chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I experienced hearing loss and had to be referred to an ENT who diagnosed me with Tinnitus. He sent me for a hearing test with a specialist. The test was performed a hearing test and the recommendation was that I get hearing aids because it helps with the condition.
She got her vaccine, her side of her leg was sore, but then noticed on the right leg redness that is baseball size, and the lump itself is golfball size, and now it's itching, purple red spotted area. The next day she was achy and slept all day.   Two days later she then on the left leg has a lump on her calf towards the backside, about 1" below the bend of the knee which is another lump, redness around it about the size of a quarter.  This morning when she woke up and the right shoulder at the injection site is itching, redness and lump area is getting bigger about the size of a quarter and hot to touch.  The redness on the leg is getting bigger.   Said that she will take a Benadryl tonight for the reaction.   She did talk to her doctor who told her to contact us.
10SEP92 t99, irritable-noticed dull red, raised clustered rash over abdomen & under arms; 11SEP92 rash more noticeable temp nl;
Awoke from sleep 5 am 6/17/06 with severe substernal chest pain 11 days post-smallpox vaccine.  cardiac enzymes + CPK-MB peak @ 46.6 with index of 11.1.  Cardiac cath 6/19:  clean coronary arteries. Follow-up: Patient is military and has been "lost to civilian follow-up". Military may be able to provide additional information.
Itching and burning day #1 Itching, redness, small bump day #3 Day #7 and #8 large 4"x3" area of induration/erythema/puritis/warmth. Very hot, hard, and itchy. Also, intermittant headache, fatigue, runny nose, sneezing.
Breakthrough case admission after three vaccines  Moderna 2/4/21 Lot# 013M20A: Moderna 3/4/21 Lot# 030A21A;  Moderna 11/12/21 Lot# 039D21A
the baby threw up; when the vaccine was administered, the baby threw up; This spontaneous report as received from Other Health Professional (HCP), referring to an infant patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 27-JUN-2023, the patient was administered with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (orally, exact dose, lot #, expiration date and anatomical location were not provided) for prophylaxis.  On 27-JUN-2023, when the vaccine was administered, the baby threw up (Accidental underdose). The outcome of the event of vomiting was unknown. Action taken with suspect vaccine regarding the events was not applicable.  The causal relationship between the event of vomiting and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.
Dizziness, Headache, Arthralgia, Chills, Fatigue, injection site pain/redness Narrative:
Fever vomiting chills seizure ( the injection triggered it) fell bad since the injection.
SHORTNESS OF BREATH Respiratory distress Hypoxia Pneumonia due to COVID-19 virus Death
Had palpitations, tachycardia, shortness of breath about 10 hours after injection.  Continued for about a week and then decided to get checked out.  Found to be in AFlutter with RVR 120+ bpm.  Sent to ED.  Admitted.  Required TEE-Cardioversion twice and time in the ICU.  Discharged and seen in follow up today.  No longer having symptomatic aflutter.  No known objective prior history of CHF or Aflutter.
Muscle aches; joint aches; exhausted feeling; slight headache; This is a spontaneous report from a non-contactable consumer (patient herself). A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on the right arm on 18Jan2021 at 12:00 PM at a single dose for COVID-19 immunization, given by the retirement home and administered at the nursing home/senior living facility. Relevant medical history included pre-diabetic, obesity, high lipids, and allergies to some psychiatric (psych) medications (meds) only. Concomitant medications included risperidone, calcium levomefolate (DEPLIN), travoprost (TRAVATAN), ibuprofen, and famotidine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Jan2021 at 15:30 (also reported as "beginning around 3 pm"), the patient experienced muscle aches, joint aches, exhausted feeling, and slight headache mainly in the afternoon. The reporter assessed all the events as non-serious. The patient did not receive any treatment for the events. The patient was recovering from all the events.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia, Arthralgia, Fever, Rash,  Swollen lymph nodes. Rash was 7 days after vaccine on  both doses, injection site extending down arm
Information has been received from a consumer concerning her 23 year old daughter with codeine reaction/allergy and an history of acne at 17 year old which was resolved who was vaccinated with the first, second dose and third dose of GARDASIL on 06-MAY-2009, 26-AUG-2009 and 15-DEC-2009 respectively. Concomitant therapy included KARIVA. The consumer reported that two weeks after the first vaccination, on approximately 20-MAY-2009, the patient developed acne. The patient was seen by a dermatologist but they never attributed the acne to the vaccine till now. The consumer states that on approximately 16-DEC-2009, after the third vaccination in the arm the patient experienced tingling of the leg, on the same side of the arm that was vaccinated with GARDASIL, but the consumer could not remember if it was right or left. At the time of the report the acne outcome was unspecified and the patient's tingling of the leg persisted. It was noted that at the time of the report, the patient was talking with her physician. Additional information has been requested.
Pt very poor historian. Had to wait for ER record to complete form. Tongue swelled, started itching and legs swelled. Went to ER at 14:10 on Sunday. Told ER doctor the same thing she told me; that eggs bothered her ulcer and sometimes made her nauseated. No hives or itching or anything. The doctor Rx'd as allergy with Zantac, Medrol Dose Pack and Benadryl 50mg tid. To follow-up with regular MD the next day.
Moderna on 2/26 and 3/26. Positive on 8/29 admitted 8/29 to current
It was reported post vaccine's pt experienced fever on and off. Pt also experienced clear mucus from the nose, back pain, urinary symptoms, headache, constipation,skin rash, upper respiratory infection and malaise. The pt was treated with Tylenol and fluids. No further info is available.
Rash appeared over mid back and buttocks 7/30/08. Progressed to localized area over left thigh, clustered, mean spots, very pruritic. Area persisted in being itchy - 11/08 went to dermatologist.  Finally, biopsed in March of 09. Traces of Aluminum Chloride
1617 PT PRESENTS W/ HIVES, DENIES ITCHY. LACEY RASH, REDNESS AND RASH ON FACE, NECK AND UPPER CHEST AND BACK. BP 140/90 HR 81 RESP 15 O2SAT 99 AT 1620. SKIN CLAMMY DIAPHORETIC, RASH AND HIVES. ISOLATED AND OBSERVED.  1635 BP 124/88 HR 73 RESP 15 O2SAT 99, SKIN CLAMMY DIAPHORETIC RASH AND HIVES. BREATH SOUND CLEAR BILATERALLY.  REASESS IN 15 MINUTES DISPOSITION. HOME BY SELF.
large knot under skin at injection site, red rash around injection site that is itchy, burning (painful) and hot to the touch,
This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. On 20-FEB-2013, the patient was vaccinated with a dose of GARDASIL (lot number reported as 667194/1271Z, dose and route unspecified) that had expired on 11-DEC-2012. No adverse effect was reported. This is one of the two reports from the same reporter. Additional information has been requested.
Persistent screaming spells that began ~3 1/2 hours after vaccines, treated with acetaminophen. Episodes lasted for approximately 48 hours. Baby was seen in office, with comprehensive exam, and no cause was found for fussiness/screaming/irritability. He had had no fever, no apparent local reaction to injections, no other signs or symptoms.
Felt like he had the normal flu, not the COVID flu; He had no energy; Itching injection site; Tired/ Fatigued; Swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like he had the normal flu, not the COVID flu), ASTHENIA (He had no energy), VACCINATION SITE PRURITUS (Itching injection site), FATIGUE (Tired/ Fatigued) and VACCINATION SITE SWELLING (Swollen injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Felt like he had the normal flu, not the COVID flu), ASTHENIA (He had no energy), VACCINATION SITE PRURITUS (Itching injection site), FATIGUE (Tired/ Fatigued) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like he had the normal flu, not the COVID flu), ASTHENIA (He had no energy), VACCINATION SITE PRURITUS (Itching injection site), FATIGUE (Tired/ Fatigued) and VACCINATION SITE SWELLING (Swollen injection site) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-403087 (Patient Link).
pt recvd DTaP/OPV 18APR92 & in late AM & late evening of same day devel a fever; mom stated temp wasn't measured; pt felt very warm & temp estimated to be 104; pt talked in sleep throughout noc which was unusual;
Pt. recieved vaccine 12 hours past expiration. MD contacted pt. No adverse event. Pt. declined revaccination
allergy symptoms, tested for COVID-19 1/02/2021 and was Positive
states rt arm became red & sore;became unable to move arm d/t pain;went to hosp ER;told infect in arm & given ATB;
Burning sensation/nerve burning in fingers on right hand; Dull achy pain in right arm that comes and goes; Spontaneous report received on 13MAY2020.  A female patient reported that she experienced burning sensation/nerve burning in fingers on right hand (PT: Burning sensation) and dull achy pain in right arm that comes and goes (PT: Pain in extremity) following immunization with BioThrax (anthrax vaccine adsorbed). It was reported that she received BioThrax (lot number: 300032; expiry 10AUG2020) third shot and experienced burning sensation and nerve burning in fingers and dull achy pain in right arm that comes and goes. Additionally, it was reported that she thought the vaccine might have been expired as she heard that all the people who were supposed to get the shot, they did not receive it because they were told that it was expired. She was the first to get the shot and now she was wondering if she received an expired shot. The outcome was unknown, at the time of report.    Company Comment: A consumer received third shot of BioThrax on an unknown date and then had burning sensation in fingers of her right hand (burning sensation) along with painful right arm (Pain in extremity). Further information of the events is limited. Burning sensation and pain in extremity are expected after BioThrax vaccination, and assuming the injection was in the right arm, the causality of both the events is assessed as possible. The case will be followed-up for the expiration date of BioThrax Lot number which was administered to the patient.; Sender's Comments: A consumer received third shot of BioThrax on an unknown date and then had burning sensation in fingers of her right hand (burning sensation) along with painful right arm (Pain in extremity). Further information of the events is limited. Burning sensation and pain in extremity are expected after BioThrax vaccination, and assuming the injection was in the right arm, the causality of both the events is assessed as possible. The case will be followed-up for the expiration date of BioThrax Lot number which was administered to the patient.
Unusually severe mood swings, depression before menstrual period, worse cramps than normal. These symptoms started during my period immediately following the vaccination (July) through August. Still not completely normal in September but better.
I was deathly ill for 30 hours starting at 0300 on 1/26/21.  I took Ibuprofen every 8 hours around the clock and was shivering with severe body aches, fever, dizziness and feeling of exhaustion. I've had a sore shoulder since receiving the vaccine on 1/25/21 that feels like arthritic pain.  I have been exhausted daily since getting the vaccine.  I want to go to bed at 1900 nightly and that was never my normal.
I was given the vaccine on 1/16/2021 on my left arm.  Exactly 8 days later on 1/24/21, I developed a rash/redness like the size of of a tennis ball and was very red, hot to the touch, a little painful and itchy on the site near  where the vaccine was given.   As of today the actual rash/redness has spread on my upper arm.  It seem like is fading a bit but its still very much there.  I have been a little feverish, a little headache, I guess overall ok.
shoulder rotating cuff is messed up in the arm; Feels like she is having arthritis and cannot even open bottles; Feet hurt, specifically her toes; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder rotating cuff is messed up in the arm), ARTHRALGIA (Feels like she is having arthritis and cannot even open bottles) and PAIN IN EXTREMITY (Feet hurt, specifically her toes) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced ARTHRALGIA (shoulder rotating cuff is messed up in the arm), ARTHRALGIA (Feels like she is having arthritis and cannot even open bottles) and PAIN IN EXTREMITY (Feet hurt, specifically her toes). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (shoulder rotating cuff is messed up in the arm), ARTHRALGIA (Feels like she is having arthritis and cannot even open bottles) and PAIN IN EXTREMITY (Feet hurt, specifically her toes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
received a dose of menomune when he was 11 years old, then a second dose of menveo (non-sanofi product) one year after when he was 12 years old with no adverse event; Initial information received on 29-Mar-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12-year-old male patient who received a dose of menomune when he was 11 years old, then a second dose of menveo (non-sanofi product) one year after when he was 12 years old with no adverse event after receiving meningococcal vaccine a/c/y/w conj (crm197) (Menveo) and meningococcal a-c-y-w135 vaccine [Menomune].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect Menveo not produced by Sanofi Pasteur and received a dose of suspect Menomune lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event as received a dose of menomune when he was 11 years old, then a second dose of menveo (non-sanofi product) one year after when he was 12 years old with no adverse event (inappropriate schedule of product administration) (unknown latency). The Caller stated that patient is now 16 years old and want to know if he needs a booster or not since he already received two doses.   Action taken was not applicable.  Outcome was Unknown.    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.
Got a rash on my arm about two days later along with hives. The rash may be unrelated and was said to be eczema. The hives have been frequent and daily. Mostly effecting my arms but have been on all limbs, back and stomach.
Dry feet. The day after my first shot the bottom of my feet were very painful, so painful I could hardly walk and couldn't sleep. This was my second shot, and the pain was not as bad but it still hurt to walk and I had to tiptoe around the day after. My feet are mostly better but are still painful and abnormally dry. This has never happened to me before.
A week after my first shot I got "covid arm".  Originally after the first shot my arm was sore for about two days then it went away. One week after the shot the injection site swelled up and got really hot and itchy.
I experienced a breakthrough case of COVID-19 with fever, sweating. aches, body aches and sore throat.
her father developed Bell's Palsy; This is a spontaneous report from a Pfizer-sponsored program Support from a non-contactable consumer or other non hcp (Reporter's father) Via medical information team. An 88-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration on unspecified date of Mar2021 (age at the time of vaccination 88-years-old), as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date of Mar2021, patient experienced her father developed Bell's Palsy. Reporter's father took Pfizer BioNTech COVID-19 vaccine the next day he started experiencing bell's palsy which he is still experiencing, and he didn't get second dose. The outcome of event was not recovered.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The next day my temperature increased to 100 degrees and I had a pain in my left hip when I walked.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 11th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. On 11th October 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. On 12th October 2018, the patient experienced general body pain, tiredness, headache and sleep excessive. On 14th October 2018, the patient experienced injection site rash. In October 2018, the patient experienced chills and fever. In October 2018, the outcome of the general body pain, tiredness and headache were recovered/resolved. On an unknown date, the outcome of the chills and fever were recovered/resolved and the outcome of the injection site rash was not recovered/not resolved and the outcome of the pain in arm was recovering/resolving and the outcome of the sleep excessive and injected limb mobility decreased were unknown. It was unknown if the reporter considered the chills, general body pain, injection site rash, tiredness, pain in arm, fever, headache, sleep excessive and injected limb mobility decreased to be related to SHINGRIX. Additional details were reported as follows: The patient received the SHINGRIX on Thursday before the reporting date. On the same day of vaccination, the patient experienced that the patient could not raise the arm where she received the injection because the whole arm was painful. On 11th October 2018, about 8 hours later the patient started with the chills and the low grade fever. The next day after vaccination, the patient experienced severe body aches all over, headache, tiredness and she ended up the fever with a 100 degree F. The patient slept all day. The patient felt better about her arm but it was not gone at the time of reporting. On Sunday, 3 days after vaccination, the patient noticed the rash, it was about 3 inches across her arm and 2 inches down at the injection site. The patient had denied permission to contact their physician.
Approximately one month after receiving the bivalent booster, the patient got COVID; Approximately one month after receiving the bivalent booster, the patient got COVID; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the parent.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Approximately one month after receiving the bivalent booster, the patient got COVID".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency; however, a contributory role of BNT162b2, BNT162b2 omi ba.4-5 to the events COVID-19 and drug ineffective cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300069827 same patient/drug, different event.;
approx. 10-15 minutes after vaccine given, pt felt dizziness.  placed on the gurney, CP then started. MD contacted, 911 called. VVS, 5-10 mins later pt became unresponsive, VS remain stable. no breathing issues. paramedics arrived. ekg and blood sugar obtained. pt regained consciousness and transferred to the ED
shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months 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 details were reported as follows: The age at vaccination was not reported. At the time of reporting, the patient had shingles after 1st dose of Shingrix. The patient was due for 2nd dose. The reporter asked, if the patient waits one month is it still ok to get then 2nd shot at 7 months. The reporter consent to follow up.
Day #7 itching, raised red rash - approx 4? diameter, warm to touch around injection site, left deltoid, over next two days erythema increased to size of my hand, remains red, itching less, non-tender...simply increasing in size
Patient started to have palpitations w/i 24 hours of receiving the vaccine, at rest heart rate can go up to 120, EKG  done at clinic showed NSR Patient having reticular rash on chest, neck, shoulder, back.