chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Muscle weakness; tired; Feeling hot; eyeball pain; Headache; Caller is the patient that received one dose of the Moderna Covid vaccine on 20 Jan 2021. Yesterday he received the Pfizer Biontech covid 19 vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer sponsored program support. A 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0198, expiry date: not reported) via an unspecified route of administration, administered in Arm Left, on 30Jun2021 at 15:00 ( at the age of 61 years), as 0.3 ML single for covid-19 immunisation. The patient received covid-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE, Batch/Lot Number: 027L20A), via an unspecified route of administration, on 20Jan2021 at standard dose, in left arm, for covid-19 immunisation and had a bad reaction to it. The patient medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior vaccination (within 4 weeks) was reported as the patient had shingles vaccine about a month ago. Family Medical History Relevant to AE was reported as no. On an unspecified date, the patient had experienced muscle weakness, tired, feeling hot, eyeball pain, headache. Reported feeling a little bit of eyeball pain, not bad and a little bit of a headache. The symptoms started the night before the day of reporting and most of the effects were on that night and on the morning of reporting. Stated his cup of coffee made him really hot. Side effects were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Adverse events did not require visit to emergency room or physician office. The outcome of the event headache was reported as recovered. The outcome of other events was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Oropharyngeal pain
Clinical narrative: Sore throat; Difficulty in swallowing; This is a spontaneous report from a contactable Nurse. This 54-year-old female nurse (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0171), via an unspecified route of administration (on the right arm) on 30Jun2021 at 16:00 (at the age of 54-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included migraine, depression and fibromyalgia. Concomitant medications were not reported. Nurse stated, "I wanted to just report a side effect. It just hurts to swallow. It is a sore throat and difficulty in swallowing which started about an hour after I got the vaccine which was about 4'o clock yesterday afternoon and it got a little better with the Tylenol but it comes back again". The patient took some medications for depression, for sleep and some PRN medication for migraine. The reporter provided the causality as related (method of assessment: global introspection) to the drug. The therapeutic measures were taken in response to the events. Outcome of the events was not resolved.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Therapeutic response unexpected
Clinical narrative: ingredient in the vaccine is making her knees feel better; sore arm; This is a spontaneous report from a contactable consumer or other non hcp. An 81-year-old female patient received an unknown dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Jun2021 (at age of 81-year-old) as single dose for COVID-19 immunization. The patient medical history included "she has been having problem with her knees for quite some time". The patients concomitant medications were not reported. The patient mentioned that she has lots of medical problems and is taking lots of medication but still decided to get the vaccine yesterday. She experienced a sore arm, but so far feels okay. She has also stated that she has been having problem with her knees for quite some time. She wants to know what ingredient in the vaccine is making her knees feel better or is it just a combination of other factors. She said that "Everyone who gets the vaccine is a guinea pig. As a guinea pig, I want to know and that her physician probably did not know any of the ingredients of the vaccine". The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Person tested positive after receiving vaccination; Person tested positive after receiving vaccination; This is a spontaneous report from a non-contactable consumer. The consumer reported for a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer stated that the "person tested positive after receiving vaccination" on an unspecified date. The patient lab test and procedures which included sars-cov-2 test was positive after receiving vaccination. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, COVID-19, Inflammation, Paraesthesia
Clinical narrative: Low back/sacroiliac joint inflammation. Tingling in feet and pins and needles in feet after walking 1/2 mile.; Low back/sacroiliac joint inflammation. Tingling in feet and pins and needles in feet after walking 1/2 mile.; Low back/sacroiliac joint inflammation. Tingling in feet and pins and needles in feet after walking 1/2 mile.; This is a spontaneous report from a non-contactable consumer (patient). A 29-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for Injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm on an unspecified date (vaccinated at the age of 29-year-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient experienced low back/sacroiliac joint inflammation, tingling in feet and pins and needles in feet after walking 1/2 mile. These adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. No hospitalization required or prolonged. On an unknown date, the patient underwent nasal swab test for covid-19, which resulted negative. The treatment received for the adverse events was physiotherapy (PT), chiropractic care and unspecified medications. The outcome of the events was not resolved.  Device Date : 01Jul2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching; Rash, in the creases of the upper arm and in the inner thighs, after first vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable Other HCP reported that an 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not re-ported) via an unspecified route of administration on 10Jun2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 10Jun2021 the patient experienced rash after her first dose of the Pfizer Covid-19 vaccine. Per the patient's daughter, the rash occurred several hours after the first dose in her upper arms creases and inner thighs, and it lasted for 2 days. There was no itching or swelling associated with the rash. The patient was taking a medication at the same time that did cause itching. The reporter wanted to be sure it was alright to administer the second dose of the Pfizer Covid 19 vaccine, to the patient. Therapeutic measures were taken as a result of itching. The clinical outcome of the event rash was recovered in Jun2021. Outcome of the event itching was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Depression, Emotional distress, Laboratory test, Laboratory test abnormal
Clinical narrative: Depression; All my exams started to change; very disappointed and living hell; This is a spontaneous report from a contactable Healthcare professional (Physician) (patient, self-reported). A patient of an unspecified age and gender received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified, the patient wanted to say that the patient was going to file an investigation against everything that's going on. When the patient was chose Pfizer it was because you said the vaccine was good for patients and cancer, chronic diseases. The patient lived working paying bills and taking care of children until the day the patient got this vaccine and then all the patient's exams started to change. The patient was very disappointed and living hell and even depression because of the health. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling abnormal, Headache, Parosmia
Clinical narrative: Since receiving the first dose Pfizer Covid Vaccine on 18JUN2021, has had a very strange metallic taste in mouth; Dares to say, thinks can sort of smell a metallic when the caller urinates; Feels head feels sort of quite foggy; headache; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 18Jun2021 as dose 1 single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that, since receiving the first dose Pfizer Covid Vaccine on 18Jun2021, the patient has had a very strange metallic taste in her mouth. Also, the patient dares to say, she thought she can sort of smell a metallic when the patient urinates. Patient also had a headache on the second day as well as felt " sort of quite foggy in her head on an unspecified date in Jun2021. The patient knew obviously from what she had read and heard that the second dose Pfizer Covid Vaccine can have worse symptoms. The patient hoped this taste was not going to be with the patient forever. Patient was asking had Pfizer heard of any of these symptoms. Patient wanted to know if metallic taste had been reported and if it might be worse after the second dose. It was questioned that patient had a side effect after the first dose of the vaccine. Should I get the second dose. In Response: you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The outcome of the event taste metallic was not recovered and outcome of the other events was unknown.  Information about lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: Fatigue; body aches; She just had a sore arm as well that was super mild at the injection site.; This is a spontaneous report from a contactable consumer (Patient). A 42-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0185), via an unspecified route of administration, administered in Arm Left on 04Jun2021 (at the age of 42-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical History (including any illness at time of vaccination) was None. Family history was none. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On 04Jun2021, the patient experienced fatigue, body aches. On Jun2021, she just had a sore arm as well that was super mild at the injection site. It was reported that if the patient was hospitalized, how many days was the hospital stay. No vaccine administered at military facility. Therapeutic measures were taken as a result of fatigue. The clinical outcome of she just had a sore arm as well that was super mild at the injection site was unknown and other events were recovered on 09Jun2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Suffocation feeling
Clinical narrative: suffocating and sometimes needs air; sore left arm; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number ER8731, expiration date unknown), via an unspecified route of administration, administered in Arm Right on 30Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. No relevant medical history and family history reported. Concomitant medication included ongoing norethindrone acetate (NORETHINDRONE ACETATE, LOT: 548586A, Expiry date: Jul2023) 0.35gm 1 pill a day by mouth taken for contraception, from an unknown start date. Patient did not receive any other vaccine prior to 4 weeks of vaccination. Patient previously received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0158, expiration date unknown), via an unspecified route of administration, administered in Arm Left on 08Apr2021 (at the age of 41 years) as DOSE 1, SINGLE for COVID-19 immunization. On an unknown date in Apr2021 post vaccination, the patient had sore left arm. On an unknown date in May2021, the patient experienced suffocation and sometimes needed air. Patient was still having an uncomfortable feeling in the arm. It was reported that when she felt like she needed air, it felt like her arm felt a bit better. It was like it moved from her arm to her chest and she started to feel like she was suffocated. It has been about a month since she started to feel suffocated like that. The patient was treated with Diclofenac and she stated that it is not helping her. The outcome of the events was reported as not recovered at the time of report. Investigation Assessment: No.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Suffocation feeling
Clinical narrative: feel like sometimes she needs air/feel like she is suffocated; Uncomfortable feeling on her arm; This is a spontaneous report from a contactable female consumer (patient). The report was not related to a study or programme. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0158), via an unspecified route of administration, administered in arm left on 08Apr2021 (at the age of 41-year-old), as dose 1, single for covid-19 immunization. Medical history was none. No family medical history relevant to AE. Concomitant medications included Norethisterone (NORA-BE, Lot number: 548586A, Expiration date: Jul2023), orally on an unspecified date and ongoing at 0.35 g, daily for birth control. The patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8731), via an unspecified route of administration, administered in Arm right on 30Apr2021, as dose 2, single for covid-19 immunization. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AE(s) following prior vaccinations was none. Patient medical history (including any illness at time of vaccination) was none. On an unspecified date in Apr2021, the patient started having uncomfortable feeling on her arm and started feels like sometimes she needs air from an unspecified date in May2021. She reported that uncomfortable feeling on her arm from an unspecified date in Apr2021. She just wanted to ask about the vaccine she had in April after her first dose and said she was still having a uncomfortable feeling in her arm. She stated her symptoms started after she had the first vaccine. She did notice that she does feel like sometimes she needs air after receiving the vaccine too. She said that when she feels like she needs air, it feels like her arm feels a bit better. It is like it moves from her arm to her chest and she started to feel like she is suffocated. It has been about a month since she started to feel suffocated like that. She stated she was only taking birth control pills and unsure if it is causing her symptoms. It was reported that the events of uncomfortable feeling on her arm and feels like sometimes she needs air required a visit to emergency room (went once) and physician office (went once). She was given a medication of Diclofenac to treat the events by the doctor, but she did not feel that it is helping her. Relevant tests were none. No investigation assessment was performed. The clinical outcome of the feel like sometimes she needs air/feel like she is suffocated, uncomfortable feeling on her arm was not resolved at the time of this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chest pain, Dysphonia, Lymphadenopathy
Clinical narrative: Was like something sitting on her chest holding her throat closed; Chest tightness; Arm swelling up; Arm pain/Sore arm; Lymph nodes very swollen; Arm pain at injection site: 5 to 6 hours after it was pretty intense; Sounded hoarse; Joint pain; was like something sitting on her chest holding her throat closed; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0202, Expiry date was not reported) dose 2 via an unspecified route of administration on 28Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient's medical history (including any illness at time of vaccination) and family medical history relevant to adverse events were none. The patient did not take concomitant medications (No other products). Patient previously had first dose of BNT162b2 (Batch/lot number: EW0185) at left arm around shoulder on 04Jun2021 (at age of 42-years old) for covid-19 immunisation and experienced fatigue which started 8 hours after the first dose and treatment - took acetaminophen, Body aches which was started - 8 hours on 04Jun2021 to 09Jun2021 and she just had a sore arm as well that was super mild at the injection site. No adverse evets following prior vaccinations. No prior vaccinations (within 4 weeks. No additional vaccines administered on same date of the pfizer suspect. On 28June2021 she was okay right after the second shot for the first 5 to 6 hours, she felt normal and only had arm pain. They did inject it in the same arm. Arm pain at injection site: 5 to 6 hours after it was pretty intense, she did well with the first one. Arm swelling up: It was not mild swelling it was the size of a large grapefruit. Treatment, they advised her to put ice on it and to take ibuprofen. She looked in the mirror and her lymph nodes very swollen and she sounded hoarse and had chest tightness. She experienced it was like something sitting on her chest holding her throat closed. Lymph nodes very swollen was started at bedtime 8 or 9 pm 28Jun2021 and treatment was she went to urgent care and they sent her to the hospital. Chest tightness was started at 10pm on 28Jun2021. She had pain and tightness. Treatment was she went to the urgent care and they sent her to the hospital. She was really concerned about the lymph node swelling, joint pain, and chest and asked them what treatment there was and what could she do to feel better. The urgent care suggested going to the Emergency Room. There was no relevant tests. The outcome of the events chest tightness and chest pain was recovering, arm swelling up and lymph nodes very swollen are not recovered and rest of all events was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Throat tightness, Vaccination site pain
Clinical narrative: Was like something sitting on her chest holding her throat closed; Chest tightness; Arm swelling up; Arm pain/Sore arm; Lymph nodes very swollen; Arm pain at injection site: 5 to 6 hours after it was pretty intense; Sounded hoarse; Joint pain; was like something sitting on her chest holding her throat closed; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0202, Expiry date was not reported) dose 2 via an unspecified route of administration on 28Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient's medical history (including any illness at time of vaccination) and family medical history relevant to adverse events were none. The patient did not take concomitant medications (No other products). Patient previously had first dose of BNT162b2 (Batch/lot number: EW0185) at left arm around shoulder on 04Jun2021 (at age of 42-years old) for covid-19 immunisation and experienced fatigue which started 8 hours after the first dose and treatment - took acetaminophen, Body aches which was started - 8 hours on 04Jun2021 to 09Jun2021 and she just had a sore arm as well that was super mild at the injection site. No adverse evets following prior vaccinations. No prior vaccinations (within 4 weeks. No additional vaccines administered on same date of the pfizer suspect. On 28June2021 she was okay right after the second shot for the first 5 to 6 hours, she felt normal and only had arm pain. They did inject it in the same arm. Arm pain at injection site: 5 to 6 hours after it was pretty intense, she did well with the first one. Arm swelling up: It was not mild swelling it was the size of a large grapefruit. Treatment, they advised her to put ice on it and to take ibuprofen. She looked in the mirror and her lymph nodes very swollen and she sounded hoarse and had chest tightness. She experienced it was like something sitting on her chest holding her throat closed. Lymph nodes very swollen was started at bedtime 8 or 9 pm 28Jun2021 and treatment was she went to urgent care and they sent her to the hospital. Chest tightness was started at 10pm on 28Jun2021. She had pain and tightness. Treatment was she went to the urgent care and they sent her to the hospital. She was really concerned about the lymph node swelling, joint pain, and chest and asked them what treatment there was and what could she do to feel better. The urgent care suggested going to the Emergency Room. There was no relevant tests. The outcome of the events chest tightness and chest pain was recovering, arm swelling up and lymph nodes very swollen are not recovered and rest of all events was unknown.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0196, Expiration date: Sep2021), via an unspecified route of administration, administered in left arm on 09Jun2021 as DOSE 1, SINGLE and dose 2 via an unspecified route of administration, administered in left arm on 30Jun2021 (Batch/Lot Number: EW0181; Expiration Date: Aug2031) as DOSE 2, SINGLE (age at the vaccination 28-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive prior vaccinations (within 4 weeks). Patient experienced fever on 01Jul2021. Patient was not checked it in a while, but he still feels hot. The last time he checked it might have been ten minutes ago. patient confirms it was 101.5 ten minutes when he checked. When he checked it at first it was 100.7 The patient underwent lab tests and procedures which included body temperature: 101.5 and 100.7 on 01Jul2021. The outcome of the event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: his arm was sore a little bit / little bit of a sore arm; muscle and joint pain; muscle pain / complains of muscle pain to right knee / muscle and joint pain / still have muscle pain after the vaccine; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, NDC number and expiry date was not provided) via an unspecified route of administration on 20Jun2021 in right arm as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date of 2021, the patient experienced little bit of a sore arm for couple of days, and he had muscle pain to right knee and joint pain. He reported no fever or injection site redness. He called to find out if muscle pain was a side effect of the Pfizer covid vaccine. The outcome of the event pain in arm was recovered in 2021 and for other events was unknown.  Information on Lot/Batch information has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Swelling
Clinical narrative: under his armpit is a little swelling on the left side where he took the shot; felt like something was sticking in his back; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0181) via an unspecified route of administration, in the left arm on 19Jun2021 (at the age of 75-years-old) as dose 1, 0.3 ml single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL) taken for pain and inflammation, start and stop date were not reported. The caller was calling about the Pfizer covid vaccine. The caller took the vaccine on 19Jun2021. The first week the caller didn't notice anything. The past 7 days the caller has felt like something was sticking in his back (on 24Jun2021). Then yesterday the caller was washing and under his armpit and noticed a little swelling on the left side where he took the shot (on 30Jun2021). He noticed his left arm pit (left arm where he got the vaccine) was kind of puffy and swollen but the right arm pit appears normal. When he laid down there was a slight discomfort, almost like the caller took the shot in his back and not his arm. Caller mentioned that he asked his girlfriend to check if there was something in his back but the girlfriend said his back was clear. Caller wanted to know if these are reported side effects of the vaccine. Reporter seriousness was unspecified for both events. Outcome of event sticking in his back and under his armpit was recovering and under his armpit was a little swelling on the left side where he took the shot was not recovered.  Follow-up attempts are possible. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, SARS-CoV-2 test
Clinical narrative: With my first dose, dizziness didn't happen until nearly a weak later"; During the next several days, both lost their balance; This is a spontaneous report form a contactable consumer (patient) via Medical information team. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced dizziness 3 to 4 days after the shot which lasted a while then stopped. Patient wanted information if this is a side effect of the vaccine and how long they will last. Caller mentioned that she "researched online and read a bunch of people talking about their experience with the vaccine and several people had the same experience as her husband dizziness, almost like a vertigo effect". Patient mentioned that with my first dose, dizziness did not happen until nearly a weak later. It scared me enough to get COVID tested. Results were negative. It seemed to go away until the second dose. Patient figured it had to be from the vaccine. Patient mentioned the next day, and after her husband caller got the vaccine, both almost fell over getting out of bed. It did not last very long. During the next several days, both lost their balance and caller had been reading that all over the internet that people losing their balance, getting dizzy. The patient underwent lab tests and procedures which included sars-cov-2 test: results were negative on an unspecified date. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, SARS-CoV-2 test
Clinical narrative: "It seemed to go away until the second dose. Then, bam! The next morning, I nearly fell down. When I got up"; dizziness didn't happen until nearly a weak later. It seemed to go away until the second dose. The next morning, I nearly fell down.; This is a spontaneous report from a contactable consumer. This female consumer (patient) of an unspecified age reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. With her first dose, dizziness didn't happen until nearly a weak later. It scared her enough to get COVID tested. Results were negative. It seemed to go away until the second dose. The next morning, she nearly fell down. When she got up, she figured it had to be from the vaccine and crazy part was it had not completely gone away yet. It was still lurking there just into the surface. Patient mentioned that the next day, after patient and her husband got the vaccine, both almost fell over getting out of bed. It did not last very long. During the next several days, patient lost her balance. The outcome of event was not recovered.  Information about lot/batch number requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Fever; she was dazed/she didn't feel good; Her arm was hurting; Sleepiness; sick; This is a spontaneous report from a contactable Nurse (patient's mother). A 17-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 30Jun2021 15:30 (at the age of 17-years-old) (Batch/Lot Number: EW0172) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient had been a healthy child, she had not ever had any problems. No additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). There was no AE(s) following prior vaccinations. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 09Jun2021 (at the age of 17-years-old) (Batch/Lot Number: EW0150) for COVID-19 immunisation and with the first dose she was aright. The patient was 17 years old and got the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine last day (30Jun2021) and was currently experiencing sleepiness and fever. With the first dose she was aright this second one was hitting her hard. She had came down with a fever and she was pretty much been sleeping all day. On 01Jul2021, morning at 4:30 AM, the patient got her mother up telling that her arm was hurting and that she didn't feel good after that mother gave her some Tylenol. She felt her and she was pretty warm so she gave her the couple Tylenol and they would go from there and she had been asleep ever since. The patient woke up at 4:30 AM this morning (01Jul2021) and it was hitting her hard, she woke up and the caller gave her Tylenol to break the fever. She confirms the fever started 01Jul2021. The fever seemed to have broken with the Tylenol but when she checked on her she was dazed, she had been sleeping all day she has never had her sleeping like this. When asked when sleepiness began she said, they all went to bed around 10 or 10:30 last night and her daughter had been asleep ever since then, it was ongoing. She had been a healthy child, she has not ever had any problems with her being sick. Her fever had improved but the sleepiness it seems had gotten worse. They wanted to know if sleepiness and fever are included among the commonly reported side effects after the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine. She wanted to know if that was a normal situation. They were referred to HCP. The AE(s) did not require a visit to: Emergency Room/Physician Office. There were no relevant tests and investigation assessment done. Outcome of the event fever was recovered on 01Jul2021, sleepiness was not recovered and other events was unknown.  Follow-up actions are needed. Further information has been requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Tubulointerstitial nephritis and uveitis syndrome, Uveitis
Clinical narrative: Within two weeks of getting my second dosage of the Pfizer Covid vaccine, I developed panuveitis; My ophthalmologist diagnosed me with TINU, Tubulointerstitial Nephritis and Uveitis Syndrome; I experienced pain, sensitivity to light, and ankle sores; I experienced pain, sensitivity to light, and ankle sores; This is a spontaneous report from a contactable physician (patient). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9264), via an unspecified route of administration in arm left on 20Jan2021 (at the age of 25-year-old) as a dose 2, single for COVID-19 immunisation. The patient's medical history was reported as none, No family history of autoimmune disease or significant medical history of disease. The patient had no known allergies. The patient's concomitant medications received within 2 weeks of vaccination was reported as no. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL1283), via an unspecified route of administration in left arm on 20Jan2021 at 05:00 PM (at the age of 25-year-old) as a dose 1, single for COVID-19 immunisation. It was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On an unspecified date in 2021, within two weeks of getting his second dosage of the Pfizer Covid vaccine, the patient developed panuveitis. Stated that, his ophthalmologist diagnosed him with TINU, Tubulointerstitial Nephritis and Uveitis Syndrome. On an unspecified date in 2021, the patient experienced pain, sensitivity to light and ankle sores and had to go to urgent care clinic to get steroid eye drops to reduce inflammation in his eye. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The reporter seriousness and seriousness criteria was non serious. Treatment medication included prednisone eye drops. Device date was on 01Jul2021. The outcome of the events was not recovered.; Sender's Comments: Based on the temporal relation between the BNT162b2 and the onset of Tubulointerstitial Nephritis and Uveitis, the association cannot be ruled out. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: wooziness; tired; This is a spontaneous report received from a contactable (patient). A 86 year-old male patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was happy to report that the only side effects had were wooziness and tired after the first dose that caused to wait about an hour before felt it was safe to drive home. The events were reported as non-serious. The outcome of the events was unknown.  Information on the batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired; This is a spontaneous report from a contactable consumer (patient). An 86-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date, as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) for covid-19 immunisation and she felt wooziness after the first dose that caused her to wait about an hour before and it was safe to drive herself home. On an unknown date, the patient experienced tired after both doses. The outcome of the event was unknown.  No follow-up attempts are needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Hypoaesthesia, Paraesthesia, Tremor
Clinical narrative: anaphylaxis; tingling, numbness and shaking in the same arm where the vaccine was administered; tingling, numbness and shaking in the same arm where the vaccine was administered; tingling, numbness and shaking in the same arm where the vaccine was administered; This is a spontaneous report from a contactable pharmacist.    A female patient of an unspecified age received BNT162B2, 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 reporter reported her youngest sister received the vaccine within five minutes developed tingling, numbness and shaking in the same arm where the vaccine was administered. She had anaphylaxis and was taken to a hospital. Event anaphylaxis also reported as life-threatening. Other events were non-serious. The tingling, numbness and shaking of the arm were still ongoing until now. There was no product complaint associated with this case. The outcome of event anaphylaxis was unknown. The outcome of event tingling, numbness and shaking in the same arm where the vaccine was administered was not recovered.  No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Myocarditis, Neck pain, Pain, Pain in extremity
Clinical narrative: chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; patient had some of the symptoms of the myocarditis or pericarditis; patient had some of the symptoms of the myocarditis or pericarditis; This is a spontaneous report from a contactable pharmacist. A 33-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Batch/Lot number was not reported) via an unspecified route of administration and administered in left arm on 07Jun2021 (at age of 33 -years-old) as first dose 0.3 ml, single dose for COVID-19 immunization get protection from covid 19. The patient medical history and concomitant medications were not reported. Caller was a pharmacist calling on behalf of her patient who received the first dose of the Pfizer-BioNTech COVID19 vaccine on 7 Jun 2021 and experienced chest pain, but it was more like a radiating pain that also effected their neck and arm on the same day of vaccination. The patient came in to get their second dose. patient had some of the symptoms of the myocarditis or pericarditis. He was supposed to get the vaccine on Monday (28 Jun 2021) but caller said she wanted to talk to Pfizer to see if we had any recommendations on getting the second dose with a potential of having myocarditis or pericarditis. The chest pain lasted 3-4 days and was improved. Investigations as the caller does not think the patient had any tests done as he didn't seek any medical attention about this. Outcome of the chest pain was recovered on unspecified date in 2021 and other events was unknown. Reporter seriousness for chest pain but it was more like a radiating pain that also effected their neck and arm as Not serious and assessed as Related.  Information on the lot/batch, further information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Myocarditis and Pericarditis and the suspect drug bnt162b2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; patient had some of the symptoms of the myocarditis or pericarditis; patient had some of the symptoms of the myocarditis or pericarditis; This is a spontaneous report from a contactable pharmacist. A 33-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Batch/Lot number was not reported) via an unspecified route of administration and administered in left arm on 07Jun2021 (at age of 33 -years-old) as first dose 0.3 ml, single dose for COVID-19 immunization get protection from covid 19. The patient medical history and concomitant medications were not reported. Caller was a pharmacist calling on behalf of her patient who received the first dose of the Pfizer-BioNTech COVID19 vaccine on 7 Jun 2021 and experienced chest pain, but it was more like a radiating pain that also effected their neck and arm on the same day of vaccination. The patient came in to get their second dose. patient had some of the symptoms of the myocarditis or pericarditis. He was supposed to get the vaccine on Monday (28 Jun 2021) but caller said she wanted to talk to Pfizer to see if we had any recommendations on getting the second dose with a potential of having myocarditis or pericarditis. The chest pain lasted 3-4 days and was improved. Investigations as the caller does not think the patient had any tests done as he didn't seek any medical attention about this. Outcome of the chest pain was recovered on unspecified date in 2021 and other events was unknown. Reporter seriousness for chest pain but it was more like a radiating pain that also effected their neck and arm as Not serious and assessed as Related.  Information on the lot/batch, further information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Myocarditis and Pericarditis and the suspect drug bnt162b2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.