chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Vaccination site mass, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Today, 09JUL2201, wakes up and there is a little allergy, like little pimples around.; Today, 09JUL2201, wakes up and there is a little allergy, like little pimples around.; The day after receiving the vaccine, had a little ball in the area where the vaccine was given; a rash/itching in the area of the vaccine injection; a rash/itching in the area of the vaccine injection; This is a spontaneous report from a contactable consumer (patient's daughter). This consumer reported for a 66-year-old female (patient) reported that: A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 07Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The caller was a consumer who called regarding her mother, the caller's mother received the first dose Pfizer COVID 19 vaccine two days ago, 07Jul2021 at the "PRIVACY" Hospital. The callers mother has a reaction to the first dose Pfizer COVID 19 vaccine and the caller wants to make sure it was okay and part of the reaction to the Pfizer COVID 19 vaccine. On 08Jul2021, the day after receiving the first dose Pfizer COVID 19 vaccine, the callers mother got a little ball in the area where the patient received the first dose Pfizer COVID 19 vaccine and a rash/itching in the area of the vaccine injection. The caller states her language was kind of bad. The patient put ice and lotion on, like when "you" are working out. The patient's little ball in the area was getting better. "Today", 09Jul2021 the patient wakes up with a little irritation a little allergy little pimple around. The caller has never seen this reaction. The caller's husband said maybe the caller should call Pfizer. The caller stated her mother does not have a doctor and came to visit the caller, no doctor or anything. The caller would like to know if these reactions are part of the Pfizer COVID 19 vaccine, this irritation the patient was having. The outcome of "vaccination site mass" was reported as resolving and rest of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Myalgia, Oral herpes, Pain
Clinical narrative: pain spreading through his body, arm, should, elbow, it gets worse when he uses more force like when lifting.; minimum pain at inject site of Left arm; had fever blisters all over on my lower lip; I tried moving the couch and both arms went numb gave out on me; felt like I had internal fever until they showed up; as severe muscle and joint pain; as severe muscle and joint pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 25Jun2021 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization. No medical history and concomitant medications were not reported. It was reported that side effects started the same day as vaccine stated it was normal at injection site went on for 2 to 3 days minimum pain at inject site of Left arm. By the 4th day till today it has gotten worse, pain spreading through his body, arm, should, elbow, it got worse when he used more force like when lifting. 2 or 3 days ago (as reported), he started experiencing internal fever, although no temperature had fever blisters all over on his lower lip. they are still there and started 3 days ago, when his joint pain got worse, felt like had internal fever until they showed up. Right now, few hours ago, tried moving the couch and both arms went numb gave out on him. It was also reported that he did not want to go to the emergency room (ER) until he spoke. He wanted to know if this was a severe reaction. The patient explained that he was experiencing severe muscle and joint pain. The outcome of the events was not resolved.   Follow-up attempts are possible. Information on lot/batch number can be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: pain spreading through his body, arm, should, elbow, it gets worse when he uses more force like when lifting.; minimum pain at inject site of Left arm; had fever blisters all over on my lower lip; I tried moving the couch and both arms went numb gave out on me; felt like I had internal fever until they showed up; as severe muscle and joint pain; as severe muscle and joint pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 25Jun2021 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization. No medical history and concomitant medications were not reported. It was reported that side effects started the same day as vaccine stated it was normal at injection site went on for 2 to 3 days minimum pain at inject site of Left arm. By the 4th day till today it has gotten worse, pain spreading through his body, arm, should, elbow, it got worse when he used more force like when lifting. 2 or 3 days ago (as reported), he started experiencing internal fever, although no temperature had fever blisters all over on his lower lip. they are still there and started 3 days ago, when his joint pain got worse, felt like had internal fever until they showed up. Right now, few hours ago, tried moving the couch and both arms went numb gave out on him. It was also reported that he did not want to go to the emergency room (ER) until he spoke. He wanted to know if this was a severe reaction. The patient explained that he was experiencing severe muscle and joint pain. The outcome of the events was not resolved.   Follow-up attempts are possible. Information on lot/batch number can be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Localised infection, Pain, Ventilation/perfusion scan
Clinical narrative: Got infection in left arm 1 week after injection; Hit too touch painful and had to get VQ scan to see if u had a blood clot; This is a spontaneous report from non-contactable consumer (patient). A 29-year-old female (not pregnant) patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 18Jun2021 15:30 (Batch/Lot number was not reported) at the age of 29 years as single dose for covid-19 immunisation. Medical history included Factor 5 linden and known allergies: Ceclor product, sulfur, cat scan dye. The patient had no concomitant medications. The patient previously took cefaclor (CECLOR) and sulfur and experienced allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient got infection in left arm 1 week after injection. Hit too touch painful and had to get VQ scan to see if patient had a blood clot. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient had to go on antibiotics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chest pain, Dyspnoea, Pyrexia
Clinical narrative: Fevers over 100; chest pain; hard time breathing.; Sore Joints; This is a spontaneous report from a contactable consumer.  A  non-pregnant 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for inejction), dose 1 via an unspecified route of administration, administered in left arm on 23Jun2021 13:00 (Batch/Lot Number: EW0217) as dose 1, single (at the age of 14 years old) for COVID-19 immunisation.  The patient had no medical history. The patient's concomitant medications were not reported.  The patient experienced fevers over 100, chest pain, hard time breathing and sore joints on 23Jun2021. The patient received TYLENOL. Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in 2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Pallor, Pyrexia
Clinical narrative: a temperature of 101.7; I had a pale/ blue appearance to my skin and shivering; I had a pale/ blue appearance to my skin and shivering; I had a pale/ blue appearance to my skin and shivering; the injection site was very swollen almost all the way around my arm; wispy breathing; This is a spontaneous report from a contactable consumer.   A non-pregnant 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 07Jul2021 13:30 (Batch/Lot Number: FA6780) as dose 1, single (at the age of 43 years old) for COVID-19 immunisation.  Medical history included ADHD and anxiety and known allergies: only to penicillin. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]), quetiapine fumarate (SEROQUEL), buspirone hydrochloride (BUSPAR) and guanfacine all taken for an unspecified indication, start and stop date were not reported.  The patient stated, "the second day (08Jul2021) I had a pale/ blue appearance to my skin and shivering and had to take a hot shower to warm up.  Third day, the injection site was very swollen almost all the way around my arm and I have pictures and a temperature of 101.7, and wispy breathing. I had to call the nurse advise line for what to do and the nurse said to treat at home". Prior to vaccination, was the patient was not diagnosed with COVID-and not been tested for COVID-19. The patient received no treatment for the events. The outcome of the events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Vaccination site swelling
Clinical narrative: a temperature of 101.7; I had a pale/ blue appearance to my skin and shivering; I had a pale/ blue appearance to my skin and shivering; I had a pale/ blue appearance to my skin and shivering; the injection site was very swollen almost all the way around my arm; wispy breathing; This is a spontaneous report from a contactable consumer.   A non-pregnant 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 07Jul2021 13:30 (Batch/Lot Number: FA6780) as dose 1, single (at the age of 43 years old) for COVID-19 immunisation.  Medical history included ADHD and anxiety and known allergies: only to penicillin. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]), quetiapine fumarate (SEROQUEL), buspirone hydrochloride (BUSPAR) and guanfacine all taken for an unspecified indication, start and stop date were not reported.  The patient stated, "the second day (08Jul2021) I had a pale/ blue appearance to my skin and shivering and had to take a hot shower to warm up.  Third day, the injection site was very swollen almost all the way around my arm and I have pictures and a temperature of 101.7, and wispy breathing. I had to call the nurse advise line for what to do and the nurse said to treat at home". Prior to vaccination, was the patient was not diagnosed with COVID-and not been tested for COVID-19. The patient received no treatment for the events. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Dyspnoea
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non hcp. A 50-years-old female patient received bnt162b2 (COMIRNATY,Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on Mar2021 as DOSE 1, SINGLE for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced later that evening she had shortness of breath (dyspnoea) , after one hour, she had severe dizziness, slept for one hour and when patient woke up she had abdominal cramps that lasted about an hour (abdominal pain) on 26Mar2021.The outcome of the events was recovered.The patient didn't received any other vaccine within 4 weeks after covid vaccine. The patient was not admitted to hospital as the case was not serious.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: they gave it to me 'in my leg'; This is a spontaneous report from a contactable consumer reported for self. This 76-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in Leg  on 18Feb2021 at age of 76-year-old as DOSE 1, SINGLE (Lot # EL9265) for covid-19 immunisation. Medical history included Rheumatoid arthritis, Osteoarthritis, Hypertension, breast cancer issues, knee replacement. Concomitant drugs included hydroxychloroquine sulfate (PLAQUENIL S), Gabapentin, Levothyroxine for thyroid problem, and diazepam (VALIUM) at 5 mg. No vaccination prior to the COVID 19 Vaccine. The patient got the first shot in January, they gave it to the patient 'in my leg' because of breast cancer issues. They got permission to give it to in my 'leg', two weeks 'of debate they wanted to give it in my legs'.  Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Vaginal haemorrhage
Clinical narrative: I haven't had my periods from almost 10 years; all of the sudden I started vaginal bleeding; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 10Jul2021 09:15 as dose number unknown single for COVID-19 immunization. Patient stated, she just wanted to know that the whole sheet of information that she was given to from the pharmacy that she got the shot today this morning 10Jul2021 at 9:15 and she came home she had not had her periods from almost 10 years and all of the sudden she started vaginal bleeding. Patient stated, the name of the product was the Pfizer shot which she got this morning, the COVID, (confirmed as Pfizer Covid 19 vaccine). The outcome of the event was unknown.   Information about lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 42-years-old, via an unspecified route of administration, administered in upper arm right on 09Jul2021 14:15 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Patient's weight: 83.91 kg and Height: 174 cm. Medical history included ongoing visually disabled, scarred kidneys, one side of body shorter than other half and epilepsy. Concomitant medication included levetiracetam (KEPPRA) taken for epilepsy from an unspecified start date and ongoing. The patient experienced seizure on 10Jul2021 16:30 which did not require emergency room of physician's office visit. Someone in the background of the call could be heard sounded like stating patient gets a seizure when he gets sick. He just rested at home and took care of himself at home. He just treated the seizure like he would any other time and rested. He commented his seizure was due to visual disability. The patient had no previous immunization and no other vaccines administered within 4 weeks. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Heart rate increased, Insomnia, Investigation
Clinical narrative: His heart is beating too fast/a rapid heartbeat; Chills; Fever; He has been feeling like very very different; He feels like his muscles is not, he feels like he is not himself; He cannot sleep with his heart like that; This is a spontaneous report received from a contactable consumer (Patient mother). A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0181) via an unspecified route of administration in left arm on 07Jun2021 (at the age of 21-years-old) as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were No. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0174), via an unspecified route of administration on 07May2021 as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccine prior to COVID-19 vaccine. The patient mother reported that the patient got his second shot like almost month and half ago but since then from an unspecified date, he has been feeling like very, very different like his heart is beating too fast and he feels like his muscles is not, he feels like he was not himself, and a week later he started with symptoms of chills, fever and a rapid heartbeat, like he can't control it. Patient mother took him to the hospital, but they found nothing, he was hospitalized for a few days from an unspecified date, but they found nothing. He was healthy before, so patient mother knew that this was related to the vaccine. Patient mother stated that he can't sleep with his heart like that, and she was very worried and was just calling to know what she can do or what's happened with him or she don't know because she already took him to the hospital, they kept him to the hospital till 8 and they couldn't find nothing, so she was like worried, and it was desperate already. The reporter seriousness was assessed as serious (hospitalization). The patient underwent lab tests that included a lot of checkup of the health, and everything says normal range on an unspecified date. When asked about treatment, the patient mother replied as, "No they didn't give nothing". The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle disorder, Pyrexia
Clinical narrative: His heart is beating too fast/a rapid heartbeat; Chills; Fever; He has been feeling like very very different; He feels like his muscles is not, he feels like he is not himself; He cannot sleep with his heart like that; This is a spontaneous report received from a contactable consumer (Patient mother). A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0181) via an unspecified route of administration in left arm on 07Jun2021 (at the age of 21-years-old) as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were No. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0174), via an unspecified route of administration on 07May2021 as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccine prior to COVID-19 vaccine. The patient mother reported that the patient got his second shot like almost month and half ago but since then from an unspecified date, he has been feeling like very, very different like his heart is beating too fast and he feels like his muscles is not, he feels like he was not himself, and a week later he started with symptoms of chills, fever and a rapid heartbeat, like he can't control it. Patient mother took him to the hospital, but they found nothing, he was hospitalized for a few days from an unspecified date, but they found nothing. He was healthy before, so patient mother knew that this was related to the vaccine. Patient mother stated that he can't sleep with his heart like that, and she was very worried and was just calling to know what she can do or what's happened with him or she don't know because she already took him to the hospital, they kept him to the hospital till 8 and they couldn't find nothing, so she was like worried, and it was desperate already. The reporter seriousness was assessed as serious (hospitalization). The patient underwent lab tests that included a lot of checkup of the health, and everything says normal range on an unspecified date. When asked about treatment, the patient mother replied as, "No they didn't give nothing". The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Syringe issue
Clinical narrative: Physician did not give it to the patient/Unknown if the patient missed the dose; had a failure of one of the syringes, the glass broke in the middle; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date (Lot number DW2998, Expiry Date: Feb2023) as DOSE NUMBER UNKNOWN, SINGLE for immunisation. The patient medical history and concomitant medications were not reported. Physician administered to the patients a Pfizer product called TRUMENBA one dose pre-filled syringes and the physician had a failure of one of the syringes the glass broke in the middle and physician want to report it and get the dose replaced and also report the problem because it was obviously unusable but also it seemed to physician kind of dangerous that it broke like this. Physician did not give it to the patient. It broke before it got to the patient. Thank goodness broke in physician's hand as the physician was getting it ready. Unknown if the patient missed the dose. Physician stated the other thing was the product was unusable. The physician would like it to be reimbursed for the value of that. Physician was suggested not to discard the product as the report would be forwarded for review by Quality Department and if it was determined that the sample was needed for further evaluation a pre-paid mailer might be sent to you within 3 to 10 business days. There might be a delay due to ongoing COVID19 situation.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Aches and pains on ours hands and our legs and sometime we cannot even close our fist; This is a spontaneous report from a contactable consumer or other non hcp (patient). This is the 1st case of 2 split cases.  A elderly 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 31Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on an unknown date for COVID-19 immunisation. On an unknown date, patient stated,I had the Pfizer, my 2nd shot I had it at the end of March this year and my wife had it at the same time and we have had aches and pains on ours hands and our legs and sometime we cannot even close our fist and I was just wondering if anybody else called and have this complaint at all. Consumer stated, I am going in for surgery, back surgery and that is why I wanted this information. (Further clarification unknown) No treatment was received. The outcome for event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021874165 as same reporter/drug/event, different patient.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: fatigue; I felt some chills; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 25-years-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 03May2021 (at the age of 25-years-old) (Batch/Lot Number: Er8731) as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included polycystic ovaries, depression, insulin resistance, asthma, allergies. The patient's concomitant medications were not reported.  It was reported that the patient felt some chills and fatigue for the first 24 hours after first vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Chest pain, Dysmenorrhoea, Dyspnoea
Clinical narrative: When the heart starts pounding, it starts going really fast, like it is taking her breath away, like she can't breathe.; menstrual cramping; chest pain; heart palpitations, like pounding and felt like her chest was going to burst; Shortness of breath; chest real tight; This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: EW0196), via an unspecified route of administration, administered in Arm Left on 05Jul2021 as dose 1, single for covid-19 immunisation. Medical history included ongoing asthma. Patient has probably had it for about 6 years. It came on as an adult. She doesn't even take an inhaler regularly. It is not extreme or anything like that. Concomitant medication(s) included hydrocodone (HYDROCODONE) taken for back pain. No prior vaccination with in four weeks. No illness at time of vaccination and family medical history was None. Caller stated regarding the Pfizer Covid vaccine. She got vaccinated on Monday, which would have been 5Jul2021. Starting yesterday, she started to have chest pain, shortness of breath and felt like her chest was really tight. It was basically like she was having heart palpitations, like pounding and, felt like her chest was going to burst. Her heart was pounding really fast. It lasted for maybe about 30 minutes to an hour. It was constant for that long and then, it went away. She still felt it but was not as strong. She ended up going to sleep. She woke up this morning and felt it again, it was getting strong again. It was reported that, The patient experienced chest pain, heart palpitations, like pounding and felt like her chest was going to burst, shortness of breath, chest real tight on 08Jul2021, when the heart starts pounding, it starts going really fast, like it is taking her breath away, like she can't breathe, menstrual cramping on an unspecified date. It subsided, then she went to bed. Today, she is feeling it again. She was up for about an hour or so, then it started with the pounding heart again. When the heart starts pounding, it starts going really fast, like it is taking her breath away, like she can't breathe. Is still experiencing all of the symptoms. It feels like it is getting worse, then it subsides a little, then comes back. Like, her heart goes back to normal for a little bit then, just hits, like back and forth. The only thing she took yesterday was, Pamprin for menstrual cramping. She does know that it has caffeine in it. However, she takes it every month during the cycle, and this has never happened before. The outcome of all events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: When the heart starts pounding, it starts going really fast, like it is taking her breath away, like she can't breathe.; menstrual cramping; chest pain; heart palpitations, like pounding and felt like her chest was going to burst; Shortness of breath; chest real tight; This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: EW0196), via an unspecified route of administration, administered in Arm Left on 05Jul2021 as dose 1, single for covid-19 immunisation. Medical history included ongoing asthma. Patient has probably had it for about 6 years. It came on as an adult. She doesn't even take an inhaler regularly. It is not extreme or anything like that. Concomitant medication(s) included hydrocodone (HYDROCODONE) taken for back pain. No prior vaccination with in four weeks. No illness at time of vaccination and family medical history was None. Caller stated regarding the Pfizer Covid vaccine. She got vaccinated on Monday, which would have been 5Jul2021. Starting yesterday, she started to have chest pain, shortness of breath and felt like her chest was really tight. It was basically like she was having heart palpitations, like pounding and, felt like her chest was going to burst. Her heart was pounding really fast. It lasted for maybe about 30 minutes to an hour. It was constant for that long and then, it went away. She still felt it but was not as strong. She ended up going to sleep. She woke up this morning and felt it again, it was getting strong again. It was reported that, The patient experienced chest pain, heart palpitations, like pounding and felt like her chest was going to burst, shortness of breath, chest real tight on 08Jul2021, when the heart starts pounding, it starts going really fast, like it is taking her breath away, like she can't breathe, menstrual cramping on an unspecified date. It subsided, then she went to bed. Today, she is feeling it again. She was up for about an hour or so, then it started with the pounding heart again. When the heart starts pounding, it starts going really fast, like it is taking her breath away, like she can't breathe. Is still experiencing all of the symptoms. It feels like it is getting worse, then it subsides a little, then comes back. Like, her heart goes back to normal for a little bit then, just hits, like back and forth. The only thing she took yesterday was, Pamprin for menstrual cramping. She does know that it has caffeine in it. However, she takes it every month during the cycle, and this has never happened before. The outcome of all events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Migraine
Clinical narrative: dizzy; migraine; fatigued; This is a spontaneous report from a Non-contactable consumer (patient). A 21-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 08Jun2021 15:00 (21-years-old at the time of vaccination), as dose 1, single for covid-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. 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 four weeks prior to the vaccination. Patient reported that, on 09Jun2021 (24 hours after 1st dose), felt very dizzy and fatigued. Had to leave work and go home early due to feelings that I might pass out. Thankfully, I did not pass out. Patient had a migraine for the rest of the day, was fine 36 hours after dose. Patient did not take any treatment for the event. The clinical outcome of the events was recovered on 10Jun2021.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pain in extremity, Ultrasound Doppler
Clinical narrative: Severe pain in her left leg; the pain is becoming increasingly difficult; Severe pain in her left leg; the pain is becoming increasingly difficult; This is a spontaneous report from a contactable consumer (patient's husband). This is the second report out of two split reports. A 79-year-old female patient received bnt162b2 (formulation: solution for injection; COVID-19 Vaccine manufacturer: Unspecified; NDC number, UPC number, expiry date and Lot number: Unknown), dose 2 via an unspecified route of administration, administered in left arm (at the age of 79 years) on 18Apr2021 as dose 2, single for covid-19 immunisation. Medical history included heart issues from an unknown date and unknown if ongoing and too many dimensions (not clarified) she had heart issues, mainly heart issues. The patient's concomitant medications were not reported. The patient historical vaccine included BNT162B2 dose 1 (lot number: ER8732) on 28Mar2021 for Covid-19 immunization at the age of 79 years. The patient's husband reported that his wife had the same shots, at different times of Pfizer and we were just beginning to explore what the issue was. She had severe pain in her left leg. After her second shot on an unknown date in Apr2021. Patient had been dealing with her primary care doctor. She had doppler on her leg because she had the similar pain in her left leg and it's not been resolved yet. This was an ongoing thing. So, she had now taken a doppler and the pain is becoming increasingly difficult, and she is in the process of evaluating what this is and gone down the emergency room the next day. The patient underwent lab test which included Doppler scan with unknown result in 2021. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Emotional disorder, Feeling abnormal, Muscle twitching
Clinical narrative: Eyes won't stop twitching spastically all day from the moment of waking until sleeping. Eyes twitch at least 1000 times a day. Right eye twitches more than left.; Cognitive disconnect after first and second doses for a week; Brain fog; emotional disassociation.; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age (adult) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EW 0177) dose 1 via an unspecified route of administration, administered in arm right on an unspecified date (at the age of 21-year-old) as dose 1, single and dose 2 via an unspecified route of administration, administered in arm right on an unspecified date (Batch/Lot Number: EW 0172; at the age of 21-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications (other medications within 2 weeks of vaccination) included docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3); ascorbic acid (VITAMIN C); vitamin D3; curcuma longa (TURMERIC); all concomitant medications taken for an unspecified indication, start and stop date were not reported. Patient received the most recent dose of vaccination at pharmacy or drug store facility. 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 an unspecified date, the patient's eyes would not stop twitching spastically all day from the moment of waking until sleeping. Eyes twitch at least 1000 times a day. Right eye twitched more than left. Cognitive disconnect after first and second doses for a week. Brain fog and emotional disassociation. The events immediately followed both vaccines but the eye twitching started more profusely after the second dose. No hospitalization prolongation was reported. No treatment received for events. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: I am experiencing significant hair shedding (tellogen effluvium). The hair loss started approximately 3 months after the first vaccination.; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old non pregnant female patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 12Mar2021 15:00 (at the age of 52-years-old) as dose 1, single  and second dose (Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 12Mar2021 15:00 (at the age of 52-years-old) as dose 2, single for covid-19 immunisation in hospital. The patient medical history included lupus, endometriosis, fibroid tumors, hypersensitivity. Concomitant medications were not reported. The patient had allergies to medications, food, or other products. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested for covid-19 since the vaccination. On 15Jun2021, it was reported that, she was experiencing significant hair shedding (tellogen effluvium). I have had no change in medication, diet, etc. The hair loss started approximately 3 months after the first vaccination. Ethnicity information was available. Treatment was not received for the adverse event. Device Date was 12Jul2021. The reporter assessed the events as non-serious. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: itchy; redness; rash; Hives; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) from Pfizer sponsored program. A 72-years-old female patient 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 (at the age of 72-years), on 28May2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unknown date in 2021, the patient experienced itchy, redness, rash, hives. She received her vaccination of Pfizer covid 19 first dose on 28May2021 and the second 18Jun2021. After receiving both doses she started getting itchy and redness and would like to report. Caller stated she also had a rash and hives. She wanted to know what she could buy to put on it. The clinical outcome for the events was reported as unknown.  Reporter details: Alternative Telephone & Email Address: Caller declined to provide at this time. She wanted to go to the pharmacy to see what she can put on for the terrible itch.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: She has been having aches and pain; This is a spontaneous report from a Program. A specialty pharmacy (other HCP) reported for patient that, A 63-year-old female 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 as dose number unknown, single for covid-19 immunisation. The patient's medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. Patient stated that  is not as effective since receiving covid vaccines, she has been having aches and pain on unspecified date. She has been to hospital emergency room, urgent care and md office (dates not provided), nothing has been determined as to source/cause of pains and aches, patient was told it's not rheumatoid arthritis, had seen md 3 weeks ago, will see md again a couple of weeks. The outcome of the event was unknown.  Information about batch/Lot number has been requested
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Rash, Skin exfoliation, Urticaria
Clinical narrative: I broke out in gradual hives on extremities especially hands blistered and shed new skin, (still healing after a month)arms, legs, hives then rash worsening at night and better upon wakening; I broke out in gradual hives on extremities especially hands blistered and shed new skin, (still healing after a month)arms, legs, hives then rash worsening at night and better upon wakening; Very horrible reaction burned me from inside out; I broke out in gradual hives on extremities especially hands blistered and shed new skin, (still healing after a month)arms, legs, hives then rash worsening at night and better upon wakening; I broke out in gradual hives on extremities especially hands blistered and shed new skin, (still healing after a month)arms, legs, hives then rash worsening at night and better upon wakening; This is a spontaneous report from a contactable consumer (patient). This 54-year-old non-pregnant female patient reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0176) via an unspecified route of administration on 27May2021 at 13:00 in right arm (at 54-year-old) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. Concomitant medications included estradiol, estriol (Biestrogen), testosterone cypionate and progesterone all were taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0162) via an unspecified route of administration on 28Apr021 at 15:00 in right arm (at 54-year-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. The patient had no known drug allergies (NKDA). It was mentioned that patient received no other vaccine in four weeks, did not have covid prior vaccination and was not tested for covid post vaccination. Six-days later, on 02Jun2021 at 12:00 hours patient broke out in gradual hives on extremities especially hands blistered and shed new skin (still healing after a month) arms, legs, hives then, rash worsening at night and was better upon wakening. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with MEDROL pack and improved but returned as soon as tapered off med, she had very horrible reaction that burned her from inside out (onset: 02Jun2021 12:00 hours). The patient was recovering from all the events.  No follow-up attempts were possible. No further information was expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, SARS-CoV-2 test
Clinical narrative: Shoulder pain after shot; This is a spontaneous report from a contactable consumer(patient).A 52-years-old non-pregnant adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection,Batch/Lot Number: EJ1685)via intramuscular route of administration, administered in Arm Left on 03Mar2021 at 09:00 (at the age of 52-years-old)as Dose 1,Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. There were no any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19.On 02Apr2021 at 08:00,the patient experienced Shoulder pain.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14May2021 for a Nasal Swab.The outcome of event was recovering.   Follow-up(13Jul2021): New information received in response to the mail trait sent regarding the confirmation of query. The response included: Clinical information   Follow-up attempts are needed. Further information is requested
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Feeling abnormal, Palpitations
Clinical narrative: "an electric shock down her left arm"; she's been having heart palpitations; it is scary; This is a spontaneous report from a contactable consumer (patient). This 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 13Jun2021 as single dose for Covid-19 immunisation. The patient's medical history and medications were not reported. Historical vaccine included first dose of BNT162B2 for COVID-19 Immunization. The patient experienced An electric shock down her left arm, she's been having heart palpitations on, it is scary on Jun2021.  There was no Investigation Assessment. There were no Prior vaccinations within 4 weeks. Reporter asked, "Okay, can I ask you a question. Okay, well done, I am looking for a cardiologist to see me because that palpitation I don't like it. It happens when I was reading my book and when I was washing tv and its scary. So, I need to speak to somebody. So, please." Consumer was informed about the Pfizer medical information department. The outcome for all the events was unknown.  Information on lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: Pain worsened; swelling of feet, legs, hands, arms and lips and is still ongoing; This is a spontaneous report from a contactable consumer 78-year-old female consumer (patient) reported for herself that: A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07Jul2021 10:00 (Batch/Lot Number: EW0161) as DOSE 1, SINGLE for Covid-19 immunisation. Medical history included cardiac failure congestive from 2004 and ongoing. The patient's Concomitant medications were not reported. The patient experienced Swelling of feet, legs, hands, arms and lips and is still ongoing on 09Jul2021, Pain worsened on an unspecified date. There was no Investigation Assessment. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect administration date of the suspect vaccine. AE(s) did not require a visit to Emergency Room and Physician Office Doctor came to her home. There was no Prior Vaccinations within 4 weeks. There was no AE(s) following prior vaccinations. Communication: Reference number provided. Caller initially said her first dose was on Thursday, then clarified it was on 07JUL 2021 when looking at vaccine card. Provided with phone number and hours of operation prior. The outcome of event was not recovered.