chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight chills; soreness at the injection site; This is a spontaneous report from a contactable consumer female patient(daughter) reported that. A 47-years-old female patient received bnt162b2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 13Feb2021 (Batch/Lot Number: EL9266; Expiration Date: 31May2021) as DOSE 2 SINGLE for covid-19 immunization (Age at vaccination 47 years). The patient medical history and concomitant medications were not reported. The patient past vaccine took first dose 23Jan2021. Caller is calling about the Pfizer COVID vaccine. He says on Saturday, his wife, his daughter and his self-went to get their second shot. Caller says he and his daughter experienced mild side effects. They experience slight chills and soreness at the injection site on an unspecified date. His wife experienced tremendous side effects, her arm was bothering her a lot, she had fever until Monday up to 103 and diarrhea. She had chills nausea fatigue.The fever stopped today she no longer has fever, but she is still experiencing dizziness and fatigue. She woke up dizzy this morning, she is tired today, she had diarrhea twice again today, but the dizziness is bothering her the most. She also has loss of appetite; she does not want to eat. She wants to know why she is dizzy all these days later. Dizziness started this morning she was very dizzy. It went away for a while she ate lunch, she forced lunch down, but she is still dizzy now. She was drinking water because her husband thought she was dehydrating herself. She ate a piece of chocolate and sat down incase her sugar was dropping. She had diarrhea starting Saturday and she had the feeling yesterday, but she didn't go then today she went twice. Her chills were Saturday, Sunday, and now she is done with the chills and the fever. That went away yesterday. Now she just has the tiredness and the dizziness. The tiredness she can handle but she can't stand buy herself she gets dizzy when she is walking. The event outcome was unknown.  Follow-up attempts completed. No further information expected.
Started feeling tired in evening, did not sleep well, strange dreams. Following day - tired, muscle aches, felt like I was coming down with the flu. Went back to bed. Took a 1.5 hour morning nap. Began to feel better in the afternoon. The next day was feeling better but skipped my 28 mile bike ride.
doses of improperly stored MMR II were administered to 9 patients on  unspecified dates; No additional adverse symptoms reported; This spontaneous report has been received from an officer manager, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and, previous drugs reactions or allergies were not provided by the reporter.  On an unknown date, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (therapy type: rha), lot number S006051, and expiration date 27-FEB-2021 for prophylaxis. Details about strength, dose, dose number, route of administration, and anatomical location were not provided. It was unknown if the sterile diluent (DILUENT MRK) (lot number and expiration date were unknown by the reporter) used for reconstitution of the vaccine, was stored at proper temperature.  The highest temperature was above 47 degree Fahrenheit (°F) (53 Fahrenheit ), for a timeframe of 17 hours, with no previous temperature excursion. The call was due to the Digital Data Logger.  No additional adverse symptoms were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA005521: US-009507513-2001USA005516: US-009507513-2001USA005523: US-009507513-2001USA005524: US-009507513-2001USA005525: US-009507513-2001USA005519: US-009507513-2001USA005518: US-009507513-2001USA005520:
Had MCV4 vaccine 12-21-11. On 12-24-11 had "bad" head ache, dizzy and vomiting, no fever. Better next day but still nausea. Some days later (12-27-11). On 12-28-11, was back to usual self. No v/d. Reg urination. Good appetite.
Appears Shingles rash; Appears Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash zosteriform in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingrix. On 4th July 2019, 3 days after receiving Shingrix, the patient experienced rash zosteriform and shingles. On an unknown date, the outcome of the rash zosteriform and shingles were unknown.   It was unknown if the reporter considered the rash zosteriform and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient received a dose of Shingrix on an unknown arm. The patient appeared as Shingles rash. The reporter wanted to know, how to proceed with the 2nd dose of the Shingrix vaccine. The reporter was unable to provide patient and vaccine details. This case has been linked with case US2019123785, reported by the same reporter.
Information has been received from a woman working in a physician's office concerning a 4 yr old white male who on 02Aug02 was vaccinated with a first SC dose of varicella virus vaccine live (lot642640/0308M). On 23May05 the pt experienced papular vesicles plus excoriations. Medical attention was not sought. Additional information has been requested.
Pfizer on 3/16 and 4/6. Positive on 8/25
Pfizer-BioNTech COVID-19 Vaccine EUA  Bilateral partial bicep tendon tears. R medial epicondylitis. Multiple joint pain lasting 2 weeks.
Patient received Moderna vaccine from us on 4/27/21.   When logging the shot onto our state immunization registgry, we noticed that he had already received 2 Pfizer shots at a different location.  Upon reviewing his immunization record this morning,  the pfizer shots are missing.
Female patient 69 years old at approximately 5 minutes of receiving vaccine dose Pfizer, has difficulty "irritation" on throat and nausea. Vitals signs are taken 180/100, sat oz: 96, glucose:95. Emergency protocol is immediately activated and consulted with Doctor (medical director) at 1:30pm. The paramedic, with a medical order from Doctor administered Epinephrine injection, USP Auto-injector 0.3 mg is given 50mg/ml of diphenhydramine HCL injection. At 2:57 pm a call was received from the patient's daughter indicating patient was in Hospital. The medical team at the hospital indicates that the allergic reaction was caused by the vaccine.
Racing heart rate; waking in middle of night with heart racing over 120+; resting spiking to 100 and dropping back to 64  Went from Hypothyroid to Hyperthyroid following vaccine; meds adjusted and now back in normal range with lower dose medication; heart rate still racing
I woke up 2/23/2021, 8 days after receiving the injection. Left arm was swollen, hot, hard and had an itchy rash. I was very tired for 2 days. All symptoms have left except redness and mild itching.
After the second dose Felt run down the next day.   Arm soreness lasted a couple of days.  The one that?s worrisome is the swelling at the injection site. That one is still present.  It?s very noticeable when I raise my arm above shoulder height.  It?s been two weeks. I hope it?s not permanent.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "SVT" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE, start date: 10Sep2014; CRESTOR, start date: 14Feb2018, stop date: 01Nov2023; DILTIAZEM, start date: 04Feb2020, stop date: 01Nov2023. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 01Nov2023 to 06Nov2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out,Linked Report(s) : US-PFIZER INC-202300370066 Same patient, different product, different dose/event;
I received my Covid-19 vaccine on 10/03/2022. On 12/06/2022 I woke up with a slight sore throat. After testing positive for Covid-19 I started to have symptoms of high fever, achiness, nasal congestion, throat congestion. Symptoms lasted about a week after taking PAXLOVID.
fever, lethargy, body aches and pains, headache worsened through the day and lasted about 24 hours.
I put in the info for my first vaccine, but I had my 2nd booster that was supposed to protect against new variants on 9/23/22. I have had 4 moderna vaccines in total. I had a dry throat starting on 10/21 while arriving for vacation and then tested positive for Covid using at home  tests on 10/26 upon returning home. I had to schedule a doctor's appointment to get a note to say when it was safe to return to work. Starting on 10/27, I had severe congestion, runny nose, reduced ability to smell, headache , and fatigue. I still have some fatigue.
Case number PHEH2013US026018 is an initial spontaneous report received from a pharmacist on 13 Dec 2013. This report refers to a 58-year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml dose of FLUVIRIN (batch number: 13464P) intramuscularly on 13 Dec 2013. This FLUVIRIN prefilled syringe reached 48 F on 03 Dec 2013 at 6 pm; at 08:55 am on 04 Dec 2013 it was at 46 F. This first excursion was 15 hours. Same vaccine then reached 47 F on 04 Dec 2013 at 5 pm. This second excursion duration was 16 hours. Reporter stated that the vaccine has been in range since that excursion. Vaccine was administered to patient after excursions. No adverse reactions were reported. Seriousness, outcome and causality of the event were unknown.
Information has been received from a physician concerning a 16 year old female with no pertinent medical history who on 29-APR-2008 was vaccinated intramuscularly with the 0.5 ml second dose of GARDASIL.  There was no concomitant medication.  The physician reported that the patient had seizures after her second dose of GARDASIL.  On 14-JUN-2008 the patient was taken to the emergency room and had repeated seizures since.  The patient is now under the care of a neurologist.  The patient's seizures persisted.  Upon internal review, seizures were determined to be an other important medical event.  Additional information has been requested.
Migratory polyarthralgia-hips,shoulders,wrists,ankles,feet,knees and fatique
2 DAYS OF THE FLU; This spontaneous report received from a consumer concerned multiple patients.  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: unknown) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On JUN-2021, the subject experienced 2 days of the flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 2 days of the flu on JUN-2021. This report was non-serious. This case, from the same reporter is linked to 20210622311.
This spontaneous report was received from a consumer and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions or medical history provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX vial (exact dose, route of administration, lot# and expiration date were not reported) to prevent shingles. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patient was told that ZOSTAVAX was ineffective. However, the reporter stated she was also vaccinated with a dose of ZOSTAVAX in approximately 2015 (reported as 3 years ago) and did not get shingles. The outcome of the event and the relatedness between the event and ZOSTAVAX were not reported.
Asthma episode 48 hours later/Asthma was related to the moderna's covid-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of ASTHMA (Asthma episode 48 hours later/Asthma was related to the moderna's covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Splenectomy. Previously administered products included for Product used for unknown indication: GSK's Shingrix vaccine. Past adverse reactions to the above products included Asthma with GSK's Shingrix vaccine. Concurrent medical conditions included Immunocompromised and Asthmatic. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHMA (Asthma episode 48 hours later/Asthma was related to the moderna's covid-19 vaccine). The patient was treated with PREDNISONE for Asthma, at a dose of 1 dosage form. At the time of the report, ASTHMA (Asthma episode 48 hours later/Asthma was related to the moderna's covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ASTHMA (Asthma episode 48 hours later/Asthma was related to the moderna's covid-19 vaccine) to be related.    Reporter stated that age of the patient was in the 60's. And also stated that the vaccine was not IgE mediated. Other treatment information includes: Required increase of asthma medications.
snored all night so loudly that it kept waking me up got up in the am, had coffee and then back to bed until 1 pm and contifnued to snore nonstop as during the nighttime very unusual for me, never snore like this and never sleep during the day
ITCHING MOUTH, FACE,NECK, LASTED 3-4 DAYS TOOK BENEDRYL
Patient inadvertently received Tdap instead of DTaP. Within 12 hours mom said fever went to 106 and fussiness. Temp decreased to 103 after mom gave cold water. At time of exam temp 101.6 no antipyretic had been administered.
Unknown if related but had preventative care mammogram 2 weeks after vaccination and showed lymph nodes swollen in same arm as injection. Had follow imaging and ultrasound that found various enlarged lymph nodes and 2 abnormal nodes. Arm soreness only noticed after injection and continues the intermittently ache even after 4 weeks. Provider to rescan axillary lymph nodes in 8 weeks and monitor. 2nd injection given in opposite arm
Provider discharge summary "Pt came to ED due to sore throat for 5 days. She was found to have covid 19. Briefly hypoxic on ambulation but later on improved. Her DD was elevated, duplex and CTA chest negative for any clots. She did well overnight. She was started on xarelto 10 mg daily for 30 days for DVT prophylaxis. She lives alone but will be going to her daughter's home.  PCP to follow up for pulm nodules."
Received oral vaccine in our clinic on 11/27/2014. Kept pills refrigerated as per instructions. Did not begin the pills until 12/4/2014 at 7 am. That evening began to develop abdominal cramping and distention with reflux. Also reports headache dizziness, and "prickly eyes". 12/5/2014- Reports small amount of bright red blood in stool. Denied any diarrhea or constipation. Continued gas pains, abdominal distention, dizziness, headache and "prickly eyes". Self treated with an OTC antacid, Gas-X and Visine for eye discomfort. Reports speaking with a "Doctor friend who advised her to stop the pills because they did not agree with her".  12/6/2014 - Reports feeling a little better and took #2 pill. Reports that the symptoms described above became more intense. She again self treated with OTC antacid, Gas X, and Visine. Her symptoms continued and she reports being "very sick". Did not seek emergency or medical care. Reports improvement of symptoms over the next 1-2 days. Did not take pill #3 on 12/8/2014. Reports feeling better; headache, dizziness, abdominal cramping, blood in stool, and prickly eyes have resolved, but still experiencing some abdominal bloating.
I administered the vaccine at 05:50pm. patient seemed fine for at least 10 minutes. Was very talkative. She called me at 7pm complaining a feeling of a bubble in her throat and swollen tongue. I advised her to go to the emergency.
This spontaneous case was initially received on 30-Nov-2015. The case report was received from a Non Health Professional and concerns a female patient. The patient has a medical history of High blood pressure. The patient has no drug reactions/allergies. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received Influenza vaccine in early Oct-2015, Batch no: not provided, Route of administration: Unknown, Dose: Unknown. PNEUMOVAX 23, Batch no: Unknown, Route: Intramuscular. On an unknown date, after starting treatment with Flu vaccine the patient experienced Rash. Reporter's assessment: Not reported.
Came home my shift at work 1/28/21 at 8:30pm and all of the sudden I had the chills and within 1/2 hour a fever of 101, muscle aches, very tired.  I went to bed and in morning fever was gone but still fatigued and soreness at injection sight
Pt recv #1dose vax on 5/22/97;on 5/26/97 pt exp rash on arms & legs, angioedema of the upper lip & eyelids;5/30/97 pt exp itching; tx=Benadryl &Atarax w/ out help;pt exp aches &tingling in arms/ pt recv #2 vax 7/28/97;exp inc hives&itching Follow up report to previously submitted report on 03/01/1999: Information has been received from a physician concerning a 12 year old patient with cerebral palsy and had silastic and metal appliances in body who on 22-MAY-1997 was vaccinated with the first dose of hepatitis b vaccine recombinant. On 26-JUN-1997 the patient experienced a rash on arms and legs with no itching initially. In addition, the patient alos experience angioedema of the upper lip and eyelids upon wakening in the morning. It was noted that the patid did not have upper airway obstruction or increased work of breathing. approximately 4 days late, the patient experienced itching. The patient was seen by a physician who initially suspected arythema multiforme. Therapy with BENADRYL and ATARAX did not hpel with the itching. The patient then experienced aches and tingling in her arms. On 28-JUL-1997 the patient received the second dose of hepatitis b vaccine recombinant. Subsequently, an increase in hives and chronic itching was noted. On 30-JUL-1997, laboratory tests included erthrocyte sedmentation rate - 20, ANA - 1/160 ang GGT -17. The patient's thryroid function test were normal. The patient was diagnosied with chronic urticaria "with some relief" with ATARAX. As of 16-SEP-1998 the patient's experiences persisted. The urticaria was considered to be an other medical event. Follow-up information from a physician reported that in October of 1998, the patient recovered.
This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.
4 hrs after receiving injection began feeling ill, Temp 102 coughing, sneezing chills abrupt onset, in bed 3 days and woke wed day 4 feeling perfectly fine, as reported by patient.
body aches, fever 1st 24 hrs, diahrea, headache 48 hrs  and swelling  of eyes, nasal passages and shortness of breath at 50hrs. Treated with antihistines and steroids for a week .Feeling better now but have been extra tired.
Case number PHEH2013US009498, is an initial spontaneous report received from a nurse on 24 Apr 2013 with a follow up received from a nurse on 21 May 2013 and 31 Jan 2014: This case refers to a 16-years-old female patient. She received only Men A lyophilized conjugate component of MENVEO vaccine (batch number: M12023) reconstituted with sterile water by mistake (instead of liquid component Men CYW) intramuscularly into right deltoid on 23 Apr 2013. On the same day, she was vaccinated with Tdap (manufacturer unknown, batch number: 44431AA) at a dose of 0.5 ml intramuscularly into her deltoid. On an unknown date, after vaccination, she had a fever for 1-2 days. She had a sore arm on an unspecified date. She was completely recovered from the fever as of 28 Apr 2013. She was revaccinated with MENVEO (batch number: unknown) which was missed correctly on 29 Apr 2013. outcome of sore warm was not reported. The causality and seriousness of events were not reported. Follow up received from a nurse on 21 May 2013: Updated reporter comment, vaccination anatomical location (right deltoid), event (fever, sore arm), suspect product (Tdap) and revaccination information. Follow-up received from the nurse on 31 Jan 2014: Updated patient demographics (height and weight).
Patient was given COVID-19 mRNA LNP-S, bivalent PF 12yrs-adult booster (Pfizer), 30mcg/0.3mL as first dose of COVID vaccination series
Two weeks after receiving this 2nd dose, I woke up with a swollen lymph nodes.  It was painful. It was around the neck. A few days after, I had multiple lymph nodes under the armpit and in the groin area. One was very painful. Dr. put me on antibiotic. Got better for that time. Two weeks after that, I had another episode of swollen lymph nodes and cold sores on my lips (which I never had in the past) and I saw my provider again and he ordered blood tests. It has now resolved and it didn't come back (didn't need to take another round of antibiotics).
Patient received the vaccine on the evening of 03-09-2021.  R.N. states she was "fine " at 440 AM bed check.  At 0830 03-10-2021 patient was found slumped over on her bathroom toilet having expired sometime between 440AM and 830 AM