chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu vaccination was given to me on Sept 1st.  On Sept. 7th, I became extremely dizzy and nauseated.  The symptoms continued until Sept 9th.  I made an appt. to see urgent care at the Medical Center.  The nurse practitioner said I had labyrinthitis/vertigo which usually follows a viral infection or a flu or your bodys immune response to fight off a virus or flu.  I have no symptoms of an upper respiratory infection and no other symptoms besides dizziness and nausea.  I am currently not experiencing any dizziness at this time.
2 days p/shot red blotches on rt arm & stomach, back, chest, itches sl;
a terrible reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION. At the time of the report, VACCINATION COMPLICATION outcome was unknown.            No concomitant medication was provided. No treatment medication was provided.   Reporter did not allow further contact.
Two hours after receiving IZ child had fever, HA diarrhea, vomiting. Fever reached 104.7deg
Pain, redness, swelling, fever, chills and joint pain. Treated with Prednisone and BENADRYL.
pt recv vax 23OCT98 11AM & grandma saw pt covered w/small red bumps all over skin;thought was getting chickenpox;no vesicles devel & red areas inc in size;multiple large wheals, plaques (8 inches x 5" hives, urticarial rxn on abd;edema
Pt received his 1st dose of the Pediatric Pfizer COVID19 vaccination, as soon as the injection was over the pt stood up and immediately felt dizzy. Pt was guided to the ground where he had a near syncopal episode. Pt was flushed and sweaty. Did not hit head or lose consciousness. EMS was on site to evaluate pt.  Initial BP 86/42, repeat 95/27, repeat 110/60. Pt recovered well on site, mom declined transport to hospital.
Fever (101.5), headache, and nausea started showing up about 6 hours later. At 9 hours extreme vomiting, including the vomiting of the contents of the small intestines. Urine production stopped from 9pm Monday until 6pm on Tuesday. Went into Urgent Care treated with a liter IV for dehydration and checked for intestinal blockage-none found, and released.
Patient reported sharp generalized pain in entire right arm, with shooting pains up neck with warmth; felt lightheaded, had mild shortness of breath. Denied redness, swelling, and site tenderness of right deltoid; referred to urgent care after calling PCP; EKG performed to rule out cardiac event. Oral OTC pain medicine recommended.
Information has been received from a physician concerning a 24 month old male pt with no pertinent medical history who on 10/23/03 was vaccinated in the thigh with a dose of varicella virus vaccine live (Lot # 645044/0207N). Concomitant vaccines included Prevnar and MMRII.  The physician reported that, about 7 days (approximately 10/30/03) after varicella virus vaccine live administration the pt developed a half dollar sized red patch at the injection site with about 10 papules. No additional information was provided. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
Acute demyelinating polyneuropathy-in hospital getting IVIG; Dose number=1, 20Jan2021; Dose number=2, 06Feb2021; Dose number=1, 20Jan2021; Dose number=2, 06Feb2021; This is a spontaneous report from a contactable physician. A 25-year-old female patient received second dose of BNT162B2 (lot number and expiry date unknown), intramuscular on 06Feb2021 13:30 at single dose in the left arm for COVID-19 immunization. There were no medical history. No known allergies. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (1st dose), Lot number unknown, intramuscular on 20Jan2021 17:00 in the left arm for COVID-19 immunization. On 06Feb2021 20:00, the patient experienced acute demyelinating polyneuropathy-in hospital getting IVIG. The patient was hospitalized for acute demyelinating polyneuropathy for 6 days. Therapeutic measures were taken as a result of acute demyelinating polyneuropathy which includes IVIG. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications in two weeks. 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 outcome of the event "acute demyelinating polyneuropathy" was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported acute demyelinating polyneuropathy cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient presented to the office with increased lower extremity weakness, imbalance, frequent falls, and numbness in her legs bilaterally. The patient stated that she started having also urine incontinence in last 24 hours. The patient did receive COVID-19 vaccine, Pfizer in June.  Concerned about a CNS process disorder or even transverse myelitis, the patient was admitted directly to the hospital. The patient also had an unclear and puzzling rash on her dorsal aspect of her hands bilaterally and started having seen the rash on her foot.  She attributed that recently to a sunburn, however, it has been 2 weeks with no improvement.
red rash on arm that did not get vaccinated, no problems breathing. patient received benadryl at 11:16 pm 2/27/21 and was advised to follow up with PCP regarding allergies prior to receiving 2nd dose
big bump (0.5-1 inch) at injection site, no other symptoms report by patient right after medication injection
starting 12.5 hours post vaccine - chills, headache, body aches, nausea, rash at injection site, fatigue. Chills and headache resolved after 24 hours. Other symptoms still present 36 hours later. Treated with tylenol.
Within 24 hr of vax pt devel severe swelling from shoulder to elbow w/erythema. Pt devel cellulitis. Pt seen by MD tx/Keflex & Atarax.
Rectal T 102.6. Erythema, swelling, warmth, and pain around injection site. Irritable began 8-10 hrs after injection. Seen about 24 hrs. Left lateral thigh
body aches (all over); stuff nose; Chills; Headaches; Weakness; Tiredness; Heavy head; A spontaneous report was received from a consumer concerning a 69-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed body aches (all over), stuff nose, chills, headaches, weakness, tiredness, and heavy head.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not provided.  On 11 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Jan 2021, the patient developed body aches (all over), stuff nose, chills,headaches, weakness, tiredness, and heavy head.  Treatment for the event included 3 baby Aspirin tablet.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event, body aches (all over), stuff nose, chills,headaches, weakness, tiredness, and heavy head, was considered unknown  Follow-up  On 18 Jan 2021 ,the outcome of the event,date body aches (all over), stuff nose, chills,headaches, weakness, tiredness, and heavy head, was considered not recovered.
pt recv vax & was fussy for 48hr, no temp, no redness or swelling to site although child limped & babbled for 3 days;
Information has been received from a clinical practice manager concerning a female patient of unknown age. There was no information about concurrent condition, concomitant medication and medical history. On 01-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # M026317, expiration date 11-JAN-2018) (dose, frequency and route unknown) for prophylaxis. On an unspecified date in 2016 after vaccinated with PNEUMOVAX23, the patient developed cellulitis, which extended beyond the injection sites. Treatment with unspecified antibiotics was given to the patient. The outcome of the event was unknown. The causality between the event and PNEUMOVAX23 was not provided. Upon internal review, cellulitis was determined to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected as there is no consent for follow-up. Sender's Comments: US-009507513-1612USA012869: US-009507513-1612USA012870.
Within two hour head felt "off"  Like I was there but I was not.  Lips felt tingly.  Very nauseous feeling.  By the evening I had very bad headache and fever of 100.4.  During the night I had a pain running up my left arm up to my neck.  The next day very achy, still h ad headache and fever.  Was taking Tylenol every 6 house. By bedtime that night fever was 99.  When I woke up on Sunday morning fever was gone and so was the achy and nauseous feeling.  Headache gone also.  Arm still sore but that is to be expected
20 years old received the Td (Tenivac) Vaccine instead of the Tdap (Adacel) vaccine; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional via phone.  This case involves a 20 years old female patient received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 03-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to wrong vaccine administered.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on batch number was requested.  Document held by the sender: none.
Broke out in hives and started itching within 45 minutes.  Took Benadryl and hives started to recede after a half hour but itching continued for 24 hours
Hands itchy. Progressed later that night to whole body itching and hives present. Then hands became swollen.  On second day began having difficulty swallowing and shortness of breath with chest tightness.
It was reported that the EE felt funny and heart was fluttering. EE was brought to the ED.
4 days after 1st dose I developed a hive like rash on my upper stomach area. Very itchy and blistered after 2 days
After the first dose of the vaccine given on April 11 2021, every time I have menstruation I get abnormally heavy bleeding for 1-1.5 days. The total amount of total blood loss during one menstruation increased from 25-30 ml to 130-150 ml (measured by using the menstrual cup). More than 100 ml are lost during that one day of heavy bleeding.
Pt given DTaP on 4/12/06, On 4/13/2006 pt goes to ER with left thigh swollen and red. Pt F/U with us on 4/17/06.
Janssen 4/8/2021. Positive on 2/3/2022.
Chills, hot flashes, low grade fever, headache, fatigue, sore arm, lower back ache
Difficulty breathing, extreme fatigue, nausea, headache, fever and injection site soreness.
Numbness starting in right ankle to knee and hip area. Hospital performed sensation tests and after CT and MRI discovered multiple leasions on brain and spine.  4/24/2008 MR received for neuro consults beginning 12/21/2007 to 4/2/2008 with DX: Multiple sclerosis and Optic Neuritis. Pt developed numbness in R foot in October 2007 which progressed into the R trunk and R arm.  Weakness of the R arm resulted in pt dropping things. Two weeks later pt noted blurred vision in the L eye, associated with some mild pressure and pain with movement of the eye and unable to read.  Brain and cervical MRIs were c/w dx of MS. 6 weeks after onset pt noted unsteadiness on feet and emesis. (+) Urinary frequency and urgency as well as fatigue.  Initial PE (+) for optic pallor, weakness in R wrist, diminished pinprick and sensation in R forearm and hand.  Initally txd with Prednisone. Vision deterioration noted 12/26/07. Improved with Solumedrol. (+) Depression r/t medical condition etc.  Clinically stable 4/2008. Follow-up: I have MS, Optic Neuritis (Loss of Vision), Spine burns, legs numb, wear diapers sometimes due to problems there.
Immediate arm pain, from shoulder to wrist. At one month out, pain is severe in shoulder and exists into the elbow. Saw primary physician, 10/29/2012.
Evening after receiving vaccine, developed electric shocks to left knee and calf region periodically (2-3 per day). As days/weeks have passed has progressed into electric shock down full length of left leg, needling sensation to left great toe lasting 3-5 seconds at a time, 3-4 times per day. Also have intermittent tingling sensation to right leg, both arms and hands. Electric shock sensation to left leg only lasts 3-5 seconds but it is startling and severe when it does occur.
Many smells and tastes have become metallic and/or putrid. This is most noticeable with coffee, peanut butter, beef, sweat, bodywash, and deodorant
The participant experienced pain in her chest, hard time taking deep breaths and sharp pains in her chest.
after 6 days after shot the area of injection has swelled up and is red and itchy. it is very sensitive to the touch.
PATIENT REPORTED SIDE EFFECTS STARTED EXACTLY 2 DAYS AFTER RECEIVING VACCINE, HAD FEVER AND CHILLS THAT LASTED 2 DAYS, BUT SEVERE MUSCLE ACHES, PAINS, AND FATIGUE THAT LASTED 7 DAYS, LONGER THAN USUAL REPORTED SIDE EFFECTS.  HE REPORTED VISITING HIS PHYSICIAN DUE TO CONCERNS OF PROLONGED SIDE EFFECTS.
a grey cap vaccine was taken out and left at room temperature  for 25.5 hours and then administered to patient; a grey cap vaccine was taken out and left at room temperature  for 25.5 hours and then administered to patient; This is a spontaneous report received from a contactable reporter pharmacist from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FN2908, Expiration Date: 12Aug2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown" and all described as "a grey cap vaccine was taken out and left at room temperature for 25.5 hours and then administered to patient".  Additional information:-The product was undiluted. the product stored outside of fridge when excursion occurred. temperature reported/measured during excursion, maximum temperature was 74-degree F (23 degree C) and minimum temperature was 68 degree F (20 degree C) and it was left out at room temperature for 25.5 hrs after punctured and was administered to patient and reporter wants to know if patient needs to be re-vaccinated. Vials kept in fridge prior to taken out at 2-8 degree C.
Covid Arm. Red, puffy, hard, and hot to touch. Slight pain involved such as a bruised feeling
I developed a cough in the morning that woudl go away after an hour, but on following days the cough and chest congestion persisted longer until it was all day. My Doctor prescribed Sopiriva and it got much worse. I stopped using Spiriva and started taking  Mucinex. The cough eventually subsided after about three weeks. Previously reported shortness of breath that began with the first dose in Aprick, 2021 has persisted.
BODY ACHE; CHILLS; FEVER 102.8; This spontaneous report received from a vaccine facility 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 on 21-MAR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested.  On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 22-MAR-2021, the subject experienced body ache. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced fever 102.8. Laboratory data included: Body temperature (NR: not provided) 102.8 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 102.8, chills and body ache was not reported. This report was non-serious.
area around the injection site was slightly more  warmth; area around the injection site was slightly more  red; there was swelling about the size bigger than a quarter / swelling is around 10 inches in circumference; the injection the injection site started to hurt /  painful; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2020, the patient received the 2nd dose of Shingrix. On 21st August 2020, immediately after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site pain. On 22nd August 2020, the patient experienced injection site warmth and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site warmth and injection site erythema were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site warmth and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient received the second dose of the Shingrix vaccine on in her left arm. Soon after the injection the injection site started to hurt and there was swelling about the size bigger than a quarter.  The patient She stated may be around 22nd August 2020, the patient noticed the area around the injection site was slightly more red, warm, painful, and the swelling was around 10 inches in circumference and the patient stated the swelling diameter had been increasing. The reporter consented to follow up.
Moderna COVID-19 Vaccine EUA Low back stiffness and pain within 20 minutes of the shot. Continued mild to moderate low back pain...taking  Naproxen daily to manage the pain. 3 days of vaccine site(R arm) moderate pain. Dizziness 20 minutes after taking the shot. The dizziness lasted for about 20 minutes.
Pain/ right knee; Inflammation; Swelling; This case was reported by a pharmacist via call center representative and described the occurrence of pain ankle in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number ZG47A, expiry date 12th February 2021) for prophylaxis.   On 24th January 2019, the patient received the 2nd dose of Shingrix. On 27th January 2019, 3 days after receiving Shingrix, the patient experienced pain ankle, inflammation and swelling. On an unknown date, the outcome of the pain ankle, inflammation and swelling were unknown.   It was unknown if the reporter considered the pain ankle, inflammation and swelling to be related to Shingrix.  Additional details were provided as follows: The patient started experiencing right knee and ankle pain, inflammation and swelling, which happened to be on the same side of the injection. The reporter consented to follow up.
Pt developed whelts and rash approximately 8:00 PM on day of vax. Broke out head to foot by the next day. Somewhat itchy. No fever or breathing difficulties. Was seen by family MD and given Atarax. Rash is resolving. MD didn't feel like it was due to the injection, but nothing else had been performed recently except on 1/2/00, the pt was given adult Nyquil, had been receiving children's Nyquil prior.
Information has been received from a consumer concerning her male son with allergies to eggs, soy, wheat, mustard, peaches, maple syrup, milk, shellfish, and nuts (expect peanuts) who on an unspecified date was vaccinated with a first dose of MMR II. Subsequently, the patient experienced "some allergic reaction" after receiving the vaccination. Unspecified medical attention was sought. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/17/2022,  9/24/2022,   2/19/2023  -- RECURRENCE OF SAME SYMPTOMS
Rash all over body, spreading times 2 days, complain of itchiness.
Pfizer-BioNTech COVID-19 Vaccine EUA I experienced soreness in the left side of my neck within a few minutes of getting the vaccine shot in my left arm. Approximately 5 minutes after the shot I experienced swelling in my throat. The swelling did not restrict my breathing but it was uncomfortable and unlike anything I have experience before. I have never had a previous allergic reaction to any shot, medication, or food in my medical history. Approximately 10 minutes after the symptoms began, the swelling of my throat went away.