chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shaking; Pain in kidneys; Burning eyes; Cramps in ribcage; Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 09Apr2021 at 16:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included chlortalidone (MANUFACTURER UNKNOWN), quinapril (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12), ascorbic acid (VITAMIN C), vitamin d not otherwise specified (NOS) (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 10Apr2021 at 05:00, the patient experienced fever, chills, shaking, pain in kidneys, burning eyes, and cramps in the ribcage. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events which included treatment with two ibuprofen (MANUFACTURER UNKNOWN) on 10Apr2021 at 16:00. The clinical outcome of the events fever, chills, shaking, pain in kidneys, burning eyes, and cramps in ribcage were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Cough; itchy; getting rashes; This is a spontaneous report from a contactable consumer. An 84-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL9261), via an unspecified route of administration on 22Jan2021 at single dose at arm right for COVID-19 immunization. Medical history included Reflux, and fatty tumor. Concomitant medication included pantoprazole from 11Jan2021 and ongoing for reflux. On 24Jan2021, the patient experienced itchy, getting rashes. On an unspecified date, the patient experienced cough. The outcome of the event cough was not recovered while unknown for the other events. Therapeutic measures were taken as a result of itchy (pruritus), getting rashes (rash), cough (cough).
Onset of herpes zoster ophthalamicus approximately 24 hours following vaccination Patient is fully vaccinated against varicella with no clinical history of wild-type varicella infection
Pain at injection site with swelling (large red bump and hot to touch); pain in entire arm that was injected; next day low grade fever with chills and muscle aches; 24 hours from injection diarrhea and vomiting still with low grade fever and lack of energy.
Patient received Moderna COVID-19 vaccine Dose #1 on 3/15 and Dose #2 on 4/12, unsure where patient received vaccine. Admitted to hospital for syncopal episode at a store on 7/8. The ED provider note does mention that the patient reports increased weakness and fatigue over the last month with heart rates in the 40-50s. She had bleeding head laceration on admission. New Afib noted this admission. Platelets low on admission (9) with no prior CBC's in the chart. Three units of platelets were ordered to be transfused. Low platelets are an incidental finding.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012488 with expiry date: 20-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
pt recv vax & devel inj site rxn of redness, tenderness & a lump. Tx w/ice.
Toes and both thumbs hurting; Joint pain,excruciating pain all over joints, hips started to hurt, toes,ankles, knees, and hips hurt; excruciating pain all over muscles and joints; Felt very sluggish; Slept a lot; joint inflammation,hips started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (joint inflammation,hips started to hurt), SLUGGISHNESS (Felt very sluggish), HYPERSOMNIA (Slept a lot), PAIN IN EXTREMITY (Toes and both thumbs hurting) and MYALGIA (excruciating pain all over muscles and joints) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteoarthritis (Had surgery years ago on her feet.). Concurrent medical conditions included Drug allergy (Allergic to codeine.). Concomitant products included CARVEDILOL and AMLODIPINE for Blood pressure, VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced ARTHRITIS (joint inflammation,hips started to hurt). On 04-Apr-2021, the patient experienced SLUGGISHNESS (Felt very sluggish) and HYPERSOMNIA (Slept a lot). On 05-Apr-2021, the patient experienced MYALGIA (excruciating pain all over muscles and joints). On an unknown date, the patient experienced PAIN IN EXTREMITY (Toes and both thumbs hurting) and ARTHRALGIA (Joint pain,excruciating pain all over joints, hips started to hurt, toes,ankles, knees, and hips hurt). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ARTHRITIS (joint inflammation,hips started to hurt) and ARTHRALGIA (Joint pain,excruciating pain all over joints, hips started to hurt, toes,ankles, knees, and hips hurt) had not resolved and SLUGGISHNESS (Felt very sluggish), HYPERSOMNIA (Slept a lot), PAIN IN EXTREMITY (Toes and both thumbs hurting) and MYALGIA (excruciating pain all over muscles and joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD21-083788 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received on 20-JUL-2021 : Event (Joint pain) outcome was updated.; Sender's Comments:  MOD21-083788:Sisters case
Sudden death; getting COVID; getting COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, 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: SUDDEN DEATH (death), outcome "fatal"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 1 week after the suspect product(s) administration, outcome "unknown" and all described as "getting COVID". The patient date of death was unknown. Reported cause of death: "Sudden death". It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300320987 same reporter/drug/event, different patient;; Reported Cause(s) of Death: Sudden death
Shortness of breath, can't walk up stairs even.  Pain in the base of spine.
Information has been received from a registered nurse concerning a 12 month old male who on 15 APR 1999 was vaccinated with .5 ml dose of varicella virus vaccine live (lot #626406/1841H). There were no concomitant therapies. On approximately 10 MAY 2001, the patient developed minimal lesions. It was noted that his brother had the same thing too. Subsequently, the patient recovered from the minimal lesions. The treating physician also reported the experience of several other patients who were vaccinated with varicella virus vaccine live (WAES01072424). Additional information has been requested.
This spontaneous report as received from a pharmacist refers to female patient in her 50s. Pharmacist states that on an unspecified date, patient had received ZOSTAVAX (dose, route and lot number were not provided) and later developed shingles. The outcome of the patient was not reported. The relationship between ZOSTAVAX and shingles was not reported. Additional information is not expected.
pt received pfizer covid shot, after about 5 minutes he passed out while sitting in the waiting area.........laid pt down and took blood pressure which was normal 120/73.......put an ice pack back of his neck.......pt then wanted to try to leave with his father but his stomach hurt and proceeded to throw up. ...pt then left the store with his father.
Back ache, sore on mouth, sneezing, crusted blood in nasal passages.
This spontaneous report as received from other health professional refers to a patient of unknown age and gender. On 19-DEC-2013 the patient was vaccinated with M-M-R II 0.5 ml, first dose subcutaneous. On 19-DEC-2013, second dose of M-M-R II was administered and no adverse effects were reported. No product quality issue has been involved. The outcome of first dose of event was unknown. Additional information has been requested.
I got up around 9:00 am and felt weak. I ate breakfast and began to feel achy and nauseous so I went back to bed. For the rest of the day I experienced: Feaver 102.4 Feaver 100.6 Severe vomiting 3x chills sweats body aches pain behind my eyeballs headache extreme weakness I continued to rest and take Tylenol all day to break the fever.   The next morning, 2/17/2021 I woke up with a fever of 100.4 and took Tylenol. All other symptoms were gone by 2/17 except for low grade fever and fatigue. Fatigue continues still as of this reporting 2/19/21
Swelling, erythema at injection site, headache, chills. Pt seen in urgent care and released with Tylenol
Itching and mild hives started within 10 mins of the vaccine injection. Patient was treated with antihistamine and responded well. symptoms improved after 2 hours of monitoring.
Three days after receiving the vaccine I began getting ringing in my ears.  This was especially loud in the left side.  On the 15th I felt like it was diminishing  some.  But while sleeping became loud again.  It has been 12 days since vaccine was given and about 9 days since ringing began.
Throat and tongue swelling and pain 2 days after receiving vaccine Dx Angioedema with stomatitis continues to have rash, whelps and itching on 10/1/04.
Within 25-30 mins after shot, as driving home, I began to feel mildly dizzy, then my throat started to close, (these two symptoms lasted maybe 2-4 seconds and one after another). Then I had a sharp pain in heart area and palpitations/tightness which I have had since then. Chest Tightness/ pressure got worse and on 3/1 taken to ER with heart attack symptoms.
Parent reported temperature of 105 deg F earlier in the day on 06/11/02. At time of call at 3:30pm, mother noted temp of 102 deg F, swollen, red left arm. Pt admitted to hospital.
Inconsolable and irritable 3 hours from 7 PM - 10 PM night of vaccine administration. Temp 100.4 R.
Arm sores; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Arm sores) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm sores). The patient was treated with ALCOHOL (topical) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm sores) was resolving. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Outcome added as recovering. Consumer doesn't need further follow-up.
shingles breakout; . This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 7th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than 2 weeks after receiving Shingrix, the patient experienced shingles. The patient was treated with acyclovir (Aciclovir). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was received as follows: Age at vaccination was not reported but was taken as an adult as per vaccine indication. Reporter called in to request information of how to proceed during a shingles breakout for a patient that had the first dose of Shingrix and just recently had a Shingles breakout. Patient normally treats the condition with aciclovir and was wondering if this was alright, given the recent vaccination. Reporter mentioned to 2nd line agent that patient had experienced shingles breakouts for the past 20 years. Reporter did not have any patient or vaccine information due to "patients just come here to buy the products". Agent did not pursue for more information. The reorter did not consent to follow-up.
OFF LABEL USE; VACCINE WAS GIVEN 16 MINUTES PAST THE 6 HOUR USE TIME FRAME; This spontaneous report received from a health care professional concerned a 97 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced off label use. On 09-JUN-2021, the subject experienced vaccine was given 16 minutes past the 6 hour use time frame. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine was given 16 minutes past the 6 hour use time frame was not reported. This report was non-serious.
Panuveitis with significant choroidal thickening and inflammation of the anterior chamber and vitreous; This is a literature report.  A 43-year-old female patient received bnt162b2 (BNT162B2, solution for injection) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (FIRST DOSE, (MANUFACTURER UNKNOWN)), for COVID-19 immunisation. The following information was reported: UVEITIS (medically significant), outcome "unknown", described as "Panuveitis with significant choroidal thickening and infammation of the anterior chamber and vitreous".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event UVEITIS and the vaccine (BNT162B2 )cannot be 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."
Father stated that 10 hrs post vax, pt developed severe hives from chin to toes and ended up in the ER.  He was treated with steroids and benadryl.
w/in 36 hrs p/2nd DTP had shrieking, different cry for brief period; mom noted fever but did not take temp;
After about 2 weeks post vaccine I did get bloodwork done that did indicated higher thyroid hormone levels that was completely abnormal from my earlier bloodwork taken earlier this month. I did go to see my PCP a few days after my bloodwork and they also noted that my thyroid hormone levels were tripled in comparison to my bloodwork from January of 2022. I was prescribed a medication to help combat the elevated levels. No biopsies or scans were done at this time with presenting symptoms however I have had Ultrasounds of my thyroid in the past and they were completely normal. I am periodically having fatigue that does come and go and it does make it feel like my energy is very low.
Admitted 12/21/2022 to a local Medical Center for acute hypoxemic respiratory failure COVID positive 12/21/2022 Date of death 12/26/2022
Expired Engerix-B (Dec. 04,2004) was administered to a newborn and he did not suffer any adverse effects.  Baby was revaccinated the next day per the manufacturer and CDC guidelines. Baby was revaccinated with Engerix-B with expiration date of November 02, 2007.  Parents were notified of the incident.  Mother of baby did sign consent for vaccination and revaccination. Certain measures were implemented in the facility to prevent such an error in the future. Baby was discharged with no adverse effects or events.
pt began p/vax to bob heads a series of times & eyes would shift to the side;pt taken to hosp & p/a series of diagnostic test pt was found to have cryptogenic infantile spasms;tx w/med;unsure of how complete recovery will be;
Passed away on the sleep; A spontaneous report was received from a pharmacist concerning a 73-years-old male patient who received Moderna's COVID-19 vaccine and passed way on the sleep/death.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (lot number: 024M20A) on 23 Jan 2021.  On 23 Mar 2021, patient received second of two planned doses of mRNA-1273 (lot number: 047A21A) intramuscularly for COVID-19 prophylaxis.  On an unknown date in Mar 2021, the patient passed away on the sleep.  The patient received both scheduled doses of mRNA-1273 prior to the event therefore, action taken with the drug in response to the event was not applicable.  The patient died on the sleep on an unspecified date in Mar 2021. The cause of death was unknown. Plans for an autopsy were unknown.; Reporter's Comments: This case concerns a 73-years-old, male patient, who died. The cause of death was unknown. Plans for an autopsy were unknown.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. No concurrent conditions, medical history, concomitant medications and drug allergies were reported. On 19-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot number L005297, expiration date: 17-AUG-2016, albumin status HSA; dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient is a previously healthy 15 year-old presenting with chest pain and elevated troponin in the setting of recently receiving his second COVID vaccine.   He was in his USOH and received his second COVID vaccine 6/17. He subsequently experienced tactile fevers, headache, and malaise for two days that resolved. Then 6/21 he developed congestion and chest pain. It is in the center of his chest, not pleuritic but worsened with sneezing/coughing. Tylenol/Motrin help, but given persistence of the pain he presented to the hospital ED.   Lyme titers were sent, troponin at 1814 was 2.12, then at 1646 2.49 (normal <0.06), chem was normal, CBC had wbc 11.5 with 66% neut and Hgb 12.3. EKG and CXR were reportedly normal. He received Tylenol and Ativan and was transferred for further management.   In the ED, he was afebrile with normal VS. Repeat troponin was 0.25. EKG was normal. Given elevated troponin, he is being admitted for further workup and serial cardiac enzymes and EKG.  Hospital Course: Patient was admitted to the cardiology floor for troponin and chest pain monitoring. His troponin levels were trended x4 and showed return to normal. Just prior to discharge, troponin level was 0.04 (normal < 0.09). His EKG was normal throughout, and at discharge showed normal sinus rhythm. He did not have any chest pain prior to leaving the hospital. On discharge, he was tolerating a normal diet. Plan for return was discussed with family for cardiac MR on 6/25. Return precautions were discussed and family expressed understanding.
This case was reported by a lawyer and described the occurrence of arthralgia in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unknown time after vaccination with Lymerix, the subject experienced, arthralgia, fatigue, rash, sinus problems, gastrointestinal problems, memory problem, body pain, eye problems, headache, mental fog, dizziness, autoimmune disease, rheumatological symptoms, cognitive impairment, decreased ability to perform activities and decreased activity level. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the event were was unspecified.