chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: 4-5 days ago I started to develop little skin bumps,2 days ago they became extra itchy, now im getting so many of them around my body like small pimples and they itch so much.a day right before my second phizer shot.im afraid to go for the second shot now.what should I do? Thank you!
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Ear pain, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; ear pain; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program . A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 21Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Mar2021, she experienced ear pain and sore throat. She had no other symptoms such as fever. A covid-19 test was administered and she tested positive in Mar2021. She went into quarantine for 11 days and was fully recovered from her symptoms. She is almost finished with being quarantined. She got her 1st Covid dose and a week later got COVID on 28Mar2021. She was supposed to get her second dose on 12Apr2021 and was wanting to know when she can get her 2nd dose. But she called CVS and cancelled the second dose. Her doctor and one person at CVS told her she could get the second dose of BNT162B2 after 1 month, 30 days after the COVID. Another person at CVS told her that she needed to wait 3 months after COVID to get the second dose of BNT162B2. The outcome of events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoacusis, Injection site pain, Malaise
Clinical narrative: The day of getting my vaccine, I had received the shot at 1:30pm on 4/30. I had no symptoms besides a sore arm at the injection site. I woke up at 4:00am on 5/1 with a fever of 99.9F and chills. I decided to take a hot shower because I couldn?t get warm. At the end of my shower I suddenly got a ?sickly? feeling in my chest, similar to symptoms of a chest cold. My vision started going black, almost like when you stand up too quickly. I experienced a sudden throbbing headache out of nowhere. My ears were ringing with partial hearing loss, and I started getting very nauseous. I stumbled out of the shower and immediately vomited.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tinnitus, Visual impairment, Vomiting
Clinical narrative: The day of getting my vaccine, I had received the shot at 1:30pm on 4/30. I had no symptoms besides a sore arm at the injection site. I woke up at 4:00am on 5/1 with a fever of 99.9F and chills. I decided to take a hot shower because I couldn?t get warm. At the end of my shower I suddenly got a ?sickly? feeling in my chest, similar to symptoms of a chest cold. My vision started going black, almost like when you stand up too quickly. I experienced a sudden throbbing headache out of nowhere. My ears were ringing with partial hearing loss, and I started getting very nauseous. I stumbled out of the shower and immediately vomited.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Rash, Swelling face
Clinical narrative: Day 1 - I developed a rash on my face and upper chest, just below the neck. Day 2 - I woke with a severely swollen left cheek and right eye. The swelling remained severe for three days, worsening on Day 2, and lessening on Day 3. Over three days, I continued to develop new rashes on various parts of my body, including both arms and legs, and along my spinal column.  The rashes remained on my face and upper chest. I remained bedridden Day 2 and 3. It is currently Day 5 - the swelling has gone down considerably, though is still present in my left cheek and right eye.  I still have multiple rashes. I feel I'm on my way toward recovery.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Impaired work ability, Injection site pain, Malaise
Clinical narrative: 4/20/21 shot at 2 p.m.  Injection site pain came on in about 2 hours and stayed for a few days but got better each day.  Chills came on around 6 p.m. (4 hours after the shot) then just a general feeling of malaise.  By morning of 4/21/21 (6 a.m.), joint pain had set in and I felt like I could feel every bone and joint in my body.  I also had chills on and off through the day.  I missed part of work that day while I tried to rest.  Took tylenol as directed at .  That night I had chills again then spiked a fever of 101.8.   Pain subsided the next morning  of 4/22/21 around 10 a.m.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: ?Pfizer-BioNTech COVID-19 Vaccine EUA:  Pain in right arm 3 hours after 2nd dose.  Pain became generalized.  Fever on 5/1/2021 at 4:30am of 100.3
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pain, Pain in extremity, Pyrexia
Clinical narrative: ?Pfizer-BioNTech COVID-19 Vaccine EUA:  Pain in right arm 3 hours after 2nd dose.  Pain became generalized.  Fever on 5/1/2021 at 4:30am of 100.3
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Neuropathy peripheral, Pain in extremity
Clinical narrative: Peripheral Neuropathy: 3 years ago I had an adverse reaction to Ciproflaxacin of intense peripheral neuropathy. That lasted for about 1.5 to 2 years but had abated.  After my second dose of Moderna my peripheral neuropathy has returned. Now when I exert myself I get intense PN in arms and sometimes legs.  I also get fatigued easily.  This reaction has not abated so far from April 1 to May 1.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus for a day.
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a Pfizer sponsored program  support. A contactable consumer (patient) reported that a 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), 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. The patient had a UTI and was taking antibiotics on an unspecified date. The patient wanted to know if he needs to postpone his second dose because of his antibiotic prescription. The outcome of the event was unknown.No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Peripheral swelling, Vaccination site pain, Vaccination site swelling
Clinical narrative: Experienced left arm soreness and swelling; Experienced left arm soreness and swelling/Left deltoid arm it is really sore; Lymph node swelling; Soreness at injection site/Left deltoid arm it is really sore; swelling in the arm where she got vaccinated; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program . A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left deltoid arm on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient experienced left arm soreness and swelling, left deltoid arm it was really sore, lymph node swelling, swelling in the arm where she got vaccinated, soreness at injection site, all on apr2021 with outcome of unknown. Clinical course: The patient received the first dose of the Pfizer COVID vaccine in her eft deltoid arm and experienced left arm soreness and swelling more so yesterday than the first day and she also had some swelling under her left armpit. That is her non-dominant arm and it was really sore. The patient had read a lot of side effects too and they also told her at the testing site at the hospital and they noticed like yesterday, it was under her arm, like in her arm pit she felt swelling. Soreness at injection site and armpit was swollen wanted to know if this was a normal side effect and how long it would last. She was reading the factsheet and it stated could have swollen lymph nodes.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives and itchiness from scalp to foot; hives and itchiness from scalp to foot; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hives and itchiness from scalp to foot on 09Apr2021 with outcome of unknown. The patient got the Pfizer shot on 08Apr2021 and breaking out in full body hives, it was the first shot of Pfizer Covid 19 vaccine. The patient would like to know what she was supposed to do, she had full body hives everywhere from head all the way down to her feet. Reporter seriousness for the events: Unspecified.   No follow-up attempts are needed. No further information is expected. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Lacrimation increased, Rhinorrhoea
Clinical narrative: watery eyes; persistent cough; runny nose; This is a spontaneous report from a contactable consumer (patient herself). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  Caller stated she was scheduled to receive the second dose of the Pfizer COVID vaccine this afternoon around noon. Caller stated she began to have a persistent cough, runny nose, and watery eyes in Apr2021 since Easter. Caller would like to know if she should receive the second dose today. No information in PI regarding cough, runny nose, and watering of eyes after Pfizer COVID vaccine. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Tension headache
Clinical narrative: tension headache; soreness in her arm; feeling tired; This is a spontaneous report received from a contactable consumer (patient herself). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  Caller mentioned that she was allergic to metronidazole (FLAGYL) but didn't say what kind of reaction she had before. Patient stated that she received her 1st dose of the Pfizer Covid Vaccine yesterday and in the afternoon she experienced some side effects such as soreness in her arm, feeling tired, and tension headache. She said that she was now feeling fine except for the headache which she still had until now. She didn't experience any other AE aside from the ones she mentioned. Patient wanted to know if she can take BC Powder for her headache since it was the only thing she has and was already advised during vaccination not to take it until she's completed her vaccine doses. Outcome of tension headache was not recovered, and outcome of other events was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt after the first shot/Pain in arm; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm on 19Mar2021 as single dose for COVID-19 immunization. Medical history included rotator cuff syndrome. The patient's concomitant medications were not reported. The patient experienced his arm hurt/pain in arm after the first shot on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021407624 same reporter/drug, different patient/AE;US-PFIZER INC-2021407625 same reporter/drug, different patient/AE;US-PFIZER INC-2021407626 same reporter/drug, different patient/AE
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Herpes simplex, Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient) reported for herself. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Lot Number: EP7533; Expiration Date: Jul 2021), dose 2 via an unspecified route of administration, administered in Deltoid Left on 07Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 07Apr2021, that evening about 12 hours after the shot, the patient experienced most of the side effects, fever, chills, joint pain, headache, it triggered a Herpes outbreak. The patient took Ibuprofen and was trying to find out if it is okay that it's okay to take Valtrex, didn't know yet. Ibuprofen on April 7th and 8th and 9th, tablet, 1st time patient took two 200mg tablet and then each time after that one 200 mg tablet. Probably two or three times, patient didn't remember for fever and headache and joint pain. Fever, chills and joint pain have gotten better. The outcome of event herpes outbreak and headache was not recovered, outcome of the other events was recovering. No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Myalgia, Rhinorrhoea
Clinical narrative: runny nose; coughing; muscle aches; dizziness; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine,), dose 1 via an unspecified route of administration on 08Apr2021 as a single dose Batch/Lot number was not reported for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 08Apr2021, the patient had adverse reactions, including runny nose, coughing, muscle aches, dizziness and lasted until 10Apr2021. The outcome of events was unknown.   The  Centers for Disease Control & Prevention (CDC)'s Advisory Committee on Immunization Practices (ACIP) has provided interim considerations for the use of mRNA COVID-19 Vaccines during the Emergency Use Authorization. These interim considerations state mRNA vaccines, including the Pfizer BioNTech COVID-19 vaccine, can safely be given to persons with a history of a prior COVID-19 infection. The vaccine should be offered even if you had symptoms or no symptoms of COVID-19 infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain, Vaccination site pain
Clinical narrative: dizziness; body aches; chills; sore at injection site; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as SINGLE DOSE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient experienced body aches, chills, sore at injection site, all on 09Apr2021 with outcome of unknown, dizziness on 10Apr2021 with outcome of unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: My menstrual cycle started early and has not stopped . It has been 12 days of menstrual bleeding and this has never happened before. It started the week after my 2nd vaccine shot. My sister and friend; My menstrual cycle started early and has not stopped . It has been 12 days of menstrual bleeding and this has never happened before. It started the week after my 2nd vaccine shot. My sister and friend; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 3 patients (her sister, friend and herself). This is a 1st of 3 reports. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. My menstrual cycle started early and has not stopped . It has been 12 days of menstrual bleeding and this has never happened before. It started the week after my 2nd vaccine shot. My sister and friend have reported a similar side effect and we do not believe it is coincidence. We think it is a side effect of the COVID 19 vaccine. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : PFIZER INC-2021407009 same reporter/drug/event, different patient.; PFIZER INC-2021407010 same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Muscle tightness, Nausea, Oral discomfort, Throat tightness
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient medical history and the concomitant medications were not reported. The patient had an allergic reaction to Pfizer covid 19 vaccine. She had jaw, mouth and throat tightening, nausea and dizziness from the first shot which got cleared by Benadryl.  She would like to know if she should take the second shot or not. The outcome was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: headache; fever; This is a spontaneous report from a contactable consumer.A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and  concomitant medications were not reported. Patient previously received  the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunization. The patient experienced headache, fever on an unspecified date.  Outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: hives; rash; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for self that the female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Mar2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced hives on an unspecified date with outcome of unknown, rash on an unspecified date with outcome of unknown, she was given a prescription for 5 days of steroid. she also mentioned that she read online that steroids can affect the efficacy of the vaccine on an unspecified date with outcome of unknown, she was given a prescription for 5 days of steroid. she also mentioned that she read online that steroids can affect the efficacy of the vaccine on an unspecified date with outcome of unknown. Consumer is about to take their 2nd dose of the PFIZER-BIONTECH COVID-19 VACCINE and wanted to know if she is able to take steroids alongside the vaccine that has been prescribed to her for hives and rash (for 5 days) . Also, she would like to know; if she's able to do that, if it would affect the efficacy of the vaccine and if not, does she have to repeat the whole vaccination series. Also, consumer went to her physician and she was prescribe of this steroid for her hives and rash, but physician does not believe this to be a side effect of taking the vaccine because she did not develop the hives and rash not later than 15 days after her vaccination. Consumer reported that she received the 1st dose of covid-19 vaccine last 24Mar2021. She had hives rash after the vaccine but not sure if it's because of the vaccine. She mentioned that she was given a prescription for 5 days of steroid. She also mentioned that she read online that steroids can affect the efficacy of the vaccine. She wanted to ask if this is true and she also wanted to know if it's okay to take the steroid. The 2nd dose scheduled on 15Apr2021, which is more than 21 days.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program. A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Apr2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not provided. Patient was experiencing a headache on 11Apr2021. Patient would like to know if he can take aspirin for his headache. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: feeling yucky; no sense of taste; headache; muscle pain; tired; This is a spontaneous report from a contactable consumer reported for boyfriend. A 58-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The reporter stated the patient "started feeling yucky" on 05Apr2021. The patient had no sense of taste, a headache, muscle pain, and was tired in Apr2021. The reporter stated that she received the first dose on 02Apr2021 as well. The reporter asked if the loss of taste was a side effect of the Covid vaccine. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: arm was a little sore; pain has now moved to under armpit; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced arm was a little sore, pain had now moved to under armpit, both in Apr2021 with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: the muscle on her leg from her hip to her knee was really sore (same side she was injected); This is a spontaneous report received from a contactable consumer. This consumer (patient) reported that a 40-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated that just got 2nd dose yesterday, was reading about the vaccine and it said it prevent severe illness. But didn't state what kind of illness it prevents. She didn't get any side effects except 1: no fever or chills. It had been 24 hours since her 2nd dose the only side effect she had was: the side where she got injected, the muscle on her leg from her hip to her knee was really sore (same side she was injected). Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: swollen lymph nodes that are "extremely swollen and very painful."; swollen lymph nodes that are "extremely swollen and very painful."; she has incredible pain; fever; experienced shivering that wouldn't stop; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was experiencing swollen lymph nodes that were "extremely swollen and very painful." She had incredible pain and it was hard for her to put her arm down or to reach forward or backwards. On 10Apr2021 she had a fever and experienced shivering that wouldn't stop. The event outcome was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: bad rash on my body; This is a spontaneous report from a contactable consumer (patient). This 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient received the first dose of the Covid vaccine a week before and reported 5 days later, she had a really bad rash on her body. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: very little arm trouble the next day (barely); This is spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. This consumer reported events for both doses of bnt162b2. This is for the first dose. An 86-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The first shot the patient had no issues. The patient told them he wanted them to give it to him slow. He had very little arm trouble the next day (barely). The outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021407944 Same patient, different dose and event
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Cold sweat, Feeling abnormal, Loss of personal independence in daily activities
Clinical narrative: feeling crappy/feeling bad; chills; felt clammy and was sweating; was unsteady and couldn't stand to cut the grass / wasn't as easy on his feet and out of balance; couldn't stand to cut the grass; after receiving the vaccine the ringing in his ears also came back and was getting worse as well; This is a spontaneous report received from a contactable consumer reporting for himself. This 62-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date in 2021, for COVID-19 immunization. Medical history included COVID in Dec2020 and he had ringing in his ears, also known as tinnitus, and this was clearing up and almost gone. Concomitant medications were not reported. The patient felt okay on 10Apr2021 but was unsteady and couldn't stand to cut the grass. The patient wasn't as easy on his feet and out of balance and this was his only symptom on 10Apr2021. On 11Apr2021 the patient was feeling crappy and wanted to know if he should go to the hospital. When he went to church on 11Apr2021 morning he began feeling bad and almost left because he had chills, felt clammy and was sweating. He had COVID in Dec2020 and he had ringing in his ears also known as tinnitus and this was clearing up and almost gone but after receiving the vaccine the ringing in his ears also came back and was getting worse as well. His doctor told him that people who had COVID prior to receiving the vaccine may have an increased immune response and he guessed that it was what was taking place with him currently but he did not like it and did not want to go through it again with the second dose. Events outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: feeling crappy/feeling bad; chills; felt clammy and was sweating; was unsteady and couldn't stand to cut the grass / wasn't as easy on his feet and out of balance; couldn't stand to cut the grass; after receiving the vaccine the ringing in his ears also came back and was getting worse as well; This is a spontaneous report received from a contactable consumer reporting for himself. This 62-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date in 2021, for COVID-19 immunization. Medical history included COVID in Dec2020 and he had ringing in his ears, also known as tinnitus, and this was clearing up and almost gone. Concomitant medications were not reported. The patient felt okay on 10Apr2021 but was unsteady and couldn't stand to cut the grass. The patient wasn't as easy on his feet and out of balance and this was his only symptom on 10Apr2021. On 11Apr2021 the patient was feeling crappy and wanted to know if he should go to the hospital. When he went to church on 11Apr2021 morning he began feeling bad and almost left because he had chills, felt clammy and was sweating. He had COVID in Dec2020 and he had ringing in his ears also known as tinnitus and this was clearing up and almost gone but after receiving the vaccine the ringing in his ears also came back and was getting worse as well. His doctor told him that people who had COVID prior to receiving the vaccine may have an increased immune response and he guessed that it was what was taking place with him currently but he did not like it and did not want to go through it again with the second dose. Events outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID19 infection well after successful vaccination; COVID19 infection well after successful vaccination; This is a spontaneous report from a contactable other health professional. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EJ1685), dose 1 via an unspecified route of administration, administered in Arm Left on 18Dec2020 as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 25Jan2021 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number:EJ1686) as single dose for COVID-19 immunization. On an unspecified date the patients medical history included drug hypersensitivity(Penicillin, Rocephin). On an unspecified date concomitant medications included sertraline hydrochloride (ZOLOFT), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), amlodipine (AMLODIPINE) taken for an unspecified indication. The patient previously took rocephin [ceftriaxone sodium] and experienced drug hypersensitivity. On 19Mar2021 the patient experienced covid19 infection well after successful vaccination, covid19 infection well after successful vaccination. The outcome of the events recovering.; Sender's Comments: The event COVID19 is most likely an intercurrent condition. Based on temporal relation, the association between onset of event COVID19 and vaccination cannot be ruled out.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Body temperature, Chills, Decreased appetite
Clinical narrative: feeling unwell; Just stayed in bed and rode it out.; slight rash at injection sight/red rash; injection site itchy; armpit swollen/armpit swollen; 103 fever; sweats; severe pounding headache; no energy; tired; chills; wiped out/weak; nausea; diarrhea; no appetite; This is a spontaneous report from a contactable consumer or other non hcp.   A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: ER8729) dose 2 via an unspecified route of administration, administered in right arm on 07Apr2021 11:00 as SINGLE DOSE for covid-19 immunization.  Medical history included Blood pressure, Diabetic, potassium and some known allergies of Sulfa, Bees. Historical vaccine was covid 19. The patient's concomitant medications were not reported. On 08Apr2021 at 12:00 AM, the patient experienced chills, sweats, up to 103 fever, severe pounding headache, no energy, tired/wiped out/weak, nausea, diarrhea, no appetite, red rash at injection site, itchy, armpit swollen, started about about 12 hours after shot. The patient stated that first 3 days was roughest. Everything above lasted for 4 days. Day 5 just little energy, feeling unwell and slight rash at injection sight/sight swelling armpit and no appetite. Just stayed in bed and rode it out. The outcome of the events was reported as recovering. The action taken in response to the events for bnt162b2 was not applicable.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Hyperhidrosis, Malaise
Clinical narrative: feeling unwell; Just stayed in bed and rode it out.; slight rash at injection sight/red rash; injection site itchy; armpit swollen/armpit swollen; 103 fever; sweats; severe pounding headache; no energy; tired; chills; wiped out/weak; nausea; diarrhea; no appetite; This is a spontaneous report from a contactable consumer or other non hcp.   A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: ER8729) dose 2 via an unspecified route of administration, administered in right arm on 07Apr2021 11:00 as SINGLE DOSE for covid-19 immunization.  Medical history included Blood pressure, Diabetic, potassium and some known allergies of Sulfa, Bees. Historical vaccine was covid 19. The patient's concomitant medications were not reported. On 08Apr2021 at 12:00 AM, the patient experienced chills, sweats, up to 103 fever, severe pounding headache, no energy, tired/wiped out/weak, nausea, diarrhea, no appetite, red rash at injection site, itchy, armpit swollen, started about about 12 hours after shot. The patient stated that first 3 days was roughest. Everything above lasted for 4 days. Day 5 just little energy, feeling unwell and slight rash at injection sight/sight swelling armpit and no appetite. Just stayed in bed and rode it out. The outcome of the events was reported as recovering. The action taken in response to the events for bnt162b2 was not applicable.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: feeling unwell; Just stayed in bed and rode it out.; slight rash at injection sight/red rash; injection site itchy; armpit swollen/armpit swollen; 103 fever; sweats; severe pounding headache; no energy; tired; chills; wiped out/weak; nausea; diarrhea; no appetite; This is a spontaneous report from a contactable consumer or other non hcp.   A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: ER8729) dose 2 via an unspecified route of administration, administered in right arm on 07Apr2021 11:00 as SINGLE DOSE for covid-19 immunization.  Medical history included Blood pressure, Diabetic, potassium and some known allergies of Sulfa, Bees. Historical vaccine was covid 19. The patient's concomitant medications were not reported. On 08Apr2021 at 12:00 AM, the patient experienced chills, sweats, up to 103 fever, severe pounding headache, no energy, tired/wiped out/weak, nausea, diarrhea, no appetite, red rash at injection site, itchy, armpit swollen, started about about 12 hours after shot. The patient stated that first 3 days was roughest. Everything above lasted for 4 days. Day 5 just little energy, feeling unwell and slight rash at injection sight/sight swelling armpit and no appetite. Just stayed in bed and rode it out. The outcome of the events was reported as recovering. The action taken in response to the events for bnt162b2 was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: sore arm; aches; chills; overall tiredness; This is a spontaneous report from a contactable consumer. Follow-up (20Apr2021) was received from same reporter and processed together with initial information.  An adult female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Unknown) via an unspecified route of administration on unspecified date in Mar2021 as single dose for COVID-19 immunization. The patients' medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. It is unknown whether the patient is pregnant at time of vaccination. On Mar2021, the patient experienced sore arm, aches, chills, overall tiredness. It was unknown if the patient received treatment to the events. It was unknown if the patient has been tested for COVID-19 since the vaccination. Outcome of the events was recovered on unspecified date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Dose 2: headache, chills, sore arm; Dose 2: headache, chills, sore arm; Dose 2: headache, chills, sore arm; Aches; This is a spontaneous report from a contactable consumer. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), dose 2 via an unspecified route of administration on Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown whether the patient diagnosed with COVID-19 prior to vaccination. On an unspecified date Mar2021, the patient experienced Dose 2: headache, chills, sore arm, and aches. It was unknown whether the patient has been tested for COVID-19. Treatment received for the events was unknown. The outcome of the events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pain, Vaccination site pain
Clinical narrative: injection site soreness; general body aches; upset stomach; This is a spontaneous report from a contactable consumer (patient's guardian). A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 07Apr2021 at 16:15 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 17Mar2021 at 04:15 PM at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not allergic to medications, food, or other products. The patient received 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 had not been tested for COVID-19. On 07Apr2021 at 19:00, the patient experienced injection site soreness, general body, aches, upset stomach. No treatment was received for the adverse events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Headache, Malaise
Clinical narrative: I just do not feel good; I was kind of feeling weak and now I am feeling even worse; Shortness of breath; Mental fatigue; Headache; Chills; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included had knee replacement surgery on 08Mar2021 and was kind of feeling weak. The patient's concomitant medications were not reported. The patient went on Wednesday to get the Pfizer vaccine and just did not feel good. The patient had knee replacement surgery on 08Mar2021 and was kind of feeling weak before getting the shot and now was feeling even worse. The patient had shortness of breath and mental fatigue. The patient had headache that would not go away, patient had chills. The outcome of events feeling weak before getting the shot and now was feeling even worse and headache was not recovered; other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Mental fatigue
Clinical narrative: I just do not feel good; I was kind of feeling weak and now I am feeling even worse; Shortness of breath; Mental fatigue; Headache; Chills; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included had knee replacement surgery on 08Mar2021 and was kind of feeling weak. The patient's concomitant medications were not reported. The patient went on Wednesday to get the Pfizer vaccine and just did not feel good. The patient had knee replacement surgery on 08Mar2021 and was kind of feeling weak before getting the shot and now was feeling even worse. The patient had shortness of breath and mental fatigue. The patient had headache that would not go away, patient had chills. The outcome of events feeling weak before getting the shot and now was feeling even worse and headache was not recovered; other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chills, Fatigue, Myalgia
Clinical narrative: Chills; aches in bones and muscles; aches in bones and muscles; fatigue; This is a spontaneous report from a contactable consumer (parent) reported for his/her son. A 19-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 at 09:00 AM (Lot number: EP6955) on the right arm as single dose for covid-19 immunization. Medical history included depressed left ventricular function due to COVID-19. Prior to vaccination, the patient had diagnosed with COVID-19. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); metoprolol tartrate; probiotic; ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS); that patient received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Mar2021 at 09:00 AM (lot number: EP6955) on the right arm as single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced chills, aches in bones and muscles, fatigue; that the symptoms started late evening 09Apr2021 at 23:00. Treatment of Tylenol received for the adverse event. The outcome of the events was recovered on 11Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: his 2nd Pfizer COVID19 vaccine today and is asking if it would be okay for him to get vaccinated today after being cleared from quarantine last Saturday because he had COVID; his 2nd Pfizer COVID19 vaccine today and is asking if it would be okay for him to get vaccinated today after being cleared from quarantine last Saturday because he had COVID; This is a spontaneous report from a Pfizer-sponsored program  via medical information team. A contactable consumer (patient) reported that a male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On an unknown date patient was diagnosed with COVID and he was enquiring that he was scheduled for his 2nd Pfizer COVID19 vaccine today and was asking if it would be okay for him to get vaccinated today after being cleared from quarantine last Saturday. Outcome for the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She got the first one and then she got Covid.; She got the first one and then she got Covid.; This is a spontaneous report from a contactable consumer (reported for her aunt). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) dose 1 via an unspecified route of administration on an unspecified date (Lot number and expiry date was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced got the first one and then she got COVID. She said that she had registered her aunt to get that vaccine. She asked, what does she do about her second dose. Caller thinks that, the patient was still having the symptoms. The patient was scheduled for the 16th. Caller asked that, would she contact pharmacy to reschedule. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events were unknown.  Information on the lot/batch number has been requested.