nausea and basically not feeling well and I also had some weakness and I think that was because, I mean I felt so bad I was pretty much in bed and today is my first day up since Tuesday." The patient underwent lab tests and procedures on unspecified date which included Body temperature: 101.6. The outcome of the events Injection site redness, Soreness arm was reported as not recovered and outcome for other events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Malaise, Nausea, Pain in extremity
Clinical narrative: Injection site pain; Tiredness; Headache; Chills; Fever was 101.6; Injection site redness; Nausea; Not feeling well; Felt bad; Weakness; Soreness arm; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 21Feb2021 at single dose for COVID-19 immunisation. Medical history included Pulmonary hypertension and high blood pressure from an unknown date and unknown if ongoing. Patient previously took first dose of vaccine for Covid-19 immunisation. Concomitant medication not reported. When probed for the concern, consumer stated, "I was just calling to pass on my experience with the second vaccine. I ended up having all of the side effects that you had listed. I have injection site pain and redness and it still is as up today and I had the injection on Tuesday (23Feb2021). I had tiredness, headache, chills, fever and my fever was 101.6, injection site redness, nausea and basically not feeling well and I also had some weakness and I think that was because, I mean I felt so bad I was pretty much in bed and today is my first day up since Tuesday." The patient underwent lab tests and procedures on unspecified date which included Body temperature: 101.6. The outcome of the events Injection site redness, Soreness arm was reported as not recovered and outcome for other events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Injection site pain; Tiredness; Headache; Chills; Fever was 101.6; Injection site redness; Nausea; Not feeling well; Felt bad; Weakness; Soreness arm; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 21Feb2021 at single dose for COVID-19 immunisation. Medical history included Pulmonary hypertension and high blood pressure from an unknown date and unknown if ongoing. Patient previously took first dose of vaccine for Covid-19 immunisation. Concomitant medication not reported. When probed for the concern, consumer stated, "I was just calling to pass on my experience with the second vaccine. I ended up having all of the side effects that you had listed. I have injection site pain and redness and it still is as up today and I had the injection on Tuesday (23Feb2021). I had tiredness, headache, chills, fever and my fever was 101.6, injection site redness, nausea and basically not feeling well and I also had some weakness and I think that was because, I mean I felt so bad I was pretty much in bed and today is my first day up since Tuesday." The patient underwent lab tests and procedures on unspecified date which included Body temperature: 101.6. The outcome of the events Injection site redness, Soreness arm was reported as not recovered and outcome for other events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: Tiredness/was in bed most of the time for two days, but was up some. She was awfully tired; slept a lot; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 15Jan2021 (Batch/Lot Number: EL8982) as single dose for covid-19 immunisation.The patient medical history was not reported. It was reported that she is on high blood pressure medication. It was reported that she had chemo years ago. She dont have no product name or NDC/Lot/exp to provide. The patient's concomitant medications were not reported. On an unspecified date the patient experienced tiredness/was in bed most of the time for two days , but was up some. she was awfully tired and slept a lot. The events were considered as non-serious. She had first dose of COVID vaccine on 15Jan2021. She was in bed most of the time for two days, but was up some. She was awfully tired. She guesses she slept a lot. This was from 2PM to 9PM. It was reported that tiredness, she didn't pay too much attention to when it started. Forgot what time of the day it was. She did ok up until she went to bed and then slept. She slept a lot the next day. The COVID vaccine is the first shot she has had a problem with. The outcome of the events was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse reaction, Asthenia, Eating disorder symptom, Fatigue, Hypersomnia
Clinical narrative: Tiredness/was in bed most of the time for two days, but was up some. She was awfully tired; slept a lot; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 15Jan2021 (Batch/Lot Number: EL8982) as single dose for covid-19 immunisation.The patient medical history was not reported. It was reported that she is on high blood pressure medication. It was reported that she had chemo years ago. She dont have no product name or NDC/Lot/exp to provide. The patient's concomitant medications were not reported. On an unspecified date the patient experienced tiredness/was in bed most of the time for two days , but was up some. she was awfully tired and slept a lot. The events were considered as non-serious. She had first dose of COVID vaccine on 15Jan2021. She was in bed most of the time for two days, but was up some. She was awfully tired. She guesses she slept a lot. This was from 2PM to 9PM. It was reported that tiredness, she didn't pay too much attention to when it started. Forgot what time of the day it was. She did ok up until she went to bed and then slept. She slept a lot the next day. The COVID vaccine is the first shot she has had a problem with. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams
Clinical narrative: unusual dream; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the 2nd of two reports. This consumer reported for (his friends wife) that a female patient of an unspecified age received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose and was previously administered first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) 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. Reporter stated that the second night after the second shot he had a dream that someone or something had ahold of him three different times trying to pull him somewhere he didn't want to go. He had a phone call from a friend of him two weeks later. He said his wife and he had recently had the Covid shot and asked if he had any reaction. Reporter said no and asked if they had reactions. He said no. But he told him of his unusual dream. He said the second or third night after the second shot his wife woke up screaming and related to him that someone had ahold of her and was trying to drag her somewhere. Reporter was wondering as it was very unusual to have the same type of dream shortly after the second shot. Event abnormal dreams was considered non-serious as reported. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : PFIZER INC-2021216334 same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable female consumer (patient) received from 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 24Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced running a little fever on an unspecified date. Patient wants to know if she can take Advil for medication. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was unknown. Information about lot/ batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Heart rate normal, Vaccination site pain
Clinical narrative: Only has a little pain on my arm where I was given the shot; This is a spontaneous report from a contactable consumer reported for herself in response to Non-HCP letter sent in cross reference case. A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included heart rate increased, blood cholesterol increased, hypertension from an unknown date and unknown if ongoing. Concomitant medications included ongoing metoprolol 25mg, twice daily, lisinopril 5mg once daily from Jun2020 for hypertension, ongoing atorvastatin (LIPITOR (ATORVASTATIN) 20 mg once daily from Jun2020 for blood cholesterol increased, ongoing levothyroxine, diphenhydramine hydrochloride (BENADRYL) from an unknown date to unknown date for unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration (Lot number: EL9261) as SINGLE DOSE for covid-19 immunisation causes rapid heartbeat was monitored, it keep going up and down/went to the emergency room. The patient only has a little pain on my arm where i was given the shot on an unspecified date. Drank a lot of water before after shot, Nurse suggested taking Benadryl after the shot which I did and had no reaction. The patient underwent lab tests and procedures which included heart rate increased: 135-120-110 bpm (Normal BPM 55-65 was up to 135-120-110 etc after vaccine (1st shot)), heart rate normal: 55-65 bpm (Normal BPM 55-65). The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.  Information about batch/lot number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Myalgia, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 15:00 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included type 2 diabetes, thyroid cancer, ovarian cancer from an unknown date and unknown if ongoing. Concomitant medications included metformin, glipizide, levothyroxine, omeprazole. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Feb2021 15:15 (Batch/Lot Number: EL9265) as SINGLE DOSE for COVID-19 immunization. On 29Jan2021 22:30, The patient experienced severe fatigue, nausea, vertigo, muscle aches, lack of appetite, diarrhea, vomiting and soreness at injection site. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vertigo, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 15:00 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included type 2 diabetes, thyroid cancer, ovarian cancer from an unknown date and unknown if ongoing. Concomitant medications included metformin, glipizide, levothyroxine, omeprazole. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Feb2021 15:15 (Batch/Lot Number: EL9265) as SINGLE DOSE for COVID-19 immunization. On 29Jan2021 22:30, The patient experienced severe fatigue, nausea, vertigo, muscle aches, lack of appetite, diarrhea, vomiting and soreness at injection site. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This is a spontaneous report from a contactable Pharmacist reported in response to HCP letter sent in cross reference case. A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 intramuscular, administered in Deltoid Left on 09Jan2021 16:45 (Batch/Lot Number: EL3249; Expiration Date: 31May2021) as SINGLE DOSE for covid-19 immunisation and Prevention of SARS-COV-2 at Hospital. patient medical history and concomitant medications were not reported. The patient experienced arm pain on 09Jan2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient had the first dose of Pfizer's COVID vaccine in December and got COVID; patient had the first dose of Pfizer's COVID vaccine in December and got COVID; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on dec2020 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She got COVID. She was asking if she would be able to get the second dose next week. The events got COVID and drug ineffective were assessed as medical significant with outcome unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: Based on the information currently available, lack of efficacy of the vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. The case will be reevaluated should additional information become available.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: he might have been exposed to Covid around the same time as getting the vaccine; This is a spontaneous report received from a contactable consumer (reporting for himself). A 54-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number Expiry date was not reported), via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunization. The patient medical history was and concomitant medications were not reported. It was reported that patient received his first dose of the BNT162B2 03Mar2021 and then found out the on 04Mar2021 that he might have been exposed to Covid around the same time as getting the vaccine. He wants to know if he can get the second dose of the vaccine since this has happened. Can this affect the vaccine and can he get the second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: temperature went up to 98.2 Celsius.; like headache, body ache and flu; headache; body ache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself. A female of unspecified age 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 09 Feb 2021, as a single dose for COVID-19 immunisation. The patient medical history included flu shot on 17Nov2020. Concomitant medications were not reported. After the first dose the patient experienced headache, body ache & flu she said her temperature went up to 98.2 Celsius. Patient scheduled for 2nd dose on 02Mar. At the time reporting, the outcome of the events were unknown.  No follow up attempts are possible. Information about lot/ batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: she had cold and tested positive on the day she is scheduled for her second; she had cold and tested positive on the day she is scheduled for her second; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program. CEP ID: 159558  A female patient of an unspecified age received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, solution for injection, Lot No unknown), via an unspecified route of administration on 04Feb2021 as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Feb2021 (on the day she is scheduled for her second), patient experienced cold and tested positive. The patient underwent lab test which included SARS-CoV-2 test: Positive on 25Feb2021. The patient stated that stated she came out of quarantine on 06Mar2021 (Saturday). The patient was advised that she was not allowed to take the second dose because of her cold. Patient asked if she could get the second dose now since she no longer has cold. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Flatulence, Gastrointestinal pain, Malaise, Pain, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 67-year-old female patient received BNT162B2 (COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, in her left arm on 24Feb2021 12:00PM (Batch/Lot Number: EN62026/21) (at the age of 67-years-old) as single dose for covid-19 immunisation. The patient medical history was reported as none and had no known allergies. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On the second day after the first vaccination dose (on 26Feb2021), the patient experienced pain throughout the GI system, sharp pain, swelling, gassy of course and all around feeling ill. It lasted for about 24 hours. The onset occurred on the second day after the 1st vaccine dose. No treatment was given for the events. The outcome of the events was recovered on an unknown date in Feb2021. No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Influenza, SARS-CoV-2 test
Clinical narrative: got her first dose on 11Feb2021 and Tested positive; got her first dose on 11Feb2021 and Tested positive; Influenza Type A; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunization and Tested positive but wants to know if she can still continue to get her second dose as per schedule on 04Mar2021. As she was diagnosed with Influenza She wants to know if she can go through and continue the 2nd appointment. Upon follow up on 26Feb2021 said as patient received COVID-19 Vaccine on 02Feb2021. The patient medical history and concomitant medications were not reported. The patient experienced got her first dose on 11feb2021 and tested positive (drug ineffective and sars-cov-2 test positive) and influenza type a on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test as positive on an unknown date. The outcome of the event was unknown.  Follow-up (05Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation date of 1st dose of vaccine (02Feb2021) which was previously reported as 11Feb2021 and confirmed that the 1st dose of her vaccine was on 11Feb2021.  Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got positive after done taking the 1st and 2nd dose of Pfizer Vaccine; got positive after done taking the 1st and 2nd dose of Pfizer Vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that an unspecified aged male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 for COVID-19 immunization. On an unspecified date it was reported as patient got positive after done taking the 1st and 2nd dose of Pfizer Vaccine. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a Pfizer Sponsored Program. An unspecified aged male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 20Feb2021 as a single dose for COVID-19 immunization. Patient medical history and concomitant medication were not reported. On an unspecified date the patient experienced COVID-19 positive (diagnosed on 25Jan2021)/received his dose last on 20Feb2021 and after a week on 27Feb2021 he experienced the feeling of tiredness. His second dose was supposed to be on 13Mar2021. The patient underwent lab tests and procedures which included COVID-19: Positive on 25Jan2021. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: got tested positive with Covid-19 today; got tested positive with Covid-19 today; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. An unspecified aged male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via unspecified route of administration on 15Feb2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medication was not reported. Consumer (patient) got his 1st dose on 15Feb2021 and his second dose schedules on 08Mar2021. Consumer would like to know if he needs to reschedule his second dose because he got tested positive with Covid-19 today. On 01Mar2021 the patient got tested positive with Covid-19 today. The patient underwent lab tests and procedures which included covid-19: positive on 01Mar2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Laboratory test abnormal
Clinical narrative: beta protein fractions slightly elevated; This is a spontaneous report from a contactable physician. A male patient (physician's friend) of an unspecified age received first and second both doses of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter states he was a physician, an infectious disease specialist, states a friend of his received both doses of Pfizer Covid vaccine, states his friend also routinely donates plasma, states for the last two times, the plasma center has informed him that his beta protein fraction is slightly elevated. Reporter wants to know if the mRNA vaccine causes the beta protein fractions to be slightly elevated. The patient underwent lab tests and procedures which included beta protein fractions slightly elevated. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Mass, Neoplasm
Clinical narrative: saw a lump on his heel that wasn't there before; a lump on his heel, it is swollen it happened right after the shot; he was walking with a limp/he couldn't walk out fine; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6199), via an unspecified route of administration on 04Mar2021 as single dose for COVID-19 immunisation/to stay alive and not get sick. There was no medical history and no concomitant medications. The patient reported that he received his first covid vaccine dose yesterday, he waited the 15 minutes which was recommended after getting the vaccine and when he got up to leave and walk out he felt like his sock had rolled up on his foot and he was walking with a limp on 04Mar2021. Patient reported that he took his shoe off and saw a lump on his heel that wasn't there before. His heel was bothering him so he checked to see if there was something stuck in his shoe like a rock or whatever and he found nothing and he kept walking and it was getting worse to he checked again and still found nothing and he was just curious, he has read all the paper work and cannot find anything with issues like this with a lump on his heel, it was swollen and it happened right after the shot. He asked if he was daydreaming or has there been anything like this with other people. He reported that he has never had this before and it was all of a sudden he walked in fine but he couldn't walk out fine, it was strange. Patient was asking if this was normal or something that has been reported. Outcome of events was not recovered.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood glucose, Blood glucose increased, Blood pressure measurement, Diplopia
Clinical narrative: sight problems; double vision issue; eyelid was drooping; high blood sugar; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 21Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. On Sunday, 21Feb2021, he got the second dose of Pfizer's COVID-19 vaccine, at night he started experiencing a reaction, he began having sight problems. He thought it would be temporary, so he went to bed (used slang), but on Monday he still had the double vision issue, he had problems in his vision, his eyelid was drooping, so he went to the emergency room at (Name). They determined he has double vision and right now his eyelid is completely drooped. He is very surprised after receiving the vaccine, he has low cholesterol and high blood sugar at 126, his blood pressure was 133-135. The patient underwent lab tests and procedures which included blood cholesterol: low on an unspecified date, blood glucose: 126 on an unspecified date, blood pressure measurement: 133-135 on an unspecified date. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Eyelid ptosis, Visual impairment
Clinical narrative: sight problems; double vision issue; eyelid was drooping; high blood sugar; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 21Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. On Sunday, 21Feb2021, he got the second dose of Pfizer's COVID-19 vaccine, at night he started experiencing a reaction, he began having sight problems. He thought it would be temporary, so he went to bed (used slang), but on Monday he still had the double vision issue, he had problems in his vision, his eyelid was drooping, so he went to the emergency room at (Name). They determined he has double vision and right now his eyelid is completely drooped. He is very surprised after receiving the vaccine, he has low cholesterol and high blood sugar at 126, his blood pressure was 133-135. The patient underwent lab tests and procedures which included blood cholesterol: low on an unspecified date, blood glucose: 126 on an unspecified date, blood pressure measurement: 133-135 on an unspecified date. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dysarthria
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A 69-year-old male patient 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 immunization. Medical history and concomitant medications were not reported. It was reported that patient has slurred speech and wants to know if this is a normal side effect. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. The patient of an unspecified age and gender received BNT162B2 (PFIZER COVID-19 VACCINE, Lot number: unknown) via an unspecified route of administration as a SINGLE DOSE on an unknown date, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient underwent an antibody test, and it came back negative. The outcome of the event of antibody test came back negative was not reported. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.