chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever / He was at a feverish point; his body was warm and getting warmer and warmer; sweating; Chills; This is a spontaneous report from a contactable consumer reporting for himself. This 75 years old male consumer received the first single dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9261) on 28Jan2021 at 09:50, in left arm, for COVID-19 immunisation. The patient was a veteran; gave him the COVID vaccine. Medical history included malaria (and another unspecified condition during, they used "IVs to bring him back" and he even had a spinal tap, he was also in "a coma, on his way out to the next" and they said he was shaking like a leaf on the tree), skin problems (he had already been under the (government organization) care of malaria and skin problems), prostate problems, back problems since the war, he was still in a back brace for his back problems (he had been wearing it since the 60's), major spinal surgery in Mar2019 where his L1 and L5 were taken out (he lost a lot of fluid as a result of this surgery). Since they took his L1-L5, he had no real body control of his lower extremities and due to this he was awarded money from the (government organization). The patient received an unspecified influenza vaccine in the past, on an unknown date, for immunization. Concomitant medications were not reported. On 12Feb2021 at 03:30 AM, the patient experienced fever, he described his body was warm and getting warmer and warmer and was sweating. He was at a feverish point, his sheets he was sweating and wet from his back to feet. He also had chills. He got up thinking this reaction was from the COVID vaccine, he had an drink in his fridge and took powdered acetylsalicylic acid (ASPIRIN) and then he laid there and let his body go through the changes. He knew that his body can recover from heat. He went to sleep, woke up and had no more chills; he was sweating, but it was gone, his body was normal, he was under the covers. It was like how his normal body just took it like penicillin, it did the same thing. The events resolved on 12Feb2021 at 07:00 AM. His second vaccine dose was schedule on 18Feb2021 at 9:50 AM.
E. coli infection; The patient was sent to emergency room/ symptoms unknown; This spontaneous case was received on 14-Sep-2020 from pharmacist via Med Communications (reference number: SEQW20-01644) and concerned 73-year-old, male patient.   The patient's medical history and concomitant medications were not reported.   On 24-Aug-2020, the patient was vaccinated with Flucelvax QIV (Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid) as protection against seasonal influenza. The reported batch number was 276530 and expiry date was 01-Jun-2021.   On 11-Sep-2020, 18 days after receiving Flucelvax QIV, the patient was sent to emergency room (ER) and sent home on the same day. He was not hospitalized. The reporter did not know the symptoms that prompted the ER visit.    On 13-Sep-2020, 20 days after receiving Flucelvax QIV, the patient was subsequently hospitalized. The patient underwent blood culture which revealed E. coli and the patient had E. coli infection. He was treated with unspecified intravenous (IV) antibiotics.   At the time of initial reporting on 14-Sep-2020, the patient was still in hospital and had not recovered.  The outcome of unevaluable event' was not reported.    The patient's hospital healthcare provider told that E. coli could have been due to receiving Flucelvax QIV. The reporter did not provide a causality assessment for unevaluable event'.  The reporter assessed the case as serious.  Company comment: The patient was vaccinated with the suspect product, Flucelvax QIV. Reportedly, 18 days after vaccination the patient was sent to emergency room (ER) and sent home on the same day. The reporter did not know the symptoms that prompted the ER visit. Twenty days post vaccination, the patient was hospitalized, and blood culture revealed Escherichia infection. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and Escherichia infection is assessed as not related due to biological implausibility. Causality for unevaluable event is assessed as unassessable.; Reporter's Comments: The patient's hospital healthcare provider told that E. coli could have been due to receiving Flucelvax QIV.; Sender's Comments: The patient was vaccinated with the suspect product, Flucelvax QIV. Reportedly, 18 days after vaccination the patient was sent to emergency room (ER) and sent home on the same day. The reporter did not know the symptoms that prompted the ER visit. Twenty days post vaccination, the patient was hospitalized, and blood culture revealed Escherichia infection. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and Escherichia infection is assessed as not related due to biological implausibility. Causality for unevaluable event is assessed as unassessable.
TONGUE FELT FUNNY, WEAKNESS AND PAIN IN LEFT HAND, AND LEFT SHIN PAIN.  SHE LEFT AFTER ABOUT AN HOUR WITH SHIN PAIN GONE, WEAKNESS AND HAND, AND TONGUE FELT FUNNY
Patient started feeling very dizzy, sick like, and weak starting about 24 hours after getting the vaccine.  He was taken by ambulance to the local hospital and treated with fluids I believe.  After regaining strength, he went home and was given meclizine for nausea and dizziness.  He was told to keep up fluids and rest.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the multiple unspecified patients were vaccinated with GARDASIL (lot#, dose, frequency and route unspecified) that was stored improperly. No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
Evening/overnight 1/19/2022: achy, trembling, chills, probably a fever. 1/20/2022: fever of 101.2. Slept all day, no Food no appetite.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2022 at 14:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 78 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mitrovalve prolapse" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies: demerol, reaction(s): "Known allergies: Demerol". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Sep2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19; began COVID 19 treatment PAXLOVID from 09Sep2022 to 13Sep2022. Follow-up attempts are completed. No further information is expected.
Student received third hepatitis B shot of series during school based program. He reported to school nurse approx 2.5hrs after shot was given with complaints of swollen left arm and hand. School nurse informed health dept supervisor. Nurses from health department went to school and assessed child. He was noted to have swollen left hand. Student stated his hand was numb. Denied injury to hand. No swelling noted at vaccination site. 4/15 student back to school. No swelling or complaint. Did not see doctor.
Patient is 4 months pregnant and did not make the provider aware prior to getting 5 vaccines.
He had MMR, Varicella, Pneumococcal shots at Doctor's office.  That evening he turned noticably yellow. Several friends asked me what was wrong with him. I took him to the doctor the next day.  Dr. ignored the symptoms and blamed on diet, although diet hadn't changed and he had never been yellow before.  He was babbling and completely stopped. His energy level dropped. He continued being yellow for about a year.  We have since changed doctors, and she suggested we fill out the report.
This spontaneous report was received from a consumer who read an article on the internet refers to a 12 year old female patient. No medical history reported. On an unknown date, same day or day after they took her home the patient was vaccinated with GARDASIL (dose number and route of administration unknown) (lot number unknown). No concomitant therapies reported. On 19-AUG-2014 the patient went to bed and didn't wake up (death). The patient died on 19-AUG-2014. The cause of death according to the consumer was reported as GARDASIL. The causality was unknown. Additional information has been requested.
pt recv vax 6JUN96 parent called stating since vax pt crying for 2hr-ongoing;recommended to take to hosp-verbalized understanding;call made 7JUN96 mom took pt to hosp-pt stop crying, no temp;
I have developed a large knot in my arm and red fevered area the size of a baseball. It is getting bigger throughout the day. Ice does not help the swelling. Very tender to touch and hard to lift my arm for basic tasks.
Child given Dtap/IPV component of vaccine.  Omitted the HIB  component.
Left upper arm swelling/deltoid region warm to touch, erythema.  No complaints of pain or discomfort, no complaints of fever.
230PM began crying (high-pitched cry) for 1 hr T99.6 (ax) @ that time-quieted down, not hungry, tongue seemed to be thick; 6APR95 fever 99 ax, lack of appetite;
FEVER BLISTER/ COLD SORES; LIPS  EXFOLIATING/ PEELING; This spontaneous report received from a patient concerned a 56 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced fever blister/ cold sores, and lips exfoliating/ peeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever blister/ cold sores and lips exfoliating/ peeling was not reported. This report was non-serious.
Information had been received from an office manager concerning a 62 year old female with no medical history or known drug allergies who on 03-APR-2007 was vaccinated intramuscularly into the left arm with a second 0.5 ml dose of Pneumovax (Lot # 651320/1008P). Concomitant therapy included CIPRO, ATENOLOL, MICARDIS, SYNTHROID, testosterone gel, CENTRUM, cranberry tablet, ascorbic acid and baby aspirin. On 04-APR-2007 the patient developed swelling and redness along and underneath her left arm towards her elbow after vaccination. The patient visited an urgent care center and was given DECADRON and BENADRYL. It was noted that the patient had previously received a dose of pneumococcal 23v polysaccharide vaccine in 2000 and the patient did not experienced any adverse reaction at that time. At the time of report, the patient was recovering. A lot check was requested by the reporter. Swelling and redness along and underneath her left arm towards her elbow was considered to be disabling. Additional information has been requested.
sore arm; felt very lazy; fatigued; felt anxious/feels very nervous; felt hyper; tired; confused/feels like he wants to slap, bite, and wants to scream/feels like he needs to grind his teeth; Itching/itching in his legs and arm; This is a spontaneous report from a contactable consumer or other non hcp. A 59-year-old-male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via intramuscular, administered in Arm Left on 09Feb2021 12:15 as (at the age of 59-years-old) dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 09Feb2021 the patient experienced sore arm and felt very lazy. On Feb2021 he experienced fatigued, felt anxious, felt hyper, tired, confused and itching. The caller asked, if his symptoms following his first vaccine are normal and what he should do about them. As he got the vaccine at around 12:15 in the afternoon, stayed for 20 minutes at the vaccination facility and 4 hours later he started having a sore arm, felt very lazy, wanting to go to sleep, went to sleep but when he woke up, he felt more fatigued and lazier. He stated that he like someone to stretch his legs, he felt anxious and had a lot of anxiety and felt hyper. He went back to sleep and got up in 5 hours and again felt anxious then fatigued and tired and confused. he also reports that he notices that he "eat a lot and then he was not burping". Caller asked how long he will feel like this. Upon fallow up received Caller said that he feels like he has fatigue, pain in his arm when he sleeps on it, feels like he needs to grind his teeth, and itching in his legs and arm. He said that he also feels like he wants to slap, bite, and wants to scream. It is bothering him. He said that he feels very nervous, but it is not because he was scared. He said that he feels bad and stated that he is tired and wants to sleep all day. Caller said that he feels fatigued along with his hands and his legs. He feels lazy and he is nervous. He said that no one has this with the first vaccine. He feels like something may have damaged his body. When asked about his concomitant medications, medical conditions and relevant tests, the caller said that he takes a lot of medications but provided no further information when queried. Patients second dose was scheduled for 02Mar2021.The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right leg:  Red rash above right ankle  Left Leg: red streak halfway up his calf - looked like a streak but was actually an oblong circle
This spontaneous report was received from a physician and refers to a 8 month old patient of unknown gender. No medical history, current conditions and concomitant therapies were reported. On 01-JUN-2015, the patient received the first dose of ROTATEQ orally (lot # expiration date and dose were not reported). No adverse event was reported. Additional information has been requested.
Mom noticed small red area where shot given yesterday (6-27-07) at 1200 pm call to office at 1:38 PM - child seen at 2:30 had increased in redness and in swelling (5cm erythema and induration).
Cough has intensified; Fever, I took it 4 times and got readings between 100.1 and 101.1; Slight headache; This spontaneous case was received on 08-Oct-2022 from other non-health professional (patient) (reference number: SEQW22-04224), with additional information received on 11-Oct-2022 2022 (reference number: SEQW22-04246) (being processed together) via agency, and concerned a 42-year-old male patient.  The patient's current conditions included mild discomfort/tickle in throat and cough. The patient's concomitant medications were not reported.  On 06-Oct-2022, the patient took a Covid test which was negative.   On 06-Oct-2022, at 9 am, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration and anatomical location: not reported) for seasonal prevention of influenza. The batch number reported was not reported.  On 08-Oct-2022, two days after receiving Flucelvax Quadrivalent,  the patient's cough had intensified and he experienced fever, with temperature between 100.1 and 101.1 (units not provided), and very slight headache. He had also did another Covid test that was still negative. The patient stated that he also noted these symptoms on the form at time of vaccination.  At the time of the initial reporting, the patient had not recovered from the event.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 42-year-old patient experienced cough aggravated, pyrexia, and headache two days after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.; Reporter's Comments: The patient stated that he also noted these symptoms on the form at time of vaccination.; Sender's Comments: A 42-year-old patient experienced cough aggravated, pyrexia, and headache two days after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.
ARM WAS SORE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAY-2021, the subject experienced arm was sore. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from arm was sore. This report was non-serious.
on 08-01-07 @ 10:30am started having problems getting his breath, simple walking up a incline was difficut, after that noticed he was lethargic, drowzy, nausious feeling, unable to eat, gag reflex was weak, muscle pain started in neck, back, upper legs and later progressed to tops of his feet, slept from 1:00pm to 4:30am. Through out night had shivvering. noticed arm pain when rolled over on it.  7-8:00 am got out of bed noticed his lymph node pain in left arm was there and seems to be getting worse.  GAg reflex gets worse when he moves around.  Took Ibuprofen 3x yesterday, last dose was @ 4:30 this morning.
History of gout (ankles, feet, knees) since 1997. Diagnosed with tendonitis in ankles 2003; 2003/2004  increased pain in wrists/elbows. Diagnosed with tennis elbow. 2007 right ankle pain. Began to have headaches in 2005--stabbing pain around his eyes which lasted for hours, no nausea, vomiting, photophobia or visual changes. Treats with TYLENOL with relief. Has not sought medical care. Since 2003/2004 has had "pimples" in his hair. Since 1997 has suffered from nervousness and a bad temper.
Day 2: arm pain  Day 8: new onset skin reaction at site of injection and below (left deltoid); swollen, red, itchy/painful, 3 quarter-sized hives
Patient experienced swelling, redness and itching at both injection sites. She took benadryl OTC and her symptoms improved.
Pt was seen during a routine physical doctor noted rt upper arm swollen, red, painful to touch. When pt was questioned, he reported getting a shot and that his brother has been "slugging him hard" on that spot since. Was instructed to use ice packs on arm and Tylenol as needed. Brother and mother spoken to 06/11/02. Much improved.
parent called states unconsolable crying, swelling in lt leg; referred to MD who ordered cold compresses and continue APAP;
This case was reported by a healthcare professional and described the occurrence of fever in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of PEDIARIX (details unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced fever and rash. At the time of reporting the outcome of the events was unspecified.
shingles; itchy rash; blisters; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had first case of shingles about 40 years ago, all on the right hip area).   In January 2022, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles, itchy rash and blister. On an unknown date, the outcome of the shingles was unknown and the outcome of the itchy rash and blister were not recovered/not resolved.   It was unknown if the reporter considered the shingles, itchy rash and blister to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR060707   Additional Information: GSK Receipt Date: 5-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix in mid of January 2022 and developed a case of shingles which was an itchy rash with blisters on her right hip.  The patient developed a second case of shingles in the same spot on her right hip about 1 week ago of reporting, the blisters were starting to crust over. The patient did not contact the HCP (Health care professional) in either case. The patient stated that for a total of about a dozen cases of shingles over the years she had. The patient did not give permission to contact HCP ((Health care professional).; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR060707:same reporter
Headache, Myalgia, Arthralgia, fatigue and arm pain Narrative:
6 episodes of diarrhea; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 17 years old male patient who experienced 6 episodes of diarrhea (diarrhea), while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Oct-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site.  On 14-Oct-2019, the patient developed a non-serious 6 episodes of diarrhea (diarrhoea) 3 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was 6 episodes of diarrhea.  It was not reported if the patient received a corrective treatment.  The outcome of the event was Unknown.  Information on the batch number was requested.
Nursing home, contacted CHD to administer COVID vaccines to 18 individuals who had not received the vaccine yet.  was one of them.  Upon return to the CHD to put dose in flshots, the nurse realized the patient had in fact received two doses of the Pfizer vaccine previously.  The nursing home was called and advised to monitor closely for three days . No adverse side effects were seen.  Measures were put in place to prevent this from happening again.
Information has been received from a medical assistant concerning herself who was vaccinated with two doses of Gardasil. Subsequently she experienced amenorrhea after each of the 2 doses of Gardasil she received. The first time the patient didn't have her menses for 6 to 8 weeks and now she has not had her menses since her most recent injection in April 2007. The patient took home pregnancy tests both times and was not pregnant. Lot number was not provided. It was reported that the patient sought unspecified medical attention. The patient has not recovered. No further details were provided. The medical assistant also reported that another patient had a similar experience which is reported in WAES # 0705USA04921. Additional information has been requested.