chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Later that evening I developed a fever, chills and a headache.  I had night sweats throught the night and was very fatigued and exhausted feeling which lasted for about 12 hours
Pt became pale and had circumoral cyanosis a few minutes after vaccine.  She briefly fainted and had thready pulse.  She was stimulated and O2 sat was initially 88, increased to the 90s over several minutes. BP was 90/50 and increased to 94/64 over the next several minutes. She was pale and felt nauseous.   EMS contacted as pt required CPR as an infant post 2 month immunizations.
TROUBLE BREATHING; PINCHING IN THE CHEST; TROUBLE GETTING OUT OF BED; SEVERE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on12-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced pinching in the chest. On APR-2021, the subject experienced trouble getting out of bed. On APR-2021, the subject experienced severe headache. On 15-APR-2021, Laboratory data included: Blood test (NR: not provided) unknown, and Scan (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, pinching in the chest, trouble breathing, and trouble getting out of bed. This report was non-serious.
This is spontaneous report based on information received by Pfizer from GlaxoSmithKline, manufacturer control A0964099A from a healthcare professional. A child subject of unspecified gender and age was vaccinated with TWINRIX, (GlaxoSmithKline), varicella virus vaccines, MMR vaccine (Non-GSK), and PREVNAR on 20 June 2011. Relevant medical history and concomitant medications were not provided. After vaccination, the subject experienced allergic reaction. The healthcare professional considered the event was clinically significant (or requiring intervention). The child was treated in the emergency room and then released. At the time of reporting the event was improved. No further details were known at the time of reporting.
This case was reported by a consumer and described the occurrence of sick in a female subject of unspecified age who was vaccinated with TWINRIX (Glaxosmithkline). A physician or other health care professional has not verified this report. On "January 26th", the subject received 1st dose of TWINRIX (unknown). The subject reported that she was on the accelerated "system". She missed the second dose due seven days later as she was "away" and was then sick for a week.  At the time of reporting the outcome of the event was unspecified. Please see A0768986A for a report of the subject's husband who also became sick.
Information has been received from a pharmacist refers to a 60 year old patient of unknown gender. Information concerning medical history and concurrent condition was not reported. The patient had no drug allergies and reactions. On 14-JUL-2015 the patient was vaccinated with ZOSTAVAX (dose, strength and route were not reported, lot # L011533, expiration date: 03-JUL-2016). There was no concomitant therapy reported. On 16-JUL-2015 the patient contacted the pharmacy complaining of injection site redness and injection site swelling which were started on an unknown date in July 2015. The patient referred to an unspecified physician for medical attention and was treated with KEFLEX. No lab diagnostics studies were performed. The events had went down (also reported as OK) at the time of report. The reporter was requesting a lot check. This case is one of several cases received from the same source. Additional information has been requested.
Information has been received from a medical assistant referring to multiple patients of unknown ages and genders. The patients' medical history, concurrent condition and concomitant medication were unknown. On multiple unknown dates, the patients were vaccinated with improperly stored PROQUAD (dose and frequency unknown, lot # M009745, expiration date: 23-AUG-2017, albumin status: rHA; lot # M015700, expiration date: 26-SEP-2017, albumin status: rHA). The vaccines were stored under 11.0 Fahrenheit degree for 30 minutes. There was no previous temperature excursion. The call was due to a "data logger". No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Headache Nausea Fatigue noticed at 9 am on 1-7-2021, Fever 100.4-101 F started at 6 PM.
After given vaccines. Patient fell from sitting position to laying position unconscious x 1-2 min. Reduced pulse after 2 min. Pt was in and out consciousness became alert after about 5-8 min. 911 was called child was took to ER. Diaphoretic pale.
I received my first Pfizer vaccine for Covid 19 on April 1, 2021 and had no side effects except a slight sore arm at the injection sight. Six days later I was abruptly awaken at 6:30 am with severe vertigo. I had never experienced vertigo ever in my life. I couldn't move my head at all. I took me 45 minutes to get out of bed. I was barely able to move around my house because I was so dizzy. I attempted to shower and nearly fell over. Prior to this point I had never heard of vertigo as a reaction to the vaccine. I read that vertigo could be a reaction to covid itself. I had a covid test and it came back negative. I went to see my doctor to discuss this. He looked up adverse reactions that were reported after the vaccine and found out that this has happened to many people. I was advised to not get the second shot. I will not get the second shot!! I have continued to be dizzy at times and Ive had brain fog. This has continued foe 2 weeks now.
Rash over both elbows, hands and on knees bilaterally; denies on buttocks and feet; pt comlains of itching; has papular erythematais; dermatitis; suggest oral benadryl
PT BECAME LIGHT HEADED SWEATY - BP 130/74 HR 84 - WITH IN 10 MINUTES FEELING BETTER BP 128/84 HR 72 DENIES LIGHT HEADED SKIN WRM DRY- C/O BEING TIRED - REFUSED CALL TO WIFE FOR PICK - KEPT 35 MINUTES FROM ONSET SYMPTOMS - WALKED OUT T O CAR BY STAFF  DENIED DIZZINESS   PT RETURNED 4/22 /21 SECOND DOSE MODERNA -  NO ADVERSE SE
shingles; This spontaneous report has received from a physician referring to a male patient of unknown age. Concurrent condition, medical history, and concomitant therapy were not reported.  On an unknown date, the patient as child was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (formulation, strength, dose, route, lot#, and expiration date were not reported).  On an unknown date, the patient as child was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (formulation, strength, dose, route, lot#, and expiration date were not reported).  On an unknown date, the patient developed a rash at posterior thigh, which was diagnosed as shingles (herpes zoster) by dermatology. The outcome of herpes zoster was unknown.  The causality between the event and the suspect vaccine was not reported.  This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002054:
TD 0.5ml, IM, administered to right deltoid on 6/11/02 at 01:30AM. Presented at 18:20 on 6/12/02 with 28 hour history of itching and swelling of left deltoid. TX with Benadryl 25 q 4 h. Watching for infection.
Patient started to have arm pain the day after the shot.  Two days later she developed redness that started at the top of her arm and ran all the way down to her elbow. She is still in pain and has redness 4 days later
fatigue; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th June 2019, 1 days after receiving Shingrix, the patient experienced fatigue. On 28th June 2019, the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The day after vaccination, the patient felt very fatigued. The symptoms resolved after 1 day. The reporter did not consent to follow-up. This case has been linked with US2019AMR159652, reported by the same reporter.
The vaccine expired on 3/18/22 per Moderna.  The patient reports zero adverse effects from the booster.
Client reports feeling a burning sensation at time of injection and shooting pain down her arm. Developed a serious cough for weeks-was given cough syrup. Continues with constant burning (L) arm. "Real shooting pain" comes and & goes. Site still tender to the touch.
Information has been received from an office manager concerning a 18 years old male patient who on 15-JUN-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number unspecified). The office manager reported that after the three doses of RECOMBIVAX HB were given to the patient, all blood work (Hepatitis B surface antibody) came back negative, not immune (lab was 5); requiring a fourth dose of the vaccine. The patient received lot# 603895/0748V but it was unknown which dose. At the time of the report, no follow up laboratories had been performed yet. The patient did not develop Hepatitis B. No other adverse experience was reported. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The office wanted to know if lot# 603895/0748V was associated with failed immunity. Follow up information has been received from the office manager who reported that on 29-SEP-1992 (at the age of 7 months) the patient was vaccinated with a dose of RECOMBIVAX HB (lot# 603895/0748V), (adult dose vaccine; actual dose unspecified), as an infant. The office manager could not confirm if the vaccine was stored correctly back in 1992. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of RECOMBIVAX HB. Additional information will be provided upon finalization of this manufacturing investigation. Follow up information received from a physician via medical records indicated that the patient who is a 18 years old non smoker male (weight 250 pounds, height 72 inches), with no allergies, birth defects and or medical conditions, who on 27-AUG-1992 was vaccinated with a first dose of RECOMBIVAX HB (lot # 603897/0750V). The patient received a second dose of RECOMBIVAX HB, (lot# 603895/0748V), (adult dose) in his right arm on 29-SEP-1992. On 03-MAY-1993 the patient received a third dose of RECOMBIVAX HB, (lot number lot# "1100AL"). On 07-JUN-2010, the patient had a serum hepatitis B surface antibody screen (5 mIU/mL), which indicated that the patient did not have immunity to hepatitis B virus. On the same date the patient had a serum varicella zoster virus antibody test (2.92); the results indicated the presence of IgG VZV antibody, which was consistent with the immunity. On 15-JUN-2010 the patient had a fourth dose of hepatitis B virus vaccine (unspecified) (lot # AHBVB789AA) (Manufacturer unknown). At the time of this report the outcome of the patient's Anti-HBs Antibody Negative was unknown. This is one of several reports received from the same source. Additional information has been requested.
2-3 days after the 2nd shot patient experience Migrains , shortness of breath and chest pain.
Initial and follow up information has been received from a nurse concerning a 74 year old female with a history of chicken pox who on 31-AUG-2007 was vaccinated SC in the left arm with a dose of Zostavax (Oka/Merck) (Lot #657765/0585U).  Concomitant therapy included estrogens, conjugated (+) medroxyprogesterone acetate (Prempro).  On 07-SEP-2007 the patient complained of a backache.  On 13-SEP-2007, (previously reported as 11-SEP-2007), the patient developed pain on the right side of her upper back and itching.  This was also described as a shingles like rash.  She subsequently developed a raised red rash on her back and under her right arm.  The patient saw the doctor and a sample of blister was sent to a lab for testing.  The patient was treated with valacyclovir (Valtrex) and prednisone.  The patient was seen in the office on 24-SEP-2007 and the rash was improving, her pain was gone.  The patient is recovering.  The nurse indicated that they sent a scraping of the rash to an outside lab and it was negative for VZV.  No further information was provided.  There was no product quality complaint involved.  Additional information is not expected.
Pt recvd series of Engerix-B vax & did not seroconvert per titers drawn sometime p/month 6;
hearing is off/his ears feel like they're full of water so he can't really hear; lost his voice; dizziness/Really dizzy; bottom of the feet is tingling; Slightly blurry vision; This is a spontaneous report from a contactable consumer (caregiver). An 82-years-old male patient (Father) received first dose of BNT162B2 (BNT162B2, lot number: EL1283), via an unspecified route of administration in left arm on 24Jan2021 13:30 at SINGLE DOSE as Scared to death to get COVID. Medical history included ongoing High blood pressure. Family history included Father died of melanoma. Concomitant medication included ongoing lisinopril (strength: 10mg) for High blood pressure. Caller stated her father received the pfizer covid vaccine first dose on this Monday and have weird side effects, he lost his voice, dizziness/ Really dizzy, hearing is off/ Ears feel like they're full of water so he can't really hear, bottom of the feet is tingling/ tingling in his feet and slightly blurry vision. Caller wanted to know if it is normal. Caller also said safety department told her to speak to quality department about the shot her farther received is it a bad batch or not. No visit to Emergency Room and Physician Office. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.
Pain and swelling of right upper arm. Redness and warmth. Tender to light touch.
2-3 minutes after receiving vaccination( patient stood up from exam table and was standing next to mother), patient passed out and collapsed on exam room floor. Nurses x 2 elevated patient feet and began taking vital signs.  Approximatley 30 seconds later patient became alert. Patient remained layed down with vitals taken everuy 5 minutes for 15 mins.  THen patient stated she felt better, walked to the bathromm where she vomited x2.  Patient remained nausous for 15 minutes more.  Mother refused staff to call for EMS support and the administrator wrote referral for mother to take patient to their dr for follow-up and eval. Mother refused.  Mother left facility with patient in her own vehicle.
At 3:30 am the Owlet went off indicating that our baby's oxygen was at 77%. I attempted to wake the baby to get her to breath...  She was unresponsive to me for seven minutes I yelled, turned on lights .. I set her in the freezer trying to shock her. We called 911 and went to the emergency room via ambulance. It was terrifying. No one at the hospital acknowledged that this might be related to the vaccines. The pediatrician told me "not to blame the vaccines."
Headache 1/7 severe fatigue, severe headache Narrative:  1/7 called out due to thursday morning severe fatigue, severe headache. Took Ceraflu. 1/8 mild fatigue, headache resolved.  Took Advil.
Patient received a 2nd dose of Moderna from a vial that expired 4 days ago. Per Moderna, the dose was still valid.
Irritable, decreased eating and was febrile (101) admitted to rule out sepsis. 08/03/2007 MR received for DOS 5/6-9/2007 for fever post vaccines.  PE WNL, non-toxic with shotty nodes.  Discharge DX: Febrile Illness likely due to vaccines.
Swelling and rigidity at injection site (immediate), shortness of breath (1:20pm) dizziness (1:20pm), nausea (1:20pm)
17JAN91 dev low grade T 830AM-(101), diarrhea; constant watery every diaper; Seen by MD- poss ear infec prescribed Amoxicillin;22JAN91 no ear infect possible viral flu; stool sample neg for bacteria.  Diarrhea resolved 1 wk later.
Patient stated his arm and shoulder (left) hurt when moved. He also had trouble gripping with the left hand. Patient came back to report trouble on 10/28/2008. Treated 10/29/2008 at the hospital. He said the diagnosis was tendonitis. On 10/31/2008 patient was contacted to find out how he was doing. Patient stated it was feeling better.
LATE MENSTRUAL CYCLE; CYCLE IS ABNORMAL; IRREGULAR MENSTRUAL CYCLE/PROGRESSIVELY WORSE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced late menstrual cycle, cycle is abnormal, and irregular menstrual cycle/progressively worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the late menstrual cycle, cycle is abnormal and irregular menstrual cycle/progressively worse was not reported. This report was non-serious.
Myalgia, erythema around the injection site that keeps spreading, itching at site of injection, started almost immediately after vaccine.
Pt awake in night p/inject recvd, c/o h/a, neck, shoulder, arm pain on lt side; arm still sore on day 5 but attended school; no fever, but listless per mom on Saturday Day 3;
Lowest temperature reached 34 degrees Fahrenheit/ Stated last temperature taken was 2:14, with no adverse event; Initial information received on 09-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional. This case involves a patient of unknown demographics who reported the suspect drug lowest temperature reached 34 degrees fahrenheit/ stated last temperature taken was 2:14 (product storage error), while treated with vaccine influenza quadrival a-b vaccine [Fluzone QIV] (batch number: uj506aa and expiration date: 30-Jun-2021), via unknown route in unknown administration site for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event improper storage of unused product (latency: unknown).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: this suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good Pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recvd vax 26AUG92 1130AM & began crying 27AUG92 2AM & did not stop until 1PM (11 hrs later); no convuls; t>104.2;
numbness and tingling in right arm down to the fingers within 10 minutes of shot, injection site red, hot, itchy and hard knot within 2 days of injection, neck/clavicle area swollen (size of a lemon) and squishy by 6 pm the day of injection, 2 days after injection and swollen again today.  My face was red, hot and flushed the evening of the injection, 2 days after injection and today.  I'm still experiencing face redness and heat as well as the swollen area on my neck as of today.  It is not constant, but it is quite often.
FIRST let me say both my doctor and I do not feel my illness was related to the flu shot but I am reporting it only because it was so close to the time of my vaccination.... High fever  104 oral  Nausea & vomiting for 5 hours  temp down to 101 by 2 am after ASA and tylenol   Called ambulance and was admitted to hospital with pnemonia bilaterally  pulse ox 90  difficulty breathing... 10/19/09 Discharge summary and hospital records received for dates 9/22/09 to 9/24/09.  DC DX: pneumonia. Presenting SX: Pt. seen by PCP with c/o difficulty urinating, frequency, burning. PCP gave abx, pt started abx 2 days later when fever developed along with shortness of breath, cough. Pt was admitted. Assessment: O2 sat 90% diagnostics performed, IV abx given. Pt improved and DC home. Follow: I want to make sure you know that I filed this report on the advice of my doctor only to be informative to you. Neither she nor I feel that my illness was at all related to the flu shot I received that day. Just as a precaution I filed the VAERS form but in fact it is most likely NOT a Reaction to the shot but just a coincidence that I look ill suddenly hours after the injection.
Pt had vasovagal episode during observation related to anxiety.  Advised pt to do pursed lip breathing for 15 minutes, car seat lowered and elevated both legs on the dashboard in his car.  Pt recovered w/o difficulties.  Observed for 30 minutes.  Pt calmed down and left w/o difficulties.  EP precaution given.
Spoke with the patient Thursday (7-29-2021) who was concerned about side effects she had been experiencing after here Covid-19 vaccination. Upon questioning, the patient reported her throat felt coarse and she was having chest discomfort and difficulty breathing. She reported her chest discomfort was comparable to bad heartburn. She reported using her husbands albuterol inhaler due to her difficulty breathing. Patient also reported that it has been worsening since she received the vaccine on Friday (7-23-2021). Patient did not have a diagnosed history of Covid-19. I recommended the patient contact her primary care physician and seek treatment as soon as possible as these side effects seemed concerning. She understood and said she would follow through. I reported this to both her primary care physician and the standing order physician. A report was also filed with the FDA through VAERS. Patient was seen at PCP on 7-30-21 and was prescribed Doxycycline, Prednisone, and Benzonatate.
This spontaneous report as received from a nurse, refers to a 52 year old male patient. Nurse states that a patient was tested for titers for measles, mumps and rubella (MMR) on 26-FEB-2013 for "work hiring purposes". Levels showed measles and mumps "immune" and rubella "less than 1". It was unknown whether patient has received MMR shots before. Nurse reports that a dose of M-M-R II (lot # H012572 exp date 25-JUN-2014), 0.5 ml, subcutaneous for non-immune titer on hire for employer, was administered to the patient on 06-MAR-2013. No other concomitant medications were reported. IgG and IgM levels were drawn on an unspecified date in 2013, after M-M-R II shot was administered, and results showed rubella went from "less than 1 to 175." On 20-MAR-2013, "Two weeks" after receiving M-M-R II, the patient developed an unspecified rash. The rash resolved on 22-MAR-2013 "within two days." The patient went for an office visit in mid April (approximately on 15-APR-2013) because he began experiencing "tenderness in underarm on left side as well as tenderness on his groin on right side." It is unknown whether the patient has recovered from tenderness. The patient sought unspecified medical attention. The nurse reported no treatment was given for adverse events. Additional information has been requested.