chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt awful; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a day after receiving Shingrix, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was not recovered/not resolved.   It was unknown if the reporter considered the feels awful to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient felt awful during the night and on the day of reporting after receiving Shingrix.
Pt recvd 2nd dose of vax on 27JUL92 & 10AUG92 approx 2 to 2 1/2 wks following 2nd vax, exp arthralgias, insomnia, dizziness, devel petechiae; pt treated w/DPH; @ time of the report, hives devel;
Extreme Headache, Pain all over my body, general sick feeling, watery red itchy eyes, low grade fever and chills all over my body especially the head, extreme weakness.  It lasted for 2 days.
10/12 -10/14: 10-grade temp (=99.5degrees) within 2hrs of shot. 10/15/10 - 10/16/10: chills, temp. spikes (101.7 degrees). 10/14 -10/21:Purpura around ankles. 10/14 - present: rash over most of body; dry cough; feet and fingers swollen; opthamalic migraines. Diagnosis: Hypersensitivity Vasculitis; reaction to flu vaccine. Hospital ER - Prednisone 60mg/day (1 week).
This spontaneous report as received from a physician refers to a 12 year old female patient. Pertinent medical history was none. There was no history of drug allergy or reactions. On 22-OCT-1988, the patient was vaccinated with first dose of (Oka/Merck) VARIVAX (unknown route, strength and dose) and on 11-MAR-2008, the patient received the 2nd dose of (Oka/Merck) VARIVAX (unknown route, strength and dose) (inappropriate schedule of drug administration). On 19-JUN-2015. The patient was seen in the office on 19-JUN-2015 and had titers drawn. The medical assistant stated, the titers showed low immunity on an unknown date in 2015. The patient was in the office today, 31-JUL-2015, in order to receive a "booster dose" of (Oka/Merck) VARIVAX due to the "low immunity"  however the patient was inadvertently administered a dose of ZOSTAVAX (lot # L006381 and exp. 25-MAY-2016) instead of "booster dose" of (Oka/Merck) VARIVAX. No treatment was received in response to the event. The outcome of the events was unknown. The causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
large local rash from shoulder rt to elbow hard red & swollen resolved p/4 days treatment was symptomatic;
recent IGG test for mumps and the result came back as less than 10, below the accepted protective level; This spontaneous report was received from a physician via a company representative referring to a 6-year-old patient of unknown gender. Information of the patient's medical history, concomitant medication and concurrent condition was not reported.  On unknown dates, the patient was administrated with 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (strength, lot #, expiry date, anatomical location and route of administration were not provided) for prophylaxis at age 1 years and 4 years respectively.  On an unknown date (reported as recent), the patient had a immunoglobulin G (IGG) test for mumps and the result came back as less than 10 (unit not provided), below the accepted protective level. The reporter was requesting medical information and inquiring if the patient should be revaccinated and if so should the patient receive 1 or 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The outcome of the event was unknown. The causal relationship between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
upper arm swelling ("several timed bigger"); lips and tongue swelling; lips and tongue swelling; a hot burning rash from head to toe; a hot burning rash from head to toe; recent diagnosis of chronic heart failure; very hard of hearing; This spontaneous report as received from currently a 83 years old female patient, reporting on herself.  The patient reported that while working in a hospital in 1982, she was exposed to unknown "medicinal chemicals" that broke down the immune system and caused a "multitude off problems from the point on". The patient experienced chemical and environmental sensitivities, allergies to seasonal pollen, and various unknown autoimmune problems as a result of the exposure. She also had "numerous side effects to a lot of medications and allergic reactions to medications". The only treatment provided at that time, was being sent to another region for twenty years to get away from any pollution in order to try to get her immune system to heal itself, "and it get stronger but has not healed completely". When she was asked to about the concomitant therapies, she reported "a multitude of medications for various ailments" that she could not remember.  In an unspecified date in March 2006, in the afternoon, when she was approximately 68 years old, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) 0.5 milligram (lot number reported as 121OR, but upon internal verification determined as 1210R which has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent), with expiration date reported as March 2007, but upon internal validation established as 30-MAR-2007) for prophylaxis (route of administration and anatomical location were not reported).  She reported that she had a severe reaction to the vaccine. She waked up at 4 am with upper arm swelling ("several timed bigger"), a hot burning rash from head to toe, lips and tongue swelling. Therefore, on an unspecified date in 2006, she was hospitalized and was treated with an unknown medication by an allergist for an unknown amount of time. Additionally, she reported that was very hard to hear, and that she was recently diagnosed with chronic hear failure. The outcome of the events was not reported.  The causal assessment between the events hypoacusis and cardiac failure chronic with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not provided.  Upon internal review, the event cardiac failure chronic was determined to be medically significant.
Patient noticed some swelling of injection site 11/7/12.  Awoke on 11/8/12 with hives on left arm from shoulder to wrist, very itchy.  Also with 2cm erythematous induration at left deltoid injection site - very tender to touch.
acute onset B/L LE weakness, pain and numbness/tingling, consistent with early atypical AIDP.  Client vaccinated on 1/25. First noticed weakness in lower extremities on 2/15, sought care,  discharged home with oral steroids.  Returned to health care on 2/22 due to worsening of symptoms. Transferred to Hospital for evaluation for possible GBS. MRI and Lumbar puncture performed, no suspicious findings.  Discharged home with adjustment in pain medications and referral to Neurology Neuromuscular Clinic on 3/3/22.
Got covid vaccine around 0745, Driving home from hospital, felt like throat was warm and closing, heart racing and shakey, pulled over call 911 at 0816 and ambulance arrived. Blood pressure was elevated, symptoms subsided and took Benadryl. Minor tingling in throat post- event.
Rash, welts, fever and nausea 24 hours after administration of vaccine. Started with flu like symptoms progressing to welts on extremities and trunk. Placed on Prednisone 20 mg PO/q day and increased to 40mg per order Dr. On 09/19/2001, to be titrated down to 5mg over several days time. Return ro clinic if symptoms increase.
Started showing symptoms of Covid on August 31, 2021. Tested positive for Covid on September 3, 2021. Symptoms began with scratchy throat and stuffy nose. Continued for days with stronger productive cough and congestion. These symptoms lessened by September 5, 2021 but remained for a few weeks (only minimum cough and stuffyness). Loss of taste and smell on September 5, 2021 which continued for two weeks or so. Smell still is not fully recovered. The tiredness and brain fog became more present on September 6, 2021 and continued for days. By the 10 days of quarantine on September 10, 2021, the symptoms were mostly minimum but a few weeks before I felt fully recovered.
Patient received her second dose on march 30th. On April 5, patient started to have redness, swelling, and itchiness on the injected arm (upper arm to above elbow).  She reported slightly improvement in a couple days.
Myalgia & Fever Narrative: x2 d after #2 dose fever 101 and myalgia  stayed home from work  Other Relevant History:
Persistent arm soreness, bruising, stiffness. Used heating pad/pain patches sometimes relieves pain. Still stiff but hurts when extend arms.
Pt requested J&J vaccine but was accidentally administered Moderna. He was given a follow up appointment for 4 weeks for his second dose
Side effects 24hr after; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects 24hr after) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects 24hr after). At the time of the report, VACCINATION COMPLICATION (Side effects 24hr after) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. No treatment details were provided
Came in with nausea, vomiting and diarrhea. Complained of generalized weakness.
Redness, swelling, pain, nausea, August 12, 2021 Dizziness, August 18,2021
Woke at 6:00 a.m., began having dull headache around 6:30.  Nothing severe. Do not normally get headaches.
Patient is a 76 y.o. male patient of MD with history of hypothyroidism, CAD, HLD, HTN, asthma, chronic cough, and former tobacco use.  Presents with SOB, chills, decreased appetite.   Acute hypercapnic/hypoxic respiratory failure HHF on admission  VBG w/ pH 7.36, pCO2 62.2, HCO3 34.9 CXR: left sided airspace disease, prominence of hilar region Respiratory status worse1/3-1/6 Now improving, weaned to NC on 1/11  Scheduled/PRN nebs, Pred taper  On NC, autopap at night  DC w oxygen, home O2 eval ordered for 1/13  Needs OP pulm f/u and PFT  Patient qualifies for home O2   Covid-19 Virus Infection Sx onset 12/27/22, positive 12/29/22  Out of isolation on 1/7/23  Was symptomatic w respiratory failure  Treated w remdesivir and steroids     Hypothyroidism Continue home Synthroid 88mcg   HTN Holding metoprolol, hyzaar in setting of sepsis Home meds: metoprolol 25mg at bedtime, hyzaar  Gradually reintroduce meds as able/needed Monitor BP    CAD HLD Daily ASA, Rosuvastatin   Asthma No formal PFT Consider PFT outpatient   GERD Endorses use of Nexium at home Protonix daily   Constipation  Last bowel movement on 01/12/23   Increase bowel regimen
During post-vaccination observation, patient stated her vision was blurry when looking upward. She was concerned her blood pressure was high. She denied dizziness, nausea and lightheadedness. She admitted she did not take her morning blood pressure medication Telmisartan 20 mg tab. She requested to have her BP checked. She was able to stand on her own and walk to exam area #5. At 11:53 a.m. BP 125/85 (L,sitting); HR 86/m; O2sat 99% on RA. She felt well otherwise. She returned to her seat in the observation area; was stable and blurriness resolved over the next 5 minutes. She was released from the vaccination clinic.
Patient received second vaccination on 07/06/2021. The next day the patient was having problem breathing  with shortness of breath.
C/0 rash/hives starting on arms, wrists spread to face and legs 7-9 days post injection. Treatment prescribed by primary care MD, ----->, Medrol pack --->, -----> rash/hives disappeared within 24 hours of start of treatment.
FEVER WITH CHILLS; PAINFUL WARM RED KNOT AT VACCINATION SITE; This spontaneous report received from a patient concerned a 37 year old female. The patient's weight was 220 pounds, and height was 63 inches. The patient's past medical history included anxiety, and postural orthostatic tachycardic syndrome, and concurrent conditions included penicillin allergy, and other pre-existing medical conditions included patient was not pregnant at the time of vaccination. Patient is allergic to some anti-anxiolytic drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced painful warm red knot at vaccination site. On 07-APR-2021, the subject experienced fever with chills. Treatment medications (dates unspecified) included: ibuprofen, loratadine, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever with chills, and had not recovered from painful warm red knot at vaccination site. This report was non-serious.
Got the 2nd dose of the vaccine at 11 am on 2/13/2021, My arm started to get sore around 4 pm, around dinner time about 6 pm I started to get a headache, chills and body aches. Was not able to sleep that night, got up the following morning with a massive migraine and body aches, chills were not that bad. As the day progressed by migraine stayed, probably the worst migraine I ever had. The chills went away early afternoon and the body aches deceased as the day went on.  Sunday night did not sleep much woke up with a migraine but not as strong.  Monday progressed  and the migraine deceased as the say went on. Slept well Monday night and woke with Tuesday feel normal.
Patient reported feeling sweaty, hot, short of breath and dizzy about 6 minutes after receiving vaccine. MA brought patient back to room to room so she could lay down, and reported that she was very unsteady on her feet. Gave patient water, crackers and an ice pack. She denies prior reaction to vaccines or injection. Denies feeling anxious prior to receiving vaccine.   After five minutes, checked on patient, who reported that she felt better.   Checked on patient again about 30 minutes after having received the vaccine. She reported feeling fine. Denied any of the previous symptoms at that point
17NOV98 pt presented to ER w/throat lightening, wheezing, tachycardia & dizziness;sx lasted hr;pt stated anxious about the rxn;DPH given;
15 minutes after injection, nausea, stomach cramps, and hot flush from head to toe, no fever noted. Tylenol 650 mg taken water and crackers with no change in symptoms. Symptoms resolved by 7pm after sleeping 2 hours. Injection site non sore/tender quarter size discoloration noted at site.
15AUG88 8 1/2 p/DTP & 5 hrs p/vax had generalized tonic/clonic sz lasting approx 40 minutes; pt taken to ER by ambulance, intubated & sz stopped by IV drugs; febrile seizure cont until JUN89; JUN90 nonfebrile sz dx epilepsy;
Severe headache, muscle aches,fever, chills lasting for 15 hoursnone
- He felt dizzy and nauseous  after he got vaccinations. On exam was pale. Was taken to exam room and kept on exam table. He felt better and repeat B.P was 102/72 mm Hg. Lungs were clear; CVS exam was normal. Pulses were full and regular. Stayed in exam room for about 25 minutes for observation and was sent home..
left leg red hot to touch and swollen. Dr gave Keflex 250/05 susp to be taken for 5 days.
No adverse reaction reported - *Child mistakenly given Hep A 35 days prior to 1st Birthday.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Systemic: Nausea-Medium
Patient states he had radiating pain (radiculitis) and muscle spasms in left shoulder and neck starting the day after the injection and has gotten worse and has been unable to sleep.  Patient symptoms got worse 10/10/23 (day 9 after injection). Patient started taking a medrol dose pack starting 10/10/23. Patient went to orthopedic prescriber 10/12/23 and he was given flexeril and meloxicam.   Orthopedic prescriber took xrays and diagnosed patient with arthritis in neck.  Patient was unsure this was from the vaccine but is highly encouraged to fill out a form.
my arm was really itchy; lump; This is a spontaneous report from a consumer (patient) reported for herself that. A 67-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 13Apr2021, the patient noticed her arm was really itchy and a lump there, not at the injection site, it's 2 inches over from the injection site. It was reported that, she laid on her left side all the time. Not sure if side effect or something else. Outcome of events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Employee states on 2/2/2021 started feeling tired, fatigued and running low grade temperature; on 2/5/2021 started to feel lightheaded, experienced mild confusion, running low grade temperature; started to experience mild memory issues, i.e. forgetting simple directions of previous places visited and difficulty in spelling common words; notified EH, on 2/9/2021 she was evaluated by her primary care physician and he is currently running lab tests.
The evening of 4/07/2021, I  had chills and body aches. Since then I have headaches off and on .
difficulty swallowing; jaw got very sore like it started popping out of joint and couldn't open wide/large dime size knot on the left side of jaw right at tmj area; jaw got very sore like it started popping out of joint and couldn't open wide; tingling down left leg down to toes, left leg only/tingling on the left leg; large cyst on the left side of her jaw; sore right jaw with clicking sounds; large dime size knot on the left side of jaw, right at TMJ area;hardness; pimple; This is a spontaneous report from a contactable other health care professional. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Batch/Lot Number: EN8203; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. There were no medical history and concomitant medications. On 04Mar2021, reports getting the vaccine on 04Mar2021 and has had a large cyst on the left side of her jaw, sore right jaw with clicking sounds and tingling on the left leg, an hour and a half after. Also reported difficulty swallowing. Reported that she had reactions, not immediately, but 1 hour and 15 minutes after the vaccine. Caller reports a large dime size knot on the left side of jaw, right at temporo mandibular joint (TMJ) area. Injection was on left side. Caller reported that minutes later, her jaw got very sore like it started popping out of joint, and couldn't open wide. She also states that she had tingling down the left leg, down to the toes, left leg only. States this all happen pretty much right at the same time, maybe 5-10 minutes of each thing happening. She is at home with grandson. She was on hold for a while already. Weird reactions, not the common ones. States that she is not going to take the second vaccine, is afraid to take it. At this point, it is just a hard knot (described as a large dime size knot), and he (the doctor) said to take a Benadryl, which she did. Knot, hardness resolved gone by 06Mar2021, but a pimple remained for 7 days. The outcome of the event jaw disorder, jaw pain, was recovered on an unspecified date, for the event tingling of extremity was recovered on 04Mar2021, for the event large dime size knot on the left side of jaw, right at TMJ area;hardness  was recovered on 06Mar2021, while unknown for the other events.   No follow-up attempts possible. No further information expected. Batch/lot number already provided; Sender's Comments: Considering the close temporal association (reportedly, the reactions occurred  hour and 15 minutes after the vaccine), a causal association between the reported events and BNT162B2 vaccine 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.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information on patient's pertinent medical history and drug reactions/allergies were not reported. On 02-JUL-2018, the patient was vaccinated with one dose of VARIVAX (strength, dose and route of administration were not reported) (lot # N026071 and expiry date: 20-SEP-2019) for prophylaxis. The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (unknown manufacturer) (lot # and expiry date were not reported). The vaccine was stored in the range -9 °C (degrees Celsius) to 8 °C (maximum -6.0 C) for 9 hours 44 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1807USA006960.
Mother called to  to report daughter started to have knee pain sometime after receiving the first dose of HPV vaccine. States currently daughter is experiencing fevers on and off and has had increased joint pain since receiving the second dose of HPV vaccine in June 2022. Advised I could not confirm if symptoms were due to vaccine but usually vaccine side effects are seen during the 2 weeks after vaccine administration. Also advised to seek medical attention if fevers and joint pain continue. Mother states child has been seen by doctor. Advised I would also complete a VAERS report.
I got the shots /felt alittle tinged across my lower back; This case was reported by a consumer via interactive digital media and described the occurrence of back pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of back pain (received 1st dose on an unknown date. For the tolerance of 1st dose, refer linked case US2021AMR135358).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced back pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the back pain was recovered/resolved.   It was unknown if the reporter considered the back pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient felt a little tinged across lower back for a few days.