chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Impaired work ability, Throat irritation
Clinical narrative: Having nose bleeds/ nose bleeds as really heavy nose bleeds noting it is like a crime scene; Scratchy throat; Not able to go to work; This is a spontaneous report from a contactable consumer. This consumer (mother) reported for a 15-year-old male patient (son) that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 01Jun2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that her 15-year-old son had his first dose of the Pfizer covid 19 vaccine this past Tuesday, on 01Jun2021. He was fine on Tuesday and Wednesday and started with a scratchy throat on Thursday, on 03Jun2021. He started having nose bleeds on Friday, on 04Jun2021. She described the nose bleeds as really heavy nose bleeds noting it was like a crime scene. Her son has never had this before and stated they keep coming on. On an unspecified date in Jun2021, he was not able to go to work. She wanted to know if there have been any reports of nose bleeds and stated they have all had the vaccine and had nothing like this. Outcome was unknown for all the events.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: He began having a fever on Thursday night up to 102/he woke up again with a fever this morning; This is a spontaneous report from a contactable consumer. A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 03Jun2021 as 2nd dose single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on 13May2021 as single dose for COVID-19 immunisation. On 03Jun2021 the reporter reported that the patient began having a fever on Thursday night up to 102 but she has been able to keep it under control with Ibuprofen. She reports concern that he woke up again with a fever this morning and didn't know if she should be worried, asking, how long should the fevers last? Reporter stated that she already gave all of the adverse event information to someone else to file a report, no reference number for that encounter. Treatment was received for fever with ibuprofen. The patient underwent lab tests and procedures which included body temperature: 102 on an unspecified date. Outcome of the event was unknown.  Information about the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Ear pain, Feeling abnormal, Malaise, Pain
Clinical narrative: Head spinning; Body ache/Intense body ache; Aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs; Felt horrible; Aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs; Temperature of 101/Had a temperature of 101; She just feels like the remnants of how you feel after you have a headache ; did not want to move; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172 and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 03Jun2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 04Jun2021 the patient experienced head spinning , body ache/intense body ache, aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs, felt horrible, thumbs and ears on the inside were aching, aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs, Temperature of 101/Had a temperature of 101. Also, At 5:00 am this morning, she took 325 mg Aspirin (treatment) and is feeling so much better now.  She just feels like the remnants of how you feel after you have a headache ; did not want to move. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date. The outcome of event was recovering.  Follow up attempts are needed. Further information has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vertigo
Clinical narrative: Head spinning; Body ache/Intense body ache; Aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs; Felt horrible; Aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs; Temperature of 101/Had a temperature of 101; She just feels like the remnants of how you feel after you have a headache ; did not want to move; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172 and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 03Jun2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 04Jun2021 the patient experienced head spinning , body ache/intense body ache, aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs, felt horrible, thumbs and ears on the inside were aching, aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs, Temperature of 101/Had a temperature of 101. Also, At 5:00 am this morning, she took 325 mg Aspirin (treatment) and is feeling so much better now.  She just feels like the remnants of how you feel after you have a headache ; did not want to move. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date. The outcome of event was recovering.  Follow up attempts are needed. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Movement disorder, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-Health Care Professional. This consumer (patient) reported for herself that: A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 2021 as  single dose for COVID-19 immunization .Medical history included breast cancer, cervix carcinoma; cervical cancer, lung neoplasm malignant; Lung cancer (thyroid disorder); thyroid problems (pyrexia); having fever about 102.5 (COVID-19) ; I have had COVID-19 (blood magnesium); I am lacking magnesium (blood calcium); since COVID-19 I am lacking calcium from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced having fever about 102.5, aching/ hurt so bad, can't move, headache, getting tired of having to repeat everything and  sick. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on patient have COVID-19 and was in the hospital. At the time of reporting, the outcome of the events were unknown. Follow up attempts are needed. Further information has been requested. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-Health Care Professional. This consumer (patient) reported for herself that: A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 2021 as  single dose for COVID-19 immunization .Medical history included breast cancer, cervix carcinoma; cervical cancer, lung neoplasm malignant; Lung cancer (thyroid disorder); thyroid problems (pyrexia); having fever about 102.5 (COVID-19) ; I have had COVID-19 (blood magnesium); I am lacking magnesium (blood calcium); since COVID-19 I am lacking calcium from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced having fever about 102.5, aching/ hurt so bad, can't move, headache, getting tired of having to repeat everything and  sick. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on patient have COVID-19 and was in the hospital. At the time of reporting, the outcome of the events were unknown. Follow up attempts are needed. Further information has been requested. Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Malaise, Pruritus, Urticaria
Clinical narrative: she experienced her arm was itching all up and down, not on the side where she took the shot, the other arm the other arm It's really bad, it's like under your skin it's itching; I was rubbing my arm and I broke out in little welt, I broke out with the welt on each arm.; Sick of the discomfort I am having because I am itching; Sick of the discomfort I am having because I am itching; I don't know what's happening with me and I didn't like feeling I feel with this side effects. So, that's what I am trying to figure out; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0185) via an unspecified route of administration on 03Jun2021 at 09:00 (at the age of 72 years) as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Jun2021, patient took the COVID shot morning about 9 O'clock and just a minute ago right after the vaccination, her arm was itching all up and down, not on the side where she took the shot, the other arm. Well at both of them at the bottom, she was rubbing her arm and broke out in little welt on each arm. And it's real bad, it's like under the skin its itching. Patient was really trying to find out about her arm as she was sick of the discomfort she was having because of itching. Patient enquired that she does not know what's happening with her and she didn't like feeling she felt with this side effects. Patient just wanted to know what was wrong, why she was having side effects, why does she have to go through all of that. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: I get a lot of itching like a itching rash and I haven't been experiencing it until I got the COVID shot So, number one, I want to report it; This is a spontaneous report from a contactable consumer or other non hcp. A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EW0150; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration (in muscle), administered in arm left on 24Apr2021 09:30 as 1st dose, single dose for COVID-19 immunization. Age at the time of vaccination is 53 years. The patient medical history and no concomitant medications were not reported. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EW0165; Expiration Date: 31Aug2021) dose 2 via an unspecified route of administration (in muscle) in arm left on 15May2021 11:15 as 2nd dose, single dose for COVID-19 immunization. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient experienced I get a lot of itching like a itching rash and I haven't been experiencing it until I got the covid shot so, number one, I want to report it on an unspecified date with outcome of unknown. Treatment medications included allergy medicine like Zyrtec or something, I think it was like the generic allergy relief Loratadine, an anti-histamine that seems to give me some kind of relief. Outcome of the event was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling cold, Headache, Peripheral coldness
Clinical narrative: feeling cold; stomach pains; coldness was in hands and feet; headache; This is a spontaneous report from a contactable consumer (patient's daughter).   A 96-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number: EW0164 and Expiration Date was not reported), via an unspecified route of administration in Arm on 16Apr2021, as 1st dose, single dose for COVID-19 immunization. Medical history included hypertension from Oct2009 and ongoing, cardiac disorder from Oct2009 to an unknown date, myocardial infarction from an unknown date and unknown if ongoing, stent placement from an unknown date and unknown if ongoing. Concomitant medication(s) included apixaban (ELIQUIS); metoprolol (METOPROLOL); simvastatin (SIMVASTATIN); isosorbide (ISOSORBIDE); acetylsalicylic acid (ASPIRINE) all taken for an unspecified indication from an unspecified start date and ongoing. It was reported that within the week prior (Prior to death), she complained of being cold, and had stomach pain, coldness was in hands and feet, she also mentioned headache. The outcome of the events was unknow.  Follow up needed, further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Developed a rash on my body, starting with chest first, than shoulders, following belly, arms and upper legs. It shows little spots and it is very itchy; developed a rash on my body, starting with chest first, than shoulders, following belly, arms and upper legs. It shows little spots and it is very itchy; This is a spontaneous report received from a contactable consumer, the patient. A 56-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP7534) via an unspecified route of administration in right arm on 19Mar2021 12:15 AM as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included allergies of latex and walnuts (from an unknown date and unknown if ongoing). Concomitant medications included levothyroxine sodium (LEVOTHYROXINE SODIUM), ibuprofen (ADVIL 12 HOUR), vitamin B complex (VITAMIN B) and magnesium (MAGNESIUM) taken for an unspecified indication (start and stop date were not reported). Patient also received first dose of bnt162b2 (Batch/lot number EP7534) in the right arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 (five days after second Pfizer vaccine), patient developed rash on the body, starting with chest first, then shoulders, following belly, arms and upper legs. It showed little spots and it was very itchy. Events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events was steroids and hydroxyzine 25 mg four times per day:  The clinical outcome of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Hangover, Headache
Clinical narrative: Caller states she woke up, feeling like she had a hangover, dehydrated with a blistering headache, after the first vaccine.; Caller states she woke up, feeling like she had a hangover, dehydrated with a blistering headache, after the first vaccine.; Caller states she woke up, feeling like she had a hangover, dehydrated with a blistering headache, after the first vaccine.; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration, administered in Arm Right on 01Apr2021 at 09:00 as a single dose for covid-19 immunisation. Medical history included overweight from 1993 to 2010, Childhood history of asthma (she was diagnosed sometime in middle school and had an inhaler for a couple years. Reclarified, Caller did not use the inhaler in college or after that time), hormone therapy. Concomitant medication included estradiol cipionate (DEPO-ESTRADIOL) taken for hormone therapy from Aug2019 and ongoing (1.5 cc every other week, injection), PROGESTERON taken for hormone therapy from 15Apr2019 and ongoing via oral (200 mg, daily). Historical vaccine information included Flu shot on unspecified date and experienced she got sick for the first couple of years. Caller reports that she would get mildly sick, for a day or two and this included feeling like she had a cold, chills, and was achy. Caller states it started, in the eighth grade, around 2007. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Apr2021 at 14:30, the patient states she woke up, feeling like she had a hangover, dehydrated with a blistering headache, after the first vaccine . Caller stated a few hours later, around 05:30 pm, she felt fine. On 02Apr2021 at 17:30, the outcome for event was recovered
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Pulse abnormal
Clinical narrative: Patient felt anxious; Patient's pulse was not beating right; This is a spontaneous report from a contactable consumer (patient's mother). A male patient of an unspecified age received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 30May2021, the patient felt anxious, and pulse was not beating right. Reporter mentioned that her son and daughter had this same reaction. The patient was reporter's son. After receiving the first dose of Pfizer COVID-19 vaccine, patient felt anxious, and the patient could not explain it. The patient's pulse was not beating right. The reporter declined to complete a safety report about patient. The reporter could not say much about patient and does not know when patient received the COVID-19 vaccine. The reporter does not know anything other than patient told her that he had the same feeling. The feeling went away for patient after about a week. No further information or patient identifiers provided. Details regarding other products and investigation assessment was not provided. The outcome of the events was recovered on an unspecified date of Jun2021.  Follow up attempts are needed. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypersensitivity, Nausea
Clinical narrative: I am little sick to my stomach; Dizzy; being dizzy that's a severe allergic reaction; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Jun2021 as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she was little confused, when got her shot yesterday, she was little sick to her stomach and then she was dizzy, being dizzy that's a severe allergic reaction, should she need to call 911. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Pulse abnormal
Clinical narrative: patient felt anxious. Patient can not explain it. Patient's pulse was not beating right.; patient felt anxious. Patient can not explain it. Patient's pulse was not beating right.; This is a spontaneous report from a contactable consumer (patients mother). The report is cross referenced to report ID: #. Report 3 of 3.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date reporter called about the Pfizer covid vaccine. Reporter called to report her side effects after the first dose of the covid vaccine and was wondering if her side effects were normal. It was reported that after receiving the first dose of Pfizer covid vaccine, patient felt anxious. Patient cannot explain it. Patient's pulse was not beating right. The feeling went away for patient after a couple of days. Reporter declined to complete a safety report about patient. Reporter did not say much about patient. Reporter does not know when patient received the covid vaccine. Reporter does not know anything other than patient told her that she had the same feeling. Unable to clarify details provided or gather additional information. No further information or patient information provided. The outcome of event pulse abnormal was unknown and for anxiety the outcome was resolved on an unspecified date.   Follow-up needed, Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Eating disorder, Headache, Nasopharyngitis
Clinical narrative: Headache; shakes; shivers/Chills; throwing up/vomiting; quit eating things; Bad taste in his mouth; Cold; This is a spontaneous report from a contactable consumer or other non health professional (Parent) reported for a patient(son). A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration on 03Jun2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 04Jun2021, the patient experienced headache, shakes and shivers/chills; throwing up/vomiting; quit eating things; bad taste in his mouth and cold. Reporter stated that he had headache at school the next day, he had the shot yesterday. Today real bad headache and stuff at school today. He came home and started having shakes and shivers. Then he started vomiting, throwing up, quit eating things. Had bad taste in his mouth. (distorted voice and unclear) but then he had problems like cold, chills, shakes in it. Reporter wants to know why patient was having chills, shakes and he was throwing up. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Headache; shakes; shivers/Chills; throwing up/vomiting; quit eating things; Bad taste in his mouth; Cold; This is a spontaneous report from a contactable consumer or other non health professional (Parent) reported for a patient(son). A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration on 03Jun2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 04Jun2021, the patient experienced headache, shakes and shivers/chills; throwing up/vomiting; quit eating things; bad taste in his mouth and cold. Reporter stated that he had headache at school the next day, he had the shot yesterday. Today real bad headache and stuff at school today. He came home and started having shakes and shivers. Then he started vomiting, throwing up, quit eating things. Had bad taste in his mouth. (distorted voice and unclear) but then he had problems like cold, chills, shakes in it. Reporter wants to know why patient was having chills, shakes and he was throwing up. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Fatigue, Frustration tolerance decreased, Gait disturbance
Clinical narrative: They had too many days with dizzy; pain only the first day I had pain when I put the vaccine; Headache; Nausea; Feeling sick; I have very frustration; I walk to the front I feeling like somebody pull like itself hard for me to walk; Not feeling good; I  have my pressure high; Tired; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, (Batch/Lot number was not reported), via an unspecified route of administration on 24May2021 as a single dose for COVID-19 immunization. Medical history included hypertension. The patient concomitant medications were not reported. The patient got the vaccine on the 24May2021 and after that patient had problems with disease High pressure for that. The patient had pain only the first day when he/she put the vaccine. The next day it was little bit very dizzy like drunk. The patient thought to report it because they had too many days with dizzy. The patient reported feeling sick. The patient did not know what to do, his/her pressure was so high. The patient reported that he/she had High pressure before but this time it was so much, and he/she was so dizzy that it had caused problem to walk and was like somebody pulling back to his/her place. The patient reported that he/she walk to the front and feeling like somebody pull like itself hard for him/her to walk. Second day after putting the vaccine patient got the dizzy and a little, he/she tried to lower his/her pressure because his/her pressure was high all the time. The patient did not know it was for these and all then he/she had headache, but it was ok. The patient was tired. The patient had nausea. The patient reported that it was already two weeks since his/her pressure was so high every day. The patient was worried because his/her pressure was far to normal. The patient stated that he/she had no medical records. The patient tried to call and click all day to talk to anyone and gone to the internet and there was no answer. The patient had very frustration. The patient did not want to go hospital and did not want to see doctor. The patient wants somebody to talk for his/her many things. The patient got to do something to down his/her high pressure. The patient reported that it already happened to him/her with flu shot. The patient underwent lab tests and procedures which included blood pressure measurement: high in 2021. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hypertension, Malaise, Nausea, Vaccination site pain
Clinical narrative: They had too many days with dizzy; pain only the first day I had pain when I put the vaccine; Headache; Nausea; Feeling sick; I have very frustration; I walk to the front I feeling like somebody pull like itself hard for me to walk; Not feeling good; I  have my pressure high; Tired; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, (Batch/Lot number was not reported), via an unspecified route of administration on 24May2021 as a single dose for COVID-19 immunization. Medical history included hypertension. The patient concomitant medications were not reported. The patient got the vaccine on the 24May2021 and after that patient had problems with disease High pressure for that. The patient had pain only the first day when he/she put the vaccine. The next day it was little bit very dizzy like drunk. The patient thought to report it because they had too many days with dizzy. The patient reported feeling sick. The patient did not know what to do, his/her pressure was so high. The patient reported that he/she had High pressure before but this time it was so much, and he/she was so dizzy that it had caused problem to walk and was like somebody pulling back to his/her place. The patient reported that he/she walk to the front and feeling like somebody pull like itself hard for him/her to walk. Second day after putting the vaccine patient got the dizzy and a little, he/she tried to lower his/her pressure because his/her pressure was high all the time. The patient did not know it was for these and all then he/she had headache, but it was ok. The patient was tired. The patient had nausea. The patient reported that it was already two weeks since his/her pressure was so high every day. The patient was worried because his/her pressure was far to normal. The patient stated that he/she had no medical records. The patient tried to call and click all day to talk to anyone and gone to the internet and there was no answer. The patient had very frustration. The patient did not want to go hospital and did not want to see doctor. The patient wants somebody to talk for his/her many things. The patient got to do something to down his/her high pressure. The patient reported that it already happened to him/her with flu shot. The patient underwent lab tests and procedures which included blood pressure measurement: high in 2021. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: experienced significant cramping; This is a spontaneous report from a contactable consumer (patient). A elderly male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown; Expiration date: unknown), dose 2, via unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history include patient remained in the hospital for 5 or 6 days, the concomitant medications were not reported. The patient previously took BNT162B2 (Lot Number: unknown; Expiration date: unknown), via unspecified route of administration on an unspecified date as first dose, single dose for COVID-19 immunisation. The patient stated that while there is no conclusive link between the vaccine and hospitalization, patient reported that within 12 hours of the first shot had severe abdominal cramping. Within 24 hours patient was in the hospital with a bowel blockage. Patient remained in the hospital for 5 or 6 days with a nasal/gastric tube. The blockage did eventually clear, but after a rather miserable visit. The patient has had blockages in the past and have had two resections which no doubt has left some scar tissue. DR and the patient decided that patient should wait for 5-6 weeks before having the second shot and waited 40 days. Also, patient went on a liquid diet for 2 days prior to and after the second shot. After the second shot the patient again experienced significant cramping, but since there was nothing solid in-patient system, patient did not have a blockage. And patient mentioned one of the side effects (7-8%?) of the vaccine was gastric distress and because of patients scar tissue, distress was a shutdown of bowel rather than diarrhea. In the event boosters were needed patient planned on following the path used above. The outcome of the event was unknown.  Information related to lot/batch number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A female patient of an unspecified age received first and second dose of bnt162b2 (Pfizer COVID Vaccine, Solution for injection), via an unspecified route of administration on an unspecified date as 1st dose, single dose, via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm after both the doses. While reporting adverse event for her daughter with Pfizer COVID Vaccine, caller stated that all four of them in the family had sore arm and everybody said that was to be expected. She had both of them and all she had was a sore arm and declined to proceed with a report for herself and other family members. The clinical outcome of the event sore arm was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: post-menopausal women that have had a period; This is a spontaneous report from a non-contactable consumer via Pfizer- sponsored program COVAX US Support. A female patient of an unspecified age received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as 1st dose, single dose for COVID-19 immunisation. On an unspecified date, patient had post-menopausal women that have had a period. The reporter inquired whether there has been reports of post-menopausal women that have had a period after receiving the vaccine. Caller advised they have received both doses and experiencing a period after menopause. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity
Clinical narrative: 14 yr old received the 2nd dose of the Pfizer Covid vaccination; Sore arm; This is a spontaneous report from a non-contactable consumer. A 14-year-old patient of an unspecified gender received second dose of BNT162B2 (Pfizer Covid vaccine, Solution for injection) via an unspecified route of administration on 03Jun2021 (Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (at age of 14-year-old) as single dose for Covid-19 immunization. It was reported that, 14-year-old received the second dose of the Pfizer Covid vaccination on 03Jun2021 and had a slight sore arm the following morning. Event took place after use of product. Reporter did not wish to be contacted for follow-up. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Malaise, Suspected COVID-19
Clinical narrative: Feeling weird at the work; Feeling a little sick; I function properly but I have like Covid symptoms; Have some COVID symptoms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 23-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0158; Expiration Date: 30Jul2021), dose 1 via an unspecified route of administration, administered in Arm Right on 31May2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation (23 years old at the time of vaccination). Patient medical history and concomitant medications were reported. When probed for the concern, consumer stated that he started feeling weird at the work the other day because of 1st dose of the Pfizer vaccine and he have gotten that on Monday (31May2021) and he started feeling a little weird, first 3 days he knew was normal. Now it was already 5 days in, and he was still feeling a little sick, had a little bit of COVID symptoms but he did not know if he should be going in to work or not if he does had symptoms. Received follow-up on 05Jun2021, 07Jun2021, Consumer was informed about Pfizer Medical Information Department. He spoke with five persons, but call was not given to medical department. He was asked for dates for already five days since he got vaccinated it was unspecified. Patient did not receive any other prior vaccination. The clinical outcome of events was unknown.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Fatigue; light-headed; nausea; physical weakness; headache; body ache; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 07May2021 07:15 (Batch/Lot Number: EW0185) as a single dose for covid-19 immunization. Medical history included allergy to peanuts and shellfish allergy. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient has not been tested for COVID-19. After the administration of first dose, the patient experienced fatigue lasting from 2 days after dose through receiving 2nd dose, light-headed, nausea, physical weakness, headache and body ache. Following questions of what were caused can't be answered. The patient received full-time care while bedridden first day and a half from his partner and continue to receive care daily as he was not able to accomplish much on his own at this point. He does not know if this was a permanent condition caused by the vaccine nor does he know what the extent of any permanent damage was. This was the worst his body has ever felt. The outcome of the events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Fatigue; light-headed; nausea; physical weakness; headache; body ache; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 07May2021 07:15 (Batch/Lot Number: EW0185) as a single dose for covid-19 immunization. Medical history included allergy to peanuts and shellfish allergy. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient has not been tested for COVID-19. After the administration of first dose, the patient experienced fatigue lasting from 2 days after dose through receiving 2nd dose, light-headed, nausea, physical weakness, headache and body ache. Following questions of what were caused can't be answered. The patient received full-time care while bedridden first day and a half from his partner and continue to receive care daily as he was not able to accomplish much on his own at this point. He does not know if this was a permanent condition caused by the vaccine nor does he know what the extent of any permanent damage was. This was the worst his body has ever felt. The outcome of the events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: slight sore arm; This is a spontaneous report from a non-contactable consumer reported for a 12-year-old male patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 03Jun2021 (Batch/Lot number was not reported) as second dose single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the second dose of the Pfizer Covid vaccination on 03Jun2021 and experienced a slight sore arm the following morning (i.e., on 04Jun2021). The event took place after use of the product. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Nausea, Swelling
Clinical narrative: Nausea as well when she is standing and walking; Gets dizzy when she is standing up for walking, she cannot walk for more than 5 seconds; she cannot walk for more than 5 seconds; Swelling under armpit; This is a spontaneous report from a contactable pharmacist. A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0187; Expiration Date: 31Aug2021), via intramuscular route of administration, administered in Left Deltoid muscles on 27May2021 16:39 (age at vaccination 29-year), as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 29May2021 the patient experienced swelling under armpit and patient gets dizzy when she is standing up for walking, she cannot walk for more than 5 seconds, on 31May2021. The patient also experienced nausea as well when she is standing and walking on an unspecified date. It was reported as, the pharmacist stated patient has a swelling under armpit, patient got the vaccine on friday, it started on saturday morning and still has a swelling no change since then from one week, that's the number one complaint. Second complaint is dizziness, she says that it started on monday, she gets dizzy when she is standing up for walking, she cannot walk for more than 5 seconds and when she stands up she get dizzy and it started on monday and till now past five days she still has that and it's not getting better. Third is nausea as well when she is standing and walking when she is sitting down she doesn't get nausea or dizzy. The seriousness of the events was reported as non-serious. The clinical outcome of the events was unknown.  No follow up attempts are required; Information about Lot and Batch number was obtained.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; little tired; This is a spontaneous report from a contactable consumer or other non hcp.  A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0177 and Expiration date: unknown), dose 1 via an unknown route of administration on 20May2021 as single dose for covid-19 immunisation. Medical history included stroke from 2019 that was caused because the heart valve, PFO, never closed when he was born so he had an occluder put in. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) taken once a day for an unspecified indication and ongoing. On 20May2021, the patient experienced sore arm and a little fatigue. He has scheduled to get the second dose on 10Jun2021. Outcome of events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Dysstasia, Hypokinesia
Clinical narrative: She couldn't move or stand.; And she couldn't talk for 8-9 hrs; She couldn't move or stand.; This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection (Lot number was not reported expiry date was not reported) via an unspecified route of administration on an unspecified dose, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 03Jun2021 patient experienced she couldn't move or stand, she couldn't talk for 8-9 hrs and she couldn't move or stand. The outcome of the events was unknown.  Product Complaint: There is no product complaint associated with this case  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tachycardia
Clinical narrative: Racing heartbeat; Dizzy; This is a spontaneous report from a contactable consumer (parent). A 12-year-old female patient received first dose of BNT162B2 (COVID-19 Vaccine, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/lot number: EW0161, NDC/UPC number/Expiry Date: Unknown) as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, the patient experienced racing heartbeat and dizzy. Reporter stated, "her daughter had the COVID Vaccine, she was 12 years and 10 months old and she was supposed to be having her second dose today but she had a problem, she had a lot of tachycardia and had the racing heartbeat, it was racing very fast, she was very dizzy and was having for the last week we passed like a very bad time, contacted her primary doctor and he had ordered to ask for X-Ray to check the chest and check the thyroid gland". Reporter stated, "patient was having her second dose appointment today but I am very concerned about her dizziness and her fast, racing heart and if like recommend getting the dosage or to wait because she was very worried about that". Reporter was provided with the number of Pfizer Medical Information Department. Reporter further stated, "she did not know what to do, it was so scary the doctor sent her daughter to the cardiologist". Product details (Expiration Date, NDC number and UPC number) and purchase details could not be probed over the call as the reporter hung up abruptly. Hence, limited information was available over the call. The events were assessed as non-serious. Outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: She experienced migraine; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection), via an unspecified route of administration on 04Jun2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that she received the 1st dose of Pfizer COVID- 19 vaccine yesterday and she experienced migraine that was yesterday on 04Jun2021 and this morning and she drank acetaminophen (NDC number, UPC number and Expiry Date of acetaminophen were unknown) as treatment and now she was asking if she can drink Butalbital 335 mg? It was reported that she was still experiencing Migraine. The outcome of the event was not recovered.   Information on Lot/Batch number has been requested.