chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Great grandson reported issue at approximately 6:30 pm. Extreme pain in the arm, could not lift arm. Still cannot lift arm 24+ hour later. Weak. Dizzy. Nauseous.
Hand swelling episodes began within 2 weeks of 1st Anthrax shot. The swelling lasted from days to weeks. No worsening of symptoms with 2nd or 3rd shots, although episodes continue.
on right thigh, where PCV13 was given, there was erythema/swelling/heat noted morning after vaccine which spread daily, tried cold compresses/ibuprofen/Benadryl and on day 3 when reaction continued with spreading erythema started Bactrim, no purulence or fever, area was the size of a hand
Rash, pain in area of shot.  Resulting in welt and redness in area of shot and additional rash approximately one inch above shot area.  Soreness less on 12/06/2012, but rashes are more pronounced.
Information has been received from a physician concerning a 17 year old patient who on 21-JAN-2008 was vaccinated intramuscularly with a 0.5 mL third dose of GARDASIL (lot # not reported). Subsequently the patient developed a mass and pain at the injection site. The patient sought unspecified medical attention. An MRI was performed and the results were unspecified. Therapy with human papillomavirus vaccine was discontinued on 21-JAN-2008. Additional information has been requested. This is a follow-up to report(s) previously submitted on 1/14/2008. Information has been received from a physician and health professional concerning a 17 yar old patient who on 21-JAN-2008 was vaccinated intramuscularly with 0.5 mL third dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 558560/1062U). On 06-FEB-2008 the patient developed a lump at the injection site. It was also reported that the patient developed pain at the injection site (onset date unknown). The patient came to the office two weeks after the lump appeared. Diagnostic testing performed on 20-FEB-2008 included a sonogram of the left upper arm indicating a nonspecific mass within the upper left extremity: MRI was recommended, and a complete blood cell count was within normal limits except for red (cell) distribution width-cell volume (RDW-VV) was increased at 15.0% (11.5-14.5). An MRI was performed and the results were unspecified. The patient was treated with cephalexin (KEFLEX) 500MG three times a day for ten days. AT the time of reporting the patient's lump has since improved. No further treatment was needed. Additional information has been requested.
Pt was dizzy and sweating immediately after vaccine. On Monday 07/15/2019, patient was in pain, flu -like symptoms, nausea, low grade fever .
Numbness in different parts of tongue.; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 06Apr2021 at 09:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to onions and the patient had no other relevant medical history. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 12:00, the patient experienced numbness in different parts of tongue. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event numbness in different parts of tongue was resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Balance problem first noticed a week after first shot.  I started walking to the right for periods of a few 10s of seconds several times a day.  On April 30, 2020 8 days after second shot while taking a walk and walked like a drunken sailer to the right until stopped by a fence.   Conditions passed after a minute and I went to emergency room .  They found I had bigeminy but ruled out stroke with complete brain MRI and heart ultrasound. It is not yet clear whether the balance issue if inner ear or the bigeminy.  Have monitor and will be consulting with cardiologist and ear doctors to gain clarity.
The tinnitus in my left ear has worsened and I have slight hearing loss in that same ear.
This spontaneous report was received from a medical assistant (also reports as healthcare worker) refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L016428, expiry date 30-JUL-2017, with temperature of 1.8 degree centigrade, time frame of 92 hours, 40 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Intense rash all over body. Itch and burning feeling then subsides to redness and chills. Due to current asthma condition unsure if tightness of chest is from reaction/asthma. Lasts about an hour/two with allergy med increase and a hot bath after first incident.
Rash on L arm, painful, went down into the upper chest. Rash gone but very sore. Pt. took ADVIL.
administered Hiberix after it was reconstituted with sterile water; administered Hiberix after it was reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacy student reported that a patient was inadvertently administered Hiberix after it was reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not had additional information at the time of reporting. The reporter did not consent to follow-up. The reporter declined follow-up from safety.
Patients left thigh broke out in a rash 1-2 days after vaccine. Rash was from diaper area to knee. Rash was bumpy & red with no swelling. Rash became scabby. Area became very dry.
Flu like symptoms. Bad headache, dizzy, exhausted for ten days. Could not move right arm for one full day. Pain in arm ten days followed by itching. Continue to feel fatigued.
Lethargic; Pain; Headache; Urinary tract infection; blood in urine; Incontinence; Shaking; Chills; This case was reported by a consumer via call center representative and described the occurrence of urinary tract infection in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   On 8th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). On 8th October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced urinary tract infection, hematuria and incontinence. On an unknown date, the patient experienced tremor, chills, lethargy, pain and headache. The patient was treated with ciprofloxacin hydrochloride (Cipro). On an unknown date, the outcome of the urinary tract infection and lethargy were unknown and the outcome of the hematuria, tremor and chills were recovered/resolved and the outcome of the incontinence, pain and headache were recovering/resolving.   It was unknown if the reporter considered the urinary tract infection, hematuria, incontinence, tremor, chills, lethargy, pain and headache to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe urinary tract infection, blood in urine and incontinence. The patient also experienced shaking, chills, pain in her lower region, feeling lethargic and had a headache. No further details were provided. The patient did not consented to follow up.
Information has been received form a respiratory therapist (R.T.) concerning to an unspecified patient (unknown age and gender). The patient's pertinent medical history and concurred conditions were not reported. On an unknown date the patient was inadvertently vaccinated with a dose of PROQUAD (lot #, expiration date, concentration, dose and therapy route were not reported) and with a dose of VARIVAX (lot #, expiration date, concentration, dose and therapy route were not provided), at the same office visit. Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Severe spinal and pelvic pain. Could not walk or be up on feet longer than two minutes. Had to lay down for relief.
COVID-19; COVID-19; vaccine brand=Pfizer/BioNTech; vaccine dose number=2 / vaccine brand other=Moderna; vaccine dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EP6955) and on 07Apr2021 as dose 2, single (Lot number: ER8733) at the age of 59 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Aug2022 as dose 3 (booster), single (Lot number: 002M214) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis (off treatment for vaccines)" (unspecified if ongoing). Concomitant medication(s) included: PROTONIX [OMEPRAZOLE]; ZOLOFT; CAMPRAL; LOSARTAN; MELATONIN; MAGNESIUM; STELARA, stop date: 07Jul2022; Multivitamin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Aug2022, outcome "unknown", described as "vaccine brand=Pfizer/BioNTech; vaccine dose number=2 / vaccine brand other=Moderna; vaccine dose number=3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: It was reported that patient had no known allergies. Patient had treatment with Paxlovid from 14Oct2022 to 18Oct2022.
Dx Sinus Problem  ? Cough  ? Sore Throat ? Generalized Body Aches ? Chills Reason for Visit  Clinical Support 3/15/2021  RN COVID-19 virus infection Dx Medication Infusion Reason for Visit Progress Notes (Registered Nurse) ? ? Encounter Date: 3/15/2021 ? ? Signed    The patient arrived to the ambulatory infusion site with her husband who is also receiving MAB. Reports nausea, diarrhea, fatigue, and coughing     Office Visit 5/4/2021    Internal Medicine Acute non-recurrent maxillary sinusitis +2 more Dx Sore Throat ? Earache ? chest congestion Reason for Visit
Received Td booster in right arm and Hepatitis B #2 in Left arm.  Within 3 minutes of having the immunizations he had a 10-15 second seizure.  (Had a problem with DPT in past but not Td).  Complained of lips being numb/tingling and tip of tongue being numb.  (Faxed to Dr's office).
DEATH; This spontaneous report received from a consumer via a company representative from social media concerned an 8 decade old of unspecified age, sex, 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, and batch number were not reported, expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. 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 died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210844359.; Sender's Comments: V0: 20210845181-covid-19 vaccine ad26.cov2.s- Death.This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
I experienced several commonly reported vaccine side effects for a few days after the vaccine (body aches, headache, exhaustion, low grade fever, chills, joint pain/stiffness, mild nausea.) Then about 2 weeks after the second vaccine dose I developed a macular rash on my chest and then a day later on my upper back.  The rash lasted a few days. I don't get rashes without cause and never had a rash such as this, so it seemed possible it was related to the vaccine. The rash was itchy but not painful, and it dissipated over a few days time. It was not problematic for me, but since the COVID vaccine is new and information is evolving I thought I should report it.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional detauils were provided as follows: The age at vaccination was not reported. The age group of the patient selected as adult as per vaccine indication. No other details were provided. This case has been linked with case US2019192783, reported by same reporter.
15 minutes after returning home the pt began vomiting followed by urticaria, wheeze and slight difficulty breathing.  Pt was immediately brought back to clinic and epinephrine was given as well as blow by O2 and oral benedryl.  Pt. was taken to ER where epinephrine was given again and admitted for 23hr observation.  Pt. was then refered to allergy clinic.  Suspected diagnosis: gelatin allergy (results pending). 11/28/06 Received medical records from hospital which reveal patient seen by PCP that day for routine check & vax.  Began vomiting when arrived home & developed itch all over.  Exam revealed facial flushing with fine papular rash severe itching, clear nasal discharge & swollen nasal mucous membranes, lung congestion & intermittent wheezing.  Tx with epi & Benadryl in PCP office & sent to ER for IV solumedrol but were unable to get IV access so was given oral steroids.  Gradually imrpoved with overnight observation.  Was referred for allergy testing. Final DX: acute anaphylaxis.
Pain & redness - Left deltoid - pt. did not use ice or take analgesic.  She decided not to wait for Dr. - he was seeing in-pts @ hospital.  Advised to use ice on arm & return if still red & painful.
Crippling/Severe Pain starting from my shoulders down to my knees (both sides).  Could not raise my arms or use them to dress completely, severe pain when getting into and out of bed, lifting blankets off of me, walking was the easiest to do, standing up and down from a sitting position.  The worse time was bedtime and in the morning.  It was less severe during the day.  I was prescribed Prednisone.
I did not have a fever, my blood oxygen level was fine , I did have nausea and diarrhea, lots of congestion, runny nose , ringing in my ear, lot of shortness of breath which I did go to urgent care, lots of muscle aches and fatigue. I still have no smell or taste. Mainly dry coughing. I felt at first like it was just my allergies. At urgent care they gave me IV fluids, some meds to help with inflammation and sent me home with albuterol. I still am very winded from walking or an exertion, I feel like my symptoms were mild but they felt pretty rough, I'm so thankful I was vaccinated because it could have been worse.
2 days, post vax, the pt developed a fever of 104F and a cough. Went to ER and was dx'd with a viral infection. Still having fever of 104F today.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 02-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Onset of erythema, induration, warmth at injec site within approximately 6 hrs to 8 hrs of injection - subjective fever also noted by patient.
2 Days after the vaccine, I fell asleep on the couch and when I wen to get up, the whole underarm area of my left arm was in excrutiating pain! For the next 2 days I iced it and went to off-hours clinic and they triaged me and said to come back the next day if it was still bad. I didnt go. My lymph nodes were swollen and sore in my left side of my neck. The pain was out of this world! 11 out of 10! It started to ease up by 9/10. each day after it subsided a little more til I didnt need the ice packs. All the pain was localized in my underarm and toward the breast area.
Within a month of the vaccine patient had ear infections.  These could not be cleared by antibiotics.  These ear infection lasted 8 months.
11 patients received doses of temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (11 patients received doses of temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (11 patients received doses of temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (11 patients received doses of temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment information was reported   This case was linked to US-MODERNATX (E2B Linked Report). This case was linked to MOD-2021-232457, MOD-2021-232457 (Patient Link).; Sender's Comments:  US-MODERNATX:irms
Information has been received from a registered nurse concerning a 7 year old male with asthma and no allergies who on 26-APR-2001 was vaccinated with 0.5ml intramuscular (IM) dose of varicella virus vaccine live (Oka/Merck) (lot# 636565/0922K). Concomitant therapy included albuterol. On 20-MAR-2007 the patient experienced lesions on his ear, lip, neck and trunk, 35 to 50 total lesions. The patient was treated with acyclovir 800mg four times a day for 5 days. VZVID was offered and declined. Subsequently, the patient recovered. No additional information is available at this time. No product quality complaint was involved. Additional information has been requested. Follow-up information received from a registered nurse stated that this patient with no pre-existing allergies, birth defects or medical conditions received a first dose of varicella virus vaccine live (Oka/Merck) in the right leg on 26-APR-2001. Concomitant vaccine administered on the same day included a second intramuscular dose of PREVNAR vaccine (CRM197) (Lot #"471-171") in the left leg. Illness at the time of vaccination included allergic rhinitis. On 20-MAR-2007, the patient developed lesions on the nape of the neck, right ear, and lip. No medical attention was sought.
Chills, shaking, headache, body aches, fever 101.5, fatigue.  Chills and shaking started around 1:00 am without fever, lasted about 1.5 hours. Woke up  at 6:00 am with severe headache, body aches, and fever. Fever resolved with Tylenol and reoccurred later around 6:00 pm at 100.4 along with body aches and chills. Headache has persisted the entire day.
Severe Muscle Aches day after second injection; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0170) via an unspecified route of administration in the right arm on 03May2021 15:45 hours (at the age of 50-year-old) as a single dose for COVID-19immunisation. Medical history was not reported. Concomitant medications included  amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate         (ADDERALL), sertraline hydrochloride (ZOLOFT), zolpidem tartrate (AMBIEN) and alprazolam (XANAX) and LOMICTAL all for unknown indication, from an unknown date. The past medication history include sulfadiazine (SULFA) for unknown indication on an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0158) via an unspecified route of administration in the right arm on 12Apr2021 15:45 hours as a single dose for COVID-19immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four week of vaccination. On 04May2021 at 07:00 the patient experienced severe muscle aches day after second injection. The clinical outcome of the event severe muscle aches day was recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
vaccine given 12 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 12 days post expiry) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 12 days post expiry). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 12 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to  (Patient Link).