chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2013US006931 is an initial spontaneous report received from a pharmacist on 11 Mar 2013. This case refers to an 85-year-old elderly male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A10053, expiration date: Jan 2013) on 07 Nov 2012. No adverse events were reported following vaccination. It was also confirmed by the reporter that the patient was not revaccinated. No other information was available.
Severe headache , dizziness/ vertigo ( ?)abdominal pain, nausea , whole body malaise and bed ridden x  4 days   ,  ,  then I had headache during sleep , woke me up  , it has been moved morning headache daily  to date
This case was reported by a healthcare professional, via a GSK sales representative, and described the occurrence of pain in an adult male subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 16 January 2008 and on an unspecified date, the subject received the 1st dose and 2nd dose of TWINRIX (1 ml, intramuscularly, left arm). At an unspecified time after vaccination with TWINRIX, the subject experienced pain and reduced range of motion. The sales representative had limited information to provide, but stated that the same adverse events occurred following the 1st and 2nd doses of TWINRIX. At the time of reporting, the outcome of the events was unspecified. Follow-up information was received on 09 May 2008 via a healthcare professional, who indicated that this case was reported to a Regulatory Agency (VAERS ID # 309478). The subject was a 61 year-old male who was reported to have a "cold" on the date of vaccination with TWINRIX. It was unspecified if the subject had the cold on the date (s) of the 1st and/or 2nd doses of the TWINRIX vaccination (s). Concomitant medications at the time of vaccination with TWINRIX included an unspecified thyroid medication. The subject had no history of adverse events following previous vaccinations. The immunization series was neither delayed, nor discontinued. The symptoms did not recur following subsequent vaccinations (dates and doses unspecified). The healthcare professional reported that the onset date of the earliest signs or symptoms occurred on 16 January 2008. The reporting healthcare professional indicated that the events were not serious, and considered the events to be unrelated to vaccination with TWINRIX. At the time of reporting, the outcome of the events was unknown.
Give second dose of vaccine 10 days before due; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Give second dose of vaccine 10 days before due) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Give second dose of vaccine 10 days before due). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Give second dose of vaccine 10 days before due) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter called in to ask if it was okay to give the second dose of vaccine 10 days before the due date (appointment/scheduled day).  No Concomitant product use was reported. No treatment information was provided.
Information has been received from a physician concerning a 22 year old female patient who on unknown dates was vaccinated with the first and second dose of GARDASIL. It was reported that the patient experienced syncope immediately following her initial 2 doses of GARDASIL while she was in the physician's office. The patient was treated in the office and fully recovered before leaving. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash of 3inches across his arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031L20A) for COVID-19 vaccination. The patient's past medical history included Bypass surgery and Heart attack (several heart attacks). Concurrent medical conditions included Cancer. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH ERYTHEMATOUS (Red rash of 3inches across his arm). At the time of the report, RASH ERYTHEMATOUS (Red rash of 3inches across his arm) outcome was unknown. This case was linked to MOD-2021-051915.
Pt recv vax on 10/10/98; on same day pt exp nausea & vomiting
Initial unsolicited report received from a consumer (patient herself) on 07-Feb-2018. This case involves a female patient (age not reported), who was vaccinated with 0.5 ml dose of FLUZONE HIGH-DOSE once (batch number, expiration date, dose in series and site of administration were not reported) via intramuscularly on 07-Nov-2017. Medical history and concomitant medications were not reported. On an unknown day, five to six weeks post vaccination, the patient experienced diarrhea and some localized hives on her arms. On an unknown day, patient visited doctor. Laboratory investigations was not reported and other corrective treatment include DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL). The outcome of all the events were recovered on an unknown day. List of documents held by sender: none Follow up received fom a nurse on 14-JUN-2018. Patient received corrective treatment. List of documents held by sender: none.
I tested positive for Covid-19 on  February 6, 2023, I experienced tiredness. I was prescribed Paxlovid for my symptoms.
Dizzy after recieving the injection.  Back of neck to spine felt warm. Walked to the car and still felt dizzy.  Was advised to have EMT access the situation. B/P was 197/128. Taken by ambulance to ER
Left arm began swelling within 2 hrs of immunization, shortness of breath reported that night. Left arm hot and achy and it's still swollen 04/10/2002.
C/O REDNESS AND SWELLING TO LEFT ARM AROUND THE INJECTION SITE.  Given Ice pack and Benadryl 25 mg.
Frequent menstruation for months after 2nd vaccine - May 4, May 18, June 3, June 18
Tested positive for COVID after first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID after first dose of vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028l20A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included APIXABAN (ELIQUIS) and DILTIAZEM for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID after first dose of vaccine). At the time of the report, COVID-19 (Tested positive for COVID after first dose of vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID after first dose of vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028l20A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included APIXABAN (ELIQUIS) and DILTIAZEM for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID after first dose of vaccine). At the time of the report, COVID-19 (Tested positive for COVID after first dose of vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Severe Bronchitis requiring treatment with Azithromycin and Prednisone starting July 14. Although this condition does occur 1-2 times/year, this was a far more serious and threatening event than typical.
very cold the night after shot. very tired the next day. a few days later had blood pressure and heart rate fluctuating. sore red swollen arm. md says infected.
Received seasonal flu vaccine on 9/14/2017 approximately 3pm. Awakened the next am (9/15/2017) with a swollen tongue, lips, flushed face. Took antihistamine upon waking, Reported incident to Employee Health Office at 915a, at this time stated the swelling had subsided. Encouraged to go to ER for work up, however patient declined going.
Breakthrough case admission after vaccination Moderna 1/5/21 Lot# 039K20A;  Moderna 1/14/21Lot# 039K20A;  Moderna 2/2/21 Lot# 028L20A
This spontaneous report was received from a healthcare worker refers to a 17 year old female patient. On 01-APR-2013, the patient was vaccinated with first dose of 0.5 ml GARDASIL, (lot # 672193/1524AA expiry date 23-AUG-2014, route was intramuscular). On 10-JUN-2013, the patient was vaccinated with second dose of 0.5 ml GARDASIL, (lot # 672193/1524AA expiry date 23-AUG-2014, route was intramuscular). Concomitant therapies included SPRINTEC. On 01-APR-2013, the patient experienced tonic clonic movements and syncope after the first dose of GARDASIL. On 10-JUN-2013, the patient experienced worsening of tonic clonic movements and syncope after the second dose of GARDASIL vomiting. There was no treatment rendered for the events. The outcome of the reported events were unknown. The patient sought medical attention. Additional information has been requested.
I did NOT keep the paper which specified flu vaccine details! Pharmacist did. 5:00 pm 9/12 pain @ injection site similar to bursitis. 12:30 am 9/13, chills, shivering, teeth chattering despite warm bed wear, bedclothes, room temp. 3:30 am 9/13 stabbing pain in joints (both shoulders, both knees, neck both sides near mastoid, both hips, uncontrollable shivering, teeth chattering. Got up to take temp 101.1 (patient basal temp is 97.9). Forehead headache across brow temple to temple.
customer had syncope about 5 mins after the vaccine administration. The pharmacist immediately placed a cold compress on her forehead and arms. She was breathing  and had a low pulse. She became responsive in 1-2 mins and started responding to our questions. We gave her glucose tablet and some water as she stated she had not had anything to eat for the past 2  hours. We monitored  her for additional 30 mins and let her leave when she was normal.
On 6/23/21, patient reported to pharmacist that a few hours after receiving his 1st Moderna vaccine on 5/7/21, he began to experience numbness and tingling in left arm, on left side of face, and did not have full range of motion  in both the left and right arms. This experience lasted "a few hours" according to patient.
On day 8, patient experienced a red, swollen lump at the injection site, it is very itchy and burns
Flu; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional (patient's spouse) via public post on social media.   This case involves male patient (unknown age) who got flu (influenza), after he received INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) on an unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.   It was not reported if the patient received a corrective treatment.  The outcome of event influenza was unknown.  There will be no information available on the batch number for this case.
pt recv vax 27AUG96 & 12MAY97 pt devel chickenpox;
On May 17, 1999 the pt experienced chicken pox with an unknown number of lesions, mild severity without complications. The pt was treated with acyclovir.
disseminated varicella-zoster virus (VZV) infection; This is a literature report.  A 58 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "acute myeloid leukemia" (unspecified if ongoing), notes: for 12 months; "Immunosuppression" (unspecified if ongoing), notes: for 12 months; "blood stem cell transplantation" (unspecified if ongoing), notes: umbilical cord blood stem cell transplantation, 20 months ago. The patient's concomitant medications were not reported. Vaccination history included: Recombinant zoster vaccination (Shingrix,GlaxoSmithKline, 8 months ago), for immunization. The following information was reported: DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION (medically significant), outcome "recovering", described as "disseminated varicella-zoster virus (VZV) infection". The patient underwent the following laboratory tests and procedures: biopsy: unknown; blood immunoglobulin g: elevated vzv; blood immunoglobulin m: elevated vzv; immunohistochemistry: positive, notes: varicella-zostervirus; laboratory test: without cutaneous or systemic side effects; 12.14, notes: mild leukocytosis, lymphocyte-predominant, K/uL; pathology test: extensive epidermal ulceration and a florid, notes: mixed dermal inflammatory infiltrate; physical examination: erosions and intact vesicles and pustules, notes: on erythematous bases over the scalp, neck, trunk, genitali and extremities; polymerase chain reaction: varicella-zostervirus dna from blood, and elevated, notes: varicella-zostervirus DNA from blood, and elevated varicella-zostervirus immunoglobulin M and IgG antibody titers; white blood cell count: 12.14, notes: Unit: k/ul lymphocyte-predominant). Therapeutic measures were taken as a result of disseminated varicella zoster virus infection.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available. 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.
Frontal thinning noticed sometime in 10/2017. Alopecia Aerata noticed on 1/15/2018, started on corticosteroid injections to scalp on 1/19/2018, and Rogaine, not yet recovered.
rash/hives rt upper arm and upper back, bilateral forearms (back side) and bilateral upper legs/thighs
A nurse reports post vaccine, later that evening the pt developed an injection site reaction characterized by swelling, redness, and pain which progressed to include her left leg. Follow up information rec'd from pt's physician indicated 2 wks prior to vaccine's the child experienced gastrointestinal symptoms. At the time of vaccine the pt has a 1-2 day history of cough with sneezing.
Fever, shaking awakened patient presented to clinic still not feeling well. Responded well to naproxen otc
When I caught COVID-19 I had achiness, a fever, and the worst hacking cough. My nose was constantly running nonstop for 3 days. I had a lack of appetite. I had a little change in my taste and smell. For a few days all I could taste was something very sweet or very salty. I had started getting headaches. I am very weak and very tired. My sinuses are still somewhat congested. I have an occasional dry cough. My temperature, oxygen, and blood pressure is normal. My eyes are dry. I spoke with my doctor and they advised that I take paxlovid, but I refused to take it. I just took some liquids, Tylenol, Cold-Eeze Zinc Lozenges, and throat lozenges like halls.
Patient developed fever > 102, night sweats, nausea, body aches, (L) arm pain and swelling that he developed the night of the injection. Sxs persisted > 48 hours.
Per pt's dtr, pt's arm was swollen; tingling in arm radiating to shoulder and back; pain in (R) hand; body ache and nausea.
fever, fatigue, nausea, sweating, dizziness, runny nose.  Started with a fever and fatigue, took Advil for muscle aches, Through the night I had sweating and nausea.  I had dizziness upon standing the next day after the vaccine.  About 48 hours after vaccine, I developed a burning sensation in my nose and had a very runny, stuffy nose for one day.  By day 3 after vaccine, everything went back to normal.
Body aches and mild fever the following morning. Lasted throughout most of the day. Next day back to normal.
Information has been received from a health professional concerning a 20 week old white female who on 22Jun04 at 9:30AM was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 646712/1179N) (IM). Concomitant therapy that day and time included a second dose of diphtheria toxoid ((+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) (lot U1301AA) (IM), a second dose of Hib conj vaccine (tet toxoid) (ACTHIB) (lot UE179AA) (IM) and a second dose of poliovirus vaccine inactivated (Vero) (Ipol) (lot W1440) (SC). On 22Jun04, at 11:30AM, the pt was reportedly crabby when she woke up from nap. The pt reportedly ate and went back to sleep. The pt recovered. Additional information has been requested.
Redness and edema left arm from elbow to shoulder appeared on 5/15. On 5/16 edema gone, blotchy redness remained, warm to touch, child complained of itching. Child seen in clinic, evaluated by MD, who prescribed Benadryl prn and Keflex QID.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021 at 9:04 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021 at 9:04 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 36.41. Concomitant products were not provided. Treatment medications were not reported.  Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 27 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021.  On 02-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 29, 11 AM: 32, 12 AM: 33, 1PM: 36, 2 PM: 35, 3 PM: 36, 4 PM: 37 and 5 PM 37.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   This case was linked to MOD-2022-566976.
Skin blisters; Rash on neck and under her breast; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Skin blisters) and RASH (Rash on neck and under her breast) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLISTER (Skin blisters) and RASH (Rash on neck and under her breast). At the time of the report, BLISTER (Skin blisters) and RASH (Rash on neck and under her breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.
Nausea, vomiting,diarrhea for 4 days, headache
Evening and all next day tired/weakness feeling and achy joints(shoulders, wrists, ankles.) mild headache the evening after the injection.
Middle of the night woke up with chills, sweats. Lasted for the night. Took Tylenol. I no longer have a fever. Headache that started at 4am  on 4/13/2021 and lasted throughout the day. I have been having headaches on and off throughout the week.  I have had a metallic taste in my mouth for about a week with increased heartburn. I am still having these symptoms.  Increased fatigue.
Shortly after the second shot I had terrible body pain and chills. Later that night stabbing pain vomiting and diarrhea. I waited one more day the pain as unbearable and when to the hospital and appendix had to be removed.
Patient started coughing/clearing throat about 13 minutes into the 15 minute observation period. I gave her a cold bottle of water. She said her throat was feeling itching and she was having trouble swallowing. I gave her 50 mg of benadryl and called for paramedics to come and check on her. While waiting for the paramedics to arrive her throat started feeling worse and slightly dizzy and she said it felt like it does when she is exposed to her other allergies. We waited a little longer and her throat was getting worse so an epi-pen was administered. The paramedics arrived and checked her over and she was feeling better. She declined going to the hospital.