chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Prothrombin time, Total cholesterol/HDL ratio, Troponin, Ultrasound scan, Vision blurred
Clinical narrative: right vision got more blurry; stroke on the left side of brain; felt weird; tongue started to go numb; Right side of face went numb; Headache; CBCT scan found nothing but calcification; overall cholesterol was 221; LDL was 124; triglyceride was 156; This is a spontaneous report from a contactable consumer (patient). A 57-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 09Apr2021 (lot number: EW0162), as 1st dose, single dose, at age 57 years old, for COVID-19 immunisation. Medical history included asthma, arthritis, environmental allergies, and allergy to grass ragweed, mold, tree pollen which triggers the asthma. Concomitant medications included celecoxib (CELEBREX) taken for arthritis from an unspecified date and ongoing; nicotinamide (VITAMIN B3); vitamin C; and vitamin b complex, taken for unspecified indications, start and stop dates were not reported. On 19Apr2021, between 19:30 to 20:00, the patient had a stroke on the left side of brain. It was also reported that on an unspecified date in Apr2021, the patient felt weird, tongue started to go numb, right side of face went numb, right vision got more blurry, and had headache. These events resulted to hospitalization on 20Apr2021 for 2 and a half days (as reported). In Apr2021, when the patient was in the hospital, laboratory tests were performed which included activated partial thromboplastin time (APTT), blood thyroid stimulating hormone (TSH), Hemoglobin A1C, lipid panel, basic metabolic panel, comprehensive metabolic panel, CBC platelet with automated differential, prothrombin INR, prothrombin time, i-STAT Troponin and Sonogram of carotid bilateral vascular in neck which were all normal; Triglycerides was 156, High density lipoprotein (HDL) was 53, Low density lipoprotein (LDL) was 124, Total cholesterol (overall cholesterol) was 221. On 10Apr2021, the patient underwent CBCT scan of the whole body which showed no aneurysm, no cancer, found nothing but calcification. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Malaise, Mouth injury
Clinical narrative: headache/sharp shooting pain on the left side of her head; feeling sensational on the left side of her face; mouth is being swelling; cuts on her cheeks and on her tongue; extremely tired; sick; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the right arm on 07May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in Apr2021 in the right arm for COVID-19 immunization. The patient called to know if there was any research about people having any adverse effects with the shot. The patient stated that she went to the emergency room and saw the doctor and was hospitalized since she had a very several headache which started on 10May2021, over 6 days that has not gone away with medication (unspecified medication). The patient also stated that she has taken a shot (unspecified) for the headache and it worked for a little bit of time and the headache came right back. The headache is almost so bad it's giving birth, it's terrible. The headache has not been letting her take care of her children so she wants to know if there are researches that could help her situation. This happened right after she took a shot and does not have a history of headache ever. She has always been very healthy and so she believes it is the shot that is causing her the problem. She has a sharp shooting pain on the left side of her head. She has feeling sensational on the left side of her face (as reported), her mouth is being swelling, has cuts on her cheeks and on her tongue from swallowing. The patient stated that overall she is extremely tired and a lot of bad things has been happening ever since she took the shot over a week ago and she has been sick the whole time. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling
Clinical narrative: headache/sharp shooting pain on the left side of her head; feeling sensational on the left side of her face; mouth is being swelling; cuts on her cheeks and on her tongue; extremely tired; sick; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the right arm on 07May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in Apr2021 in the right arm for COVID-19 immunization. The patient called to know if there was any research about people having any adverse effects with the shot. The patient stated that she went to the emergency room and saw the doctor and was hospitalized since she had a very several headache which started on 10May2021, over 6 days that has not gone away with medication (unspecified medication). The patient also stated that she has taken a shot (unspecified) for the headache and it worked for a little bit of time and the headache came right back. The headache is almost so bad it's giving birth, it's terrible. The headache has not been letting her take care of her children so she wants to know if there are researches that could help her situation. This happened right after she took a shot and does not have a history of headache ever. She has always been very healthy and so she believes it is the shot that is causing her the problem. She has a sharp shooting pain on the left side of her head. She has feeling sensational on the left side of her face (as reported), her mouth is being swelling, has cuts on her cheeks and on her tongue from swallowing. The patient stated that overall she is extremely tired and a lot of bad things has been happening ever since she took the shot over a week ago and she has been sick the whole time. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Herpes zoster oticus, Photosensitivity reaction
Clinical narrative: Ramsay Hunt syndrome triggered by sun light; Ramsay-Hunt syndrome; This is a solicited report based on the information received by Pfizer. A non-contactable consumer (patient) reported that a 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) intramuscular on Feb2021 as 1st dose, single for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous from an unspecified date and ongoing, at an unspecified dose and frequency for moderate to severe rheumatoid arthritis. Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. The patient experienced Ramsay-Hunt syndrome on 15Mar2021 and Ramsay Hunt syndrome triggered by sun light on 04Apr2021. The patient was treated with PREDNISONE. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for adalimumab was unknown. Outcome of the events was recovered in 2021. The reporter's causality for the events and adalimumab was not provided.   The reporter's assessment of the causal relationship of the event with the suspect drug 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.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Ramsay-Hunt syndrome and Photosensitivity reaction  due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Pain, Periorbital swelling
Clinical narrative: Eye lids were puffy; Slept for about 15 hours; Achy; This is a spontaneous report from a contactable consumer.   A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on right arm on 07May2021 16:30 (Batch/Lot number was not reported) as 2nd dose, single dose (at the age of 48 years old) for COVID-19 immunisation.  Medical history included ongoing migraine, seasonal outdoor allergies and COVID-19 from 26Feb2021. Concomitant medications included sumatriptan (SUMATRIPTAN) taken for migraine. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection),  dose 1, at 16:45 on the right arm on 15Apr2021 for COVID-19 immunisation The patient stated, "the next morning and couple days following, my eye lids were puffy. I took BENADRYL. 24 hours after the shot, I was achy and slept for about 15 hours. Overall, the 2nd dose reactions were better than having COVID". The outcome of the events was recovered on May2021.   Information on the lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, SARS-CoV-2 test
Clinical narrative: Rapid heart rate up to 163 bpm. 2.5 hours, unable to reduce. Required emergency pharmaceutical intervention.; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration in right arm on 09Mar2021 at 15:15 (at the age of 75-years-old) at unknown, single dose for COVID-19 immunization. Medical history included chronic lymphocytic leukaemia (CLL) and penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine and fluticasone propionate. The facility where the most recent COVID-19 vaccine was administered was reported as other. On 14May2021 at 09:00, the patient experienced rapid heart rate up to 163 bpm which has not reduced in 2.5 hours. The event required emergency pharmaceutical intervention with intravenous (IV) dialtiazem, diltiazem 120 mg, and ELIQUIS 5 mg 2x, doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included heart rate: rapid heart rate up to 163 bpm and nasal swab for COVID-19: pending result, both on 14May2021. The outcome of the event was not recovered. The event was reported as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive Covid test approximately 33 days after second shot; positive Covid test approximately 33 days after second shot; dose 1 administered on 09Mar2021; dose 2 administered on 09Mar2021; This is a spontaneous report from a contactable consumer (patient). An adult female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 09Mar2021 (lot number: EN6207), as 2nd dose, single dose; and via an unspecified route of administration, administered in the left arm, on 09Mar2021 13:30 (pending clarification) (lot number: EN6204), as 1st dose, single dose, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. There was no medical history, no known allergies. The patient's concomitant medications were not reported. On 05May2021 (also reported as "33 days after the second shot"), the patient tested positive in COVID test despite being fully vaccinated and mounting an "amine response" (as reported, pending clarification) after both shots, The patient was extremely ill for two weeks. The events resulted to physician's office visit and was treated with "Pquenil", azithromycin, dexamethasone and ivermectin. The patient underwent lab tests and procedures which included COVID-19 nasal swab: positive on 05May2021. The outcome of the events "positive Covid test approximately 33 days after second shot" and "mounting an amine response" was not recovered.  Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Internal haemorrhage
Clinical narrative: internal bleeding; This is a spontaneous report from a contactable consumer (patient's husband). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration in May2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date for COVID-19 Immunization. The patient's husband stated that both he and his wife received the second dose of the vaccine a week ago (May2021). His wife is currently in the hospital due to internal bleeding and has had to receive several blood transfusions. The patient's husband would like to know if the transfusion could have any effect on the efficacy of the vaccine. He also stated that his wife does have a chronic issue. The outcome of the event was unknown.   Information on the batch/lot number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Illness, Nervous system disorder
Clinical narrative: Extremely sick; Affected neurological; Increased pain in fibro; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the right arm on 21Apr2021 (10:30) as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included fibromyalgia; complex regional pain syndrome (CRPS); small fiber neuropathy; brain lesions; thrombocytopenia; chronic arthritis; nerve damage in elbows and hands; tree nut allergy; shellfish allergy; and allergy to lots of medications. The patient was not pregnant at the time of vaccination. Concomitant medication included lisdexamfetamine mesilate (VYVANSE). On 12May2021, the patient was extremely sick; affected neurological; and had increased pain in "fibro". The events had resulted into doctor or other healthcare professional office/clinical visit. The patient had received prednisone, diphenhydramine (BENADRYL) and epinephrine as treatment for the events. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: bleeding; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received bnt162b2 (BNT162B2), first dose on 16Apr2021 (lot no.: ER8735) and second dose administered in left arm on 07May2021 14:00 (Lot Number: EW0167); at the age 44-year-old both via an unspecified route of administration single dose for COVID-19 immunization. Medical history included Diabetes type 2. Concomitant medications included metformin; sitagliptin (JANUVIA); and multivitamins. The patient previously took acetylsalicylic (ASPIRIN) and experienced allergy. On 18Apr2021 at 12:00, the patient started bleeding 2 days after the first dose but did not think anything of it because she was due to start her period. After her period ended, she continued spotting for 3 weeks some days more than others. She received her 2nd dose on 07May2021 and started bleeding again like a period. And it has not stop as of today (16May2021). There was no treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable healthcare professional (patient). A 71-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm in 2021 (Lot Number: EN6200) as 2nd dose, single for covid-19 immunization, administered at the hospital. Medical history included high blood pressure, hypothyroid, and hypercholesterolemia. Historical vaccine included first dose of bnt162b2 on 05Feb2021 at 14:30 in the right arm (lot number EL9263) for covid-19 immunization. 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. The patient has not been tested for COVID-19 since the vaccination. Concomitant medications included hctz; levothyroxine; and rosuvastatin. The patient experienced shingles on 10May2021 at 13:00. The event resulted in emergency room/department or urgent care. The patient received treatment for the event which included valacyclovir 3 times a day, 1 gram per dose. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Drug ineffective, Dysstasia, Fall
Clinical narrative: patient covid test date was on 12May2021; patient covid test date was on 12May2021; Falling; weakness; unable to stand; malaise; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11May2021 13:45 (Batch/Lot Number: Ew0173) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Prostatectomies and high blood pressure both from an unknown date and unknown if ongoing. There was no other vaccine in four weeks. Concomitant medication included levetiracetam (KEPPRA) taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: ER8731), on 20Apr2021, 10:45 AM for covid-19 immunization. It was reported that the patient experienced Falling, weakness, unable to stand, malaise on 12May2021. The event resulted in Emergency room/department or urgent care, Hospitalization. Treatment includes: Oxygen, saline. It was reported that if covid prior vaccination :Yes; and if covid tested post vaccination :Yes. It was also reported that  the patient covid test date was on 12May2021 and with positive result. The reporter considered the event as serious (criteria: Caused/prolonged hospitalization). The outcome of the events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test
Clinical narrative: patient covid test date was on 12May2021; patient covid test date was on 12May2021; Falling; weakness; unable to stand; malaise; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11May2021 13:45 (Batch/Lot Number: Ew0173) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Prostatectomies and high blood pressure both from an unknown date and unknown if ongoing. There was no other vaccine in four weeks. Concomitant medication included levetiracetam (KEPPRA) taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: ER8731), on 20Apr2021, 10:45 AM for covid-19 immunization. It was reported that the patient experienced Falling, weakness, unable to stand, malaise on 12May2021. The event resulted in Emergency room/department or urgent care, Hospitalization. Treatment includes: Oxygen, saline. It was reported that if covid prior vaccination :Yes; and if covid tested post vaccination :Yes. It was also reported that  the patient covid test date was on 12May2021 and with positive result. The reporter considered the event as serious (criteria: Caused/prolonged hospitalization). The outcome of the events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Before the administration of Pfizer COVID vaccine it was diluted by one of the pharmacists on duty, however she did not dilute it with the correct amount of diluent. The proper dilution amount is 1.8 ml of diluent added to the vial, but it was discovered that the vial was only diluted with 0.8 ml. The error was discovered, after 3 doses had been administered. While determining the number of doses remaining in the vial it was discovered that only 1 more dose remained instead of 3. This was caused by too little diluent being added resulting in each vaccine dose to be A higher concentration than recommended.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Before the administration of Pfizer COVID vaccine it was diluted by one of the pharmacists on duty, however she did not dilute it with the correct amount of diluent. The proper dilution amount is 1.8 ml of diluent added to the vial, but it was discovered that the vial was only diluted with 0.8 ml. The error was discovered, after 3 doses had been administered. While determining the number of doses remaining in the vial it was discovered that only 1 more dose remained instead of 3. This was caused by too little diluent being added resulting in each vaccine dose to be higher concentration than  recommended.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Nodule, Pruritus, Swelling
Clinical narrative: Swelling/lump, redness, itching, and bruising in area still today. Thought I should report to note as a symptom for people with blood thinners as it?s been three weeks since my second dose, the bruise is still there, it?s light, but there. Bruising is a side effect of eliquis so could be enhanced by the vaccine
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: Pfizer-BioNT ech COVID-19 Vaccine EUA.  Rise in body temp from 94.3 to 99.6, than to 100.3.  Body temp returned to 98.3 after a couple of hours rest.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Skin lesion
Clinical narrative: Swollen, red lesion at injection sight. Lesion measuring about 2-3 inches in diameter.  Lesion painful to the touch but extremely itchy.  Lesion became noticeable about 2 days after injection. Lesion became itchy about 3 days after injection. Lesion beginning to disappear but itchiness remaining at injection sight even on day 6.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Computerised tomogram, Electrocardiogram
Clinical narrative: Sent heart into A-fibrillation
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Musculoskeletal stiffness, Pain, Pain in extremity, Paraesthesia
Clinical narrative: RA flare up on my left side of my body; I"m still in a lot of pain; I've had tingling in my hand and pain in my left breast; I've had tingling in my hand and pain in my left breast; sharp shooting pain in my arm that continued for an hour. Then my arm was very stiff and sore.; sharp shooting pain in my arm that continued for an hour. Then my arm was very stiff and sore.; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 05May2021 at 14:30 (at the age of 44-years-old) at 1st dose, single dose for COVID-19 immunization. Medical history included rheumatoid arthritis (RA), injuries, surgery, Celiac (dairy and gluten made her very sick), Hashimoto's, and ACL repair on left knee. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), liothyronine sodium (T3), and naltrexone. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as unknown. Since the vaccination, the patient has not been tested for COVID-19. Minutes after injection on 05May2021, the patient experienced a sharp shooting pain her arm that continued for an hour, then her arm was very stiff and sore. She then had an RA flare up on the left side of her body where she had several injuries and surgery on 06May2021. It's been over two weeks and she was still in a lot of pain, additionally, she had tingling in her hand and pain in her left breast, all of which started in 06May2021. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: RA flare up on my left side of my body; I"m still in a lot of pain; I've had tingling in my hand and pain in my left breast; I've had tingling in my hand and pain in my left breast; sharp shooting pain in my arm that continued for an hour. Then my arm was very stiff and sore.; sharp shooting pain in my arm that continued for an hour. Then my arm was very stiff and sore.; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 05May2021 at 14:30 (at the age of 44-years-old) at 1st dose, single dose for COVID-19 immunization. Medical history included rheumatoid arthritis (RA), injuries, surgery, Celiac (dairy and gluten made her very sick), Hashimoto's, and ACL repair on left knee. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), liothyronine sodium (T3), and naltrexone. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as unknown. Since the vaccination, the patient has not been tested for COVID-19. Minutes after injection on 05May2021, the patient experienced a sharp shooting pain her arm that continued for an hour, then her arm was very stiff and sore. She then had an RA flare up on the left side of her body where she had several injuries and surgery on 06May2021. It's been over two weeks and she was still in a lot of pain, additionally, she had tingling in her hand and pain in her left breast, all of which started in 06May2021. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Antiphospholipid syndrome, Blood immunoglobulin A, Heavy menstrual bleeding
Clinical narrative: Super Heavy Periods and Bloodwork to check for autoimmune disease showed positive results for APS IGA.; Super Heavy Periods and Bloodwork to check for autoimmune disease showed positive results for APS IGA.; This is a spontaneous report from a non-contactable consumer (patient). A 50-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 12:00 (at 50 years old, not pregnant) (Batch/Lot Number: ER8733) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. No concomitant medications. The patient had her first dose of bnt162b2 on 19Mar2021 12:00 (lot: En6206) on left arm for COVID-19 immunization at 50 years old. Patient experienced on 19Apr2021 12:00, Super Heavy Periods and Bloodwork to check for autoimmune disease showed positive results for APS IGA. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event resulted in visit to Doctor or other healthcare professional office/clinic. No treatment for the events. The outcome of the events was unknown. No covid prior vaccination. Not covid tested post vaccination. Device Date: 15May2021.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Cough, Dry mouth, Headache, Pain in extremity
Clinical narrative: I only slept 1 hour; My arm, head and back hurt.; My arm, head and back hurt.; My arm, head and back hurt.; Dry mouth; coughing; random thoughts; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 15May2021 12:00 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 15May2021 12:15, the patient only slept 1 hour, his arm, head and back hurt. Dry mouth, coughing, random thoughts. He felt like he was dying over here. Events were considered serious, disability. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Thinking abnormal
Clinical narrative: I only slept 1 hour; My arm, head and back hurt.; My arm, head and back hurt.; My arm, head and back hurt.; Dry mouth; coughing; random thoughts; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 15May2021 12:00 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 15May2021 12:15, the patient only slept 1 hour, his arm, head and back hurt. Dry mouth, coughing, random thoughts. He felt like he was dying over here. Events were considered serious, disability. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Streptococcus test, Tonsillar hypertrophy, Tonsillitis streptococcal
Clinical narrative: the strep test came back positive; his tonsils were very, very swollen; This is a spontaneous report from a contactable consumer (parent). An 18-year-old male patient received the first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 09Apr2021 (Lot Number: ER8737) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The consumer was reporting for their son. Their son is 18-years-old and received the Pfizer vaccine on 09Apr2021. On the next day (Confirmed as 10Apr2021), his tonsils were very, very swollen and by that evening. At about 2000H, it was so badly swollen, they took him to emergency care, and they did a strep test on him and the strep test came back positive. So, they prescribed him amoxicillin and finished the course of amoxicillin. Then on 07May2021, his tonsil was swollen again then he goes back to the doctor and they did another strep test but did not find strep and they gave him Methylprednisolone and Azithromycin. So, he just finished his last course yesterday (12May2021). He had his second Pfizer vaccine on 07May2021 and tonight he came home, his tonsils are swollen again, very swollen, almost touching, is this a reaction to the vaccine." Outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Angina pectoris, Arthralgia, Bone pain, Chest discomfort
Clinical narrative: heart pain; bone pain; muscle pain; heart palpitations; headache; joint pain lasting 3 weeks; severe dizziness; severe stomach pain; chest tightness 1 week; cough 1 week; exhaustion 1 week; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 at vaccination age of 34-year-old via an unspecified route of administration in the left arm on 24Apr2021 11:00 (Lot Number: ew0169) as 2nd dose, single for covid-19 immunisation. Medical history included JME (juvenile myoclonic epilepsy). The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 34-year-old on 03Apr2021 11:00 AM (lot number: ew0150) in the left arm for COVID-19 Immunisation. Concomitant medications included divalproex sodium (reported as Divalproex Sodium ER) taken for an unspecified indication, start and stop date were not reported. The patient previously took phenobarbital but experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a doctor's office/urgent care. On 24Apr2021 04:00 PM, the patient experienced bone pain, muscle pain, headache, heart palpitations, heart pain, joint pain lasting 3 weeks (May2021), severe dizziness, severe stomach pain, chest tightness 1 week (May2021), cough 1 week (May2021) and exhaustion 1 week (May2021). The adverse events resulted in an emergency room/department or urgent care and the patient received treatment for the adverse events which included medicine for stomach pain, instructions to wait. The patient has not been tested for Covid-19 since the vaccination. The outcome of the events chest tightness, cough, exhaustion and joint pain were recovered in May2021 with sequelae while the outcome of the other events was recovered on an unspecified date in 2021 with sequelae.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: heart pain; bone pain; muscle pain; heart palpitations; headache; joint pain lasting 3 weeks; severe dizziness; severe stomach pain; chest tightness 1 week; cough 1 week; exhaustion 1 week; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 at vaccination age of 34-year-old via an unspecified route of administration in the left arm on 24Apr2021 11:00 (Lot Number: ew0169) as 2nd dose, single for covid-19 immunisation. Medical history included JME (juvenile myoclonic epilepsy). The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 34-year-old on 03Apr2021 11:00 AM (lot number: ew0150) in the left arm for COVID-19 Immunisation. Concomitant medications included divalproex sodium (reported as Divalproex Sodium ER) taken for an unspecified indication, start and stop date were not reported. The patient previously took phenobarbital but experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a doctor's office/urgent care. On 24Apr2021 04:00 PM, the patient experienced bone pain, muscle pain, headache, heart palpitations, heart pain, joint pain lasting 3 weeks (May2021), severe dizziness, severe stomach pain, chest tightness 1 week (May2021), cough 1 week (May2021) and exhaustion 1 week (May2021). The adverse events resulted in an emergency room/department or urgent care and the patient received treatment for the adverse events which included medicine for stomach pain, instructions to wait. The patient has not been tested for Covid-19 since the vaccination. The outcome of the events chest tightness, cough, exhaustion and joint pain were recovered in May2021 with sequelae while the outcome of the other events was recovered on an unspecified date in 2021 with sequelae.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart pain; bone pain; muscle pain; heart palpitations; headache; joint pain lasting 3 weeks; severe dizziness; severe stomach pain; chest tightness 1 week; cough 1 week; exhaustion 1 week; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 at vaccination age of 34-year-old via an unspecified route of administration in the left arm on 24Apr2021 11:00 (Lot Number: ew0169) as 2nd dose, single for covid-19 immunisation. Medical history included JME (juvenile myoclonic epilepsy). The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 34-year-old on 03Apr2021 11:00 AM (lot number: ew0150) in the left arm for COVID-19 Immunisation. Concomitant medications included divalproex sodium (reported as Divalproex Sodium ER) taken for an unspecified indication, start and stop date were not reported. The patient previously took phenobarbital but experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a doctor's office/urgent care. On 24Apr2021 04:00 PM, the patient experienced bone pain, muscle pain, headache, heart palpitations, heart pain, joint pain lasting 3 weeks (May2021), severe dizziness, severe stomach pain, chest tightness 1 week (May2021), cough 1 week (May2021) and exhaustion 1 week (May2021). The adverse events resulted in an emergency room/department or urgent care and the patient received treatment for the adverse events which included medicine for stomach pain, instructions to wait. The patient has not been tested for Covid-19 since the vaccination. The outcome of the events chest tightness, cough, exhaustion and joint pain were recovered in May2021 with sequelae while the outcome of the other events was recovered on an unspecified date in 2021 with sequelae.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood test, Cardiac monitoring, Echocardiogram, Electrocardiogram
Clinical narrative: significantly increased heart rate; do not feel well; anxiety; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 12Mar2021 17:00 (Batch/Lot Number: EP6955) as 2nd dose, single dose for COVID-19 immunization. Patient received the first dose of bnt162b2 on 19Feb2021 17:00 (lot number: EN6200) in the left arm. Medical history included neurofibromatosis type 1. Concomitant medications included magnesium sulfate and unspecified multivitamin, multimineral, protein. 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. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Since 05Apr2021, the patient have had a significantly increased heart rate. Things seemed to be improving but patient still do not feel well. Patient went to the ER, a cardiologist, and her primary doctor. Patient underwent several tests: blood, EKG, echo, and heart monitor. All seemed to show no signs of any problems but patient still do not feel well. Something is wrong. Since they could not find anything wrong, the doctors were saying anxiety. AE resulted in: Doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment was received. Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021264467 same patient/drug, different event/dose
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Malaise
Clinical narrative: significantly increased heart rate; do not feel well; anxiety; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 12Mar2021 17:00 (Batch/Lot Number: EP6955) as 2nd dose, single dose for COVID-19 immunization. Patient received the first dose of bnt162b2 on 19Feb2021 17:00 (lot number: EN6200) in the left arm. Medical history included neurofibromatosis type 1. Concomitant medications included magnesium sulfate and unspecified multivitamin, multimineral, protein. 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. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Since 05Apr2021, the patient have had a significantly increased heart rate. Things seemed to be improving but patient still do not feel well. Patient went to the ER, a cardiologist, and her primary doctor. Patient underwent several tests: blood, EKG, echo, and heart monitor. All seemed to show no signs of any problems but patient still do not feel well. Something is wrong. Since they could not find anything wrong, the doctors were saying anxiety. AE resulted in: Doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment was received. Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021264467 same patient/drug, different event/dose
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Decreased appetite, Electrocardiogram, Laboratory test, Palpitations
Clinical narrative: significantly increased heart rate; do not feel well; anxiety; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 12Mar2021 17:00 (Batch/Lot Number: EP6955) as 2nd dose, single dose for COVID-19 immunization. Patient received the first dose of bnt162b2 on 19Feb2021 17:00 (lot number: EN6200) in the left arm. Medical history included neurofibromatosis type 1. Concomitant medications included magnesium sulfate and unspecified multivitamin, multimineral, protein. 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. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Since 05Apr2021, the patient have had a significantly increased heart rate. Things seemed to be improving but patient still do not feel well. Patient went to the ER, a cardiologist, and her primary doctor. Patient underwent several tests: blood, EKG, echo, and heart monitor. All seemed to show no signs of any problems but patient still do not feel well. Something is wrong. Since they could not find anything wrong, the doctors were saying anxiety. AE resulted in: Doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment was received. Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021264467 same patient/drug, different event/dose
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: significantly increased heart rate; do not feel well; anxiety; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 12Mar2021 17:00 (Batch/Lot Number: EP6955) as 2nd dose, single dose for COVID-19 immunization. Patient received the first dose of bnt162b2 on 19Feb2021 17:00 (lot number: EN6200) in the left arm. Medical history included neurofibromatosis type 1. Concomitant medications included magnesium sulfate and unspecified multivitamin, multimineral, protein. 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. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Since 05Apr2021, the patient have had a significantly increased heart rate. Things seemed to be improving but patient still do not feel well. Patient went to the ER, a cardiologist, and her primary doctor. Patient underwent several tests: blood, EKG, echo, and heart monitor. All seemed to show no signs of any problems but patient still do not feel well. Something is wrong. Since they could not find anything wrong, the doctors were saying anxiety. AE resulted in: Doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment was received. Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021264467 same patient/drug, different event/dose