chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 30 minutes after being vaccinated, client felt itchy on one half of her face, stating it "felt as if she was coming out of Novocaine". She said she then decided to eat something and after about an hour the feeling was restored.
Patient had rash around injection site within 15 minutes of administering vaccine. No breathing issues. Prescribed Benadryl.
NAUSEA, DIARRHEA, EXTREME PAIN IN LEFT ARM, SEVERE BRUISING AROUND INJECTION SITE; LETHARGIC FOR ABOUT 2 DAYS
Fever for 24 hrs starting 14 hrs post vaccination (highest 100.5), fever returning the following day, chills, headache, fatigue, joint pain, muscle pain, nausea, swollen and painful supraclavicular lymph node on left side starting about 40 hours after vaccination
Pt had a syncopal event.   Vitals: 94/50,77, 18, 100%, T 97.8 -- > 109/65,78,18, 100%, 97.7 Instructed pt to seek medical care if symptoms persist.  Pt stable and released from the vaccination site.
3 hours after injection, felt like hands, arms, and legs were swelling (but they weren't), and had a total brain fog, felt like I was either on drugs or had alzheimers. Paced around my house and backyard in a fog, confused, not clear of thought. Had a hard time spelling words in emails. Symptoms went away within 45-60 minutes and did not return. Since that time felt a little tired but nothing serious. Today I feel completely normal.
Given 10/20/08 @ 11:15 AM, 1:15 PM developed hoarseness, tightness in throat, felt SOB, coughing 3:00 PM. Came to nurse T 97.5, BP 103/70, P 72 Peak flow 350. Given BENADRYL 50 mg P.O. 7:00 PM - chills, fever, nausea - took ADVIL 400mg next morning - all symptoms resolved.
This gentleman did not disclose that he had a prior dose of Pfizer, and in fact denied that he had any previous doses
Body aches, pain and swelling at injection site,  headache, fever, chills, nausea, and hives on left leg; symptoms began just over 3 hours after vaccination
This non-serious spontaneous case, initially received from pharmacist on 14-Mar-2018 and concerns a 36-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 05-Feb-2018, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XT33908, and expiry date: 30-Jun-2018) with foreign particles floating in syringe. No adverse event was noted after vaccination. Non-significant case correction received with IRD 14-Mar-2018: It was reported that, no adverse event was noted after vaccination. Follow up report received from the pharmacist on 16-Apr-2018: The vaccination date (05-Feb-2018) was added. The patient's age was updated from 35 to 36 years. The narrative was amended accordingly. Significant case correction received with IRD 14-Mar-2018: LLT for the event 'particles in the AFLURIA/[Four patients were administered vaccine with] foreign particles floating in syringe' was changed from 'product contamination particulate matter' to 'particle present in liquid product'. Amended narrative accordingly.
I developed chills later that evening. I took Tylenol and went to bed. Middle of the night I had chills again and took more Tylenol. In the morning I had a fever of 102. I took Tylenol every 6 hours and in-between doses I had headaches and chills as the Tylenol wore off. 6:30 am the next day I had a fever just below 100. My arm is also warm and achy and I have body aches.
A nonserious report of expired dose of vaccine administered has been received from a nurse concerning a child above two-years old. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. No relevant medical or drug history information was reported. The patient was given FluMist on 29-Feb-2008. The FluMist had expired on 26-Feb-2008. No adverse events were reported from this error. Rechallenge is not applicable. Causality assessment is not applicable. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of ROTATEQ orally, (dose number, dose and lot number were not reported), wihch were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 4 month old patient of unknown gender who on 23-JUL-2014 was vaccinated with improperly stored dose of ROTATEQ oral, lot#J011344, expiration date 10-MAY-2015 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
Felt really awful; My arm felt as if it had been hit by a baseball bat / sore arm; Red arm; Swollen arm; This case was reported by a consumer and described the occurrence of feels awful in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feels awful, pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the feels awful was unknown and the outcome of the pain in arm, erythema of extremities and swelling arm were recovered/resolved.   It was unknown if the reporter considered the feels awful, pain in arm, erythema of extremities and swelling arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in an unknown arm. The patient had the shingles vaccine one of two shots recently and had multiple side effects that seemed way outside of normal. The patient's arm felt like that had been hit by a baseball bat, was extremely sore red swollen for 5 days and patient felt really awful. The patient was almost scared to get the second shot. The patient tried multiple other options of teaching our to your company all fruitless. The reporter gave permission to follow up.
Little bit of itchiness; Redness; Substantial hives at the site of vaccination; A spontaneous report was received from a physician concerning a 42-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and who developed substantial hives at the site of the vaccination, a little bit of itchiness and redness.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included etanercept, hydroxychloroquine sulfate, omeprazole, aspirin and a multivitamin.   The patient received their first of two planned doses of mRNA-1273 (LOT: 011J20A) on 28-Dec-2020 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, she had developed substantial hives at the injection site.  She also reported a little bit of itchiness & redness.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, substantial hives at the site of the vaccination, a little bit of itchiness and redness, was not provided.   The outcome of the events, substantial hives at the site of the vaccination, a little bit of itchiness and redness, was not reported.   The reporter did not provide a causality assessment for the events, substantial hives at the site of the vaccination, a little bit of itchiness and redness.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
loss of taste; metallic taste; small cough; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration on 04May2021 (Batch/Lot number was not reported, expiry date: unknown) as dose 2, single for COVID19 immunisation. The patient's medical and concomitant medications were not reported. The patient had previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration on unspecified date (Batch/Lot number was not reported, expiry date: unknown) as dose 1, single for COVID19 immunisation. On 07May2021 the patient reported ''started get-ting very small cough and non other he got but also to had what's his taste, his taste almost like metal, he almost feel like metal taste and he told he know it was reaction that happens like three days after the shot and he was fine before but he took on the for since today's like 10 days later was that normal to last this long (loss of taste, metallic taste, and small cough). Patient was asking whether is it normal after 14 days to still have side effects and what he should do about it. Patient stated he would rather speak to doctor right now considering un-comfortable. The outcome of the events was recovered on unspecific date in May 2021  No follow-up attempts are needed; Information related to batch/Lot number could not be re-quested.
Patient received Pfizer Covid vaccine # 1 02/05/2021. She developed the bumps on scalp (15 raised nodules and sores around her mouth). She states the bumps wer not itchy and were no where else but on scalp. The sores around mouth were non vessicular. She did not present until 02/13/2021 and had taken steroids at home as she has so many reactions. 1 day she took 20 mg and the next 10 mg.  several days later another 10 mg pill. On 02/13/2021 the scalp bumps not the lip sores were non visible. The was 1 raised area on the side of left face that appeared to be a stuck on lesion. She states the steroids took car of the rest. She was instructed to follow up with PCP and Dr to see if she should take second vaccine. Er for any s/s of distress. I dod not give her any additional therapy as the symptoms had abated.
Pt was seen 8 days after receiving shot. Next day of receiving vaccine patient developed increase redness, chills and temp. Dark central purple area a little bigger but the enlarging redness has decreased in past 4 days. Felt a little damp to area (R arm). (R) arm with 3x2 cm oblong darkened, bruised patch with mild surrounding 3 cm of erythema, warm to touch. No fluctuance or discharge.
pt recvd vax & was 4 wks pregnant;pt elected to terminate the pregnancy @ 6wks gestation; no further details are expected
Information has been received from a licensed practical nurse referring to a female patient of unknown age. There was no concurrent condition or medical history reported. The nurse noted that several years ago, the patient was administered the first two doses in the GARDASIL (dosage, strength, route and lot # unknown) vaccination series on two unspecified dates. On 26-JAN-2016 the patient was in the office to be administered the third dose of GARDASI (dosage, strength, route and lot # unknown). No adverse event was reported. Additional information has been requested.
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 66 years old male patient who was inadvertently given a second dose of FLUZONE HIGH DOSE lot UJ044AB and Exp. date 04-JUN-2019 via intramuscular route in unknown administration site(extra dose administered), on 12-Nov-2018 and on 10-Nov-2018, the patient received a first dose. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was as actual medication error case due extra dose administered. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
This spontaneous report as received from medical assistant (also reported as doctor's nurse) refers to a 7 years old male patient. On unknown date, the patient was vaccinated with the first dose of Hep A (manufacturer unknown) (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient had injection site reaction with a sunburn appearance, redness and swelling at the injection site. The patient sought unspecified medical attention. Patient was treated with ice and BENADRYL. At the time of report, the second dose of Hep A (manufacturer unknown) was not given (also reported as not reintroduced). It was reported that the patient's events resolved (date unspecified). Additional information has been requested.
Started on 10/27 during the first cycle of menstruation  after the initial vaccine dose. Period blood was abnormally heavy, saturating one pad every 3 hours. This is extremely unusual. This continued for 2 days straight. Then the period ended after the 5th day. Two weeks later it returned and was bright red blood. I have NEVER had irregular periods  my entire life! I can?t believe this vaccine has caused my body such changes. Please advise others of menstrual side effects prior to administering. I hope this does not continue. I have always been regular with my period since I began menstruating during puberty so I know my body and this vaccine has caused my period to be irregular.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 10-MAR-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (route subcutaneous, dose 0.65 ml, lot # K000995, expiration date reported as 06-MAR-2015, expiration date after lot verification 16-MAR-2015). No adverse event was reported. Additional information has been requested.
Circum oral cyanosis. Red, puffy eyelids and ears, swollen face, bronchospasms. Rash from neck down. Patient given Benadryl and epinephrine.
Heaviness in foot, both lower extremities weakness and tingling,ataxia. Dx'D mild Guillain Barre Discharge summary states headache.  Medical record states dizziness, nausea
Patient had a rash after immunization, but lingering wart-like bump at site of injection after 5 months.
PATIENT WAS GIVEN A BOOSTER DOSE OF 0.5MLS INSTEAD OF 0.25MLS FOLLOWING THE JANSSEN VACCINE. PATIENT HAD FATIGUE FOR A DAY AND A SORE ARM FOR A FEW DAYS.
w/in 24hr sore throat, aches, runny nose;pt states poss it was a big coincidence?; pt states throat & runny nose, sore arm & aches were there in AM;
Information has been received from a 32 year old male and his physician. The patient, noticed that his sister had a Varicella in late December 2000. On 01/12/01 the patient was vaccinated with his first dose of Varicella virus vaccine live, SQ in his left arm. The patient reported there were no vesicles or scabbing noted. On 02/01/01 the patient developed hives on his entire body. On 02/02/01 the patient received Prednisone med pak for 6 days. On 02/04/01 the patient developed edema of the lips, eyes and face, and was seen in the ER. Therapy with intravenous antihistamine was given and the symptoms subsided. Upon internal review it was determined that the hives and edema of the lips, eyes and face were considered to be an Other Important Medical Event. The physician reported that on 02/05/01 or 02/06/01 the patient broke out in chicken pox pustules that disappeared quickly. At the time of this report the rash was better but continued to itch. The physician indicated that the patient did not think he should receive the second dose due to this experience and the physician agreed. Additional follow up from a public health nurse revealed that the patients condition has subsided and the patient was able to return to work.
Large itchy red rash around injection site on left arm starting around 8 days out. Injection site also bruised. Took a tylenol and benadryl. Rash lasted for a couple of days.  Putting hydrocortisone cream seemed to aggravate it, but the benadryl helped with the itching.
This spontaneous report as received from a consumer refers to a 16 months old female patient (Reporter's daughter). No pertinent medical history, no concomitant medications, no drug reactions or allergies were reported. On 20-FEB-2018, the patient was vaccinated with VARIVAX injection subcutaneously (Lot # unknown, Exp date: unknown) in the left thigh for prophylaxis. On 25-FEB-2018, the patient had red dots all over the face after receiving VARIVAX and patient was treated for this event. Reporter's daughter was seen by physician (sought to medical attention) on 26-FEB-2018 and still had not recovered. No lab diagnostics or studies were performed. There was no intervention to prevent seriousness criteria and no product quality compliant (PQC) was present. No further information was provided. The reporter did not report the causal relation of event with respect to varicella virus vaccine live (oka/merck).
Pt received initial dose on 4/1/21 and the second dose outside the recommended 4-6 weeks on 7/21/21 (91 days later).
Breakthrough case admission after 4 vaccines Pfizer 10/5/21 Lot# 30155BA;  Pfizer 10/26/21 Lot# FF2590'  Pfizer 4/5/22 Lot# FK9895;  Pfizer 8/9/22 Lot# FN2908
Subjects has COVID-19; Subjects has COVID-19; This is a spontaneous report received from a contactable consumer. A 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route pf administration on 07Jan2021 at single dose for Covid-19 immunization. Patient medical history and concomitant medications were not reported. Lab data was reported as patient was tested post vaccination and results was reported as unknown. On an unspecified date in Jan2021 it was reported as subjects has COVID-19. Outcome of events was unknown.  Information about lot/batch number has been requested.
Information has been received from a pharmacist concerning a 67 year old female patient with asthma and hypertension and no drug allergies who on 05-AUG-2010, was vaccinated with a SC dose of ZOSTAVAX (Merck) (lot # 664672/0478Z). Concomitant therapy included PRILOSEC, hydrochlorothiazide (manufacturer unknown), metformin, sertraline HCl, clonazepam and KLOR-CON. On 06-AUG-2010, the patient experienced the "hard knot" area about the size of a half dollar at the injection site. No lab diagnostics studies were performed. The patient's "hard knot" area about the size of a half dollar at the injection site persisted. The patient would see the physician tomorrow. Follow-up information received from the physician indicating that the patient's adverse events went away. Follow-up information received from a pharmacist concerning a 67 year old female who at 3:15 PM on 05-AUG-2010 was vaccinated with the first dose of ZOSTAVAX (Merck)  (lot # 664672/0478Z) in the left deltoid. Concomitant therapy included omeprazole 20, clonazepam 1mg, etodolac 400mg, XOPENEX and ADVAIR. In the evening of 05-AUG-2010 the patient developed large knot at the injection site, swollen and itching. The patient used ice and calamine lotion for treatment. No other swelling or rash. The patient had doctor visit the next day on 06-AUG-2010. No test or action was done by the doctor. The condition resolved. No further information is available.
Information has been received from a physician who reported that a report was posted about two patients who developed amyotrophic lateral sclerosis 4 months after receiving their second dose of GARDASIL. At the time of the report, the patient's status was unknown. Attempts are being made to verify the existence of an identifiable patient and reporter. Additional information has been requested.
First time, morning when drinking coffee, thought my nose was running, but when to dab it and there was blood.  Stopped relatively quickly (I am a slow coagulator, but had not had a nosebeed for about 8-9 months).  This happened every other morning just like this until April 4, when it started bleeding uncontrollably for 2 hours.  So I went to Urgent Care, and they finally got it to stop.  I had it happen a couple of days later, but used the stuff they suggested on cotton and stuck it up my nose and it stopped, and then it didn't occur again.  I have not had any nosebleeds since that time.  I should also say that 12 hours after receiving the seonc dose, I had a high fever, chills, shivering for about 16 hrs.
Swelling and tenderness of lymph nodes under left arm following injections; Swelling and tenderness of lymph nodes under left arm following injections; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control pills, sleeping pills and thyroid medications; all from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced swelling and tenderness of lymph nodes under left arm following injections. The swelling and tenderness of lymph nodes under left arm where both shots were given was still continuing after 4 months. On an unknown date, the patient underwent lab test which included ultrasound and the result was not cancer or related to other infections. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swelling and tenderness of lymph nodes under left arm following injections was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2 hours after 2nd shot I had extreme pain in my left arm. I couldn't raise my left arm over my head.  Then I had extreme muscle tightening and cramping up and down my spinal cord.  Had to take ADVIL to reduce muscle pain.  Then around midnight I started experiencing chills which lasted until 5:00am when I finally fell asleep and woke up at 7:00am drenched in sweat.  The extreme muscle pain and tightness in my back lasted for 2 days and the muscle pain in my legs and joints gradually went away after 2 weeks.