chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Began with body aches and mild fever on day 2. Day 3 and 4 started to notice pain in my hands, fingers and wrists. Progressively became worse daily until I could not turn door knobs, lift objects, cook, button clothing, drive. Eventually left wrist became swollen and I lost the ability to use my left hand for days. Went to the ER and was told I had tendinitis and cellulitis. ER doctor told me he'd seen other cases of this response after vaccine. He treated me with antibiotics which I am still taking.
Patient was due for his second dose of vaccine and inadvertently received the BIVALENT booster dose.
On evening of vax, PT had chills, vomiting, myalgia and went to Emergency dept. Given IVF, Reglan, and Benadryl. The medical center felt this was "normal vax reaction". Next day, PT's complaints were consistent w/acute sinusitis - 48 hrs post vax PT felt much improved.
Chills but low temp (97.1); Chills but low temp (97.1); Tremors; sore arm but arm was mobile; Exhaustion; This is a spontaneous report from a non-contactable consumer. A 76-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN5318, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 10Feb2021 at 08:15 (at the age of 76-years-old) as dose 2, single for COVID-19 immunisation. Medical history included hashimotos, hypertensive and known allergies to fentanyl. Concomitant medications included pregabalin (LYRICA), levothyroxine sodium (SYNTHROID), valsartan, vitamin supplements, and nasal spray. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL0142, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 18Jan2021 at 09:00 (at the age of 76-years-old) for COVID-19 immunisation. On 10Feb2021 at 18:00, the patient experienced chills but low temp (97.1), tremors, sore arm but arm was mobile, and exhaustion. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Feb2021.   No follow-up attempts are possible. No further information expected.
10/20/2020 Child presents to parents upon waking with localized swelling and bruised right upper arm following vaccination the previous afternoon. Reports her ?arm really hurts? rates pain 6/10 using Wong-Baker FACES scale. Child is guarded with arm, and cries when being dressed. Body temperature 97.8 F, BP and pulse within normal range. Radial pulse strong and equal bilaterally. 200mg Ibuprofen administered PO Q6h for pain.  10/21/2020 Bruising is diminished, but erythema and edema (1+) are present at injection site and immediately surrounding tissue. Firmness detected in deltoid muscle not present on opposite non-injected arm. Pain reported at 4/10. Child remains guarded with arm, will not allow parents to dress her. Winces when raising affected arm above shoulder level. Body temperature 98.1 F, BP and pulse within normal range. Radial pulse strong and equal bilaterally. 200mg ibuprofen administered Q6 h for pain. 10/22/2020 Erythema and edema (1+) extending from shoulder to elbow. Firmness in deltoid has increased, and is visible from a profile view. Swelling visible and noticeable without close inspection. Pain not reported, but child will still not allow parents to assist in dressing. Winces when arm is touched, or raised above shoulder level. Body temperature 98.1 F, BP and pulse within normal range. Radial pulse strong and equal bilaterally.  10/23/20 Erythema and edema (1+) extend from shoulder to elbow, erythema splotchy v. contiguous in nature. Firmness in deltoid has increased further. Child does not want to move arm above shoulder level, says ?it pinches.? Denies pain. Body temperature 97.9F, BP and pulse within normal range. Radial pulse strong and equal bilaterally. Pediatrician notified. Will continue to monitor for signs of infection and range of motion.
Faint erythematous rash, started on the chest, spread to face and arms and back. More around eyes.
Myocarditis/ swelling around my heart on my heart; Pericarditis; Swelling around left lung; My ribs and collar bones feel bruised; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis/ swelling around my heart on my heart) and PERICARDITIS (Pericarditis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 MYOCARDITIS (Myocarditis/ swelling around my heart on my heart) (seriousness criterion medically significant), PERICARDITIS (Pericarditis) (seriousness criterion medically significant), PNEUMONITIS (Swelling around left lung) and CONTUSION (My ribs and collar bones feel bruised). At the time of the report, MYOCARDITIS (Myocarditis/ swelling around my heart on my heart), PERICARDITIS (Pericarditis), PNEUMONITIS (Swelling around left lung) and CONTUSION (My ribs and collar bones feel bruised) outcome was unknown. Not Provided          The concomitant medications were not reported. The treatment information was not provided.  Very limited information regarding these events have been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.
red rash around injection site; Headache; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 08Apr2021 at 09:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, gluten (unspecified). The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unspecified date for an unspecified indication and experienced drug allergy. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 17Mar2021 at 09:15 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 19:00 the patient experienced approximately 3 inches red rash around injection site and headache for two days since vaccination and still had at the time of report. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events red rash around injection site and headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a representative as reported by a colleague concerning a 13 year old female who on an unspecified date was vaccinated with a 0.5 ml dose of GARDASIL. It was reported that the patient developed low hemoglobin levels after receiving GARDASIL. She was taken to hospital where she received blood infusions. The outcome of the patient was not reported. The reporter considered "low hemoglobin levels" to be an other important medical event because the patient received blood infusion. No further information is available.
Information has been received from a registered nurse, concerning a 13 year old female with multiple allergies, who on 23-JAN-2007 was vaccinated IM in the right arm, with the first dose of Gardasil (yeast) (Lot # 655165/1425F). There was no concomitant medication. Approximately five to ten minutes later, the patient developed a rash that "started at the injection site and then spread to the arm and the whole body." Treatment with ZYRTEC was immediately given in the office, and the patient was instructed to take BENADRYL at home, if needed. The nurse reported that "rash was mild and self-limiting," and remarked "it was easily treated with antihistamine and resolved soon after treatment was given." He clarified that "this was a mild reaction," and he did not feel the patients condition would have required hospitalization or threatened her safety. The mother of the patient wanted her daughter to receive the subsequent doses of the vaccine, however the nurse stated he felt the patient's system was "sensitized" and believed a second dose would be "too risky." Additional information has been requested.
SIDE EFFECT; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unk) 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 side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effect was not reported. This report was non-serious.
sinus infections; This spontaneous case was reported by a patient and describes the occurrence of SINUSITIS (sinus infections) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus infections). At the time of the report, SINUSITIS (sinus infections) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       It was unknown if patient was received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient already received all her Moderna shots, and she did not remember the dates and currently she wanted to get Spikevax next week, but she recently had sinus infections and received several different antibiotics, name was not specified.   Reporter did not allow further contact
Employee reports that following his tetanus vaccination in November, he developed pain and impaired range of motion/function to his left arm. Symptoms developed approximately 1 week after the injection, which was administered on 11/29/07 in the left deltoid muscle.  At that time, he reports that he noted pain radiating from his left shoulder to his elbow, and his arm was "weak".  He states that he had difficulty abducting his left arm, however he was able to move his left shoulder in all other range movements.  He states that he was unable to lift items with his left arm for a period of a "few weeks".  He reports that these symptoms have slowly improved over time, and at this time he is able to demonstrate active range of motion to the left shoulder and arm without evidence of limitation.  He states that he currently experiences "pain from my shoulder to my elbow when I cough".
Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 17-19-year-old male patient who had received MENACTRA (lot number, route, site and date of administration not reported) and three months after vaccination developed meningococcal sepsis, year reported as 2007 (Q 3). Neisseria meningitidis serogroup was determined to be serogroup C. Treatments were not reported. No further information was available at the time of report. The patient's outcome was fatal. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
First dose Pfizer COVID-19 vaccine given after pt already received two doses of Moderna COVID-19 vaccine on 01/13/2021 and 02/10/2021.  No immediate adverse reactions observed or reported by pt while patient remained in clinic observation.  Dr.  notified by phone call.  Dr.  to follow up with patient via phone call.
Developed slight nausea about 10 minutes after vaccine administered. Started having sensitivity to light, lightheaded, dizzy, sweaty/clammy then dry heaves.
Fever, body aches, chills, joint pain, headache, felling inwell, fatigued, sore arm all started 12/28/2020 at 2100. Took cold/flu medicine
patient received 3rd dose of Pfizer (booster) vaccine earlier than 6 months. Patient received 1st dose of Pfizer on May 2, 2021 , 2nd dose on May 22, 2021, and third dose October 28, 2021. No adverse reactions occurred during 15 minute observation period.
This spontaneous report was received from the consumer's mother on a newspaper article and refers to a 12 year old female patient. The patient's medical history and concurrent condition were not reported. The patient on an unknown date in 2010 was vaccinated with quadrivalent HPV vaccine (manufacturer unknown) (dosing information not provided). Concomitant medication were not reported. After the first shot on an unknown date in 2010, it was reported that the patient had sore glands, headaches and tiredness, all normal symptoms which had subsided after a few days. Following the second shot on an unknown date, the patient had profuse bleeding from the injection site and then developed severe headaches. On an unknown date within eleven months the patient was barely able to get out of bed. She was surviving on rice cakes and water yet had piled on 3 stones in two months. Every inch of her body had ached. Numerous trips to the General Physician (GP) and tests conducted at the hospital (unspecified) failed to get a diagnosis other than teenage hormones or emotional problems. On an unknown date in 2013 the patient was diagnosed with chronic fatigue syndrome by a pediatrician (unspecified). It was reported that the patient didn't feel right after the vaccine. The patient had coped with initial symptoms but now on an unknown date had chronic pains, her left leg has started to turn in. It was reported that the patient on an unknown date 18 months ago had lost her eyesight. It came back but the peripheral sight in her left eye never came back. The patient was under a neurologist (unspecified) for ice pick headaches. Action taken with quadrivalent HPV vaccine (manufacturer unknown) was not applicable. The outcome of activities of daily living impaired, visual field defect, chronic fatigue syndrome, pain (chronic pain), injection site hemorrhage and headache (severe headache and ice pick headache) was unknown. The outcome of lymphadenopathy, headache and fatigue was reported as recovered on an unknown date. The patient was recovering from blindness. The reporter did not provide the causality assessment between the events and quadrivalent HPV vaccine (manufacturer unknown). The event "barely able to get out of bed" was considered serious due to disability and upon internal review the event visual field defect, blindness were considered serious as medically significant. This case is linked to the case 1512USA001052 and 1512USA001053. Additional information has been requested.
SEVERE CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (SEVERE CHILLS) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Three weeks prior to getting the vaccine, the patient had Covid) in February 2021.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced CHILLS (SEVERE CHILLS). At the time of the report, CHILLS (SEVERE CHILLS) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication and treatment were unknown
The next morning after my shot you weren't as sick as with the first dose with 2nd dose. I had a cough and headache. I was sick for week and had to use inhaler. I went to the  doctor and not sure of date but they called in z-pack. I still have a cough and sometimes I get shortness of breath. I still have to use an inhaler.
105 fever, high pitch screaming (couldn't even hear it-but could see was screaming), convuls then went to sleep; This was the 1st DTP pt recvd pt now 10 yrs old-mom just found out about this form;
patient received the vaccine on 9/17/20 at 16:15. No adverse effects noted.  However, next day noted that the vaccine given was from a lot of expired flu vaccines (last years flu vaccines).
pt had a positive COVID test on 7/20/21; pt to ED on 7/22/21 with SOB, lethargy; in DKA, was treated accordingly; given Tocilizumab; O2 supplementation; 7/24/21 had another positive COVID test in hospital; respiratory status worsened requiring intubation, mechanical ventilator support; multiorgan failure; acute renal failure; family made pt DNR and he was admitted to GIP hospice with comfort care; pt extubated and he expired in the hospital
Hurt the next day; Tiredness; Rash around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hurt the next day), FATIGUE (Tiredness) and VACCINATION SITE RASH (Rash around injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included METOPROLOL, AMIODARONE, HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESARTAN HCTZ) and HYDRALAZINE for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced PAIN (Hurt the next day), FATIGUE (Tiredness) and VACCINATION SITE RASH (Rash around injection site). On 07-May-2021, PAIN (Hurt the next day), FATIGUE (Tiredness) and VACCINATION SITE RASH (Rash around injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-214886 (Patient Link).
Fever. Muscular discomfort and dizziness 26 hours after vaccine and then urticaria all over body that has been going on even up to today that's 30 days going down every day. I am presenting with amenorrhea x5 days late, what we don't know is if it is due to the vaccine but it coincides. Inflammation and fluid retention some days worse than others.
1-11-10 @ 12N received 2009 H1N1 nasal mist. Within a few minutes became dizzy, itchy with red rash. At 3:30pm hives of stomach and upper arms, dizzy, "bright red" color. Given IVF and BENADRYL. Given steroids in ER and sent home. 1/15/10 - again became dizzy with hives and swollen hands. Went to local ER given BENADRYL and 5 day tapering dose of Steroids. 1/19/10 - Mother states all issues resolved, returned to normal health.
1 hr p/shot dull, staring, whining wanted to go to bed, restless, clingy, crying; trembled 45 mins; 3PM MD give APAP; t100.5 slept 30 mins; trunk sore to touch x 2 days; slept knee/chest x 2 days; MD said no pertussis only Td;
SHINGRIX vaccine received on 5/07. The following day (5/08), the patient experienced flu-like symptoms and subsequently L-sided pain with eventual development of L T10-11 vesicular rash (first noted 5/13). He sought care in the ED and was diagnosed with shingles and prescribed valacyclovir. Symptoms have improved on antiviral therapy but with residual post-herpetic neuralgia.
Blood clot; This is a solicited report. PSP-Eliquis-Lash-CW2891702, received from a contactable consumer, based on information received by Pfizer (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-116774), license party for apixaban (ELIQUIS). A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), unknown on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; apixaban (ELIQUIS), unknown from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for embolism venous. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced THROMBOSIS (seriousness criterion medically significant). The action taken with APIXABAN(Unknown) was unknown. At the time of the report, THROMBOSIS outcome was unknown. The patient developed blood clots in his Leg (venous thromboembolism) and was prescribed Eliquis. The patient got the Covid-19 vaccine and developed another blood clot. The action taken with Covid-19 vaccine was unknown and causality was not provided for the same. For APIXABAN(Unknown), the reporter did not provide any causality assessments.; Sender's Comments: Medical Evaluation Comment: This patient who was on apixaban therapy had blood clot. Based on the limited information regarding the suspect therapy details, event onset details, medical history it cannot be ascertained with reasonable possibility that apixaban contributed to the reported event. Pfizer comment: Based on the limited available information and temporal relationship, the causal relationship between thrombosis and bnt162b2 use  cannot be fully 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.