chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever; body ache; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL0142, unknown expiration), intramuscular in right arm on 13Jan2021 at 07:15 AM at a single dose for COVID-19 immunization in a hospital.  Medical history included diabetes and high cholesterol.  The patient's concomitant medication included unspecified vitamins. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, unknown expiration) via intramuscular in left arm on 23Dec2020 at 07:15 AM in a hospital. The patient also had known allergies to codeine. The patient experienced fever and body aches on 13Jan2021 at 13:00. The patient did not receive other vaccines in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not received treatment for the events. The patient had not yet recovered from the events.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Haemoptysis
Clinical narrative: coughed up what looked like blood in his spit; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received his first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at a single dose on 14Jan2021 for COVID-19 immunization, and apixaban (ELIQUIS)  via an unspecified route of administration at an unspecified dose from an unspecified date as blood thinner. The patient's medical history and concomitant medications were not reported. The patient received his first shot of vaccine in the morning 14Jan2021 while on apixaban. After going to sleep at night, he woke up a couple hours later and coughed up some spit that looked like it had blood. It was 6 or 7 times. He stated he was "ok now" and it was just last night that one time. The action taken for apixaban was unknown. The outcome of the event was resolved on a unspecified date in Jan2021. He will have his second shot in 4 weeks and he is asking if he should get the second shot and if he should stop taking apixaban before his second shot.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Sinus pain
Clinical narrative: 101.8F fever; chills; nausea; headache; sinus pain; This is a spontaneous report from a contactable healthcare professional. A 32-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246) on his left arm, via an unspecified route of administration on 14Jan2021 08:45 at a single dose for COVID-19 immunization. Medical history included allergies to sulfa drugs. Concomitant medication included loratadine (CLARITINE) and crisaborole (EUCRISA). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 (first dose). The patient experienced 101.8F fever, chills, nausea, headache, sinus pain; all on 14Jan2021 11:00pm. No treatment was received for the events. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: experiencing diarrhea that is a little bit on the loose side; This is a spontaneous report from a non-contactable consumer (patient herself).  A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 also known as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date not reported), via an unspecified route of administration on 13Jan2021 at single dose, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced diarrhea that she was a little bit on the loose side on an unspecified date in Jan2021. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Really dizzy; This is a spontaneous report from a contactable consumer (wife). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 15Jan2021 the patient experienced the event really dizzy. The reporter called to ask if dizziness was a side effect of the vaccine. The clinical outcome of the event, really dizzy, was unknown.   The lot number for vaccine BNT162B2, was not provided and will be requested during follow-up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: both cheeks were very rosy red; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246) via an unspecified route of administration on 14Jan2021 (in the morning) at a single dose as COVID-vaccine, she got it as a protection to her because she's elderly with underlying conditions. Medical history was not reported. Concomitant medications included unspecified five prescriptions which she has been taking for a long time (nothing new). She has had no reaction to medications. Her diet was her normal diet. The patient experienced both cheeks were very rosy red on 14Jan2021 21:30. She wanted to know if experiencing very rosy red cheeks, on both sides, after receiving the Covid vaccine was a normal side effect. She received the first dose of the COVID Pfizer vaccine yesterday morning on 14Jan2021, everything was fine (good) at 7:30 p.m. Then at 9:30 p.m., while she was brushing her teeth, she noticed that both cheeks were very rosy red (her cheeks were rosy red). This morning, her cheeks appeared to be skin tone (skin looked normal). It was gone now; both cheeks were her normal skin tone and everything looked normal now. She didn't eat anything unusual the day of the vaccine. She was wondering if she should go back on 15Feb2021. She was going to ask her doctor and was going to notify her primary care doctor as well if she experiences any redness today or tomorrow. Investigation assessment was noted as no. The outcome of the event was recovered on 15Jan2021.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: bronchitis; Arm soreness; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: A3246/H3246, via an unspecified route of administration from 12Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included asthma and ongoing cough. There were no concomitant medications. The patient had a minor cough and was spitting up phlegm but had no temperature before he got the vaccine. The patient had bronchitis but no virus currently. He still has a bit of cough. He wanted to know if it gets worse was, he allowed to take an antibiotic and if taking antibiotics or prednisone will interfere with the vaccine as he already received the first dose. He was asking if it got worse, should he wait five more days and then go to the doctor. He wanted to know if prednisone affects the vaccine. The only side effect of COVID-19 Vaccine was his arm was hurting for about four to five hours on 12Jan2021, but that was it. The patient took two Tylenol. Arm soreness went away maybe five to seven hours later. The outcome of the event arm soreness was recovered while bronchitis was unknown.    Information on the lot/ batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pain in extremity, Pruritus, Rash, Rash vesicular
Clinical narrative: it itches quite a bit/ Itching; pain and discomfort with her arm; pain and discomfort with her arm; couldn't get to sleep; rash looks like little blisters; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient started received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248 and expiry date: Nov2021), via an unspecified route of administration on her left arm on 12Jan2021 12:40 at a single dose  for her age (COVID-19 immunization). Medical history included blood pressure (abnormal) and surgeries (had so many surgeries but none recently). Concomitant medications included ongoing atorvastatin for more than a year for blood pressure, ongoing amlodipine for more than year for blood pressure, ongoing losartan for more than year for blood pressure and ongoing terazosin from 09Dec2020 for blood pressure. The patient got her first injection on 12Jan2021 Tuesday and the following day (13Jan2021) she broke out with a rash on her right arm, right under her wrist and where you bend arm. She was asking if this a normal or expected side effect. The patient mentioned it was not in the arm where she received the vaccine. The rash was located in four places on her right arm; at the bend; maybe about two inches from where she bends it; a little bit on the outside of the arm and at the inside of her wrist. Last night (14Jan2021) she went to bed at 11PM and couldn't get to sleep until 3:00AM due to the pain and discomfort with her arm. Now (15Jan2021), it itches quite a bit. She put Neosporin (31254-7238-090 Lot 3259L or a 1 2/1 Expiration date Oct2021) on it and it helped but then when it dries up she can feel the itching again and was painful. The rash looks like little blisters. She is planning to get the next dose; she has to call in. Her next dose is due by 02Feb2021. The events did not require a visit to physician or ER. No prior vaccinations (within 4 weeks). The outcome of the events rash looks like little blisters, Pain in arm and it itches quite a bit/ Itching was not recovered and it was unknown for the other events.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: it itches quite a bit/ Itching; pain and discomfort with her arm; pain and discomfort with her arm; couldn't get to sleep; rash looks like little blisters; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient started received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248 and expiry date: Nov2021), via an unspecified route of administration on her left arm on 12Jan2021 12:40 at a single dose  for her age (COVID-19 immunization). Medical history included blood pressure (abnormal) and surgeries (had so many surgeries but none recently). Concomitant medications included ongoing atorvastatin for more than a year for blood pressure, ongoing amlodipine for more than year for blood pressure, ongoing losartan for more than year for blood pressure and ongoing terazosin from 09Dec2020 for blood pressure. The patient got her first injection on 12Jan2021 Tuesday and the following day (13Jan2021) she broke out with a rash on her right arm, right under her wrist and where you bend arm. She was asking if this a normal or expected side effect. The patient mentioned it was not in the arm where she received the vaccine. The rash was located in four places on her right arm; at the bend; maybe about two inches from where she bends it; a little bit on the outside of the arm and at the inside of her wrist. Last night (14Jan2021) she went to bed at 11PM and couldn't get to sleep until 3:00AM due to the pain and discomfort with her arm. Now (15Jan2021), it itches quite a bit. She put Neosporin (31254-7238-090 Lot 3259L or a 1 2/1 Expiration date Oct2021) on it and it helped but then when it dries up she can feel the itching again and was painful. The rash looks like little blisters. She is planning to get the next dose; she has to call in. Her next dose is due by 02Feb2021. The events did not require a visit to physician or ER. No prior vaccinations (within 4 weeks). The outcome of the events rash looks like little blisters, Pain in arm and it itches quite a bit/ Itching was not recovered and it was unknown for the other events.
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: The caller and his wife are to receive the second dose 28 days after the first; This case has been considered invalid since there is no indication that the consumer experienced an event under Product BNT162B2, just medical inquiry.  This is a spontaneous report from a contactable consumer (patient). The reporter reported similar event for two patient (reporter and his wife). This is the first case of 2 reports, for consumer himself.  A male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL1283, on unknown date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient explained that yesterday he and his wife were scheduled to get the Modera vaccine in (address). They drove down there only to find out they ran out of the Moderna vaccine so they gave them the Pfizer one, which was fine, it was good actually. Now his second dose was based on the Moderna one and was scheduled at 28 days out. He was reading and found out we recommend it being given at 21 days. The patient explained the site said it was fine but he wanted to know if there's a problem with getting it at 28 days instead of 21 days or should he raise a fuss with the Health Department to make them give it to them at 21 days. He and his wife both got the shot that day with the same lot number: EL1283.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling hot, Hyperhidrosis, Injection site erythema, Injection site pruritus
Clinical narrative: Chills; feeling very hot; arm also swelled, about 3 inches around the site; arm also swelled, about 3 inches around the site/ it was red and itchy; arm also swelled, about 3 inches around the site/ it was red and itchy; she woke up in a horrible sweat; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1284, expiry date: 30Apr2021), via an unspecified route of administration upper arm probably only about 4inches down from shoulder blade on the left on 12Jan2021 18:00 at a single dose for COVID-19 immunization. Medical history included COVID on 01Oct2020. Concomitant medication included rivaroxaban (XARELTO) as blood thinner. The patient previously took a flu and shingles shot and experienced her redness and swelling on her arm. The patient did not have vaccinations four weeks prior, and no additional vaccines were administered on the same date. She got it because she was told by her doctor that her antibodies will not last forever and it was still necessary to get it even though she already had COVID antibodies. She contracted COVID on 01Oct2020, that was the date when she had a positive test then she was last tested in December and she still had the antibodies then. She received her first dose of the vaccine on Tuesday 12Jan2021 and 24 hours later on 13Jan2021, she experienced chills and feeling very hot, which she took Tylenol extra strength for and it disappeared the next day. Her arm also swelled, not the whole arm, she would say about 3 inches around the site, 4 inches at the most and it was still swollen, it was red and itchy. Then she woke up in a horrible sweat but by the following morning it was gone. She wouldn't say it was a horrible reaction but she wanted to be certain she can go ahead and get the second shot which she had an appointment for. She said everything has resolved completely except for the swelling, her arm was still swollen, itchy, and red. Since the swelling, redness and itchiness began she would say it was slightly better than it was. The patient received the vaccine at an independent assisted living facility, not a military facility. The adverse events did not require a visit to the emergency room or physician's office. Outcome of the events chills, feeling very hot and woke up in a horrible sweat was recovered on 14Jan2021, while the remaining events was recovering.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling
Clinical narrative: Chills; feeling very hot; arm also swelled, about 3 inches around the site; arm also swelled, about 3 inches around the site/ it was red and itchy; arm also swelled, about 3 inches around the site/ it was red and itchy; she woke up in a horrible sweat; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1284, expiry date: 30Apr2021), via an unspecified route of administration upper arm probably only about 4inches down from shoulder blade on the left on 12Jan2021 18:00 at a single dose for COVID-19 immunization. Medical history included COVID on 01Oct2020. Concomitant medication included rivaroxaban (XARELTO) as blood thinner. The patient previously took a flu and shingles shot and experienced her redness and swelling on her arm. The patient did not have vaccinations four weeks prior, and no additional vaccines were administered on the same date. She got it because she was told by her doctor that her antibodies will not last forever and it was still necessary to get it even though she already had COVID antibodies. She contracted COVID on 01Oct2020, that was the date when she had a positive test then she was last tested in December and she still had the antibodies then. She received her first dose of the vaccine on Tuesday 12Jan2021 and 24 hours later on 13Jan2021, she experienced chills and feeling very hot, which she took Tylenol extra strength for and it disappeared the next day. Her arm also swelled, not the whole arm, she would say about 3 inches around the site, 4 inches at the most and it was still swollen, it was red and itchy. Then she woke up in a horrible sweat but by the following morning it was gone. She wouldn't say it was a horrible reaction but she wanted to be certain she can go ahead and get the second shot which she had an appointment for. She said everything has resolved completely except for the swelling, her arm was still swollen, itchy, and red. Since the swelling, redness and itchiness began she would say it was slightly better than it was. The patient received the vaccine at an independent assisted living facility, not a military facility. The adverse events did not require a visit to the emergency room or physician's office. Outcome of the events chills, feeling very hot and woke up in a horrible sweat was recovered on 14Jan2021, while the remaining events was recovering.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urinary tract infection
Clinical narrative: Chills; feeling very hot; arm also swelled, about 3 inches around the site; arm also swelled, about 3 inches around the site/ it was red and itchy; arm also swelled, about 3 inches around the site/ it was red and itchy; she woke up in a horrible sweat; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1284, expiry date: 30Apr2021), via an unspecified route of administration upper arm probably only about 4inches down from shoulder blade on the left on 12Jan2021 18:00 at a single dose for COVID-19 immunization. Medical history included COVID on 01Oct2020. Concomitant medication included rivaroxaban (XARELTO) as blood thinner. The patient previously took a flu and shingles shot and experienced her redness and swelling on her arm. The patient did not have vaccinations four weeks prior, and no additional vaccines were administered on the same date. She got it because she was told by her doctor that her antibodies will not last forever and it was still necessary to get it even though she already had COVID antibodies. She contracted COVID on 01Oct2020, that was the date when she had a positive test then she was last tested in December and she still had the antibodies then. She received her first dose of the vaccine on Tuesday 12Jan2021 and 24 hours later on 13Jan2021, she experienced chills and feeling very hot, which she took Tylenol extra strength for and it disappeared the next day. Her arm also swelled, not the whole arm, she would say about 3 inches around the site, 4 inches at the most and it was still swollen, it was red and itchy. Then she woke up in a horrible sweat but by the following morning it was gone. She wouldn't say it was a horrible reaction but she wanted to be certain she can go ahead and get the second shot which she had an appointment for. She said everything has resolved completely except for the swelling, her arm was still swollen, itchy, and red. Since the swelling, redness and itchiness began she would say it was slightly better than it was. The patient received the vaccine at an independent assisted living facility, not a military facility. The adverse events did not require a visit to the emergency room or physician's office. Outcome of the events chills, feeling very hot and woke up in a horrible sweat was recovered on 14Jan2021, while the remaining events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Nausea, Pain in extremity
Clinical narrative: a little soreness in the arm; nauseated/cannot throw up anything, he was just continually nauseated; his stomach hurt; headache; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unspecified route of administration, on 10Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The wife stated that the patient received the Covid vaccine on 10Jan2021 with a little soreness in the arm on 10Jan2021 when he first received the shot. However, in a couple days in Jan2021, he got nauseated and his stomach hurt, but cannot throw up anything, he was just continually nauseated. He also had a headache for a while on Jan2021 but that's gone now. The patient's wife asked if there was something to help the patient with the nausea after receiving the vaccine and also asked if the patient should receive the second dose if he was experiencing nausea. The outcome of the event headache was recovered on Jan2021; nausea was not recovered; while the outcome of the other remaining events was unknown.  Information about the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: her blood sugar is 260's; This is a spontaneous report from a Non-contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter indicated that she received her first dose of vaccine yesterday (14Jan2021) and her blood sugar is 260's on an unspecified date. She ate a slice of toast and exercised, asking if steroids are in vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Sleep disorder, Urticaria
Clinical narrative: losing night time sleep; welts on his body; rashes on delicate parts of belly, buttocks, scalp which were itchy/The rash gradually developed an itch; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899 and expiry date: 31Mar2021), via intramuscular route of administration on 30Dec2020 at 11:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021, a week after the injection, the patient experienced rashes on delicate parts of belly, buttocks, scalp which were itchy. The rash gradually developed an itch and he is now losing night time sleep. Patient stated that there were welts on his body on an unspecified date. He tried everything to stop the itch. He later stated there were objects across the counter that he tried, not prescription. One was alcohol and the other one was peroxide and a third one is Jergen's hand lotion and none worked. The outcome of the event itchy rash was not recovered, while unknown for the other events.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Dyspnoea, Fatigue, Feeling abnormal, Injection site pain
Clinical narrative: Fever/a temp of 101; feels something is different; intermittent minimal pain especially when he wakes up; Tachycardia; His CRP was up a little at 1.1; Nausea; Shortness of breath; Fatigue; Pain at injection site left shoulder; This is a spontaneous report from a contactable physician reporting for himself. A 44-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 28Dec2020, at a single dose on the left shoulder (arm left) for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 28Dec2020. Since receiving the vaccine, he has experienced multiple side effects at varying time points: pain at injection site left shoulder (experienced pain first day of receiving vaccine on 28Dec2020 and couple of days after fever (unspecified date) resolved (on an unspecified date); he was currently experiencing intermittent minimal pain especially when he wakes up; feels something is different; fever (experienced 08Jan2021); fatigue (developed 07Jan2021). He went to the ER on 08Jan2021 when he developed fever, nausea and shortness of breath which also resolved that day. When he went to ER, his CRP was up a little at 1.1. His PCR and antigen test was negative at that time (08Jan2021); a retest of PCR done 5 days after sxs started (unclear of time window) was negative. He was concerned that he had the fever many days after the vaccine. HCP was asking if any cases of fever and fatigue reported after 7 days (around the 10 day mark) of receiving the first dose. He stated that he is planning on taking the second dose. The patient is a physician calling about the Pfizer covid vaccine. He received his first dose on 28Dec2020. He had a little bit of pain in his left arm on same day, but it went away. About 10 days later, 07Jan2021, he had fever and fatigue. On 08Jan2021, he went to the ER with a temp of 101. He had tachycardia, nausea and shortness of breath. He was not admitted, stated his fever was controlled and his breathing was better. His oxygen was 100% and everything was ok and he was sent home. In the ER he had xrays and labs and everything was ok, except his CRP was a bit up. In the ER he had an antigen and pcr covid test (08Jan2021) and they both came back negative. About 4 or 5 days after the symptoms started, he had an outpatient repeat pcr test and nucleic acid rapid test (unspecified dates) and they both came back negative. He is on his way to get his second dose and he is asking if the symptoms could be side effects from the vaccine. Outcome the event fever was recovered on an unspecified date. Outcome of nausea and shortness of breath was recovered on 08Jan2021, while outcome of pain at injection site left shoulder was recovered on 28Dec2020. Outcome of the remaining events was unknown.    Information about lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test normal, Nausea, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Fever/a temp of 101; feels something is different; intermittent minimal pain especially when he wakes up; Tachycardia; His CRP was up a little at 1.1; Nausea; Shortness of breath; Fatigue; Pain at injection site left shoulder; This is a spontaneous report from a contactable physician reporting for himself. A 44-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 28Dec2020, at a single dose on the left shoulder (arm left) for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 28Dec2020. Since receiving the vaccine, he has experienced multiple side effects at varying time points: pain at injection site left shoulder (experienced pain first day of receiving vaccine on 28Dec2020 and couple of days after fever (unspecified date) resolved (on an unspecified date); he was currently experiencing intermittent minimal pain especially when he wakes up; feels something is different; fever (experienced 08Jan2021); fatigue (developed 07Jan2021). He went to the ER on 08Jan2021 when he developed fever, nausea and shortness of breath which also resolved that day. When he went to ER, his CRP was up a little at 1.1. His PCR and antigen test was negative at that time (08Jan2021); a retest of PCR done 5 days after sxs started (unclear of time window) was negative. He was concerned that he had the fever many days after the vaccine. HCP was asking if any cases of fever and fatigue reported after 7 days (around the 10 day mark) of receiving the first dose. He stated that he is planning on taking the second dose. The patient is a physician calling about the Pfizer covid vaccine. He received his first dose on 28Dec2020. He had a little bit of pain in his left arm on same day, but it went away. About 10 days later, 07Jan2021, he had fever and fatigue. On 08Jan2021, he went to the ER with a temp of 101. He had tachycardia, nausea and shortness of breath. He was not admitted, stated his fever was controlled and his breathing was better. His oxygen was 100% and everything was ok and he was sent home. In the ER he had xrays and labs and everything was ok, except his CRP was a bit up. In the ER he had an antigen and pcr covid test (08Jan2021) and they both came back negative. About 4 or 5 days after the symptoms started, he had an outpatient repeat pcr test and nucleic acid rapid test (unspecified dates) and they both came back negative. He is on his way to get his second dose and he is asking if the symptoms could be side effects from the vaccine. Outcome the event fever was recovered on an unspecified date. Outcome of nausea and shortness of breath was recovered on 08Jan2021, while outcome of pain at injection site left shoulder was recovered on 28Dec2020. Outcome of the remaining events was unknown.    Information about lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia, X-ray normal
Clinical narrative: Fever/a temp of 101; feels something is different; intermittent minimal pain especially when he wakes up; Tachycardia; His CRP was up a little at 1.1; Nausea; Shortness of breath; Fatigue; Pain at injection site left shoulder; This is a spontaneous report from a contactable physician reporting for himself. A 44-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 28Dec2020, at a single dose on the left shoulder (arm left) for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 28Dec2020. Since receiving the vaccine, he has experienced multiple side effects at varying time points: pain at injection site left shoulder (experienced pain first day of receiving vaccine on 28Dec2020 and couple of days after fever (unspecified date) resolved (on an unspecified date); he was currently experiencing intermittent minimal pain especially when he wakes up; feels something is different; fever (experienced 08Jan2021); fatigue (developed 07Jan2021). He went to the ER on 08Jan2021 when he developed fever, nausea and shortness of breath which also resolved that day. When he went to ER, his CRP was up a little at 1.1. His PCR and antigen test was negative at that time (08Jan2021); a retest of PCR done 5 days after sxs started (unclear of time window) was negative. He was concerned that he had the fever many days after the vaccine. HCP was asking if any cases of fever and fatigue reported after 7 days (around the 10 day mark) of receiving the first dose. He stated that he is planning on taking the second dose. The patient is a physician calling about the Pfizer covid vaccine. He received his first dose on 28Dec2020. He had a little bit of pain in his left arm on same day, but it went away. About 10 days later, 07Jan2021, he had fever and fatigue. On 08Jan2021, he went to the ER with a temp of 101. He had tachycardia, nausea and shortness of breath. He was not admitted, stated his fever was controlled and his breathing was better. His oxygen was 100% and everything was ok and he was sent home. In the ER he had xrays and labs and everything was ok, except his CRP was a bit up. In the ER he had an antigen and pcr covid test (08Jan2021) and they both came back negative. About 4 or 5 days after the symptoms started, he had an outpatient repeat pcr test and nucleic acid rapid test (unspecified dates) and they both came back negative. He is on his way to get his second dose and he is asking if the symptoms could be side effects from the vaccine. Outcome the event fever was recovered on an unspecified date. Outcome of nausea and shortness of breath was recovered on 08Jan2021, while outcome of pain at injection site left shoulder was recovered on 28Dec2020. Outcome of the remaining events was unknown.    Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Not feeling well; Really bad headache; This is a spontaneous report from a non-contactable consumer via the Medical Information Team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the patient that she was not feeling well and have a really bad headache. The outcome of the events was unknown.  No follow-up attempts are possible: information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site mass, Maternal exposure during breast feeding, Musculoskeletal stiffness, Sleep disorder
Clinical narrative: in the injection site she has a "large mass hard and stiff"; large mass and it hasn't resolved. The area was really hard and stiff; breastfeeding; breastfeeding; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and baby. This is the maternal report. A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284, expiration date not reported) via an unspecified route of administration on the left arm on 07Jan2021 07:00 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. She received the first dose of the vaccine on Thursday and in the injection site she has a "large mass hard and stiff", she's concerned about this and she would like to know what she can do. In the injection area a large mass and it hasn't resolved. The area was really hard and stiff. Wanted to know if she should be concerned or be seen. Received the first dose on 07Jan2021 and kind of had this issue with the injection arm all week and maybe noticed it Tuesday because she was afraid to sleep on that side. No history of problems with vaccines in past. She is due for the second dose on 28Jan2021. Caller later provides that she is breastfeeding at the moment, but no further details provided. The events did not result to a physician office and emergency room visit. Vaccination Facility Type was hospital. There were no additional vaccines administered on same date of Pfizer suspect. No relevant tests done and no family medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Event was reported as non-serious. Outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021051752 mother/baby
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: He was scheduled for the 2nd dose on 09Feb2021, longer than the 3weeks; dizzy; vertigo; This is a spontaneous report from a contactable consumer reporting for himself. A 78-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: not reported), via an unspecified route of administration on 12Jan2021 (around 11:00 or 11:30 AM) on left shoulder (arm left) for COVID-19 immunization. Vaccine was not administered at a military facility. There were no additional vaccines administered on same date of bnt162b2. He did not receive other vaccines 4 weeks prior to COVID-19 vaccination. Medical history and concomitant medications were none. The patient had his 1st dose on 12Jan2021. He was fine that day, but on the 13Jan2021, he woke up and was dizzy. He stated that he had no problem after having the shot, 15 minutes later, he had no problems; but, the next day he began having vertigo and dizziness. Vertigo and dizziness began 13Jan2021 at about 8:00 AM. This has continued the past 3 days. It is getting better, but he is wondering if that is a big problem. At the time of report, it's getting better but still have it. He asked if he should be concerned. It is quite a bit improved but it's still there. If he had to drive a car for an emergency, he thinks he could do it, but he wouldn't volunteer for that right now. He looked up all that stuff and it says that 20% of the people who take it have that. But when they list the side effects, they don't list dizziness until they list severe that is the only thing that has concerned him. He was scheduled for the 2nd dose on 09Feb2021, longer than the 3weeks. Outcome of the events was recovering.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site hypersensitivity, Injection site swelling
Clinical narrative: Local skin allergic reaction at the injection site; Swelling (about the size of a quarter) at the injection site; Red dots (about the size of a pencil eraser) that appeared around the injection site; some spots around the area approximately the size of pencil erasers; This is a spontaneous report from a contactable pharmacist (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302), intramuscular in the left upper deltoid muscle, on 13Jan2021 at 10:30, at a single dose, for COVID-19 vaccination. The patient had no medical history and concomitant medications. On 13Jan2021, the patient received first dose of vaccine and immediately (about 5 minutes after she received the vaccine at 10:35) developed non-severe local skin allergic reaction and swelling at the injection site, and some spots around the area approximately the size of pencil erasers. The patient had swelling (about the size of a quarter) at the injection site, along with red dots (about the size of a pencil eraser) that appeared around the injection site. The patient's vital signs were normal, her breathing was fine, and she had no swelling in her throat or lips. The patient took diphenhydramine hydrochloride (BENADRYL) 25 mg tablet, and a minute or two after taking the diphenhydramine hydrochloride tablet, all the symptoms went away. The patient was calling to see if she should receive the second dose of the vaccine. The patient asked if she should get the second COVID-19 vaccine dose, based on her adverse reactions after receiving the first dose. The patient recovered from the events on 13Jan2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Ear pain
Clinical narrative: Pain traveled up shoulder to ear; Pain traveled up shoulder to ear; strong dizziness that dissipated to minor dizziness within 15 minute wait; Pain in shoulder to neck; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date unknown), via an unspecified route of administration (left arm) on 13Jan2021 at 10:45 at a single dose for COVID-19 immunization. Medical history included Polycystic Ovarian Syndrome (PCOS), allergies, excessing calcification of veins and arteries, high blood pressure (BP), and known allergies to trees, grass and weeds. Concomitant medications included metformin (METFORMIN), rosuvastatin (ROSUVASTATIN), levothyroxine (LEVOTHYROXINE), and liothyronine (LIOTHYRONINE). The patient had no other vaccine in four weeks. On 13Jan2021, the patient experienced pain traveled up shoulder to ear, strong dizziness that dissipated to minor dizziness within 15-minute wait and pain in shoulder to neck has lessened 48 hours later, but still present. The patient had no COVID prior vaccination and had no COVID test post-vaccination. No treatment administered for the events. The events were resolving at the time of the report.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Erythema, Fatigue, Pain in extremity
Clinical narrative: chills; tiredness; temperature was 100.8; sore arm with redness; sore arm with redness; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left arm on 12Jan2021 at a single dose for covid-19 immunisation. Medical history included covid-19 in Apr2020. There were no concomitant medications. On 13Jan2021, the patient experienced chills and tiredness and at the end of the day, her temperature was 100.8. The patient also experienced sore arm with redness in Jan2021. The patient stated that every once in a while, she get a shot and get a sore arm. She added that she noticed that her arm was more sore with redness that morning of reporting. The outcome of events chills, tiredness and temperature was 100.8 recovered on 14Jan2021, event sore arm with redness was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Vomiting
Clinical narrative: vomiting; does not feel good; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received a 1st shot of Pfizer vaccine yesterday (14Jan2021) and has been vomiting since this am (morning) (15Jan2021) and does not feel good (exact date unspecified; Jan2021). The outcome of events was unknown. This case is non-serious.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: pain; headache; shiver; a fever which is currently 99.7 F; This is a spontaneous report received from a non-contactable consumer (patient's husband). A female patient of an unspecified age (reported as 62, unit not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date: unknown), via an unspecified route of administration, on 14Jan2021 10:00, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the vaccine yesterday (14Jan2021) around 10:00 and around 20:00, the patient experienced pain, headache, shiver and a fever which is currently 99.7 F. The reporter asked if the patient can use antipyretics before or after vaccination with the BNT162B2 vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Peripheral swelling
Clinical narrative: large swelling around his right leg; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of unspecified age received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 13Jan2021, at a single dose for COVID-19 immunization. The patient also received insulin (manufacturer unknown), via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. Medical history and concomitant medications were not reported. The patient got the COVID vaccine shot on Wednesday, 13Jan2021. At the morning of the report, 15Jan2021, he noticed a large swelling around his right leg. When he takes insulin through his right leg, he sees a few spots, but it usually goes away. This morning, when he woke up, a large area around the right site was swollen and it's not going away. He had been injected insulin around the same site a few times. He called to know if this was normal. The action taken in response to the event for insulin was unknown. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness
Clinical narrative: light headiness; feel tightness around my chest; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 15Jan2021 11:15 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated "I already reported the side effects to Pfizer before calling you. I received the vaccine today (15Jan2021) at 11:15 am. I felt light headiness for 5 to 19 minutes. I attributed this to the fact that I was fasting. I felt better after drinking water and a little walk. When I got home I started to feel tightness around my chest, no difficult breathing, no high pulse and no fever." The patient wasnted to know if this was considered a severe allergic reaction that may require hospitalization. The outcome of the event light headiness was recovering, while feel tightness around my chest was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Shortness of breath Chest Heavy Lightheaded; Shortness of breath Chest Heavy Lightheaded; Shortness of breath Chest Heavy Lightheaded; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246, expiration date not reported), intramuscular on 14Jan2021 10:15 at single dose on the right arm for COVID-19 immunization. Medical history included chronic pain and known allergies to sulfa. The patient's concomitant medications were not reported. The patient experienced shortness of breath, chest heavy, lightheaded on 15Jan2021 at 10:00. The patient has not recovered from the events at the time of the report. The patient was not pregnant, has no prior COVID vaccination and was not tested for COVID post vaccination.