chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Copy of letter sent to FDA is enclosed. Best used to describe adverse events and outcomes. On August 2, 2018 I had the SHINGRIX vaccine given to me in my left arm by a Pharmacist. On August 6th my entire back started to itch very terribly for the whole day. Because I had a standing appointment with my general practitioner on Wednesday, I had her look at my back. She told me it looked like chicken pox. (??) By then the itching had stopped. A few days later I started to break out in red welts on the inside of my left arm which itched badly for two to three days. I made another trip to my general practitioner due to the fact that along with these welts, swelling also appeared, and I was very concerned over that. She said it looked as though there was fluid where the small welts came through. Another group broke out somewhere else and also itched for two to three days. For better than two months I have been breaking out with these very itching welts - on my arms, my legs, my stomach, and my breasts. After going to my Dermatologist, I was given a cream to help with the itching. He took a biopsy of one of these welts, and the result was "non specific allergic reaction". This allergic reaction was of course due to something in the SHINGRIX Vaccine because these welts, along with pain, started immediately after receiving it. I was lucky to have one whole week without a reoccurrence of welts, thinking they had at last gone away. No such luck! I now have a cluster of them on my stomach, and three of them on my neck. (Hope they never make it to my face!). I am 84 years old, but have always been healthy - sure, I have high cholesterol, high blood pressure, and the like, but otherwise have been healthy enough to care for my sick husband (who originally started with an extreme case of shingles with the pain never going away), then failing kidneys required three trips to Dialysis every week for 6 months, in and out of hospitals for almost two years. I am not "tooting my own horn", just calling attention to the fact that I am basically healthy. It was suggested that I do not get the Shingles vaccine (the live one) while he was with us. My left leg had a venous closure procedure on August 1st, 2018, and the knee was very swollen and considerably painful, sometimes making its way down to my ankle. I have been to my orthopaedic specialist where X-rays were taken, resulting in the fact there is no arthritis in my knee. At the vascular office an ultrasound was done on that leg, indicating fluid around the knee. My left wrist has been quite painful over the last few weeks. I only mention all this because I did read on the computer that some of the RARE side effects are "Ankle, Knee, Great Toe Joint Pain; Joint Stiffness or Swelling". Of course we have no idea what I might be allergic to in this vaccine; however, I sure would be very happy to discuss this with someone. Quite frankly, the itching welts are driving me crazy (after having them on and off for better than two months, I would think they would)! I would so appreciate hearing from someone, as these are very definitely adverse effects.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks: Yes. Patient had not known allergies. Patient had received Paxlovid as treatment for ae(Treatment start date: 19Dec2022, stop date: 24Dec2022).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Moderna Covid 19 vaccine, he had syncopal/unresponsive episode.  Medical emergency called; vitals and glucose obtained. RN and Dr. to vacccine clinic. Pt brady at 40-41, diaphoretic, pale, all other vitals wnl.  911 called.  Oxygen applied 2L NC. Pt talking in short sentences, complains of headache and dizziness.  No resp distress or chest pain.  Has had anxiety (vasovagal) episodes  to needles in past.
This case is a part of a cluster of 3 cases and is linked to 2012-10349 and 2012-10322 (reported by same reporter, after FLUZONE ID batch number: UT4472AA). Initial report received from a healthcare professional on 01 November 2012. A female patient, whose medical history and concomitant medications were not reported, whose age, medical history and concomitant medication were not reported, had received an intradermal dose of FLUZONE ID (batch number UT4472AA, site of administration was not reported) on an unspecified date. On an unspecified date, after vaccination, the patient developed redness on entire length of upper arm with warmth. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was not reported. Follow-up information received from a healthcare professional on 25 March 2013: The patient's age was updated as 52 years. The patient had no illness at the time of vaccination and had no pre-existing physician diagnosed allergies birth defects or medical conditions. The patient had no history of adverse event post vaccination in the past. The vaccine was administered in the left deltoid on 24 October 2012. Redness of arm and warmth had started on 25 October 2012. The patient received warm compression and TYLENOL as corrective treatment approx. 04 days. The patient's outcome was recovered on an unspecified date.
Patient became very angry, then became disoriented for about an hour, with sleepwalking type symptoms during the day, probably complex partial seizure.
Body ache; headache; Dizziness; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Body ache), HEADACHE (headache) and DIZZINESS (Dizziness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced MYALGIA (Body ache), HEADACHE (headache) and DIZZINESS (Dizziness). At the time of the report, MYALGIA (Body ache), HEADACHE (headache) and DIZZINESS (Dizziness) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up information received on 28may2021 contains updated contact details (email id)
Information has been received form an LPN concerning a 64 year old white female with a hx of gastrointestinal bleeding and with cephalosporins allergy, high cholesterol and osteoarthritis who on 9DEC203 at 1:20 PM was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine, IM in the right deltoid. There was no illness at the time of vaccination. On 11DEC2003 at 10:30 Am the pt developed erythema left upper extremity described as "dry scaly." The pt was treated for signs and sxs with cold packs and Benadryl. Subsequently, the pt recovered. It was noted that the pt received the first dose of pneumococcal 23v polysaccharide vaccine on 12NOV1997. Additional info has been requested.
nausea, queasiness; 11PM: severe throwing up and diaherra to last off and on until 6AM, unable to keep down any fluids, called doctor on call from primary physicians office around 2:30AM, advised to take Benadryl due to arm swollen twice the size of my uninjected arm, swelling went down, fever continued to climb to 102 degrees.
Site: Pain at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient suspects vaccine was given too high and thinks its shoulder injury related to vaccine administration. She has a doctor's appointment on Wed 9/15 for evaluation. Limited range of motion. Some finger numbness/tingling running down her arm and into her armpit/left breast area.
Pain in heart; Pain in right & left Lungs; Permanent running Nose; overall health is weakend; Facial cyst got infected; Hand cellulitis (no cuts / no bites); This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Hand cellulitis (no cuts / no bites)) and INFECTED CYST (Facial cyst got infected) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 0S0CHA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Allergic reaction to antibiotics, Drug allergy, Fruit allergy, Gluten sensitivity (Gluten sensitivity (Autoimmune disorder) (7 years ago approximately)) and Psoriasis ((7 years ago approximately)). Concomitant products included COLECALCIFEROL (VIT D3), VITAMIN B12 NOS and ECHINACEA ADVANCED IMMUNE for an unknown indication.   On 07-May-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced CELLULITIS (Hand cellulitis (no cuts / no bites)) (seriousness criterion medically significant). On 27-Aug-2021, the patient experienced INFECTED CYST (Facial cyst got infected) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (Pain in heart), PULMONARY PAIN (Pain in right & left Lungs), RHINORRHOEA (Permanent running Nose) and ASTHENIA (overall health is weakend). At the time of the report, CELLULITIS (Hand cellulitis (no cuts / no bites)), INFECTED CYST (Facial cyst got infected), RHINORRHOEA (Permanent running Nose) and ASTHENIA (overall health is weakend) outcome was unknown and CHEST PAIN (Pain in heart) and PULMONARY PAIN (Pain in right & left Lungs) had not resolved.            Patient administered unknown antibiotics on 19 Aug 2021 for hand cellulitis On 27 Aug 2021 patient got injected for Face cyst and administered unknown antibiotics. She mentioned she didn't had any of the symptoms before vaccination. Patient mentioned that adverse event pain in heart and lungs would come and go. Company Comment :  This case concerns a 46-year-old female patient with no relevant medical history, who experienced the unexpected event of Cellulitis. The event occurred approximately 3 monthsh after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-300087 (Patient Link).; Sender's Comments: This case concerns a 46-year-old female patient with no relevant medical history, who experienced the unexpected event of Cellulitis. The event occurred approximately 3 monthsh after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX (batch number CA374, expiry date 28th June 2021) for prophylaxis. On 5th April 2019, the patient received SHINGRIX (intramuscular) .5 ml. In April 2019, less than a week after receiving SHINGRIX, the patient experienced shingles, influenza-like symptoms, blister and erythropapular rash. On an unknown date, the outcome of the shingles and influenza-like symptoms were unknown and the outcome of the blister and erythropapular rash were not recovered/not resolved. It was unknown if the reporter considered the shingles, influenza-like symptoms, blister and erythropapular rash to be related to SHINGRIX. Additional details were provided as follows: The patient had general flu like symptoms, but she was concerned because she was getting blisters and red bumps under her right breast. It was reported that the patient believed that she had shingles from SHINGRIX. The reporter did not want to share date of birth nor additional details.
This spontaneous report as received from a pharmacist refers to an 83 year old female patient. No medical history was provided. In September 2012 the patient was vaccinated with PNEUMOVAX23. This may have been a booster dose of PNEUMOVAX23. The patient had previously been hospitalized at an unspecified facility on unspecified dates. The pharmacist also states that "the patient cannot tolerate the (unspecified) flu vaccine," but that the patient is "otherwise healthy." The pharmacist stated that she was unsure whether the patient did receive more than one dose of PNEUMOVAX23 and if the patient was hospitalized after receiving a dose of PNEUMOVAX23 before September 2012. The outcome was reported as recovered. Additional information has been requested.
Left lateral upper arm swelling, redness and warmth. Positive itching and, discomfort approximately 24 hours after injection.
Diarrhea X1 wk, hematochezia - No treatment given - Will observe.
01Sept95 Pt recv 1 dose vax. Concomitant therapy loratadine (Claritin). Pt was recently exposed to varicella. 16Jan98 Pt devel mild case of chickenpox w/approx 40 lesions.
anaphylactic reaction; neuropathy in fingers, toes, roof of mouth/lips; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL0140) at single dose on left arm on 30Dec2020 at 09:00 for COVID-19 immunization. Medical history included asthma (controlled); hypertension diagnosis 1 year ago; allergies to medications, food and environmental. Concomitant medications in two weeks included antihypertensives - amlodipine and losartan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Dec2020 at 9:15 AM, the patient experienced anaphylactic reaction within 10 minutes of administration, neuropathy in fingers, toes, roof of mouth/lips. Neuropathy continued to date. The adverse events resulted in emergency room/department or urgent care. The patient received treatment Epinephrine IM (intramuscular) and IV (intravenous) steroids. The outcome of events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of anaphylactic reaction and neuropathy peripheral due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including serum tryptase and nerve conduction studies, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
About 5 min after vaccine administration, Light headed, feeling of heaviness and weakness throughout body.  notably slow speech.  patient monitored additional 30 min per her request.  Symptoms did not improve.  Patient was escorted by colleague via wheelchair to gather her belongings at her office, to be p/u by her SO.  Patient declined going to ED
Fever up to 101.5, chills, severe body aches, pain and swelling at injection site, nausea, headache, fatigue
Numbness and tingling  in left lips and face Dizziness N/V Heart racing
Temperature excursion: Vaccine left in freezer past 14 days and administered to patients.
This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a patient of unknown age. On 13-SEP-2014 the patient was vaccinated with a dose of (Merck) VARIVAX (lot#, expiration date, dose and route not reported) which was exposed to unknown out of range temperatures since 25-JUL-2014. No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
patient was tired the next day and lethargic after the booster; patient was tired the next day and lethargic after the booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004355.  A 56-year-old female patient received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "Patient was tired", "Lethargic"; Bnt162b2 (DOSE 2, SINGLE), administration date: 2021, for COVID-19 immunization, reaction(s): "Patient was tired", "Pfizer COVID-19 Vaccine dose 1, on an unspecified date (reported as 2 months later) with Pfizer COVID-19 Vaccine dose 2", "Lethargic". The following information was reported: LETHARGY (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "unknown" and all described as "patient was tired the next day and lethargic after the booster".  Additional information: it was reported that a patient started treatment on an unspecified date in early 2021 with Pfizer COVID-19 Vaccine dose 1, on an unspecified date (reported as 2 months later) with Pfizer COVID-19 Vaccine dose 2, on an unspecified date in Sep2021 with Pfizer COVID-19 Vaccine dose 3 (reported as 1st booster) and on an unspecified date in Apr2022 with dose 4 (reported as 2nd booster) for COVID-19 immunisation. It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200124812 same patient /event different dose number;
pt states the injection hurt his arm and made it very sore.  He developed a pin prickling feeling  in his right arm. It was a constant pressure that went up his arm into his shoulder and his neck like he had nerve damage.  He still has this feeling in his right arm from time to time.  He developed Covid on September 13th, 2021.  He had his booster shot and the flu shot on 10/26/21 which gave him some flu like symptoms.
Information has been received from a registered nurse concerning a female with no allergies and no medical history reported, who was vaccinated with the first dose of GARDASIL vaccine (yeast) and two weeks later "broke out in hives". The patient was given a Prednisone Dose Pack. It is not known if the hives resolved. The patient sought unspecified medical attention. Additional information has been requested.
Did not start developing symptoms until the night of with body aches and hot flashes. Then the next day body aches from the waist down, was unable to stand for more than 2 mins. Sitting down had mild relief. Then fatigue, fever, cough, headache, chills/hot flashes. Symptoms started to fade down towards the end of the day. Just still feverish, headache, and cough. Treatment tried are two 500 MG of tylenol, sleep, and Vicks rub. The next day, only had a headache and cough which had resolved overnight.
Body aches; Coughing; Sneezing; Runny nose; Felt sick; This is a non-serious spontaneous case  initially received from other non-health professional (consumer) on 18-Dec-2018, concerning a female patient of unspecified age.  On an unspecified date, the patient was administered was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose, route anatomical location, batch number and expiry date: not reported] for an unknown indication.   On an unspecified date, the patient experienced body ache, coughing, sneezing, runny nose and felt sick. It was reported that the events experienced by the patient was a lot worse than her friend.  The outcome of the events was not reported.  This case is linked to 201806211 (due to same reporter).; Reporter's Comments: A female patient of unspecified age experienced body ache, coughing, sneezing, runny nose and felt sick on unspecified date after administration of Fluad (TIV). The company assessed the causality of the events as unassessable to the suspect vaccine due to lack of information regarding the onset latency of the events.
Arm was a little sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 2, single (Lot number: EN6202) at the age of 76 years for covid-19 immunization. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "Gaint cell arthritis" (unspecified if ongoing); "Lumpectomy" (unspecified if ongoing); "ascending aorta replacement" (unspecified if ongoing), notes: Three years ago, her ascending aorta was replaced. Concomitant medication(s) included: ANASTROZOLE taken for breast cancer; METHOTREXATE taken for breast cancer; PREDNISONE [PREDNISONE ACETATE]. Vaccination history included: BNT162b2 (Dose 01, Lot: EN5318), administration date: 10Feb2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "her arm was little sore". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Arm was a little sore".  Additional information: Takes a thyroid medication daily and a bunch of vitamins. She has some serious conditions. Three years ago, her ascending aorta was replaced. The illness she has is giant cell arthritis. Had lumpectomy in both breasts. Takes prednisone because of the giant cell arthritis. Anastrozole because of the breast cancer. Methotrexate to work with the steroids. Has a history of breast cancer and giant cell arthritis. On 23May2022, she had the Prolia injection. Something she gets twice yearly. No additional vaccine were administered on the same day of the Pfizer vaccine administered. No prior vaccinations within 4 weeks of first administration. No adverse event prior vaccination. Patient's arm was a little sore after the COVID vaccines, that was it. No Antipyretic use around the date of vaccination.  Follow-up attempts are completed. No further information is expected.