chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around 9 hours after injection (shot was at 12:45pm Tuesday, Day 1) and for a full day after (Wednesday, Day 2), I began to experience an intense headache, on/off mild fever (up to 100.5), chills, aches and body weakness.  On Thursday, Day 3 for half of the day, my symptoms were milder and I felt a less acute headache, less severe body aches and overall weakness/lack of energy.  Then I began to feel better quickly the second half of the day, and symptoms resolved by about 95% by Friday, Day 4.  I took 3 doses (400mg/each dose) of Ibuprofen from Day 1 through Day 2.
Pain at injection site; Arm hurt; Hair loss; This is a spontaneous report from a contactable consumer. This consumer reported for a 77-year-old female patient (wife) that:   A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in Arm Left on 20Jan2021 (at the age of 77-year-old) as single dose for covid-19 immunisation. Medical history included reversible shoulder surgery from 03Dec2020 to an unknown date and ongoing blood cholesterol from an unknown date. Concomitant medication only prescription medication she takes is a stating drug to control cholesterol she has been on it for 2 to 3 years. He doesn't know the dose. Patient previously took flu shot and a pneumonia shot he thinks it might have been the end of Oct2020. Additional vaccines administered on same date of the Pfizer Suspect reported as none. Consumer reported side effect from the first dose was pain at the injection site along with for a day or two her arm hurt. But as far as fever and chills none. They received the first dose of the Pfizer vaccine on 20Jan2021 at the (facility name) in (place). The reason he called before around the eighth was because 10 days to two weeks after the vaccine his wife started a lot of hair loss, she continues to have a lot of hair loss she doesn't have much hair left. He is calling because he is curious to know. He talked to family doctor too. Received the first dose of COVID19 Vaccine on 20Jan2021. Ten to fourteen days after the vaccine his wife developed hair loss. It was around the first week of February. It is worsening and her hair is currently coming out. They were also told that she should have the second dose initially they were supposed to receive Moderna, but when it came their turn, they had run out of Moderna and had 20 vials of Pfizer left, so they got Pfizer. Because of the hair loss they had called the family doctor and asked if it would be a good idea to get the second dose since she is having a lot of hair loss. The doctor's response was yes, he would recommend the second dose. the doctor told them it would be better off to have no hair. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administered on 11Feb2021 as single dose for covid-19 immunisation. The outcome of the event hair loss was reported as not recovered and Pain at injection site, Arm hurt was unknown.   Follow-up attempts are completed. No further information is expected.
COVID Positive after vaccine; This is a spontaneous report from a contactable consumer (reporting on himself). A 39-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 07Jan2021 (at the age of 39 years old) as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was stated that patient had the first dose of the pfizer covid vaccine on 7Jan2021 and about one week later he tested positive for the Covid virus on 17Jan2021. The patient wants to know what are the Pfizer recommendations for the second vaccine after testing covid positive. The patient states he was due for his second dose on 28Jan2021, but he missed it because he had been recovering from being sick with covid. The patient underwent lab tests and procedures which included covid test positive on 17Jan2021. Outcome of the event was recovered on 21Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
felt flushed and nauseated. Given Benadryl 50 mg po. felt better in about 20 minutes
Myalgia SWOLLEN REGION AT INJECTION SITE RED AND WARM TO TOUGH, FATIGUE, MUSCLE AHCES Narrative:
17 year old received a Mentactra vaccine on 10Aug2021 and then she accidently received another one today 24Aug2021 with no reported adverse event; Initial information received on 24-Aug-2021 regarding an unsolicited valid  non-serious case received from a pharmacist via non-healthcare professional.  This case involves a 17 years old female patient who received a MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on 10-Aug-2021 and then she accidently received another one on 24-Aug-2021.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 10-Aug-2021, the patient received a first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and  she accidently received another one on  24-Aug-2021 lot number not reported via unknown route in unknown administration site for prophylactic vaccination.   It was a case of actual medication error due to extra dose administered.  It was reported, "She states that it was a mistake by the doctor's office. When the pharmacist was asked to provide additional adverse event information she states "not at this time."  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 the 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.
Client received 3rd dose of Moderna COVID vaccine @12:50 pm.  At 1:15pm, client reports seeing dark rings/spots in left eye and hard to focus with that eye.  Client moved over to zero-gravity chair to lie back, client "resting her eyes".  Vital signs @ 1:15pm included a blood pressure of 195/105.  Client denies any shortness of breath, trouble breathing, chest pain, no nausea.  Client denies history of high blood pressure, reports Rheumatoid Arthritis and Depression.  Continued to monitor vital signs, blood pressure 171/86, pulse 52 @1:23 pm.  Client reports she is able to focus vision with left eye, not as blurry.  Continued to observe, @1:40 pm client denies vision changes, reports she feels 100% better, blood pressure is 178/92.  At 1:50 pm, client states she has no more symptoms, 100% better.  Blood pressure at 2:00pm 158/80.  Client leaves @ 2:08pm, will follow up with primary care provider.
This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (BAD ANXIETY), NASOPHARYNGITIS (COLDS) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Moderna vaccine 1st dose on 01-Jan-2021 and 2nd dose on 03-Mar-2021) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis. Concurrent medical conditions included Ulcerative colitis (Moderate to severe). On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate Free. On 03-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Moderna vaccine 1st dose on 01-Jan-2021 and 2nd dose on 03-Mar-2021). On an unknown date, the patient experienced ANXIETY (BAD ANXIETY) and NASOPHARYNGITIS (COLDS). At the time of the report, ANXIETY (BAD ANXIETY) and NASOPHARYNGITIS (COLDS) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Moderna vaccine 1st dose on 01-Jan-2021 and 2nd dose on 03-Mar-2021) outcome was unknown. Not Provided. No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. The reporter causality for the events bad anxiety and cold with Humira was not reported. No treatment information was reported.
Fully vaccinated with Covid19 Pfizer EUA 04/08/2021-04/29/2021
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-NOV-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2014, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed acyclovir and oxycodone for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Itchy, red rash and swelling at and around injection site, 8 days after vaccination. After day 8, the rash subsided, but on day 10 the swelling and tenderness is still present.
Excessive fatigue, nauseated, body aches, dizzy, and possible Covid  Tongue? Although I asked my CNP today, and she did not feel I needed to worry about these  blotchy, red areas on my tongue. The red color is lessening however.
Information has been received from a pharmacist concerning a 47 year old male patient with heart disease and high cholesterol and no drug reaction or allergies who on 10-OCT-2010 was vaccinated IM in right deltoid with a dose of PNEUMOVAX 23 (lot #665904/0866Z). Concomitant therapy included PLAVIX and CRESTOR. On 11-OCT-2010 the patient developed a flat, blotchy redness to the right of the injection site, that extended to the armpit. It was "the size of a fist". It was "tingling and itchy". No lab diagnostics studies were performed. The pharmacist recommended BENADRYL. At the time of reporting, the patient was recovering after therapy. The patient sought unspecified medical attention. The patient's wife also received an injection from the same vial, but did not experience a rash. Additional information has been requested.
Patient had a Non-STEMI MI on 6/24/21 with new onset A-Fib also.  Pt arrived to ER from clinic with c/o chest and Left shoulder pain for 2weeks. Arrived to ER with HR in 150s that converted with IV Diltiazem. Pt showed s/s of MI with elevated Troponin. IV Heparin drip and IV Heparin bolus was given. Pt was transported by helicopter to hospital for further treatment and studies.
This spontaneous report was received from a healthcare worker (also reported as Office Manager) referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored GARADASIL 9 injection (dosing details unspecified) (lot # L037554, expiry date: 25-DEC-2017; lot # M011840, expiry date: 01-FEB-2018). No adverse effects were reported. It was reported that vaccines were not discontinued. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse practitioner concerning a female who was vaccinated with the first dose of GARDASIL. "Few months ago" the patient found a hard round cyst in left breast after receiving GARDASIL. The patient performed breast exam. At the time of the report the patient was not recovered. The patient sought medical attention. Additional information has been requested.
lethargy x 1 1/2 hrs; t104.4 R w/consistent tempra use; shrill cry x 45 minutes;
1. Severe shaking 2. Chills 3. Elevation of temp  4. Generalized body aches 5. Bone pain in addition to local muscle pain  Onset of symptoms = overnight  Vaccine recipient took Ibuprofen
9 pm noticed red puffy area on face with burning sensation Woke up 3/03 with headache
Had Tetanus and Pneumonia vaccine on 5/25/2010 and on 5/27/2010 woke up with rash on neck and by midmorning rash had spread all over torso.  Called doctor's office and was told I probably had a reaction to the shots and to use Benadryl and Hydrocortisone cream.  Per doctor, rash would probably take a week to clear up.
About 12-15 hours after her booster shot, patient experienced fever/chills, bright red rash on face, uncontrollable urine, aching,  and cough. Patient took tylenol and benadryl to help with symptoms. Symptoms subsided about 24-36 hours after onset.
I experienced fatigue. I also experienced mild joint pain that increased to severe joint pain all over my body. At the doctor, we did some tick panels and autoimmune panels. The autoimmune panels came back positive. I was prescribed an anti inflammatory, 5 days of steroids ( 20mg 2xday), NSAIDs.
Patient received the COVID-19 5-11Y Pfizer-BioNtech vaccine on 12/18/2021 and patient is 39 years old.
PT REPORTS RASH ARISING TWO HOURS AFTER INJECTION 2 INCHES BELOW INJECTION SITE. AREA WAS ALSO RED. ABOVE INJECTION SITE WAS "FEVERISH." APPLIED ICE Q2 HOURS FOR EVENING.
Rash on arms back legs torso; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 27Apr2021 at 11:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included finasteride (MANUFACTURER UNKNOWN) and simvastatin (MANUFACTURER UNKNOWN); both taken for unknown indications from an unknown date and unknown if ongoing. On 27Apr2021 at 17:00, the patient experienced rash on arms back legs torso. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash on arms back legs torso was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Client was given Pediatric dose of Pfizer (ages 5-11) and client was 12 years old at time of administration of both doses of vaccine on 11.10.21 and 12.1.21.  When discussed with client father, father reports was aware signed client up for the pediatric clinic and answered the required questions that asked if client was ages 5-11 and that client was eligible.  Father marked "yes" that client was eligible for the pediatric clinic/dose.  Father stated client "was barely 12, and was fine with that dose".  Father denies any issues or concerns with client receiving the pediatric dose.  Client has had no adverse reaction or issues.
Pt got influenza 12/01 @ family doctor. Was admitted 3/28/02 for lumbar laminectomy worked by neurosurgeon anf internist. Determined the possible reaction of post-vaccination demyelination and encephalomyelitis. Requested that Pharmacy report. The discharge summary states lumbar canal, stenosis, prostate CA, and melanoma.
This is a spontaneous report from a contactable consumer.   A 66-year-old male patient of an unspecified race received  PREVNAR 13, at single dose in Nov2016 for immunisation. Medical history included oral surgery to have a tooth removed and to prepare for a tooth implant. The patient's concomitant medications were not reported. In Nov2016, the patient experienced pain in his arm, chills and body aches with outcome of unknown.
I felt very tired, had palpitations, my Heart rate went up to 139, oxygen saturation rate down to 92%, blood pressure went up to 159/98. Symptoms lasted for approximately 15 hours. I took an extra blood pressure pill, an extra blood thinner pill.
The adult patient received a dose of 0.2. An additional dose of 0.3 was given.
Was referred to ER by PCP, was having left chest pain as of the day of vaccine , that afternoon at appx 1600; gradually got worst. Unable to sleep that Sunday dt pain. At ER had elevated DDimer and CRP but no other positives from CT Angio. Was also diagnosed with Cellulitis of L arm, given abxs. Numbness to L hand.
Severe Headache, Shingles around area of vaccine, Shingles in usual area of previous breakouts.
This case was reported by a pharmacist via sales rep and described the occurrence of pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced pain, erythema and swelling. On an unknown date, the outcome of the pain, erythema and swelling were unknown. It was unknown if the reporter considered the pain, erythema and swelling to be related to SHINGRIX. Additional details were provided as follow: The age at vaccination was not reported. The patient experienced pain, redness and swelling 3 days post vaccination. The reporter did not agreed to be followed up.
Child developed extensive rash maculopapular, erythematous, coalescent rash on chest, abd and back. Areas of coalescent up to 4" spotty rash on face and legs. Had a temp of 102 F on 4/12/03 lasted one day only. This case is an unusual adverse effect in sense the child had rash of measles but no ? symptoms (except temp 102 for few hrs.).
Very large blotchy itchy rash developed around injection site on left arm nine days after injection. Becoming larger and slightly painful to a touch with slight pressure, almost bruised looking over next 4 days (as of today)
Pt recvd 1st dose of vax on 18MAR92; later that day devel a h/a, fever of 100, & malaise & muscle ache;
Cough, productive w/green sputum; rt upper quad pain, stomach cramps, severe h/a, severe arthrlagias, pharyngitis, ear pain, dec in appetite;
chest pain, subjective fever 9 days after vaccine; 10 days after hospital admit Dx with pericarditis + 8mm pericardial effusion
headache; generalized muscle aches; brain fog; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; MYALGIA (non-serious), outcome "unknown", described as "generalized muscle aches"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog". Additional information: The patient experienced mild headache and generalized muscle aches on the day after the second dose of Pfizer COVID-19 vaccine and experienced "brain fog" the day after and day 3. The events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient was vaccinated SC with a dose of ZOSTAVAX (Lot number not reported) 0.65 ml on 01-OCT-2012. NO other co-suspects were reported. No concomitant medications were reported. It was reported that on 02-OCT-2012, the next morning after vaccination with ZOSTAVAX, the patient experienced a half-egg shaped swelling with redness and heat at the injection site and in the afternoon the patient went to his doctor because he had a couple of vesicles (location unspecified). On 02-OCT-2012, the patient's wife also experienced half-egg shaped swelling with redness and heat at the injection site and vesicles on both sides of her body from her armpit to her waist (MARRS # 1210USA003999). At the time of the report, the patient's outcome was unknown. The relatedness for half-egg shaped swelling with redness and heat at the injection site and vesicles (location unspecified) was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.
Infant started having apparent seizures at 2330 on 10/3/19, apnea noted at 0345 on 10/4 which responded to tactile stimulation. Another episode of apnea and seizure activity at 0514 on 10/4 which required PPV .   No more seizures or apnea noted at the vaccination facility after phenobarbital . unaware of what happened after infant was transferred to Medical Center
pt c/o burning, tenderness inj site on outside of lt forearm p/inj;stated no problems pain or burning @ site p/10min;
Within about 15 minutes, I noticed the headache and the body pain. About 1 pm or 2 pm, I had to lay down and chill. I didn't want to take anything to combat the vaccine. I noticed after I took a bath and I did have my period at the time of the vaccine, but it started bleeding heavier and heavier and that heavy bleeding lasted six days instead of four (my normal) and I'm still bleeding now (2 weeks later) and on the 7th day it finally got back to a normal amount of bleeding for a usual bleeding; by day 8 I could finally wear a regular tampon but the bleeding was still bright red. On the afternoon of the 22nd, I reached out to my doctor because a lot of clots were coming out. That evening, (the day after the shower), I passed out in the shower. I was going down with a squeegee in the shower and so I could get to the ground before I fell. The next day, I got up from my work chair and I knew it was going to happen - and I passed out again. They did CBC tests but it was way past the day. The nausea is still there but not as as bad as it was. Nausea, lethargy - extreme, lightheaded and I didn't eat. All those symptoms I was experiencing at the same time. Lightheadedness is gone now. Ongoing bleeding is a little weird. It's coming on two weeks. They gave me Medication - to help with the bleeding but I ended up not taking it.  Doctor - doctor was a email portal message back and forth - not in person.
Within 1-2 hrs of administration-Baby started screaming-afebrile went to ER for evaluation after 6 hours of screaming, cried all night and next day. Seen in office next AM. Flat plate of ABD (-)/ urine cath sent and lab
Fever and "diffuse macular eruption over whole body" that lasted 3 weeks. Start Triamcinolone Acetonide Lotion, 0.025 %, 1 application sparingly to affected area, Externally, Twice a day, 5 days, 60 ml, Refills 0. Mother states no change to rash after lotion applied.