chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a 47-year-old male patient with diabetes mellitus and with no drug reactions or allergies. On 28-MAR-2017, the patient was vaccinated with M-M-R II (rHA) (dose and route of administration were not provided) lot # M029919, expiration date: 13-JUN-2018. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) lot#M034194, expiration date: 25-FEB-2019. Concomitant medication included an unspecified antihypertensive drug. On 03-APR-2017, the patient sought medical attention at the hospital, because he had developed a rash on both legs, both arms, his torso and his back. The nurse described the rash on his back appearing like "one big welt". The patient also experienced abdominal discomfort and joint pain. The nurse considered this a significant disability for the patient as he had to miss work for an unspecified amount of time. An unspecified treatment was given for the reported adverse events. On 04-APR-2017, the patient had lab diagnostics performed, including complete blood count, comprehensive metabolic panel, thyroid stimulating hormone and hepatic panel (reported as "hepati"), but results were not provided. The outcome of the adverse event was reported as not recovered. The causality between M-M-R II and the adverse events was not provided. Additional information has been requested.
Temprature excursion occurred due to the  vials not being pulled out of the freezer on 10/19/21 according to storage guidelines vials were not pulled out until November 2, 2021 @ 0800.
Patient was administered their 2nd dose of Moderna 2 weeks earlier than the recommended 28 day time interval from the first dose administered. First dose was administered 4/28/2021 and second dose was administered 5/12/2021.
Can't use my left arm now the joint in my arm hurt and the muscle in my arm the movement in my (L) arm can't work. Use my right arm to move my Left arm.
Approximately 20 hours after administration of the second dose, the following symptoms arose and subsided (except for pain at injection site) over approximately 48 hours, seemingly completely:  pain at injection site; fatigue; heavy chills; and serious diarrhea.
Information has been received from a certified medical assistant concerning a 70 year old female patient with hypertension, hyperlipidemia and pre-existing heart conditions and no drug reactions or allergies who on 21-FEB-2011 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 666639/0564Z, expire date 09-OCT-2011), 0.5 ml, intramuscularly. There was no concomitant medication. Certified medical assistant stated that after the patient was administered PNEUMOVAX 23 on 21-FEB-2011, the patient's right arm became swollen and hot to the touch. The patient complained of pain radiating to her right hand and stated that it was also itchy. The patient also complained of chest pain which certified medical assistant reporting stated that the chest pain was completely unrelated to this event. The nurse practitioner provided the patient with antihistamines of unknown origin. There were no laboratory diagnostics studies performed. At the time of the report, the patient had not recovered. Right arm became swollen, hot to the touch, pain radiating to her right hand, itchy and chest pain were considered to be disabling "for a few days" by the certified medical assistant. This is one of two reports received from the same source. Additional information has been requested.
Patient developed angioedema after both dose one and dose 2. More pronounced with itchy swollen eyes; improved with Benadryl.
This spontaneous report was received from a Registered Pharmacist (R.Ph) regarding a patient of unknown age and gender. Concomitant therapies were not reported. On unspecified dates, the patient received the first and second doses of GARDASIL (Lot #, Expiration date, dose and route were not provided). On 22-DEC-2015, the patient was vaccinated with GARDASIL 9 (lot # L001312, expiration date was 24-FEB-2017( (dose and route were not reported) as the third dose in a series. There were no adverse effects reported. Additional information has been requested.
Patient presented to physical therapy on 03/19/2021 for routine therapy follow-up visit.  Patient reported prior to the start of the session he received his first COVID vaccine on 03/16/2021 and the proceeding 24-48 hours following had nausea, diarrhea, fever, and increased redness, swelling, and warmth of the right arm.  Patient had a recent right shoulder surgery and received his injection in the surgical arm.  Comparing his arm from Monday's visit to when he presented on Friday there was a significant change around his incision with increased redness, warmth, and firmness of his arm tissue.  Call was placed immediately to patient's surgeon office and patient was seen later in the day by his surgeon for further follow-up.  Therapy was put on hold for the day.   Patient seen by surgeon 3/19/2021, arm warm to the touch so oral antibiotics started. Unsure if related to covid vaccine. Patient seen again 3/19/2021, still some warmth to mid humerus area and swelling that has been present since surgery. No active infection noted.
body itchy; Fever; watery eyes; has been working with a person that found out that he is positive for Covid; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on 08Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that he had a vaccine yesterday and after that the patient experienced body itchy, fever and watery eyes on unspecified date. The patient Wanted to know if this is normal if the vaccine does this. The patient takes care of an elderly person and before he got the vaccine that the person had a Covid test which he got back and they told him that it was positive on an unspecified date. The patient reported he is a provides care to this elderly person that is 86 years old and Wanted to know if he can still work with him. The events outcome was Unknown.  Information on the lot/batch number has been requested.  Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
Within 24 hrs my arm became very sore and I started to feel as though I was getting the flu. I became very lethargic and weak and later that evening very chilled, the chilled effect last most of the night and by morning it subsided. I still felt very weak the entire next day but by the third day I was feeling fine but still had a sore arm. I never remember having any reaction ever before with any vaccine.
Received my first vaccine at 10:40 or so on Tuesday, March 10, 2021, went back to work, felt good until around 9:30 pm , started getting chills, low grade fever of 99.8, soreness at the site and a headache.  Took Alka Seltzer Cold went to bed, chills continued most of the night, woke up at 5:45 am still had the fever, chills were gone, headache still there, took Advil, (called off work) went back to bed until 11:50, fever continued low grade never beyond 99.8 until around 3:00, which  at that time all the side effects were gone and I felt fine. I was surprised that the first vaccine caused side effects, most people I know said they had nothing for the first vaccine.  I am scheduled for the second shot on April 7, 2021 at 10:50 AM
COVID-19 virus test positive; COVID-19; Allergy to vaccine; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4256643-00.  A 51 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 10Mar2021 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25Jan2022, outcome "unknown", described as "COVID-19 virus test positive"; COVID-19 (medically significant) with onset 25Jan2022, outcome "unknown", described as "COVID-19"; ALLERGY TO VACCINE (non-serious) with onset 10Mar2021, outcome "unknown", described as "Allergy to vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Jan2022) positive. The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for adalimumab (HUMIRA) - The reporter's causality for the event(s) of PFIZER VACCINE ALLERGIC REACTION and COVID-19 TESTED POSITIVE was not provided. The reporter's causality for the event(s) of Allergy to vaccine was provided as possible and causality for COVID-19 virus test positive was provided as not reported for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN),  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, COVID-19 and the use of suspect product BNT162B2 cannot be fully excluded.
Pt received Tdap on Monday. Went to work that night although in pain. Took Tylenol with some relief. Took another Tylenol at end of shift and then went home and took a Percocet for the pain. Tuesday, called in sick and went to ER with arm swelling, temp 100.5, pain into neck from injection site. Dx with cellulitis and was hospitalized w/IV antibiotics. WBC's elevated. Pt fell while in Er--she states they had given her Morphine and Phenergan and when she stood up she passed out and hit her head. She states she did NOT have a seizure but ER staff said she did. When she lost conciousness she had "twitching" in her legs and was incontinent. ER staff thought she might have had hypotonic respiratory distress and did a CAT scan to r/o PE. Pt states she is doing much better and most of the sx have resolved.  05/22/2007 MR received for 2 night hospital stay for c/o R shoulder rash which extends up to the neck.  Admitted for tx of cellulitis, pt. had a seizure while OOB to the BR.  Pt fell to the floor and her lower extremities  began shaking.  Incontinent of urine.  Pt. c/o fever, chills, and R arm/shoulder pain increased with ROM. Pt also complained of SOB with decreased O2 sats-mildly hypoxic on RA.  PE: WNL except R shoulder rash 8x5cm.  Txd with Abx. Principal DX:  Right shouder cellulitis.  Hypoxic respiratory insufficiency.   2' DX:  Possible isolated seizure.
Information has been received from a Licensed practical nurse concerning 5 female patients aged 14-15, who were vaccinated with Gardasil vaccine. Subsequently the patients fainted, this "happened at all 3 doses not just one in particular". Unspecified medical attention was sought. All continued with the therapy. The patients recovered, "all were ok". This is one of several reports received from the same source. Additional information has been requested.
Fatigue, chills, body aches. Patient said arm hurt so badly she was unable to perform normal tasks like taking a shower. Symptoms began approximately 4 hours after vaccination.
administrated with an expired dose of Menveo; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA398A, expiry date 31st August 2021) for prophylaxis.   On 7th September 2021, the patient received Menveo. On 7th September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: On 7th September 2021, patient received an expired dose of Menveo, which is expired on 31st August 2021, which led to expired vaccine used. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021190968:deleted duplicate case
Fatigue; rash on my stomach; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 22nd July 2022, the patient received the 1st dose of Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced fatigue and rash. On an unknown date, the outcome of the fatigue and rash were not recovered/not resolved.   It was unknown if the reporter considered the fatigue and rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-JUL-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient had first vaccination the day before reporting. The patient was fatigued but that was common but the patient was concerned about a rash that came up on his/her stomach. The follow up not possible since contact details not provided.
shingles; PAINFUL; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional case details were reported as follows: The case was reported by patient. The age at vaccination was not reported. The patient got the Shingles shot which then gave shingles, painful too. No contact details were reported.
This pharmacist reports that a patient of unknown age and gender received PNEUMOVAX 23, at an unknown dose, on 27Aug2013. The patient's relevant medical history, concomitant medications, and past drug history are unknown. On 28Aug2013, the patient reported pain in the whole upper arm where the PNEUMOVAX 23 was given and there was a little lump and redness on the muscle at the back of the upper arm. It is unknown if any relevant laboratory testing was performed. As of 28Aug2013, the patient has not received another PNEUMOVAX 23 vaccine and the events continue. The lot number and expiration date of the vaccine are unknown as the pharmacist declined to provide any further information for the report.
Patient said his vision got weird and his throat felt funny. His lips began to swell visibly. This started about 5-10 minutes after vaccine was given. EpiPen 0.15mg administered. Symptoms began to improve within a couple of minutes. 911 was called. Paramedics called in for follow-up and monitoring.
Knot in right arm where shot was administered.  Knot was hot for over 2 days.  Knot was tender to the touch
Large red area, about 6 inches, swelling from the injection site to near the elbow, itching, headache.
pain in lt arm in the axilla area-site of inj sore but not remarkable;axilla & underarm pain treated w/ice & APAP;no redness;no swelling;
Pain around the rotating left shoulder. Missed work the first two days after the shot. Patient has been using the adhesive tape to wrap around the upper arm to give support. Complaint still pain even a mark after or up to today date.
Headache, joint pain in shoulders, fingers, legs and back; stomach pain and diarrhea. Loss of appetite. All these symptoms lasted 8 hours and diarrhea continues for 48 hours. Took Tylenol and rested for first 12 hours, then continued normal daily routine. I had a severe bought of COVID 19 in March 2020, resulting in 3 weeks hospitalization. Exhaustion and pain in finger joints continue today.
This spontaneous report was received from a mother of patient who is a registered nurse, and refers to a currently 12-year-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date between 2003-2008 (reported as when the patient was a young child), he was vaccinated with the first dose of M-M-R II (dose, route of administration and lot # were not reported). 8 hours after vaccination, the patient experienced seizure, was taken by ambulance to a hospital and his outcome was reported as quit progressing after that. On an unknown date, the patient was vaccinated with the second dose of M-M-R II (dose, route of administration and lot # were not reported). On unknown date after that he became violent, did not speak, and was diagnosed with autism. After many years of different therapies the patient was "doing incredibly well" according to the reporter. The relatedness between the events and the vaccine was not provided. Upon internal review, the event of seizure was considered to be medically significant adverse event. Additional information has been requested.
Patient states he had muscle aches, fever, weakness and difficulty breathing 3-4 hours after the shot. Did not seek medical attention. States he went to bed and woke up during the night with vomiting and diarrhea which lasted 7 days.  Finally saw family doctor who told him he had allergic reaction to flu shot
Information has been received from a licensed practical nurse concerning a 12 month old Hispanic male patient (previously reported as female), with a cough and runny nose and no previous medical history, who on 05-Nov-2003 (previously reported as 16-Sep-2003) was vaccinated SC into the left thigh with a first dose of MMR virus vaccine live (lot #645902/0509N). Concomitant vaccination on 05-Nov-2003 included a first dose of varicella virus vaccine live (lot #646361/0572N) SC into the right thigh, a third dose pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) IM into the left thigh (lot #494-303) and a third dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (lot #643888/753M) IM into the right thigh. On 18-Nov-2003, the patient developed a rash and a body temperature measurement of 98.6 degrees Fahrenheit (axillary) for three days. It was reported that the patient was diagnosed with an "MMR vaccine reaction". It was reported that the patient recovered from his experiences. There was no relevant laboratory or diagnostic tests done. No further information was expected.
Patient presented to emergency department on 12/18/2021 with worsening confusion and generalized swelling. During admission, she was found to be COVID-19 positive on 1/3/2022. Patient had a very complicated hospital admission due to acute renal failure, NSTEMI, sepsis with UTI, and pneumonia. She was changed to comfort measures only on 1/7/22 and patient expired on 1/16/22.
Employee had varicella titer done- negative. Varicella immunity required for employment. Varicella vaccine #1 given on 2/21/18- employee did not know she was pregnant at that time. Employer asked whether employee was pregnant prior to administering vaccine, employee denied that she was pregnant. Upon receipt of reminder for Varicella vaccine #2, employee informed NP on 3/29/18 that she was about 8 weeks pregnant, and thus was pregnant when she received the first Varicella vaccine. She was not given varicella #2 vaccine.
I had severe nerve pain in the arm I received the injection in/the pain is intermittent and severe and starts from upper arm to my fingers; This is a spontaneous report from a contactable nurse.  A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), via an unspecified route of administration on 07Jan2021 10:30 at single dose at left arm for COVID-19 immunization. Medical history included seizure, meningioma, and asthma. Known allergies: Latex, reglan, and Bactrim. Concomitant medications included lamotrigine (LAMICTAL), mirabegron (MYRBETRIQ).  The patient previously took reglan [metoclopramide], and bactrim and experienced allergies. On day 2, 09Jan2021 21:00 post vaccine the patient reported "I had severe nerve pain in the arm I received the injection in. the pain is intermittent and severe and starts from upper arm to my fingers." It was unknown if the patient received treatment for the event. The patient underwent lab tests and procedures which included Nasal Swab: negative, and PCR: negative covid test name post vaccination PCR; both on 04Jan2021. The outcome of the event was not recovered.
After 3 weeks of getting FLUZONE HD shot, patient felt very tired, fatigued. Couldn't get out of bed or stay on her feet. This last 2 weeks. She even tried to stop all her medications but she still felt very fatigued. Pt has gotten this vaccine in previous years but never felt this way before.
Patient experienced coldness at the injection site upon administration. Then quickly felt a burning sensation in same area. Started to complain of dizziness, nausea, and lightheadedness. About 15 minutes later complained of increased dizziness, blurred vision and slow response. Ambulance took to emergency room at this point. After a couple of hours was released & instructed to take BENADRYL & an NSAID.
Pt received Hep, H1N1, tetanus. C/o SOB and tight feeling in chest, weakness - BP 132/78. Pt took EXEDRIN, BENADRYL 25 mg and ASA 81 mg X2 with immunization
Altered menstrual cycle, date of the last menstruation April 27, 2021, the cycle lasted only 17 days. Heavy discharge, mild burning in the vaginal area, no menstrual pain (cramps).
headache during the whole night and next day; This is a spontaneous report received from a consumer. A 33 years old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN6202) via an unspecified route of administration in the right arm on 01Mar2021 at 15:00 (at the age of 33 years old) as a single dose for COVID-19 immunisation. Medical history was not reported.  No concomitant medications were reported. The Patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested positive for COVID-19. On 01Mar2021 at 19:00, the patient experienced headaches about every three days, the headache starts at night and is present during the whole night and the next day. The patient underwent nasal swab on 25Sep2020 and resulted negative and nasal swab on 04Dec2020 and resulted negative and Nucleic acid amplification PCR and TMA, Nasal swab on 11Nov2020 and resulted negative and nasal swab on 10Feb2021 and resulted negative and Nucleic acid amplification PCR and TMA, Nasal swab on 26Feb2021 and  resulted negative. The patient did not receive any treatment for the events. The clinical outcome of the headache was not recovered.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a nurse practitioner, and refers to an unspecified number of patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were administered an unspecified number of improperly stored doses of M-M-R II, lot number reported as "M046372", expiration date 08-JUL-2019, for prophylaxis (routes of administration were not provided); which were reconstituited with an sterile diluent (manufacturer unknown) (lot and expiration date unknown) that did not undergo a temperature excursion. On unknown dates, the doses of M-M-R II underwent temperature excursions of 47 degrees Fahrenheit (°F) to 77°F for a time frame of 12 hours and 47°F to 77°F for 9 hours, which were detected by the data logger. No adverse effects were reported.  This is one of two reports received from the same reporter. Lot number M046372 is an invalid lot number for M-M-R II.; Sender's Comments: US-009507513-1709USA010588: