chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of acute hepatitis B in a subject who received Hepatitis B vaccine. The subject's past medical history included hepatitis B exposure (after 1987). On an unknown date, unknown after receiving Hepatitis B vaccine and Hepatitis B vaccine, the subject developed acute hepatitis B. Serious criteria included GSK medically significant. The outcome of acute hepatitis B was unknown. The investigator considered that there was a reasonable possibility that the acute hepatitis B may have been caused by Hepatitis B vaccine and Hepatitis B vaccine. Relevant Tests: Lab tests performed on an unspecified date Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Alanine aminotransferase result was 30 u/L. On an unknown date, Hepatitis B core antibody result was anti-HBc IgM positive unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of possible acute hepatitis B virus infection in a patient of unspecified age and gender who was vaccinated with unspecified hepatitis B virus (HBV) vaccine (manufacturer unknown). The patient was part of the study that evaluated the Health System (HS) HBV vaccination program effectiveness at protecting against symptomatic illness among persons receiving equal to or more than 1 HBV vaccine dose during 1987-2011. In this study, among the 31 persons with acute HBV infection (27 confirmed and 4 possible), 20 were male. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On unspecified dates, the patient received 2 doses of unspecified HBV vaccine (administration site and route unspecified; batch number not provided). In 1984, HS began offering HBV vaccination to all infants starting at birth (99% 3 dose HBV coverage in children aged 19-35 months by 1998). The age of vaccination was not provided. On an unspecified date, an unknown period after the vaccination, the patient developed acute HBV infection. This case was considered as possible acute HBV infection. (In this study, possible acute HBV infection (symptomatic or subclinical) case was defined as persons lacking an alanine aminotransferase (ALT) less than or equal to 30 days from a positive anti-HBc IgM but with serologic evidence of exposure to HBV infection after 1987. The patient's laboratory investigation revealed ALT equal to 30 U/L at time of positive anti-HBc result. Treatment was unknown. The outcome of the event was not provided. The authors did not comment on the relationship between the event of possible acute hepatitis B virus infection and unspecified HBV vaccine. The authors concluded "The HS HBV vaccination program was highly effective because no confirmed acute symptomatic HBV infection cases were identified among specific persons followed through HS who received equal to or more than 1 HBV vaccine dose during the 25 year study period".
This spontaneous report as received from a certified medical assistant refers to a 5 years old patient of unknown gender. Healthcare worker stated that on 20-MAY-2013, VARIVAX (Merck) (lot number, dose and route were not reported), that was stored improperly was administered to the patient. Concomitant medications were not reported. Healthcare worker stated that VARIVAX (Merck) was storage with multiple temperature excursions up to 13F since February 2013 (vaccines were received in November 2012) exceeding one week (168 hours) then progressively up to 22F for an estimated 96 hours through June 2013. The healthcare worker did not believe overall temperature was maintained at 5F. No adverse effects reported. This case is linked to cases MARRS# 1307USA002435, 1307USA002437, 1307USA001233, 1307USA002434 via same reporter link. Additional information has been requested.
Felt Covid-19 Positive; Felt Covid-19 Positive; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4393868-00.  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, (citrate free), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "Felt Covid-19 Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "felt covid-19 positive" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product to the development of the reported events cannot be totally excluded.
Approximately 2:30 am I awakened from sleep with difficulty breathing and a stuffy nose.  Similar to a common cold, but with the breathing issue. I contacted Dr on Demand to ask if it was ok to take medication.  This was ok and as I would normally at the onset of a cold with these symptoms I took one Mucinex and used one inhalation of BREO. After about 30 minutes I felt better and was able to sleep.  I woke up approximately 8 am and had symptoms of a common cold, no breathing issues.  I did not repeat the BREO.  However at 10PM that night I took another Mucinex for a stuffed nose.  On Feb 14 I took a Mucinex at 10 am.  as the day progressed the stuff nose lessened.
Immediately after the vaccine, I was sick for approximately four days. Vomiting, diarrhea, inability to stand or walk, extreme fatigue. In the weeks following, I have been to the Emergency room at Clinic twice for extreme weakness, inability to stand or walk for long periods, shortness of breath, vomiting, loss of appetite, dehydration, severe magnesium deficiency, and other symptoms that I can only attribute to an autoimmune dysfunction. Now I'm mostly bedridden, have no medical insurance, had to quit my job, and can't properly care for my five year old daughter. All I want is to figure out what is happening to my body.
Tenderness and swelling at site of 4 yo deltoid vaccines on 7/21/17 while  on amoxicillin for scarlatiniform rash. Afebrile. Mom reports there was blood at the time of the vaccines. on exam, significant induration and warmth of entire right upper arm.  Not tender. Distal pulses intact. Full ROM of arm.  Referred to ER for cellulitis vs  hematoma vs vaccine reaction.  Changed from amoxicillin to Keflex for likely cellulitis.  Problem resolved.
On 9/13/00, pt developed a rash on her abdomen that spread to her back, neck and face. On 9/15/00, she had a fever >102F and decreased appetite and fluid intake.
Headache started next morning. Very severe headache. The next day fever and chills developed along with severe fatigue and swelling in left arm (vaccination site)
- patient was given flu shot then on the other arm after 1 minute she was given the HPV #2 Few second after that, she fainted while sitting down, then had a tonic seizure for about 40 seconds. she then woke up in about 1 minute and asked what happened. We had lifted her up to the exam table. she sat up and was ok for few minutes, then she vomited. She stated that she is very tired and needs to rest T50.Z95A: Adverse effect of other vaccines and biological substances, initial encounter
non-raised rash under both arms & rt deltoid; no other areas involved; denies fever; no mass noted @ inject site;
Information has been received from a medical technologist concerning a male pt who on 08Jun05 or 09Jun05 was vaccinated with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 647661/0055R). It was noted that the pt had injection site reactions. On approx 09Jun05, the pt called the doctor's office because he experienced temp to 103 deg F, chills, nausea, weakness, redness, swelling, and soreness of the arm to the elbow. It was noted that he was taking ibuprofen (Motrin) and or acetaminophen (Tylenol). Unspecified medical attention was sought. The pt's outcome was unk. The caller was concerned about further use of this lot number. No product quality complaint was involved. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
slept a lot; she was feeling sick and took a half day; took half day off of work; sore arm / arm pain was the right arm (the side that was injected); chills; headache the whole time; cold; shaky; This case was reported by a other health professional via call center representative and described the occurrence of sleep excessive in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In December 2020, less than a week after receiving Shingrix, the patient experienced pain in arm, chills, headache, cold and tremor. On 28th December 2020, the patient experienced sleep excessive, sickness and activities of daily living impaired. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the sleep excessive, pain in arm, chills, headache, cold, tremor and sickness were recovered/resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the sleep excessive, sickness and activities of daily living impaired to be related to Shingrix. The reporter considered the pain in arm, chills, headache, cold and tremor to be related to Shingrix.   Additional details were received as follows: The case was reported by the patient for herself. The patient used to be a medical assistant. The patient received 1st dose of Shingrix in the right deltoid.  The patient had headache the whole time, chills a little and a sore arm. About 24 hours after the shot, she began to experience side effects, like cold and shaky which continued through the night and Monday.  She was worked on Monday morning and was feeling sick and taken a half day and on the same afternoon, the patient slept a lot.  For headache the patient taken Tylenol, headache did not resolve until Tuesday night.  The patient reported that all the events were resolved, even the arm pain, three days after (by Tuesday night).  She stated that the arm pain was the right arm (the side that was injected) but that there was no redness or swelling at the injection site. The patient did not had a physician. The reporter did not want to provide her email address and does not have a personal fax number.
Swelling at innoculation site after injection. Muscle spasms in neck. Unable to move neck for 24 hr period. Limited mobility for lasting another 48 hours.
Duplicate administration. Patient has not had any reactions as of now. Patient received influenza vaccine from Pharmacy on 10/18/2022. Facility had consent from power of attorney to receive influenza vaccine from Pharmacy on 10/19/2022. Facility and Pharmacy were unaware of previous administration non 10/18/2022.
shingles rash on back and left leg starting 1 wk after vaccine given.  had headache and felt warm but no documented fever
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization.  The following information was reported: ARTHROPOD BITE (non-serious), RASH (non-serious), outcome "unknown" and all described as "got bit by a tick recently and I have a rash on my arm".  Additional information: Patient stated "I have gotten my Pfizer original, and booster shots and I have an appointment to get the second booster for the Omicron variants. I got bit by a tick recently and I have a rash on my arm. Is there any issue with me getting that booster dose while having this rash?"  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Administered 2 vaccines (Adacel and Flublok) to a pregnant patient, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00479733) and transmitted to Sanofi on 17-Feb-2021.  This case involves a 28 years old female patient who was exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in context of administered two vaccines (adacel and flublok) to a pregnant patient (Exposure during pregnancy).  Data regarding this pregnancy were received prospectively.  The date of last menstrual period was not reported.  The estimated due date is 05-Apr-2021.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included INFLUENZA VACCINE RHA 3V (BACULOVIRUS) (FLUBLOK).  On an unknown date, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot U6846AA and expiry date: 16-Oct-2022] via an intramuscular route in right arm for prophylactic vaccination.  It was reported that, vaccine presentation for specific vaccine if baby was delivered: delivery date and if baby experienced an adverse event- not delivered. Inform that they would be receiving a follow up questionnaire and it was done. All pregnancy cases were added to the registry, it was an FDA requirement.  Product used: Used.  Still using product: No.  It was the case of vaccine exposure during pregnancy [Latency on the same day].   Pregnancy outcome was unknown at the time of report.  Details of laboratory data not reported.  There will be no information available on the batch number for this case.
This spontaneous report as received from a nurse refers to a female patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that the patient completed Hepatitis B vaccine (manufacturer unknown) series in 1992-1993, had titer drawn and result came out low and patient was recommended to repeat the series. The reporter reported that for repeat series, RECOMBIVAX HB was used and patient received first dose of new series on 31-JUL-2014. The reporter also stated that second dose of RECOMBIVAX HB (for the new series) was not due about a month later but nurse administered a second dose of RECOMBIVAX HB on 19-AUG-2014, about 10 days too early than recommended. No adverse effects reported. The outcome of events reported is unknown. The patient sought medical attention. No product quality complaint was involved. This case is linked to the case 1409USA001257 via same reporter link. Additional information has been requested.
PT experienced very bad nerve pain on her shoulder  and md said it is parsonage turner syndrome post covid vaccination. PT was prescribed with gabapentin and still taking the med.  pain has improved since the med
Pt contacted me the day after vaccine to inform me that she ended up having an adverse reaction including hives up neck to her cheeks. Also complained of skin being red and hot. Stated she had taken her normal medication which consisted of a daily allergy pill, SINGULAIR ADVAIR and had received a steroid shot from her allergist the day before.
Mild headache (started hour after injection) became moderate headache about 23 hours after dose of vaccine. Treated with 1000mg Acetaminophen orally and sleep for 3 hours. Became mild headache and treated with 500mg Acetaminophen in morning and afternoon.
This is a spontaneous report from a contactable pharmacist via a sales representative. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain in the arm on an unspecified date. The event took place after use of the product. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Received Adacel in left arm 2/1/10. 2/2/10 had H.A., fever, pain and redness in left arm, numbness in both forearms and wrists.
exposed to freezing temperatures; This case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in a 23-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received the vaccines after being exposed to freezing temperatures (minus 1 degree C for total amount of time of 25 min) on 18th October 2021 and 19th October 2021. The reporter consented to follow up. This case is one of the five, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021218244:same reporter US-GLAXOSMITHKLINE-US2021218242:same reporter US-GLAXOSMITHKLINE-US2021218245:same reporter US-GLAXOSMITHKLINE-US2021218239:same reporter
On 05/07/2021 I felt foggy, light headed- but not vertigo light headed, just didn't feel on my game. That lasted for about a week, and I was trying to change my diet so I wasn't drinking any alcohol, eating any sugar, and I wasn't taking any ibuprofen or anything. A week later on 05/13/2021 I noticed at night that my heart rate and blood pressure was high, so I tested my BP and it was indeed high 160/90 and I noticed my heart felt funny and it was irregular heart beats-4 strong beats and then a soft mushy beat. I felt light headed during this. I called nurse line and she encouraged me to call doctor and talk to on call doctor and she encouraged me to go to the ER. in the ER they immediately hooked me up to the EKG machine, and within minutes they made declaration I was having the PVC (Premature ventricular contractions). They also did a blood test and found that my potassium level was low and they gave me potassium and monitored me and then sent me home. At home for the next several days I was diligent about taking electrolytes. I was drinking daily electrolyte drinks (powder). The PVC continued but tapered off (05/13/2021-05/20/2021). Then I did a f/u blood test and found that my electrolytes were well balanced and fine. I did at this point decide to opt to use a heart  monitor for 2 weeks to see what patterns were detected in my heart but I haven't gotten that data back (survey was from June 14, 2021). I continued to have PVC incidents every other day frequently-I notice them most at night. I am mostly waiting for the heart monitor results but I did have a f/u blood test done a week ago and the numbers are normal for the electrolytes. I still have symptoms of the PVC and I haven't had them before in my life and that's why I'm curious. The main thing is the idea of having had chemotherapy plays apart (Chemotherapy from breast cancer 1994 --drugs taken were Adriamycin and Cytoxan).
took Norco; cold and allergy medication; nothing take the headache away; Joint pain/in my hips I am like waking up in the middle of the night crying for some reasons cause my hips hurt so bad; severe headache that will not go away; head will not stop throbbing; I am in so much pain; hips hurt; This is a spontaneous report from a contactable consumer or other non hcp. A contactable patient (consumer) of unspecified age and gender received bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (age at the time of vaccination was not provided) as DOSE 1, SINGLE for covid-19 immunisation and hydrocodone bitartrate, paracetamol (NORCO), route of administration, start and stop date, batch/lot number and dose were not reported for headache and pain and other Unspecified suspect medications. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on Tuesday on an unspecified date and had severe joint pain and a severe headache on an unspecified date that would not go away, the asked what can be taken. The patient mentioned, took Norco, for pain (the pain medication) and headache on an unspecified date. The patient took unspecified cold and allergy medication (Further clarification unknown hence captured as unspecified medications) but nothing took the patient's headache away but in the hips, the patient was like waking up in the middle of the night crying for some reasons cause the hips hurt so bad all on an unspecified date. The patient had Joint pain. The patient mentioned, never experienced anything like this. The patient asked, what can be done, was in so much pain and the head would not stop throbbing on an unspecified date. The action taken in response to the events for hydrocodone bitartrate, paracetamol (NORCO) was unknown. The outcome of the event took NORCO; cold and allergy medication; nothing took the headache away (drug ineffective) was unknown, while for all other it was not recovered. Reason for no lot number: of Covid-19 Vaccine, Norco and Other Unspecified suspect medications: Complainant hung up abruptly/transfer incomplete.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On unknown dates, the patient was vaccinated with unspecified number of improperly stored VARIVAX (Merck), (dose and route not provided). Lot information of VARIVAX (Merck) was provided as lot# J014131, expiration date: 07-NOV-2015 and/or lot# K016132, expiration date: 24-SEP-2016. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.