chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Maternal exposure during pregnancy
Clinical narrative: Fatigue; Dizziness; Headache; Female patient was vaccinated during pregnancy; This is a spontaneous report received from a contactable consumer, the patient. A 36-year-old pregnant female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot/batch number: EP6955) via an unspecified route of administration as a single dose on 16Mar2021 at 15:15 (at the age of 36-years-old) in the right arm for COVID-19 immunisation. Her last menstrual period was on 24Jul2020 with gestational age of 33 weeks. Her expected delivery date was 01Jun2021. Medical history of the patient was not reported. It was reported that she had no allergies to medications, food, or other products. Concomitant medications included prenatal vitamin (MANUFACTURER UNKNOWN), fluoxetine (PROZAC) and magnesium (MANUFACTURER UNKNOWN); all used for an unspecified indication (all received within 2 weeks of vaccination). Vaccines taken within 4 weeks included TDAP vaccine (MANUFACTURER UNKNOWN) on the left arm and RHOGAM vaccine (MANUFACTURER UNKNOWN) on right hip; both on 05Mar2021 for immunization. The patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 17Mar2021 at 12:00, the patient experienced dizziness, fatigue and headache. No therapeutic measures were taken to treat the events. At the time of the report, the outcomes of the reported events dizziness, fatigue and headache were recovering. The outcome of the event vaccine exposure during pregnancy was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Illness, Limb discomfort, Malaise
Clinical narrative: sick; not feeling well; I had a feeling of "intoxication", which included sporadic slurred speech and heaviness in legs and feet.; I had a feeling of "intoxication", which included sporadic slurred speech and heaviness in legs and feet.; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration on 24Mar2021 at 12:45 PM (at the age of 54-year old), as 2nd dose, single, in right arm for COVID-19 immunisation and received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3248), via an unspecified route of administration on 03MAR2021 at 16:45 (at the age of 54-years old) as 1st dose, single in right arm for COVID-19 immunisation at Workplace clinic. The patient's medical history included uterine cancer and bipolar 2. Concomitant medications received within 2 weeks of vaccination included oxycarbaxepine, alprazolam, quetiapine, lorazepam, D-amphetamine, vitamins D3 and biotin. Patient had no allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021, approximately 7 hours following vaccination, the patient had a feeling of ''intoxication'', which included sporadic slurred speech and heaviness in legs and feet. Symptoms resolved within 24 hours. After first vaccination, patient had a feeling of ''euphoria'' SUPER HUMAN and was able to complete very difficult CrossFit moves in the gym, which she was never able to complete for the past 6 years. First vaccine event was not reported because it was a positive event and not an adverse event, but now patient wondered if there was a connection between her reactions to both vaccines, or possibly an interaction with her concomitant medications. There was no treatment received for the adverse events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Upon FU received on 06Apr2021, patient reported to be too sick and upon FU received on 09Apr2021, patient reported that he was still not feeling well, but still alive.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Loss of personal independence in daily activities, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: itching all over my body/itchy; fever of 98.5F; I can't even work; sore arm; feeling crappy; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 47-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EP6955) via unknown route of administration on 27Mar2021 at left arm as a single dose for COVID-19 immunization. The patient medical history included ongoing Crohn's disease. Concomitant medications included certolizumab pegol (CIMZIA) as a SINGLE DOSE (2 shot Once a month) for Crohn's disease and other unknown products. Patient states that she received her 2nd dose of the vaccine on March 26. On Sunday she started itching. Patient took 2 Benadryl and it didn't help. Patient has taken cortisone and used topical Benadryl as well. Patient was itching all over her body on an unknown date in 2021, it started on the arm where I got the shot, but it's spreading." Had a fever of 98.5F on an unknown date in 2021. Patient know someone else with Crohn's who had a bad reaction to the Moderna COVID vaccine. Patient stated, "I had some of the expected Pfizer side effect but I was not expecting this thing to be this itchy. Patient was literally wanting to crawl out of my skin. Patient have been on Benadryl since Sunday when it started and it started Wednesday and patient can't even work on an unknown date in 2021 because she have to take so much Benadryl just to stop the itching and it knocks me out. Patient was taking over the counter Benadryl and topical Benadryl and Cortisone, I mean it's bad. When confirmed that consumer took the COVID shot, consumer stated, "Yes I took my second shot, I took it on Saturday. On an unknown date in 2021, patient got sore arm which was expected, she was feeling crappy but I was not expecting to have this severe itchiness." Patient have been itchy for 4 days now since Sunday. Patient sated, "Just document that I am getting itchiness, because the itchiness is bad and they really need to disclose that on their side effects." Confirmed that consumer took the vaccine for the prevention from COVID 19 vaccine. The therapeutic measures received for the event itching included Benadryl and Cortisone. The outcome of the events was unknown.  No Follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: My left eye at the same arm I was vaccinated on is very red like it has broken blood vessels; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration in left arm on 01Apr2021 13:15, as a single dose for COVID-19 immunisation. Patient medical history was reported as none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19 was unknown. Concomitant medications were not reported. The patient did not have allergies. The patient did not receive any other vaccines within four weeks and no medications within two weeks prior to the vaccination. The patient experienced my left eye at the same arm I was vaccinated on is very red like it has broken blood vessels on 01Apr2021 13:15. The patient received treatment for the event was reported as unknown. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Tinnitus & partial hearing loss in right ear; Tinnitus & partial hearing loss in right ear; This is a spontaneous report from a contactable consumer (the patient). A 44-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 31Mar2021 as single dose for covid-19 immunization. Medical history included supplementation therapy. The patient's concomitant medications include escitalopram oxalate (LEXAPRO), Iron supplements and Vitamin D. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 05Apr2021, the patient experience tinnitus and partial hearing loss in right ear. Started 5 days after vaccine. The patient did not receive any treatment for the adverse events. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood gases, Chest X-ray, Computerised tomogram, Fatigue
Clinical narrative: Patient reported fatigue and progressive weakness since given vaccination.  Now admitted to ICU in hypercarbic and hypoxemic respiratory failure on invasive vent support.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Hypercapnia, Hypoxia, Intensive care, Mechanical ventilation
Clinical narrative: Patient reported fatigue and progressive weakness since given vaccination.  Now admitted to ICU in hypercarbic and hypoxemic respiratory failure on invasive vent support.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Respiratory failure
Clinical narrative: Patient reported fatigue and progressive weakness since given vaccination.  Now admitted to ICU in hypercarbic and hypoxemic respiratory failure on invasive vent support.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dyspnoea, Neck pain, Nodule, Pain
Clinical narrative: 5/12, 5/13 and 5/14 - Arm Pain, specially when trying to lift anything. 5/15, 5/16, 5/17 - noticed shortness of breath, very sleepy, throat clearing, heavy post nasal drip. Weird taste in mouth. 5/18 - Neck Pain 5/19 - Felt a small moving ball on top of the left side of my collarbone, closer to my throat, it is painful and tender to the touch. My neck feels in pain, actually more like a burning sensation
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Taste disorder, Tenderness, Throat clearing
Clinical narrative: 5/12, 5/13 and 5/14 - Arm Pain, specially when trying to lift anything. 5/15, 5/16, 5/17 - noticed shortness of breath, very sleepy, throat clearing, heavy post nasal drip. Weird taste in mouth. 5/18 - Neck Pain 5/19 - Felt a small moving ball on top of the left side of my collarbone, closer to my throat, it is painful and tender to the touch. My neck feels in pain, actually more like a burning sensation
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: 5/12, 5/13 and 5/14 - Arm Pain, specially when trying to lift anything. 5/15, 5/16, 5/17 - noticed shortness of breath, very sleepy, throat clearing, heavy post nasal drip. Weird taste in mouth. 5/18 - Neck Pain 5/19 - Felt a small moving ball on top of the left side of my collarbone, closer to my throat, it is painful and tender to the touch. My neck feels in pain, actually more like a burning sensation
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Angiogram, COVID-19, Chest X-ray, Chest pain
Clinical narrative: Shortness of breath, burning in chest, not feeling well since second vaccine dose.  Now admitted with acute hypoxemic respiratory failure with PULMONARY EMBOLI and pulmonary infiltrates that are suspicious for COVID 19 with + Ab testing but many negative PCRs.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoxia, Lung infiltration, Malaise, Pulmonary embolism
Clinical narrative: Shortness of breath, burning in chest, not feeling well since second vaccine dose.  Now admitted with acute hypoxemic respiratory failure with PULMONARY EMBOLI and pulmonary infiltrates that are suspicious for COVID 19 with + Ab testing but many negative PCRs.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Shortness of breath, burning in chest, not feeling well since second vaccine dose.  Now admitted with acute hypoxemic respiratory failure with PULMONARY EMBOLI and pulmonary infiltrates that are suspicious for COVID 19 with + Ab testing but many negative PCRs.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Diarrhoea, Influenza like illness, Pain in extremity
Clinical narrative: bilateral leg pain, diarrhea, flu like symptoms, death
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dehydration, Sleep disorder
Clinical narrative: Woke up sometime around 18 Hrs post vaccination (2nd Dose). Extreme chills, dehydration, and skin tempreture (Internal showed normal at 97.9)
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: within 1 hour after- arm soreness and fatigue 1 hour to 10 hours after- fatigue, progressive muscle soreness 15 hours after- fever, fatigue, muscle soreness, arm soreness, malaise
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood test, Neck pain, Pain in extremity
Clinical narrative: back pain that shifted positions and was then in the left neck, shoulder and arm regions; back pain that shifted positions and was then in the left neck, shoulder and arm regions; back pain that shifted positions and was then in the left neck, shoulder and arm regions; back pain that shifted positions and was then in the left neck, shoulder and arm regions; This is a spontaneous report from a contactable consumer (patient). This 35-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 28Jan2021 (at 35-years of age) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included testosterone cipionate, vortioxetine hydrobromide (TRINTELLIX) and propranolol, all from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number EK9231) on 06Jan2021 at 16:00 (at 35-years of age) for COVID-19 immunisation. The patient reported experiencing rapid onset of back pain that shifted positions and was then in the left neck, shoulder and arm regions on 04Feb2021 at 07:00, 7 days following the second shot. He reported he was referred by his primary care physician and physical therapist to a physiatrist specializing in spine/neck issues. It was unknown if treatment was received for the events. The clinical outcomes of back pain that shifted positions and was then in the left neck, shoulder and arm regions were not recovered. It was also reported that since vaccination, the patient had tested negative for COVID-19 via blood test on 15Feb2021.  No follow-up attempts are needed; information about lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Prostatic disorder, Renal disorder
Clinical narrative: little tired; scan is for my kidney or prostate, I'm not sure if the problem was there before i got the 1st dose, but it was discovered through a blood test I did after the 1st dose; scan is for my kidney or prostate, I'm not sure if the problem was there before i got the 1st dose, but it was discovered through a blood test I did after the 1st dose; This is a spontaneous report from a non-contactable consumer (patient). This male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 06Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported he received his first dose on 06Apr2021 and was schedule for his second dose on 27Apr2021. He reported that on 03May (2021) he had to go to the hospital to get magnetic resonance imaging (MRI) and computerized tomography (CT) scans done and inquired if it was okay to get the tests done after the vaccine or if he should reschedule. The patient stated that after his first dose he was just a little tired and didn't have any other side effects; further stating the MRI and CT scan were for his kidney or prostate. He was not sure if the problem was there before he got the first dose, but it was discovered through a blood test after the first dose. He also inquired if he could reschedule the vaccine. The clinical outcomes of little tired and scan is for my kidney or prostate, I'm not sure if the problem was there before I got the first dose, but it was discovered through a blood test I did after the first dose were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Piloerection, Vaccination site pain
Clinical narrative: metal taste in mouth; chills; soreness in the area of the vaccine; Her skin had a little chill like as if she went out in the cold and her hair stood up or like she had gotten scared; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EY18121 or CW0164) via an unspecified route of administration on 17Apr2021 at 08:16 (at the age of 58-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included fractured her right foot in three places around 2 months ago (as of 18Apr2021) and she has gotten bruises her whole life "and nobody can figure out why." The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE) from an unknown date for headaches, calcium and vitamin D from unknown dates (for about a month) because she fractured her right foot. On 17Apr2021 the patient experienced metal taste in mouth, chills, and soreness in the area of the vaccine. An hour and a half after getting the shot (also reported as an hour after) she had a metal taste in her mouth. She ate something and then got a chill. Her skin had a little chill like as if she went out in the cold and her hair stood up or like she had gotten scared. She took a nap and woke up 3 hours later and it was gone. She does not know how long the metal taste went on for. She still had a little taste and it was still a little bit bitter or something. She did not know if it was that or if it was from what she ate. She knows that yesterday (18Apr2021) she did not have this taste. She did not know how long it lasted for the first day because she went to sleep.  She thought she did have the taste Saturday(17Apr2021). It was "like metal when you take iron pills that taste like that."  There was soreness in the area on Saturday (17Apr2021) and Sunday (18Apr2021).  It was right away. Today it was fine.  If she touched it now, there was very little soreness. The patient did not receive any treatment for the events. The outcomes of metal taste was unknown. The outcome of soreness in the area of the vaccine was recovering. The outcome of chills was recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Nasal congestion, Upper respiratory tract infection
Clinical narrative: had a cough; she was tired; she had body chills; she had some kind of upper respiratory infection; congestion; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient had no medical history and did not take any concomitant medications. On an unspecified date after dose 1 of BNT162B2 the patient experienced a cough, she was tired, and she had body chills. She was struggling for two weeks maybe. The patient visited an urgent care as a result of the events and she had some kind of upper respiratory infection. After almost two and a half weeks after the first dose, or maybe a little longer, she was struggling with cough and congestion but she doesn't think that she has completely recovered. Once in a while she will start coughing and she doesn't know if she is one hundred percent recovered. The outcomes of cough, she was tired, chills, upper respiratory infection, and congestion were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild headache the next day for 1 day; This is a spontaneous report  from a Pfizer-sponsored program. A non-contactable consumer (patient) reported a patient of unspecified age and gender received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced mild headache the next day for 1 day. The outcome of mild headache was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Photophobia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Within a few minutes after injection patient developed arm pain around the injection site.; headache; sensitivity to light, about half an hour after injection.; This is a spontaneous report from a contactable pharmacist. A 36-years-old female patient (non-pregnant at the time of vaccination) received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), intramuscular, administered in Arm Left on 20Apr2021 at 11:30 as first dose single for COVID-19 immunization. Medical history included infertility, menstruation irregular, chronic spontaneous urticaria, insomnia, hypersensitivity (Seasonal allergies with particular allergy to oak and Allergic to dust) and food allergy from an unknown date and unknown if ongoing. Concomitant medications were not reported. Patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. On 20Apr2021 at 11:45 Within a few minutes after injection patient developed arm pain around the injection site. Patient also developed headache and sensitivity to light, about half an hour after injection on 20Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test as negative on 07Apr2021. Treatment was not received. The outcome of the events was not recovered.  Follow-up (PRD 26Apr2021): No new AE is available. I am the reporter in this case. Please update reporter email to Awareness date of the initial item is 20Apr2021 as indicated in initial report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Panic attack
Clinical narrative: panic and anxiety increase/ panic attack; panic and anxiety increase/ panic attack; panic and anxiety increase; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunisation on 16Mar2021. Medical history included: anxiety and panic attacks. He stated he had been free of anxiety/panic attacks for 6 years. Concomitant medication was not reported. The first week he felt fine, then the second week (Mar2021) he began to feel his panic and anxiety increased and he had a panic attack in which he was admitted to the emergency department. Outcome of the events was unknown.  No follow-up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date as unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced hives on unspecified date. The outcome of the event was not reported.  Information about lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Itching on both hand and legs and red color; Itching on both hand and legs and red color; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 (Batch/Lot Number: ER8730, at the age of 46-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced itching on both hand and legs and red color on 19Apr2021. 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. The patient was not pregnant. The outcome of the events was unknown.  No Follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable pharmacist. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date in Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID-19 vaccine 3 weeks ago (Apr2021), and he was supposed to receive the second dose today. The patient stated that ever since the first dose, he had a headache that will not go away. The pharmacist would like to know if there were any recommendations from Pfizer to apply the second dose. The outcome of headache was not recovered.  No follow-up attempts are needed; information about lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: just a little draggish; This is a spontaneous report from a contactable consumer or other non hcp.A 74-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0162, Expiration Date: 31Jul2021) via an unspecified route of administration on 20Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient is not related to study or programme.On an unspecified date, the patient experienced just a little draggish. The outcome of events was unknown.  No follow up attempts possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Thrombosis
Clinical narrative: Severe calf muscle cramps, possible blood clot; Severe calf muscle cramps, possible blood clot; This is a spontaneous report from a contactable other hcp.  A 28-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 24Mar2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history was reported as "none". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. the patient previously received the first dose of BNT162B2 on 26Feb2021 at 10:00 administered in the left arm for COVID-19 immunization. The patient's concomitant medications were not reported. The patient experienced severe calf muscle cramps, possible blood clot on 01Apr2021 12:00. The outcome of events was not recovered.  Patient did not receive any treatment for the events.   Follow up needed, further information has been requested; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. Case will be reassessed upon receipt of follow-up information. 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea haemorrhagic, Feeling hot, Nausea, Pyrexia
Clinical narrative: Blood in diarrhea; Throwing up; Fever of 102; Nausea; feeling overheated; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: EW 0162), via an unspecified route of administration, administered in the right arm on 28Apr2021 at 11:00, as a single dose for COVID-19 immunization. Medical history included allergy to Cephzil (as reported) from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included lithium (manufacturer unknown); clonazepam (KLONOPIN) and clonidine (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced blood in diarrhea, throwing up, fever of 102, nausea and feeling overheated on 29Apr2021 at 21:00. The patient did not receive treatment for the events. The outcome of the events was not recovered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Blood in diarrhea; Throwing up; Fever of 102; Nausea; feeling overheated; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: EW 0162), via an unspecified route of administration, administered in the right arm on 28Apr2021 at 11:00, as a single dose for COVID-19 immunization. Medical history included allergy to Cephzil (as reported) from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included lithium (manufacturer unknown); clonazepam (KLONOPIN) and clonidine (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced blood in diarrhea, throwing up, fever of 102, nausea and feeling overheated on 29Apr2021 at 21:00. The patient did not receive treatment for the events. The outcome of the events was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lip swelling, Urticaria
Clinical narrative: Have has 3 severe allergic reactions; Hives; Lip swelling; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 04Apr2021 13:00 (Batch/Lot Number: E97533) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included Hypertension and "Hashimotos". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included metoprolol, potassium, furosemide (LASIX), famotidine and levothyroxine sodium (LEVOTHYROX); all from unspecified dates and unknown if ongoing, for unspecified indications. Patient's known allergies includes, strawberries, aspirin, zyban, eggs. On 23Apr2021 08:00, the patient had 3 severe allergic reactions; these reactions include hives and lip swelling requiring treatment via injection of epinephrine, decadron, albuterol and pepcid. Due to pandemic isolation, any other possible triggers for reaction have been tested and excluded. the events resulted in Emergency Room/ Physician's Visit.  The outcome of event was reported as recovering.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: had a heavy menstrual bleeding for 3 weeks following the first dose, very large clots; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: EW0176) as 1ST DOSE, SINGLE for COVID-19 immunization. The vaccine was administered at a pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history was not reported. The patient was not pregnant. The patient had no concomitant medications. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient reported she had a heavy menstrual bleeding for 3 weeks following the first dose, very large clots on 09Apr2021 15:00. Outcome of the event was not recovered.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Arthralgia, Arthritis, Enteritis
Clinical narrative: sleepless night; abdomen pain; rash that started on my left ankle and spread onto both feet, legs, and arms/red dots on my extremities; Joint pain that got progressively worse; inflamed bowels; joint inflammation and pain; currently home in the same pain and red dots on my extremities; Henoch schoenlein purpura vasculitis; Stomach ache that got progressively worse as the day went on; This is a spontaneous report from COVAES. This is a report from a contactable consumer (patient).   A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:15 (Batch/Lot Number: EW0164) as 1st dose, single (at the age of 31 years) for covid-19 immunisation.  Medical history included hypersensitivity to Penicillin. 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. Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient's concomitant medications were not reported.  The patient experienced stomach ache that got progressively worse as the day went on (hospitalization) on 22Apr2021 08:00 with outcome of not recovered , sleepless night (hospitalization) on an unspecified date with outcome of unknown, abdomen pain (hospitalization) on an unspecified date with outcome of unknown , rash that started on my left ankle and spread onto both feet, legs, and arms/ red dots on my extremities (hospitalization) on an unspecified date with outcome of unknown , joint pain that got progressively worse (arthralgia) (hospitalization) on an unspecified date with outcome of unknown.  The patient went to the ER (emergency room) 2 times in 3 days, then was admitted into the hospital for 5 days of tests and observation. The patient was diagnosed with henoch schoenlein purpura vasculitis (hospitalization) on an unspecified date with outcome of unknown , inflamed bowels (hospitalization) on an unspecified date with outcome of unknown , joint inflammation and pain (hospitalization) on an unspecified date with outcome of unknown and currently home in the same pain and red dots on my extremities (hospitalization) on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included nasal swab: negative on 26Apr2021, sars-cov-2 test: results not on unspecified date.  Since the vaccination, the patient has been tested for COVID-19 however, no results were reported.  Therapeutic measures were taken as a result of stomach ache that got progressively worse as the day went on. Treatment included Pain medication, diet change/reduction, and observation.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Henoch-Schonlein purpura, Insomnia, Laboratory test, Pain, Rash
Clinical narrative: sleepless night; abdomen pain; rash that started on my left ankle and spread onto both feet, legs, and arms/red dots on my extremities; Joint pain that got progressively worse; inflamed bowels; joint inflammation and pain; currently home in the same pain and red dots on my extremities; Henoch schoenlein purpura vasculitis; Stomach ache that got progressively worse as the day went on; This is a spontaneous report from COVAES. This is a report from a contactable consumer (patient).   A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:15 (Batch/Lot Number: EW0164) as 1st dose, single (at the age of 31 years) for covid-19 immunisation.  Medical history included hypersensitivity to Penicillin. 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. Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient's concomitant medications were not reported.  The patient experienced stomach ache that got progressively worse as the day went on (hospitalization) on 22Apr2021 08:00 with outcome of not recovered , sleepless night (hospitalization) on an unspecified date with outcome of unknown, abdomen pain (hospitalization) on an unspecified date with outcome of unknown , rash that started on my left ankle and spread onto both feet, legs, and arms/ red dots on my extremities (hospitalization) on an unspecified date with outcome of unknown , joint pain that got progressively worse (arthralgia) (hospitalization) on an unspecified date with outcome of unknown.  The patient went to the ER (emergency room) 2 times in 3 days, then was admitted into the hospital for 5 days of tests and observation. The patient was diagnosed with henoch schoenlein purpura vasculitis (hospitalization) on an unspecified date with outcome of unknown , inflamed bowels (hospitalization) on an unspecified date with outcome of unknown , joint inflammation and pain (hospitalization) on an unspecified date with outcome of unknown and currently home in the same pain and red dots on my extremities (hospitalization) on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included nasal swab: negative on 26Apr2021, sars-cov-2 test: results not on unspecified date.  Since the vaccination, the patient has been tested for COVID-19 however, no results were reported.  Therapeutic measures were taken as a result of stomach ache that got progressively worse as the day went on. Treatment included Pain medication, diet change/reduction, and observation.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: sleepless night; abdomen pain; rash that started on my left ankle and spread onto both feet, legs, and arms/red dots on my extremities; Joint pain that got progressively worse; inflamed bowels; joint inflammation and pain; currently home in the same pain and red dots on my extremities; Henoch schoenlein purpura vasculitis; Stomach ache that got progressively worse as the day went on; This is a spontaneous report from COVAES. This is a report from a contactable consumer (patient).   A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:15 (Batch/Lot Number: EW0164) as 1st dose, single (at the age of 31 years) for covid-19 immunisation.  Medical history included hypersensitivity to Penicillin. 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. Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient's concomitant medications were not reported.  The patient experienced stomach ache that got progressively worse as the day went on (hospitalization) on 22Apr2021 08:00 with outcome of not recovered , sleepless night (hospitalization) on an unspecified date with outcome of unknown, abdomen pain (hospitalization) on an unspecified date with outcome of unknown , rash that started on my left ankle and spread onto both feet, legs, and arms/ red dots on my extremities (hospitalization) on an unspecified date with outcome of unknown , joint pain that got progressively worse (arthralgia) (hospitalization) on an unspecified date with outcome of unknown.  The patient went to the ER (emergency room) 2 times in 3 days, then was admitted into the hospital for 5 days of tests and observation. The patient was diagnosed with henoch schoenlein purpura vasculitis (hospitalization) on an unspecified date with outcome of unknown , inflamed bowels (hospitalization) on an unspecified date with outcome of unknown , joint inflammation and pain (hospitalization) on an unspecified date with outcome of unknown and currently home in the same pain and red dots on my extremities (hospitalization) on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included nasal swab: negative on 26Apr2021, sars-cov-2 test: results not on unspecified date.  Since the vaccination, the patient has been tested for COVID-19 however, no results were reported.  Therapeutic measures were taken as a result of stomach ache that got progressively worse as the day went on. Treatment included Pain medication, diet change/reduction, and observation.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Ear pain, Eye discharge, Facial paresis, Headache
Clinical narrative: Bells Palsy; Facial weakness on right side; Headache; earache; mouth ache; runny nose; runny eye; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) dose 2 via an unspecified route of administration, administered in Arm Left on 24Apr2021 14:30 (Lot Number: EW0171) as second dose, single for COVID-19 immunisation. The patient previously took the first dose of BNT162B2 on 03Apr2021 15:00 (Lot number: EW0151) administered to left leg for COVID-19 immunization. Medical history included high blood pressure, chronic kidney disease and diabetes mellitus. The patient has no known allergies and was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included isosorbide, metoprolol, ticagrelor (BRILINTA), clonidine and ayurvedic preparation (NEFID) all taken for an unspecified indication, start and stop date were not reported. On 01May2021 01:00, the patient experienced Bell's Palsy, facial weakness on right side, headache, earache, mouth ache, runny eye and runny nose; all on the right side. The patient did not receive treatment for the events. Since the vaccination, has the patient has not been tested for COVID-19. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Rhinorrhoea
Clinical narrative: Bells Palsy; Facial weakness on right side; Headache; earache; mouth ache; runny nose; runny eye; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) dose 2 via an unspecified route of administration, administered in Arm Left on 24Apr2021 14:30 (Lot Number: EW0171) as second dose, single for COVID-19 immunisation. The patient previously took the first dose of BNT162B2 on 03Apr2021 15:00 (Lot number: EW0151) administered to left leg for COVID-19 immunization. Medical history included high blood pressure, chronic kidney disease and diabetes mellitus. The patient has no known allergies and was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included isosorbide, metoprolol, ticagrelor (BRILINTA), clonidine and ayurvedic preparation (NEFID) all taken for an unspecified indication, start and stop date were not reported. On 01May2021 01:00, the patient experienced Bell's Palsy, facial weakness on right side, headache, earache, mouth ache, runny eye and runny nose; all on the right side. The patient did not receive treatment for the events. Since the vaccination, has the patient has not been tested for COVID-19. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cytogenetic analysis, Cytogenetic analysis abnormal
Clinical narrative: BCR-ABL test jumped very high; This is a spontaneous report received from a contactable consumer (patient) via medical information and via Pfizer-sponsored program. An 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 80 years old via an unspecified route of administration, administered in arm left on 26Jan2021 (Batch/Lot Number: CN5318) as 2nd dose, single for COVID-19 immunization and bosutinib (BOSULIF), oral from an unspecified date (Batch/Lot Number: unknown) to an unspecified date at 300 mg, 1x/day for chronic myeloid leukemia. Patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right on 05Jan2021 (Batch/Lot Number: EK4176) as 1st dose, single. Medical history included chronic myeloid leukemia. The patient's concomitant medications were not reported. Patient experienced: BCR-ABL (Philadelphia chromosome) test jumped very high on 12Apr2021 (her results went from 1.9 to 11.8). The event was considered related to the medicinal products. Seriousness criteria reported as serious. Outcome of the event was unknown. She has not had any testing since. Action taken in response to the event for bosutinib was dose not changed.