chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight pain at injection site; This is a spontaneous report from a contactable consumer. This consumer reported for herself that,   A 52-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL3247) (at the age of 52 years old), dose 1 via an unspecified route of administration, administered in arm right on 02Mar2021 09:30 as dose 1, single for covid-19 immunisation, workplace clinic. Medical history included drug hypersensitivity to penicillin from an unknown date and unknown if ongoing. Concomitant medication(s) included ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. It was reported that on 02Mar2021 patient experienced slight pain at injection site. Treatment for the event was not received. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome for the event was recovering.  No follow-up attempts are needed. No further information is expected.
reported by grandmother, 6SEP97 T105 taken to ER;motrin & APAP were prescribed;
Pt. states "didn't feel well" night given. Localized reaction noticed next day. Tx cold pack. Seen by MD 11-1-11 - 2x3 warm erythema area - no skin break down. No oral edema. No pulmonary changes. Tx Prednisone, doxy & pain med.
Pt. reported feeling flushed and requested BP be taken.  BP was 170/9.  Pt. observed for an additional 15 minutes.  Pt. has complaints of intermittent CP.   Pt. advised to go to ED, but declined.  Pt. BP retaken and was 155/87.  Pt. chose to leave clinic.
This spontaneous report as received from a physician refers to a female patient over 80 years old. Information regarding the patient's medical history was not provided. In the year 2007 (exact date not reported) the patient was vaccinated, subcutaneously, with ZOSTAVAX. Further information regarding dosing regimen was not provided. No other co-suspects were reported. No concomitant medications were reported. On an unknown date (reported: "while on ZOSTAVAX") the patient experienced shingles. The patient had sought medical attention, no treatment information was reported. The outcome of shingles was reported as not recovered. A reporter causality for shingles was not provided for ZOSTAVAX. Additional information is not expected.
At 9:55 client complained of 'something sitting on my chest'. Stated she is 'allergic to unknown substance'. Vitals were stable throughout the incident and at 10:10, client stated that the pressure was relieving.
some issues with her arm; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (some issues with her arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 028d21a) for COVID-19 prophylaxis.     The patient never had COVID-19 positive test or diagnosis. The patient had no history relating to mentioned and both Acute and Chronic illnesses at the time of vaccination. The patient had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Treazodone).   On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIMB DISCOMFORT (some issues with her arm). At the time of the report, LIMB DISCOMFORT (some issues with her arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: result not reported Result not reported.         No concomitant medications were reported. The patient was not sure if she experienced a similar event in the past. The adverse event was ongoing with no improvement but instead the symptoms worsened. Treatment included Cortisol and also to do therapy by an orthopedic doctor, no one seemed to understand to why she had this issues.
Heart palpitations (PAC); perpetual, severe rhinitis, fatigue, worsening insomnia.  7/17/07 Received medical records which reveal patient experienced palpitations upon awakening 11/17/06.  Seen in ER that day & d/c to home.  Holter monitor done 11/22/06 revealed 1 PVC & occasional PACs.  Cardiology consult done 11/28/06 revealed patient w/high anxiety& no treatable cardiac disease.  FINAL DX: palpitations & anxiety.
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently the patient experienced a sore arm. It was unknown if the patient sought medical attention. No further information is available.
passing out (losing consciousness); Seriousness criteria: medically significant.  Initial information was received on 14-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (patient).  This case involves a female patient (in her 20's) who passed out (losing consciousness) (loss of consciousness), after she received INFLUENZA VACCINE  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient just participated in a track meet, and immediately afterwards received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination, over 30 years ago.  On an unknown date, the patient passed out (losing consciousness) (loss of consciousness) (unknown latency) following the administration of INFLUENZA VACCINE. She was taken to the hospital. She did not receive any flu shot since that time.   This event was assessed as medically significant.  No laboratory data was provided.   It was not reported if the patient received any corrective treatment.  On an unknown date, the patient recovered from the event.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a female patient who had loss of consciousness after vaccination with IFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
This case was considered medically important (OMIC). Info regarding Flumist was received from a physician regarding a 4 year old male pt who experienced a seizure approximately 26 hrs after receiving Flumist. The pt received a dose on 1/5/04. The physician reported that the child was a "walk-up pt" and had no history at his office. The physician did not see the child post-immunization, but learned of the seizure after receiving a telephone call from the child's mother. No additional info was available at the time of this report. Follow-up information received from the physician provided a "likely" diagnosis of febrile seizure and recovery status (patient recovered). The child recovered without sequelae, and was discharged from the emergency room on the same day as admission. The physician spoke with the father the following day, and was told that all was well with the child. Follow up information received from the physician provided a likely diagnosis of febriel seizure and recovery status (patient recovered).
I took a PCR test on 27Jun2022. Today 29Jun2022 I received the results that i tested positive for COVID.; I took a PCR test on 27Jun2022. Today 29Jun2022 I received the results that i tested positive for COVID./sinus congestion/ cough/ cold/ low grade fever (99.5)/ felt tired/ sluggish; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EL3247) and on 17Mar2021 as dose 2, single (Lot number: EL3247) at the age of 41 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jun2022, outcome "recovering", described as "I took a PCR test on 27Jun2022. Today 29Jun2022 I received the results that i tested positive for COVID."; COVID-19 (medically significant) with onset Jun2022, outcome "recovering", described as "I took a PCR test on 27Jun2022. Today 29Jun2022 I received the results that i tested positive for COVID./sinus congestion/ cough/ cold/ low grade fever (99.5)/ felt tired/ sluggish". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99.5, notes: low grade fever (99.5); SARS-CoV-2 test: (27Jun2022) Positive, notes: I took a PCR test on 27Jun2022 Today 29Jun2022 I received the results that i tested positive for COVID; (26Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: if other vaccine in four weeks: No. other medications in two weeks: Metoprolol 25mg bid (twice a day). Adverse event - On 22Jun2022 I started feeling symptoms of sinus congestion and cough that i thought were attributed to a cold. On 25Jun2022 I had a low grade fever (99.5) and felt tired and sluggish the entire weekend. I took a PCR test on 27Jun2022. Today 29Jun2022 I received the results that i tested positive for COVID. If covid prior vaccination: No. If covid tested post vaccination: Yes.   No follow-up attempts are possible. No further information is expected.
Patient received VARIVAX immunization 5/11/09, mom noticed rash on arms, legs and trunk 5/13/09. 8-10 small slightly raised lesions on arm, leg and trunk, no vesicles.
Bruising below injection site of PREVNAR. Cranky, running temp based on mother's guess. Today temp without meds is 98.2. Mother has been giving ADVIL every 8-12 hrs.
A headache that has lasted for an entire week and is still prevalent. Sometimes it is sharp and hurts on the right side and then will move to the left side. It never goes away, just a dull headache.  He. has taken Tylenol, Advil and Aleve in an effort to alleviate the pain. All medicines have been taken according to the instructions. The  medicine has helped but has not alleviate the headache. Today, Day 8, he felt like he was being bitten on his arms and legs by stinging ants.
Pt seen by Dr. for reaction to immunizations. Localized reaction on right thigh. Redness, firm, warm to the touch.
Moderna COVID-19 Vaccine EUA - 1/29/21 3:00pm Noticed a small (dime sized) bump developed at injection site (left arm). Over a few hours the bump grew to larger than a quarter size and was painful (painful to the touch) and itchy (6:00pm). Also developed muscular pains in arm (discomfort/mild pain to lift arm). Patient took tylenol at 9:00 pm and pain subsided. 1/30/21 The following morning the bump persisted, and decreased in pain (no longer painful to the touch) and did not experience itchiness. 1/31/21 Bump was still large but no longer painful nor itchy. 2/1/21 Bump and symptoms have disappeared.
Information has been received from a physician concerning his male cousin who on 31-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, on 07-APR-2008 the patient developed a rash. The rash was described as a maculopapular rash on the patient's arms forearms, and chest. Medical attention was sought, the patient spoke to the physician. It was unspecified if lab studies were performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Pulse was 139 at resting, fever 103.1, uncontrollable shaking, aches, painful headache (8 on a scale of 1-10) Lasted for about 8 hours. Took Tylenol for fever.
BODY ACHES; MILD FEVER; This spontaneous report received from a parent concerned a 44 year old female. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, and mild fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, and mild fever. This report was non-serious.
Severe pain in right arm (felt like my arm was being ripped out of socket) along with severe shocks of pain. Aching and pain throughout body, fever
Patient was awoken 3 days following the vaccination with acute onset of chest pain. He went to the ED and was found to have elevated cardiac enzymes, diffuse elevated ST changes on EKG, and fluid surrounding the heart on bedside U/S. he was diagnosed with pericarditis and treated with Motrin 800 mg. So far, no sequela. He is doing well, as symptoms have improved considerable.
nystigmus, quadraparesia, progressive numbness from the neck down, unsteadiness, generalized joint aches & pains 1 wk p/receiving Engerix-B; hospitalized on 6JUL94; Encephalomyelitis probably secondary to Engerix-B;
Itching, scratching with red blotches on neck and chest and reported a feeling of hot all over.
Pain started day of injection at site and progressed down arm all way to elbow by 10-14-2018. Could not lift my arm without pain and it is less today but still hurts today from shoulder to elbow. Also had a lump at injection site that has not gone away. Having headaches which I do not usually have.
patient reports pain, pain with abduction of the arm, pain w/sleeping on the arm, no redness, no swelling, no fever, using NSAIDs/icing/heating
Pt reported that she had a rash after leaving our pharmacy, but she did stay at the pharmacy for 30 minutes to be monitored because she mentioned some hx of rash with injections.  Pt took benadryl and rash resolved
Cough, after the 2nd dose vaccine.; Fever, after the 2nd dose vaccine.; Headache, after the 2nd dose vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough, after the 2nd dose vaccine.), PYREXIA (Fever, after the 2nd dose vaccine.) and HEADACHE (Headache, after the 2nd dose vaccine.) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (Cough, after the 2nd dose vaccine.), PYREXIA (Fever, after the 2nd dose vaccine.) and HEADACHE (Headache, after the 2nd dose vaccine.). At the time of the report, COUGH (Cough, after the 2nd dose vaccine.), PYREXIA (Fever, after the 2nd dose vaccine.) and HEADACHE (Headache, after the 2nd dose vaccine.) outcome was unknown.            Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable    This case was linked to MOD21-086685, US-MODERNATX, INC.-MOD-2021-106915, US-MODERNATX, INC.-MOD-2021-106829 (E2B Linked Report).; Sender's Comments:  MOD21-086685: US-MODERNATX, INC.-MOD-2021-106829:Case for patient nephew US-MODERNATX, INC.-MOD-2021-106915:Case for patient nephew
Times approximate. Patient given Gardasil vaccine for HPV. Within a minute or so, was pale and dizzy and felt near-syncopal. He did not faint. Placed supine with feet elevated and recovered in 5-7 minutes without residual symptoms. Observed about one hour.
This spontaneous report as received from a other health professional refers to a patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L000610 and M041990 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1708USA002369: US-009507513-1708USA002371: US-009507513-1708USA002372: US-009507513-1708USA002373: US-009507513-1708USA000870.
This case was reported by a consumer via call center representative and described the occurrence of sickness in a elderly female patient who received Influenza vaccine Quadrivalent for an unknown indication. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced sickness, fever, chills and vomiting. On an unknown date, the outcome of the sickness, fever, chills and vomiting were recovered/resolved. It was unknown if the reporter considered the sickness, fever, chills and vomiting to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at the vaccination was not reported. The patient received an unknown flu vaccine three years ago that caused her to be deathly sick with a fever, chills and vomiting. This case was linked to the case US2018140244, reported by the same reporter for the same patient.
The patient received the first MMR dose on 10/24/22 and the second dose on 11/14/22 which is 7 days earlier than CDC recommendation.
Pt recvd Hep B vax 8FEB91 & w/in 2 min of inject pt exp severe pain in lt arm; pt had raised erythematous welts from elbow to shoulder; pt tx DPH & improved w/in 30 mins; pt later recovered;
Patient was administered vaccine and called in the next morning  saying he felt weak with flu like symptoms.  He came in the next day to work and was still feeling bad, now with shortness of breath and faintness.  This progressively got worse on the following days. He was uninsured so refused medical care.  The following Monday, he passed out on his shift and had to be seen at an urgent care, then sent to an Emergency Room.  Exam was within normal limits aside from the chest x-ray where cardiomegaly was cited. EKG also normal. He was referred to a cardiologist.
11-16-09 9:45 am -auxillary temp 102.2. 11-16-09 11:00 am rectal temp 101.4. 11-16-09 6:45 pm-rectal temp 99.8.
Information has been received from a registered nurse concerning an actually 60 weeks male patient who on 06-SEP-2011, was vaccinated with the 2.0 ml first dose of ROTATEQ and on 21-NOV-2011, was vaccinated with the second 2.0 ml dose of ROTATEQ. Both vaccines were administered orally (Lot numbers not reported). No adverse events were reported. Additional information has been requested.
Patient was nervous about receiving the vaccine and felt nauseous almost immediately after receiving the vaccine.  She felt faint as she walked away and wanted to sit down. After a minute or two she fainted while sitting in the chair.  Her husband who had been with her the whole time was able to arouse her after about 20 seconds.  She felt as though she needed to vomit but was did not.  After a few minutes the patient laid down on the floor.  Had a fan positioned at them and had the lights off in our pharmacy's counseling room.  After about 30 minutes she was feeling a little better and sat up on the floor and was able to drink a little ice water.  After a few more minutes she progressed to sitting up in a chair.  At no time did she have any rash, hives, or breathing issues. she said she felt very nervous.  About an hour after the immunization the patient felt like things were better and was able to stand up and walk out on her own.  she held on to her husband's arm as a back up in case she felt faint again.
Information has been received from a physician concerning an approximately 8-week-old infant who was vaccinated with a first oral dose of ROTATEQ.  It was reported that 20 hours after receiving the vaccination the patient developed severe diarrhea.  Medical attention was sought, and the child was hospitalized and required total parenteral nutrition.  At the time of the report, the diarrhea had not resolved.  No product quality complaint was involved.  The reporter considered diarrhea to be an other important medical event.  Additional information has been requested.
Tel call on 12/7/06 Pt reported fever,rash-face,neck,chest,back and arms, and itching. Symptoms began 4 hours after immunizations were given. Home visit 12/11/06  Pt took benedryl and tylenol. Itching resolved, Temp-98F, Some red raised pimple-like rash is evident on face, back, chest and reddened areas on neck and arm.   Pt. reports soreness from a blister like formation on left floor of mouth under tongue. Nurse observed grayish flap of skin approximately 3/16" square. Pt used  listerine and salt water to rinse area X1 with no relief. Nurse recommende pt. go to doctor for evaluation. Pt.'s response "I don't like doctors." Nurse recommended continued rinsing of mouth with saltwater and listerine for one week and see doctor if soreness continues and flap is not gone.
Screamed from time recvd shot took a 15 min nap p/returning home, screamed non stop until 6PM; MD contacted & APAP given; lt leg swollen & red w/knots into hip; could not stand or walk; made chill cry, t100.3;
Cough  Fatigue  Muscle or body aches  Headache  Sore throat  Congestion or running nose  Nausea or vomiting  Suspected COVID-19 virus infection  Acute upper respiratory infection  Acute nonintractable headache, unspecified headache type  Seasonal allergic rhinitis due to pollen
This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of VAQTA, (lot# M015290 and expiry date 20-SEP-2017) (lot# M030598 and expiry date 13-OCT-2017) (lot# M036459 and expiry date 18-JAN-2018) (lot# M032492 and expiry date 02-MAR-2018) (lot# M033611 and expiry date 02-MAR-2018) (lot# M031696 and expiry date 26-MAY-2018) and (lot# M034896 and expiry date 26-MAY-2017) subcutaneously (also reported as depends on the vaccine). The vaccine was exposed to temperature excursion of 1.4C for 21 minutes. No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
The day after receiving booster of Pfizer I started getting bumps on right side back . 2 days later the bumps were over entire body and looked like blisters, very itchy and puffy. went to Dr office, got steroid cream and told to take Benadryl  at night and Loratadine during the day. had to go back to  Dr and got prescription for prednisone, after 2 weeks the bumps turned into flaky skin and all my skin is falling off, very itchy.