chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia
Clinical narrative: loss of taste and smell; loss of taste and smell; joint pain; This is a spontaneous report from a contactable consumer (patient's father) reported. A 16-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199; Expiration Date: Jun2021) via an unspecified route of administration, administered in arm right on 10Mar2021 13:30 as first dose, single dose for COVID-19 immunization. The patient medical history was not reported. There were no allergies reported. Concomitant medication included MULTIVITAMIN, VITAMIN D3 and VITAMIN C. After Received the first dose of Covid Vaccine, the patent had every side effect on the list plus those not listed, loss of taste and smell to some extent and joint pain. He missed 5 days of school. He got it on a Wednesday, 31Mar2021 and was too sick to get out of bed on Thursday, 01Apr2021 and Friday, 02Apr2021. Thursday morning, 01Apr2021 he passed out and hit the floor. On the following Monday, 05Apr2021 he struggled back to school after 5 days, but came home early. He has just been trashed, too trashed to train for his sport, further described as too weak to train, he hasn't trained for 3 weeks. He still has a fever. His local doctor here does not have any suggestions other than he should take acetaminophen and ibuprofen alternately to get rid of the headache and fever. The patient was administered his second dose of Pfizer Covid Vaccine on 31Mar2021. After the 2nd dose of vaccination, the patient experienced Pain in the arm, Redness, Swelling, 2 inch diameter raised circle at injection site, Tiredness, Fever, Shortness of breath, Passed out, Hit the floor, Put a big bump on his head; Chills, Headache, Muscle pain, Leg pain, Fatigue, Too trashed to train for his sport, Joint pain, Swollen glands, Loss of taste and smell to some extent, Brain fog, The time to recover from any exertion seems to be longer by a lot. Onset time after receipt of second dose of Pfizer Covid Vaccine: 3 hours. When patient experienced peak expression of adverse event after receipt of second dose of Pfizer Covid Vaccine: 48 hours. No other vaccine within four weeks prior to the first administration date of the suspect vaccine. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Full blood count, Oral herpes
Clinical narrative: This is a spontaneous report from a contactable consumer (the patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration, in left arm on 10Feb2021 as a single dose for COVID-19 immunisation. Medical history included intracranial pressure increased. Concomitant medication included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT62B2 for COVID-19 immunization on 20Jan2021 and Valtrex for cold sores (which the patient had that through childhood but the patient had not had it for like 10 years. Doctor set patient on Valtrex and then when patient stopped Valtrex it started up again). On an unspecified date, the patient experienced flair out or outbreak of cold sores. It was reported that the patient had seen some article saying that It could be like that a Pfizer vaccine could be a trigger for someone that had that in the past, and wanted to get some information on it. The patient underwent lab tests and procedures which included full blood count: unknown result on an unspecified date. Therapeutic measures were taken as a result of flair out or outbreak of cold sores (oral herpes) with Valtrex. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Sensory loss
Clinical narrative: He lost feeling in his entire arm.; He had complete numbness in his arm; Later in the day he got tingling and then had feeling back in his arm and hands; This is a spontaneous report from a contactable consumer (patients wife). A 57-year-old male patient received 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 (at the age of 57-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications. On an unspecified date, the patient had a reaction at the site and they kept him there to monitor him. He lost feeling in his entire arm. He had complete numbness in his arm. Later in the day he got tingling and then had feeling back in his arm and hands. Outcome of the events are reported as unknown at this point of time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: very sore arm; low grade fever; rash chest and back; electrical shock feeling like upper side of teeth; aches; This is a spontaneous report received from a contactable consumer (Patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9266 and Expiration date was not reported), via an unspecified route of administration, in left arm, on 21Feb2021 at 15:00 (at the age of 58 years), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9262 and Expiration date was not reported), via an unspecified route of administration, in arm left, on 31Jan2021 at 15:00 (at the age of 58 years), as a single dose for COVID-19 immunisation. On an unknown date, the patient stated that very sore arm for 2-3 days onset immediate stayed in bed next day aches, low grade fever better by evening, rash chest and back(shoulders) 3rd day electrical shock like feeling right side upper teeth-lasted about 1 week. AE doesn't require a visit to Emergency Room, Physician Office. There was no treatment received. Outcome of the events was reported as unknown.  No follow up attempts are needed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sluggishness, Throat tightness, Vaccination site pain
Clinical narrative: Tightness in throat for 15 minutes; light fever; feeling very sluggish; pain when the vaccine was administered.; This is a spontaneous report from a contactable consumer (patient). A 21-years-old male patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration, in left arm on 30Apr2021 at 16:30 (at the age of 21-years-old) as First dose , single dose for covid-19 immunisation. Medical history included crohn's disease, coeliac disease, asthma and Bactrim allergy. Concomitant medications included amoxicillin (AMOXIL), codeine phosphate, paracetamol (TYLENOL WITH CODEINE) and ibuprofen (IBUPROFEN) taken for an unspecified indication. Patient has not received any other vaccine in four weeks. Prior vaccination, patient was not diagnosed with covid-19. Since the vaccination, patient has not tested positive for covid-19. On 30Apr2021 at 16:30, the patient experienced tightness in throat for 15 minutes, light fever, feeling very sluggish and pain when the vaccine was administered. Therapeutic measures were taken as a result of tightness in throat for 15 minutes, light fever, feeling very sluggish and pain. Treatment received for the events included Tylenol 500 mg. Outcome of events was recovering.  No follow-up attempts needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Condition aggravated, Influenza like illness, Oral herpes, Pyrexia
Clinical narrative: outbreak of herpes on her lip; Herpes AE: states it is getting worse, it started as one now she has seven to eight.; tching around the site of injection, spots of itching, no pattern, little tiny red raised dots, one arm, one near ankle, bunch on her back. So small remind her of tiny insect bites.; Flu Like Symptoms; Low Grade Fever; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EW0164) via an unspecified route of administration in the left arm, on 22Apr2021 at 18:00, as 2nd dose, single dose for COVID-19 immunization. Historical vaccine included the patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EW0150) via an unspecified route of administration, as 1st dose, single dose for COVID-19 immunization. Medical history included oral herpes. Concomitant medications were not reported. On 23Apr2021, the patient experienced herpes outbreak, Arm, Itching around the site of injection, spots of itching, no pattern, little tiny red raised dots, one arm, one near ankle, bunch on her back. So small remind her of tiny insect bites, flu Like symptoms and low Grade Fever. The patient stated nothing happened with the first vaccine. The patient stated that she wanted to self report, and she had some drive time, so she was calling to self report a side effect. The patient also stated she doesn't know how common it was but she read shingles was something that was reported in rheumatology. She had an outbreak of herpes on her lip and used to getting one spot once or twice a year, usually with extreme weather changes. The patient reported that 8-12 hours after the shot, she had multiple outbreaks, 7-8 outbreaks where the lip meets the skin. The patient had called her physician to order Valtrex. The patient also stated what she saw on the websites, there have been reports of shingles outbreaks. Stated she had shingles before, but not the shingles vaccine. The patient received treatment Benadryl and Valtrex. Additional vaccines administered on same date of the Pfizer Suspect was none. Prior Vaccinations within 4 weeks was both doses of the Pfizer Covid Vaccine. The outcome of the event oral herpes was not recovered. Outcome of the event condition aggravated was unknown. Outcome of the event vaccination site pruritis was recovering. On 24Apr2021, the outcome of the event flu like symptoms and pyrexia was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: outbreak of herpes on her lip; Herpes AE: states it is getting worse, it started as one now she has seven to eight.; tching around the site of injection, spots of itching, no pattern, little tiny red raised dots, one arm, one near ankle, bunch on her back. So small remind her of tiny insect bites.; Flu Like Symptoms; Low Grade Fever; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EW0164) via an unspecified route of administration in the left arm, on 22Apr2021 at 18:00, as 2nd dose, single dose for COVID-19 immunization. Historical vaccine included the patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EW0150) via an unspecified route of administration, as 1st dose, single dose for COVID-19 immunization. Medical history included oral herpes. Concomitant medications were not reported. On 23Apr2021, the patient experienced herpes outbreak, Arm, Itching around the site of injection, spots of itching, no pattern, little tiny red raised dots, one arm, one near ankle, bunch on her back. So small remind her of tiny insect bites, flu Like symptoms and low Grade Fever. The patient stated nothing happened with the first vaccine. The patient stated that she wanted to self report, and she had some drive time, so she was calling to self report a side effect. The patient also stated she doesn't know how common it was but she read shingles was something that was reported in rheumatology. She had an outbreak of herpes on her lip and used to getting one spot once or twice a year, usually with extreme weather changes. The patient reported that 8-12 hours after the shot, she had multiple outbreaks, 7-8 outbreaks where the lip meets the skin. The patient had called her physician to order Valtrex. The patient also stated what she saw on the websites, there have been reports of shingles outbreaks. Stated she had shingles before, but not the shingles vaccine. The patient received treatment Benadryl and Valtrex. Additional vaccines administered on same date of the Pfizer Suspect was none. Prior Vaccinations within 4 weeks was both doses of the Pfizer Covid Vaccine. The outcome of the event oral herpes was not recovered. Outcome of the event condition aggravated was unknown. Outcome of the event vaccination site pruritis was recovering. On 24Apr2021, the outcome of the event flu like symptoms and pyrexia was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sore on roof of mouth and on inner lower lip; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 42-years-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01May2021 at 12:15 (Batch/Lot Number: EW0172) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation at Pharmacy or Drug Store (42-years-old at the time of vaccination). Patient received first dose of (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 10Apr2021 12:00 (Batch/Lot Number8729) for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing and there were no allergies. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE SODIUM), fluoxetine hydrochloride (PROZAC), ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. Post or prior to the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021, the patient experienced cold sore on roof of mouth and on inner lower lip. Patient did not receive any treatment for the event. The clinical outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Loss of personal independence in daily activities
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. It was reported that she received her first dose of the Pfizer BioNTech COVID-19 vaccine and on an unspecified date, the patient was sick for 4 days after where she could not get out of bed and could not even get up to eat. She stated that with the second dose of the vaccine, she was sick for 5 days after. The outcome of the events was unknown. Additionally patient states that she was calling to report side effects that her 84 year old mother is experiencing after taking Olmesartan (did verify that spelling with the caller). She states that her mother has been experiencing dizziness, headaches, "always sneezing", "always cleaning her eyes and especially her nose", vomiting, and "terrible" diarrhea. patient reported that this has been going on for "many, many long years." Caller only wanted to call in to report this but did ask how long it has been since Pfizer discontinued making this product. Response: Reviewed the attached VR but let caller know that I was unable to find the discontinuation date for this product as it was not listed. Let caller know that I am only trained to speak on the Pfizer BioNTech COVID-19 vaccine and we can only speak about Pfizer produced products here at Pfizer. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Constipation, Herpes zoster, Weight decreased
Clinical narrative: Shingles; stomach issues/pain in his stomach; constipation; He has lost a lot of weight.; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received bnt162b2 (BNT162B2, Lot number: ER9731 and Expiration date: unknown), via an unknown route of administration, in left arm on 18Apr2021 (at the age of 67-years-old) as first dose, single dose for covid-19 immunisation. The patient had no medical history was not reported. The patient concomitant medications were not reported. Patient had not received any other vaccine within 4 weeks. On 23Apr2021, a week later after first dose of vaccine he got shingles. He had been to his family doctor. He was on medication for it at the time of reporting. On an unknown date in Apr2021, he lost a lot of weight. He was going for an ultrasound and they saw his side. They hold him that the ultrasound could not be done because that was shingles. He was getting the ultrasound because he was having stomach issues which started after the vaccine. He was having constipation and pain in his stomach that started on 21Apr2021 or 22Apr2021 (Wednesday or Thursday as reported). That part was getting better. He was put on Valacyclovir, 1 tablet a day for 10 days. He has three more prescriptions. They are all Prednisone. He was on tapered dose. He took on the first day, then drops down to a smaller dose after three days and then drops to an even smaller dose. Patient went to physician office. Therapeutic measures were taken as a result of shingles (herpes zoster), stomach issues/pain in his stomach (abdominal pain upper). Outcome of events constipation and weight loss was unknown while outcome of event abdominal pain upper was recovering and for event herpes zoster was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Pain, Polymerase chain reaction, SARS-CoV-2 test positive
Clinical narrative: Rapid came back positive for covid; Achiness got worse; This is a spontaneous report from a contactable other hcp Nurse (patient).  A patient of an unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 27Apr2021 09:30 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included achiness. The patient's concomitant medications were not reported. On 27Apr2021 13:00, the patient experienced achiness got worse; On 28Apr2021 13:00, had a fever and had a 101 temperature; 14:30 rapid came back positive for COVID and 14:30 patient was just not feeling good. The patient underwent lab tests and procedures which included body temperature: 101 centigrade on 27Apr2021, polymerase chain reaction: positive on 27Apr2021, sars-cov-2 test positive: positive on 27Apr2021. It was reported that patient was not feeling good. The patient just wanted to call to make sure that the patient has COVID and got a vaccine, and it was not a problem. The patient had COVID and at night was feeling some achiness, but thought it was from exercising that patient was doing and then after had the vaccine that was 1 o'clock had a fever. So, was thinking if the patient did not have that achiness, the patient just wanted to go get tested just to be sure because the patient did not want to walk around. The patient finds it odd from first vaccine to be getting any kind of symptoms like that so had a 101 temperature and the achiness got worse. So, the patient went and had a test at 2:30 and had a rapid and a PCR and the rapid came back positive for COVID. The patient wants to know was there any concerns that should have having the vaccine while the patient was positive for COVID. The outcome of all the events was unknown.  No Follow-up attempts are needed. Information about lot/batch cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash, Vaccination site pain, Vaccination site pruritus
Clinical narrative: the site itches, sometimes it burns, and sometimes there is pain.; the site itches, sometimes it burns, and sometimes there is pain.; Shingles; Rash; This is a spontaneous report from a contactable consumer(patient).  A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number was not reported) via an unspecified route of administration, administered in Arm Left on 18Apr2021 14:30 as 1st dose single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Apr2021, a week after first shot he developed the shingles, rash, Therapeutic measures were taken because of rash and treatment included, he was putting hydrocortisone on it. He said that sometimes the site itches, sometimes it burns, and sometimes there is pain. The patient had not recovered from shingles and outcome of the events rash, site inches, burns, pain was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The 2 weeks after receiving second dose of vaccine patient developed shingles on an unspecified date. The patient stated that patient knew 6 other people in patients age group (50s - 60s) that also developed shingles as well, 14 days after your vaccine. Patient had to be hospitalized for an afternoon and the doctors said that the vaccine could have definitely woke up the sleeping virus in body. This has been an extremely painful experience, but patient still would have gotten the C19 vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Pain, Pain in extremity
Clinical narrative: fast heart beat; Fever; body aches; significant arm pain; headache; tiredness; feeling unwell; This is a spontaneous report received from a non-contactable consumer (patient). A 37-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown), in left arm via an unspecified route of administration on 18Apr2021 at 12:15 PM (at the age of 37-year-old) as single dose for Covid-19 immunisation. The patient was not pregnant at the time of vaccination. She took her first dose of vaccination at the age of 37-year-old on 21Mar2021 at 12:15 PM in left arm via unspecified route of administration as single dose for Covid-19 immunisation. Past drug included bactrim and erythromycin for allergies. Medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. No any other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After vaccination, on 18Apr2021 at 16:00, the patient experienced fever, body aches, significant arm pain, headache, fast heartbeat, tiredness, feeling unwell. Since the vaccination, the patient had not been tested for COVID-19. Device date was reported as 29Apr2021. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia
Clinical narrative: fast heart beat; Fever; body aches; significant arm pain; headache; tiredness; feeling unwell; This is a spontaneous report received from a non-contactable consumer (patient). A 37-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown), in left arm via an unspecified route of administration on 18Apr2021 at 12:15 PM (at the age of 37-year-old) as single dose for Covid-19 immunisation. The patient was not pregnant at the time of vaccination. She took her first dose of vaccination at the age of 37-year-old on 21Mar2021 at 12:15 PM in left arm via unspecified route of administration as single dose for Covid-19 immunisation. Past drug included bactrim and erythromycin for allergies. Medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. No any other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After vaccination, on 18Apr2021 at 16:00, the patient experienced fever, body aches, significant arm pain, headache, fast heartbeat, tiredness, feeling unwell. Since the vaccination, the patient had not been tested for COVID-19. Device date was reported as 29Apr2021. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: Sore arm after first dose; This is a spontaneous report from a contactable other hcp (patient, retired registered nurse).    A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EL9264, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 04Feb2021 13:00 as 1st dose, single dose for covid-19 immunisation. The patient medical history included diabetes mellitus, hypertension. Concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer suspect. It was reported that, on 4Feb2021 patient had her first vaccine and had no symptoms of a reaction. She had a sore arm after first dose for a couple days from 4Feb2021 to 6 Feb 2021. Patient took Pfizer Covid-19 vaccine to prevent the disease. Relatedness for event sore arm after first dose was related. The patient underwent lab tests and procedures which included ultrasound scan: numerous blood clots below the knee on 04Apr2021.  Seriousness for sore arm after first dose was reported as not serious. The outcome of the event was recovered.  Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021499940 same patient/drug, diff dose/event
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Positron emission tomogram, White blood cell count increased
Clinical narrative: white blood cell count was very high; This is a spontaneous report from a Pfizer sponsored program. A contactable 59-year-old female consumer (patient) received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation; palbociclib (IBRANCE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 125 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. Historical vaccine included Pfizer Covid Vaccine, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient stated, she had a little rough patch after she got the Pfizer Covid Vaccine. The patient experienced white blood cell count was very high, and it was normally not that high on an unspecified date. The patient underwent lab tests included (PET Scan) positron emission tomogram was come back to show that my tumor had not grown and what I was shrinking. The outcome of event was unknown. The action taken in response to the event for palbociclib was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Diarrhoea, Hypertension, Malaise, Pain in extremity
Clinical narrative: blood pressure was high; Arm was really sore; feeling sick; vomiting; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0158; Expiration date: Jul2021; NDC number: 59267-1000-02), via an unspecified route of administration in right arm on 12Apr2021 (at the age of 42-year-old) as single dose for COVID-19 immunization. Medical history of the patient included ongoing hypertension (from 2020), ongoing acid reflux (from an unspecified date), allergies (unspecified) and stomach problems. Family medical history of the patient included high blood pressure and diabetes. Concomitant medication included Diphenhydramine 25 mg once daily (started in Apr2021 and ongoing) for allergies, Womens Vaginal and Digestive Health Probiotic (started in Apr2021) for stomach problems and multivitamin one tablet once daily (started in Apr2021) to keep up with her health as patient was in her 40s. Patient previously took Amlodipine Besilate/Telmisartan (expiration date: 31Dec2022) in 2020 and stopped the medication because her blood pressure went down. Patient reported that she had not taken the amlodipine/telmisartan at all previously in 2021, but her blood pressure was high this week, so amlodipine/telmisartan was started again in in May2021. Patient previously received flu vaccine (unspecified) on an unspecified date for immunization and did not get sick. Patient stated that she does not usually get sick with vaccinations. On 12Apr2021, patient's arm was really sore, patient had to sit and wait after receiving the first dose of vaccination, and by the time she got home her arm was progressively getting sore and tender. Patient reported that her arm hurt the rest of the week into the weekend. In Apr2021 (two days later after first dose of vaccination), patient was feeling sick when she woke up and experienced a little vomiting and diarrhea. Patient was really sick for a few hours with vomiting and diarrhea. Next day, when patient woke up her stomach had settled. Reportedly, as per patient she had a small reaction to the first dose of the COVID-19 vaccine where she experienced a little vomiting and diarrhea on the third day and reported that the vomiting and diarrhea passed. Patient did not report the vomiting and diarrhea because vaccine information had said that about the third day after the vaccine, patients would get a little sick and the caller thought it was normal. Events arm was really sore, little diarrhea and vomiting resolved in Apr2021 while outcome of event feeling sick was unknown and blood pressure was high as unknown. Investigation Assessment: No  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: blood pressure was high; Arm was really sore; feeling sick; vomiting; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0158; Expiration date: Jul2021; NDC number: 59267-1000-02), via an unspecified route of administration in right arm on 12Apr2021 (at the age of 42-year-old) as single dose for COVID-19 immunization. Medical history of the patient included ongoing hypertension (from 2020), ongoing acid reflux (from an unspecified date), allergies (unspecified) and stomach problems. Family medical history of the patient included high blood pressure and diabetes. Concomitant medication included Diphenhydramine 25 mg once daily (started in Apr2021 and ongoing) for allergies, Womens Vaginal and Digestive Health Probiotic (started in Apr2021) for stomach problems and multivitamin one tablet once daily (started in Apr2021) to keep up with her health as patient was in her 40s. Patient previously took Amlodipine Besilate/Telmisartan (expiration date: 31Dec2022) in 2020 and stopped the medication because her blood pressure went down. Patient reported that she had not taken the amlodipine/telmisartan at all previously in 2021, but her blood pressure was high this week, so amlodipine/telmisartan was started again in in May2021. Patient previously received flu vaccine (unspecified) on an unspecified date for immunization and did not get sick. Patient stated that she does not usually get sick with vaccinations. On 12Apr2021, patient's arm was really sore, patient had to sit and wait after receiving the first dose of vaccination, and by the time she got home her arm was progressively getting sore and tender. Patient reported that her arm hurt the rest of the week into the weekend. In Apr2021 (two days later after first dose of vaccination), patient was feeling sick when she woke up and experienced a little vomiting and diarrhea. Patient was really sick for a few hours with vomiting and diarrhea. Next day, when patient woke up her stomach had settled. Reportedly, as per patient she had a small reaction to the first dose of the COVID-19 vaccine where she experienced a little vomiting and diarrhea on the third day and reported that the vomiting and diarrhea passed. Patient did not report the vomiting and diarrhea because vaccine information had said that about the third day after the vaccine, patients would get a little sick and the caller thought it was normal. Events arm was really sore, little diarrhea and vomiting resolved in Apr2021 while outcome of event feeling sick was unknown and blood pressure was high as unknown. Investigation Assessment: No  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Groin pain, Herpes zoster, Penile pain
Clinical narrative: Herpes zoster right buttock with associated inguinal and penile pain.; Herpes zoster right buttock with associated inguinal and penile pain.; Herpes zoster right buttock with associated inguinal and penile pain.; This is a spontaneous report from a contactable Physician. A 76-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- El9263) via intramuscularly in right arm on 03Feb2021 at 08:30 AM as 2nd dose, single dose for COVID-19 immunization at Clinic. Medical history included crohns, allergic to some seafood, hypertension, hyper cholesterol. Concomitant medication included adalimumab (HUMIRA). Patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- El3246) via intramuscularly in right arm on 13Jan2021 at 08:45 AM as 1st dose, single dose for COVID-19 immunization. On 09Apr2021 at 14:00 PM, patient experienced herpes zoster right buttock with associated inguinal and penile pain. Therapeutic measures were taken as a result of the events included Ibuprofen, acetaminophen, lotions. Patient had not been covid tested post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible . No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives to different parts of her body that include, the neck and back.; This is a spontaneous report from a contactable consumer (Patient) via medical information team. A female patient of an unspecified age received BNT162B2 (COMIRANTY; Solution for injection; Lot number and expiration date was not reported) 2nd dose, via an unspecified route of administration on 23Apr2021 as single dose for covid-19 immunization. The patient historical vaccine included BNT162B2 (COMIRANTY; Solution for injection; Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced hives to different parts of her body that include, the neck and back on an unspecified date in 2021. Patient being followed up by a HCP and treated with antihistamines cream for relief. patient wanted to know the duration of this side effect. There might be many factors to considered including patient medical history and medical condition. Patient was recommended to consult healthcare provider about what she experienced. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report received from a contactable consumer (friend). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient concomitant medications were not reported. The patient experienced shingles on an unspecified date. It was reported that it was full blown shingles. The patient took the covid vaccine and had shingles about a week later. Reporter stated that it might be on his back. The patient didn't realize it until he took the second shot and 3 or 4 weeks later it was bad on his back and chest. The patient had really bad shingles. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021515262 same reporter/drug/AE, different patient;US-PFIZER INC-2021503505 same reporter/drug/AE, different patient
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: tiredness; Nausea, wanting to throw out; I was trying throw up I wasn't really throwing out; I was starting to gag; symptoms of COVID all over; Nausea, wanting to throw out; I was trying throw up I wasn't really throwing out; I was starting to gag; Today (May 07, 2021) feeling sick today; She couldn't move; I was unable to get up of my bed and get medicine or anything; couldn't get up; Mostly I feel lousy all over around; Bad headache; My arm was hurting a little bit then it started getting worsen, worsen and worse; It was very painful; dizziness/ I couldn't rest; I felt dizzy; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0179) dose 1 via an unspecified route of administration, administered in Arm Right on 05May2021  as SINGLE for covid-19 immunization. Medical history included anxiety, depression, foot amputation, hand amputation and thyroid. Concomitant medications includ levothyroxine sodium (LEVOTHYROXINE) taken for thyroid disorder, clonazepam (CLONAZEPAM), duloxetine  and morphine sulfate (MORPHINE SULPHATE). The day when patient came home Wednesday her arm was hurting (stinging) a little bit then it started getting worsen, worsen and worse. It was very painful. When she tried to go to bed, she started getting the feeling symptoms of COVID all over that bad headache, dizziness, nausea, wanting to throw out and was feeling sick. She was trying throw up I wasn't really throwing out, but I was starting to gag and I couldn't rest, she felt dizzy. She was unable to get up of my bed and get medicine or anything, couldn't get up. Mostly She felt lousy all over around. She took medication last night and it helped her. She was going really badly was unable to get up to get my medicine. She couldn't move. Oxycodone (treatment) 30 mg no 10 mg. When asked If she have there was my blood doctor. She did lab test last week and there was her doctor of oncology it was blood work that they checked in everything checked out good. She just wanted to let they know that she was having these severe reactions and she did not know what to do. It was asked if it was ok to take medication and make her feel better, and she doesn't know what to do and was there anything she could do to make herself feel better or no she just had to wait it out. It was stated that 2nd dose will be 26May2021. The outcome of the events was not recovered.  No Follow-up attempts are needed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Malaise, Nausea, Pain in extremity, Retching
Clinical narrative: tiredness; Nausea, wanting to throw out; I was trying throw up I wasn't really throwing out; I was starting to gag; symptoms of COVID all over; Nausea, wanting to throw out; I was trying throw up I wasn't really throwing out; I was starting to gag; Today (May 07, 2021) feeling sick today; She couldn't move; I was unable to get up of my bed and get medicine or anything; couldn't get up; Mostly I feel lousy all over around; Bad headache; My arm was hurting a little bit then it started getting worsen, worsen and worse; It was very painful; dizziness/ I couldn't rest; I felt dizzy; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0179) dose 1 via an unspecified route of administration, administered in Arm Right on 05May2021  as SINGLE for covid-19 immunization. Medical history included anxiety, depression, foot amputation, hand amputation and thyroid. Concomitant medications includ levothyroxine sodium (LEVOTHYROXINE) taken for thyroid disorder, clonazepam (CLONAZEPAM), duloxetine  and morphine sulfate (MORPHINE SULPHATE). The day when patient came home Wednesday her arm was hurting (stinging) a little bit then it started getting worsen, worsen and worse. It was very painful. When she tried to go to bed, she started getting the feeling symptoms of COVID all over that bad headache, dizziness, nausea, wanting to throw out and was feeling sick. She was trying throw up I wasn't really throwing out, but I was starting to gag and I couldn't rest, she felt dizzy. She was unable to get up of my bed and get medicine or anything, couldn't get up. Mostly She felt lousy all over around. She took medication last night and it helped her. She was going really badly was unable to get up to get my medicine. She couldn't move. Oxycodone (treatment) 30 mg no 10 mg. When asked If she have there was my blood doctor. She did lab test last week and there was her doctor of oncology it was blood work that they checked in everything checked out good. She just wanted to let they know that she was having these severe reactions and she did not know what to do. It was asked if it was ok to take medication and make her feel better, and she doesn't know what to do and was there anything she could do to make herself feel better or no she just had to wait it out. It was stated that 2nd dose will be 26May2021. The outcome of the events was not recovered.  No Follow-up attempts are needed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: tiredness; Nausea, wanting to throw out; I was trying throw up I wasn't really throwing out; I was starting to gag; symptoms of COVID all over; Nausea, wanting to throw out; I was trying throw up I wasn't really throwing out; I was starting to gag; Today (May 07, 2021) feeling sick today; She couldn't move; I was unable to get up of my bed and get medicine or anything; couldn't get up; Mostly I feel lousy all over around; Bad headache; My arm was hurting a little bit then it started getting worsen, worsen and worse; It was very painful; dizziness/ I couldn't rest; I felt dizzy; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0179) dose 1 via an unspecified route of administration, administered in Arm Right on 05May2021  as SINGLE for covid-19 immunization. Medical history included anxiety, depression, foot amputation, hand amputation and thyroid. Concomitant medications includ levothyroxine sodium (LEVOTHYROXINE) taken for thyroid disorder, clonazepam (CLONAZEPAM), duloxetine  and morphine sulfate (MORPHINE SULPHATE). The day when patient came home Wednesday her arm was hurting (stinging) a little bit then it started getting worsen, worsen and worse. It was very painful. When she tried to go to bed, she started getting the feeling symptoms of COVID all over that bad headache, dizziness, nausea, wanting to throw out and was feeling sick. She was trying throw up I wasn't really throwing out, but I was starting to gag and I couldn't rest, she felt dizzy. She was unable to get up of my bed and get medicine or anything, couldn't get up. Mostly She felt lousy all over around. She took medication last night and it helped her. She was going really badly was unable to get up to get my medicine. She couldn't move. Oxycodone (treatment) 30 mg no 10 mg. When asked If she have there was my blood doctor. She did lab test last week and there was her doctor of oncology it was blood work that they checked in everything checked out good. She just wanted to let they know that she was having these severe reactions and she did not know what to do. It was asked if it was ok to take medication and make her feel better, and she doesn't know what to do and was there anything she could do to make herself feel better or no she just had to wait it out. It was stated that 2nd dose will be 26May2021. The outcome of the events was not recovered.  No Follow-up attempts are needed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Got shingles after 5 weeks of 2nd dose of COVID vaccine; This is a spontaneous report from a non-contactable consumer. A 34-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration on 25Mar2021 as single dose in arm for COVID-19 immunization. The patient past drug event included that Known Allergy: Pollen. Concomitant medications were not reported. Previously patient received of BNT162B2 (first dose) for COVID-19 immunization. Patient did not receive other vaccine in four weeks and no other medications in two weeks. The patient got shingles after 5 weeks of 2nd dose of COVID vaccine on 02May2021 and received unspecified treatment. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected. Lot/Batch number cannot be requested.