chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unsolicited report received from a consumer on 27 January 2016. This case involves 39-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu-shot) (batch number, route and site of administration not reported) on 01 October 2015. The patient's medical history and concomitant medications were not reported. On 02 October 2015, 1 day following the vaccination, the patient had experienced strong headache in the morning and elevated temperature (99 degree farad) in the evening. Other laboratory data and corrective treatment were not reported. The outcome of events was not reported. List of Documents held by sender: none.
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage than recommended.  No adverse affects reported.
Patient reported initial pain and swelling at vaccine site which resolved. Patient then developed pain with shoulder abduction and localized swelling within deltoid at vaccine site which was delayed in onset, about one week after vaccine.
Day 9 swelling redness warmth on injection site 2 inch by 2 inch circle started dime size day one and has increased photo available
"Had her TRUMENBA and Flu shot yesterday and slept after that. She woke this AM and ate breakfast, Felt nauseated and did not eat any lunch. Presented to clinic due to numbness in her left arm from shoulder to elbow. This progressed over a couple of hours to weakness of her entire left arm. On arrival to clinic she started to have headache. Glucose was 96 and CBC and CMP are pending. She was given water and IV 1000 ml. During this time her headache escalated to pain of 10/10 and the very worst headache that she has ever had. As she continued to be disoriented and increasing headache as well as increasing weakness, she is transferred to the ED for CT scan and further work up. No fever, no diarrhea or vomiting--just nausea and unwilling to eat. Able to keep water down. Not wanting solids.
Dizziness; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-016013), license party for apixaban (ELIQUIS).  This case was received via Pfizer Inc (Reference number: 2021162914) on 15-Feb-2021 and was forwarded to BMS on 16-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of dizziness in 65-year-old male patient who received apixaban (ELIQUIS) for venous thromboembolism. Co-suspect products included covid-19 vaccine for covid-19 immunisation. Patient weight was reported as approximately between 185-190 (Units not specified). The patient's past medical history included Open heart surgery (had two open heart surgeries. Believes first one was 2002 or 2004, second was 5 years ago, sometime in 2016) and COVID-19 in November 2020. Concurrent medical conditions included Diabetes and Coronary artery disease in 2002. In November 2020, the patient started ELIQUIS (unknown route), 5 milligrams twice a day. On 14-Feb-2021, the patient started covid-19 vaccine (unknown route). On the same day, the patient experienced dizziness. The dose of ELIQUIS (unknown) was not changed. At the time of the report, dizziness did not resolve. For ELIQUIS (unknown), the reporter did not provide any causality assessments. About three hours after getting covid shot patient felt dizziness. It was like he was disoriented or something. It was like his equilibrium was off. He was off balance with it. He is not 100 percent balanced. Patient got Flu Shot, Pneumonia shot previously. No prior vaccinations within 4 weeks. Further follow up was not performed, as sufficient data reported.  Causality Assessment: Drug: ELIQUIS Dizziness Per Reporter = No Information Per Company (Bristol-Myers Squibb) = Related
Subacromial bursitis of the right shoulder that is resolving with time and therapeutic exercise program.
Left deltoid erythema reported on 8/18/10. Treatment - MEDROL dose pack 4 mg apply warm compress.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions or concomitant medications was not provided. In or around 23-JUL-2013, the patient was inoculated (by an unspecified person) with ZOSTAVAX (dose, route of administration, and lot # were not reported) for routine health maintenance and for its intended purpose: prevention of shingles. Shortly after receiving ZOSTAVAX, the patient has suffered from numerous, reoccurring instances of pneumonia requiring several hospitalizations. As a direct and proximate result of the vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The outcome of the event was unknown.  Causality assessment was considered to be related. Upon internal review, the event of pneumonia recurrent was determined to be medically significant. The event of pneumonia recurrent was considered to be disabling. Additional information has been requested.
Acute urticaria with long lasting dermatographisma .  The hives have mostly resolved, however, the dermatographism is long-standing and is poorly managed with oral antihistamines.
Mother telephoned and reports localized redness, swelling and warmth.  Advised warm, moist packs and to seek medical treatment if symptoms persist or worsen.
Pt was administered COVID-19 Pfizer vaccine on 2/12/2021 at approximately 1415. At 1440 pt was observed to be coughing. Pt stated, "It feels like there is something in my throat". POX remained 98% on RA with HR 105-112.    Pt observed by nursing staff until 1445 when she was taken to the ED from the vaccination tent. At this time pt exhibited increasing SOB with notable tongue swelling. Pt reports previous anaphylaxis reaction to bee venom.
Fever, rash, chills, submandibular lymphadenopathy, headache and  fatigue started on 8/27/13. Facial swelling started on 8/28/13. Started on Atarax and Prednisone on 9/3/13.
BRUISING ALL OVER; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, 1 time every 2 weeks, from 16-APR-2021 for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On APR-2021, the subject experienced bruising all over. The action taken with covid-19 vaccine was not applicable. The outcome of bruising all over was not reported. This report was non-serious.
After 2-3 hours, she felt some type of sensation in her tongue; Then it felt like burning in back side of the tongue; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA ORAL (After 2-3 hours, she felt some type of sensation in her tongue) and TONGUE DISCOMFORT (Then it felt like burning in back side of the tongue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS], L-CARNITINE [LEVOCARNITINE], UBIDECARENONE (CO Q-10) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced PARAESTHESIA ORAL (After 2-3 hours, she felt some type of sensation in her tongue) and TONGUE DISCOMFORT (Then it felt like burning in back side of the tongue). At the time of the report, PARAESTHESIA ORAL (After 2-3 hours, she felt some type of sensation in her tongue) and TONGUE DISCOMFORT (Then it felt like burning in back side of the tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medications include Blood Pressure medicine, and Cholesterol Medicine. No treatment medications were reported
While sitting in a chair waiting 15 minutes after the shot she  was fine one minute and then passed out.  When she  came to the pharmacist gave her some orange juice.  It didn't help and she  was very nauseous.  When  she got up to leave she was totally incoherent, was unable to walk on her own.  When she got home she was no better so I first called our family doctor which both said take her to the ER.  There they did many tests and they all came back fine so they sent her home.  By that evening she was able to walk on her own and talking right.  She was terribly tired and still today 4/14 she is feeling worse but still not 100%. With the pause today for this vaccine we are very worried about this.
experiencing moderate pain and discomfort in kidneys and bladder.; experiencing moderate pain and discomfort in kidneys and bladder.; experiencing moderate pain and discomfort in kidneys and bladder; experiencing moderate pain and discomfort in kidneys and bladder; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 13:15 hours (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. The patient was allergic to opiates. The patient did not receive concomitant medications. 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 30Mar2021 at 19:30 hours the patient experienced experienced moderate pain and discomfort in kidneys and bladder within 6 hours of vaccination. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event moderate pain and discomfort in kidneys and bladder was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Student reported 12:15 pm ten min after shot delt dizzy, nauseated, head hurt and felt shaky. Then ate lunch and "threw it all up". She guesses she got shot at 10:25 am. Clt now-denies any symptoms. No signs hives. Denies respiratory difficulty. Oriented x 4 PEERL. Color nl. dry no treatment given.
7x7cm red raised area on rt mid-deltoid;area warm to touch;c/o aching in rt shoulder afeb @ this time may have had temp last noc;advised to use ice & rx for atarax given;
Information has been received from letter to the editor published in a newspaper, concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (Lot number, route and site of administration not reported). Subsequently the patient developed hearing loss and visual problems which make it very hard for her to read and retain information, which was her stronger suit, according to her mother. The consumer felt that her daughter problems were due to therapy with GARDASIL. Additional information is not expected.
Within seconds after administering the vaccine, injection site became red, swollen and bruised. Pt. c/o itchiness. Ice applied. Pt. went home mom gave BENADRYL and applied cream to area. 12/14/10 follow up phone call. Area just bruised.
No additional AE/PQC reported; HCP calling to report that a patient was administered a improperly stored vaccine; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported.  On 13-JUL-2023, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (product storage error) (lot number W035460, has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with an expiration date established as 06-MAY-2024, therapy type rHA), administered for prophylaxis (strength, and anatomical site of administration were not provided). No additional Adverse events were reported.
Dizziness; Fever; Headaches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PYREXIA (Fever), HEADACHE (Headaches) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088021A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced DIZZINESS (Dizziness), PYREXIA (Fever), HEADACHE (Headaches) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), PYREXIA (Fever), HEADACHE (Headaches) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Pt received PNEUMOVAX on 6/13/2016. On 6/14/2016 she called physician to report that she awakened at 3am due to nausea and severe joint pain. She can barely move her left arm where she received the injection. She feels like she has the flu, and has pain in all of her joints of the left arm and the right arm. Has funny noises in her head, like a washing machine.
This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored M-M-R II (strength, dosing details, anatomical location, lot# and expiration date were unknown). There were previous temperature excursions, but no information was provided on previous excursions. The temperature excursions were detected by a data logger. No product quality complaint was involved. Additional information has been requested.
Convulsions due to pain; Severe pain; A spontaneous report was received via voicemail from daughter, concerning her mother, a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced convulsions due to pain and severe pain.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On unknown date, the reported stated her mother experienced severe pain to the point of convulsing. She mentioned her mother was at the doctor. No treatment information provided.   The outcome for the event, convulsions due to pain and severe pain, were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
This case was reported by a healthcare professional and described the occurrence of diaphoresis in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced diaphoresis, chest pain, shortness of breath and fatigue. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. Four additional subjects had similar symptoms. Linked case include: A0751892A, A0751893A, A0751894A and A0751895A. Linked case A0751880A was more severe and included subject and event specifics.
Lump in throat and dizzy, worsened over time. Given 50 mg PO Benadryl, 0.3 mg epi
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 trainees and among others 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 9 months after vaccination developed meningococcal meningitis, year reported as 2008 (Q 2). Neisseria meningitidis serogroup was unknown for this case. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08254, and -08256. Documents held by sender: None.
sharp pain come up into in her leg for about five hours; has bulging veins in that area; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0217, Expiration Date: 30Sep2021), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that about half an hour after first dose of the Pfizer Covid 19 Vaccine she noted sharp pain come up into in her leg for about five hours and has bulging veins in that area. Patient asked if this was in the range of muscle and joint pain or was there anything to keep an eye out for or be wary of. She states she does not know if these were normal side effects or not. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
overall body fatigue with angina-like symptoms, bone aches, fever, head ache for next 36-48 hours. Head ache (frontal lobe with right eye visibility impairments at times for the next 6 days). For the next 2 weeks approx 50% lower strength/fitness during gym workouts.
Patient waited the requisite 15 minutes but when she left she complained of her hands itching and asked if that was normal. I told her it was unlikely to be caused by the vaccine but if they continued to itch or she noticed a rash or swelling to go be seen by her PCP. Patient went to walk-in clinic on 10/1 where they diagnosed her with an allergy to the Pfizer Covid vaccine.
Around August 20th my wife and I were traveling abroad. We contracted COVID. I have had high blood pressure for years, but my blood pressure has become worse. I developed Edema in my legs, and it went above my knees. I also developed severe lower back and hip pain. I also have sciatic pain. I talked to my doctor several times regarding the issues. These seemed to get worse after the 5th vaccination as well. Because of the edema and high blood pressure for many months. We had to change my medications. I think that these are more related to getting COVID rather than the vaccine.
started crying inconsolable for days prior, began having seizures. taken to emergency room twice.  diagnosed with infantile spasms. in hospital with onset on medicine ACTH. also in hspital twice for 24 video EEG.
Rash and Blisters on arms and face; Rash and Blisters on arms and face; This is a spontaneous report from a contactable consumer (patient) . A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Fc3184), via an unspecified route of administration in Arm Left on 05Sep2021 (at 42 years) at 13:15 as single dose for covid-19 immunisation  .  The patient medical history was not reported. There were no concomitant medications.  Prior to vaccination the patient was not diagnosed with COVID-19; since the vaccination she has not been tested for COVID-19. On 08Sep2021 the patient experienced rash and blisters on arms and face. Events required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse events included prednisone.Outcome of the event was recovering.No follow-up attempts are needed. No further information is expected.
Pt c/o dry mouth, dizziness, muscle aches, joint pain, lethargy, slight confusion, low grade temperature per phone call. Received MMR & TD 2/6/02 in afternoon. Stated symptoms began that night & he couldn't sleep. He called Health office from his apt with above complaints. Had no one to take him to doctor. Ambulance called and pt to nearest ED. Please see copy of ED notes attached.
DELAYED RASH APPEARED AT SITE OF VACCINE  ON LEFT ARM AND EXTENDED DOWNWARD . SIZE OF RASH IS 2 INCHES WIDE BY 4 INCHES LONG.
Swollen lymph node above my clavicle; This is a spontaneous report received from a contactable consumer (patient). A 75-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318), via an unspecified route of administration on 09Feb2021 09:45(at the age of 75-years-old) as a SINGLE DOSE in Left Arm for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of bnt162b2 via an unspecified route of administration on 19Jan2021 as SINGLE DOSE in Left Arm for COVID-19 immunization. Concomitant medications included: estrogens conjugated (PREMARIN) vaginal cream and multi vitamin. On 11Feb2021, the patient experienced swollen lymph node above my clavicle two days after vaccine administration. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any treatment for the adverse event. The outcome of event was not recovered.