chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Influenza like illness
Clinical narrative: Angioedema; Flu like symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of ANGIOEDEMA (Angioedema) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dental operation (dental procedures in the last 6-12 months.) and Lip cosmetic procedure (Botox and Fillers). Concurrent medical conditions included Penicillin allergy and Drug allergy (Sulfa drugs.).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, ANGIOEDEMA (Angioedema) outcome was unknown and INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications information not reported. Treatment information not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-268524 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PERICARDITIS (Pericarditis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Pericarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.  Patient commented saying that while she may not have been evaluated for pericarditis as of yet, she has heard of others who have and ER nurses have also mentioned this to her.  Very limited information regarding the events has been provided at this time; Sender's Comments: Very limited information regarding the events has been provided at this time
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Reading disorder, Speech disorder
Clinical narrative: experienced cognitive disruption for approximately 4 hours.; Disruption included inability to read; difficulty with speech/context/numbers.; This is a spontaneous report from a contactable consumer (patient). A 14-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0202 and Expiration Date: unknown), via an unknown route of administration, administered in left arm on 27Jun2021 at 13:00 (at the age of 14-years-old) as dose 2, single for covid-19 immunisation. The patient has no other medical history. The patient's concomitant medications were not reported. Patient has no known allergies. The patient previously took first dose of bnt162b2 (Lot number: EW0178) administered in left arm on 04Jun2021 at 12:00 PM (at the age of 14-years-old) as dose 1, single for covid-19 immunisation. Patient did not receive any other vaccine in four weeks. On 08Jul2021 at 10:00, 11 days after second dose, the patient experienced cognitive disruption for approximately 4 hours. Disruption included inability to read and difficulty with speech/context/numbers. The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 post vaccination. No treatment was received for the events. Outcome of events was recovered on an unknown date in Jul2021.
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Pruritus, SARS-CoV-2 test, Skin discolouration
Clinical narrative: bleeding; urticarial rash for almost three months; all four limbs very itchy; causes bleeding because I scratch it when I am sleeping; fatigue; vasculitis where I have had my fingers turned purple; My heel turned purple; bruising; This is a spontaneous report from a contactable physician (Patient). A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EH9899 and Expiry date: Unknown), via an intramuscular, administered in Deltoid Right on an unspecified date, at the age of 52-years-old as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced bleeding, urticarial rash for almost three months, all four limbs very itchy, causes bleeding because i scratch it when i am sleeping, fatigue, vasculitis where i have had my fingers turned purple, my heel turned purple, bruising, i think i had a re-infection from covid. The patient stated that "I did not retest myself until I had an adequate amount of time to treat what I thought was a COVID Infection just because I need to get back to work and I can't go back to work if test positive for COVID my health department at the hospital advised me to continue therapy and then to retest late last week. Actually, today is Saturday so I tested out on Thursday and it came back negative." The patient underwent 27 different lab tests this past week those results are pending. The patient underwent lab tests and procedures which included Covid-19 swab test: negative on an unspecified date. Therapeutic measures were taken as a result of the events. Treatment currently taking immunosuppressant doses of PREDNISONE and taking IVERMECTIN. The outcome of event was unknown. Regarding causality, the patient stated, "That is my suspicion. Yes. That's just the only thing I can think of." The reporter provided the causality as related.
Sex: M
Vaccine: COVID19
Symptoms: Skin haemorrhage, Skin lesion, Urticaria, Vasculitis
Clinical narrative: bleeding; urticarial rash for almost three months; all four limbs very itchy; causes bleeding because I scratch it when I am sleeping; fatigue; vasculitis where I have had my fingers turned purple; My heel turned purple; bruising; This is a spontaneous report from a contactable physician (Patient). A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EH9899 and Expiry date: Unknown), via an intramuscular, administered in Deltoid Right on an unspecified date, at the age of 52-years-old as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced bleeding, urticarial rash for almost three months, all four limbs very itchy, causes bleeding because i scratch it when i am sleeping, fatigue, vasculitis where i have had my fingers turned purple, my heel turned purple, bruising, i think i had a re-infection from covid. The patient stated that "I did not retest myself until I had an adequate amount of time to treat what I thought was a COVID Infection just because I need to get back to work and I can't go back to work if test positive for COVID my health department at the hospital advised me to continue therapy and then to retest late last week. Actually, today is Saturday so I tested out on Thursday and it came back negative." The patient underwent 27 different lab tests this past week those results are pending. The patient underwent lab tests and procedures which included Covid-19 swab test: negative on an unspecified date. Therapeutic measures were taken as a result of the events. Treatment currently taking immunosuppressant doses of PREDNISONE and taking IVERMECTIN. The outcome of event was unknown. Regarding causality, the patient stated, "That is my suspicion. Yes. That's just the only thing I can think of." The reporter provided the causality as related.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: itchy full body hives; 102 degree fever; minorly ill (general body soreness/fatigue/headache); minorly ill (general body soreness/fatigue/headache); minorly ill (general body soreness/fatigue/headache)/low grade headache; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 12Jul2021 (at the age of 24-year-old) as single dose for COVID-19 immunisation. Medical history included season allergies for pollen. Concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. The patient previously received 1st single dose in left arm of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jun2021 (at the age of 24-year-old) for COVID-19 immunisation. Patient felt minorly ill (general body soreness/fatigue/headache) on Tuesday 13Jul2021 and felt better on Wed (14Jul2021) during the day with low grade headache as main symptom. Wed night, patient had a 102 degree fever which dissipated by noon on Thurs. Thursday night (15Jul2021 20:00), patient developed itchy full body hives which still had currently. Patent was taking diphenhydramine hydrochloride (BENADRYL) and prescribed prednisone steroid to prevent itchiness. Essentially stayed in bed the majority of the week and ate very basic meals - not aware of anything that would have triggered these hives and have never had hives before. AE resulted in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. No covid tested post vaccination. The outcome of the event Hives was not recovered, of the event Fever was recovered on 15Jul2021, of other events was recovering.  Information about Lot/Batch number have been requested.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: itchy full body hives; 102 degree fever; minorly ill (general body soreness/fatigue/headache); minorly ill (general body soreness/fatigue/headache); minorly ill (general body soreness/fatigue/headache)/low grade headache; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 12Jul2021 (at the age of 24-year-old) as single dose for COVID-19 immunisation. Medical history included season allergies for pollen. Concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. The patient previously received 1st single dose in left arm of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jun2021 (at the age of 24-year-old) for COVID-19 immunisation. Patient felt minorly ill (general body soreness/fatigue/headache) on Tuesday 13Jul2021 and felt better on Wed (14Jul2021) during the day with low grade headache as main symptom. Wed night, patient had a 102 degree fever which dissipated by noon on Thurs. Thursday night (15Jul2021 20:00), patient developed itchy full body hives which still had currently. Patent was taking diphenhydramine hydrochloride (BENADRYL) and prescribed prednisone steroid to prevent itchiness. Essentially stayed in bed the majority of the week and ate very basic meals - not aware of anything that would have triggered these hives and have never had hives before. AE resulted in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. No covid tested post vaccination. The outcome of the event Hives was not recovered, of the event Fever was recovered on 15Jul2021, of other events was recovering.  Information about Lot/Batch number have been requested.
Sex: M
Vaccine: COVID19
Symptoms: Homosexuality
Clinical narrative: It made me gay; This is a spontaneous report from a non-contactable consumer (patient) for himself. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included COVID-19 (If covid prior vaccination: yes). Concomitant medications were not reported. The patient experienced it made him gay on an unspecified date with outcome of recovering. AE resulted in disability or permanent damage. No treatment for AE. No COVID tested post vaccination.  No follow-up attempts are possible; Information on lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Hyperhidrosis, Suffocation feeling
Clinical narrative: Had to remove my mask, felt like it was suffocating me (normally no issues with a mask); Broke into heavy sweat, soaked my clothing.; Felt disorientated, could not get up from chair.; This is a spontaneous report from a contactable consumer. This consumer reported for herself that the 47-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Pfizer) at the age of 47-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 16Jul2021 13:00 (Batch/Lot Number: EW0181) as dose 2, single for covid-19 immunisation. Medical history included Known allergies: Penicillin from unknown date and unknown if ongoing. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19, Pfizer, lot number: EW0198) administered in Arm Left on 24Jun2021 02:00 PM for covid-19 immunization.No other vaccine in four weeks. Other medications in two weeks included Birth control. The patient experienced had to remove my mask, felt like it was suffocating me (normally no issues with a mask)  on 16Jul2021 13:00 with outcome of recovering , broke into heavy sweat, soaked my clothing on 16Jul2021 13:00 with outcome of recovering , felt disorientated, could not get up from chair on 16Jul2021 13:00 with outcome of recovering. The clinical course was reported as follows: Broke into heavy sweat, soaked my clothing. Felt disorientated, could not get up from chair. Stayed for about a half hour. Had to remove my mask, felt like it was suffocating me (normally no issues with a mask). No treatment AE. No COVID prior vaccination. No COVID tested post vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report from a contactable physician through a Pfizer sales representative.   A patient of an unspecified age and gender received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination the patient experienced myocarditis. Treatment was received. Clinical outcome of the adverse event was unknown at time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information and the plausible drug-event association, a possible contributory role of the suspect product BNT162B2 to the development of the event cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: Colon cancer, Pain in extremity, Tumour marker test
Clinical narrative: diagnosed with colon cancer; Sore arm; This is a spontaneous report form a Pfizer sponsored program. A contactable consumer (the patient) reported that: A 73-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On an unspecified date, the patient was diagnosed with colon cancer and also experienced sore arm. It was reported that the patient and her husband had both doses of the Pfizer COVID19 vaccine and had only experienced sore arm as side effect of the vaccine. The patient stated that she was diagnosed with colon cancer and has been undergoing chemotherapy (12 cycles). Using a special blood test that helped in detecting tumor markers and cancer cells, the patient reported that before her 1st dose and up until her 1st dose, her cancer/tumor marking detection was 0. However, 3 days after getting her 2nd dose, there was an observed elevation on the said markings. The patient had already reported this to her physician, and her PCP highlighted that it was not because of the vaccine. In line with this, the patient would like to know if there are any information in regards tumor markings/cancer cells markings elevation in patient who had received the Pfizer COVID19 vaccine with pre-existing Cancer diagnosis. On unspecified date, the patient underwent lab tests and procedures which included special blood test: cancer/tumor marking detection was 0 (before her 1st dose and up until her 1st dose), special blood test: observed elevation of cancer/tumor marking (3 days after getting her 2nd dose). Therapeutic measures were taken as a result of diagnosed with colon cancer. The outcome of events was unknown.  Information about lot/Batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: The caller and his wife got fully vaccinated and after their second vaccine they both tested positive for covid.; The caller and his wife got fully vaccinated and after their second vaccine they both tested positive for covid.; This is a spontaneous report from a Pfizer sponsored Program . This consumer reported similar events for 2 patients. This is 2nd of two reports. This consumer (patient's husband) reported for a 24-year-old female patient that she received the second of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 09Feb2021 (Batch/Lot Number: EN5318) 0.3 ML, SINGLE for COVID-19 immunization. She received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 19Jan2021 (Batch/Lot Number: EL8982) as DOSE 1, 0.3 ML, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that he and his wife got fully vaccinated and after their second vaccine they both tested positive for COVID. leading to vaccination failure on 19Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 19Jul2021 with outcome of unknown. The clinical outcome for the events unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100918542 same reporter/product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient). A 40-years-old female patient 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 17Jul2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 18Jul2021, the patient experienced swollen lymph nodes (which started on a day later, as reported). Reportedly, she is asking if there is a guideline on receiving the second dose of the vaccine. She also wants to know if this is a side effect of the vaccine and if it is considered severe. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received first dose of bnt162b2 (PFIZERBIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199), via an unspecified route of administration, administered in Arm Left on 07Mar2021 12:45 (age at the vaccination 56-year-old) as DOSE1, SINGLE for covid-19 immunisation. Medical history included ongoing high blood pressure (diagnosed with high blood pressure quite a while ago, Probably a good 15 years ago and ongoing). Concomitant medications included ongoing amlodipine at 10 mg, daily for blood pressure and hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. Historical vaccine included flu shot (Caller reported that just sometimes with the flu shot she would get a sore arm, but she does not have any details regarding vaccination dates). Patient reports she received her first dose on 07Mar2021 and then tested positive for Covid-19 infection on 28Mar2021. She reports her pharmacy spaced her second dose for 4 weeks after her first, but she never got the second dose. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 28Mar2021. The outcome of the events was unknown.  Follow-Up (26Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Vaccine not working as intended; COVID-19; This is a spontaneous report from a non-contactable consumer or other non hcp. A 74-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07Mar2021(age at vaccination: 74-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that vaccine not working as intended on an unspecified date. The outcome of the events was unknown.  No further information was reported.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Fluid retention, Limb discomfort, Myalgia
Clinical narrative: discomfort in his arm; like a little bit of hydraulic pressure from injecting fluid into tissue; he did consider general muscle pain in his shoulders as a source for the discomfort in his arm; he did consider general muscle pain in his shoulders as a source for the discomfort in his arm; Fatigued; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EW0176, Expiry date: Unknown), via an unspecified route in the left arm on 29Apr2021, as a single dose for covid-19 immunization. Medical history included diagnosed with high blood pressure probably 3 years ago, ongoing and had two hip replacements, one in Sep2019 and one in Sep2020, ongoing. Concomitant medication included began taking lisinopril a couple of years ago for high blood pressure, periodically takes ibuprofen or naproxen for aches and pains, he's had 2 hip replacements, and it's not the hip itself because it's synthetic, but the muscles around them every once in a while, get a little sore, so sometimes he has to take them more regularly, like lately they've had incredible weather that's been very rainy. Patient mentioned that he is still pretty active, very active for 71 years old, and working. On 29Apr2021, patient experienced some discomfort in his arm like a little bit of hydraulic pressure from injecting fluid into tissue, that went away in a day or two and fatigued. He did consider general muscle pain in his shoulders as a source for the discomfort in his arm. The clinical outcome of some discomfort in his arm like a little bit of hydraulic pressure from injecting fluid into tissue was recovered, muscle pain in his shoulders was unknown and fatigued was recovered on 30Apr2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye contusion
Clinical narrative: she had had the Pfizer Vaccine and had a black eye too; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced black eye. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness, Urticaria
Clinical narrative: broke out in hives; she was sick as well; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 15-year-old female patient (reporter's daughter) that: A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation crisaborole (EUCRISA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. The reporter stated that her daughter got the vaccine, and she broke out in hives and she was sick as well and does not know if she broke out because she was sick or the vaccine. The outcome of the events was unknown at the time of reporting.  Information about batch/lot number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hyperhidrosis, Pain, Peripheral swelling, Pruritus
Clinical narrative: Swelling to my lower body; Some pain; Itching; Diarrhea; Vomiting; Body sweats; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0169, Expiration date not reported), via an unspecified route of administration, administered in arm right on 30Jun2021 at 13:00 (at the age of 47-year-old) as single dose for COVID-19 immunisation. Family medical history included colon cancer (Verbatim: mother colon cancer), cataract, high blood pressure and diabetes mellitus (Verbatim: Grandmother cataracts, high blood pressure, diabetes). The patient's medical history and concomitant medications were reported as none. Prior vaccinations were reported as none. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0202, Expiration date not reported), via an unspecified route of administration, administered in arm left on 09Jun2021 at 08:30 (at the age of 47-year-old) as single dose for COVID-19 immunisation and experienced from bottom of my knees all down its swollen. On an unspecified date, the consumer reported that she had a lot of swelling to her lower body, some pain, Itching, diarrhea, vomiting, body sweats, but all of this was after she took the Vaccine shots. Relevant tests were reported as none. The reporter classified the events as non-serious. The outcome of the events was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Swelling to my lower body; Some pain; Itching; Diarrhea; Vomiting; Body sweats; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0169, Expiration date not reported), via an unspecified route of administration, administered in arm right on 30Jun2021 at 13:00 (at the age of 47-year-old) as single dose for COVID-19 immunisation. Family medical history included colon cancer (Verbatim: mother colon cancer), cataract, high blood pressure and diabetes mellitus (Verbatim: Grandmother cataracts, high blood pressure, diabetes). The patient's medical history and concomitant medications were reported as none. Prior vaccinations were reported as none. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0202, Expiration date not reported), via an unspecified route of administration, administered in arm left on 09Jun2021 at 08:30 (at the age of 47-year-old) as single dose for COVID-19 immunisation and experienced from bottom of my knees all down its swollen. On an unspecified date, the consumer reported that she had a lot of swelling to her lower body, some pain, Itching, diarrhea, vomiting, body sweats, but all of this was after she took the Vaccine shots. Relevant tests were reported as none. The reporter classified the events as non-serious. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Tiredness; Headache; This is a spontaneous report from a contactable consumer(patient). A 28-years-old female patient received first dose of bnt162b2 (BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 24Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included pregnancy, anxiety, drug hypersensitivity, urticaria, insomnia, dizziness. Concomitant medications included ocrelizumab (OCREVUS), prednisone (PREDNISONE), paracetamol (TYLENOL). On 25Apr2021, The patient experienced tiredness, headache. The outcome of the events was resolved.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache, Photopsia
Clinical narrative: Chest pain; Severe headache; White flashes in eyes; This is a spontaneous report from a contactable consumer. This consumer reported for a 35-year-old male patient (reporter's son) received bnt162b2 (BNT162B2, solution for injection, Lot number was unknown), dose 1 via an unspecified route of administration on May2021 as dose 1, single for COVID-19 immunisation. Medical history included covid-19 from Jan2020 to an unknown date had covid in Jan2020. The patient's concomitant medications were not reported. On 2021, the patient experienced chest pain, severe headache and white flashes in eyes. Patient received covid vaccine approx 2 months ago, 1st dose, he had chest pain severe headache white flashes in eyes, he is 35 years old and had covid in Jan2020, he went to doctor after having this for 2 weeks, no tests were done but was told do not have 2nd shot or you will have stroke. I got him in to see cardiologist they ordered tests to be done, his insurance denied tests being done except a blood test. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Coating in mouth, Oropharyngeal discomfort, Pain in extremity, Taste disorder, Tongue coated
Clinical narrative: sharp pain in my right upper arm; coated tongue; bad taste; coated mouth; coated throat; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that patient with unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date at DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient stated that 'I had the 1st Pfizer vaccine. After the Pfizer vaccine I felt ok. Later in the day I experienced sharp pain in my right upper arm. Saturday morning I woke up with a coated tongue and coated mouth and coated throat and this bad taste and sharp pain in my right arm Sunday morning and Monday I woke up with a coated tongue and coated mouth and coated throat and this bad taste with sharp pain my upper right arm.'' This outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not feeling well; This is a spontaneous report received from a Pfizer sponsored program and medical information team. A Non-contactable consumer (patient's parent, Caregiver) reported that  a 17-year-old male patient (her son) 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 DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced not feeling well (non-serious) on an unspecified date. Caller was calling on behalf of her son who is 17 years old and scheduled to get the 2nd dose today (20Jul2021) but he is not feeling well. Caller said that his son already received the 1st dose but she did not know the date. The caller was asking if her son needs to get tested before getting the 2nd dose. Resolution: Call got disconnected while providing Privacy Statement. No demographics gathered. There were not any medical questions unaddressed by this program forwarded/referred to Medical Information. This is to confirm receipt of inquiry. MI cannot follow-up due to no contact information provided. Unable to follow up with requester due to no contact information provided. Serious: No. The outcome of event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Extrasystoles
Clinical narrative: her blood pressure was bottoming out; feeling like her heart was skipping; This is a spontaneous report from a contactable consumer or other non-HCP via Medical Information Team. A 55-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 20Jul2021 as dose 2, single (at the age of 55-years-old) for COVID-19 immunization. Patient medical history included heart disease and 5 heart attacks. The concomitant medications were not reported. Patient was a 55-year-old female. She received the second dose yesterday (20Jul2021) and after an hour she began feeling like her heart was skipping and her blood pressure was bottoming out. She was highly disappointed in the situation. She had really bad heart disease.  She has had 5 heart attacks.  She was in the hospital in January for her heart. She thought she had made an appointment to see her doctor yesterday however it was for a drive through site. She had to fill out paperwork while moving and by the time she was able to see the side effects she had already gotten the vaccine and she got an outdated fact sheet. Yesterday allowed them knowing more information and that she had a bad heart no one said anything.  She was terrified to get the vaccine but it was better than taking the chance of dying. There was too much they did not know about this shot. She would not let her husband and son get it. She would tell everyone not to get it. We were going to take up for Pfizer because we work for them. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity, Product use issue
Clinical narrative: I received my J and J vaccine in March. I was very concerned about the quality, issues and side effects. After a while I lost confidence in their vaccine. After consulting my PCP I decided to get your vaccine. Both shots are now complete; sore arm; felt slightly under the weather; This is a spontaneous report from a contactable consumer. This 59-year-old female consumer (patient) reported that she received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; covid-19 vaccine janssen (COVID-19 VACCINE JANSSEN), via an unspecified route of administration from Mar2021 (Batch/Lot number was not reported) to Mar2021, at unspecified dose for an unspecified indication. The patient medical history and concomitant medications were not reported. Patient received J and J vaccine in March. She was very concerned about the quality, issues and side effects. After a while she lost confidence in their vaccine. After consulting PCP she decided to get vaccine. Both shots are now complete. She has no side effects other than sore arm and felt slightly under the weather. If you want to follow progress or conduct any tests or have a clinical trial related to mixing vaccines please let them know. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive test for she have corona virus; positive test for she have corona virus; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Pfizer product), dose 2 via an unspecified route of administration on 07May2021 as single dose for COVID-19 immunisation. The patient historical vaccine included first dose of BNT162B2 for Covid-19 immunization. The patient concomitant medications were not reported. As reported, the patient experienced 'She just received a positive test for she have corona virus right now she received the positive test for the virus test' on 20Jul2021. As reporter stated, his wife just received a positive test for she had corona virus right at that time. She received the positive test for the virus test. He just, want to get first the concern, if the quality of the vaccine, and happened accidents with corona virus and he guess if they can start quarantine, what should he do about that." Reporter stated, "I haven't been tested yet, but I am about to". The test that she got that day was a swab test and it was a rapid test on 20Jul2021. He asked was it possible that a false positive test occur after she received the vaccine." The patient lab data included rapid test for corona virus with results of positive on 20Jul2021. The outcome of the events was unknown.    The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: Received the Pfizer Covid vaccine second dose after waiting 10 weeks before taking the second dose; Acute fatigue; This is a spontaneous report from a contactable consumer (patient) received from Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included arthritis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient experienced acute fatigue and received the Pfizer Covid vaccine second dose after waiting 10 weeks before taking the second dose on an unspecified date. Patient questioned if they all are lab rats, and Pfizer is of no help. Everything that she was told could be found on the internet. Doctors had no idea what to say. In response, informed client that current information provided is all that is available and referred to MD. Patient received the Pfizer Covid vaccine second dose, after waiting 10 weeks before taking the second dose, at the advise of a physician. Patient stated that 48 hours after taking the second dose of the vaccine, the last 9 days she had been experiencing acute fatigue. Patient stated that she had no significant medical history and was very healthy other than some arthritis. Patient wanted to know how long the acute fatigue would last. Caller not offered transfer to hospital as she was not pleased with response provided, unable to obtain age. In response, caller was told that beyond what was described in the Pfizer-Biontech Covid Vaccine Prescribing Information, Pfizer does not have information on how long what she was experiencing may last and there may be many factors to consider including patient medical history and condition. And advised to consult with her doctor or healthcare provider about what she had experienced or experiencing. And was told that patient's doctor or healthcare provider is in the best position to advise her about the appropriate action to take as they would be most familiar with her medical condition, clinical history, how her treatment had been conducted and any relevant information to her specific case. The events were states as not serious. The clinical outcome of acute fatigue was not recovered.  Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient) received via medical information team.  A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), via an unspecified route of administration, on 06Apr2021, at dose 1, single, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had not received her second dose of vaccination at the time of report. The patient experienced sore arm on Apr2021. The outcome of the event was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neurological symptom
Clinical narrative: neurological reaction; This is a spontaneous report from a contactable dentist (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Feb2021 (Lot number was not reported) as dose 1, single for CVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced neurological reaction after the first dose, on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Internal haemorrhage, Neuropathy peripheral, Pain
Clinical narrative: neurological reaction; This is a spontaneous report from a contactable dentist (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Feb2021 (Lot number was not reported) as dose 1, single for CVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced neurological reaction after the first dose, on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received their first dose in Mar2021, tested positive for Covid a few weeks later; received their first dose in Mar2021, tested positive for Covid a few weeks later; This is a spontaneous report from a contactable pharmacist.A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via unspecified route of administration, on an unknown date in Mar2021, as dose 1, single for COVID-19 Immunization.Medical history and concomitant medications were not reported.The patient underwent lab test included Covid test: positive in 2021 (a few weeks after first dose).It was reported that on an unknown date in 2021, the patient was contracted Covid a few weeks later and missed second shot. Now 3.5 months later, she has received second shot asking if patient should restart regime. The pharmacist inquired about additional information regarding receiving the second dose of the Pfizer Covid-19 vaccine after the recommended time frame. The pharmacist stated the patient asked if she needed to restart the vaccination series. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 antibody test
Clinical narrative: I got really sick/I was sick long time after the vaccine/I got sick months later; This is a spontaneous report from a contactable consumer (patient) received via Pfizer COVID-19 Vaccine Call Center.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  After received the vaccine, months later (on an unspecified date ),  got really sick and was there for long time.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: (against delta and COVID vaccine antibodies). It came back zero. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: caller received his first dose of the Pfizer Covid vaccine in March and then got Covid; caller received his first dose of the Pfizer Covid vaccine in March and then got Covid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Mar2021, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got Covid after first dose in 2021. The patient was unsure if he should now restart the series or get the second dose. He had talked to multiple doctors and one said he can start again after waiting 3 months and another doctor said he should wait and start all over again. He stated he was still confused and didn't know what to do. Everyone was giving him different answers and it was still very very confusing. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.