chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Heart injury, Renal injury
Clinical narrative: Permanent damage to heart and kidneys; Permanent damage to heart and kidneys; This is a spontaneous report from a contactable consumer or other non hcp. A 90-years-old male patient (reporters uncle) received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 2 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 was not reported. The patient received the Pfizer-BioNTech COVID-19 Vaccine first dose last 08Mar2021. This was on a Monday, and Caller reported that throughout the rest of the week until Friday (12Mar2021), the caller experienced muscle aches, fatigue (especially mental fatigue in a fog). The patients concomitant medications were not reported. On an unspecified date, the patient experienced permanent heart damage and damage to the kidneys. Caller mentioned he is 65-year-old and his 90-year-old uncle was hospitalized after the second shot. Caller is concerned regarding these possible side effects for the second dose and is seeking information. This report is cross referenced to reportum reference. Received call from consumer regarding the Pfizer COVID vaccine. While reporting for himself, he mentioned that his Uncle, who is 90, received first COVID injection and then went for his second injection. Right after that, he started getting negative symptoms. It did permanent damage to his heart and kidneys and ended up in the hospital for a couple of days. This report is to capture information for his uncle. He did not wish to create report. No further details provided. The outcome of the events were not reported.  Information on the lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Diarrhoea, Drug ineffective, Fatigue
Clinical narrative: suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; exploding diarrhea; extreme tiredness she could hardly walk; muscle aching; Joint pain; felt very sick and couldn't really function; could hardly walk; stayed in bed all day; This is a spontaneous report from a contactable (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2nd via an unspecified route of administration, administered in Arm Right on 11Feb2021 09:00 (Batch/Lot Number: GL9269) as single dose, dose 1st via an unspecified route of administration, administered in Arm Right on 21Jan2021 (Batch/Lot Number: el8982) as single dose for covid-19 immunization. Medical history included apnoea from 2019 to (Verbatim: Apnoea, Diagnosed 2 years ago) , hypertension ( Verbatim: Blood pressure high, diagnosed 15-20 years ago). The patient's concomitant medications were not reported. Family Medical History Relevant to adverse event was none. On 10Mar2021 the patient woke up to a big reaction. The patient had exploding diarrhea, extreme tiredness she could hardly walk, muscle aching, joint pain, felt very sick and couldn't really function, she stayed in bed all day, got better in the late afternoon. It was as if the patient had covid, then it disappeared. The outcome of the events was recovered.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Illness, Myalgia, SARS-CoV-2 antibody test, Suspected COVID-19
Clinical narrative: suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; exploding diarrhea; extreme tiredness she could hardly walk; muscle aching; Joint pain; felt very sick and couldn't really function; could hardly walk; stayed in bed all day; This is a spontaneous report from a contactable (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2nd via an unspecified route of administration, administered in Arm Right on 11Feb2021 09:00 (Batch/Lot Number: GL9269) as single dose, dose 1st via an unspecified route of administration, administered in Arm Right on 21Jan2021 (Batch/Lot Number: el8982) as single dose for covid-19 immunization. Medical history included apnoea from 2019 to (Verbatim: Apnoea, Diagnosed 2 years ago) , hypertension ( Verbatim: Blood pressure high, diagnosed 15-20 years ago). The patient's concomitant medications were not reported. Family Medical History Relevant to adverse event was none. On 10Mar2021 the patient woke up to a big reaction. The patient had exploding diarrhea, extreme tiredness she could hardly walk, muscle aching, joint pain, felt very sick and couldn't really function, she stayed in bed all day, got better in the late afternoon. It was as if the patient had covid, then it disappeared. The outcome of the events was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection arm was "a little" sore after getting the first dose.; This is a spontaneous report from a female consumer (patient herself) of unspecified age who received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's Medical history included tooth disorder, Was prescribed doxycycline antibiotic.The patient's concomitant medications were not reported.The patient experienced injection arm was "a little" sore after getting the first dose on Mar2021.The patient was due for second dose on 07Apr2021.She had  been to the dentist and was being treated for a dental infection and was prescribed doxycycline antibiotic. She wanted to know if this would interact with the second dose of the vaccine. Per response made to referred caller to discuss with health care professional and informed the caller that company cannot make treatment recomendatons. Reviewed contraindications with caller as per attached document CONS-who should not get the vaccine.The outcome of the event was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Ear injury
Clinical narrative: damage to his ear; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received first dose of BNT162B2 (Solution for injection, Lot number: unknown) via an unspecified route of administration in Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient incurred damage to his ear in Mar2021. His doctor prescribed a tapering high dose of prednisone 10 mg tablets over the next 7 days. He had not started the medication yet. He received his first dose of the Pfizer Covid 19 vaccine one week ago today. The outcome of the event was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Red blotches/The blotches are golf ball sized. The blotches came and then went away and then came back; This is a spontaneous report from a contactable consumer (patient's husband). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 24Feb2021 to 24Feb2021 (Lot Number: EN6198; Expiration Date: 30Jun2021, at the age of 67-years-old) as single dose and dose 2 via an unspecified route of administration on 16Mar2021 to 16Mar2021 (Lot Number: EN6204; Expiration Date: 30Jun2021) as single dose for preventative measure (COVID-19 immunisation). Medical history included ongoing blood pressure. Concomitant medications included losartan potassium at 25 mg twice a day (low dose) for blood pressure, centrum, Vitamin D and fish oil. The caller was calling about the covid vaccine. The caller was calling for his wife. The caller and his wife both had 2 shots. He states that she received her first dose of the Pfizer BioNTech COVID-19 vaccine on 24Feb2021 and afterwards reports finding two red large blotches the size of a golf ball, one on her throat and one on her forehead. The blotches went away and then came back before the patient received her second dose. Then after the patient had the second dose on 16Mar2021 and got a third red blotch the size of a golf ball under her ear. The blotches are golf ball sized. The blotches came and then went away and then came back. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pollakiuria, Urinary retention
Clinical narrative: Problem with urine retention; Increased tendency to urinate.; Minor cold symptoms day after and 5 days after.; This is a spontaneous report from a non-contactable consumer (patient). A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN6206), via an unspecified route of administration on Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no covid prior vaccination. The patient was not covid tested post vaccination. The patient experienced Increased tendency to urinate. Problem with urine retention. Minor cold symptoms day after and 5 days after. Onset dates unspecified. The outcome of the events was unknown.    No follow-up attempts are possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Acne, Thrombosis
Clinical narrative: I broke a pimple and came liquid after taking the pimple out, it came a little thing like clear and then it came like blood; it was like a clot; broke a pimple; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer stated, "I am kind of concerned because I was showering myself like 30 minutes ago, well I was cleaning my face and well you like night routine and I broke a pimple that I didn't have and came liquid after taking the pimple out, it came a little thing like clear and then it came like blood not too much for sure, then I realized that the blood that came out wasn't liquid, it was like a clot. I cleaned it with a t-shirt and I was able like to move it. So I am kind of concerned because I got my first dosage of the Pfizer vaccine on March the 6th, I am about to get my second dosage this Saturday and as you know and everyone should know right now what's going on with this (name) and (name) vaccine and then what everyone is talking about, it's impossible to not be concerned about the side effects." The event clot blood was assessed as serious (medically significant). The outcome of the events was unknown.    Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthropod bite, Erythema, Pruritus, Rash erythematous, Swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (BNT162B2, Solution for injection) via an unspecified route of administration, administered in arm left on Mar 2021 as single dose for COVID-19 immunization. Medical history included cardiac patient on meds. Concomitant medication included apixaban (ELIQUIS), atorvastatin, lisinopril and amlodipine. The patient had a historical vaccine of codeine and known allergies with codeine. The consumer stated, "I received my COVID-19 vaccine. Approximately, I think it was Tuesday or Wednesday of last week, probably Tuesday. Everything was fine but I noticed they didn't have a phone in case of any complications or issues. I took the vaccine, everything was fine, no problem but I guess it was 3 days ago (Mar 2021), I woke up with hives, swelled, hives and itchy. I thought it was bed bug bite or something. I didn't associate the vaccine and also reported as rash. It is red, swelled. In the front of my body, lower abdomen, my back and one on my foot, right on my ankle and I don't know why I got this adverse so many days later. Patient reported that he received the 1st dose of the vaccine on Mar 2021, roughly 48hrs later he developed hives and an itchiness of the skin. He also has concerns on whether he should receive the 2nd dose as a result of the reaction. The action taken in response to the events for BNT162B2 was not applicable. Therapeutic measures were taken as a result of rash/it is red, swelled. in the front of my body, lower abdomen, my back and one on my foot, right on my ankle, hives/it is red, swelled. in the front of my body, lower abdomen, my back and one on my foot, right on my ankle, swelling/it is red, swelled. in the front of my body, lower abdomen, my back and one on my foot, right on my ankle. The outcome of the events red rash, hives and swelling were recovered on an unspecified date and remaining all events were unknown. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (BNT162B2, Solution for injection) via an unspecified route of administration, administered in arm left on Mar 2021 as single dose for COVID-19 immunization. Medical history included cardiac patient on meds. Concomitant medication included apixaban (ELIQUIS), atorvastatin, lisinopril and amlodipine. The patient had a historical vaccine of codeine and known allergies with codeine. The consumer stated, "I received my COVID-19 vaccine. Approximately, I think it was Tuesday or Wednesday of last week, probably Tuesday. Everything was fine but I noticed they didn't have a phone in case of any complications or issues. I took the vaccine, everything was fine, no problem but I guess it was 3 days ago (Mar 2021), I woke up with hives, swelled, hives and itchy. I thought it was bed bug bite or something. I didn't associate the vaccine and also reported as rash. It is red, swelled. In the front of my body, lower abdomen, my back and one on my foot, right on my ankle and I don't know why I got this adverse so many days later. Patient reported that he received the 1st dose of the vaccine on Mar 2021, roughly 48hrs later he developed hives and an itchiness of the skin. He also has concerns on whether he should receive the 2nd dose as a result of the reaction. The action taken in response to the events for BNT162B2 was not applicable. Therapeutic measures were taken as a result of rash/it is red, swelled. in the front of my body, lower abdomen, my back and one on my foot, right on my ankle, hives/it is red, swelled. in the front of my body, lower abdomen, my back and one on my foot, right on my ankle, swelling/it is red, swelled. in the front of my body, lower abdomen, my back and one on my foot, right on my ankle. The outcome of the events red rash, hives and swelling were recovered on an unspecified date and remaining all events were unknown. Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Fatigue; sore lower left leg; sore arm; This is a spontaneous report received from a contactable consumer. A 44-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 23Mar2021 11:15 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included calcium carbonate, colecalciferol (VITAMIN D 2000); linaclotide (LINZESS). The patient experienced fatigue and sore lower left leg and sore arm (pain in extremity) on 24Mar2021 at 07:00. Tylenol was taken as a result of fatigue, sore lower left leg, sore arm. The action taken in response to the events for bnt162b2 was not applicable. Outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Muscle spasms, Muscle twitching, Nausea
Clinical narrative: dizzy; nauseated; my vision was a bit fuzzy; my ears started ringing very loud; I was twitching and that I wasn't very coherent; color was coming back to my face; Felt tired; a sore arm; muscle spasms; This is a spontaneous case received from a contactable consumer(patient). A 23-year-old female non-pregnant patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Mar2021 19:00 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Mar2021, 10-15 minutes after getting the shot she felt very dizzy and nauseated. As she was leaving the pharmacy to go to car her vision was a bit fuzzy. When she sat back down she had to close her eyes because she was so dizzy and her ears started ringing very loud. Her roommate said that she was twitching and that she wasn't very coherent. She went back to get the pharmacist who brought Wal-Dryl and a soda. After sitting and drinking for another 10-15 minutes she felt slightly better and color was coming back to her face. Felt tired and dizzy the rest of the night. Felt fine the next day just a sore arm. She had a few muscle spasms since getting vaccinated. The patient lab tests included sars-cov-2 test negative: negative on 09Feb2021 type: Nasal swab, sars-cov-2 test negative: negative on 15Mar2021 type: Nasal swab. The action taken in response to the events for bnt162b2 was not applicable. Outcome of the events was Recovered on an unspecified date.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pallor, SARS-CoV-2 test negative, Tinnitus, Vision blurred
Clinical narrative: dizzy; nauseated; my vision was a bit fuzzy; my ears started ringing very loud; I was twitching and that I wasn't very coherent; color was coming back to my face; Felt tired; a sore arm; muscle spasms; This is a spontaneous case received from a contactable consumer(patient). A 23-year-old female non-pregnant patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Mar2021 19:00 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Mar2021, 10-15 minutes after getting the shot she felt very dizzy and nauseated. As she was leaving the pharmacy to go to car her vision was a bit fuzzy. When she sat back down she had to close her eyes because she was so dizzy and her ears started ringing very loud. Her roommate said that she was twitching and that she wasn't very coherent. She went back to get the pharmacist who brought Wal-Dryl and a soda. After sitting and drinking for another 10-15 minutes she felt slightly better and color was coming back to her face. Felt tired and dizzy the rest of the night. Felt fine the next day just a sore arm. She had a few muscle spasms since getting vaccinated. The patient lab tests included sars-cov-2 test negative: negative on 09Feb2021 type: Nasal swab, sars-cov-2 test negative: negative on 15Mar2021 type: Nasal swab. The action taken in response to the events for bnt162b2 was not applicable. Outcome of the events was Recovered on an unspecified date.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Hives including 1 that was blister like; Redness on arm; itching; arm soreness; This is a spontaneous report received from a contactable consumer. A 60-year-old (age at vaccination) female consumer reporter for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; ER8727) via an unspecified route of administration on 23Mar2021 at 11:45 am at single dose on left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Vaccine was administered at hospital facility. Patient's medical history included COPD mild (Chronic obstructive pulmonary disease) and allergies to medications, food, or other products (unspecified). Concomitant medications included (received within two weeks of vaccination) inhaler and vitamins (drug name unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced Hives including 1 that was blister like, redness or arm, itching and arm soreness on 23Mar2021 at 01: 15 pm. Self- warm compression initially then iced was the treatment given. It was unknown if the patient was diagnosed with covid-19 prior to vaccination. Patient was not tested for covid-19 since the vaccination. The outcome of events was unknown.   information on lot expiry has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Headache, Lethargy
Clinical narrative: swollen lymph node above my collar bone; chest tightness; issues breathing; hives; dizziness, headache and severe lethargy about 1 hour after the injection; dizziness, headache and severe lethargy about 1 hour after the injection; dizziness, headache and severe lethargy about 1 hour after the injection; This is a spontaneous report from a contactable consumer reported for herself. A 36-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on 17Mar2021 at 03:30 PM (at the age of 36-year-old) on the left arm at single dose for COVID-19 immunisation. Medical history included Asthma. The patient had no allergies to medications, food, or other products. Concomitant medications were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Most recent COVID-19 vaccine was administered in hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced dizziness, headache and severe lethargy about 1 hour after the injection on 17Mar2021 05:00 PM. The next day (18Mar2021), the patient felt chest tightness and issues breathing along with hives, today (24Mar2021) a week later, still have chest tightness with issues breathing, hives and now a swollen lymph node above my collar bone. The patient did not receive any treatment for the events. The outcome of the events was reported as not resolved.  Information on lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Urticaria
Clinical narrative: swollen lymph node above my collar bone; chest tightness; issues breathing; hives; dizziness, headache and severe lethargy about 1 hour after the injection; dizziness, headache and severe lethargy about 1 hour after the injection; dizziness, headache and severe lethargy about 1 hour after the injection; This is a spontaneous report from a contactable consumer reported for herself. A 36-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on 17Mar2021 at 03:30 PM (at the age of 36-year-old) on the left arm at single dose for COVID-19 immunisation. Medical history included Asthma. The patient had no allergies to medications, food, or other products. Concomitant medications were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Most recent COVID-19 vaccine was administered in hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced dizziness, headache and severe lethargy about 1 hour after the injection on 17Mar2021 05:00 PM. The next day (18Mar2021), the patient felt chest tightness and issues breathing along with hives, today (24Mar2021) a week later, still have chest tightness with issues breathing, hives and now a swollen lymph node above my collar bone. The patient did not receive any treatment for the events. The outcome of the events was reported as not resolved.  Information on lot/batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Testicular swelling, Varicocele
Clinical narrative: Dull pain; swelling in left testicle; varicocele; This is a spontaneous report from a contactable consumer reported for himself that at the age of 33-year-old the patient received the dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the right arm on 12Mar2021 at 16:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history reported was Eosinophilic esophagitis and allergies to Season allergies, shellfish, tree nuts, sheep's cheese. Prior to the vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient had not been tested for COVID. Concomitant medications reported was omeprazole. It was reported that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Mar2021 at 11:00 it was reported that the patient experienced dull pain, possible swelling in left testicle for about nine days. Coincident with diagnosed varicocele. The patient did not receive any treatment for the events. Outcome of the events was recovered on unspecified date in Mar2021.  No follow-up attempts possible. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Illness, Insomnia, Vaccination site irritation
Clinical narrative: every joint in her was so painful, she couldn't sleep, rollover, or walk. She said she had a lot of pain in every joint of her body; neck, feet, ankles, and everything; every joint in her was so painful, she couldn't sleep, rollover, or walk. She said she had a lot of pain in every joint of her body; neck, feet, ankles, and everything; every joint in her was so painful, she couldn't sleep, rollover, or walk. She said she had a lot of pain in every joint of her body; neck, feet, ankles, and everything; get sick; injection site irritation; wheezy; This is a spontaneous report from a contactable other HCP. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot Number: EN6198) via an unspecified route of administration, administered in Arm Left on 01Mar2021 as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, diabetes mellitus, cardiac pacemaker insertion from Dec2020 and ongoing, ongoing asthma and covid-19 from Mar2020. The patient's concomitant medications were not reported. On 02Mar2021, the patient stated that every joint in her was so painful, she couldn't sleep, rollover, or walk. she said she had a lot of pain in every joint of her body; neck, feet, ankles, and everything. The patient also had wheezy on Mar2021, get sick on 02Mar2021 and injection site irritation on 01Mar2021. The events joint pain, insomnia and gait disturbances were assessed as disability by the reporter. Outcome of the events insomnia, joint pain and gait disturbances were recovering while outcome of the remaining events was recovered on an unspecified date.; Sender's Comments: The information currently provided is very limited hence the causal association between the suspect drug and reported events arthralgia, insomnia and gait disturbance cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: every joint in her was so painful, she couldn't sleep, rollover, or walk. She said she had a lot of pain in every joint of her body; neck, feet, ankles, and everything; every joint in her was so painful, she couldn't sleep, rollover, or walk. She said she had a lot of pain in every joint of her body; neck, feet, ankles, and everything; every joint in her was so painful, she couldn't sleep, rollover, or walk. She said she had a lot of pain in every joint of her body; neck, feet, ankles, and everything; get sick; injection site irritation; wheezy; This is a spontaneous report from a contactable other HCP. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot Number: EN6198) via an unspecified route of administration, administered in Arm Left on 01Mar2021 as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, diabetes mellitus, cardiac pacemaker insertion from Dec2020 and ongoing, ongoing asthma and covid-19 from Mar2020. The patient's concomitant medications were not reported. On 02Mar2021, the patient stated that every joint in her was so painful, she couldn't sleep, rollover, or walk. she said she had a lot of pain in every joint of her body; neck, feet, ankles, and everything. The patient also had wheezy on Mar2021, get sick on 02Mar2021 and injection site irritation on 01Mar2021. The events joint pain, insomnia and gait disturbances were assessed as disability by the reporter. Outcome of the events insomnia, joint pain and gait disturbances were recovering while outcome of the remaining events was recovered on an unspecified date.; Sender's Comments: The information currently provided is very limited hence the causal association between the suspect drug and reported events arthralgia, insomnia and gait disturbance cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested Covid 19 positive; This is a spontaneous report from a contactable female consumer (patient) via a Pfizer-sponsored program, Covax US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 (Batch/Lot Number: EL9269) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had the first dose of Pfizer COVID-19 vaccine on 09Mar2021 and supposes to receive the second dose on 30Mar2021, however, she tested positive for COVID 19. The patient stated that on 18Mar2021, she got tested for Covid and it just came back positive (on an unspecified date). She was supposed to get second dose on this 30 of this month (March), and she don't know if she is getting the next shot; she asked how she can get her second shot. The outcome of event was unknown.  Information on lot/batch number was available. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Heart rate irregular
Clinical narrative: heart rate goes up and down; 12 hours after she got it her heart rate ran high for 12 hours straight.; heart rate goes up and down; 12 hours after she got it her heart rate ran high for 12 hours straight.; This is a spontaneous report from a contactable consumer (patient) reported that a 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), via an unspecified route of administration on an unspecified date as a single dose (at the age of 49-years-old) for covid-19 immunization. The patient had ongoing covid-19 from Nov2020 and has been having post Covid symptoms. The patient also had ongoing heart issues and heart rate issues right now. The patient's concomitant medication included beta blocker (unspecified). It was reported that the patient was calling about the vaccine. She got the first vaccine almost 3 weeks ago and she was due for her second one tomorrow (23Mar2021). She had Covid 3 months ago (reported as Nov2020) and she has been having post Covid symptoms, she have gotten diagnosed with post Covid symptoms. The patient's heart rate goes up and down anyway when she got the first vaccine, about 12 hours after she got it her heart rate ran high for 12 hours straight, that's was the only thing that have ever done that so she was guessing a very usual effect from the vaccine, so she was concerned about getting the second dose. The patient did not received any treatment for the events. The outcome of the events was unknown.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Night sweats, Pain
Clinical narrative: Fever, Headache, Body Aches, Chills, Night Sweats, Fatigue, Sore Arm
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever, Headache, Body Aches, Chills, Night Sweats, Fatigue, Sore Arm
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: tested COVID-19 positive; tested COVID-19 positive; This is a spontaneous report from a Pfizer sponsored  reported by contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 via an unspecified route of administration on 04Mar2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she received the 1st dose of vaccine last 03/04 and she is due for the 2nd dose on 03/25 (exactly 21 days apart). Patient tested COVID-19 positive (on an unspecified date) and wants to make sure if she can still take the 2nd dose after being cleared. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Fatigue, Oropharyngeal pain, Rash
Clinical narrative: Severe allergic reaction, sore throat, itchy throat, body rash, dizziness, fatigue, anxious. All symptoms have happened between the day of the injection shot.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Severe allergic reaction, sore throat, itchy throat, body rash, dizziness, fatigue, anxious. All symptoms have happened between the day of the injection shot.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash at site of injection  about 2.5? wide
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Unevaluable event
Clinical narrative: none
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site mass, Injection site nodule, Joint range of motion decreased, Malaise
Clinical narrative: severe L arm pain limiting ability to raise arm followed by slow recovery 2 weeks out but then a day of severe fatigue, feeling unwell and resurgence/worsening of the L arm pain - exam is consistent with a deltoid tendonitis (supraspinatus seems rather intact) and she also has a mass/nodule mid arm inferior to the vaccine site
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rotator cuff syndrome, Ultrasound scan
Clinical narrative: severe L arm pain limiting ability to raise arm followed by slow recovery 2 weeks out but then a day of severe fatigue, feeling unwell and resurgence/worsening of the L arm pain - exam is consistent with a deltoid tendonitis (supraspinatus seems rather intact) and she also has a mass/nodule mid arm inferior to the vaccine site
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Skin burning sensation
Clinical narrative: My arm where the injection was given is very itchy, red, and tender to the touch.  This started today approximately 9 days from when I received the 1st dose.  My skin has a burning sensation and the area feels hot to the touch (mainly all around the injection site.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature increased, Chills, Headache
Clinical narrative: At dawn on Tuesday, the day after the vaccination, I started to feel a sharp pain in my body and joints, accompanied by hives in the back and legs, chills, mild headache. A slight rise in temperature on Tuesday morning. The body pain is constant until this moment ( 11:00 pm on Tuesday, April 7) Excessive weakness
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Urticaria
Clinical narrative: At dawn on Tuesday, the day after the vaccination, I started to feel a sharp pain in my body and joints, accompanied by hives in the back and legs, chills, mild headache. A slight rise in temperature on Tuesday morning. The body pain is constant until this moment ( 11:00 pm on Tuesday, April 7) Excessive weakness
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Blood test, Dehydration, Muscle spasms
Clinical narrative: Sore arm; Muscle cramps all over the body; Sugar was very high; Dehydrated; This is a spontaneous report from a contactable consumer (patient's mother). A 46-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 27Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history included heart attack (at the age of 39) and had couple of stents (and the things done) later after that, and Lyme disease (past this Summer). The patient was taking several concomitant medications (unspecified). The patient's mother was calling for her son (patient) as he works out on the road, but he has had a heart attack at 39 years old and has had some other problems. The patient got his first Pfizer shot and about 2 to 3 days later while he was working, he first just had the sore arm on 03Mar2021. The patient worked in fiber glass repair on pools and it was very warm, and he started having muscle cramps all over the body on 03Mar2021. The patient ended up in the hospital on 03Mar2021 and his sugar was very high, and he was dehydrated. As treatment taken for the events, they gave him fluids through an IV and they gave him metformin medication 500 mg. The patient underwent laboratory tests and procedures (his doctor did the laboratory work), and they did laboratory work at the hospital where he went. It was clarified that they just did blood work on 03Mar2021, but the patient's mother didn't know what it was. The patient was just held for observation and was out the next day (04Mar2021). That was only the first shot, so the patient was really afraid to get the second shot one. The patient's mother told him she will try to find out something about it. patient's mother looked up the side effects and she did not see that as a side effect. At the time of reporting, the patient still had cramps once in a while. The patient had not recovered from "Muscle cramps all over the body". The outcome of the other events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; Muscle cramps all over the body; Sugar was very high; Dehydrated; This is a spontaneous report from a contactable consumer (patient's mother). A 46-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 27Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history included heart attack (at the age of 39) and had couple of stents (and the things done) later after that, and Lyme disease (past this Summer). The patient was taking several concomitant medications (unspecified). The patient's mother was calling for her son (patient) as he works out on the road, but he has had a heart attack at 39 years old and has had some other problems. The patient got his first Pfizer shot and about 2 to 3 days later while he was working, he first just had the sore arm on 03Mar2021. The patient worked in fiber glass repair on pools and it was very warm, and he started having muscle cramps all over the body on 03Mar2021. The patient ended up in the hospital on 03Mar2021 and his sugar was very high, and he was dehydrated. As treatment taken for the events, they gave him fluids through an IV and they gave him metformin medication 500 mg. The patient underwent laboratory tests and procedures (his doctor did the laboratory work), and they did laboratory work at the hospital where he went. It was clarified that they just did blood work on 03Mar2021, but the patient's mother didn't know what it was. The patient was just held for observation and was out the next day (04Mar2021). That was only the first shot, so the patient was really afraid to get the second shot one. The patient's mother told him she will try to find out something about it. patient's mother looked up the side effects and she did not see that as a side effect. At the time of reporting, the patient still had cramps once in a while. The patient had not recovered from "Muscle cramps all over the body". The outcome of the other events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Pruritus, Throat irritation
Clinical narrative: Itching all over body 3 minutes after administration.  Difficulty swallowing, thick feeling in throat.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site discharge, Injection site reaction, Joint range of motion decreased, Peripheral swelling
Clinical narrative: I was slightly overheated after shot but that lessened quickly. My arm hurt and was swollen the first time I got the covid shot but yesterday after the second shot it got really itchy and swollen. It is hard to lift my arm and started to worse throughout today. The injection site is a misshapen red rash that has spread. It started to leak a clearish pus liquid about an hour ago. I am recovering with a bandaid and adding antibiotics cream just in case. I will call my dr tomorrow if it continues to worsen.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: I was slightly overheated after shot but that lessened quickly. My arm hurt and was swollen the first time I got the covid shot but yesterday after the second shot it got really itchy and swollen. It is hard to lift my arm and started to worse throughout today. The injection site is a misshapen red rash that has spread. It started to leak a clearish pus liquid about an hour ago. I am recovering with a bandaid and adding antibiotics cream just in case. I will call my dr tomorrow if it continues to worsen.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Fever, chills, body aches, stabbing/pinching pains in feet, itching
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Chills, Headache
Clinical narrative: Facial tingling around 1:00 PM followed by drowsiness. Around 6:30 PM chills started followed by a headache. Drowsiness continued and then fever of 102 throughout the night. Headache at temples, in between eyes and eyes continued to get worse along with pressure in those areas. Full body aches also developed. Nausea also occurred along with grassiness. Around 9 AM the next day the fever broke but headache continued. Aches subsided but persisted in neck, shoulders and most notably middle to lower back along with stomach aches. Weakness in the arms and hands still noticeable.  Dull headache still exists, aches, and weakness as of 9:00 PM.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Nausea, Neck pain, Ocular discomfort, Pain
Clinical narrative: Facial tingling around 1:00 PM followed by drowsiness. Around 6:30 PM chills started followed by a headache. Drowsiness continued and then fever of 102 throughout the night. Headache at temples, in between eyes and eyes continued to get worse along with pressure in those areas. Full body aches also developed. Nausea also occurred along with grassiness. Around 9 AM the next day the fever broke but headache continued. Aches subsided but persisted in neck, shoulders and most notably middle to lower back along with stomach aches. Weakness in the arms and hands still noticeable.  Dull headache still exists, aches, and weakness as of 9:00 PM.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Somnolence
Clinical narrative: Facial tingling around 1:00 PM followed by drowsiness. Around 6:30 PM chills started followed by a headache. Drowsiness continued and then fever of 102 throughout the night. Headache at temples, in between eyes and eyes continued to get worse along with pressure in those areas. Full body aches also developed. Nausea also occurred along with grassiness. Around 9 AM the next day the fever broke but headache continued. Aches subsided but persisted in neck, shoulders and most notably middle to lower back along with stomach aches. Weakness in the arms and hands still noticeable.  Dull headache still exists, aches, and weakness as of 9:00 PM.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Migraine
Clinical narrative: 1pm next day:  congestion, body aches, chills, slight fever, headache. 5:30am 2nd day:  severe headache like migraine. 2nd day thought the day pretty wiped out, a bit dizzy,
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: 1pm next day:  congestion, body aches, chills, slight fever, headache. 5:30am 2nd day:  severe headache like migraine. 2nd day thought the day pretty wiped out, a bit dizzy,
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Nodule
Clinical narrative: I have developed a lump above my left collarbone causing discomfort.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Pallor, Vision blurred
Clinical narrative: Patient immediately started sweating, turned pale, complaining of dizziness and blurred vision. We observed him for approximately 30 minutes. Sweating stopped; coloring became better and normal vitals were seen before he left.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Lymphadenopathy
Clinical narrative: As of 4/4 swollen lymph node in armpit on same side as injection in arm. Still swollen on 4/6.  4/6 evening, noticed itchiness at injection site and slight rash.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site scar, Muscular weakness, SARS-CoV-2 test negative
Clinical narrative: I did not experience any adverse effects to the second shot until 50 or so hours until after the shot. From then on I felt extreme exhaustion, joint pain, and muscle weakness for 9 days. So much so that on day 6 after the shot I reached out to my Doctor and scheduled a Covid PCR Test, which came back negative.  It was not until 11 days after the second shot that I felt back to "normal"   In the past few days I have noticed a scar at the site of injection. I haven't seen any information on scaring after the second shot.