chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Brain oedema, Fatigue, Feeling abnormal, Head discomfort, Pain in extremity
Clinical narrative: Brain swelling sensation/ like it was swelling again; Severe pressure in my head; Extreme fatigue for 4 days; Sore arm; It felt like I had just had the surgery again.This sensation tapered off over a month/ brain swelling sensation; This is a spontaneous report from a contactable consumer (patient). A 45-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 26Jan2021 09:15 (Lot Number: EL9261) (at the age of 45-years-old) as dose 1, single for covid-19 immunisation. Medical history included brain surgery, brain bleed and brain blood clotting throughout patient's brain in 2018, small stroke, sulfa allergy, gluten allergy and rice allergy. Concomitant medications within 2 weeks of vaccination included apixaban (ELIQUIS), baclofen and daily vitamin; all taken for an unspecified indication, start and stop date were not reported. The patient previously took Vicodin and Celebrex, and experienced allergy with both drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient stated that she was an early vaxer in January due to medical status. This first dose of the vaccine resulted in severe pressure in her head, like it was swelling again, it felt like she had just had the surgery again. This sensation tapered off over a month. She had extreme fatigue for 4 days and sore arm but those weren't a big deal. The onset of all the events was reported as 26Jan2021 21:15. The events did not cause hospitalization. The patient did not receive treatment for the events. It was the brain swelling sensation that resulted in her not getting the 2nd vaccine. The outcome of the events was recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.  Follow-Up (11Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy pain in right leg; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), second dose, via an unspecified route of administration on 24Sep2021 as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced neuropathy pain in right leg in Sep2021. The patient felt like (withheld), the patient had neuropathy pain in right leg; the patient's doctor thought it was a pseudo relapse that was coming from the patient's 2nd Pfizer COVID 19 Vaccination which was 4 days ago, the patient's doctor does not want to do anything because it might do something with the vaccination; he said for the patient to just wait. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate, Nausea, Oxygen consumption, Oxygen saturation decreased
Clinical narrative: Fever; chills; nausea-vomiting; nausea-vomiting; aches/pain; low oxygen level. 92; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration in the left arm, on 29Sep2021 13:00 (lot number: FF8839), at age 71 years old, as dose number unknown, single, for COVID-19 immunisation, at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. Relevant medical history included Graves' disease, high BP, and thyroid disease from unknown dates, not reported if ongoing or not. Concomitant medications included levothyroxine sodium, aloe barbadensis and vitamin b nos all taken for unknown indications, not reported if ongoing or not. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive any other vaccines in four weeks. The patient previously took erythromycin and had an allergy. On 29Sep2021 19:00, the patient experienced fever, chills, nausea, vomiting, aches/pain, and low oxygen level at 92. On the same day, the patient's heart rate was 96. The events resulted to physician's office visit. Treatment for the events included unspecified nausea medications (as reported). The outcome of the events was not resolved.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Fever; chills; nausea-vomiting; nausea-vomiting; aches/pain; low oxygen level. 92; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration in the left arm, on 29Sep2021 13:00 (lot number: FF8839), at age 71 years old, as dose number unknown, single, for COVID-19 immunisation, at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. Relevant medical history included Graves' disease, high BP, and thyroid disease from unknown dates, not reported if ongoing or not. Concomitant medications included levothyroxine sodium, aloe barbadensis and vitamin b nos all taken for unknown indications, not reported if ongoing or not. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive any other vaccines in four weeks. The patient previously took erythromycin and had an allergy. On 29Sep2021 19:00, the patient experienced fever, chills, nausea, vomiting, aches/pain, and low oxygen level at 92. On the same day, the patient's heart rate was 96. The events resulted to physician's office visit. Treatment for the events included unspecified nausea medications (as reported). The outcome of the events was not resolved.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Ophthalmoplegia, Orbital myositis, SARS-CoV-2 test
Clinical narrative: developed PCR + COVID; developed PCR + COVID; EOM paralysis; intraocular myositis; This is a spontaneous report from a contactable physician via a company representative. A healthy young adult male patient (reporter's son) of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in summer of 2021 (unspecified date, Batch/lot number and expiration date unknown) at dose 1 and dose 2, single for COVID-19 immunization. Medical history included COVID-19 in spring of 2020 (not ongoing). The patient's concomitant medications were not reported. The patient developed intraocular myositis with extraocular movement (EOM) paralysis, treated with 40 days of prednisone with resolution, then developed PCR+ COVID-19 again "this week", 16 weeks after second shot. The outcome of events intraocular myositis with extraocular movement (EOM) paralysis was resolved on an unspecified date in 2021, for other events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  event Covid-19, Drug ineffective, Ophthalmoplegia, Orbital myositis and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cellulitis, Cellulitis, Erythema, Lymph node pain, Vaccination site lymphadenopathy
Clinical narrative: possible cellulitis right axillary skin and right breast skin; possible cellulitis right axillary skin and right breast skin; injection site on right deltoid with painful swelling lymph nodes; injection site on right deltoid with painful swelling lymph nodes; erythema/erythema over right axilla/progressive erythema over breast; This is a spontaneous report from a contactable other health care professional (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284), intramuscularly in the deltoid right on 13Jan2021 at 07:00 (at the age of 62-year-old), dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included levocetirizine dihydrochloride (XYZAL); mometasone furoate (FLONASE); pregabalin (LYRICA); baclofen; ibuprofen; diazepam (VALIUM). The patient previously took Sulfa and had allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) intramuscularly in the right deltoid on 23Dec2020 at 13:00 (at the age of 62-year-old), dose 1, single for COVID-19 immunisation. On 09Mar2021, the patient had erythema. On 09May2021, the patient started Keflex for possible cellulitis right axillary skin and right breast skin. The patient had erythema over right axilla, the injection site on right deltoid with painful swelling lymph nodes and progressive erythema over breast. The patient seen at physician on 09May2021. The patient received Keflex for the events. The patient was not hospitalized for the events. The events did not result in multiorgan involvement but had dermatological/mucosal involvement. The patient did not receive any recent vaccines for any other conditions prior to the event and did not receive any other vaccines around the time of COVID-19 vaccine. The outcome of the events was unknown.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101206514 Same reporter/patient/ product, different dose/events.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypersensitivity, Pain, Product administered at inappropriate site
Clinical narrative: Vaccine location=Left leg; Joint pain; increased pain at sites of old injuries; Increase in allergy symptoms.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 via an unspecified route of administration on 30Jul2021 10:00 (at 69-year-old) (Batch/Lot number was not reported) as unknown dose, single in leg left (inappropriate site) for COVID-19 immunisation. Medical history included asthma, high fever, ongoing old injuries pain, and known allergy: morphine. No COVID prior vaccination. Concomitant medications included rosuvastatin; and losartan. The patient experienced joint pain, increased pain at sites of old injuries, increase in allergy symptoms in Jul2021 at 10:00 AM. Emergency room visit and treatment received. The seriousness criteria of this case was reported as disability. No COVID tested post vaccination. The outcome of the events except vaccine administered at inappropriate site was not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid 19 virus; Tested positive for Covid 19 virus; This is a spontaneous report from a contactable consumer (patient), via medical information team. A 57-year-old male patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on 23Mar2021 (at 56-year-old) (Lot Number: FP7534 or EP7534) as dose 1, single, and on 13Apr2021 (at 56-year-old) (Lot Number: EN8729) as dose 2, single; both in arm left for COVID-19 immunisation. The physician denied any other medical history or immunosuppression. There were no concomitant medications. The patient didn't have any medical conditions in terms of making him compromised for the COVID 19 virus and he had no medical history or problems with being immune compromised. He tested positive for the COVID 19 virus on 28Sep2021 at a large testing site. He stated he works in an office and has zero exposure to the public, and he did go out to buy coffee and a few things here and there. He stated he did not have any positive contact with any persons infected by COVID-19 and also had very little exposure to the public except for occasional shopping trips. The outcome of the events was unknown.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EP7534 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. No root cause or corrective/prevent ative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: Appendicitis; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3183, Expiration date: Not reported), via an unspecified route of administration in left arm on 05Sep2021 at 15:30 as dose 1, single for COVID-19 immunization in a pharmacy or drug store. The patient's medical history was not reported. Concomitant medications/other medications received within 2 weeks of vaccination included ascorbic acid, biotin, calcium carbonate, calcium pantothenate, chromium nicotinate, colecalciferol, cupric oxide, cyanocobalamin, ferrous fumarate, folic acid, magnesium hydroxide, manganese gluconate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, selenomethionine, sodium molybdate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTIVITAMIN). No past drug history was reported. The patient was not pregnant at the time of report and didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced appendicitis on 15Sep2021 at 13:00. The patient was hospitalized for this events in Sep2021 for 3 days and there was no prolongation of hospital. This event resulted in emergency room/department or urgent care and received the treatment with surgery. Since the vaccination, the patient had been tested for COVID-19 with nasal swab and the result was negative on 15Sep2021. The outcome of the event was recovering at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Eructation, Fatigue, Headache
Clinical narrative: neuropathy of the feet and hands; headaches; chest pain; elevated heart rate; exhaustion/ am extremely fatigued following minor tasks; severe inflammation; belching; excessive sweating; cant' sleep through the night; am out of breath frequently; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 dose 1 via an unspecified route of administration, administered in arm left on 17Aug2021 16:00 (Lot Number: EW0175) as single dose, at the age of 34-year-old, for COVID-19 immunisation. Medical history reported as none. There was concomitant therapy but unspecified. No other vaccine in four weeks. And there were other medications in two weeks. The patient had not contracted COVID prior vaccination and no COVID tested post vaccination. No known allergies. The patient experienced neuropathy of the feet and hands, headaches, chest pain, elevated heart rate, exhaustion/ am extremely fatigued following minor tasks, severe inflammation, belching, excessive sweating, cant' sleep through the night, am out of breath frequently, all in 2021 with outcome of not recovered. Occasionally had elevated heart rate, and still deal with the belching and sweating, all in 2021. The patient underwent lab tests and procedures which included heart rate: elevated in 2021; testing: unknown result in 2021.  Treatment received for the events that included various medications and testing. Events resulted in physician office visit.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hyperhidrosis, Inflammation, Insomnia
Clinical narrative: neuropathy of the feet and hands; headaches; chest pain; elevated heart rate; exhaustion/ am extremely fatigued following minor tasks; severe inflammation; belching; excessive sweating; cant' sleep through the night; am out of breath frequently; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 dose 1 via an unspecified route of administration, administered in arm left on 17Aug2021 16:00 (Lot Number: EW0175) as single dose, at the age of 34-year-old, for COVID-19 immunisation. Medical history reported as none. There was concomitant therapy but unspecified. No other vaccine in four weeks. And there were other medications in two weeks. The patient had not contracted COVID prior vaccination and no COVID tested post vaccination. No known allergies. The patient experienced neuropathy of the feet and hands, headaches, chest pain, elevated heart rate, exhaustion/ am extremely fatigued following minor tasks, severe inflammation, belching, excessive sweating, cant' sleep through the night, am out of breath frequently, all in 2021 with outcome of not recovered. Occasionally had elevated heart rate, and still deal with the belching and sweating, all in 2021. The patient underwent lab tests and procedures which included heart rate: elevated in 2021; testing: unknown result in 2021.  Treatment received for the events that included various medications and testing. Events resulted in physician office visit.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Neuropathy peripheral
Clinical narrative: neuropathy of the feet and hands; headaches; chest pain; elevated heart rate; exhaustion/ am extremely fatigued following minor tasks; severe inflammation; belching; excessive sweating; cant' sleep through the night; am out of breath frequently; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 dose 1 via an unspecified route of administration, administered in arm left on 17Aug2021 16:00 (Lot Number: EW0175) as single dose, at the age of 34-year-old, for COVID-19 immunisation. Medical history reported as none. There was concomitant therapy but unspecified. No other vaccine in four weeks. And there were other medications in two weeks. The patient had not contracted COVID prior vaccination and no COVID tested post vaccination. No known allergies. The patient experienced neuropathy of the feet and hands, headaches, chest pain, elevated heart rate, exhaustion/ am extremely fatigued following minor tasks, severe inflammation, belching, excessive sweating, cant' sleep through the night, am out of breath frequently, all in 2021 with outcome of not recovered. Occasionally had elevated heart rate, and still deal with the belching and sweating, all in 2021. The patient underwent lab tests and procedures which included heart rate: elevated in 2021; testing: unknown result in 2021.  Treatment received for the events that included various medications and testing. Events resulted in physician office visit.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Pulmonary embolism
Clinical narrative: pulmonary embolism; has issues with breathing; pain in his left upper chest; This is a spontaneous report from a contactable consumer (patient self). An 88-year-old male patient received second dose of bnt162b2 via an unspecified route of administration, administered in left deltoid on 07Mar2021 (Batch/Lot Number: EN6206) at age of 88-year-old as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient previous received first dose of bnt162b2 via an unspecified route of administration on 31Jan2021 (Batch/Lot Number: EN5318) at age of 88-year-old as single dose for covid-19 immunisation. There were no concomitant medications. The patient experienced pain in left upper chest on 10Mar2021. On 20Mar2021, 13 days post vaccine, patient had issues with breathing, patient was admitted to the hospital with pulmonary embolism on the same day. Seriousness criteria of events were reported as caused/ prolonged hospitalization. Patient was on an oxygen generator at night and during day if needed. Stated that he had pain in his left upper chest and thought that he was having a heart attack but was told it was pulmonary embolism and was hospitalized. Stated that the breathing has become a chronic situation. Stated that he was given blood thinners. Was taking Eliquis to prevent future blood clots. The patient was discharged on 22Sep2021. The outcome of event pain in left upper chest was recovered with sequel on unknown date in 2021, of other events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Severe bruising; This is a spontaneous report from a Pfizer sponsored program regulatory authority. A non-contactable female consumer (patient) reported for herself.  A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 20Sep2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date on Sep2021 the patient experienced severe bruising. She had the 1st dose of the vaccine on 20Sep2021 and within a week she developed severe bruising, after vaccination ever since then she has had severe bruising - She called her pharmacist and told her that it is a rare side effect of the vaccine. She went to her primary care who said it was not a side effect of the Pfizer COVID19 vaccine. Her primary care physician told her that it is not vaccine related - She wants to know if severe bruising is side effect of the vaccine. The reporter asked if it could be side effect. She just wanted to see if it is a possibility that it is a side effect. The reporter stated that it doesn't matter what lot number she got. The pharmacist seems to be in agreement or has first-hand knowledge of reports of this with people. It has been rare. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis/SEVERE Psoriasis covering her entire body from her Toes to the Scalp; This is a spontaneous report from a contactable consumer (patient's daughter/caregiver). An 88-year-old female patient received bnt162b2 (BNT162B2, Lot number was not reported), dose 2 via an unspecified route of administration in Mar2021 as dose 2, single 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 Feb2021 as single dose for COVID-19 immunization. In Apr2021 the patient was diagnosed with Psoriasis (which she had never had prior) this subsequently went to severe psoriasis covering her entire body from her toes to the scalp. The outcome of the event was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 50.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Carditis, Electrocardiogram, Heart rate increased, Palpitations
Clinical narrative: Carditis; Palpitation; Sudden Heart Beat; This is a solicited report based on information received by Pfizer (Mfr. Control No.: 21K-163-4093548-000). A contactable consumer (patient) reported a 50-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), first dose, intramuscularly on 23Jun2021 at the age of 50 years old, as single dose, second dose, intramuscularly on 21Jul2021 as single dose for covid-19 vaccination; adalimumab (HUMIRA), subcutaneous from an unspecified date to an unspecified date, at unspecified dose for moderate to severe chronic plaque psoriasis. Medical history included moderate to severe chronic plaque psoriasis. The patient's concomitant medications were not reported. On an unknown date, the patient experienced slowed not as thick but persisting plaques with HUMIRA (adalimumab). The patient experienced carditis in 2021, palpitation in 2021, sudden heart beat in 2021. In 2021, the patient experienced noticed reaction to first dose and second dose was carditis, palpitation and sudden heart beat. The patient underwent lab tests and procedures which included heart monitor: unknown results in Aug2021. The action taken in response to the events for adalimumab was unknown. The outcome of the events was recovered in 2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of noticed reaction to first dose and second dose was carditis, palpitation and sudden heart beat onset in 2021 with humira(adalimumab) was no reasonable possibility. The reporter's causality for the events of noticed reaction to first dose and second dose was carditis, palpitation and sudden heart beat onset in 2021 with BNT162b2 was possible.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available in narrative the reported  event of  carditis, palpitation, heart rate increased is assessed as related to suspected vaccine BNT162B2 The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: sudden, generalize, red, raised, itchy, splotchy rash from head to toe; This is a spontaneous report from a contactable nurse (patient). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 30Sep2021 13:15 at the age of 51-years-old (Lot Number: 30130BA) as single dose for COVID-19 immunization. Medical history included Kidney stones, COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 administered in Right arm on 09Sep2021 08:00 PM at the age of 51-years-old (Lot Number: FL3182) for COVID-19 immunization. Concomitant medications included indapamide; potassium; influenza vaccine taken for immunization on 09Sep2021; tetanus vaccine taken for immunization on 09Sep2021. It was reported "Two hours following the shot, I developed a sudden, generalize, red, raised, itchy, splotchy rash from head to toe - most concentrated at wrists and hands, armpits, chest, lower back, waist, groin, knees, and ankles but scattered in between." Adverse event start date was 30Sep2021 14:00. No treatment was for AE. No Covid tested post vaccination. The outcome of event was not recovered.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event rash and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Contusion, Diplopia, Glaucoma, Sensation of foreign body
Clinical narrative: Glaucoma; Frog in Throat/ Lump feeling in throat; eye problems/ saw two figures instead of one when driving and watching television/ double vision; Started Leaking Liquid/ Wound secretion; Bruised Leg/ Bruising of leg; Arthritis; This is a solicited report based on the information received by Pfizer Mfr. Control No.: 21K-163-4087842-00). A contactable consumer (patient) reported that a 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date (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 rheumatoid arthritis. The patient medical history and concomitant medications were not reported. The patient experienced events of non-serious frog in throat/ lump feeling in throat, verge of glaucoma, eye problems/ saw two figures instead of one when driving and watching television/ double vision, Bruised Leg/ Bruising of leg/ Started Leaking Liquid/ Wound secretion and Arthritis. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Reporter causality for bnt162b2 with events Lump feeling in throat, Glaucoma, Double vision, Wound secretion, Bruising of leg, Arthritis was possible. The action taken in response to the events for adalimumab was unknown.The outcome of the events Glaucoma and Wound secretion was unknown, other events was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Wound secretion
Clinical narrative: Glaucoma; Frog in Throat/ Lump feeling in throat; eye problems/ saw two figures instead of one when driving and watching television/ double vision; Started Leaking Liquid/ Wound secretion; Bruised Leg/ Bruising of leg; Arthritis; This is a solicited report based on the information received by Pfizer Mfr. Control No.: 21K-163-4087842-00). A contactable consumer (patient) reported that a 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date (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 rheumatoid arthritis. The patient medical history and concomitant medications were not reported. The patient experienced events of non-serious frog in throat/ lump feeling in throat, verge of glaucoma, eye problems/ saw two figures instead of one when driving and watching television/ double vision, Bruised Leg/ Bruising of leg/ Started Leaking Liquid/ Wound secretion and Arthritis. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Reporter causality for bnt162b2 with events Lump feeling in throat, Glaucoma, Double vision, Wound secretion, Bruising of leg, Arthritis was possible. The action taken in response to the events for adalimumab was unknown.The outcome of the events Glaucoma and Wound secretion was unknown, other events was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Apraxia, Blepharospasm, Neurological examination
Clinical narrative: blepharospasm- ataxia of the eyelids; apraxia of the eyelid; This is a spontaneous report from a contactable consumer (patient's father). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EWO185), via an unspecified route of administration on 14May2021 (at the age of 17-year-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: ER8737), on 03Apr2021 (at the age of 17-year-old) as single dose for COVID-19 immunization. The reporter stated that 1 to 2 weeks after the second dose his son began having a side effect diagnosed as blepharospasm- ataxia of the eyelids in May2021. Both eye lids were involved. He stated that it had not gotten any better since it began at the end of May. He stated that his son (patient) had to physically hold his eyelids open with his hands or apply pressure or physical stimulation to the side of the area to cause the muscle to stop contracting. He recently had Botox injected to cause the muscles to relax and provide some relief but he stated that this was temporary. He stated that they had been back and forth to the doctor and he had had a neurological work up which provided so answers. He had seen an optical surgeon as well. The reporter stated he had gone through all the doctors and neurologists and no one could make sense of it. He stated that it was unmanageable. The patient started process a month ago to get labs and went through doctor, his eyes would close and if he pushed his knuckle to side of head it would trigger them to open. The reporter stated that when looking at the CDC website he saw there were around 400 reports of this occurring. He would like to know if there was any data on this or anything that may be related to helpful to his sons case. The outcome of the events was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: temperature of 103.8/running low fever; body aches/pain all over; chills; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 37-year-old) at single dose for COVID-19 immunization. The patient medical history and  concomitant medications were not reported. The patient stated she got the Pfizer COVID 19 vaccine on Tuesday and ever since that evening, she had  been running low fever and body aches. Now she had a temperature of 103.8.  It had been two days since vaccine and stated she had had severe body aches, chills and pain all over. She was wondering if she should go to the hospital or should she continue to take Ibuprofen rotating with Tylenol. She was  taking 1000mg of Tylenol and 800mg of  ibuprofen, every 4 to 5 hours, clarifying it would help for only three hours maybe. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Shortly after she developed tingling sensation; This is a spontaneous report from a contactable consumer (mother/caregiver). A 38-years-old female patient (daughter) received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration in left arm on 30Sep2021 at 12:15 (at the age of 38-year-old) as dose 2, single for COVID-19 immunization. Medical history included eye disorder and sinus disorder. Patient previously took Novocaine and experienced numbness and tingling (Shortly after she developed tingling sensation (similar to when Novocain wears off; like when you had novocaine, there's feeling of numbness). Concomitant medications were not reported. The patient previously received bnt162 (COMIRNATY, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On 30Sep2021, shortly after the administration of vaccine, the patient experienced tingling sensation under her left eye left sinus. It was reported that the tingling sensation (similar to when Novocain wears off; was like when you had novocaine, there's feeling of numbness) under her left eye left sinus after her second vaccine. Outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anti-thyroid antibody, Anti-thyroid antibody positive, Blood thyroid stimulating hormone, Body temperature, Chills
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
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Hyperthyroidism, Myalgia, Nausea
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
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Physical examination, Swelling, Thyroid stimulating immunoglobulin, Thyroiditis
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