chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feels foggy in the head; Couldn't wake up; slept more than was awake; Vomited; Couldn't eat anything; Nauseous; Heart Burn, felt like Acid Reflux; Uncomfortable/ just really uncomfortable; Appetite lost; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 (Lot number: EW0179) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Dwarfism" (ongoing), notes: Verbatim: Dwarfism , Condition since birth. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number : 1, Start date : 05Apr2021, Lot/Batch : EW0169, Vaccine location : Right arm), administration date: 05Apr2021, for COVId-19 Immunization. The following information was reported: DECREASED APPETITE (non-serious) with onset 07May2021, outcome "recovered" (08May2021), described as "Appetite lost"; VOMITING (non-serious) with onset 08May2021, outcome "recovered" (08May2021), described as "Vomited"; FATIGUE (non-serious) with onset 06May2021, outcome "not recovered", described as "Tired"; ABDOMINAL DISCOMFORT (non-serious) with onset 08May2021, outcome "recovered" (08May2021), described as "Couldn't eat anything"; NAUSEA (non-serious) with onset 08May2021, outcome "recovered" (08May2021), described as "Nauseous"; DYSPEPSIA (non-serious) with onset 08May2021, outcome "recovered" (08May2021), described as "Heart Burn, felt like Acid Reflux"; DISCOMFORT (non-serious) with onset 08May2021, outcome "recovered" (08May2021), described as "Uncomfortable/ just really uncomfortable"; SOMNOLENCE (non-serious) with onset 09May2021, outcome "recovered" (09May2021), described as "Couldn't wake up; slept more than was awake"; FEELING ABNORMAL (non-serious) with onset 10May2021, outcome "unknown", described as "Feels foggy in the head". Additional information: Clinical course includes that Caller states she is a little person; has dwarfism.  Says that she was wondering if the dosage amount was maybe too much; maybe that could be a factor. After reviewing the call recording and the documentation, the caller stated per her verbatim, "She was sleepy and tired, the first (06May2021) and second day (07May2021), that started around 6 o' clock.The second day(07May2021), she started to lose her appetite and only ate like one meal that day, the 3rd day (08May2021),  she could not eat anything. She started having heartburn, like acid reflux, just really uncomfortable and nauseous, and finally did throw up into the night around 10pm, she finally vomited. The 4th day (09May2021),  she just couldn't wake up, she was sleeping more than she was awake, but her stomach felt better and she was able to eat some strawberries and half of a banana. She did not expect that it would last so long and she would be so tired. Today (10May2021),  she woke up and immediately went back to sleep for like an hour, but she still feels just really foggy in the head."  No follow-up attempts are possible. No further information is expected.
Patient experienced nausea, lightheadedness, fainting, seizure, loss of consciousness.
No symptoms at the time of injection. Diagnosed with Bell's Palsy on 3.28.21.
she tested positive for COVID-19 with symptoms (side effects); she tested positive for COVID-19 with symptoms (side effects); This is a spontaneous report received from contactable consumer (patient) via Pfizer Sponsored Program. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: UNKNOWN) via an unspecified route of administration on 22Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Two days after getting the vaccine, patient developed symptoms (side effects) and a week later, she tested positive for COVID-19. Patient second dose was scheduled on April 12. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient felt faint and his father caught him before he fell, sat in chair for >30 minutes. Had an ice bag to use against head and to chew on ice chips.
Moderna COVID 19 Vaccine EUA  Experienced equilibrium issues for two days (during the day) stability issues walking ? at night dizziness ? room spinning.  Subsided after two days.
27Mar23 I had runny nose, cough like a bad cold. Feeling bad. I called the doctor and she prescribed PAXLOVID. The cough stayed for a longer time.
Information has been received concerning a female patient between 65 and 78 years old who on 15-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 663888/0627Y).  Subsequently, the patient experienced a fever, severe swelling, redness and pain at the injection site after she received PNEUMOVAX 23.  The patient sought medical attention with the physician.  The patient was given unspecified oral antibiotics (manufacturers unknown).  At the time of the report, the patient recovered on an unspecified date.  All telephone attempts to obtain follow-up information have been unsuccessful.  The health care professional contacted during telephone follow-up could not supply the following information:  patient's name, or date of birth.  This is one of several reports received from the same source.  Additional information has been requested.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies, and concomitant medications were not provided. On an unknown date, the patient may have received an improperly stored dose of PROQUAD for prophylaxis, lot #N025718 and expiration date 17-MAR-2019; lot #N021725 and expiration date 06-FEB-2019; lot #N035171 and expiration date 19-JUN-2019; and lot #N028447 and expiration date 09-APR-2019 (strength, dose, frequency and route of administration were not reported); or may have received an improperly stored dose VARIVAX for prophylaxis, lot #N022986 and expiration date 23-AUG-2019; lot #N025934 and expiration date 19-SEP-2019; lot #N025933 19-SEP-2019; and lot #N030410 and expiration date 30-OCT-2019 (strength, dose, frequency and route of administration were not reported); or may have received an improperly stored dose of ZOSTAVAX for prophylaxis, lot #N025569 and expiration date 13-DEC-2018 and lot #N025704 16-DEC-2018 (strength, dose, frequency and route of administration were not reported). No adverse event was reported. The temperature of excursion was reported as 15°F to 46°F during a time frame of 1 hour. Previous temperature of excursion was reported as a total time in the range of 15°F to 46°F for 24 hours and in the range of 6°F to 14°F for 519 hours and 45 minutes. There was a digital data logger involved.
quarter sized reddened, erythematous area @ inj site;nodule resolved by 17JUN96 on own, redness gone by 10JUN96 on own
Closed fracture of left hip - ED visit to hospital admission. This visit is within 6 weeks of receiving the COVID vaccine.
Crohn's disease; Fibromyalgia; Hidradenitis suppurativa; This is a solicited report received from a contactable consumer (patient) from a non-interventuonal study, Facilitated Collect, based on information by Pfizer from Abbvie, (Manufacturer control number: 21k-163-4136236-00).   A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 02Jul2021 (at the age of 42 years) (Batch/Lot number was not reported) as a single dose and dose 2 intramuscular on 23Jul2021 (at the age of 42 years) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation; and adalimumab (HUMIRA, solution for injection in pre-filled syringe), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date at unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced Crohn's disease, fibromyalgia, and hidradenitis suppurativa on an unspecified date with outcome of unknown. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The action taken in response to the events for adalimumab was unknown.  Causality for Humira (adalimumab): The reporter's causality for the events of Crohn's disease, hidradenitis suppurativa and fibromyalgia was not provided.  Drug: Humira Causality: Crohn's disease, Hidradenitis suppurativa, Fibromyalgia Causality as per reporter (drug/vaccine): not reported  Drug: Pfizer Biontech COVID-19 vaccine (tozinameran), (tozinameran) Causality: Crohn's disease, hidradenitis suppurativa, fibromyalgia Causality as per reporter (drug/vaccine):  possible  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new 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.
scalp was really itchy; Dermographism; They're not as bright red or itchy; they're more pink; her sister is breastfeeding; She gets flares and has several on the body going on at the same time; hives that started the night before/pressure hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives that started the night before/pressure hives), PRURITUS (scalp was really itchy), MECHANICAL URTICARIA (Dermographism), DERMATITIS (She gets flares and has several on the body going on at the same time) and SKIN DISCOLOURATION (They're not as bright red or itchy; they're more pink) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.   On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jan-2022, the patient experienced URTICARIA (hives that started the night before/pressure hives) and DERMATITIS (She gets flares and has several on the body going on at the same time). On an unknown date, the patient experienced PRURITUS (scalp was really itchy), MECHANICAL URTICARIA (Dermographism), SKIN DISCOLOURATION (They're not as bright red or itchy; they're more pink) and MATERNAL EXPOSURE DURING BREAST FEEDING (her sister is breastfeeding). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives that started the night before/pressure hives), PRURITUS (scalp was really itchy), MECHANICAL URTICARIA (Dermographism), DERMATITIS (She gets flares and has several on the body going on at the same time), SKIN DISCOLOURATION (They're not as bright red or itchy; they're more pink) and MATERNAL EXPOSURE DURING BREAST FEEDING (her sister is breastfeeding) outcome was unknown.            No concomitant medication was reported. The patient explained that she has an identical twin sister and they didn't eat the same food, didn't use same detergent, and didn't live in same town. It was unusual for them to have the same physical thing.
This case was reported by a healthcare professional and described the occurrence of injection site induration in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 11 May 2012 at 20:15 the subject received unspecified dose of FLULAVAL (.1 ml, intradermal, right forearm) and experienced wrong vaccine administered. On 11 May 2012, the same day, after vaccination with FLULAVAL, the subject experienced nodule injection site and swelling injection site. On 12 May 2012, one day after vaccination with FLULAVAL, the subject experienced injection site induration and suspected TB (tuberculosis) based on result. A facility was providing TB test to employees when the subject received an intradermal injection. The subject reported that after the intradermal injection, the area became swollen and developed a nodule. On 12 May 2012, the subject went to the emergency room due to a suspected TB and a chest x-ray was performed. The emergency room stated that there was an induration of 22 and ? mm. The chest x-ray was clear. The healthcare professional then discovered that the subject was inadvertently injection with FLULAVAL and not the TB test. At the time of reporting the injection site induration, nodule injection site and swelling injection site were unresolved. Follow-up information was received on 25 May 2012 via healthcare professional reported the events occurred on 17 May 2012 which conflicts with previously reported 11 May 2012 and 12 May 2012 start dates. The events had resolved by 21 May 2012. The healthcare professional did not consider the events serious. At the time of the report no other information was provided.
took a covid test and the covid test came out positive; had 4 Pfizer shots and I've gotten the 2 regulars and the 2 boosters; took a covid test and the covid test came out positive; had 4 Pfizer shots and I've gotten the 2 regulars and the 2 boosters; I do have the vomiting; the diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), 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 included: "Kidney condition" (unspecified if ongoing). 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 "took a covid test and the covid test came out positive; had 4 Pfizer shots and I've gotten the 2 regulars and the 2 boosters"; VOMITING (non-serious), outcome "unknown", described as "I do have the vomiting"; DIARRHOEA (non-serious), outcome "unknown", described as "the diarrhea". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: took a covid test and the covid test came out positive. Therapeutic measures were taken as a result of covid-19.  Clinical Course: Patient reported as they have received had 2 separate, had 2 different dosages (Unspecified medications), 2 specific medication dosage and she didn't know which one it would be for kidney condition or not. Had symptoms like covid for 3 days, 3 days prior to this, I wouldn't had got a chance till I tested positive for the covid. prescription that they have received they had 2 separate, they had 2 different dosages (name not clarified). Doctor prescribed and apparently somebody got the prescription that he will back in. nurse told her that it's the regime of 5 days and that it would be starting with the Pfizer pill. I guess and so, what the pharmacist told me was that they had 2 specific medication dosage and she didn't know which one it would be, one would be if there's a kidney condition and the other would be if not be kidney condition.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approx. 2 weeks after my booster shot, I started having very noticeable vertigo, which was persistent. Whenever I move my head suddenly, I get dizziness. It was very significant for over 2 weeks and is still noticeable to this date, but less severe. I also had unusual fatigue and a very large, swollen walnut-sized lymph node just above my left clavicle.  This was very hard (like a rock) and was present for over a week. Once that resolved, I started having sharp pains in my breasts and under my armpits down my side. I am still having some of this pain and the vertigo. I have been diagnosed with the autoimmune condition, Lichen Planus, which I am being treated for.
Patient light headed and requested transport to ED. Patient did not have any food this morning and this was likely a vasovagal reaction
Body aches, chills, subjective fever, fatigue, headache starting day after vaccination and continuing, now ongoing x3 days though improving
Pt was tx for UTI on April 6th - SEPTRA BID x 5 days. Received GARDASIL vaccine on April 12th. On April 15th about 11pm pt complained of itching. Mother gave her BENADRYL. Presented to clinic AM of April 16th with raised maculopapular confluent rash generalized, was tx with ALLEGRA, Prednisone. No fever.
This spontaneous report as received from a Healthcare worker refers to a 14 year old male patient. No pertinent medical history and drug allergies reported. On 03-JUL-2014 the patient received his first dose of GARDASIL (valid lot# K004204 expiration date: 12-JAN-2017). On 03-JUL-2014, few minutes after his first dose of GARDASIL the patient fainted. The patient was able to go home with his mother on 03-JUL-2014 (reported as today). Action taken with the suspect product was unknown. The reporter asked for a lot check. On 03-JUL-2014, the patient recovered from the event of fainting. Causality was not reported. The patient sought medical attention (details unknown). No product quality complaint reported. According to the healthcare worker, this is the second fainting of a patient within 6 days in her physician's office. The other syncope is documented in the related cases # 1406USA014097, 1407USA000892 and 1407USA000891. Additional information has been requested.
Premature Atrial Complexes Atrial Tachycardia/ High Blood Pressure/ Headaches/ Joint Pain/ Anxiety/ Numbness/tingling in extremities/ cramping in legs.
throat and tongue swelled, but not enough to cause breathing problem, just enough to make it hard to talk. Resolved after a week. Developed red, bumpy, itchy rash on back of both hands and lower arms. Ended up scratching to point of bleeding. Rash resolved after 2 weeks and benadryl. Felt irritable for a full week. NEVER felt fluish, just the swollen throat and rash on back of hands and lower arms and irritableness.
2-3 hrs later pt experienced shortness of breath and tachycardia, symptoms resolved on their own. Today pt states she "she cannot take a full breath", pt also experienced swelling of tongue with other symptoms but this has resolved. Pt refereed for tx to clinic.
myocarditis; pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 26-year-old male patient received BNT162b2 (BNT162B2), in Jun2021 as dose 1, single (Lot number: EW0180) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant) with onset Jun2021, outcome "unknown"; PERICARDITIS (medically significant) with onset Jun2021, outcome "unknown".  Clinical course: It was reported she had been sending documentation for Pfizer since April, May and June about her son who was not supposed to receive the same shot, but had not received a clear answer. She mentioned since receiving the vaccination, her son had been dealing with myocarditis and pericarditis, and that she had been told by nurses that their sons have been getting sick too after receiving the vaccinations, and also a bunch of young people because of the proteins in the vaccine. Caller mentioned she had previously spoken to someone who advised her the timing between doses of the Purple Cap was 2 months and not 3 weeks and that we were lying to her.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300263441 same reprter, different patient/dose/event;US-PFIZER INC-202300263440 same reporter, different patient/event/dose;US-PFIZER INC-202300263439 same patient/event, different dose;
Flu like symptoms which include: chills, body aches, extreme fatigue, dizziness
No additional adverse events reported; posible given after temperature excursion 55 F; This spontaneous reported was received from a pharmacist and pharmacy technician, and refers to a patient of an unknown age and gander. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 22-FEB-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # S039310 was confirmed to be valid, expiration date was not reported but upon internal validation was established as 04-DEC-2021, 0.5 milliliter (route and site of administration were not reported) for prophylaxis. The administered dose was exposed to the temperature of 55 degrees Fahrenheit for 5 hours. There was no previous temperature excursion. The call was because of a digital data logger. There was no additional adverse event reported.
Patient requested a booster Bivalent Moderna vaccine. However was given the old Monovalent Moderna in errror.
First adverse event was chest pressure/pain on June 7, 2021.Pericardial effusion and myocarditis diagnosed  by echocardiogram on  June 8,2021 Treatment ongoing with cholchicine for two weeks and follow up echo and dr appt in 4 weeks
COVID vaccines - states Breast Milk dried up 3 days after 2nd covid shot. Has tried VAERs a few time but had troubles completing the form. Has talked with pcp. States as a nurse knows to increase water and did this. States she was also in bed for 3 days post the 2nd shot with body aches, fatigue, and low grade fevers. No work up was necessary, but was really upset that her breast milk dried up as she was enjoying the bonding with her baby. States he was more cuddly than her daughter was. He seemed to miss it also but transition to bottles/formula well.  He was 5 months old.  She otherwise had no changes in medications at that time and did not take antihistamines. She has also noted heavy menstrual cycles (she is not sure if related or not) thinks a light cycle in December, but since March (about a month post 2nd dose) have been much heavier & longer. Lasting 7-10+ days, changes regular sized tampon about q2 hours.  No known hx of prior covid infection.
Immediately after being vaccinated developed fascial flushing redness and mild tachycardia and took 50 mg of oral benadryl- followed by improvement. That same day in the afternoon developed exanthem, flushing and mild itchy urticaria.  Night-time had chills, malaise, with very painful soar arm. Day later had similar symptoms with body aches, rash and low grade fever. Symptoms improved 48 hours later. Rash improved as well. Day 7 and 13-14 th developed similar symptoms associated to malaise and fatigue and worsening rash with 1-2 days of body ache, pruritis. Being currently treated for intermittent flares of rash mostly on chest, abdomen and back.