chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my second shot on 9/13.  I got my period on 9/17.  9 days before my next expected period.  I track my period via app and ahve for almost 5 years.  My cycle has always been between 25-27 days.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 at 10:30 as dose 4 (booster), single (Lot number: FL3197) at the age of 52 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "HEDS" (unspecified if ongoing); "depression" (unspecified if ongoing); "Barrett's" (unspecified if ongoing); "diverticulosis" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. Concomitant medication(s) included: Sertraline; Famotidine; Omeprazole; Vitamin D [Colecalciferol]; Iron. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: EW0217, Location of injection: Arm Left), administration date: 06Oct2021, when the patient was 52-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 02Apr2021, when the patient was 51-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 12Mar2021, when the patient was 51-year-old, for COVID-19 Immunization. The following information was reported: INFECTED CYST (non-serious) with onset 11Apr2022, outcome "recovered with sequelae"; ABSCESS JAW (medically significant), ABSCESS NECK (non-serious) all with onset 11Apr2022, outcome "recovered with sequelae" and all described as "abscess on left jawline/upper neck"; CAROTID ARTERY DISEASE (medically significant) with onset 11Apr2022, outcome "recovered with sequelae", described as "carotid artery". The events "carotid artery", "abscess on left jawline/upper neck" and "infected cyst" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of carotid artery disease, abscess jaw, infected cyst, abscess neck. Clinical course included Patient received treatment cephalexin. Covid prior vaccination. No follow-up attempts are possible. No further information is expected.
Within 72 hours, post vax, my son had a seizure. I found him rigid in his crib, eyes rolled back and I picked him up and carried him to another room. I called 911 and a neighbor and held him until the rigidity stopped and his lips turned from blue to pink. He had no fever and no previous history. He had never had a reaction/seizure prior to this. I called the manufacturer and they said less than 1% of patients have reactions. The pt developed asthma several years later but nothing was wrong with him when the seizure occurred.
Chills, nausea and vomiting on days 1 and 2 post vaccine. Days 2 and 3 post vaccine developed burning sensation in esophagus and dehydration. Given GI cocktail (Maalox and viscous lidocaine), IV protonix, and 500mL fluid bolus in ER on evening of 1/23 and discharged home feeling significantly better.
I also has blurred vision; Tingling in my legs, arms and feet and its persistent/They are tingling like pins and needles; This is a spontaneous report from contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FA6780, Expiration date: Unknown), via an unspecified route of administration on 05Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Aug2021, the patient experienced I am experiencing today and through the night is tingling in my legs, arms and feet and it's persistent; I also has blurred vision; they are tingling like pins and needles. Consumer stated he has blurred vision was that something normal or do he need to seek medical attention immediately or what was that. When paraphrased above concern, Consumer stated, they are tingling like pins and needles, do you understand that, exactly yes. Consumer stated, So they are closed today and tomorrow, what do I do, how would I know if need go and seek medical attention immediately or I should wait, if I really go to the hospital for something if I know that emergency. When probed for the concern, caller stated, "I had already called someone (Pfizer Drug Safety) to report an adverse side effect. The clinical outcome of events blurred vision was unknown and outcome of other event Paraesthesia was not recovered.
Initial reaction was a sore arm. Then it would start itching and it would not go away. It was on and off. I went to the doctor 08/18/2021. Then my arm started to get swollen, hard, and red. They did not do any medical tests they just gave me an antibiotic. I started Keflex on the 18th, 500 mg 3 times a day. She only gave it to me for 7 days. It's still itching and warm so I am trying to get a refill.
Note: it was a Pfizer vaccine. I don't know which one. My card says HE4628   Hard round lump about the size of a half dollar. Warm to the touch. Red and itchy.  I've also been very very tired
Information has been received from a physician concerning a 11 year old female with environmental allergies who on 06-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (lot # 658282/0929U).  The physician reported than on 07-JUL-2008 the patient received her second dose of GARDASIL vaccine (lot # 659441/1446U) and on 18-OCT-2008 the patient experienced peeling on the palms of her hands and between her fingers and the soles of her feet.  The patient was seen at an office visit.  At the time of the report the patient's peeling on the palms of her hands and between her fingers and the soles of her feet persisted.  No lab diagnostic studies were performed.  Additional information has been requested.
Patient went to ER after experiencing numbness and tingling in hands, fingers and inability to raise arm over head.  She had an xray that showed nothing, was prescribed Ibuprofen and told to follow up with Primary care physician. She did that this week and he stated to stop ibuprofen due to high blood pressure and to follow up with him in 2 weeks if not resolved and he may prescribe physical therapy at that point. As of today the numbness and tingling is gone but still having issues raising her arm over head. She does have more mobility than earlier in the week. Seems to be improving at this point
Information has been received from a health professional concerning a 33 year old female patient with a history of asthma, who on 03-Oct-2007, was vaccinated with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. Subsequently the patient experienced fever and lymphadenopathy and that was lasted for about 3 days. Unknown medical attention was sought. Subsequently the patient recovered from fever and lymphadenopathy. No product quality complaint was involved. This is one of the multiple patients report from the same source. Additional information has been requested.
Has not stopped shaking since; This is a spontaneous report from a contactable consumer. A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date in Jun2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), on an unspecified date as single dose for COVID-19 immunization. The caller declined all further demographics, stated the patient was older. Stated the patient received second dose about a week ago and has not stopped shaking since. The patient stated that he had read the entire EUA and it states that he is part of the Phase 3 clinical trial. The patient asked why no one indicated it was experimental. The patient stated that he would not have taken it.  The patient indicated his brother was a doctor and had conveyed to him it was experimental and per VAERs this was reported adverse event. The patient asked how it was being given to kids and he knows two children that have experienced myocarditis. The patient stated was sitting there like a vegetable. He patient stated that he eats healthy, a vegan and runs. The patient stated that he would complete a VAERs report and encourages those not to receive mRNA vaccines. The patient asked if the patient was aware that mRNA vaccines do not meet the definition of vaccine. On an unknown date, the patient received the second dose of Pfizer BioNTech COVID 19 Vaccine and said about a week ago and the patient had been shaking for a week. Further probing could not be done as the consumer hung up the call before call could be connected to Pfizer Drug Safety. Call back could not be done as no information was provided over the call to the transferring agent. Hence limited information available over the call. The patient was not recovered from the event.  No follow-up attempts are possible. No further information is expected.
pt recv vax 21MAY96 & 18JUN97 pt devel a mild case of varicella w/20-35 lesions & a low grade fever;
This case was reported by a nurse via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced fever, influenza-like symptoms and chills. On an unknown date, the outcome of the fever, influenza-like symptoms and chills were recovered/resolved.  It was unknown if the reporter considered the fever, influenza-like symptoms and chills to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The reporter stated that while the reporter was speaking to the healthcare professional, she also mentioned that she had a male friend who received SHINGRIX who also complained of having fever, chills, flu-like symptoms but these symptoms started on the day of vaccination with SHINGRIX and resolved a few days later. The healthcare professional did not have any additional details.
Various headache, dehydration issues in months since vaccination and booster.  The worst side effects were in the two-three months following shots.  In August 2022, I experienced a very uncharacteristic flare up of the herpes virus which has lasted 9 days and counting.  Severe stiffness in muscles/joints of lower neck, shoulders, and collar area plus night sweats. Symptoms were quite severe for the first 7 days.
Itching at site woke me up early morning. Later in afternoon my cheeks became bright red with a temp. A little sluggish, cold but slept good and woke up next morning feeling good.
Moderate hives continuing to this day.  On arms, legs, back, and stomach.  I'd never had hives before and didn't know what they were.  Of course there is no way to prove this is specifically a reaction to the vaccine.
COVID-19 immunization on 22Dec2020/ COVID-19 immunization on 09Jan2021; Syncopal episode; loss of consciousness; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231) via unspecified route on right arm single dose for COVID-19 immunization on 09Jan2021, 11:00 AM, at 43-year-old. Medical history included: allergies: Cephlasporins; sulfa; clarithromycin (BIAXIN); metronidazole benzoate (FLAGYL). The patient did not have COVID prior vaccination. Concomitant medications in two weeks included: ibuprofen; loratadine, pseudoephedrine sulfate (CLARITIN-D); fluticasone propionate (FLONASE). The patient did not have other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on right arm for COVID-19 immunization on 22Dec2020, 12:00 PM, at 43-year-old. On 11Jan2021, 12:15AM, the patient had syncopal episode, loss of consciousness for approximate 10 minutes, more than two hours to fully recover. This resulted in emergency room/department or urgent care. Treatment received included: IVFs, sutures. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the events syncope and loss of consciousness was resolved on 11Jan2021, of else event was unknown.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events syncope and loss of consciousness 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.
A patient got the first dose in 22Jun2022 and did not get the second dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (A patient got the first dose in 22Jun2022 and did not get the second dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (A patient got the first dose in 22Jun2022 and did not get the second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (A patient got the first dose in 22Jun2022 and did not get the second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (A patient got the first dose in 22Jun2022 and did not get the second dose).    Concomitant and treatment medications were not provided.
Patient received Flu vaccine injection on 11/8/13. She call drug store to let us know she was sick all weekend and Monday. Feeling achy, feverish, tired, slept most of 2 days. As of Monday 11/11/13 her doctor has not seen her!
Pt developed a 7" erythematous area from shoulder to elbow involving entire upper arm.
pt recvd vax & exp erythema multiforme; referred to dermatologist;
The injection site was red, swollen and painful. Patient is experiencing chills, fever, headaches and been unable to sleep due to pain.
Swollen red knot developed at injection site 11 days after injection. Area approximately 2?x2?. Warm to touch, painful, and itching. Some difficulty raising arm over head. Swelling is reduced after 2 days but raised, itchy rash has developed around original swollen area of deltoid.
Expired Menveo administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (expiry date 31-MAR-2023) for prophylaxis.   On 03-APR-2023, the patient received Menveo. On 03-APR-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired Menveo administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date:04-APR-2023 The Pharmacy called for the guidance as he/she stated they inadvertently administered an expired Menveo 2-vial  dose to a patient. Intern was unable to provide any additional vaccine or patient details. The reporter did not consent to follow up. The patient was administered with expired vaccine, which led to expired vaccine used.
On 12OCT91, 6 months p/last HibTITER/DTP, pt presented in ER w/high fever, lethargy & irritability, hospitalized; dx: H. flu meningitis; rx: IV Rocephin; 14OCT stable, afebrile;
No pain - No redness - No swelling. Pt has a "lump" in arm. Sought out treatment from a physician- states MD performed X-Ray & Pt has mass in muscle.
Pt's wife called and reported that pt had an adverse reaction following PNEUMOVAX on 8/20- she reported he had a fever, night sweats, dry heaves, and very sore injection site x4 days. She reports that s/s have resolved.
High Fever started at 9am on 3/21/21, got as high as 105 degrees by 3 pm. Chills, severe joint pain, dizziness and blurred vision.
Diagnosed with Covid; Diagnosed with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 5 (booster), single (Lot number: GJ6796) at the age of 85 years, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM980A), on 03Mar2021 as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 11Nov2022, outcome "unknown" and all described as "Diagnosed with Covid". The patient underwent the following laboratory tests and procedures: Weight: she lost weight because of covid. Reporter called about her getting five injections of the different variants for the Covid-19 Vaccine (Confirmed all the Covid-19 Vaccines have been the Pfizer brand). The last one she received was on 05Nov2022. She was diagnosed with COVID past Saturday, later confirmed as, 12Nov2022. However, the symptoms started on the 11Nov2022. She clarified the symptoms she had that started on 11Nov2022 as she had aches, fatigue, some kind of heaviness over the eyes, stomach issues, chills, and cough. Further commented she lost weight and had lost appetite because of COVID. She also reported that aches was just about the same, commented she just got up this morning. On Saturday and Sunday pretty much slept off and on, or resting watching tv. She seemed to feel a little more alive today, she still feels cold, and still has a deep cough. However, her throat is not making her cough right now.  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-202201306632 same product, patient, different AEs, different dose;
My arm has been swollen; Red; Very warm to the touch; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (My arm has been swollen), ERYTHEMA (Red) and FEELING HOT (Very warm to the touch) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced PERIPHERAL SWELLING (My arm has been swollen), ERYTHEMA (Red) and FEELING HOT (Very warm to the touch). At the time of the report, PERIPHERAL SWELLING (My arm has been swollen), ERYTHEMA (Red) and FEELING HOT (Very warm to the touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
broke out in hives that evening; magnetic at the injection site/stuck at the injection site, not the whole arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out in hives that evening) and VACCINATION SITE REACTION (magnetic at the injection site/stuck at the injection site, not the whole arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced URTICARIA (broke out in hives that evening) and VACCINATION SITE REACTION (magnetic at the injection site/stuck at the injection site, not the whole arm). At the time of the report, URTICARIA (broke out in hives that evening) and VACCINATION SITE REACTION (magnetic at the injection site/stuck at the injection site, not the whole arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.  Patient was advised not to get the second dose  The patient stated that she and her coworker are magnetic at the injection site. Three of them received the Pfizer COVID19 Vaccine , two coworkers also received the Moderna COVID19 Vaccine , and two coworkers received the Johnson & Johnson COVID19 Vaccine.   They messed around with their name badges.
This spontaneous report was received from a nurse practitioner referring to a female patient of unknown age. The patient's concurrent conditions and medical history were not provided. Approximately in July 2014 (also reported as 18 months later), the patient was vaccinated with an unspecified HPV vaccine; it was unknown if it was GARDASIL or GARDASIL 9 as her first dose in HPV vaccine series (dose, route, frequency, lot # and expiry date were not reported). On 27-JAN-2016, the patient was vaccinated with GARDASIL 9 (dose, route, frequency, lot # and expiry date were not reported) as the second dose in the series. Concomitant therapies were not provided. No product quality complaint (PQC) and no adverse events were reported. Additional information has been requested.
Mother described the adverse events as redness, swelling, hot to the touch about 1" above the administration site. Next day on September 19, 2019 she took the baby to the ER for the symptoms and was diagnosed with "Cellulitis". Prescribed antibiotics treatment and benadryl on September 19, 2019 medication she had not picked up yet.
Moderna COVID- 19 Vaccine EUA COVID-19 Vaccine, 100 Mcg/0.5mL Dosage, For Intramuscular Use (Z23) (IM injection) Manufacturer Moderna US, INC Lot 012L20A Expiring 07/06/2021 ; Immunization Admin Covid-19 100mcg/0.5ml Dosage 1st Dose Moderna (Z23) Administered L deltoid on 1-6-21 ~8:51 am Had onset of itching at injection site on day 7 post-vaccine (1-13-21), photo possible urticarial appearance, but clinical exam within hours of onset, mild erythema of left upper arm in area of previous injection sight; slight warmth to touch, no pain, no urticarial. No other clinical symptoms or abnormalities on exam. Seen by doctor. Follow-up exam 1-14-21. Afebrile. left lateral proximal arm with approx. 8 x 9.5 cm warm area of confluent erythema, appears slightly swollen, nonindurated, nonfluctuant, without red streaks, no drainage or vesicles. No left axillary adenopathy. Diagnosis: serum sickness like reaction/Arthus type local reaction given symptoms/timing. Given antihistamines/H2 blocker.
day 0: normal day 1: 103 fever at night, headache day 2: 101 fever, headache day 3: 101 fever, strong cough day 4: 100 fever, strong cough, hives day 5: no fever, cough, hives