chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker concerning a 12 year old male with no known allergies who on an unspecified date was vaccinated with the first dose of VARIVAX (Oka/Merck). the patient received the first dose at another location. on 16-JUN-2008 at 9:00 AM the patient was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot no. 659434/1911U) 0.5ml via subcutaneous route in the left leg. On the same day, the patient also received DTAP and MENACTRA. Concomitant therapy included ADDERALL TABLETS. The vaccines were all given in the left leg at the patient's and mother's request. All injections were spaced from one another. On 18-JUN-2008 the patient developed a very strong local reaction with swelling, redness and pain at the injection site. The patient was treated with MOTRIN (anti-inflammation) and resolved. This is one of several reports received from the same source. Additional information is not expected.
Narrative:  COVID infection following COVID vaccine series 01/16, Pfizer, dose #1 02/06, Pfizer, dose #2 09/21, Pfizer, dose #3 09/03 COVID swab, result: detected 09/03 pt cc: exposure: unknown 09/03 FERRITIN: 103.4 09/03 SARS-COV-2 Variant Sequencing result: pending 09/03 ESR: 13 09/03 CXR impression: No acute cardiopulmonary process or significant change since May 23, 2019. Please note chest radiography is not sensitive for detection of findings related to COVID-19 pneumonia. 09/04 pt admit to obs cc: "unable to take care of himself" dx: Covid 19, dementia LOS: 3 days 09/04 FIBRINOGEN: 304 09/04 DDIMER: 13.83 09/04 CRP: 1.688 09/05 FIBRINOGEN: 292 09/05 DDIMER: 1.79 09/05 ESR: 16 09/06 FIBRINOGEN: 281 09/06 DDIMER: 1.31 09/06 ESR: 8 09/07 pt admit to medicine cc: cognitive impairment/ behavioralchanged dx: asymptomatic COVID-19 infection LOS: 21 days 09/07 FIBRINOGEN: 312 09/07 DDIMER: 1.04 09/07 ESR: 37 09/17 clinically resolved
Information has been received from a physician concerning a 13 year old female who on 15-MAR-2007 was vaccinated intramuscularly with the first dose of Gardasil (Lot# not reported). Concomitant therapy included tetanus toxoid (manufacturer unknown). On 16-MAR-2007 the patient called her physician office and reported that at an unspecified time on 15-MAR-2007 post vaccination she developed dizziness, vomiting and a fever (actual temperature not reported). Unspecified medical attention was sought. The patient has not contacted the physician again.
Found right side lymph swelling starting in the  right side armpit and running down to a large golf ball sized lump in the right side breast, between the bottom border of the nipple and the chest wall. PMD was seen the next day, we were advised to monitor the swelling and to return if symptoms became worse.  The next vaccine is scheduled for 03/25/21, an ultrasound and diagnostic mammogram is scheduled for 04-26-21. As of today 03-14-21, the swelling in the armpit has resolved, the lump in the breast is now ~75% smaller than when originally discovered. No fever or streaking noted.
The day after the shot Ihad widespread muscle an joint pain, I had fatigue and muscle weakness. I could not get out of bed or mve until 6 pm that night. Now I have daily muscle weakness, difficulty walking, muscle pain, fatigue. I wake up at night and have to take pain medication.
Left upper arm swollen from shoulder to elbow, red color outer arm to pink noted on inner aspect, hot to touch. No fever. Child alert and happy. Able to move arm well, fingers warm. Recommended cold packs and go to ER/pediatrics if worsens or fever.
partial paralysis; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A male patient received 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: PARALYSIS (medically significant), outcome "unknown", described as "partial paralysis". Clinical course: Shortly after vaccinations, and otherwise healthy male patient experienced partial paralysis, and is now wheelchair bound. No other medical explanation except for neurological vaccine side effect.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported Event Paralysis and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Inappropriate schedule of vaccine; Flu like symptoms; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms and drug dose administration interval too short. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number and expiry date of Shingrix was not reported. The office manager reported that, 1st dose was administered in error, the medical assistant should have administered Prevnar. The patient received 2nd dose of Shingrix approximately 39 days after receiving 1st dose, which led to shortening of vaccination schedule. The reporter reported that, flu like symptoms, lasted for a week. The reporter consented to follow up.
Experienced fever, chills, rapid heartbeat, elevated blood pressure and hives after taking Moderna booster shot.
This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration at single dose in the arm on an unspecified date. The patient experienced fever and achiness the day after receiving the vaccine on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of the events included TYLENOL.
Immediate pain x 2 days that improved but Erythema and induration of area starting at Day 7 and worsening; seen in clinic on day 9 and area affected was 10 cm in diameter
Woke up day after shot with moderate pain in joints, especially hips and shoulders, which got progressively much worse for 2 months.   Talked to doctor (GP) who ran many blood tests and CRP was elevated to 16, blood test 1 month later showed CRP of 30.  She said my symptoms suggested PRM (Polymyalgia  Rheumatica) and prescribed 10 mg Prednisone, once a day.  Within 72 hours pain was much better. I saw a rheumatologist a month later who diagnosed it as PRM and continued the drug therapy with 1 mg reduction every month following.  He ran CRP blood test and it after a month of the 10mg, it was at 4.
patient received covid vaccine today ( moderna). Within 15 mins she developed hives and throat tightness. She received diphenhydramine IM 50 mg. After 30 mins she was administered methylprednisolone 125 mg IM and famotidine. warm all over especially upper body (throat/chest), and hives (chest, neck, upper arms). Diffuse flushing.
Information has been received from a consumer concerning his 5 year old daughter who in 2007 was vaccinated with a second VARIVAX (Oka/Merck). The father reported that "the child had absolutely no health problems" until October 2007, when his daughter "began having seizures for no apparent reason" three weeks after receiving the second dose VARIVAX. According to the father, "neurologically she appears to be fine." The father noted that their neurological group "has done every test possible with no negative findings. The neurology group can find nothing abnormal with the child, but she continues to be medicated (not specified) which makes the situation worse." Upon internal review, the reported event, seizures, was determined to be an other important medical event. Follow up from the physician's practice indicated that they did not know what patient this event was in reference to, and were unable to provide additional information. Additional information is not expected.
Breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of BREAST FEEDING (Breast feeding) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ASCORBIC ACID (VITAMIN C CITRUS), IRON and AMBROXOL HYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOXOL) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced BREAST FEEDING (Breast feeding). At the time of the report, BREAST FEEDING (Breast feeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.
Information has been received from a physician via a company representative concerning a 4 year old male patient, with no medical history reported, who on 22APR2003 at 09:15 am was vaccinated into the right lateralis with a second dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation) . Concomitant therapy on 22APR2003 at 9:15 am included a fifth dose of alum, potassium + diphtheria toxoid + pertussis vaccine + tetanus toxoid (TRIPEDIA) into the left lateralis and a fourth dose of polio virus vaccine IPOL into the left anterior lateralis. It was noted that not ill at the time of vaccination. Subsequently,the patient developed a  "reaction." In follow up information, it was noted that on 22APR2003 at 9:15 am, the patient developed localized swelling and redness to site and hives to face and neck. The pt was treated with diphenhydramine hydrochloride (Benadryl) 12.5mg (1.5 tsp.). The patient recovered on 22APR2003. No further information is expected.
A report was received from a health professional on 10/15/01 concerning an 88 year old female patient who received a Fluvirin overdose on 10/15/01 after an initial dose of 10/08/01. The patient experienced a sore arm after the second vaccination which resolved without sequelae on 10/16/01. There was insufficient information to determine the reporters causality assessment.
Severe swelling and ternderness of left, underarm (arm pit) area, same side as shot was given.  Consulted doctor.  Took Benadryl.  Symptoms resolved after about 7 days.
Flu shot caused a local panniculitis that lasted more than 1 year and required surgical excision of inflamed necrotic fat to finally cure.
Information has been received from a physician and a Licensed Vocational Nurse (LVN) referring to multiple unspecified patients. The patients' pertinent medical history and concomitant therapies were not reported. On unspecified dates, the patients were administered improperly stored PROQUAD (dose, frequency and route of administration were not reported, lot # L007229, expiration date 03-SEP-2017). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling, redness, warmth, mild pain developing per parent 8 days after administration.
RECEIVED VACCINES ON 10/03/06. THAT EVENING STARTED GETTING PETECHIAE RASH ON FACE AND A MOSQUITO BITE LIKE RASH ON CHEST, BACK, AND GROIN AREA ABOUT 6PM. MOM TOOK CHILD TO ER.
Received ZOSTAVAX 4/8/13. Reported 4/28 as "rash" on areas of lower legs, also sm. area on back appeared sometime after shot given, shingles like in appearance pt told to take BENADRYL/ZYRTEC and have MD check.
3 days after first dose started having Hallucinations sleep deprivation paranoia uncontrolled thoughts of being stalked raped hearing voices talking about her this physcosis escalated after the second dose came night an day out of nowhere she went to medical center ER who then transferred her to hospital where she spent 5 days and was released and is now taking Lexipro and Abilify to ease these delusions.. no history of mental illness prior to receiving Moderna vaccines
That day patient was very tired, lethargic, and went to sleep. Over the course of that night and the next few days he had the common symptoms, I received notice of like runny nose, elevated temp at 99.5 via the forehead, clammy and sweaty, lack of appetite. Then it went from waiting out for the common symptoms to disappear to on day 8 he experienced nightmares waking up screaming, sensory overload, rubbing his eyes saying no no his head hurt like a headache, he also said boo boo in his legs as if he had joint paint he said his legs hurt. He also had mild diarrhea for 2-3 days, lack of appetite and refusing milk so we have been giving him water and juice. He is eating his meals. He also had itchy skin trying to rip off his clothes and trying to scratch his skin with no appearance of a rash at all.
A little over a week after receiving the vaccination, patient experienced itching inside of mouth and developed hives/swelling/welts in multiple places on hands. The welts have persisted for 7 days despite patient using oral diphenhydramine. Patient states that the welts are itching. Patient denies hives on any other part of body besides hands. I advised that the patient visit her doctor as I was not able to provide further assessment/care in the pharmacy setting.
pt was out in sun 20JUN95 & devel sl erythematous solar-type rash on forearm caused by exposure to sun;pt recvd vax 21JUN95 & 22JUN95 pt's erythema became somewhat worse & was diffusely itchy
fever 99.9/ fever 100.6; chills; sweats; muscle aches; joint aches; fatigue; confusion; migraine; severe nausea; This is a spontaneous report from a non-contactable consumer (patient). This 29-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration on 15Feb2021 at 13:00 (at the age of 29-years old) as a single dose in the left arm for COVID-19 immunization. Medical history included asthma. The patient was not pregnant at the time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccine. Concomitant medications included birth control; caffeine, paracetamol (EXCEDRIN), and ibuprofen from unknown dates for unknown indications. The patient previously received acetaminophen in doses over 500 mg and experienced allergy. On 16Feb2021 at 02:00, 13 hours after the vaccine, the patient experienced fever of 99.9, chills, and sweats. Sixteen to twenty-eight hours after the vaccine the patient experienced fever of 100.6, sweats, muscle aches, joint aches, fatigue, confusion, migraine, and severe nausea. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of fevers of 99.9 and 100.6, chills, sweats, muscle aches, joint aches, fatigue, confusion, migraine, and severe nausea were recovered. It was also reported that since the vaccine, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Medium Headache,  1 day, mild headache for another half day. Tylenol alleviated this slightly. Mild body ache, 1 day. Tylenol alleviated this completely. Medium to severe tiredness/lethargy, 1 day. Tylenol did not alleviate this.
Patient had vaccine and was in the observation area. After 10 minutes stated that her heart was racing and it was 120-130 beats per min and had a blood pressure of 187/110, pulse ox was 100%.  No complaints of headache or dizziness.  Rechecked patient after 5 minutes and blood pressure was 190/104, HR 130s.  Patient was transported to the Emergency department.
Information has been received from a registered nurse concerning an elementary school aged child who was vaccinated with a dose of varicella virus vaccine live. On approximately 23-FEB-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/12/2006. Information has been received from a registered nurst concerning an elementary school-aged child lwho on 26-JUL-2000 was vaccinated with a dose of VARIVAX (Merck). On 01-MAR-2006, the patient developed breakthrough chickenpox. Unspecified medica; attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Gastritis; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: Fa6780) via an unspecified route of administration on an unknown date (at the age of 42-year-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fa6780) via an unspecified route of administration in the left arm on an unknown date (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced gastritis and diarrhoea. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events gastritis and diarrhoea was resolved on an unknown date.   No follow-up attempts are possible. No further information is expected.
Client waited approximately 15 minutes at clinic after receiving vaccine and felt fine.  Experienced onset of headache and nausea on way home.  Called doctor's office from home and advised to take 2 Tylenol and rest.  Client had relief of symptoms approximately 5 hours after receiving vaccine.  No symptoms 9/5 except some soreness at Gardasil injection site.
Experience arm swelling - felt like could feel fluid, tingling in arm, around should blade and neck, swelling of neck and shoulder. Headache, dizziness, and extreme fatigue
At time of injection, patient reported salty taste in mouth. Several minutes later, pt reported feeling tingling at the back of tongue. No swelling identified. VS stable throughout 30 min observation, all symptoms resolved at discharge.
He was hospitalized and then he died.; fluid around his heart; This is a spontaneous report from a non-contactable consumer via a Pfizer sponsored program COVAX support. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for Covid-19 Immunization. The patient was hospitalized and then he died. The doctor said the fluid around his heart was a direct symptom of the Pfizer Covid-19 vaccine. The outcome of event died was fatal and fluid around his heart was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: He was hospitalized and then he died
Severe pain at shot location then after 2 days swelling in shoulder arm and neck area with severe migrane headaches was prescribed muscle relaxers and pain killers after 2 weeks was prescribed physical therapy and still not getting any relief from pain or swelling at this time.
Within 2 mins of receiving injection, I experienced full body sweats, deadening of sound, blackness in eyes, lightheaded, unable to hold things in my hands, uneasy stomach, very pale all over, especially face. Talked/deep breathed my way out of fainting. Within 10 minutes all the above symptoms started to lessen. 15 minutes after receiving the injection, the near fainting experience was over and I was comfortable leaving and driving. But the 10 minutes were terrible and I came very close to passing out. My husband experienced the exact same symptoms 2 days later. I will be reporting that immediately following this submission.
PASSED AWAY; CONVULSIONS; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced convulsions 3 hours after being vaccinated and shortly afterwards he passed away. On an unspecified date, the patient died from unknown cause of death. It was unknown whether an autopsy was performed. It was reported that "one of my cousins went into convulsions 3 hours after being vaccinated. Shortly afterwards he passed away". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of convulsions was not reported and on an unspecified date the patient (died) passed away. This report was serious (Death and Other Medically Important Condition).; Sender's Comments: V0: 20221257605- Passed away. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.   20221257605-convulsions. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the RA Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
R arm red swollen warm "band" posterior to lateral arm measuring about 3x5".  No drainage.  No fever, no other s/s of illness
Pt called office next day after vaccines were given .Mom stated the next day after vaccines were given pt's injection site got swollen and bruised. Mom also stated the following day pt's arm got a knot.