chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving the vaccine, the patient experienced achiness and tiredness for the rest/a majority of the rest of the day. Patient stated that the tiredness has reduced by half today. Patient reports that there is soreness at the injection site; denies rash, redness, and/or swelling at injection site. Patient took Tylenol to help with symptoms.
Had a fever, backache and eyes were burning. Took a home COVID-19 test and was positive. Called teledoc and was prescribed PAXLOVID. Took full course and tested negative 3 days later.
heart palpitations; This case was reported by a pharmacist via call center representative and described the occurrence of palpitation in a 42-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number 5D4H4, expiry date 30th June 2021) for prophylaxis.   On 19th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season (intramuscular). On 21st October 2020, 2 days after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced palpitation. On an unknown date, the outcome of the palpitation was unknown.   It was unknown if the reporter considered the palpitation to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient received Fluarix Quadrivalent 2020-2021 season in left arm. After receiving Fluarix Quadrivalent 2020-2021 season, the patient started experiencing heart palpitations. On Thursday, 22nd October 2020, the patient went to the emergency room due to heart palpitations.
tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  The information on the batch/lot number for bnt162b2 omi xbb.1.5, bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300305697 same patient, different dose/event.;
High fever of 101-102 F resulted in less than 12 hours. After 24 hours, fever reduced to 99 F. By 2/10/22, fever gone, but in its place a rash on both ears, particularly the area behind the ears. By 2/11/22, rash persists and ear lobes now experiencing swelling. On left ear, swelling slightly worse and extends down to the jaw joint, is hard and painful to the touch. Both ears are hot to the touch.
This spontaneous report was received from a healthcare worker (quality assurance coordinator) regarding a 33 year old patient(gender unknown). The healthcare worker reported that her facility had administered 9 doses of RECOMBIVAX HB, lot # J001183. On 06-MAY-2013, the one of the patient's was vaccinated with dose 1 of RECOMBIVAX HB (lot # J001183, expiry: 08-SEP-2014). At the time of this report(01-JUL-2013), the patient had not yet received dose 2 of RECOMBIVAX HB. No adverse effects reported. This is 1 of 6 reports received from the same reporter. Additional information has been requested.
Dizziness, Fever, Malaise, chills swelling at lymph node Narrative:
Little soreness in arm; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Little soreness in arm) and FATIGUE (Tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hypothyroidism. Concomitant products included HYDROCHLOROTHIAZIDE and SPIRONOLACTONE for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced MYALGIA (Little soreness in arm) and FATIGUE (Tiredness). In January 2021, MYALGIA (Little soreness in arm) and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-301073, MOD-2021-301074 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up contains no new information.
As soon as a 49-year-old female patient is immunized by the nurse, she verbalizes that she feels dizzy and patient observes her sweaty. Immediately afterwards, patient proceeds to call the EMT to evaluate it. At 1:42 pm, the patient was evaluated and her vital signs were: 60/40 B / P, 54 Pulse, 103 DXT and 100% Saturation. At 1:49 pm, the case was consulted with Doctor and she recommended leaving the patient under observation for 30 minutes and in the Trendelenburg position and then re-evaluate the vital signs. At 2:15 am, the patient was evaluated again and the vital signs were: 110/80 B / P, 60 Pulse, 103 DXT and 100% Saturation and then she reported feeling good for what she was discharged.
Head ache, neck ache, eyes ache, lymph nodes hurt.  Dizzy, tired,  chills, extreme shivering.  Unable to prepare meal.  Always dress first thing every morning.  Today was not able to get dressed until after noon.
Slurred speech, early menstrual cycle, Extreme excruciating debilitating headache  for days, lower back pain, body aches, fever, chills, sweating, unable to get out of bed for days, nausea, diarrhea, lethargy, loss of muscle strength, dizziness, foggy brain, nasal congestion. These began in the evening I received the vaccine (Thursday) And lasted until Tuesday , September 14.  I was in bed for 6 days.
Red splotches, shoulder to elbow; This case was reported by a consumer via interactive digital media and described the occurrence of red blotches in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th May 2022, the patient received the 1st dose of Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced red blotches. On an unknown date, the outcome of the red blotches was not recovered/not resolved.   It was unknown if the reporter considered the red blotches to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-MAY-2022 Reporter's Comments: The case was reported by patient via interactive digital media. The patient received 1st dose of Shingrix about 24 hours ago from the time of reporting. The patient arm was red splotches about halfway from shoulder to elbow. The patient asked whether he/she should be worried about reaction. No other information was provided. Additional Supportive Information: Follow up would not be possible since no contact details provided.
Pain in left arm immediately following injection.  12 hours after injection body aches started. Fever started at around midnight. Headache started around same time. Fatigue started 16 hours after injection.
Exposure to coworker with COVID.  Tested positive 2/17/2021 but no symptoms.
Within 10 minutes, felt lightheaded, dizzy, confused; face became flushed with burning sensation and fast beating heart. Pt felt fine 1 day later
Ringing in the ears, ear infection which caused imbalance, nausea and dizziness.
Bilateral lower back pain; Muscle Stiffness; Muscle. Stiffness ans pain for 5/6 days.; This is a spontaneous report from Pfizer colleague from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced Bilateral lower back pain, muscle stiffness ans pain for 5/6 days; all from 10Apr2021. Event took place after use of product. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 1JUN95 & 19MAY97 pt  devel moderate case of chickenpox w/spots on face, back, buttocks, arms & torso;also exp itching;
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-JUL-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II, lot # K010318 with an expiry date of 22-JUL-2016 (dose and route of administration not reported). No adverse effects were reported. The outcome of the events were unknown. There was no product quality complaint (PQC) involved. Additional information has been requested.
Information has been received from a medical assistant concerning a 6 year old male patient who was vaccinated with a dose of varicella virus vaccine live. On approximately 28-DEC-2005, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Pt. received vaccine at 11:30 AM 9/23. Developed fever few hours later. Had "staring" episodes at 10:30 PM, became unresponsive 11 P, EMS activated taken to hospital. Intubated, transferred to another hospital. Anti-epileptic medications administered. Medical Record received on 1/3/2005 states abnormal gait, sleepy, limp, and vomit.
RT ARM: FLU & ZOSTAVAX - SWELLING AND REDNESS FROM SHOULDER TO ELBOW, "BUMPY SKIN". LT ARM: PNEUMOVAX - SLIGHTLY RED AND SWELLING OF ARM, RED SPOTS.
MODERNA COVID 19 VACCINE EUA.     Warm,   red circular area approx  2.5 inches diameter around center of vaccination needle entry,  was itching  approx 2 days and now  just warm and  firm to touch, still some redness
Cellulitis/Staph at injection sites. x 3 sites (+) on bilateral arms.
vaccine given 12/23.  reported slight swelling and redness on 12/26.   on 12/27, tenderness, redness, and warmth noted to the majority of the left upper arm along with slight swelling
experienced side effects (lymph nodes); This is a spontaneous report from a Pfizer-Sponsored Program. A contactable consumer reported for a male patient (father).  The male patient of an unspecified age received the second dose of BNT162B2 (Solution for injection, Lot number: unknown) via an unspecified route of administration on Friday (date unspecified), as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (Solution for injection, Lot number: unknown) via an unspecified route of administration on an unknown date, as a single dose for Covid-19 immunization. On an unknown date, the patient experienced side effects (lymph nodes). The reporter was uncertain if it was a side effect of the vaccine. The outcome of the event of side effects (lymph nodes) was unknown.  It was notified that the lot/batch number was not available despite the follow-up attempts made. Follow-up attempts had been completed and no further information was expected.
I received the Flu Vaccine yesterday. In the middle of the night I woke up with a fever, chills, shortness of breath, body aches, headache, and uncontrollable shaking. This lasted for one hour. This morning I still have a fever.
Fever,  body aches, headache, shivering,  nothing severe. This was after second dose.  Took tylenol.
Information has been received from a healthcare professional concerning an unspecified number of patients who since January 2015 had been vaccinated with doses of oral ROTATEQ (Batch and lot No. K013410, exp. 27-FEB-2016; Batch and lot No. L004466, exp. 02-AUG-2016; Batch and lot No. "K0110222", exp. 12-MAY-2016) (dose and site not reported), doses who on unknown dates underwent temperature excursions. No adverse effects reported. Lot number K0110222 is not a valid lot for ROTATEQ. Follow up information has been received from Medical assistant on 25-NOV-2015 via a phone call. The physician was unavailable at the time of call. The phone call was transferred to Medical Assistant. The M.A stated that information was not available on patients, over the phone. Please send a written request. This report is linked to MARRS 1510USA007265, 1510USA007262, 1510USA007263 and 1510USA006129 from the same reporter. Additional information has been requested. Narrative was updated.
Initial report was received 29 November 2012 from a consumer, who is also the patient. A 35-year-old female patient with a history of a cat allergy, had received an intramuscular left deltoid injection of FLUZONE, lot number UT427AA (also reported as UT427AAI) and on the day of vaccination, she experienced an asthmatic reaction, trouble breathing and wheezing 6-8 hours after the vaccine. The patient took BENADRYL and was fine after that. An event outcome was not reported. The patient had not been taking any concomitant medications and she had previously received many doses of FLUZONE in the past. Documents held by sender: None.
Report made to agency 11/16/2021 @ 17:45: Severe respiratory distress, profuse diaphoresis, hypoxia, tachycardia 11/16/2021 @ 18:06: Respiratory arrest 11/16/2021 @ 18:10: Ventricular fibrillation, cardiac arrest. Unsuccessful resuscitation. Time of death 18:52 on 11/16/2021
Although it has been four months since I received the vaccine, I wonder if there is a connection. On 7/7/2021 I went to the emergency room with chest pain. They were able to rule out a heart attack, and with a CT scan discovered I had an acute pulmonary embolism in the lower lobe of my left lung. There is no explanation for where the blood clot came from as I am healthy and active, have had no recent surgeries, no evidence of blood clots elsewhere in the body, and no long trips that could explain the development of a blood clot. I am undergoing lots of tests but so far no underlying health condition has been discovered that would explain how a blood clot got into my lung.  Treatment = Xarelto (blood thinner).
On 03/03/2023, in the night, I woke with nasal congestion, sore throat, headache, body aches, very tired. I tested negative on 03/03/2023, I tested positive on 03/06/2023.  I had a telehealth appointment that day. She prescribed Paxlovid. I have had lingering fatigue and nasal congestion, but now I am good.
Two weeks prior from the event I was dizzy, especially when I would wake up. Then 9/30/2021 I was having a meal and during the meal I got a severe dizzy spell and hot and nauseous. I had to go to a separate area to calm down. On 10/4/2021 I had a little headache sniffles and ended up getting a COVID-19 test that came back negative. On 10/9/2021 early afternoon I was riding in a vehicle and I was in the passenger seat and the dizziness and nausea came on very strong. It was so severe I couldn't respond well. It seemed I passed out briefly because the vehicle stopped and they called the ambulance. I could hear but couldn't really respond. I must have passed out again. After giving me treatment, the emergency room doctors were concerned I was having a stroke or heart attack, I was not. I was diagnosed with vertigo. They treated me with medication, meclizine. It was basically the eye problem, dizziness, sensitivity to bright lights, and nausea. The main thing that helped was to be in a dark room and just go to sleep. It was difficult to drive, which was basically my job. I wasn't able to return to work until December. To this day, there are still certain triggers that could make me dizziness.
Consumer thought she get expired vaccine at the first time; Fatigue; Nausea for a day; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Consumer thought she get expired vaccine at the first time), FATIGUE (Fatigue) and NAUSEA (Nausea for a day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Consumer thought she get expired vaccine at the first time), FATIGUE (Fatigue) and NAUSEA (Nausea for a day). On 16-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Consumer thought she get expired vaccine at the first time) had resolved. On 17-Mar-2021, FATIGUE (Fatigue) and NAUSEA (Nausea for a day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  The reporter stated that she did not take any medication for treating the effects.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In January 2007, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a physician office as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-JUL-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
sore throat; congestion; tested positive after 2 days of being vaccinated; fever; This is a spontaneous report from a Pfizer sponsored program. A Contactable consumer  reported for male patient (son).  A 17 Year male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received the 1st dose of the Pfizer covid vaccine on Monday. He had a little bit of fever but then it went away. The patient also experienced a sore throat and congestion since today. patient took a rapid test and tested positive after 2 days of being vaccinated. The reporter would like to know whether the covid vaccine could have caused her son to test positive for COVID. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome for event fever was recovered on an unspecified date in Apr2021 and outcome for all other events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
It was reported that a 56 year old male received Fluzone SV '99-'00 on 10/12/99. "Twenty-four hours, post vax, he developed an 8cm reddened area at site" and he also experienced tenderness. No further information available at this time. From additional correspondence received on 11/22/99, additional pt and vaccine information was provided.
The pt experienced redness, warmth to a 9 X 10 cm area of the right anterior thigh. No pain, no fever was noted. The redness began approximately 4 hours post vax.
Left arm (vaccination site) had erythema, itching, and was warm to touch.  Affected area was 3X7".  It has remained the same size over the last few days, but has not yet resolved. Patient also had 100 degree temp on 9/15/07.  Advised patient to use cold compresses and take Benadryl and to report any changes or new symptoms to us and/or physician. This is in follow-up to report(s) previously submitted on 12/21/2007. Information has been received from a doctor of pharmacy concerning a 60 year old female with sulfa allergy who on 13-SEP-2007 was vaccinated with ZOSTAVAX vaccine (Oka/Merck) (658211/0884U). Concomitant therapy included NEXIUM. On 14-SEP-2007 the patient experienced erythema and itching on the left arm. The injection site was warm to the touch and the reddened area was about 3x7 inches. She developed a 100 F temperature on 15-SEP-2007. The fever resolved although the reddened area persisted without being hot and itchy. The pharmacist advised the patient to apply cold compresses and BENADRYL. As of 04-OCT-2007 she had recovered. This is one of several reports from the same source. Addtional information received indicated that no additional information is available.
pt recv vax 12MAR96 3PM & 6PM 2nd dose of APAP & bottle given;pt vomited @ 620PM;fell asleep 215AM on 13MAR96 pt shaking,t103.2 ax,vomited again;mom called ER @ 230AM;ER recommended APAP which administered @ that time;
This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 05-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, oral, (dose not reported) from lot # M031802 with expiry date: 09-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
Inflammation around site of DT, left deltoid. Severe aching in arm from shoulder to fingers, worse in wrist. Cellulitis in arm and Tendonitis in elbow per physician.