chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 08Sep2017 at single dose for immunization at doctor's office. Medical history included bronchiectasis. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced pain and tenderness at the site. The patient reported that she read that you could have pain for a few days, but it has been about a week and she still has tremendous pain. The patient wanted to know if this was normal and how long will it last. The patient also reported that on an unspecified date, it has been difficult to sleep due to the pain from her left side. The patient has taken ibuprofen and she still has the pain consistently for about a week. The outcome of the event pain and tenderness at the site was not recovered while difficult to sleep was unknown. No follow up attempts are possible. No further information is expected.
Wednesday, the 29th, I noticed a rash from my waist up and so on my abdomen, chest, neck, arms down to wrist. Similar to heat rash. It was red and the bumps were raised. That just finally resolved about three days ago. On the 9th or 10th of October it finally resolved. But if those areas of my body get too hot, they kind of come back out. No treatment. September 30, I woke up with bad cough, body aches, chills and extreme fatigue and a massive headache. I had that all day Thursday on the 30th. Friday morning, Oct 1st - the same symptoms were worse. I tested positive October 1st - for COVID. I went into Quarantine. I slept the first, second, third and fourth (of October) all day and all night with still having all of those symptoms including the cough and the rash. When I coughed, I would cough so hard, I would get short of breath. It continued on with the coughing - I still have the cough. The headaches are off and on at this time. The body aches are off and on still. The body chills have gone away for the last four or five days. I lost my sense of smell and taste about the 5th of October - I still don't have those back. My last day of Quarantine was Sunday, the 10th, I tried to be doing normal things again since Sunday but not feeling back to myself. I am completely exhausted still; I can only be up and moving for a little bit because of the body aches and my legs don't feel like they have enough energy in them. I still cough and get the headaches. I have also experienced lack of appetite. I have to force myself to drink any fluids.  No treatment other than attempting to take any over the counter cough or flu medication to help ease the symptoms - those have been unsuccessful. I have also experienced severe bloody noses. I have one or two a day probably. This is since having the symptoms - I haven't been stuffed up. I have been able to breathe the whole time, so it's weird to have the bloody noses. I get light-headed, dizzy feeling and then a small headache and then I get a bloody nose after this.  I will see my doctor on Monday for this.   Immediately after  receiving the vaccine, I only had sore arm. That lasted two or three days.
Received call from instructors , found patient lying on ground, assessed airway, given 2 doses of Epi-pen, given IV, stayed with patient. Until EMS arrived. 01/31/07-records received and reviewed. Patient seen in follow-up to ER visit, no records available. Received 7 immunizations day prior to visit. HX of treatment at ER, did not receive epinepherine but some other type of IV medication. Allergic to PCN, zithromax. No complaints at the time of office visit. Did not take Benadryl, slept all night.  PE:WNL.  Assessment:other specified adverse effects not elsewhere classified. Patient had 7 immunizations unknown which was offending agent.
This spontaneous report received from a nurse referred to a 21-year old female patient. The patient's current conditions included seasonal allergies, attention deficit disorder, depression, anxiety and asthma, allergies with latex and nickel. Concomitant medications included amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, ADDERALL, alprazolam, DULERA, LEXAPRO, SINGULAIR, ethinyl estradiol, SPRINTEC, ZYRTEC, XOPENEX, vitamin B12 and vitamin C. On 09-NOV-2016, the patient was vaccinated with GARDASIL 9 intramuscular injection as a HPV vaccination (lot number: M017983, expiry date: 30-MAY-2018). The nurse reported that about an hour of so after administration, the patient experienced nausea that lasted until the end of the day (09-NOV-2016), flushing of the chest and face that lasted until the next morning (10-NOV-2016). The patient did not take any treatment for the events. Outcome of both the events was resolved. Causality assessment was not reported. Additional information has been requested.
Patient called this morning complaining of a swelling and inflammation at the site of injection along with numbness in her arm.  It just started on day 9, so I sent her to the urgent care to see a physician.
Information has been received from a health professional concerning a 9 year old Caucasian male who on 2/13/96 was vaccinated with a dose of varicella virus vaccine live (site unknown). On 5/11/01, the pt broke out with chicken pox. The pt had been exposed to children in the neighborhood with chicken pox and then broke out 2 days later. There was no illness at the time of vaccination. Additional information has been requested.
This spontaneous report as received from a consumer refers to a 71 years old female patient with no pertinent medical history. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # and dose not reported) on 28-AUG-2012. No other co-suspects were reported. Concomitant medications included: cephalexin. The consumer stated that her sister had developed shingles many years ago in her mouth and throat and wanted to avoid this disease so on 28-AUG-2012 she received the injection of ZOSTAVAX single dose vial 10 pk. The next day during the afternoon on 29-AUG-2012 she stated that she had reactions to the injection. Her arm began to itch really bad. She placed an ice and heat pack on it to reduce the itching. Later on that evening, her arm swelled up as she stated in her own words "like the size of a lemon". As she rested for bed, she stated in her own words "that it swelled up like a size of a baseball". Later, her rest was interrupted 5 o'clock am, from the itching and pain when her arm as she stated was "the size of a grapefruit". Since her doctor could not observe her, she then decided to go to the emergency room for treatment. She was hospitalized and was prescribed an antibiotic cephalexin 500mg but did not take the treatment. Soon after she was driving back home and noticed on her waist a rash that developed with small red spots with blisters. This rash had a painful and terrible itch. At the time of the report the patient had not recovered from the events. Additional information has been requested.
Incorrect vaccine administered, patient should have received Meningococcal ACWY. Meningoococcal B Bexsero was administered instead.
Pain in deltoid muscle left arm. Cannot raise above head or reach back wiithout severe pain. Left arm is injection site.
Incorrect product storage; no additional AE reported; This spontaneous report was received from a medical assistant and refers to a 13-month-old female patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 11-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous for prophylaxis (dose, frequency, and anatomical injection site were not reported; lot number was reported as T007359, and upon internal review was determined not to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date was reported as 29-AUG-2021); with the fourth dose of pneumococcal 13v conj vaccine (CRM197) (PREVENAR 13) intramuscular (IM) (lot number CN0615 with expiration date on April 2022); with the first dose of hepatitis A virus vaccine inactivated (HAVRIX) (IM) (lot number 7595K with expiration date on 30-DEC-2021); and with the first dose of Hib conj vaccine (tet toxoid) (ACTHIB) IM (lot number NJ165AAA with expiration date on 29-MAY-2021) (for those three vaccines doses, frequencies, indications and anatomical injection site were not reported).  On an unknown date, the mentioned vaccines had a temperature excursion in freezer. No previous temperature excursions were reported. No digital data logger was involved. No adverse reaction was noted with the patient.  This is one of six reports received from the same reporter.  .; Sender's Comments:  US-009507513-2008USA008314: US-009507513-2008USA009256: US-009507513-2008USA009257: US-009507513-2008USA009258: US-009507513-2008USA001768:
Received first covid vaccine on 9/1, then began having cramping and vaginal bleeding on 9/3. Patient is approximately 6 weeks pregnant with estimated date of delivery of 4/27/22.
Onset of arthritic type pain in R arm/hand which moved to L hand arm several weeks later.  After hand symptoms subsided, same type of pain began in legs, first right then left.  Pain then moved to hips, at times severe enough that climbing stairs was difficult.  Symptoms have subsided for the most part.  Slight muscle weakness noted during worst of the pain.
I was monitored for 30 minutes because I have allergies, and a few minutes after leaving the vaccine site, I went outside and could not see. My vision was blurry and I had a headache. The two previous vaccine doses gave me severe headaches that lasted for many days. The impairment in my vision lasted about 12 hours and my eyesight started to clear and return to my baseline the next day. since the first dose of the Covid vaccine, I have also been experiencing  easy bruising and the bruises take a long time to go away.
2min post vax pt became pale & weak,vomited 10cc of clear fluids; lay down & felt fine in about 1min;
Information has been received from a physician concerning a 12 month old patient who was vaccinated with ZOSTAVAX (lot no. not reported) instead of VARIVAX (Oka/Merck). No adverse event was reported. It is unknown if the patient sought medical attention. No additional information reported. Additional information has been requested.
Information has been received on 29-JUN-2017 from a vaccine coordinator regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 27-JUN-2017 the patient received an improperly stored dose of PEDVAXHIB lot # M032150, expiration 21-APR-2019, intramuscular for prophylaxis. No adverse effects reported. The vaccine was stored between the temperatures of 47 degrees Fahrenheit to 77 degrees Fahrenheit for the time period of 50 hours. There were no previous temperature excursions reported. The call was made because of a data logger. No further information available. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA005466.
swelling to eyes and face x 24 hours after immunization, was given Phenargan 1.5 ml TID X 8 days.
13DEC93 sneezing cont x 2d; 14DEC93 PM t100.4; 15DEC93 afternoon playing @ sitters generalized tonic clonic sz, <5 mins duration sitter had noted fever prior to sz; seen in MD office;
pain diffuse swelling, erythema in the rt deltoid region 10" x 6" w/ severe tenderness; rx Analgesic, amoxicillin
a red rash approximately 2 inches by 2 inches developed over injection site. rash slightly raised and warm to touch with no pain. seems to be spreading after  about 2 weeks
Breakthrough case of Covid. Tested positive with antigen test of 7/4/22.  Fever, cough, runny nose.  Fever ~ 100.7 for 4 days; no fever as of 7/9/22.  Tested positive after 5 days isolation.  Runny nose stopped.  Some congestion and phlegm still as of 7/14/22.  Telemedicine visit with local Health on 7/6/22; decision was to not give Paxlovid or monoclonal antibody since my symptoms were mild.  Pulse OX has been consistently 97-98%.
Non-ST elevation myocardial infarction felt to be due to spontaneous coronary artery dissection in the setting of previously undiagnosed fibromuscular dysplasia.
Pt was vaccinated at 10 am on 1/25/21 He stated that at 3:00 am on 1/26/21 he began having severe chills trouble moving and extreme thirst. He started to experience tachycardia and was diaphoretic. He stated that at 8 am 1/26 he had tingling in his lips and they began to swell. He stated taking 50 mg of diphenhydramine orally at this time. He had swelling and tingling of his face, eyes and tongue shortly after the oral diphenhydramine. He called an ambulance and was taken to the ER. At the ER he was given IV diphenhydramine and kept 2 hours for observation. He was also given oral steroids. He was sent home 1/26 with prescription oral steroids. He stated he has continues to experience tachycardia  with average HR at 110. He also continues to experience night sweats but stated this symptom is improving.
Information has been received from a physician concerning a 16 year old female student, who, on 17-APR-2007 was vaccinated intramuscularly with a first dose of Gardasil (Lot#655503/0012U). Since 17-APR-2007 the patient experienced a headache "off and on" and nausea. No treatment was given except over the counter TYLENOL. On 23-JUL-2007 the patient was vaccinated intramuscularly with a second dose of Gardasil (Lot# 655503/0012U). No laboratory diagnostics were performed. The patient was placed on unspecified birth control pills during the same time between doses. No product quality complaint was involved. Additional information is not expected.
Big circular pattern on arm right at the injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE REACTION (Big circular pattern on arm right at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE REACTION (Big circular pattern on arm right at the injection site). At the time of the report, VACCINATION SITE REACTION (Big circular pattern on arm right at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Systemic: Hypertension-Severe, Systemic: Hyperventilation-Medium, Additional Details: Patient complained of "not being able to breath" and a "weird taste in mouth"... Patient's BP was 188/119 and 180/101 respectively (taken 5 min apart).  Patient was able to walk and communicate clearly.  We called an ambulance and he was transferred to the hospital for further evaluation.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. On 21-JUL-2016, the patient was simultaneously vaccinated with a dose of  PROQUAD and a dose of VARIVAX (lot#, dose, route and site of vaccination were not reported for both). No adverse effects were reported. Additional information has been requested.
Mother called in to office triage line within 30 minutes of receiving vaccines concerns with cough and rash. Patient without wheeze but mother states he did sound as if he had stridor. Rash consistent with hives based on photos that were obtained by parent at the time of the event. Mother instructed to administer Benadryl at home. By the time patient presented to the office the rash was resolved.
headache chills and head congestion; headache chills and head congestion; headache chills and head congestion; she feels horrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose number unknown, 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: HEADACHE (non-serious), CHILLS (non-serious), CEREBRAL CONGESTION (non-serious) all with onset 04Oct2023, outcome "unknown" and all described as "headache chills and head congestion"; MALAISE (non-serious) with onset 04Oct2023, outcome "unknown", described as "she feels horrible". Therapeutic measures were taken as a result of headache, chills, cerebral congestion.  Additional information: She was calling about the Pfizer Covid 19 vaccine, She wanted to know, she felt horrible how long side effects headache chills and head congestion lasts and Is there anything she could do or take aside from Tylenol. She stated, she had it Tuesday, she was sick on the reporting day and the day before reporting day.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Patient is a 71 y.o. male with past medical history of a-fib on coumadin, ischemic cardiomyopathy s/p ICD, CAD s/p BM stent 2005, and CKD III who initially presented to urgent care per family recommendations d/t persistent cough, SOB and fatigue. CXR was obtained with findings concerning for viral pneumonia vs CHF, rapid COVID was negative at that time with recommendations to come to ED for further evaluation and treatment.  Patient subsequently tested + COVID 19 in ED and was hypoxic with ambulation
I've developed a lactose intolerance; I was puking anytime I had dairy; I was puking anytime I had dairy; getting nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Sep2021 as dose 2, single (Lot number: 301358A) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy to avocado" (unspecified if ongoing), notes: Allergy to avocado. The patient took concomitant medications. Past drug history included: Known allergies: zyrtec, reaction(s): "known allergies: Zyrtec"; Known allergies: took benedryl with first dose, reaction(s): "known allergies: Took benedryl with first dose". Vaccination history included: BNT162b2 (Dose Number: 1, Single,, Batch/Lot No: Unknown. Ew0167, Location of injection: Arm Left), administration date: 30Aug2021, when the patient was 30-year-old, for COVID-19 Immunization. The following information was reported: VOMITING (non-serious) with onset 20Sep2021, outcome "recovered", DAIRY INTOLERANCE (non-serious) with onset 20Sep2021, outcome "not recovered" and all described as "I was puking anytime I had dairy"; LACTOSE INTOLERANCE (non-serious) with onset 20Sep2021, outcome "recovered", described as "I've developed a lactose intolerance"; NAUSEA (non-serious) with onset 20Sep2021, outcome "not recovered", described as "getting nauseous". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lactose intolerance, vomiting, dairy intolerance, nausea.  Clinical course: The patient did not received any other vaccines within 4 weeks prior to the covid vaccine. The other medications the patient received within 2 weeks of vaccination was Centrum multivitamin. Prior to vaccination the patient did not diagnosed with covid. Since the vaccination the patient had been tested for covid. Reported Event: Ever since the second dose, patient has developed a lactose intolerance. Immediately following the dose, she was puking anytime she had dairy. Lasted about 2 weeks. She then noticed if she had dairy she needed to find a bathroom asap. Everything she read said adverse effects were supposed to wear off after 6 months. It's been a year and she still can't have a milkshake without blowing up a bathroom or getting nauseous.
mom states was in car seat & started crying, so removed from car seat & started clawing @ mom & jerking;pt was taken to ER & MD report was a nl exam;
This spontaneous report as received from medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with VARIVAX from lot # M048200 with expiry 07-DEC-2018,  for prophylaxis, that might have been exposed to 47 degree Fahrenheit to 77 degree Fahrenheit (56F) for 12 hours. The vaccine was diluent used to reconstitute the vaccine was properly stored.  The temperature excursion was noted by digital data logger. It had no previous temperature excursion.
Severe body aches, headache, left arm severe swelling below point of injection down to elbow. skin below the injection site was hard, very warm to touch, itchy and red.  This redness and swelling included pain.   Noted lymph node pain and swelling in left arm pit.   Pain reddness, itching , and swelling severe from Sunday to Tuesday night,  after topical cream applied,  the itching and redness subsided,  the pain and swelling were improved,  noted by Friday November 12th,  the issues and symptoms were gone.
Itch, redness, rash measured 7 x 6.5 cm (Provider prescribed ZANTAC and KENALOG) 10-29-15.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Severe, Systemic: Nausea-Severe
was cold in the morning; body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (was cold in the morning), PAIN (body ache) and PYREXIA (fever) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (was cold in the morning), PAIN (body ache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, FEELING COLD (was cold in the morning), PAIN (body ache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact