chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Diarrhoea, Loss of consciousness, Vomiting
Clinical narrative: Fainted; Diarrhoea; Feels weak; bone pain from falling; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Fainted) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Fainted) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea), ASTHENIA (Feels weak), BONE PAIN (bone pain from falling) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 19-Mar-2021, LOSS OF CONSCIOUSNESS (Fainted), DIARRHOEA (Diarrhoea), ASTHENIA (Feels weak), BONE PAIN (bone pain from falling) and VOMITING (Vomiting) had resolved.            Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 was not applicable.  Company Comment: This case concerns a 77-year-old female with a serious unexpected event of loss of consciousness, and nonserious unexpected diarrhoea, asthenia, bone pain and expected vomiting. Event latency 2 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 77-year-old female with a serious unexpected event of loss of consciousness, and nonserious unexpected diarrhoea, asthenia, bone pain and expected vomiting. Event latency 2 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild soreness in my left arm where the shot was administered; This is a spontaneous report from a contactable consumer (patient). A 26-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247) via an unspecified route of administration in the left arm on 03Feb2021 at 14:45 (at the age of 26-years-old) as single dose for COVID-19 immunization. Vaccination facility was a Workplace clinic. The patient had no medical history. The patient was not allergic to medications, food or other products. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. On 03Feb2021 at 08:00 PM (same day of vaccination), patient experienced mild soreness in left arm where the shot was administered. No treatment was received for the event. Since the vaccination, the patient not tested for COVID-19. The outcome of the event was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Chills, Condition aggravated, Malaise
Clinical narrative: I thought I felt better this morning and went to the gym, couldnt stay (didnt feel well); It is worsened when I got up this morning and right now I am staying the same; yesterday I was achy; chills; rash on front and back of feet and legs (below knees); red rash face (cheeks); body temperature was still down, it's cold/ Caller says her body temperature with thermal scanner is at 93 degrees; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EJ1686) via Intramuscular in arm on 02Feb2021 at 15:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid. Concomitant medication included levothyroxine for thyroid ongoing since 2014, fish oil, vitamin E NOS (Mega Red Omega - 3's) and calcium (ORGANIC PLANT CALCIUM) ongoing since 2018, colecalciferol (D3) and magnesium ongoing since 2019; calcium (GROW BONE CALCIUM) for strengthen from 19Jan2021 to 02Feb2021 and growth factors for bones from 19Jan2021 to 02Feb2021. Medication within two weeks included levothyroxine, Mega Red Omega - 3's, calcium(ORGANIC PLANT CALCIUM, GROW BONE CALCIUM), colecalciferol (D3) and magnesium and growth factors for bones. On 02Feb2021, the patient had a red rash on face (cheeks) and rash on front and back of feet and legs (below knees), body temperature was still down, it's cold. Patient's body temperature was done with thermal scanner was at 93 degrees. The thermal scanner at the gym was reading "low" and did not provide a temperature reading. Temperature has not been obtained any other manner. On 03Feb2021, patient was achy and had chills. On 04Feb2021, patient thought felt better and went to the gym, couldnt stay (didnt feel well). says (only thermal/oral reading not attempted). Patient was still experiencing the events, she was still cold and have the rash. It was worsened when got up this morning and right now staying the same. Patient was cold and just red. Patient went to bed last night with the rash and woke up this morning it was the same. Her body temperature was still down, it was cold. On unspecified date in Feb 2021, body temperature was 91. Patient had received second dose of vaccine (Batch/Lot number: EJ1686) via intramuscularly on 23Feb2021 at 10:30 as a single dose for COVID-19 immunisation. The outcome for event red rash face (cheeks), rash on front and back of feet and legs (below knees), body temperature was still down, it's cold was not recovered and for other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Rash erythematous
Clinical narrative: I thought I felt better this morning and went to the gym, couldnt stay (didnt feel well); It is worsened when I got up this morning and right now I am staying the same; yesterday I was achy; chills; rash on front and back of feet and legs (below knees); red rash face (cheeks); body temperature was still down, it's cold/ Caller says her body temperature with thermal scanner is at 93 degrees; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EJ1686) via Intramuscular in arm on 02Feb2021 at 15:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid. Concomitant medication included levothyroxine for thyroid ongoing since 2014, fish oil, vitamin E NOS (Mega Red Omega - 3's) and calcium (ORGANIC PLANT CALCIUM) ongoing since 2018, colecalciferol (D3) and magnesium ongoing since 2019; calcium (GROW BONE CALCIUM) for strengthen from 19Jan2021 to 02Feb2021 and growth factors for bones from 19Jan2021 to 02Feb2021. Medication within two weeks included levothyroxine, Mega Red Omega - 3's, calcium(ORGANIC PLANT CALCIUM, GROW BONE CALCIUM), colecalciferol (D3) and magnesium and growth factors for bones. On 02Feb2021, the patient had a red rash on face (cheeks) and rash on front and back of feet and legs (below knees), body temperature was still down, it's cold. Patient's body temperature was done with thermal scanner was at 93 degrees. The thermal scanner at the gym was reading "low" and did not provide a temperature reading. Temperature has not been obtained any other manner. On 03Feb2021, patient was achy and had chills. On 04Feb2021, patient thought felt better and went to the gym, couldnt stay (didnt feel well). says (only thermal/oral reading not attempted). Patient was still experiencing the events, she was still cold and have the rash. It was worsened when got up this morning and right now staying the same. Patient was cold and just red. Patient went to bed last night with the rash and woke up this morning it was the same. Her body temperature was still down, it was cold. On unspecified date in Feb 2021, body temperature was 91. Patient had received second dose of vaccine (Batch/Lot number: EJ1686) via intramuscularly on 23Feb2021 at 10:30 as a single dose for COVID-19 immunisation. The outcome for event red rash face (cheeks), rash on front and back of feet and legs (below knees), body temperature was still down, it's cold was not recovered and for other events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Caller diagnosed with a UTI following first vaccine dose; This is a spontaneous report from a Pfizer Sponsored Program from contactable female consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on an unknown date as 1st dose single dose for Covid-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, consumer reported that she was diagnosed with a UTI following first vaccine dose of Pfizer COVID-19 Vaccine and placed on an antibiotic. Her second covid vaccination dose was scheduled for next Wednesday on 10Feb2021 and she was worried about a possible interaction when taking the antibiotic and the covid vaccine together and asked should she stop her antibiotic or do she reschedule the second dose of the vaccine. Also Stated that the fact sheet said do not take any other vaccinations, but her doctor put her on this antibiotic. She had to go to the doctor because she had a UTI. She was starting on antibiotic Cefuroxime 500mg for 10 days for the UTI. The lady where they are having the vaccinations told patient that she could put her second dose of Pfizer COVID-19 Vaccine off until the 15th; that they had gotten something from Pfizer or CDC or somewhere that said the second dose of Pfizer COVID-19 Vaccine could go 5 days longer than the 21 days if necessary. She asked if that information was correct and will be taking her second dose of the vaccine next Wednesday.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Immunoglobulins abnormal
Clinical narrative: This is a spontaneous report from a contactable physician (patient). A male patient (physician) of an unspecified age reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose, and received second dose via an unspecified route of administration on an unspecified date (Lot number: Unknown and Expiration date: Unknown) as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received both doses of Pfizer-BioNTech COVID-19 Vaccine and 3 weeks later had an antibody test, the reason for that was because the patient had some Immunoglobulin deficiency; test came back negative. The patient had Immunoglobulin deficiency on an unspecified date. On an unspecified date, the patient underwent lab tests and procedures which included antibody test: negative. The outcome of the event was unknown. Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on his leg/also got it on his arm; This is a spontaneous report from a contactable consumer (patient).   A male patient of an unspecified age (59, units not provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He received his 1st shot of the COVID vaccine and 2nd dose was scheduled 22 days after. About 1-2 days after the 1st dose, on an unknown date, he developed a rash on his leg which looked like poison ivy, it was on his inner thigh. He also got it on his arm, then it got better but the rash on his leg was the same. Second shot was due today. He did not get a rash at the injection site. He would like to know if he should get the 2nd dose of the Pfizer COVID vaccine. He would like to know if there was any benefit from the 1st dose of the COVID vaccine if he delays the 2nd dose. The clinical outcome of the event was unknown.  Information on Lot/Batch has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (reporting on herself). A female patient of age 29 unit unspecified received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/lot number and Expired Date: was not reported) via unspecified route of administration, in Feb 2021 as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer-BioNtech COVID-19 vaccine on Monday (Feb 2021), today (Feb 2021) in the morning, she woke up with a rash on her stomach hand wrist. She would like to report the side effect and check if this was probably related to the vaccine. The outcome of the event was unknown. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Faeces soft
Clinical narrative: Patient has been experiencing soft and mushy stool for 8 days after getting the 2nd dose; Patient has been experiencing soft and mushy stool for 8 days after getting the 2nd dose; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age 68 (unit: unknown) received second dse of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd single dose for COVID-19 immunization. Patient's medical and concomitant medication history were not reported. The historical vaccine included 1st dose of BNT162B2. On an unspecified date, It was reported that, "patient has been experiencing soft and mushy stool for 8 days after getting the 2nd dose". Patient wants to know how soon after the 2nd dose will she be at 100 percent immunity. The outcome of the event was unknown.  Information on lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Pain in extremity, Rash, Vaccination site pain
Clinical narrative: getting a rash on her back; sore arm; She mentioned that she had a sore arm after the first shot; She was told by a nurse that she could take claritin, dimetapp, or tylenol before receiving her second dose, to help lessen the potential for side effects.; This is a spontaneous report from a contactable consumer or other non hcp.  A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265; Expiration Date: 31May2021)via an unspecified route of administration, administered in Left Arm on 28Jan2021 at 08:30 as First Dose, Single Dose COVID-19 immunization. The patient's medical history included shingles seven years ago, blood pressure abnormal, rheumatoid arthritis, hysterectomy at a young age and was put on Premarin. She was on a higher dose initially but is currently taking 0.3mg daily. When they have tried to take her off of Premarin she has a reaction. She is unsure if it is a reaction or mental. Product is filled in a pharmacy bottle. NDC, Lot and Expiry are not on the label. She has had shingles twice. Clarifies that her last episode was 10 years ago. She is due a Shingrix vaccine. Her physician says with her rheumatoid arthritis, taking Hydroxychloroquine and Covid he doesn't recommend that she get the Shingrix vaccine. No Patient's Medical History including any illness at time of vaccination. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN)Hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for blood pressure abnormal from 2011 and ongoing; hydroxychloroquine (HYDROXYCHLOROQUINE) taken for rheumatoid arthritis from Dec2019 and ongoing; estrogens conjugated (PREMARIN) taken for hysterectomy. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Prior Vaccinations within 4 weeks No Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient mentioned that she had a sore arm after the first shot from 28Jan2021 to 01Feb2021 and she was told by a nurse that she could take claritin, dimetapp, or tylenol before receiving her second dose, to help lessen the potential for side effects, she was getting a rash on her back from 04Feb2021 and ongoing. This started as a little circle under her shoulder blade. Is this a reaction to the vaccine or could it be shingles. No relevant tests were performed. The patient did not visit any Emergency or Physician office for the AEs. The outcome for the events was sore arm was recovered/resolved and the Rash was not recovered/not resolved and Unknown for rest of the events.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: she received her first dose, she experienced diarrhea; This is a spontaneous report from a contactable consumer (patient herself) received via Medical Information Team. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 25Jan2021 as an 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  On 26Jan2021, the 2nd day after receiving her first dose, she experienced diarrhea. The patient reported that 2nd dose of vaccine was scheduled on 22Feb2021. The outcome of the event was unknown.  Information on Lot/Batch has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Elevated blood pressure; This is a spontaneous report from a contactable Consumer (patient).   An 85-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as 1st dose, single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Pyrexia
Clinical narrative: Fatigue; lightheaded; temperature around 99.3; This is a spontaneous report from a non-contactable consumer (patient himself). A 83-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9261; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 25Jan2021 14:00 as single dose for COVID-19 immunization. The patient medical history was not reported. Patient had not any known allergies. Patient had not received any other vaccine in four weeks. Concomitant medications included levothyroxine, pregabalin, mirabegron (MYRBETRIQ), zinc and vitamin b nos (B-COMPLEX [VITAMIN B NOS]) taken for an unspecified indication. It was reported that on 29Jan2021 patient experienced fatigue, lightheaded and temperature around 99.3, required 2 days of bed rest. Symptoms began 4 days after receiving the first dose. Therapeutic measures were taken as a result of fatigue, lightheaded and temperature around 99.3 as patient had received paracetamol (TYLENOL) and Ibuprofen. The patient underwent lab tests and procedures which included body temperature: around 99.3 on 29Jan2021. Patient was not diagnosed with COVID-19 prior and since the vaccination. The outcome of all events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Anxiety, Dyspepsia, Nausea
Clinical narrative: stomach problems; acid indigestion; anxiety; heart pounding; bloating/tight all around that area of the stomach; queasy; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3302), dose 1 via an unspecified route of administration, administered in left arm on 01Feb2021 13:35 as (at the age of 69-years) 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Patient Medical History including any illness at time of vaccination: anxiety, and drug sensitivity. It was reported that patient mother and sister and herself all have drug sensitivity, No further information provided. There were no concomitant medications. Patient did not receive any Prior Vaccinations within 4 weeks. No Other Products and Investigation Assessment were reported. Patient did not had history of any previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. On 01Feb2021 patient experienced queasy, bloating, upset stomach, tight all around that area of the stomach and heart pounding. Patient already had some stomach problems due to the anxiety before receiving the vaccine but started feeling queasy within an hour after receiving the vaccine. Her stomach problems got worse after with some bloating, tightness around the stomach area, and acid indigestion. Patient heart would start pounding a little bit off and on starting the first day through the evening. It was reported that she had the first dose on Monday and within an hour she felt queasy, bloating, upset stomach, tight all around that area of the stomach; and her heart was pounding. The heart was off and on the first and second day. This morning she started to feel a little queasy but yesterday she was fine. Patient clarified she received the first dose of the Pfizer COVID 19 vaccine on 01Feb2021 1335PM in the left arm. Patient was scheduled for the second dose on 23Feb2021 and plans to receive it depending on the answer to her question. Patient asked was stomach problems, acid indigestion, and heart pounding a common side effect. Events did not require visit to physician office or ER. No Relevant test ware reported. The outcome of event stomach problems, bloating/tight all around that are of stomach and queasy was recovering, outcome of event heart pounding recovered on 03Feb2021 and outcome of acid indigestion and anxiety was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: stomach problems; acid indigestion; anxiety; heart pounding; bloating/tight all around that area of the stomach; queasy; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3302), dose 1 via an unspecified route of administration, administered in left arm on 01Feb2021 13:35 as (at the age of 69-years) 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Patient Medical History including any illness at time of vaccination: anxiety, and drug sensitivity. It was reported that patient mother and sister and herself all have drug sensitivity, No further information provided. There were no concomitant medications. Patient did not receive any Prior Vaccinations within 4 weeks. No Other Products and Investigation Assessment were reported. Patient did not had history of any previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. On 01Feb2021 patient experienced queasy, bloating, upset stomach, tight all around that area of the stomach and heart pounding. Patient already had some stomach problems due to the anxiety before receiving the vaccine but started feeling queasy within an hour after receiving the vaccine. Her stomach problems got worse after with some bloating, tightness around the stomach area, and acid indigestion. Patient heart would start pounding a little bit off and on starting the first day through the evening. It was reported that she had the first dose on Monday and within an hour she felt queasy, bloating, upset stomach, tight all around that area of the stomach; and her heart was pounding. The heart was off and on the first and second day. This morning she started to feel a little queasy but yesterday she was fine. Patient clarified she received the first dose of the Pfizer COVID 19 vaccine on 01Feb2021 1335PM in the left arm. Patient was scheduled for the second dose on 23Feb2021 and plans to receive it depending on the answer to her question. Patient asked was stomach problems, acid indigestion, and heart pounding a common side effect. Events did not require visit to physician office or ER. No Relevant test ware reported. The outcome of event stomach problems, bloating/tight all around that are of stomach and queasy was recovering, outcome of event heart pounding recovered on 03Feb2021 and outcome of acid indigestion and anxiety was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Euphoric mood, Fatigue, Feeling abnormal, Feeling drunk
Clinical narrative: I was shaky and dizzy; I was shaky and dizzy; I was exhausted," very fatigued; She took first dose of the vaccine and she had a very weird and fairly dramatic side effect; I felt high or drunk like I had had 5 drinks; I felt high or drunk like I had had 5 drinks; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 62-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient felt high or drunk like had 5 drinks, shaky and dizzy, exhausted, very fatigued. The clinical course of the events included: patient reported that she had her 1st Pfizer vaccine a couple weeks ago and she was due to get the 2nd vaccine dose next week. Her height reported 5 feet and 95 and tiny person. Patient was hesitant to receive 2nd dose because of her side effects with the first vaccine dose. Caller stated that 1 to 1.5 hours after she got her shot, she felt high or drunk like she had 5 drinks, she was shaky and dizzy. This went on for 3 hours then she was exhausted, very fatigued for the rest of the day. After vaccination, she had a very weird and fairly dramatic side effect. Her doctors did not know whether she should get the second dose. Advised her to consult with other healthcare professional and informed they are unable to provide medical advice. Outcome of the events was unknown.  Information on the Lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nervousness
Clinical narrative: I was shaky and dizzy; I was shaky and dizzy; I was exhausted," very fatigued; She took first dose of the vaccine and she had a very weird and fairly dramatic side effect; I felt high or drunk like I had had 5 drinks; I felt high or drunk like I had had 5 drinks; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 62-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient felt high or drunk like had 5 drinks, shaky and dizzy, exhausted, very fatigued. The clinical course of the events included: patient reported that she had her 1st Pfizer vaccine a couple weeks ago and she was due to get the 2nd vaccine dose next week. Her height reported 5 feet and 95 and tiny person. Patient was hesitant to receive 2nd dose because of her side effects with the first vaccine dose. Caller stated that 1 to 1.5 hours after she got her shot, she felt high or drunk like she had 5 drinks, she was shaky and dizzy. This went on for 3 hours then she was exhausted, very fatigued for the rest of the day. After vaccination, she had a very weird and fairly dramatic side effect. Her doctors did not know whether she should get the second dose. Advised her to consult with other healthcare professional and informed they are unable to provide medical advice. Outcome of the events was unknown.  Information on the Lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Palpitations, Tremor
Clinical narrative: Hands trembling; hand tremors/Parksinson's like tremors in her hands; I got the first shot and afterwards I got heart palpitations causing me to wear a heart monitor/heart palpitations; headaches; severe fatigue; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number: Unknown) via unspecified route of administration in the left arm, on 22Jan2021 (at the age of 75-years-old), as 1st dose, single for COVID-19 Immunization. Medical history and concomitant medications were not reported. On 22Jan2021, the patient experienced severe side effects: sever fatigue and headache. On 24Jan2021, heart palpitations and on 28Jan2021, Parkinson's like tremors in her hands. On an unspecified patient also experienced hands trembling. It was reported that on 05Feb2021, the patient had a Holter monitor on, attached for 24 hours to monitor her heart. The patient had called her neurologist to report Parkinson's like tremors in her hands and also stated after the vaccine that she had severe fatigue where she normally sleeps five hours slept for 14 hours. The patient wanted to know the recommendation for getting the second shot. Reporter seriousness: non-serious. On 31Jan2021 (reported as: 9 Day), the outcome of the event severe fatigue and headache was recovered. The outcome of the event heart palpitations, Parkinson's like tremors in her hands was not recovered. Outcome of the event hands trembling was unknown.  Information on the lot/batch number not available. Follow-up attempts have been completed and no further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Palpitations, Paraesthesia oral
Clinical narrative: This is a spontaneous report from a non-contactable other healthcare professional (patient). A 29-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 07:45 (at the age of 29 years old) (Lot number was not reported) as first dose, single dose for COVID-19 immunization. The patient did not have COVID-19 prior to the vaccination. The patient was not pregnant at the time of vaccination. Medical history was reported as none. The patent had no known allergies. The patient did not take any other vaccine in four weeks. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for an unspecified indication, start and stop date were not reported. On 03Feb2021 08:45 AM, the patient experienced tingling lips, flushing in face and heart palpitations. The events resulted in Emergency room/department or urgent care. No treatment was given for the events. The patient did not get a COVID test post vaccination. The outcome of the events was recovered in Feb 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: He had sore arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) of an unspecified age received This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable male consumer (patient) of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as unknown as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient mentioned that he had sore arm while he was reading "ISI", on an unspecified date. The patient wanted to know more about the components of the COVID-19 vaccine. The outcome of the event was unknown.  It was unknown if the reporter was a health care professional. It was unknown if the reporter was the prescribing HCP.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Oral herpes
Clinical narrative: huge cold sore in my upper lip, between the lip and nose; sick; This is a spontaneous report from a contactable consumer or other non hcp. A 79 and a half years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Jan2021 (at the age of 79 and a half years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a huge cold sore in her upper lip, between the lip and nose on past Friday (05Feb2021), had a sick Friday (05Feb2021), and yesterday this thing. The patient stated that she was scheduled for second dose on Wednesday, 17Feb2021. She wondered if she should go for the next appointment. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Gastric disorder, Malaise
Clinical narrative: I feel sick; I have problems with my stomach; This is a spontaneous report received from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient have to get second vaccine today but cannot go because patient feel sick, patient have problems with stomach. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Pharyngeal mass, Throat tightness
Clinical narrative: nervous; throat was closing up; lump in her throat; This is a spontaneous report from a contactable consumer(patient).   A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW5318) via an unspecified route of administration, administered in Arm Right on 10Feb2021 07:15 as single for COVID-19 immunization. Medical history included Allergies. The patient's concomitant medications were not reported. On 10Feb2021 the patient stated that a 08:00 less than an hour later after first shot, she felt as if her throat was closing up and she started feeling like I had a lump in my throat. The patient wen to home she haven't had anything to eat or drink or anything.She just felt like the lump was getting worse and so she took some Benadryl, but her allergist she called them and just to see and they said I should have had a EpiPen or go to urgent care, but by then she was already nervous so she had taken three Benadryl which is like 12.5 it was on her right arm.She stated that so she  was wondering and she talked to her daughter and she said that well if you had a reaction like that, you're not supposed to take the second shot. The outcome of the events was unknown.   Follow-up (10Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported for herself that: suspect details, treatment details.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Her arms are sore after the 1st dose; This is a spontaneous report from a Pfizer-sponsored program, received from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  It was reported that patient mentioned that her arms are sore after the 1st dose. The patient wanted to know her schedule for 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: Confusional state, Dizziness, Throat tightness
Clinical narrative: tightness of the throat; confusion; dizziness; This is a spontaneous report from a contactable other HCP (Patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Feb2021 1st dose, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced tightness of the throat, confusion, and dizziness on an unspecified date in Feb2021. Therapeutic measures were taken for tightness of the throat with 2 Benadryl after 30 minutes. The patient was recovered from the event tightness of the throat on an unspecified date in Feb2021 and outcome was unknown for the events confusion and dizziness.    No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Nausea; body aches; headache; fatigue; This is a spontaneous report from a non-contactable other health care professional. A 21-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318), via intramuscular route of administration, administered in Left Arm on 02Feb2021 at 14:15 (at the age of 21-years-old) as First Dose, Single Dose for COVID-19 immunization. The patient's medical history included none. The patient's concomitant medications were not reported. The patient did not get tested for COVID post vaccination. The patient did not suffer from COVID prior vaccination. 1hr after vaccination, on 02Feb2021 at 15:15 the patient experienced nausea, body ache, headache, fatigue. The patient did not receive any treatment for the AEs. The outcome for the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (Reporter's Husband). This is report two of two. A male patient of an unspecified age received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 22Jan2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 22Jan2021, the patient experienced, sore arm. The outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: feeling tired; She is a little bitty sore; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot/batch no: EL9232), dose 1 via an unspecified route of administration, administered in Arm Left (Injected in left arm unable to confirm if it is in the muscle) on 03Feb2021 (at the age of 73-years-old) as single dose for a COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient was little bitty sore, and was feeling tired. She then said she was tired because she was shoveling snow. Her arm was not as sore as the flu shot. The patient did not report that she had a flu shot or not. The patient stated that the next dose they have indicated on the card was 22Feb2021, and it was her understanding she should have it 21 days after. On 22Feb2021, would be 19 days after today. It was 2 days earlier, and she wanted to know if that was significant. The outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cough, Dysphonia, Influenza, Oxygen saturation decreased
Clinical narrative: Fever; Pain from her vaccine; Body aches; Now her symptoms are worse; Flu/cold symptoms; Sneezing; Cough; Feels like she is going to lose her voice; Feels like she is lacking oxygen; This is a spontaneous report from a contactable consumer (patient's brother). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 30Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. He is worried about his sister. She got her second dose of the vaccine on 30Jan2021. The issue is she started getting symptoms. The first day, she experienced pain from her vaccine. Next day fever. Then, she had body aches. Now her symptoms are worse. Now she has flu/cold like symptoms. She is sneezing and has a cough. She feels like she is going to lose her voice. She feels like she is lacking oxygen. He is wondering if this is normal for the vaccine. The outcome of the events was unknown.  Information on Lot/Batch has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sneezing
Clinical narrative: Fever; Pain from her vaccine; Body aches; Now her symptoms are worse; Flu/cold symptoms; Sneezing; Cough; Feels like she is going to lose her voice; Feels like she is lacking oxygen; This is a spontaneous report from a contactable consumer (patient's brother). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 30Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. He is worried about his sister. She got her second dose of the vaccine on 30Jan2021. The issue is she started getting symptoms. The first day, she experienced pain from her vaccine. Next day fever. Then, she had body aches. Now her symptoms are worse. Now she has flu/cold like symptoms. She is sneezing and has a cough. She feels like she is going to lose her voice. She feels like she is lacking oxygen. He is wondering if this is normal for the vaccine. The outcome of the events was unknown.  Information on Lot/Batch has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: knee felt like it was giving out; This is a spontaneous report from a contactable consumer (patient). A 87-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9264, Expiration date: UNKNOWN), via an unspecified route of administration in right arm on 03Feb2021(at the age of 87-years-old) at 1st dose, single dose for COVID-19 immunization. The medical history of the patient included ACL surgery on her knee 20 or 30 years ago. The concomitant mediations of the patient were not reported. It was reported that patient experienced knee felt like it was giving out on 03Feb2021. The reporter stated that after her shot she waited half an hour, left at about 11:30 she was fine drove home and she walked up the driveway and went into the house from the garage, she did it again, that her knee gave out and almost fell stated this happened just the two times and it has been fine since. states the joint pain is a side effect, wants to know if this is true, have other people reported this happening. The outcome of the event was reported as unknown.  Follow-up attempts are completed. No further information is expected.