chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Thyroxine, Thyroxine free, Tri-iodothyronine, Ultrasound thyroid
Clinical narrative: thyrotoxicosis; Thyroiditis; Myalgia; Fatigue; Nausea; Chills; new progressive anterior neck pain and swelling; new progressive anterior neck pain and swelling; This is a literature report entitled Letter to the Editor: Thyroiditis and Thyrotoxicosis After the SARS-CoV-2 mRNA Vaccine. The full publication has been requested.   Rapid COVID-19 vaccine development and uptake are critical to mitigating the ongoing epidemic. Current vaccine candidates are at various stages of development and regulatory approval. These vaccines are broadly considered safe, though adverse effects have not yet been fully characterized. In this study we present the first description of thyroiditis linked to SARS-CoV-2 vaccination. A 57-year-old woman with no medical history received the first dose of the Pfizer-BioNTech SARS-CoV-2 vaccine 34 days before presentation, with associated fatigue, nausea, chills, and myalgias lasting 1.5 days. She received the second dose 13 days before presentation, and within 24 hours had recurrence of her symptoms associated with new progressive anterior neck pain and swelling. She was referred to the hospital by her outpatient provider for thyrotropin (TSH) 0.009 uU/mL, thyroxine (T4) free 2.6 ng/dL, and T4 total 17.4 mcg/dL (outpatient normal ranges [NRs] unavailable). On hospital arrival, she was febrile to 38.3 Centigrade with a pulse of 137 beats/min. Examination revealed right thyroid gland enlargement with diffuse tenderness, and no proptosis, lid lag, or periorbital edema. Laboratories showed TSH <0.008 uU/mL (NR: 0.4-4.2), free T4 1.92 ng/dL (NR: 0.8-1.5), triiodothyronine (T3) total 137 ng/dL (NR: 87-178) with thyrotropin receptor antibody <1.10 U/L (NR: 0-1.75), thyroid stimulating immunoglobulin <0.10 U/L (NR: 0-0.55), thyroid peroxidase antibody <0.5 U/mL (NR: 0-5.6), and thyroglobulin antibody 3.4 U/mL (NR: 0-4.1). Thyroid ultrasound showed an asymmetrically enlarged hypervascular heterogeneous right thyroid lobe suggestive of thyroiditis. She was treated with propranolol and ibuprofen and later started on prednisone as an outpatient.; Sender's Comments: Based on possible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported event, 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature abnormal, Chest pain, Fibrin D dimer increased, Heart rate increased
Clinical narrative: extreme sore throat; body on fire; flu symptoms; chest pain; heart rate was 140-150; D-Dimer was elevated/additional elevated D-Dimer (.69).; This is a spontaneous report from a contactable consumer. A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: fc3184), via an unspecified route of administration, administered in Arm Left on 10Sep2021 (Age at Vaccination 26-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation Pharmacy or Drug Store. Medical history included none and Concomitant medications were not reported. On 23Sep2021 15:00 the patient experienced extreme sore throat, body on fire, flu symptoms, chest pain, heart rate was 140-150 (heart rate increased), d-dimer was elevated/additional elevated d-dimer (.69). Therapeutic measures were taken as a result of extreme sore throat, body on fire, flu symptoms, chest pain, heart rate was 140-150, d-dimer was elevated/additional elevated d-dimer (.69) Patient received treatment for the event Liquid IV for one hour + Antibiotics. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination. The patient does not visit any healthcare professional or any emergency room. Device Date: 30Sep2021. The patient underwent lab tests and procedures which included blood test: additional elevated d-dimer he tested negative 2X , sars-cov-2 Nasal Swab antibody test negative: negative on unspecified date. The clinical outcome of the event was not recovered.  No follow-up attempts are possible; No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Oropharyngeal pain, SARS-CoV-2 antibody test negative
Clinical narrative: extreme sore throat; body on fire; flu symptoms; chest pain; heart rate was 140-150; D-Dimer was elevated/additional elevated D-Dimer (.69).; This is a spontaneous report from a contactable consumer. A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: fc3184), via an unspecified route of administration, administered in Arm Left on 10Sep2021 (Age at Vaccination 26-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation Pharmacy or Drug Store. Medical history included none and Concomitant medications were not reported. On 23Sep2021 15:00 the patient experienced extreme sore throat, body on fire, flu symptoms, chest pain, heart rate was 140-150 (heart rate increased), d-dimer was elevated/additional elevated d-dimer (.69). Therapeutic measures were taken as a result of extreme sore throat, body on fire, flu symptoms, chest pain, heart rate was 140-150, d-dimer was elevated/additional elevated d-dimer (.69) Patient received treatment for the event Liquid IV for one hour + Antibiotics. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination. The patient does not visit any healthcare professional or any emergency room. Device Date: 30Sep2021. The patient underwent lab tests and procedures which included blood test: additional elevated d-dimer he tested negative 2X , sars-cov-2 Nasal Swab antibody test negative: negative on unspecified date. The clinical outcome of the event was not recovered.  No follow-up attempts are possible; No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Depression, Feeling abnormal, Panic attack, Stress
Clinical narrative: had weird suicidal thoughts; panic attack; brain fog; depression; anxiety; stress; This is a spontaneous report from a contactable consumer (patient). This 27-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FF2589) via an unspecified route of administration in the left arm on 20Sep2021 at 07:00 PM at age of 27 years old as single dose for COVID-19 immunization. Medical history was none. The patient had no Covid prior vaccination, no Covid tested post vaccination, no known allergies. Concomitant medications were unknown. No other vaccine in four weeks. The patient received the first Pfizer Vaccine dose on Monday, Three days later he experienced a panic attack. The patient had  never had any anxiety or panic attacks before. He experienced 4 more attacks the next day. He had had brain fog ever since 23Sep2021 (7 days). He had had weird suicidal thoughts. Again, he had never experienced depression or anxiety before. He had read blogs of others having the same side effects from this vaccine. Adverse event start date and time were reported as 23Sep2021 07:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received. The patient was treated for stress with Hydroxyzine. Outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Suicidal ideation
Clinical narrative: had weird suicidal thoughts; panic attack; brain fog; depression; anxiety; stress; This is a spontaneous report from a contactable consumer (patient). This 27-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FF2589) via an unspecified route of administration in the left arm on 20Sep2021 at 07:00 PM at age of 27 years old as single dose for COVID-19 immunization. Medical history was none. The patient had no Covid prior vaccination, no Covid tested post vaccination, no known allergies. Concomitant medications were unknown. No other vaccine in four weeks. The patient received the first Pfizer Vaccine dose on Monday, Three days later he experienced a panic attack. The patient had  never had any anxiety or panic attacks before. He experienced 4 more attacks the next day. He had had brain fog ever since 23Sep2021 (7 days). He had had weird suicidal thoughts. Again, he had never experienced depression or anxiety before. He had read blogs of others having the same side effects from this vaccine. Adverse event start date and time were reported as 23Sep2021 07:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received. The patient was treated for stress with Hydroxyzine. Outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pruritus
Clinical narrative: entire body rash; itching; Chills; Nausea; Severe Headache; Fever 99.7; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 301308A), via an unspecified route of administration in left arm on 28Sep2021 at 09:45 (at the age of 69-years-old) at dose 3 (booster), single for COVID-19 immunization. Medical history included penicillin allergy. He has no COVID prior to vaccination. Concomitant medications included vitamin B complex, ubidecarenone (COQ 10), omeprazole (PRILOSEC), fish oil, and ascorbic acid (VITAMIN C). The patient previously took aspirin and TYLENOL and experienced allergies. He also previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at dose 1, single and via an unspecified route of administration on an unspecified date at dose 2, single for COVID-19 immunization. Vaccination facility type was reported as pharmacy/ drug store. The patient was not tested for COVID post vaccination. On 28Sep2021 at 21:45, 12 hours after the booster dose, the patient experienced fever at 99.7 that lasted for 15 hours. He also experienced chills, nausea, and severe headache on 28Sep2021 at 22:00. On 29Sep2021 at 21:45, 36 hours after the shot, the patient experienced rash on his entire body and itching. He did not receive any treatment in response to the events. The outcome of the event "fever 99.7" was recovered on 29Sep2021 at 12:45 and recovering for all other events.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: entire body rash; itching; Chills; Nausea; Severe Headache; Fever 99.7; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 301308A), via an unspecified route of administration in left arm on 28Sep2021 at 09:45 (at the age of 69-years-old) at dose 3 (booster), single for COVID-19 immunization. Medical history included penicillin allergy. He has no COVID prior to vaccination. Concomitant medications included vitamin B complex, ubidecarenone (COQ 10), omeprazole (PRILOSEC), fish oil, and ascorbic acid (VITAMIN C). The patient previously took aspirin and TYLENOL and experienced allergies. He also previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at dose 1, single and via an unspecified route of administration on an unspecified date at dose 2, single for COVID-19 immunization. Vaccination facility type was reported as pharmacy/ drug store. The patient was not tested for COVID post vaccination. On 28Sep2021 at 21:45, 12 hours after the booster dose, the patient experienced fever at 99.7 that lasted for 15 hours. He also experienced chills, nausea, and severe headache on 28Sep2021 at 22:00. On 29Sep2021 at 21:45, 36 hours after the shot, the patient experienced rash on his entire body and itching. He did not receive any treatment in response to the events. The outcome of the event "fever 99.7" was recovered on 29Sep2021 at 12:45 and recovering for all other events.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: episode of bell's palsy; This is a spontaneous case received from a contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date, as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Bell's palsy. The patient reported that her vaccine doses were finished in Jan2021 and after that was the first episode of Bell's palsy. She had a second episode in less than 7 months in August. The clinical outcome of the event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101295584 Same reporter/vaccine/event, different patient/COI
Sex: F
Vaccine: COVID19
Symptoms: Dysuria, Fatigue, Feeling abnormal, Insomnia, Investigation
Clinical narrative: fatigue; have some weirdness; had trouble sleeping.; vagina is doing "spasms"; urinate I also have a little bit of poop.; This is a spontaneous report from a contactable consumer (patient). This 69-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Feb2021 (Batch/Lot Number: EL9767) as dose 1, single for covid-19 immunisation. Our family physician, dermatologist, gynecologist, and vulva specialist have all diagnosed this as lichen planus or a variation thereof. Here is thread with DR. 01Feb2021. Medical history included left leg muscle issues at night and Known allergies: penicillin. COVID prior vaccination. Concomitant medications included Lisinopril taken from 2011 (reported as for 10 Years). No other vaccine in four weeks. Labs of the patient look good. All normal but don't have COVID-19 antibodies for some reason. We'll assume your fatigue is from COVID-19 so give it some time and keep me updated. (No symptoms as of this date). The patient had some weirdness going on and have had trouble sleeping. vagina is doing "spasms" for hours on end, keeping the patient awake at night and driving crazy during the day. It has come and gone over the past 3 weeks but has been here for the past 2 days. The other odd thing is that every time the patient urinate the patient also have a little bit of poop. Like 4 times a day. Adverse events start date was 18Feb2021. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No COVID tested post vaccination. Ae treatment: 4 physicians 16 medications. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal disorder
Clinical narrative: fatigue; have some weirdness; had trouble sleeping.; vagina is doing "spasms"; urinate I also have a little bit of poop.; This is a spontaneous report from a contactable consumer (patient). This 69-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Feb2021 (Batch/Lot Number: EL9767) as dose 1, single for covid-19 immunisation. Our family physician, dermatologist, gynecologist, and vulva specialist have all diagnosed this as lichen planus or a variation thereof. Here is thread with DR. 01Feb2021. Medical history included left leg muscle issues at night and Known allergies: penicillin. COVID prior vaccination. Concomitant medications included Lisinopril taken from 2011 (reported as for 10 Years). No other vaccine in four weeks. Labs of the patient look good. All normal but don't have COVID-19 antibodies for some reason. We'll assume your fatigue is from COVID-19 so give it some time and keep me updated. (No symptoms as of this date). The patient had some weirdness going on and have had trouble sleeping. vagina is doing "spasms" for hours on end, keeping the patient awake at night and driving crazy during the day. It has come and gone over the past 3 weeks but has been here for the past 2 days. The other odd thing is that every time the patient urinate the patient also have a little bit of poop. Like 4 times a day. Adverse events start date was 18Feb2021. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No COVID tested post vaccination. Ae treatment: 4 physicians 16 medications. Outcome of the events was not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a solicited report from a contactable consumer (patient) based on information received by Pfizer from (Control No: 21K-163-4088938-00). A 38-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 intramuscular on 15May2021 (at the age of 38-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 intramuscular on 20Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. HUMIRA, subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced covid-19 (Drug ineffective) (medically significant) on an unspecified date in Sep2021 with. The action taken in response to the events for HUMIRA was unknown. Outcome of events was unknown. The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was reported as possible and causality of events with HUMIRA was not provided.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug Ineffective and Suspected COVID-19 and the suspect drug bnt162b2 .
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate, Investigation, Tachycardia
Clinical narrative: SOB; chest pain; vomited; tachycardia/ 49 point increase in heart rate; This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 23Sep2021 (at the age of 15 years old) (Lot Number: FC3180) as dose 1, single for covid-19 immunisation. Medical history included autism, visceral hyperalgesia, and Tourette's syndrome from an unknown date and unknown if ongoing. Concomitant medications included guanfacine hydrochloride (TENEX); lamotrigine (LAMICTAL); magnesium; and sertraline hydrochloride (ZOLOFT); Probiotic; and Vitamins; all were taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient previously took OMNICEF [cefdinir] and experienced drug hypersensitivity and flu vaccine VII and experienced allergy to vaccine. The patient experienced SOB, chest pain, vomited, and tachycardia/ 49 point increase in heart rate on 24Sep2021. SOB and chest pain getting out of shower 24Sep, then vomited. Woke with chest pain two nights in a row (morning of 27Sep, 28Sep), worsening. Normal EKG and lab work, but advised to push fluids and check pulse. Noticed tachycardia on standing. 49 point increase in heart rate from laying down to standing. Patient took betablocker (Propanolol) for his treatment received. The events resulted in doctor or other healthcare professional office/clinic visit. Patient did not have Covid prior vaccination and was not Covid tested post vaccination. The patient underwent lab tests and procedures which included electrocardiogram: normal in Sep2021, heart rate: 49 point increase on 24Sep2021, lab work: normal in Sep2021. Treatment was received for the events included PRN Medication. The outcome of the events was not recovered.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: SOB; chest pain; vomited; tachycardia/ 49 point increase in heart rate; This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 23Sep2021 (at the age of 15 years old) (Lot Number: FC3180) as dose 1, single for covid-19 immunisation. Medical history included autism, visceral hyperalgesia, and Tourette's syndrome from an unknown date and unknown if ongoing. Concomitant medications included guanfacine hydrochloride (TENEX); lamotrigine (LAMICTAL); magnesium; and sertraline hydrochloride (ZOLOFT); Probiotic; and Vitamins; all were taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient previously took OMNICEF [cefdinir] and experienced drug hypersensitivity and flu vaccine VII and experienced allergy to vaccine. The patient experienced SOB, chest pain, vomited, and tachycardia/ 49 point increase in heart rate on 24Sep2021. SOB and chest pain getting out of shower 24Sep, then vomited. Woke with chest pain two nights in a row (morning of 27Sep, 28Sep), worsening. Normal EKG and lab work, but advised to push fluids and check pulse. Noticed tachycardia on standing. 49 point increase in heart rate from laying down to standing. Patient took betablocker (Propanolol) for his treatment received. The events resulted in doctor or other healthcare professional office/clinic visit. Patient did not have Covid prior vaccination and was not Covid tested post vaccination. The patient underwent lab tests and procedures which included electrocardiogram: normal in Sep2021, heart rate: 49 point increase on 24Sep2021, lab work: normal in Sep2021. Treatment was received for the events included PRN Medication. The outcome of the events was not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Drug ineffective, Stress, Suspected COVID-19
Clinical narrative: Covid-19; COVID-19; Stress; Colitis ulcerative aggravated/ulcerative colitis flare ups; This is a solicited report based on information received by Pfizer (Manufacturer Control Number 21K-163-3988258-00). A contactable consumer (patient) reported that a 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular at age of 63 years on 08Apr2021 (Batch/Lot number was not reported) as single dose, dose 1 intramuscular on 11Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose for Moderate to Severe ulcerative Colitis.  Medical history was not reported. No Known Allergies. Concomitant medications were none. On unknown dates, the patient experienced Humira Completely Stopped Working, Covid-19 and Stressed. In 2021, the patient experienced ulcerative colitis flare ups/ colitis ulcerative aggravated. The events reported as non-serious and treated with prednisone. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality as per reporter for colitis ulcerative aggravated with bnt162b2 was possible. The action taken in response to the events for adalimumab was permanently withdrawn on an unspecified date (as reported). The outcome of event colitis ulcerative aggravated was recovering, other events was unknown.  The reporter's assessment of the causal relationship of the events (except  Colitis ulcerative aggravated) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the currently available information the possibility of causal association between the events colitis ulcerative aggravated, stressed and the suspect drug BNT162B2  cannot be ruled out. The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood uric acid, Blood uric acid increased, Inflammation, Lymphadenopathy, Mass
Clinical narrative: lump in neck around clavicle, soft around it but inside, something does feel hard, the lymph node; lump in neck around clavicle, soft around it but inside, something does feel hard, the lymph node; lump in her neck, around the clavicle. It is tender to the touch and the inside feels soft around the whole big thing; She thinks it is probably a lymph node she is feeling inside. It is probably inflamed around it.; elevated uric acid; This is a spontaneous report from a contactable nurse (patient). A 65-years-old female patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 341458A, Expiration date not reported), via an unspecified route of administration, in left arm on 27Sep2021 14:45 (at the age of 65) as dose 3 (booster), single for COVID-19 immunization. Medical history included arthritis, was on supplement and had eye disorder, all from an unknown date and unknown if ongoing. Patient had no family history. Patient previously took flu shot and shingles shot, experienced body aches and low grade fever. Patient previously received first dose of bnt162b2 (Lot number: EJ1685) via an unspecified route of administration, administered in left arm on 22Dec2020 as dose 1, single, and second dose bnt162b2 (Lot number: EL1283) via an unspecified route of administration on 12Jan2021 as dose 2, single, both for COVID-19 immunization and experienced did not have a problem with the other 2 doses (dose 1 and dose 2). No prior vaccinations within 4 weeks and no additional vaccines administered on same date of the Pfizer suspect. Concomitant medication included ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS, once daily) taken for supplementation therapy, eye disorder, start and stop date were not reported; colecalciferol (D3, once daily) taken for supplementation therapy from an unspecified start date and ongoing; curcuma longa (TURMERIC [CURCUMA LONGA], once daily) taken for supplementation therapy, start and stop date were not reported (all taken for a couple of years). On 29Sep2021, in the afternoon, the patient experienced lump in neck around clavicle, soft around it but inside, something does feel hard, the lymph node. She thought it was probably a lymph node she is feeling inside. It was probably inflamed around it. It was reported that, the lump was tender to the touch and the inside feels soft around the whole big thing. She did not think it is anything to worry about. She had no fever, and no shortness of breath. She did put a little ice on it for about 2 minutes. On an unknown date in 2021, patient experienced elevated uric acid. Events did not require a visit to Emergency Room and Physician Office. The patient underwent lab tests and procedures which included blood uric acid: elevated on an unknown date in 2021. The outcome of elevated uric acid was unknown, and the other events were not recovered.   Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: lump in neck around clavicle, soft around it but inside, something does feel hard, the lymph node; lump in neck around clavicle, soft around it but inside, something does feel hard, the lymph node; lump in her neck, around the clavicle. It is tender to the touch and the inside feels soft around the whole big thing; She thinks it is probably a lymph node she is feeling inside. It is probably inflamed around it.; elevated uric acid; This is a spontaneous report from a contactable nurse (patient). A 65-years-old female patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 341458A, Expiration date not reported), via an unspecified route of administration, in left arm on 27Sep2021 14:45 (at the age of 65) as dose 3 (booster), single for COVID-19 immunization. Medical history included arthritis, was on supplement and had eye disorder, all from an unknown date and unknown if ongoing. Patient had no family history. Patient previously took flu shot and shingles shot, experienced body aches and low grade fever. Patient previously received first dose of bnt162b2 (Lot number: EJ1685) via an unspecified route of administration, administered in left arm on 22Dec2020 as dose 1, single, and second dose bnt162b2 (Lot number: EL1283) via an unspecified route of administration on 12Jan2021 as dose 2, single, both for COVID-19 immunization and experienced did not have a problem with the other 2 doses (dose 1 and dose 2). No prior vaccinations within 4 weeks and no additional vaccines administered on same date of the Pfizer suspect. Concomitant medication included ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS, once daily) taken for supplementation therapy, eye disorder, start and stop date were not reported; colecalciferol (D3, once daily) taken for supplementation therapy from an unspecified start date and ongoing; curcuma longa (TURMERIC [CURCUMA LONGA], once daily) taken for supplementation therapy, start and stop date were not reported (all taken for a couple of years). On 29Sep2021, in the afternoon, the patient experienced lump in neck around clavicle, soft around it but inside, something does feel hard, the lymph node. She thought it was probably a lymph node she is feeling inside. It was probably inflamed around it. It was reported that, the lump was tender to the touch and the inside feels soft around the whole big thing. She did not think it is anything to worry about. She had no fever, and no shortness of breath. She did put a little ice on it for about 2 minutes. On an unknown date in 2021, patient experienced elevated uric acid. Events did not require a visit to Emergency Room and Physician Office. The patient underwent lab tests and procedures which included blood uric acid: elevated on an unknown date in 2021. The outcome of elevated uric acid was unknown, and the other events were not recovered.   Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Pain in extremity
Clinical narrative: anaphylactic reaction; sore arm; This is a spontaneous report from a contactable consumer. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 13Jun2021 (Lot Number: EW0217) at age of 61 years old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma and arthritis and she take medication for both. She took inhaler for her arthritis. The patient took a flu shot every year but she did not take it this year. She is worried about the Flu vaccine now. She never had any bad reaction to the flu vaccine but only this one. After the first shot when the patient initially got the shot there was just normal reaction like sore arm and all that but nothing traumatic. Twelve hours later she experienced anaphylactic reaction and all those things described is what happened to her consumer thought she was dead. The patient had the anaphylactic reaction which sent her to the hospital for five days. The patient took the second shot of the Pfizer and she had the anaphylactic reaction to it really severely. She had exactly all the symptoms like fainting she had the fainting she fainted she passed out actually and she had a tongue swell. She had mental confusion. She had really bad breathing and she had impaired voice and her eyes rolled back in her head and she had a feeling of doom. The consumer had call the EMS and she was totally unaware what was going on for about two hours. Then she was in ambulance and then she came to and she was in hospital for five days and what they did they just said that her oxygen count was low and that was major come to the hospital at that time and then just right under three months she had the very same thing happened to her again. She was in the bathroom and she just passed out dead on the floor and she had all the symptoms you know the fast heart rate, tongue swelling, the eyes falling back into the head, mental confusion not aware what was going around did not know consumer was there didn't know EMS was there, breathing bad, feeling sub doom eyes falling back in her head, and impaired voice. She went to the hospital this time they said that she had a bacterial infection, and then they just gave her some antibiotics and send her home. She almost died twice from the shot. The first time they didn't gave her anything for treatment. The outcome was unknown.   Follow-Up (04Oct2021) attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injected limb mobility decreased, Pain, Pain in extremity, Sensory loss
Clinical narrative: pain; whole elbow pain; whole right arm had pain; losing sensation; I have lost use of my right arm where I was injected; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration in Arm Right on 15Mar2021 (at the age of 64-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history and concomitant medications reported as unspecified. The patient stated she was having very difficult time in understanding you, is there somebody that, she can be able to speak with, she didn't need medical guidance, she needed to speak with someone regarding Pfizer vaccine side effect that she had, since she received Pfizer Covid19 vaccine. She had no questions, she needed to report side effect (very bad side effects) that she has already been diagnose by three doctors. Patient added she was not comfortable, it was that they were not able to communicate because she cannot understand what you are saying, so she needed anybody else to speak with. Patient stated she was not at this time although she received a Norfloxacin because of the pain for the side effect that she had, no, she just had whole elbow pain, her whole right arm had pain, she was losing sensation, it was very detailed and very, patient did not know how to describe it to you but basically she had lost use of her right arm (confirmed as anatomical site of administration), where she was injected. Start date of adverse events was 19Mar2021. Patient stated that she did not need for help unless she spoke with someone that can help her with the side effects and help in find that what she was able to deal with her right arm since the vaccine. Outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Back pain, Chills, Dry mouth
Clinical narrative: vision got a little fuzzy; heart started racing really fast; breathing fast; anxiety; metallic taste in my mouth; tongue felt a little funny; tired; severe dry mouth; soreness/pain in my joints; soreness/pain in fingers; soreness/pain in neck; soreness/pain in back; soreness/pain in whole body; feeling chilly; inflammation; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 29Sep2021 (at the of 44 years old) (Batch/Lot Number: Ff8841) as dose 1, single for covid-19 immunisation. Medical history included neutropenia, plaquepsoriasis, and endometriosis from an unknown date and unknown if ongoing, covid-19 from Feb2021 to an unknown date. The patient was not pregnant at time of vaccination. Concomitant medication included multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced vision got a little fuzzy, heart started racing really fast, breathing fast, anxiety, metallic taste in mouth, tongue felt a little funny, tired, severe dry mouth, soreness/pain in joints, soreness/pain in joints, fingers, neck, back, whole body, feeling chilly, and inflammation on 29Sep2021. Within mins of dose, patient's vision got a little fuzzy but quickly resolved and heart started racing really fast. She was also breathing fast. About 5-10 mins it got better. She was not sure if it was anxiety or related to the medication. She was calm during injection so it was strange this happened. She also had a metallic taste in her mouth and her tongue felt a little funny. She was tired for the rest of the day. Overnight she woke up with severe dry mouth which has never happened to her. She soreness/pain in her joints, her fingers, neck, back, her whole body. She was feeling chilly but no fever as of now. She had Covid in Feb2021 and felt the same inflammation, pain/soreness in her body but not as severe. Since the vaccination, the patient has not yet been tested for COVID-19. The events were reported as non-serious. No treatment was received for the events. The outcome of a little fuzzy, heart started racing really fast, breathing fast, and anxiety was recovered in Sep2021 while the rest of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Inflammation, Neck pain, Pain
Clinical narrative: vision got a little fuzzy; heart started racing really fast; breathing fast; anxiety; metallic taste in my mouth; tongue felt a little funny; tired; severe dry mouth; soreness/pain in my joints; soreness/pain in fingers; soreness/pain in neck; soreness/pain in back; soreness/pain in whole body; feeling chilly; inflammation; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 29Sep2021 (at the of 44 years old) (Batch/Lot Number: Ff8841) as dose 1, single for covid-19 immunisation. Medical history included neutropenia, plaquepsoriasis, and endometriosis from an unknown date and unknown if ongoing, covid-19 from Feb2021 to an unknown date. The patient was not pregnant at time of vaccination. Concomitant medication included multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced vision got a little fuzzy, heart started racing really fast, breathing fast, anxiety, metallic taste in mouth, tongue felt a little funny, tired, severe dry mouth, soreness/pain in joints, soreness/pain in joints, fingers, neck, back, whole body, feeling chilly, and inflammation on 29Sep2021. Within mins of dose, patient's vision got a little fuzzy but quickly resolved and heart started racing really fast. She was also breathing fast. About 5-10 mins it got better. She was not sure if it was anxiety or related to the medication. She was calm during injection so it was strange this happened. She also had a metallic taste in her mouth and her tongue felt a little funny. She was tired for the rest of the day. Overnight she woke up with severe dry mouth which has never happened to her. She soreness/pain in her joints, her fingers, neck, back, her whole body. She was feeling chilly but no fever as of now. She had Covid in Feb2021 and felt the same inflammation, pain/soreness in her body but not as severe. Since the vaccination, the patient has not yet been tested for COVID-19. The events were reported as non-serious. No treatment was received for the events. The outcome of a little fuzzy, heart started racing really fast, breathing fast, and anxiety was recovered in Sep2021 while the rest of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Respiratory rate increased, Tongue discomfort, Vision blurred
Clinical narrative: vision got a little fuzzy; heart started racing really fast; breathing fast; anxiety; metallic taste in my mouth; tongue felt a little funny; tired; severe dry mouth; soreness/pain in my joints; soreness/pain in fingers; soreness/pain in neck; soreness/pain in back; soreness/pain in whole body; feeling chilly; inflammation; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 29Sep2021 (at the of 44 years old) (Batch/Lot Number: Ff8841) as dose 1, single for covid-19 immunisation. Medical history included neutropenia, plaquepsoriasis, and endometriosis from an unknown date and unknown if ongoing, covid-19 from Feb2021 to an unknown date. The patient was not pregnant at time of vaccination. Concomitant medication included multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced vision got a little fuzzy, heart started racing really fast, breathing fast, anxiety, metallic taste in mouth, tongue felt a little funny, tired, severe dry mouth, soreness/pain in joints, soreness/pain in joints, fingers, neck, back, whole body, feeling chilly, and inflammation on 29Sep2021. Within mins of dose, patient's vision got a little fuzzy but quickly resolved and heart started racing really fast. She was also breathing fast. About 5-10 mins it got better. She was not sure if it was anxiety or related to the medication. She was calm during injection so it was strange this happened. She also had a metallic taste in her mouth and her tongue felt a little funny. She was tired for the rest of the day. Overnight she woke up with severe dry mouth which has never happened to her. She soreness/pain in her joints, her fingers, neck, back, her whole body. She was feeling chilly but no fever as of now. She had Covid in Feb2021 and felt the same inflammation, pain/soreness in her body but not as severe. Since the vaccination, the patient has not yet been tested for COVID-19. The events were reported as non-serious. No treatment was received for the events. The outcome of a little fuzzy, heart started racing really fast, breathing fast, and anxiety was recovered in Sep2021 while the rest of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: received two doses of the Pfizer COVID vaccine and ended up getting COVID; received two doses of the Pfizer COVID vaccine and ended up getting COVID; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, and first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included immunocompromised, arthritic condition. The patient's concomitant medications were not reported. Consumer mentioned her friend who was immunocompromised had received two doses of the Pfizer COVID vaccine and ended up getting COVID. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Had the delta-variant; Had the delta-variant; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for three patients. This is the second of three reports. A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in left arm on 05Feb2021 (at the age of 76-year-old, Lot number: EL9269) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 26Feb2021 (Lot number: EL9266) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included ongoing diabetic. Prior vaccinations (within 4 weeks) and additional vaccines administered on same date of the Pfizer suspect were none. Concomitant medication included ongoing metformin for diabetic. The patient had the delta-variant in Sep2021. Patient had both doses of the Pfizer-Covid 19 Vaccine. However, he had the delta-variant. He had the same symptoms as the reporting consumer 2-3 days after she did. The reporting consumer explained she started to have covid symptoms on 08Sep2021. She had a stuffy nose, stuffy ears, slight fever, drainage, and sore throat. At first she thought it was just sinus issues, but her covid test had come back positive. She had tiredness, loose stools, headache, stuffiness, stuffiness in nose and ears really bad. She was assuming she had the delta variant. She explained her husband, the patient, had these same symptoms. Patient started to experience these events 2-3 days after she did. Events did not require a visit to emergency room or physician office, but had a tele-medicine appointment. Lab data included Covid test was positive in Sep2021. Outcome of events was unknown. This report was assessed by the reporting consumer as non-serious.   Follow-up attempts are completed. No further information is expected. Linked Report(s): US-PFIZER INC-202101294617 same reporter/drug/AE, different patient; US-PFIZER INC-202101299154 same reporter/drug/AE, different patient.