chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke to itchy on arm middle of night. Next day, hot, red itchy rash enlarging and migrating to cover area up to about 4 inch radius from injection site on left upper arm by 11/10/16 PM when they came to report back to me. Patient estimates rash came on 12-15 hours after shot. Patient had been self treating with benadryl, advised to continue and add hydrocortisone cream which they agreed to do.
Had nausea, fatigue and weakness after dose #2 11/04/2021 Now has low RBC count of 4.37 neutrophilia of 83% lymphopenia of 10% Reticulocyte count elevated -3.1%, reticulocyte antibodies (+) IRF 14.3% repeat RBC count 4.28 on 11/8/21
Tongue swelling / numbing; Tongue swelling / numbing; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 08:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis. The patient was allergic to ragweed and mugwort. Concomitant medications included levonorgestrel (MIRENA) Intrauterine Device (IUD) and multivitamin (PURE SYNERGY), both taken for unspecified indications from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 09:00, about 15 minutes after the vaccine, the patient experienced tongue swelling/numbing. The event did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were taken as a result of the event and included treatment with liquid Benadryl. The clinical outcome of the event tongue swelling/numbing was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Fever for 3 days followed by rash after administration of Varicella immunization.
vaccines were out of the stability range with no reported adverse event; clinic already had given 4 doses of the vaccine out of stability with no reported adverse event; Initial information was received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA323666(CLUSTER), 2023SA323508(CLUSTER) and 2023SA323592(CLUSTER).  This case involves a 77 years old female patient to whom clinic already had given 4 doses of the influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] that were out of the stability range with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, the patient received a 0.7 ml, total, once dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot U8162BA, expiry date: 30-Jun-2024 , strength: High dose) via intramuscular route in the left deltoid for Immunization and the time the clinic already had given 4 doses of the vaccine out of stability with no reported adverse event (poor quality product administered) (Latency: same day).  On an unknown date, vaccines were out of the stability range with no reported adverse event (product storage error).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.  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 the 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.
Left thigh red, swollen, hot to touch, and painful. Size of softball. Patient was admitted for IV antibiotics x 1 day. 03/03/08 Pt was not admitted to hospital per reporter. Just went for 1 dose IV abx and sent home with DX: Cellulitis.
From telephone contact on 05/31/01, a physician reported that a patient (3 of 3) received a Tripedia vaccination, vaccination date not specified. The patient developed  a local receipt of the vaccine. No specifics were provided. Further information is requested.
Pt describes significant arm pain, sore neck pain in temple area, and eyes fluttering.
Achey joints, chills, nausea, vomiting, headache, brain fog, mood swings, difficulty with concentration,  de-personalization,  difficulty with recall, hair loss, depression
Pt devel generalized rash following vax w/measles vax; no further details were provided;
Vaccines Administered 08/26/09. He started having high fever on 09/01/09. He began to become extremely fussy and some nausea. Fever continued to increase from 100 -101 F to 102 - 103 F. He was taken to doctor on 09/04/2009. He was diagnosed as having a reaction to MMR vaccine. Was told to monitor him. Was told to bring him back if fever continued beyond 09/07/2009.
About two minutes after receiving the vaccine, I started to feel lightheaded. Everything looked bright and I saw circular tangles of bright yellow lines. Everything was loud and sounded like I was hearing it on a radio with static. I felt like I was going to vomit and pass out. Someone brought me water, and I drank a little bit. My throat started to cramp up, and it was getting hard to breathe. I sat up suddenly and started gasping for air, then I vomited a lot. This was maybe five minutes after I started to feel badly. Immediately afterwards, the nausea and lightheadedness started to disappear. The nurse said my pulse was relaxing. I felt weak, but my symptoms went away. After about ten minutes, I drove myself home. I was a little tired when I went home, and through the day, I felt more fatigue and irritability. By the evening, I just wanted to lay down and not talk to anybody.
immunization given 18JAN95 in AM; 10PM pt awakened w/t106; pt had been on APAP q 4 hr; began vomiting; transferred to another hosp where was kept overnoc due to dehydration;
Day 1 after immunization, patient reported flu-like symptoms. Day 3 after immunization, patient reported wheel type rash at injection area and could not lift arm very high. Day 5 after immunization, patient developed tight feeling in throat and felt pain when lifting chin upward. Day 8 after immunization, patient had developed a rash and was seen at urgent care and given a shot of dexamethasone. She reports feeling better after the steroid, but now presents on 01/09/19 which small rash reappearing at site of injection.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8780), in left arm, on 22Apr2021 as dose 2, single (Lot number: EW0170), in left arm and on 19Nov2021 as dose 3 booster, single (Lot number: FD0809) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies:Sulpha meds" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received other Allergy medication in two weeks of vaccination. The patient received Paxlovid from 24Jun2022 to29Jun2022 to treat COVID 19.  No follow-up attempts are possible, no information is necessary.
Within the 15 minute monitor period I began to feel nauseous and like I was going to vomit. I sat down and began to feel my heart rate going up and having extreme anxiety, so I tried to stand up but could not move and felt ?stuck? to the chair. I tried to call for help but I couldn?t speak either. I had tingling and numbness all across my head and face, as well as generalized weakness, small twitching movements, and dilated pupils. 20 minutes later a worker finally noticed and asked if I needed help and I nodded as much as I could. 25 minutes later an ambulance arrived and I had to be assisted on the stretcher because I couldn?t move very well. I was slowly able to start speaking again but my  speech was delayed and slurred. Once I began to move and speak normally I felt extremely physically exhausted. After I was discharged I was continuing to have these same reactions minus the inability to move or speak for around 5 days so I saw a neurologist. I was not experiencing any of these symptoms until suddenly on November 21 the same thing happened again and I was once again hospitalized.
Muscle soreness did not go away after two weeks. Increased after 6 days and plateaued. Soreness and range of motion are effected.
Fever; Permanent vision loss/ Permanent vision loss in the right eye; Another eye episode; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Permanent vision loss/ Permanent vision loss in the right eye) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE, METOPROLOL SUCCINATE (TOPROL), AMLODIPINE and ALPRAZOLAM (ZOLAX [ALPRAZOLAM]) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced BLINDNESS (Permanent vision loss/ Permanent vision loss in the right eye) (seriousness criteria disability and medically significant) and EYE DISORDER (Another eye episode). On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, BLINDNESS (Permanent vision loss/ Permanent vision loss in the right eye) and EYE DISORDER (Another eye episode) had not resolved and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: normal (normal) Biopsy of artery leading to right eye.         Treatment provided included Prednisone.  After the second dose patient had an eye episode that did not go away after few minutes. It continued over the weekend and the patient visited a primary physician who was concerned about a stroke even though there were no stroke symptoms. From there patient was referred to cardiologist, rheumatologist and retinal specialist. Patient had shorter eye episode which began 22 days after the first vaccine and permanent vision loss began 20 days after the second dose. After six weeks of test and physician visits, a biopsy of the artery leading to right eye, the consulted cardiologist and found no problem in the heart, vascular specialist fount no issues in the arteries, rheumatologist found no systemic inflammation and autoimmune condition, Retinal specialist primarily provided treatment and did not diagnosed the cause but informed that the eye damage was not caused by a clot. There was no improvement in the vision and the retinal specialist was not optimistic that the vision will return.  Very limited information regarding the events has been provided at this time.  Further information has been requested.   This case was linked to (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up was received on 20-May 2021 and updated  Patient demographics, concomitant  medications, batch number of vaccine, treatment medication.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 11-JUL-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # M004662, expiry date 27-JAN-2018, dose, strength, vaccination site, route unspecified). The vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
This clinician was alerted by Pharmacy that the Covid PFizer Booster dose (given at 08:40 AM) was inadvertently mixed with sterile water as the diluent; and considered "inactiviated" per pharmacy, therefore advised to immediately re-boost the patient according to the current CDC Guidelines. The patient was alerted of the incorret diluent and recommendation to re-boost immediately with the Pfizer Vaccine. The patient expresses understanding, but also expressed concern of the need to re-boost immediately, as this is something that does not occur regularly, and she desired to proceed more cautiously. An appointment for the re-boost was scheduled Jan, 6, 2022.  On Jan. 4th, the patient reported she experienced  the same shoulder pain, a very mild headache and brain fog that she had experienced with the first two Pfizer  vaccines.  she requested cancellation of the re-booster dose that had been scheduled for Thursday Jan. 6.  On Jan. 5, 2022, the patient reported "There's no doubt that I received the vaccine and that it was not "inactivated." I had the following symptoms - shoulder pain, mild HA/brain fog, low grade temps (99.8-100.2) and even pain in the axilla that developed last night from reactive lymphadenopathy." the patient spoke with Infectious Disease and consulted with ID pharmacist. "Because this is such a rare occurrence, there's not much experience with how to handle it. There is no evidence to prove that the vaccine was "inactivated." From my own personal experience, I feel confident enough to say that it was not. The Infectious Disease specialist and I agree that I should not be re-boosted. We are also concerned that the recommendation was made so swiftly without trying to glean more information first. Getting two boosters on the same day could produce very unpleasant side effects or potential serious reaction. I believe there should be follow-up with any patient who received a re-boost or is planning a re-boost. In my opinion, if this were to happen again, I would not recommend re-boosting". The patient and I discussed her concerns and agreed that it's completely reasonable to have further discussion within our organization to learn more from this incident and her personal shared experience. From our conversation by phone today, a candid discussion is greatly appreciated as well as her feedback and recommendations to engage in open dialogue with our patients to make a personal and informed decision should a booster dose be recommended should this same or similar scenario occur as no testing, production, or research studies have been done with sterile water as a diluent per my conversation with Pfizer.  I had contacted Pfizer, the manufacturer of the vaccine that same week. 1/12/2022: Phone call to the paient who reported that her symptoms (described above) after the Covid-19 Pfizer Booster dose received on 1/03/2022 have resolved; and that she is feeling back to normal and has no other concerns.
Diarrhea started at about 10:00am, body aches started at about 9:00am. Could not sleep last night, kept waking up. Joints uncomfortable since last night. Arm sore since last night around 9:00pm
Initial unsolicited report received from a non-health care professional on 18 Jan 2017. This case is linked to 2017SA010345 (same reporter). This case involves 15 patients (age and gender was not reported) who were vaccinated with a dose of FLUZONE HD intramuscularly and FLUZONE QIV (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Illness at the time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as rheumatological Disorders. Concomitant medications were not reported. On an unknown date, following the vaccination, the patients had experienced flu like symptoms. It was a Life-threatening Illness. The patient required Emergency room or doctor visit. The patient's laboratory data included flu with throat swab test showed negative result for flu. Corrective treatment was not reported. The outcome was unknown. case was considered as serious due to a Life-threatening Illness. List of documents held by sender: none. Sender's Comments: It was reported that about 15 patients who received either INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE or INFLUENZA QUADRIVAL A-B VACCINE and experienced ill with flu like symptoms. Time to onset is unknown. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Patient received 2nd dose too early. First dose was on 8/23/21 and 2nd dose given today 9/9/21
Narrative:  pt received covid vaccine. pt passed away within 42 days of getting vaccine - pt passed away in his sleep- unknown correlation with vaccine
While playing saxophone, he noticed air leaks from his mouth on the right. Weakened right side of mouth and facial fasciculations on right. In evening he had lower R eye lid lag. He recalls aching over right mastoid and joint with jaw starting on 02/06/2010.
2 days after shots, his arm had swollen up the size of half a tennis ball & was very sore. Several days later he was :Extremely confused. Exhausted. Delayed motor skills. Slurred speak. Extreme migraines.  Had to constantly put his head under water to cool it.  2 weeks later we called his doctor. He sent us to a neurologist. He said there was nothing wrong with him. Patient only digressed. He stayed confused & said his brain "was in a constant fog." He lost a lot of weight. & got terrible facial acne. He got dehydrated very easily & had ER visits. He stayed nauseated for most of that first 6 months.  Instead of his body recovering & healing, it seems to just add more symptoms.   Extensive blood work confirms: His adrenals don't work, & his body quit producing testosterone. He has to adhere to an extremely strict diet, or he agonizes with stomach cramps & intestinal pain. He is highly allergic to eggs/gluten/dairy/soy/some grains/some legumes.
Hives on legs and arms starting at 10:00 PM, worse when woke up, extreme itching. Sought medical treatment at ED at 08:30 AM. Benadryl 25 mg x 2 pills given.
Intermittent fever of 99.0-100.1 persisting 3 days after dose was received Body aches and chills persisting 3 days after dose was received Egg sized area of swelling to the right axillary area with tenderness noted approximately 2 days after dose received Decreased appetite
elevated potassium level; Initial information received on 30-Jul-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 24 year old female patient who experienced elevated potassium level (blood potassium increased), while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication if any, not reported.   On 20-Jul-2020, the patient received a first dose of suspect RABIES (HDC) VACCINE [lot number and expiry date not reported] reported via an unknown route at an unknown administration site.   In Jul-2020, the patient experiences her elevated potassium level to 5.5 (blood potassium increased), 02 days following the administration of RABIES (HDC) VACCINE.  On 27-Jul-2020 she also received a second dose of suspect RABIES (HDC) VACCINE [lot number and expiry date not reported] reported via an unknown route at an unknown administration site. In Jul-2020, 2 days later her potassium level was 6.  It was reported that, doctor sent her to emergency and they tested her potassium level and it was 4.3.   Relevant laboratory test results included: Blood potassium - In July 2020:  [5.5] then [6] then [4.3]  Final diagnosis was blood potassium increased.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for blood potassium increased.  There will be no information available on the batch number for this case.
Migraine headache, body aches all over, dizziness, diarrhea, nausea
Shoulder had a large red and purple patch and neck started hurting and kept on hurting. So I visited my Doctor on 11/18 for a checkup and prior blood work discovery. It came back clean. After I told him about my neck, he ordered X-Ray of my neck that was done today 12/10. Follow-up is to be done on 11/15. I have not been issued any treatment yet.
Chills,  shivering, sensation of swelling in throat and beginning of hives (patchy red area on arm), some shortness of breath, palpitations and elevated blood pressure. Went to emergency room for observation. Diphenydramine administered at ER.
Patient  came in to get Moderna for their 2nd covid vaccine and Pfizer was given as their 2nd covid vaccine. I personally followed up with the patient and per patient and her husband, Patient is doing just fine and had no adverse reactions to it.
As stated in #11 above, I had just been recovering from something really bad I got hit with in January.  The vaccination seemed to "reactivate" whatever it was, as all the same symptoms started back up that night except for the scalp pain.  Gastric distress wasn't quite as bad but definitely present.  Breathing definitely compromised, started back up using multiple OTC meds to get airways open.  Breathing continued to get bad for approx 3-4 days, as did gastric issues.  Started getting better on 5th day, then by 7th day doing a lot better.
No additional AE; Caller reported that VARIVAX and PROQUAD that underwent a temperature excursion were administered; This spontaneous report has been received from a health care worker concerning to patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, a temperature excursion occurred for varicella virus vaccine live (oka/merck) (VARIVAX) in which the maximum temperature was from 6 to 14 degrees Fahrenheit for a timeframe of 50 minutes and 14 to 46 degrees Fahrenheit for a timeframe of 1 hour. No previous temperature excursions were reported.  On 30-AUG-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039723, expiration date 15-DEC-2023 (dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). No additional events were reported.  This is one of three reports from the same reporter.
Was given Adacel on 6-5-08 and 2 days later developed erythema, swelling, and terderness at the injection site.  Was examined on 6/10/08 and had minimal erythema and no warmth.
tickle and cough.  pt. has a hx of asthma.  pt. self medicated herself with her inhaler in total 4 puffs;  lungs all clear.  no SOB.  pt. states she feels better and wants to go home.  HX- Asthma- food allergies.   BP: 132/78;  O2=98%;  P=76
1 wek after getting vaccine,  patient developed  maculopapular rash all over.  This was quite itchy.  No other symptoms. Rash lasted for over a week.
Redness, swelling, warm to touch, 2 inch diameter, feels muscle soreness in hand and wrist,