chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 16-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W020540, expiration date: 28-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Vaccines given 8/28/12, 850am. Catastrophic event about 6pm 8/30/12. Found by family to be apneic, blue, unresponsive. To ER then to Hosp PICU. Hypoxic ischemic encephalopathy & multisystem organ failure. Brain dead & expired 09/02/12. Law enforcement & DSS notified - autopsy pending. No indication that death related to immunizations.
pt recvd vax; had sz,lasted less than 5 mins,arms jerked,bubbles came out of mouth, pupils big, turned blue, limp;next day, approx 11am had a staring spell which lasted less than 1 min;
30-40 minuetes after injection developed numbness and tingling of face and lips, tightness in the throat, warm/hot flashes and a fine red rash on the face. Later in the am developed a headache.  Employee took Benadryl 25mg when s/s developed and the symptoms began to subside about 45 minutes later.  Continued to have a generalized itchiness for the remainder of the day and took an a antihistamine after work. The next day had no further s/s of a reaction.
This spontaneous report as received from a healthcare worker refers to a 36 year old female patient with asthma and allergy to albuterol. On 05-MAR-2014 the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 intramuscular in left deltoid (lot# J014399, exp date 20-NOV-2014). Concomitant therapies included SYMBICORT. The healthcare worker stated client was vaccinated with PNEUMOVAX 23 on 05-MAR-2014 and the next day came into the office with an adverse event. Client's left arm was very tender, she had redness in the area, body aches and chills. The client had taken over the counter MOTRIN 600 mg. No lab diagnostics studies were performed. The patient sought medical attention by coming into office. The outcome of the events were unknown. Additional information has been requested.
PATEINT WAS ANXIOUS BEFORE GETTING VACCINE, ABOUT 10 MINUTES AFTER GETTING VACCINE PATIENT FAINTED FOR A FEW SECONDS. PARAMEDICS WERE CALLED PATIENT WAS EVALUATED AND NOT SYMPTOMS WERE FOUND. PATIENT WAS NOT EXPERIENCING ANY OTHER SYMPTOMS AND WENT HOME WITH MOM.
Injection site swollen, red, itchy - Pt visited PCP on 6/26/09; MD told Pt the reaction would go away in 2-3 days.
Pt. describes numbness down entire left arm and tingling and numbness in left hand and fingers. Unknown if due to fibromyalgia.
Approximately 10 hours after receiving my 2nd shot I woke up with a headache, extreme body aches and a low grade fever.  I also had chills and sweating.  I alternated doses of  Acetaminophen and Ibuprofen every 4 - 6 hours.  The symptoms are diminishing, but still present at 48 hours after first symptoms.  The fever has never gotten above 100.9, however, my temperature tends to run low.  My normal temperature using the same thermometer is consistently 97.7
Low grade fever (99.6), severe body aches, localized swelling/redness injection site over weekend. Pain right arm, shoulder and neck persisted. Seen at urgent care clinic 11/20/13. DX "Reaction to Tdap" told she had an "inflamed lymph node" in right upper back area. Released to full duty. Feeling much better on follow up 11/25/13.
Around 2 weeks from the 2nd dose, I started experiencing side effects.  Those symptoms include: severe fatigue, pain starting in lower back radiating down both legs to my feet, lessened sense of taste/smell, and several times a day i experience a sensation feeling disoriented lasting about 10 seconds (mostly when first waking up or sitting down/driving).  These symptoms have been going on for over 5 months now.  They have slower been getting worse since they initially started (primarily the fatigue and lower body pain)
PATIENT WAS 18 YEARS OLD AT THE TIME OF VACCINATION AND RECEIVED THE HEPATITIS B OR ENERGIX B VACCINE THAT IS RECOMMENDED FOR AGES 20 AND OLDER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT FROM THE VACCINE
Client received the COVID vaccine (Pfizer dose 1, lot # ER8736, expiration date 7/5/2021) at 1725 from RN.  RN escorted the client to a chair in observation area at 1730. Per RN, the client's gait became unsteady as he ambulated and the client became unresponsive as he sat in his chair. The  client was observed to slump forward, and he was caught by RN and his mother. EMT and RN responded at that time. The client remained unresponsive for approximately 90 seconds. While he was unresponsive, the client's breathing was rapid and shallow, and his pulse was thready. At 1732, the client became responsive and was drowsy but oriented x4. The client was transferred to the zero gravity chair at this time by RN and RPh. The client's vital signs at that time were: blood pressure 76/40, heart rate 64, respiratory rate 24, and O2 91%. The client appeared pale and diaphoretic. The client reported dizziness and blurry vision which had both progressed to "blacked out vision" before he went unresponsive. The client reported still feeling dizzy and having blurry vision. The client denied shortness of breath, chest pain, or headache. At 1737, the client's vital signs were as follows: blood pressure 102/52, heart rate 61, O2 98%. The client's pupils were equal and reactive to light. At 1738, the client was offered water, juice, and a snack, which he started to eat and drink. Per the client's mother, the client hadn't eaten prior to his appointment but was given water and a snack while in line for his vaccine. The client's mother stated that the client has no medical conditions or allergies and that he takes no medications. The client's mother stated he does not have a history of syncope. At 1740, the client's vital signs were as follows: blood pressure 96/48, heart rate 82. The client complained of feeling hot and he was provided with a cool pack. The client's color had returned to normal at this time and his pulse was normal as well. At 1745, the client's vital signs were as follows: blood pressure 96/48, O2 99%, heart rate 65. At 1750, the client stated that his dizziness and blurry vision had resolved. He was no longer diaphoretic. At 1755, the client's pulse was 74, his blood pressure was 102/52, and his O2 was 99%. Education was provided to the client and his mother by RN regarding primary care follow up and EMS activation. At 1800, the client's vital signs were as follows: heart rate 68, O2 98%, and blood pressure 106/58. The client was able to stand up without dizziness and ambulated out to the car escorted by his mother and EMT, ambulating with a steady gait.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Severe, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: Patient had fainting/suncope 5 minutes after getting 2nd dose of Pfizer vaccine. Her BP dropped to 52/25/35 with shakiness. She recovered with full consciousness very quick after 2 minutes, but it took for 20 min for her BP back 97/75/96. Advised to go to Urgent Care immediately.
Hives started around 4pm on 3/31/21 , come and go and got worse on 4/1/21. Did a doctor video appt with a dr through my insurance and was told to take Benedryl and then prescribed prednisone . Hives are on arms, legs, stomach, upper back, chest , neck and cheeks.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 25-JUL-2017 the patient was vaccinated with PNEUMOVAX 23 lot # L034335, expiration date 18-MAY-2017 for prophylaxis. On 25-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to PNEUMOVAX 23.
This is a spontaneous report from a noncontactable consumer (patient). A 32-year-old (non-pregnant) female patient received the second dose of BBNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0167), at the age of 32, via an unspecified route of administration, in the left arm, on an unknown date, in May 2021, single dose, for COVID-19 immunisation. Medical history included post-traumatic stress disorder (PTSD), fibromyalgia and known allergy to latex. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of the vaccination. The patient did not receive other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0175), at the age of 32, via an unspecified route of administration, in the left arm, on an unknown date, in Apr 2021, single dose, for COVID-19 immunisation. On an unknown date in May 2021 (following the second dose), patient experienced temporary amenorrhea that lasted for 8 weeks. The events did not result in doctor or other health care professional office/clinic visit/emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. No therapeutic measures taken as a result of the events. The outcome of temporary amenorrhea lasting 8 weeks following second dose resolved on an unknown date in 2021. No follow-up attempts possible. No further information  expected.
SORE ARM, EXHAUSTED ON SATURDAY. SUNDAY MORNING TEMP OF 102, NAUSEA, CHILLS, JOINT PAIN ITCHING LEFT NECK AND LEFT FACE FAST HEART RATE (102 AT REST NORMAL IS 60 AT REST) CONTINUED TO MONDAY MORNING.
I have developed vertigo in June. I saw my PCP and have received treatment for vertigo and it did finally resolve after 4-5 weeks. It is unknown weather the vaccine has caused the vertigo or not but I have never had this before since receiving the vaccine.
pt recv vax 6PM on 7AUG95; APAP given q 4 hrs fr time of vax on 8AUG95 @ 415PM; pt sleeping & mom found in sz; taken to hosp & observed overnoc-test returned;
Patient reports at approximately 15minutes after the vaccine, she developed a headache, frontal.  She woke up the next morning, noting a bruise encompassing the bulk of her forehead.  The following day (Post vaccine day#2) she awoke, noting a very large soft tissue bruise underside of left arm and elbow.  Pt assures me she had no trauma. No blood thinners/aspirin.   The bruise encompassed a at least the bulk of her medial L  elbow and soft tissue of the lower forearm.  No bruising reported at injection site.  She did not develop further symptoms, and within 1 week the unusual bruises resolved.  She did not report these symptoms until today, when she presented to her second vaccine.   I opted NOT to administer the vaccine in concern for ? thromboyctopenia.  Pt had normal labs (other than hyperlipidemia, isolated alt 44) 1/2021
erythema after her Moderna covid vaccine 8 days ago. She received her moderna covid vaccine on a Friday with no immediate symptoms. The next day her arm was sore which lasted 4-5 days and then resolved. She experienced a few other delayed symptoms including headache, muscle aches, fatigue, nausea that have subsided. Today her arm started to have some localized pain again at the injection site with a small knot under the skin and a few splotches of erythematous. She denies fever, chills, numbness, weakness, itching. She mentions "slight, slight warmth to the area".
decrease hearing to rt ear, discomfort related to normal sound , pain from loud and high pitch sound
After receiving MMR and VARIVAX pt broke out in hives on face and back. Administered BENADRYL and ORAPRED per MD orders. Monitored for 45 mins.
I had the routine side effects and wasn't expecting a rash but instead I experienced a rash. It felt scalding hot while at the beach when I noticed it from the shoulder down like little red dots they would open up then crust over. I am post menopausal and have spotting besides. It was so bad while on a trip I was asked if I had monkey pox, it went across my chest and down my back, now I have reaction to everything I take. I also had enlargement of the lymph nodes as well. I was diagnosed with breast cancer on August tenth 2022.
My daughter's menstrual cycle was delayed. She did not have her period for 49 days.
received a dose more than 30 days in the fridge; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose more than 30 days in the fridge) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Nov-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. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose more than 30 days in the fridge). In 2021, EXPIRED PRODUCT ADMINISTERED (received a dose more than 30 days in the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) The Caller got the first dose on 22Jan and tested positive/ Stated that she tested positive for Covid on last Sunday 31Jan; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, Expiry Date: unknown) via an unspecified route of administration on 22Jan2021 at the age of 51 years old at a single dose for COVID 19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated that she had her first shot of Pfizer on 22Jan2021 and is scheduled for the next one on 11Feb2021. She stated that she tested positive for Covid on last Sunday 31Jan2021 and she will be out of isolation on Tuesday 09Feb2021. She does not know if she will be able to get the second shot or not. Clarified that it is for Pfizer Covid shot. Stated that she tested positive after receiving the shot is her first dose. The outcome of event was unknown.  Information on the lot/batch number has been requested.
reaction a week later at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction a week later at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (reaction a week later at the injection site). At the time of the report, VACCINATION SITE REACTION (reaction a week later at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
At approx 11:50 am, After administering the PPD (flu and COVID-19 shot given prior) the patient looked at the area where PPD was administered and fainted. He fainted for approx 5 seconds and then was alert and oriented x4. The patient reported he felt nauseous and might vomit, trash can brought to the patient where he spit in the can. Patient then got onto the exam table with feet slightly elevated for approx 10 mins. Patient reported he felt much better but due to APRN recommendations had his mother come and pick him up.His mother came and patient was alert and orientated x 4 when he left.
This spontaneous report was received from an office manager referring to a male patient of unknown age. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unspecified date in 2015, the patient was vaccinated with a dose of M-M-R II for prophylaxis (route of administration, lot number and expiration date were not reported). On an unknown date, the patient broke out into hives (urticaria) and was swollen (swelling) and, due to this, he was monitored in the clinic and treated with unspecified medications. The outcome of these events was reported as resolved on unknown dates. Causality relationship between the events and M-M-R II) was not reported. No product quality complaint was involved. Additional information has been requested.
Information has been received from a physician concerning her husband, approximately a 40 year old male who in 2000 was vaccinated with a dose of varicella virus live (Oka/Merck) and received the second dose in the same year. The physician reported that her husband who came to the US was tested for varicella titer which was negative. In 2003 or 2004 the patient experienced mild case of shingles. "It was itchy and not a lot of pain". Unknown if medical attention was sought. No product quality complaint. Additional information has been requested.
Patient was administered Moderna Bivalent at 9:33am . Later that day we were notified at 2:21pm. received email stating bivalent administration given today would be considered error due to no longer being authorized.
On day 8 after the initial dose of Moderna, I developed a rash on my hands and feet. There were small red marks. During the next 48 hours the rash got progressively worse and started spreading to my legs, arms and face. I went to my dermatologist who ordered a biopsy and gave me steroids. I received the second Moderna dose on 1/19/21 and had no rash. I did get a fever, aches, chills which lasted approximately 12 hours.
Multi-vessel coronary artery disease and STEMI. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Patient reports receiving the shingles and pneumonia shots at his PCP appt on 9/26.  When he got home after  that day after work, his snapped at his wife, which is out of his norm, and started crying -cried continuously until 9/27 around 1500 - and it just went away.  Patient is calling this a "mental health emergency".  Knows now he should have been evaluated.  Has never had anything like this before.  The "only" thing he can think of that was out of the ordinary was receiving both of those injections at the same time.
Fever 101.   High pulse 120.   Body aches.    Chills. Lasted 24 hours
pt states she had a raised lump on both arms at the injection site.  She also had fatigue.  A couple of days later she had developed a 2 3/4" red raised area around the lower injection site on the left arm.  Within the next couple of days she developed hives.  She was taking Benadryl for her symptoms.  She call health line and spoke with the nurse and she was prescribed Triamcinolone.  About 2 days after starting this medicine her symptoms improved.  She still had hives but they were no longer itchy.  The itching subsided after about 3 days and once the itching passed she was fully healed with the exemption of the hard lump at the lower injection site of the left arm.  The  texture of the lump feels weird like cooked chicken and is bouncy.  She reached out to her Doctor and was told this should get better within the next couple of weeks.
This spontaneous report was received from a pharmacist, a female patient of unknown age, who was reporting on herself. The patient's medical history and concomitant conditions were not reported. On 06-NOV-2015, the patient, who was a healthy person and not on pre-dialysis, was accidentally vaccinated with a first dose of RECOMBIVAX HB (strength: 40 microgram, route of administration, lot number and expiry date were not reported). Subsequently, on 11-APR-2016, the patient was vaccinated with a second dose of RECOMBIVAX HB (strength: 40 microgram, route of administration, lot number and expiry date were not reported). No concomitant therapy was reported. No adverse effect was reported. Additional information is not expected, because there is no consent to contact the physician.
(+) Intussusception. Reduced and discharged home. Had Rotavirus immz 9d ago.
This spontaneous report as received from a registered nurse refers to a 4 years old patient of unknown gender. On 11-JUL-2014 the patient ws vaccinated with M-M-R II (therapy type: rHA, batch number: J005846, lot: 1681AA, expiry date: 17-APR-2015) that on 03/03/2014 was exposed to an unsupported temperature excursion (temperature range 45F, time frame: 24h). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
SWEATING PROFUSELY; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's past medical history included: car accident, and coma, and concurrent conditions included: no alcohol use, and smoker, and other pre-existing medical conditions included: The Patient have No known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced profusely sweating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from profusely sweating. This report was non-serious.
Pulsing feeling/noise in right ear; Feels warm; inside of the ear is twitching; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 07Apr2021 at 10:00 (at the age of 29-year-old), as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Concomitant medications included levocetirizine dihydrochloride (XYZAL) and venlafaxine hydrochloride (VENLAFAXINE), all from an unknown date, for unknown indications. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021, the patient experienced pulsing feeling/noise in right ear, not consistent like a heartbeat but happened at least once or a few times every minute. The patient felt warm and like the inside of his ear was twitching. No therapeutic measures were taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events pulsing feeling/noise in right ear, feels warm and inside of the ear was twitching was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.