chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: Pericarditis; Couldn''t Breathe; the booster dose of the Covid 19 Vaccine; This is a spontaneous report from a contactable physician.   A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 3 via an unspecified route of administration, administered in left arm on 04Oct2021 (Batch/Lot Number: FF2587) as dose 3 (booster), single (at the age of 75 years old) for COVID-19 immunisation.  The patient had no medical history.  There were no concomitant medications. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 on 26Dec2020 (Batch/Lot Number: EK9231) and dose 2 on 19Jan2021 (Batch/Lot Number: EK9231) for COVID-19 immunisation at the age of 75 years old. The patient experienced the booster dose of the Covid 19 Vaccine. States he has had what he thinks is a side effect from the booster shot. The patient stated that he has pericarditis.  States it started a week ago Sunday, so on 31Oct2021.  He was in the emergency room for 24 hours.  States he could not breathe and it was serious. He had around 30 blood test.  He had EKG's, ultrasounds, echocardiograms, CT Scans; states he had around 35 tests in all. No prior vaccinations (within 4 weeks).  The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. 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: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pericarditis, Ultrasound scan
Clinical narrative: Pericarditis; Couldn''t Breathe; the booster dose of the Covid 19 Vaccine; This is a spontaneous report from a contactable physician.   A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 3 via an unspecified route of administration, administered in left arm on 04Oct2021 (Batch/Lot Number: FF2587) as dose 3 (booster), single (at the age of 75 years old) for COVID-19 immunisation.  The patient had no medical history.  There were no concomitant medications. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 on 26Dec2020 (Batch/Lot Number: EK9231) and dose 2 on 19Jan2021 (Batch/Lot Number: EK9231) for COVID-19 immunisation at the age of 75 years old. The patient experienced the booster dose of the Covid 19 Vaccine. States he has had what he thinks is a side effect from the booster shot. The patient stated that he has pericarditis.  States it started a week ago Sunday, so on 31Oct2021.  He was in the emergency room for 24 hours.  States he could not breathe and it was serious. He had around 30 blood test.  He had EKG's, ultrasounds, echocardiograms, CT Scans; states he had around 35 tests in all. No prior vaccinations (within 4 weeks).  The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Immunisation, Pain, Tachycardia
Clinical narrative: extreme soreness; fatigue; tachycardia; Booster; This is a spontaneous report from contactable consumer (Patient). This 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Arm Right on 04Nov2021 12:30 at age of 36-year-old as DOSE 3 (BOOSTER), SINGLE (Batch/lot number: 3302680) for COVID-19 immunisation. Medical history included ulcerative colitis, known allergies: pollen and grass. Prior to vaccination, the patient did not diagnose with COVID-19. Concomitant drugs included fluoxetine hydrochloride (FLUOXETIN) 20mg and Ritual vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 07Apr2021 10:00 AM at age of 35-year-old Arm Right as DOSE 1, SINGLE (Batch/Lot No: ER8729) for COVID-19 immunisation, the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Arm Right on 28Apr2021 10:00 AM at age of 36-year-old as DOSE 2, SINGLE (Batch/Lot No: EW0167) for COVID-19 immunisation. The patient received Pfizer booster shot on Thursday 04Nov2021 at approx 12:30pm. At 3:41 am the following morning 05Nov2021 the patient was woken out of sleep with a bout of tachycardia. Per smart watch, HR upon waking was 113 at 3:41 and jumped up to 139 3:42am. It remained around 120 for 5 or so minutes, then dropped to around 100. The patient was able to fall back asleep but HR remained elevated for the rest of the day (Friday 05Nov2021), always around 95-105. Other than the patient had extreme soreness (like was hit by a truck, it hurt to move body) and fatigue on 05Nov2021 03:45, which were more normal and similar to what happened last time. The tachycardia just stood out as an odd thing, so the patient figured someone should know. Since the vaccination, the patient has not been tested for COVID-19. No treatments received. Outcome of the events tachycardia, soreness and fatigue were recovered in Nov2021.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: Arm sore, after booster; Arm sore, after booster; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 10Nov2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included first and second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an un-specified date as single for COVID-19 immunisation. The patient experienced arm sore, after booster on 10Nov2021.The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cervical radiculopathy, Immunisation
Clinical narrative: Diagnosed with cervical radiculopathy; Receiving the Pfizer booster; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 61-year-old non-pregnant female patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: FF2587), via an unspecified route of administration, administered in left arm as dose 3 (booster), single on 23Oct2021 12:00 (at the age of 61-year-old) for covid-19 immunization at pharmacy or drug store. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included atorvastatin calcium, insulin lispro (HUMALOG), lisinopril, ergocalciferol (VIT D [ERGOCALCIFEROL]), and vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]) 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 and received no other medications within 2 weeks of vaccination Humalog, Lisinopril, Atorvastatin, Vita D, B complex. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Historical vaccine included patient previously took first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration, as dose 1, single and dose 2, single on unspecified date for covid-19 immunization. Four days after receiving the Pfizer booster, patient woke up with severe pain in neck, left upper shoulder, radiating down the left arm with left arm weakness and tingling fingers on 27Oct2021 12:00 AM. Pain intensified over the next week so finally went to urgent care. On 03Nov2021, patient was diagnosed with cervical radiculopathy and never had any issues with pinched nerves prior to this time. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events with pain meds and muscle relaxants. At the time of this report, the outcome of event was not recovered.    Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Thrombosis
Clinical narrative: Blood clots; sick; This is a spontaneous report from a contactable consumer. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. she had taken the vaccine and got sick and formed Blood Clots it made her very sick and it's not a Joke. Outcome of the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Immunisation, Laboratory test, Lymphadenopathy, Vaccination site mass
Clinical narrative: my lymph node under my arm on the injection site arm are pretty swollen; whole site is more swollen; there is actually a small bump, tinier little bump for the actual injection site; it's very uncomfortable; booster; This is a spontaneous report from a contactable consumer, the patient. A 61-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: FH8028), via an unspecified route of administration, administered in Arm Left on 08Nov2021 at 14:15 as dose 3 (booster), single (at the age of 61-years-old) for covid-19 immunization. The patient medical history was not reported. Concomitant medications included ibuprofen, methocarbamol, erythromycin, isotretinoin (TRAXIN E). The patient previously took 2 doses of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration, on an unspecified date as dose 1, single and as dose 2, single for covid-19 immunization. It was reported that the patient had an unusual symptom that patient have not had till had the booster and patient did not have this symptom before. Patient having more actually, had little more symptoms which patient understand was not a bad thing but on 10Nov2021, one of thing was lymph node under arm on the injection site arm were pretty swollen. There was actually a small bump, tinier little bump for the actual injection site and it was very uncomfortable. Patient noticed this afternoon, so in last few hours and it was very uncomfortable. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included laboratory test: unknown results on 25Oct2021. The outcome of the events was not recovered.  Follow-up attempts were completed. No further information was expected.
Age: 23.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Axillary pain, Immunisation, Movement disorder, Product use issue, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable Nurse (Patient). A 23-years-old Non Pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6207, Expiry date was not reported), via an unspecified route of administration on 06Nov2021 13:30 (at the age of 23-years-old) in Arm Left as dose 3 (booster), single for COVID-19 immunization and influenza vaccine (FLU), via an unspecified route of administration on 06Nov2021 (Batch/Lot number was not reported), in Arm Left at dose 1, single for immunization. The Patient Medical history included, Vasovagal Syncope, temporomandibular joint syndrome (TMJD), bursitis in L hip. Concomitant medication included desogestrel, ethinylestradiol (KARIVA); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) and Probiotic. Previously patient received dose 1 BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6202 and Expiry date was not reported), via an unspecified route of administration on 26Feb2021 as dose 1, single for COVID-19 immunization and Patient received dose 2 BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6207 and Expiry date was not reported), via an unspecified route of administration on 19Mar2021 as dose 2, single for COVID-19 immunization. The Patient was not pregnant at the time of vaccination. Patient had no known allergies. No other vaccine in four weeks. The Patient was not diagnosed with COVID prior vaccination and Patient tested COVID post vaccination. Facility type vaccine: Pharmacy or Drug Store. On 06Nov2021 13:30, The patient received dose number 3. On 07Nov2021 08:00, Patient experienced pain and swelling in left underarm, limiting movement. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Nov2021 Nasal swab. The Patient visited emergency room. The Patient did not received treatment for the events. The outcome for the events was recovering. Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a contactable Nurse (Patient). A 23-years-old Non Pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6207, Expiry date was not reported), via an unspecified route of administration on 06Nov2021 13:30 (at the age of 23-years-old) in Arm Left as dose 3 (booster), single for COVID-19 immunization and influenza vaccine (FLU), via an unspecified route of administration on 06Nov2021 (Batch/Lot number was not reported), in Arm Left at dose 1, single for immunization. The Patient Medical history included, Vasovagal Syncope, temporomandibular joint syndrome (TMJD), bursitis in L hip. Concomitant medication included desogestrel, ethinylestradiol (KARIVA); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) and Probiotic. Previously patient received dose 1 BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6202 and Expiry date was not reported), via an unspecified route of administration on 26Feb2021 as dose 1, single for COVID-19 immunization and Patient received dose 2 BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6207 and Expiry date was not reported), via an unspecified route of administration on 19Mar2021 as dose 2, single for COVID-19 immunization. The Patient was not pregnant at the time of vaccination. Patient had no known allergies. No other vaccine in four weeks. The Patient was not diagnosed with COVID prior vaccination and Patient tested COVID post vaccination. Facility type vaccine: Pharmacy or Drug Store. On 06Nov2021 13:30, The patient received dose number 3. On 07Nov2021 08:00, Patient experienced pain and swelling in left underarm, limiting movement. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Nov2021 Nasal swab. The Patient visited emergency room. The Patient did not received treatment for the events. The outcome for the events was recovering. Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Dysmenorrhoea, Pruritus, Rash
Clinical narrative: Period Cramps; Itchy Skin; Rash; Heart Problems; This is a spontaneous report from a contactable consumer (patient). This 20-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Arm Left on 23Sep2021 16:15 at age of 20-year-old as DOSE 2, SINGLE (lot: FC3181) for COVID-19 immunisation. Medical history included depression, Covid prior vaccination. Medical history included depression. Concomitant drugs included ibuprofen and diphenhydramine hydrochloride (BENADRYL). No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Left arm on 02Sep2021 04:15 PM at age of 20-year-old as DOSE 1, SINGLE (lot number: FC3181) for COVID-19 immunisation. She experienced Period Cramps, Itchy Skin/Rash, Heart Problems on 06Oct2021. AE resulted in Doctor or other healthcare professional office/clinic visit. No covid tested post vaccination. No treatments were received. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Immunisation, Myalgia
Clinical narrative: Fatigue; body muscle aches; chills; low grade fever - 99.6F; arm pain at site of injection; swelling at site of injection; itching at site of injection; puffy face; Pfizer COVID booster shot received on 09Nov; This is a spontaneous report from a contactable consumer. This 43-year-old female consumer (patient) reported that:  A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FF2589, Expiration Date: 31Mar2022), via an unspecified route of administration on 09Nov2021 (at the age of 43 years old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history included, irritable bowel syndrome (IBS), dermatitis/eczema, sensitivity to dairy and Latex allergy (allergic contact dermatitis). The patient concomitant medications were not reported. Historical vaccine included patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) on an unspecified date as dose 1, single and the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) on an unspecified date as dose 2, single for COVID-19 (Primary Immunization series complete but unknown manufacturer). On 09Nov2021, the patient had pfizer covid booster shot received.  On an unspecified date, the patient experienced fatigue, body muscle aches, chills, low grade fever - 99.6f, arm pain/swelling/itching at site of injection - 2 inches in diameter and puffy face when waking up (transient) 5-8 AM. The patient underwent lab tests and procedures which included body temperature: 99.6 fahrenheit on an unspecified date low grade fever - 99.6F.  Patient received treatment for muscle aches Tylenol around 5:30 AM on unspecified date. The outcome of the events were unknown.  Follow-Up (15Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Fatigue; body muscle aches; chills; low grade fever - 99.6F; arm pain at site of injection; swelling at site of injection; itching at site of injection; puffy face; Pfizer COVID booster shot received on 09Nov; This is a spontaneous report from a contactable consumer. This 43-year-old female consumer (patient) reported that:  A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FF2589, Expiration Date: 31Mar2022), via an unspecified route of administration on 09Nov2021 (at the age of 43 years old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history included, irritable bowel syndrome (IBS), dermatitis/eczema, sensitivity to dairy and Latex allergy (allergic contact dermatitis). The patient concomitant medications were not reported. Historical vaccine included patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) on an unspecified date as dose 1, single and the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) on an unspecified date as dose 2, single for COVID-19 (Primary Immunization series complete but unknown manufacturer). On 09Nov2021, the patient had pfizer covid booster shot received.  On an unspecified date, the patient experienced fatigue, body muscle aches, chills, low grade fever - 99.6f, arm pain/swelling/itching at site of injection - 2 inches in diameter and puffy face when waking up (transient) 5-8 AM. The patient underwent lab tests and procedures which included body temperature: 99.6 fahrenheit on an unspecified date low grade fever - 99.6F.  Patient received treatment for muscle aches Tylenol around 5:30 AM on unspecified date. The outcome of the events were unknown.  Follow-Up (15Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: severe chest pain; This is a spontaneous report from a contactable physician. A 57-year-old female patient (Not pregnant) received bnt162b2 (Batch/Lot number was not reported), intramuscular on 07Mar2021 at the age of 57-year-old as dose 2, single for covid-19 immunization. Medical history included hypothyroidism, mixed hyperlipidemia from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, vitamins taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (Batch/Lot number was not reported) Intramuscular on 14Feb2021 at the age of 56-year-old for covid-19 immunization and experienced tolerated shot #1, previous took chloramphenicol;polymyxin b sulfate (MYCIN) and experienced allergies. The patient experienced severe chest pain on 10Mar2021. 3 days later and severe chest pain that lasted for a couple of days. No treatment received. The case was reported as non-serious. The outcome of event was resolved in 2021. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101559247 same reporter/patient, different  dose/AE.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Laboratory test
Clinical narrative: after 1st injection i had metallic taste in mouth; This is a spontaneous report from a contactable consumer (patient).   A 34-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Aug2021 (Batch/Lot Number: EW 0181) as single dose (at the age of 34) for covid-19 immunisation. No other vaccine in four weeks. No Covid prior or post vaccination. No known allergies. Medical history included attention deficit hyperactivity disorder, obsessive-compulsive disorder, gastrooesophageal reflux disease. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), omeprazole. The patient experienced after 1st injection 'I had metallic taste in mouth lasting three to 4 weeks' on an unspecified date. The outcome was not recovered. The patient underwent lab tests and procedures which included laboratory test: unknown results.   Patient underwent multiple doctor visits and lab work  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Seizure
Clinical narrative: It was my third dose the booster shot; I am having reactions to it. I am having seizures in my brain; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at age of 61 years old, dose 3 intramuscular on 09Nov2021 12:00 (Batch/Lot Number: 30155BA) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history was not reported. Patient was not taking any medication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 Immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 Immunization on 04Mar2021 at age of 61 years old. Patient took the vaccine yesterday at 12 noon. It was her third dose the booster shot and she was having reactions to it. She was having seizures in her brain (09Nov2021) and she was currently at the ER. Anatomical site of vaccination was left. No treatment was received. The outcomes of events were unknown.   Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Gait inability, Headache, Loss of consciousness
Clinical narrative: I was going to pass out, so I just let myself to go on the floor I was staring up  and I didn''t know; When I get up to go the bathroom, I couldn't even to go by my legs; I felt like I was going to faint; I felt like I was drugged; dizzy sometimes/little dizzy/ lightheaded; I was off balance; I get light headache; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at age of 81 years old, dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (Batch/Lot Number: EN6205; Expiration Date: Jun2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included blood pressure. Concomitant medication included metoprolol taken for blood pressure. The patient was received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, Expiration date: May2021) in left arm on 12Feb2021 for covid-19 immunisation at the age of 81 years old. Patient stated the first day she had it she was ok, the second day she had it, she went to take a nap, when she get up to go the bathroom, she couldn't even to go by her legs. Her husband had to help her up. She felt like she was going to faint, she felt like she was drugged, he finally could get patient to the bathroom and on the way out she knew she was going to pass out, so she just let herself to go on the floor and he said she was staring up at him and she didn't know. He washed her face and patient finally come to and then the second day in evening she almost passed out again after that for about a week or two, patient was off balance and dizzy sometimes. All events happened in Apr2021. No treatment was received for all events. Date of first shot and second shot: Consumer stated that she had Pfizer number 1 and then she had Pfizer number 2. Number 2 was when she had the reaction. Sometimes, she got light headache and little dizzy now and she didn't know if it was coordinated. Patient did not have any blood anywhere in the last 2 weeks. Patient got up in the morning and sometimes she was lightheaded. No prior vaccination (4 weeks). The outcomes of events were unknown.   Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Sedation
Clinical narrative: I was going to pass out, so I just let myself to go on the floor I was staring up  and I didn''t know; When I get up to go the bathroom, I couldn't even to go by my legs; I felt like I was going to faint; I felt like I was drugged; dizzy sometimes/little dizzy/ lightheaded; I was off balance; I get light headache; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at age of 81 years old, dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (Batch/Lot Number: EN6205; Expiration Date: Jun2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included blood pressure. Concomitant medication included metoprolol taken for blood pressure. The patient was received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, Expiration date: May2021) in left arm on 12Feb2021 for covid-19 immunisation at the age of 81 years old. Patient stated the first day she had it she was ok, the second day she had it, she went to take a nap, when she get up to go the bathroom, she couldn't even to go by her legs. Her husband had to help her up. She felt like she was going to faint, she felt like she was drugged, he finally could get patient to the bathroom and on the way out she knew she was going to pass out, so she just let herself to go on the floor and he said she was staring up at him and she didn't know. He washed her face and patient finally come to and then the second day in evening she almost passed out again after that for about a week or two, patient was off balance and dizzy sometimes. All events happened in Apr2021. No treatment was received for all events. Date of first shot and second shot: Consumer stated that she had Pfizer number 1 and then she had Pfizer number 2. Number 2 was when she had the reaction. Sometimes, she got light headache and little dizzy now and she didn't know if it was coordinated. Patient did not have any blood anywhere in the last 2 weeks. Patient got up in the morning and sometimes she was lightheaded. No prior vaccination (4 weeks). The outcomes of events were unknown.   Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Hyperhidrosis
Clinical narrative: headache; blurred, slow response vision; blurred, slow response vision; tiredness; prickly/achy pain; fever; sweats; chills; swollen glands; shortness of breath; sore arm; nausea; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 02Nov2021 09:15 (Lot Number: 30155BA; Expiration Date: 07Nov2021) as DOSE 2, SINGLE for COVID-19 immunisation at the age of 41 years old. Medical history included ongoing Birth control. Concomitant medication(s) included ethinylestradiol, ferrous fumarate, norethisterone acetate (LARIN 24 FE) taken for birth control from 1997 and ongoing.  The patient previously received first dose of BNT162B2 intramuscular in left shoulder on 12Oct2021 12:30 (Lot number: 30145BA, Exp: 30Nov2021) for COVID-19 immunisation at the age of 41 years old, and experienced almost immediate headache with blurred, slow response vision, tiredness, Prickly/achy pain moving throughout body that started hour 10 - 40 hs along with fever, sweats, chills, swollen gland. Shortness of breath. 1st dose gave a severe cough last until 2nd.  The patient experienced almost immediate headache with blurred, slow response vision. Then experienced tiredness, Prickly/achy pain moving throughout body that started hour 10 - 40 hs, along with fever, sweats, chills, swollen gland. Left shortness of breath. Additional symptoms: Sore arm for days, nausea. Both doses out of work for days and upon return, unable to work at 100%. Events onset date was reported on 02Nov2021 09:30, treatment received included oral Ibuprofen. Outcome of events was unknown. Seriousness criteria: Persistent /significant disability/ incapacity.   Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: headache; blurred, slow response vision; blurred, slow response vision; tiredness; prickly/achy pain; fever; sweats; chills; swollen glands; shortness of breath; sore arm; nausea; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 02Nov2021 09:15 (Lot Number: 30155BA; Expiration Date: 07Nov2021) as DOSE 2, SINGLE for COVID-19 immunisation at the age of 41 years old. Medical history included ongoing Birth control. Concomitant medication(s) included ethinylestradiol, ferrous fumarate, norethisterone acetate (LARIN 24 FE) taken for birth control from 1997 and ongoing.  The patient previously received first dose of BNT162B2 intramuscular in left shoulder on 12Oct2021 12:30 (Lot number: 30145BA, Exp: 30Nov2021) for COVID-19 immunisation at the age of 41 years old, and experienced almost immediate headache with blurred, slow response vision, tiredness, Prickly/achy pain moving throughout body that started hour 10 - 40 hs along with fever, sweats, chills, swollen gland. Shortness of breath. 1st dose gave a severe cough last until 2nd.  The patient experienced almost immediate headache with blurred, slow response vision. Then experienced tiredness, Prickly/achy pain moving throughout body that started hour 10 - 40 hs, along with fever, sweats, chills, swollen gland. Left shortness of breath. Additional symptoms: Sore arm for days, nausea. Both doses out of work for days and upon return, unable to work at 100%. Events onset date was reported on 02Nov2021 09:30, treatment received included oral Ibuprofen. Outcome of events was unknown. Seriousness criteria: Persistent /significant disability/ incapacity.   Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: headache; blurred, slow response vision; blurred, slow response vision; tiredness; prickly/achy pain; fever; sweats; chills; swollen glands; shortness of breath; sore arm; nausea; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 02Nov2021 09:15 (Lot Number: 30155BA; Expiration Date: 07Nov2021) as DOSE 2, SINGLE for COVID-19 immunisation at the age of 41 years old. Medical history included ongoing Birth control. Concomitant medication(s) included ethinylestradiol, ferrous fumarate, norethisterone acetate (LARIN 24 FE) taken for birth control from 1997 and ongoing.  The patient previously received first dose of BNT162B2 intramuscular in left shoulder on 12Oct2021 12:30 (Lot number: 30145BA, Exp: 30Nov2021) for COVID-19 immunisation at the age of 41 years old, and experienced almost immediate headache with blurred, slow response vision, tiredness, Prickly/achy pain moving throughout body that started hour 10 - 40 hs along with fever, sweats, chills, swollen gland. Shortness of breath. 1st dose gave a severe cough last until 2nd.  The patient experienced almost immediate headache with blurred, slow response vision. Then experienced tiredness, Prickly/achy pain moving throughout body that started hour 10 - 40 hs, along with fever, sweats, chills, swollen gland. Left shortness of breath. Additional symptoms: Sore arm for days, nausea. Both doses out of work for days and upon return, unable to work at 100%. Events onset date was reported on 02Nov2021 09:30, treatment received included oral Ibuprofen. Outcome of events was unknown. Seriousness criteria: Persistent /significant disability/ incapacity.   Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Psoriasis, Psoriatic arthropathy, Skin lesion
Clinical narrative: Psoriatic arthritis flare in hand and wrist; sores on fingers; Psoriasis in hair and ears; This is a solicited report from a Non-Interventional Study based on information received by Pfizer from AbbVie, MFR Control No: 21K-163-4140736-00. A non-contactable 53-year-old female consumer (patient) reported for herself that:  Solicited report from a consumer of an adult female with events of non-serious sores on fingers, psoriatic arthritis flare in hand and wrist and psoriasis in hair and ears with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced sores on fingers, psoriatic arthritis flare in hand and wrist and psoriasis in hair and ears. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 25Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 16Apr2021 patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer.  The reporter's causality for the event(s) of SORES ON FINGERS and PSORIATIC ARTHRITIS FLARE IN HAND AND WRIST with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of PSORIASIS IN HAIR AND EARS was not provided. The reporter's causality for all the events with PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The information provided is very limited to make a meaningful medical evaluation of the case. Patient's relevant medical history, diagnostic tests, treatment, event onset dates etc would have allowed better to assess the case. However, based on the current information available a possible contributory role of the suspect BNT162B2 for the reported events of Psoriatic arthritis aggravated, Skin lesion and Psoriasis cannot be completely excluded. The case will be reassessed further upon receipt of additional 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Condition aggravated
Clinical narrative: she had pfizer as a first dose, she had a relapse with her disease/autoimmune disease; she had pfizer as a first dose, she had a relapse with her disease/autoimmune disease; This is a spontaneous report from a contactable consumer (patient) based on information received by Pfizer, on behalf of Moderna (manufacturer control number: MOD21-162759). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history included autoimmune disease. Concomitant medications were not reported. The patient had autoimmune disease. She had Pfizer as a first dose, but two weeks after she had a relapse with her disease and landed in the ER. She said that she thinks this is related to the vaccine and that's why she chose Moderna as a second dose. The outcome was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Immunisation, Rheumatoid arthritis
Clinical narrative: dose 3 (booster); Rheumatoid arthritis flare up; Felt terrible; This is a solicited report received from a contactable consumer (patient) based on the information received by Pfizer from AbbVie Inc. (manufacturer control number: 21K-163-4141403-00).   A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), intramuscular on Sep2021 (at 60-year-old) as dose 3 (booster), single for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose and frequency for moderate to severe rheumatoid arthritis. Medical history included ongoing moderate to severe rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose and second dose, both via intra-muscular route on an unspecified date as single dose for COVID-19 Immunization. The patient experienced rheumatoid arthritis flare up (medically significant) on 2021, felt terrible on 2021. The action taken in response to the events for adalimumab was unknown. The outcome of the events was unknown.  Causality for BNT162B2: The reporter's causality for the event of felt terrible was possible, for event of rheumatoid arthritis flare up was not provided. Causality for HUMIRA (adalimumab): The reporter's causality for the events of felt terrible and rheumatoid arthritis flare up was not provided.  The reporter's assessment of the causal relationship of the event rheumatoid arthritis flare up with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected..; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and Immunization. Feeling abnormal,  Rheumatoid arthritis cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 17.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Crohn's disease, Vaccination site bruising, Vaccination site induration, Vaccination site mass
Clinical narrative: Crohns disease flare again; Injection site induration; Injection site bruising; Hard ball after HUMIRA injection and was black/blue; This is a solicited report from a non-interventional based on the information received by Pfizer from AbbVie manufacture number (21K-163-3903920-00). A contactable consumer (patient) reported that a 17-years-old female patient received bnt162b2 dose 1 intramuscular on 17Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 intramuscular on 30Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 Vaccination; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date.  Medical history included Crohn's disease flare from 2017 and ongoing. Concomitant medication(s) included mesalazine (LIALDA) taken for an unspecified indication, start and stop date were not reported.  The patient experienced crohns disease flare again (medically significant) in Apr2021 with outcome of not recovered, injection site induration in 2021 with outcome of recovered in 2021, injection site bruising in 2021 with outcome of recovered in 2021, hard ball after humira injection and was black/blue in 2021 with outcome of recovered in 2021.  The patient underwent lab tests and procedures which included blood test: unknown result on an unknown date.  The action taken in response to the event(s) for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of Hard ball after HUMIRA injection and was black/blue onset in 2021, Hard ball after HUMIRA injection and was black/blue onset in 2021 Crohn's disease flare again with HUMIRA(ADALIMUMAB) was a reasonable possibility.  The reporter's causality for the event(s) of crohns disease flare again, injection site induration and injection site bruising with bnt162b2 was possible.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2.  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.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain, Peripheral swelling
Clinical narrative: swelling underneath her armpit the same side she had the vaccine which is the right arm; swelling is the size of a large egg or small avocado and when she touches it, it's soft and it hurts; booster; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), third dose via an unspecified route of administration, administered in Arm Right on 09Nov2021 17:45 (at the age of 57 year) as DOSE 3 (BOOSTER DOSE), SINGLE for covid-19 immunization. The patient medical history and concomitant medications. Patient did not go Emergency Room or Physician Office. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration, administered on unspecified date as DOSE 2, SINGLE and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration, administered on unspecified date as DOSE 1, SINGLE both for covid-19 immunization. Patient did not took Prior Vaccinations (within 4 weeks). The patient had booster dose on 09Nov2021 and on 11Nov2021 patient experienced swelling underneath her armpit the same side she had the vaccine which is the right arm and swelling is the size of a large egg or small avocado and when she touches it, it's soft and it hurts. The outcome of the events was not recovered.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.