chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: he felt heavy heart pain for 5 or 6 times on and off since the 2nd dose of the vaccine; he felt heavy heart pain for 5 or 6 times on and off since the 2nd dose of the vaccine; pain started the next morning the vaccine shot; he had fever for few hours; stomachache; vomiting; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 12-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FC3181), second dose via an unspecified route of administration, administered in left arm on 03Sep2021 at 04:30 (at the age of 12-year-old) as dose 2, single for COVID-19 immunisation. Medical history was reported as none. No concomitant medications were not reported. No known allergies were reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3180), first dose via an unspecified route of administration, administered in left arm on 10Aug2021 at 09:15 (at the age of 12-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received any other medication within 2 weeks was reported as none. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 04Sep2021 at 16:00,It was reported that he felt heavy heart pain for 5 or 6 times on and off since the 2nd dose of the vaccine(Friday 4pm) the paint started the next morning the vaccine shot. each times the pain last at least 5 minutes. beside heart pain, he had fever for few hours, stomachache, vomiting. all these symptoms stop on 3rd day (Monday morning). the symptom about the heart pain worry me that is one of the rare side effects that Inwould like it be tracked. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was reported as unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Suspected COVID-19
Clinical narrative: Breakthrough COVID-19; Breakthrough COVID-19; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were none. On an unspecified date, the patient experienced breakthrough COVID-19. The patient stated that event took place after use of product. The patient underwent lab tests and procedures which included Covid-19 testpositive on an unspecified date. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: severe anaphylactic reaction; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sponsored program. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date, dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe anaphylactic reaction. The reporter wanted to know if she could get the ingredients of the COVID-19 vaccine and if the regulatory authority has approved the COVID-19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: they are now testing positive for COVID 19; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 25Aug2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient was received her first dose of the Pfizer COVID 19 vaccine on 25Aug2021. The patient states that they have not been exposed to anyone with COVID 19 and that they are now testing positive for COVID 19. The patient states that it has been 8-9 days and the patient tested positive on Saturday (04Sep2021). The patient would like to know if this is because of the vaccine and that they really don't have the virus. The patient makes an example of when people get the flu shot and then get sick with the flu. The patient states that it's the same because the vaccine is COVID that they put in their body. The patient was like to know if she can still get her second dose of the vaccine now since she has tested positive after the first dose. The patient states that this vaccine was the virus so that was why patient was testing positive right, patient states that the vaccine puts the virus in your body. Outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Symptoms since Covid vaccines; Symptoms since Covid vaccines; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, and 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. The patient medical history and concomitant medications were not reported. The patient experienced symptoms since covid vaccines on an unspecified date. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Intermenstrual bleeding
Clinical narrative: abdomen pain; metrorrhagia; This is a spontaneous report from a contactable consumer (patient). This 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EW0165, on 01May2021 at single dose in left arm (at the age of 34-year-old) for COVID-19 immunization.  Medical history was none. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2, Lot number EN6207, on 10Apr2021 11:00 in left arm forCovid-19 Immunization. After getting 2nd dose, the patient started to have metrorrhagia starting the 2 days after (03May2021). It lasted for 2 weeks. She never had a metrorrhagia in her entire life. She called hospital to report side effects, but they said she needed to see her doctor regarding this. She went to gynecology to see what's going on, and he said there wasn't any study regarding women's metrorrhagia side effect, but he had seen a lot of women suffering similar issue after getting vaccine, such as re-starting period after menopause. It's been almost 4 months since she got vaccinated, and she still had abdomen pain sometimes. Her biggest concern was that it would affect her body for not getting pregnant. They had been trying to get pregnant since 3 months and it's not happening. She was really worried. She was hearing similar side effects from a lot of people nowadays. No treatment was received. The outcome of the events was not resolved. The event metrorrhagia was serious with life-threatening.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Diffuse alopecia, SARS-CoV-2 test
Clinical narrative: Hair loss - Telogen Effluvium; This is a spontaneous report from a contactable Physician (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: not reported), via an unspecified route of administration on 12Apr2021 at 12:00 (age at vaccination was 53-year-old) as dose number unknown, single for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history was reported as none. The concomitant medications were not reported. The patient was not allergic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications was received within 2 weeks of vaccination. On 26Jul2021, the patient experienced hair loss-telogen effluvium. The patient underwent lab tests and procedures which included polymerase chain reaction (PCR) was negative on an unspecified date through nasal swab. Therapeutic measures were taken as a result of event. The treatment medication included over the conger medication for the event. No seriousness was reported for event. Outcome of the event was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Oropharyngeal pain, Pyrexia, Tremor
Clinical narrative: My temperature started rising, and reached 102.8 degrees; sore throat; severe chills; severe chills where I couldn't stop shaking.; This is a spontaneous report from a contactable consumer (patient herself). A 75-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Sep2021 at 14:30 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE (age at vaccination was 75 years old) for covid-19 immunization, administered at a Pharmacy or Drug Store. The patient medical history was not reported. No known allergies. Concomitant medications included carvedilol (strength: 3.125 mg) at 3.125 mg and methylprednisolone (strength: 8 mg) at 8 mg, both taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated, on 03Sep2021 at 2.30 pm, approximately 24 hours later "I started to get a sore throat, then I got severe chills where I couldn't stop shaking. My temperature started rising, and reached 102.8 degrees. My normal temperature is always 97.7 degrees. When my temp reached 101.2 degrees my husband gave me one Tylenol (extra strength). When it reached 102.6 he gave me another one. I slowly started to warm up and my temperature slowly started to come down. By about 1:30 in the morning my temperature was down to 99.3 and I was feeling good enough to finally go to sleep. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Lab data included body temperature: 102.8 degrees, 101.2 degrees and 102.6 degrees on 03Sep2021; body temperature: 99.3 on 04Sep2021. Patient received Tylenol as treatment for pyrexia and no treatment was given for any other events. At the time of this report, the outcome of all the events was resolving.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Pain in extremity
Clinical narrative: Severe arm pain into the joints; Severe arm pain into the joints; Inability to lift arm; This is a spontaneous report from a contactable other hcp (patient).  A 26-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in arm right on 04Sep2021 12:30 (Batch/Lot Number: Fc3184) (at the age of 26-years-old) as SINGLE for covid-19 immunization at Pharmacy or Drug Store. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies. Patient medical history included pre-hashimotos from an unknown date and unknown if ongoing. Patient concomitant medication(s) included dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL) taken for an unspecified indication, start and stop date were not reported. On 04Sep2021 at 14:00, The patient experienced severe arm pain into the joints and had inability to lift her arm. The patient did not received any treatment for the events. The outcome of events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Today he had little bit of fever 99.5; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: FF2589) via an unspecified route of administration on 05Sep2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose on unspecified date (Lot number: FC3181) for covid-19 immunisation. On 06Sep2021, the patient had little bit of fever 99.5. The outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dry skin, Dry throat, Glossitis, Glossodynia, Paraesthesia
Clinical narrative: It started 12 hours after I got the vaccine and it was kind of itching, prick kind of a stinging nerve like sensation and that would be all over my body; It started 12 hours after I got the vaccine and it was kind of itching, prick kind of a stinging nerve like sensation and that would be all over my body; For some reason my tongue and my throat were really dry and irritated but my tongue is sore and my throat was kind of irritated; For some reason my tongue and my throat were really dry; my tongue is sore; tongue really dry and irritated; tongue really dry; Dry skin and this would not but it was not dry skin, it was something irritating my whole body from inside out; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number not reported), dose 1 via an unspecified route of administration on 13Mar2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported.   On an unspecified date, 12 hours after getting the vaccine the patient experienced kind of itching, prick kind of a stinging nerve like sensation and that would be all over the body. Patient also reported that for some reason tongue and throat were really dry and irritated but tongue is sore and throat was kind of irritated, dry skin and this would not but it was not dry skin, it was something irritating the whole body from inside out. Patient appointment came and went to get the second shot and never got the second shot. Clinical course: It started 12 hours after patient got the vaccine and it was kind of itching, prick kind of a stinging nerve like sensation and that would be all over the body not at the same time, but it might go from nose to ankle, to elbow just one and it varied and the links of tiny twines but at times it is few seconds apart and patient does not know how to describe it. The other thing that patient had that for some reason, patient's tongue and throat were really dry and irritated but tongue was sore and throat was kind of irritated, but the thing about it was, that it lasted for 8 weeks. So, patient appointment came and went to get second shot because it was in a no way going to do that which is still going on. Patient did not know what it was or if it is going to get worse or will go away. So reason to say, patient never got the second shot but although. Patient primary care doctor treated the patient for dry skin and this would not but it was not dry skin, it was something irritating my whole body from inside out. Patient adverse reactions lasted for 8 weeks. Therapeutic measures were taken as a result of, dry skin and this would not but it was not dry skin, it was something irritating my whole body from inside out. Outcome for the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Throat irritation, Tongue dry
Clinical narrative: It started 12 hours after I got the vaccine and it was kind of itching, prick kind of a stinging nerve like sensation and that would be all over my body; It started 12 hours after I got the vaccine and it was kind of itching, prick kind of a stinging nerve like sensation and that would be all over my body; For some reason my tongue and my throat were really dry and irritated but my tongue is sore and my throat was kind of irritated; For some reason my tongue and my throat were really dry; my tongue is sore; tongue really dry and irritated; tongue really dry; Dry skin and this would not but it was not dry skin, it was something irritating my whole body from inside out; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number not reported), dose 1 via an unspecified route of administration on 13Mar2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported.   On an unspecified date, 12 hours after getting the vaccine the patient experienced kind of itching, prick kind of a stinging nerve like sensation and that would be all over the body. Patient also reported that for some reason tongue and throat were really dry and irritated but tongue is sore and throat was kind of irritated, dry skin and this would not but it was not dry skin, it was something irritating the whole body from inside out. Patient appointment came and went to get the second shot and never got the second shot. Clinical course: It started 12 hours after patient got the vaccine and it was kind of itching, prick kind of a stinging nerve like sensation and that would be all over the body not at the same time, but it might go from nose to ankle, to elbow just one and it varied and the links of tiny twines but at times it is few seconds apart and patient does not know how to describe it. The other thing that patient had that for some reason, patient's tongue and throat were really dry and irritated but tongue was sore and throat was kind of irritated, but the thing about it was, that it lasted for 8 weeks. So, patient appointment came and went to get second shot because it was in a no way going to do that which is still going on. Patient did not know what it was or if it is going to get worse or will go away. So reason to say, patient never got the second shot but although. Patient primary care doctor treated the patient for dry skin and this would not but it was not dry skin, it was something irritating my whole body from inside out. Patient adverse reactions lasted for 8 weeks. Therapeutic measures were taken as a result of, dry skin and this would not but it was not dry skin, it was something irritating my whole body from inside out. Outcome for the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Cough, Fatigue, Headache, Lymphadenopathy
Clinical narrative: swollen lymph nodes/swollen lymph nodes in armpit of injection site; Nausea; Tired; Sore armpit of injection site; Nighttime cough; Sore arm of injection site; Mild headache; This is a spontaneous report from a contactable other healthcare professional (patient) reported for herself. A 35-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: FF2588), via an unspecified route in the left arm on 02Sep2021 at 12:45 (age at vaccination: 35-year-old), as a single dose for covid-19 immunization. Medical history included HBP, Obesity, Migraine Headaches, Asthma and Known allergies to Amoxicillin, Ragweed, Dogs and Cats. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ) 10/12.5 mg QD; hydrochlorothiazide, lisinopril (ESTARLLYA) QD and cetrizine. It was unknown if prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Sep2021 at 20:00, patient experienced sore arm of injection site, Mild headache (day 1); on 03Sep2021 (day 2) sore arm of injection site, Mild headache, Nausea, Tired, Sore armpit of injection site, Nighttime cough; on 04Sep2021 (day 3) Sore arm of injection site, Nausea, Sore armpit of injection site (toward end of evening she could feel swollen lymph nodes), Nighttime cough and on 05Sep2021 (day 4) Sore/swollen lymph nodes in armpit of injection site - about marble size, tender with touch & movement, Nighttime cough. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: swollen lymph nodes/swollen lymph nodes in armpit of injection site; Nausea; Tired; Sore armpit of injection site; Nighttime cough; Sore arm of injection site; Mild headache; This is a spontaneous report from a contactable other healthcare professional (patient) reported for herself. A 35-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: FF2588), via an unspecified route in the left arm on 02Sep2021 at 12:45 (age at vaccination: 35-year-old), as a single dose for covid-19 immunization. Medical history included HBP, Obesity, Migraine Headaches, Asthma and Known allergies to Amoxicillin, Ragweed, Dogs and Cats. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ) 10/12.5 mg QD; hydrochlorothiazide, lisinopril (ESTARLLYA) QD and cetrizine. It was unknown if prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Sep2021 at 20:00, patient experienced sore arm of injection site, Mild headache (day 1); on 03Sep2021 (day 2) sore arm of injection site, Mild headache, Nausea, Tired, Sore armpit of injection site, Nighttime cough; on 04Sep2021 (day 3) Sore arm of injection site, Nausea, Sore armpit of injection site (toward end of evening she could feel swollen lymph nodes), Nighttime cough and on 05Sep2021 (day 4) Sore/swollen lymph nodes in armpit of injection site - about marble size, tender with touch & movement, Nighttime cough. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Meniere's disease, Vertigo
Clinical narrative: Caller says her vertigo and Meniere's were worse than with the first dose after the second; Caller says her vertigo and Meniere's were worse than with the first dose after the second; Dizzy; This is a spontaneous report from a contactable consumer or other non hcp. A 83-years-old female patient received bnt162b2 (BNT162B2) solution for injection, dose 2 (Lot Number: FC3181 expiry date was unknown) via an unspecified route of administration on 09Aug2021 (at the age of 83-years-old) as a single dose for covid-19 immunisation. Medical history included, meniere's disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical Vaccine dose 1 (LOT EW0168 expiry date was unknown) via an unspecified route of administration on 13Jul2021 as a single dose for covid-19 immunisation.  Consumer said that she called because after she got her first shot on 13Jul2021, clarified to being Pfizer COVID-19 vaccine, she was a patient who has suffered with Meniere's and vertigo which she has had about 6 years off and on. She said she was very concerned about getting the Pfizer shot, then she got it and after that her Meniere's was coming back. She said she got concerned that if she got the second shot it would get worse so she put it off, and ended up getting her second shot 4 days later than she should have gotten it earlier. She says she called her Ear, Nose, and Throat doctor (ENT) and her primary care provider because she was so concerned, she would get vertigo and Meniere's back, but she got it because they said at her age, she needed to get the shot. She says she talked to 5 physicians and they all said same thing, so she got the shot. She says ever since that, her Meniere's has come back as a ringing and pounding in her ears is back, and it never goes away, and she was dizzy every day, this has changed her whole life. Report Type: Reporter says she has a case number called MJYLXKDQ. Follow up report. Caller said the reason she was calling back was if she help someone else, since when she called and asked if anyone reported Meniere's and vertigo, they had nothing on file. She said she would like to help someone else who suffers with these things since there is no cure for Meniere's or of vertigo, and if you have got it, you have to ride it out. She said after the shot, hers came back with a vengeance. Email Address: Caller declined to provide. Pfizer COVID-19 vaccine:  She said no NDC/EXP were provided on her vaccine card for her doses. Reporter said her vertigo and Meniere's were worse than with the first dose after the second, it was not as much with the first. She said at her age she knew she should get it, she was very concerned, and all her doctors said she should get it, and her ENT really did, she went to them for her Meniere's and vertigo, and they said she needed the shot, to go get the shot, and they would give her Valium if she needs it.  Follow-Up (13Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Depressed mood, Fatigue, Headache
Clinical narrative: She start today with coughing; she is coughing and coughing; this coughing is really bad; coughing too much; After the shot she feels tired then during in the night; Her heart; heartbeat go more faster; She feel weak; Headache; She is very down; She do not want to eat; she feel like nausea; This is a spontaneous report from a contactable consumer (Parent). A 12-year-old female patient received 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 dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer stated that Yesterday we went to Pharmacy and put their vaccine for my daughter 12-year-old. Yesterday she was prefect, but she started today with coughing and consumer didn't find anywhere, consumer read all the information about it was Pfizer vaccine. Consumer didn't find the coughing. She felt tired, her heart and this moment, it was like heartbeat go more faster and she was coughing and coughing, and she felt weak. But consumer read a cough was normal. But consumer didn't find the coughing.  She was coughing. Yesterday she was perfect. After the vaccine, this morning she started coughing. Consumer wanted to know if this coughing could be normal for the vaccine or consumer have to take it her to doctor or consumer have to take it to hospital. Because she was coughing was really bad. She got a headache; she was very down. Her heart was got a like a fast, feel like a little bit faster. Consumer believed she was coughing too much consumer don't know. But yesterday she was perfect. After the shot she feels tired then during in the night. And this morning she start with the coughing. Consumer gave Tylenol (treatment) to her, she started with the headache. She did not want to eat. She felt like a nausea. The outcome of 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: Heart rate increased, Nausea
Clinical narrative: She start today with coughing; she is coughing and coughing; this coughing is really bad; coughing too much; After the shot she feels tired then during in the night; Her heart; heartbeat go more faster; She feel weak; Headache; She is very down; She do not want to eat; she feel like nausea; This is a spontaneous report from a contactable consumer (Parent). A 12-year-old female patient received 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 dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer stated that Yesterday we went to Pharmacy and put their vaccine for my daughter 12-year-old. Yesterday she was prefect, but she started today with coughing and consumer didn't find anywhere, consumer read all the information about it was Pfizer vaccine. Consumer didn't find the coughing. She felt tired, her heart and this moment, it was like heartbeat go more faster and she was coughing and coughing, and she felt weak. But consumer read a cough was normal. But consumer didn't find the coughing.  She was coughing. Yesterday she was perfect. After the vaccine, this morning she started coughing. Consumer wanted to know if this coughing could be normal for the vaccine or consumer have to take it her to doctor or consumer have to take it to hospital. Because she was coughing was really bad. She got a headache; she was very down. Her heart was got a like a fast, feel like a little bit faster. Consumer believed she was coughing too much consumer don't know. But yesterday she was perfect. After the shot she feels tired then during in the night. And this morning she start with the coughing. Consumer gave Tylenol (treatment) to her, she started with the headache. She did not want to eat. She felt like a nausea. The outcome of events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood test, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: Headache; body/neck aches; body/neck aches; chest pain; difficulty breathing; lower back pain; This is a spontaneous report from a contactable consumer. This 16-year-old male consumer (patient) reported for himself that.  A 16-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 03Sep2021 16:00 (Age at time of vaccination 16-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported) administered in Arm Right On Aug2021 15:30 for covid-19 immunization. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient medical history, concomitant medications were not reported. No other medical history. He eats healthy and is muscular and physically fit. Ethnicity information is available. Device Date was 05Sep2021. COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient not received any other medications  within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, Prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 2021 The patient underwent lab tests and procedures which included blood test: unknown results, electrocardiogram: unknown results, troponin: unknown results, x-ray: unknown results. On 04Sep2021 15:00 The patient experienced headache, body/neck aches, chest pain, difficulty breathing, lower back pain. Therapeutic measures were taken as a result of all events. AE resulted in Emergency room/department or urgent care. Events were consider as non serious. The outcome of events were resolving.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Neck pain, Pain, Troponin, X-ray
Clinical narrative: Headache; body/neck aches; body/neck aches; chest pain; difficulty breathing; lower back pain; This is a spontaneous report from a contactable consumer. This 16-year-old male consumer (patient) reported for himself that.  A 16-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 03Sep2021 16:00 (Age at time of vaccination 16-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported) administered in Arm Right On Aug2021 15:30 for covid-19 immunization. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient medical history, concomitant medications were not reported. No other medical history. He eats healthy and is muscular and physically fit. Ethnicity information is available. Device Date was 05Sep2021. COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient not received any other medications  within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, Prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 2021 The patient underwent lab tests and procedures which included blood test: unknown results, electrocardiogram: unknown results, troponin: unknown results, x-ray: unknown results. On 04Sep2021 15:00 The patient experienced headache, body/neck aches, chest pain, difficulty breathing, lower back pain. Therapeutic measures were taken as a result of all events. AE resulted in Emergency room/department or urgent care. Events were consider as non serious. The outcome of events were resolving.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Decreased appetite, Feeling abnormal
Clinical narrative: Fever; Chills; Lots of night sweats; Nausea; Feels like been run over the train; Weakness; Low appetite; This is a spontaneous report from a contactable consumer (Patient, reported for herself).  A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on 03Sep2021 (at the age of 76-year-old) as a dose 2, single for COVID-19 immunization. The patient medical history included lung cancer, emphysema, COPD, osteoporosis, aneurysm and blood pressure high. Patient reported that Lot number looks like an AN0187. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Unknown) as a dose 1, single for COVID-19 immunization. The patient also reported that she had 3 IV bags of immunotherapy in the year like it was in 2017 and that bags killed her. Patient had 33 reactions (three treatments ended up in ER with it) from that on 3 IV bags of Immunotherapy and she had to stop it. The concomitant medication of the patient included nivolumab (OPDIVO), verapamil (VERAPAMIL), lisinopril (LISINOPRIL), lorazepam (LORAZEPAM) and meloxicam (MELOXICAM). Patient stated that she took verapamil as it was the blood pressure medicine, lisinopril 20mg, once a day, lorazepam 1mg, about she stated it was 8 hours, but she does not take it at all. Patient took occasionally meloxicam 15 mg, but it was not an ongoing thing and don't take to thin the blood. Patient don't need no thin blood with the aneurysm. Patient stated that lisinopril causes her to cough and took it for years. Patient took it for 15-18 years. Patient stated that she took two shots and it never bothers her other vaccine prior to 4 weeks of COVID vaccine. Patient wants to take the shot but not this year. On an unspecified the patient had some reaction to this second shot. Patient started of having in less than 24 hours after she had taken the shot fever, Chills, lots of night sweats and nausea and feel like been run over the train. Patient reported that three weeks back she had the first actually the couple of days over. Patient had it about 03:15 or something like that or 03:30 before that time the next day, she don't know maybe around 2'O clock 3'O clock the next day, Patient was sick and wanted to know how long this step was going to last, this fever and weakness and last night she had night sweats and have low appetite. The patient underwent lab tests and procedures for fever. Patient received the treatment of Tylenol. Outcome for all the reported events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Night sweats, Pyrexia
Clinical narrative: Fever; Chills; Lots of night sweats; Nausea; Feels like been run over the train; Weakness; Low appetite; This is a spontaneous report from a contactable consumer (Patient, reported for herself).  A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on 03Sep2021 (at the age of 76-year-old) as a dose 2, single for COVID-19 immunization. The patient medical history included lung cancer, emphysema, COPD, osteoporosis, aneurysm and blood pressure high. Patient reported that Lot number looks like an AN0187. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Unknown) as a dose 1, single for COVID-19 immunization. The patient also reported that she had 3 IV bags of immunotherapy in the year like it was in 2017 and that bags killed her. Patient had 33 reactions (three treatments ended up in ER with it) from that on 3 IV bags of Immunotherapy and she had to stop it. The concomitant medication of the patient included nivolumab (OPDIVO), verapamil (VERAPAMIL), lisinopril (LISINOPRIL), lorazepam (LORAZEPAM) and meloxicam (MELOXICAM). Patient stated that she took verapamil as it was the blood pressure medicine, lisinopril 20mg, once a day, lorazepam 1mg, about she stated it was 8 hours, but she does not take it at all. Patient took occasionally meloxicam 15 mg, but it was not an ongoing thing and don't take to thin the blood. Patient don't need no thin blood with the aneurysm. Patient stated that lisinopril causes her to cough and took it for years. Patient took it for 15-18 years. Patient stated that she took two shots and it never bothers her other vaccine prior to 4 weeks of COVID vaccine. Patient wants to take the shot but not this year. On an unspecified the patient had some reaction to this second shot. Patient started of having in less than 24 hours after she had taken the shot fever, Chills, lots of night sweats and nausea and feel like been run over the train. Patient reported that three weeks back she had the first actually the couple of days over. Patient had it about 03:15 or something like that or 03:30 before that time the next day, she don't know maybe around 2'O clock 3'O clock the next day, Patient was sick and wanted to know how long this step was going to last, this fever and weakness and last night she had night sweats and have low appetite. The patient underwent lab tests and procedures for fever. Patient received the treatment of Tylenol. Outcome for all the reported 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, Muscle twitching, Pain in extremity
Clinical narrative: kind of tired; arm hurt; started getting these little twitches; This is a spontaneous report from a contactable consumer (patient).  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on Aug2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient had experienced kind of tired, arm hurt and getting these little twitches. At the time of reporting, the outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Supraventricular tachycardia
Clinical narrative: SVT rapid heart beats over 200. Hospitalized.; SVT rapid heart beats over 200. Hospitalized.; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number FA7485 and expiry date not reported), via an unspecified route of administration, on 19Aug2021 (at the age of 40-year-old), as dose 1, single, for COVID-19 immunisation in Pharmacy or Drug Store. The patient medical history and 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 had not been tested for COVID-19. On 20Aug2021, the patient experienced SVT rapid heartbeats over 200. Paint went to emergency room visit and was hospitalized. Patient was treated by cardiologist due to the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Body temperature, Maternal exposure during pregnancy, Pyrexia, SARS-CoV-2 test
Clinical narrative: Miscarriage; Vomiting; 103 fever (2 consecutive); Pregnancy at time of Vaccination: Yes; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Aug2021 (at the age of 28-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported and concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient was pregnant at the time of vaccination and had maternal exposure during pregnancy. On 14Aug2021, the patient experienced 103 fever (2 consecutive), vomiting and had miscarriage. The patient received ultrasound-complete miscarriage and treatment for other events. The adverse events resulted in doctor or other health care professional office/clinic visit. The outcome of the events was recovered with sequel.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Vomiting
Clinical narrative: Miscarriage; Vomiting; 103 fever (2 consecutive); Pregnancy at time of Vaccination: Yes; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Aug2021 (at the age of 28-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported and concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient was pregnant at the time of vaccination and had maternal exposure during pregnancy. On 14Aug2021, the patient experienced 103 fever (2 consecutive), vomiting and had miscarriage. The patient received ultrasound-complete miscarriage and treatment for other events. The adverse events resulted in doctor or other health care professional office/clinic visit. The outcome of the events was recovered with sequel.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergies; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program COVAX US Support via medical information team. A female patient of an unspecified age reported for herself that she received bnt162b2 (Comirnaty, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had first dose of Pfizer vaccine less than month ago. Pharmacist had told her not to get the second dose of covid vaccine because of her allergies. She did not have any issues from first dose. They told her it would be the 2nd dose that she would have an issue with. The patient wanted to know if she would be able to get second dose of vaccine. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: A major flare up of general herpes; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown), dose 2 via an unspecified route of administration on 01Mar2021 (at the age of 50-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reported that after the second vaccination shot had a major recurrence. After the second dose of the vaccine, I had a major flare up of general herpes (01Mar2021) which I had not have a flare up of in over ten years so just wanna let you know that that will happen possibly and that was an adverse event part. The clinical outcome of event was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.