chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Description of Event Patient received second dose of pediatric pfizer. A small welt formed under the right eye. Mother stated, "when he has a reaction, it always starts like this."  Interventions:Vital signs taken, patient given apple juice. Observed for an additional 30 mins.   Medications administered:  Children's benadryl 12.5 mg PO  Medications administered in accordance with:  Administration of Emergency Medications by RN's. Per County Standardized procedure.  Response to interventions and/or medications given:Condition improved.    Disposition:Home Treatment with mother
Fluctuating fever ranging between 99.9-102.4 over the course of 26 hours so far Severe headache Severe arm pain Chills Back and neck pain Joint pain Loss of appetite
Rash on back of neck, right eye swollen, Epinephrine 1:1000 0.5 ml/sc. Treatment: Benadryl 50mg/ml IM. ice pack on right eye.
7 days after H1N1 vaccine administered, pt presented with 2x2cm induration and central 1 mm eschar. Tx with KEFLEX, f/u in 4 days. At f/u, no eryth, firm nodule, no tenderness.
Broke out in hives all over legs; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308A) via an unspecified route of administration in the right arm on an unknown date, as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient experienced broke out in hives all over legs. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event broke out in hives all over legs was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Injection  was given in the extreme upper arm/shoulder area. Two  days after the injection, the upper arm (from shoulder to elbow) was in extreme pain and almost zero range of motion (pain level on a scale of 1-10 was a 10). After two days, range of motion  and pain improved slightly (pain level 6). Nine days post injection, still experiencing pain and lack of range of motion. Difficult/painful to lift arm above shoulder range (pain level 7). Pain in shoulder and upper arm. Doctors appointment made for Monday, February 1st.
Redness, swelling, pain, warm to touch, developed within 24 hours of receiving vaccine.
Low-grade fever with pain, swelling, and redness at injection site that worsened initially before symptoms/signs resolved 2-3 days after initial presentation. Treatment included analgesics - acetaminophen and ibuprofen. Patient's tachycardia and leukocytosis also worsened, but improved with treatment - fluids and antibiotics.
Vaccination failure; Herpes zoster; Pain; Information has been received from agency (agency #  AU-TGA-0000742743) On 30-OCT-2023.   This spontaneous report was received from patient via interactive digital media who was currently 73 years old with unknown gender via social media referring to him/herself. Information about medical history, concurrent conditions and concomitant therapies was not provided.   On an unknown date (at patient's 70 years old), the patient was vaccinated with zoster vaccine live (manufacturer unknown) subcutaneous injection, administered for prophylaxis (strength, dose description, lot #, expiry date, anatomical site of administration and route of administration were not provided).  On an unknown date (after 1 year), the patient had shingles (herpes zoster). On an unknown date, the patient experienced excruciating pain lasted for ages. On an unknown date, more than a year after receiving zoster vaccine live (manufacturer unknown), the patient experienced vaccination failure. On an unknown date, the patient recovered from the event of shingles and pain. At the time of reporting, the outcome of the event vaccination failure was not known. The patient enquired about having different vaccination which would be costly. The patient hoped to never get shingles again. It was reported that this case described the occurrence of suspected vaccination failure, this case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting. The causal relationship between shingles, pain, vaccination failure and zoster vaccine live (manufacturer unknown) was unknown.  The reporting institution considered vaccination failure as medically significant.
Pain in arm that began the day of flu shot administration and that is not currently resolved. The pain feels like it is coming from "inside", like a "rotator cuff injury". It is causing insomnia and muscle problems in her back. It hurts when it is immoble.
On 7/28/08 client received a PEDIARIX and PREVNAR and should not have received these 2 vaccines. Client had no adverse reactions.
Reaction noted at 3:34 pm, upon arrival of nurse to waiting room, mother stated that daughter "fell out" but, denies injury. Pt. was sitting in chair with mother standing beside her. She was alert and responsive. Denies discomfort. Phone call to mother on 3/23/15 at 915 am to follow-up with client. Mother state client ws doing fine. Denies any PCP or ER follow-up. Wt 95 lbs. V/S 3:40 pm 92/63, 78, 20-O2 stat RA 99% 345 pm - 93/59, 80, 20-O2 stat RA 100%. Left ambulatory with mother at her side.
Broke her arm; Fell; Missed her second dose; This spontaneous case was reported by a consumer and describes the occurrence of UPPER LIMB FRACTURE (Broke her arm) and FALL (Fell) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fall on 09-Aug-2021.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced UPPER LIMB FRACTURE (Broke her arm) (seriousness criterion hospitalization) and FALL (Fell) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed her second dose). At the time of the report, UPPER LIMB FRACTURE (Broke her arm) and FALL (Fell) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed her second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was hospitalized for 3-4 days. Concomitant medication use information was not provided by reporter.  Treatment medication use information was not provided by reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded However, the causality for the event of dose omission assessed as not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded However, the causality for the event of dose omission assessed as not applicable.
3 days after vaccination, patient presented w/ a hardened red area at site of administration. Both hands are swollen and sweaty. Also developed chills and headache w/o a fever (afebrile).
Entire body aches, headache, dizziness, nausea, pain in left arm from below elbow up into the neck. Lasted 10 - 14 days.
Patient came in for a Shingrix vaccination. She was given a flu shot. She had already received a flu shot on 10/3/19. This shot was not listed on GRITS. The Shingrix was also administered. Patient states that she started running a fever that evening and had a seizure from the high fever on 11/26/2019.
pt presented to ED with hx of positive COVID test earlier in the week from a dr's office, cough, weakness, fatigue x 1 wk; hypoxic, placed on nonrebreather; in respiratory failure due to COVID pneumonia; pt's condition worsened and she died in the hospital
left overnight at room temperature; administered; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT STORAGE ERROR (non-serious), outcome "unknown", described as "left overnight at room temperature"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "administered". Additional information: Additional information: Reporter details confirmed with the patient. The patient confirms he is calling about the Pfizer Covid 19 vaccine, gray cap vial and Pfizer Covid 19 vaccine, pediatric vial. The patient stated the vaccines were left out at room temperature overnight, and administered to two patients the next day. The patient clarifies that one patient received one dose of the Covid 19 vaccine, gray cap, and another patient received one dose of the Covid 19 vaccine, pediatric, for a total of two patients. The patient asks if the patients need to be revaccinated and for any information that can be provided for this situation. The patient declines to complete a full report, as he has been on hold for 35 minutes and is presently driving in the car. The patient stated to his knowledge, there have been no issues with the patients.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200419219 same reporter/drug/event, different patients.
devel gen rash, itching, wheals over back, chest, face, arms & legs;denied any SOB or tightness in chest;this occurred w/in 1-2hr of inj;recv DPH & cimetidine;
prolonged muscle soreness in left arm (first and second dose); pain at the injection site; redness at injection site; itching at injection site; tenderness in underarm lymph node; Fever; chills; body aches; headache; fatigue; This is a spontaneous report from a non-contactable consumer or other non-HCP (patient reported for self). A 33-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0164), via an unspecified route of administration, administered in left arm on 15Apr2021 08:30 (at the age of 33-years-old) as dose 2, single for COVID-19 immunization. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8737), via an unspecified route of administration, administered in left arm on 25Mar2021 at 08:30 (at the age of 33-years-old) as dose 1, single for COVID-19 immunization and experienced muscle soreness and disruption of menstrual cycle. Facility where the most recent COVID-19 vaccine was administered mentioned as Other. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination. Medical history included known allergies to Sulfa. Concomitant medications (received within 2 weeks of vaccination) included loratadine (CLARITIN [LORATADINE]); naproxen sodium (ALEVE) and Olly Women's Multi-Vitamin. On 15Apr2021 20:30 the patient experienced Fever, chills, body aches, headache, fatigue, prolonged muscle soreness in left arm (first and second dose), pain at the injection site, redness at injection site, itching at injection site, tenderness in underarm lymph node for 36 hours following vaccination. Post vaccination, patient was not tested with covid 19. No treatment was given for the reported events. The outcome of event prolonged muscle soreness in left arm and tenderness in underarm lymph node was recovered on an unspecified date of Apr2021. The outcome of rest all events was not recovered.  No follow-up attempts are possible. No further information is expected.
pt recv vax in 1991 w/2 doses of vax 5yrs later;pt devel a throat infect characterized as mild epiglottis;pt was hospitalized for tx w/ATB;intubation was not required;results of cultures are unk;pt recovered
multiple patients were vaccinated with improperly stored VARIVAX; No adverse effect; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R017642 and expiry date 20-JUN-2020) for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
A physician reported the occurrence of encephalopathy and neuropathy in a subject of unspecified age and gender who was vaccinated with Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was presented as a poster session at the 127th annual meeting of the Neurological Association. The subject's past medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject received an injection of LYMErix; it was not known if the subject had received previous injections of LYMErix. At an unspecified time post-immunization, the subject developed "neuropathy adn encephalopathy complaints." The reporting physician stated, "We are not certain the pt developed these conditions from the vaccine or possibly from Borrolia burgdorferi infection." As of 10/17/02, the outcomes of the events were unknown. Encephalopathy is considered medically serious (OMIC).
A nurse reported the occurrence of joint pain in an adult female of unspecified age who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history included an unspecified adverse event following receipt of tetanus toxoid.  Concurrent conditions and medications are not reported.  On approximately 03/15/03, the subject received her first injection of Engerix-B.  "Shortly after administration", the subject developed joint pain including shoulder and knee pain, and was "feverish".  The events resolved without medical attention after approximately two weeks.
Pt. given Tdap LA on 7/9/08 - noted swelling lymph nodes in axilla, supra clavicular area - neck also felt swollen.  Noted sx. 3 d after getting ADACEL.  All sx. on L side - no sx. at inj. site.  Lethargy, temp. 100.2, sore all over - temp. x24 hours - sx. gone by 7/14/08.
This spontaneous report as received from a pharmacist refers to a 11 year old male patient. On 08-JUL-2014, the patient was vaccinated with an inadvertent dose of ZOSTAVAX (lot#, expiration date, dose, route, strength and indication not reported). The pharmacist also stated that the patient should had received his first dose of (Oka/Merck) VARIVAX (lot#, expiration date, dose, route, strength and indication not reported). No adverse effects was reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Allergies: Thimerosal" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergies". Additional information: The patient had allergies and she wanted to know the ingredients.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
leg went out; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MUSCULAR WEAKNESS (leg went out) in a 52-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included MS. Concurrent medical conditions included Autoimmune disorder.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (leg went out). At the time of the report, MUSCULAR WEAKNESS (leg went out) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Increased blood pressure from 150/70 to 174/80 then back to "normal" after 20 minutes. Dizziness, blurred vision; this happened approx. 1/2 hour after shingles vaccine. No treatment was required, nor given.
Insomnia, persistent Night terrors Personality change with rages, which resolved over approx. 2 month period
I did not have any adverse events initially, but on the evening of 7/4/2021 I had a fever and had trouble sleeping, I just chalked it up to a day in the sun. On Monday, 7/5/2021 I had a sore throat; Tuesday, 7/6/2021 small cough; Wednesday, 7/7/2021 it moved into my chest; Thursday, 7/8/2021 loss my sense of taste. Thursday night I purchased an over the counter Covid test and it came back positive. On Friday, 7/9/2021 I went to my doctor on Friday morning and on Monday 7/12/2021 I was informed from my doctor's office the test was positive. Today on 7/14/2021, I feel pretty good, I am not doing too bad, I have a cough every so often and my taste has returned.
high pulse rate, migraine headache, aches and pains, nausea, lymphedema's
1st dose in February 2018 and the 2nd dose in November 2018; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2018).   In November 2018, the patient received the 2nd dose of Shingrix. In November 2018, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 25-OCT-2022 Reporters comment: The reporter was patient she herself reported that had both Shingrix vaccines in 2018, she had her second dose after 6 months from the date of the first dose. No additional information was provided. Lot and expiry date not available for either vaccine. Additional Supportive information: The patient received 2nd dose later than recommended interval, which led to lengthening of vaccination schedule.
Chin burning/ face on fire; This is a spontaneous report from a contactable consumer. A 16-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: EW0162; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in Arm Left on 12May2021 as single dose for COVID-19 immunisation. Medical history included ongoing asthma. The patients concomitant medications were not reported. The patient not received any other vaccinations within four weeks prior to the COVID-19 vaccine. The patient experienced chin burning/ face on fire on 12May2021. She has 3 teenagers. One is 16, and he got the vaccine approximately 2 weeks ago. The other 2 teens got the vaccine last Tuesday. The 16 year old and 13 year old both had substantial side effects. She does not seem to be hearing about them. They both received their vaccines at the same medical facility. She is concerned about whether they should get the second dose based on their reaction. She asks what Pfizer recommends. Reporter stated that her son has severe allergies and they knew that when he went in there. They were watching him. Upon getting it, 15 minutes later his chin was burning. It was not significant and did not get any worse. Then for the next 4 days his face was on fire to the point where he could not even use soap or moisturize because it was really painful. She did not make the connection until her daughter had the same symptoms the night of her vaccine. The burning in his chin went away. She is not sure when it went away. It did not last that long and face on fire His face started the night he got the vaccine. It lasted for about 4 days. It has totally gone away. The patient did not visited Emergency Room and Physician Office. The outcome of the event was recovered.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Additional Details: patient experience hypotensive, lighheaded, and sweaty after receiving his first dose. RN, monitor vitals of patient blood pressure (131/73) and pulse 66 observed. His blood pressure was monitore again and it was 96/52 and pulse 58. He was asked to lie down. He drank some water and offer to drink gatorade. He drank gatorade and feel better. He got up after 5 mins and he was asked to seat. He waited 15mins and his blood pressure was 11368 and pulse 64.
I AM HAVING FROM THE DATE OF 4/16 AND THE FIRST EPISODE OF VERTIGO CONTINUAL VERTIGO 24 HOURS ADAY
pt exp an elevated INR p/vax;pt INR were w/in nl range prior to vax;when checked on 11/10/99 INR was 69;MD stopped warfarin for 3 days;2nd day INR dec to 4.8 or 4.9;did not have the values for the subsequent INR tests;
After receiving my booster dose?Normal symptoms such as injection site soreness, sore arm, fatigue. But at 4AM next morning I awoke paralyzed, couldn?t move, couldn?t feel my arms or legs, could barely breathe.  Took short breaths and kept trying to move. Finally got feeling and then I could feel EVERY a joint in my body. Intense joint and muscle pain. Kept taking deep breaths until I got enough feeling to walk. Took Ibuprofen and Tylenol, symptoms subsided over the next few hours. Fatigue and muscle soreness the next 24-36 hours. Did not go to hospital or doctor.
achy from head to toe/had temp of 102.1 last night/then 100.6 at 4a.m this morning, severe headache, nauseated, chills/shakes, no vomiting, had some diarrhea
10:45 About 20 min post vaccination, during medical monitoring, reports feeling numbness left side of face w/scratchy throat; vital assessment: BP 114/83 P 84 O2 sat 97%RA.  11:30 Client, denies any additonal complaints, refusing any additional evaluation / treatment, released from facililty w/self