chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Headache; This is a spontaneous report from a contactable consumer or other non hcp. An adult male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 26Feb2021 at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID-19, prior to vaccination. It was unknown whether the patient had been tested for COVID-19, since the vaccination. On 26Feb2021 the patient experienced fever, headache. It was unknown whether the patient received treatment for the adverse events. Query: You reported a case for patient received COVID-19 vaccine and experienced the adverse event Fever, Headache Please confirm if the patient reported this adverse event to you. And we also would like to know when you becomes aware of the adverse event. Response: Yes the patient mentioned it to me directly in conversation on the Sunday 28Feb2021. Outcome of the events was resolved on an unspecified date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Theyre also painful/ Pain during injection; This case was reported by a consumer via interactive digital media  and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on an unknown date 3 years ago, refer case US2021AMR077282).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced injection site pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at the vaccination was not reported, however age group was captured as an adult as per vaccine indication. The patient stated he/she had vaccine 3 years ago and they were painful but having the disease was more horrible so better to have the vaccine; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR077282:Same reporter.
Patient has the 3 Moderna doses, the first two she has fever, headache but no to bad, after the third dose she started with a big headache , and never went out en February started going to doctor, by March 2022 she went to emergency room, this headache caused an inflammation of the brain,  up today 08/10/2022 she has two times a drain outside the brain, and she did not show any recuperation, now last Friday August 5,2022 the doctors decided to add the drain inside, Our concern as a family is no any test making can show why she has the swollen brain, All those headaches started with vaccination, we can not prove it, but patient was a healthy person, very active, and with not bad health record in the pass, she never went to doctor before March 2022 to complain for any healthy issue, as a family we like to know is was a consequence of Moderna vaccine, ALL HER MEDICAL TEST ARE GOOD, no one show anything that can conduce the medicine to find why her swollen brain Please can some can call me, I am her sister
test positive for COVID; test positive for COVID; 101 fever; chills; headache; coughing; congestion; fatigue; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as dose 2, single and dose 1 via an unspecified route of administration on 22Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient was tested positive for covid and was exposed to drug ineffective. The patient also experienced, 101 fever, chills, headache, coughing, congestion and fatigue on an unspecified date in 2021. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date in 2021, sars-cov-2 test: positive on an unspecified date in 2021. Outcome of all the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pain in left shoulder, exhausted, achy, couldn't lift arm without the pain. More painful than Dose 1. Allergies are worst, reactions are amplified, Soft bowel movements and minimal diarrhea. Post nasal drip and coughing. Tested for antibodies in February didn't have Covid 19. Candida infection after the vaccine.
Progressive erythema around the site of infection.  Induration and warmth.  Felt to be c/w cellulitis.  Started the day after the vaccine was given and was progressive the next day
This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. No information regarding current condition, medical history or drug allergies were reported. On 08-APR-2015 the patient was vaccinated with first dose of improperly stored GARDASIL injection (strength, dose unit and route unknown) (also reported as confirmed as not GARDASIL 9) lot # K006117 and expiry date 14-JAN-2017. No concomitant therapy was reported. The temperature excursion for GARDASIL was supported with in-house stability data and no adverse symptoms were reported. The outcome of event was unknown. No further information provided. Additional information has been requested.
Fever, headache, swelling at injection site with redness and burning pain. Pt seen again after injection...blister positive and drain. Still indurated on deltoid, lack of full range of motion, 1 cm base, blister evident, deltoid are itching.
they always made my mother so sick; Initial information was received on 08-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media (under reference number US1-SA-SAC20211116000758).  This case involves adult female patient who experienced so sick (illness) when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious so sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the outcome was unknown for the event (illness).  There will be no information available on the batch number for this case.; Sender's Comments:  US-SA-2021SA379655:
Information has been received from a nurse, referring to a multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of ROTATEQ lot # M038847, expiration date on 27-APR-2018; Lot # M034799, expiration date on 01-FEB-2018 or lot # M004726, expiration date on 19-OCT-2017 (strengths, doses, anatomical locations and administration routes were not provided) for prophylaxis. No adverse effects were reported. The vaccines had one temperature excursion of 31 Fahrenheit (F) during a time frame of 336 hours; it was confirmed that all the vaccines were administered, no previous excursions occurred and no digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA009135:
Wrong vaccine and dosage administered to a patient. Pfizer peds. vaccine 6m-4yrs .3ml was administered instead of Pfizer 12yrs + .3ml.
This spontaneous case reported by a physician, describes the occurrence of cough and oropharyngeal pain (sore throat) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included: No adverse event. On Jan 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 26, 2021, patient experienced cough and oropharyngeal pain (sore throat). At the time of the report, cough and oropharyngeal pain (sore throat) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information.
congestive heart failure; chest pain; today both shoulders are so painful she can barely move them; today both shoulders are so painful she can barely move them; symptoms worsened; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID: .  A 67-year-old female patient received tofacitinib citrate (XELJANZ), since 2020 (ongoing) at 5 mg 2x/day, oral for rheumatoid arthritis; BNT162b2 (BNT162B2), 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: CARDIAC FAILURE CONGESTIVE (medically significant), outcome "unknown", described as "congestive heart failure"; CHEST PAIN (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), MOVEMENT DISORDER (non-serious), outcome "unknown" and all described as "today both shoulders are so painful she can barely move them"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "symptoms worsened". The action taken for tofacitinib citrate was temporarily withdrawn. Therapeutic measures were taken as a result of arthralgia, movement disorder.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Reported event of cardiac congestive failure could be due to an intercurrent medical condition, unrelated to the suspect drug.
fever, headache,  muscle, joins, skin pain, light/sound sensitivity,  fatigue, nousea swollen left armpit lymph node  sore throat
Pt recv vax on 11/5/98; 30-60 min post vax pt exp hives on vax site arm, tight throat; tx=Benadryl
In early evening of vaccination date pt suffered chills and shaking. took hot shower before retiring, then suffered high fever. Took buffered aspirin and still had 103 degree fever in morning plus nausea. MD advised Tylenol liquids plus anti-nausea (Promethazine 25mg). Pt remained in bed past noon when fever receded to 89.7 degrees. By Sun am pt was near normal and able to consume some food.
- 5 hours after Covid vaccinated, I had sweating, chilly, and mild muscle ache for 2 hours. After that I had moderate pain at injection site till the next day.  - The next day, I felt dizzy and heavy headache for 3 hours; after that I felt normal and no pain at injection site. I took Tylenol 500mg  by mouth twice a day and Vit C daily to help for releasing symptoms.
Left arm red, warm, swollen, painful left shoulder to elbow. Treated with cool compresses and Benadryl.
I've had pain in the muscle right below my right collarbone ever since the vaccine (2 weeks)
MILD FEVER; FEELING OF DEATH; BODY ACHES; HARD TO WALK; This spontaneous report received from a patient concerned a 24 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known drug allergies .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 12:30 to Left Arm as prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced feeling of death. On 05-APR-2021, the subject experienced body aches. On 05-APR-2021, the subject experienced hard to walk. Laboratory data included: Body temperature (NR: not provided) 104 F. Treatment medications included: ibuprofen. On 05-APR-2021 19:30, the subject experienced mild fever. Laboratory data included: Body temperature (NR: not provided) 100-102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, hard to walk, and mild fever, and the outcome of feeling of death was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Patient said she wasn't feeling well about 10 minutes after receiving her vaccine.  She felt dizzy, thought she was going to faint.  We gave her ice for the back of her neck.  We checked her blood pressure, it was 230/130, pulse was within normal limits.  Pulse ox was low.  An ambulance was called.  She removed her mask and stepped back so that she could breath better and her oxygen and coloring improved.  She said that her lips felt numb, so we gave her some benadryl just in case.  We did not give an epi pen due to her increased blood pressure.  Her blood pressure did start improving but was still high when the ambulance came.  They took her to the ER for evaluation and she will be following up with her pcp also.  The hospital felt that it was just a fainting episode.
Chills; body aches; Joint pain worsening; This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (Chills), MYALGIA (body aches) and ARTHRALGIA (Joint pain worsening) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 2620A and 012620A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine), Drug allergy (PROCAINE), Drug allergy (SULFAMETHOXAXOLE), Drug allergy (TRIMETHOPRIM), Asthma (Mild) since January 1995 and Osteoarthritis (has gotten increasingly worse this past year especially after vaccine) since November 2014. Concomitant products included METABOLIFE for Weight loss.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced CHILLS (Chills), MYALGIA (body aches) and ARTHRALGIA (Joint pain worsening). On 07-Feb-2021, CHILLS (Chills) and MYALGIA (body aches) had resolved. At the time of the report, ARTHRALGIA (Joint pain worsening) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other Concomitant medications included Generic Voltarin  did not take prior or after second dose for a week.. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-006503 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant follow up ADR was received patent demographics were added,product details were added batch no start and stop date ,events outcome was added,
Info has been received from a health professional concerning a 39 year old adult female who was vaccinated with two 2 dose series of varicella virus vaccine live. Titers after each series have been negative. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up info indicated that the pt was vaccinated with 2 doses of varicella virus vaccine live, in another country. She was then vaccinated, SC, in the left arm with a 3rd dose (lot 648551/0286P) and 4th dose (lot 648317/0439P) of varicella virus vaccine live on 3/3/05 and 4/6/05, respectively. The pt did not seroconvert. The second antibody test was negative. This is all the info available. Additional info is not expected.
The pt returned on 04/03/2002 with redness, swelling, drainage, cellulitis two hours post vaccinationl. Was prescribed Biarin. Cellulitis resolved on 04/05/2002.
Moderna COVID-19 Vaccine EUA  Chills and exhaustion started 12 hours after innoculation and continued for 12 to 18 hours.
This spontaneous report as received from a 57 year old female consumer with diabetes, severe neuropathy and no drug reactions or allergies reporting on herself. On 30-APR-2013, the consumer was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). Concomitant therapies included "extensive" unspecified drugs. The consumer reported that on 01-MAY-2013, she developed shingles. The consumer reported that she had a headache and diarrhea after being vaccinated. She stated that had 3 active pox, and some that dried. The consumer stated that she started with "v" as treatment for the adverse event. There were no Lab diagnostics or studies performed. The outcome of shingles was unknown. This is one of several reports received from the same source. Additional information has ben requested.
Acute onset right hemisphere ischemic stroke within 12 hours of vaccine administration.  3/11/2009 Received vaccine records & PCP medical records which consisted of hospital records x 2.  Admit 1/15-1/17/2009. FINAL DX: new onset seizure; late onset HTN w/decreased left side movement Records reveal patient experienced seizures.  Tx w/antiseizure meds, antivirals & antibiotics.  Developed fever & OM.  Condition deteriorated & transferred to higher level of care.    Admit 1/17-1/19/2009. FINAL DX: arterial ischemic stroke; focal onset seizures; hypoxia, resolved; and left hemiparesis. Records reveal patient transferred from outlying hospital.  Had experienced left side facial & arm seizures when found by parent.  Had persistent left hemiparesis.  Neuro consults done.  Sick sibling w/viral syndrome.  On d/c had left facial droop, right conjugate gaze, left hemiparesis, left side decreased tone, reflexes 1/4.  Improved & d/c to home w/Neuro, PMR, hearing, ophtho & early intervention referrals.
irritable & constant crying for the first 12 hrs p/vax, t102 R; no swelling or redness noted on extremity; tx APAP;
they reminded him that he had gotten a high dose flu vaccine two weeks previously at a pharmacy,no AE; Initial information received on 17-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 66 year old male patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] lot number not reported via unknown route in unknown administration site for prophylactic vaccination on 17-nov-2020 (Extra dose administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to extra dose administered (latency same day).   The patient received Fluzone HD Quadrivalent in the clinic. When the patient arrived home and told his family that he had gotten a flu shot in the clinic, reminded him that he had gotten a high dose flu vaccine two weeks previously at a pharmacy.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Patient was given 0.3 mg of Pfizer bivalent (12+) but should have received the 0.2mg of Pfizer bivalent (5-11 y.o.) Patient woke up with headache, nausea, stomach pain and developed a fever a couple of hours later.
I got COVID-19 on 02/01/2023. I had very severe symptoms. I felt cold and hot at times, cough with sputum, mild fever, chills. I had a tele health visit on 02/01/2023. I had infusion for three days intravenously.
Pain in right leg continuing on day 3. Hives around injection site. Nausea and vomiting. Symptoms resolved day 4.
Sore arm for an entire month. No OTC medicines was able to treat it. Could not sleep on left side.
The patient developed itching, rash, difficulty breathing within 15 to 30 minutes. She was given a dose of Benadryl which helped relieve symptoms. She then became drowsy.
under 18 years old, received the vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old, received the vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old, received the vaccine). On 28-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old, received the vaccine) had resolved.        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.   No concomitant medications provided. No treatment information provided.
Red, swollen, hot, severe itching began Day 13 from injection site to approximately1 inch above elbow.