chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart palpitations; skin rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  An elderly female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: PALPITATIONS (hospitalization), outcome "unknown", described as "heart palpitations"; RASH (hospitalization), outcome "unknown", described as "skin rash".  Additional information: Reporter was not the only one that has had these types of effects, in her same age group. Reporter heard other people had reactions to it, in her age group, the heart palpitations. One woman went into hospital for a week or 2. Reporter clarified that, other people in her age group had same reactions, including woman who was hospitalized. Does not have any further details to provide for the report.  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.
Patient developed left shoulder pain immediately post vaccine administration in the left deltoid (intramuscular). Patient is currently being evaluated by orthopedic physicians.
Has a fever and body aches on 4 days after injection and was also diagnosed with Covid on that day
pt states after getting the 2nd dose Shringrix.  The following morning he started feeling weak and lightheaded and fell.  He was transported to the Hospital ER where he was given morphine and a CT.  They discovered he had a broken rib.  He was admitted for observation.  He was discharged to follow up with PCP and Cardiologist.  PCP Dr..  His Cardiologist Dr. did an EKG which was normal.  He has been having weak and dizzy spells that continue to happen periodically that come and go.  These are scary since he never knows when this will happen to him.  He has to sit down and rest when he has these spells happen until they eventually subside.  He is worried he now has Guillain barre syndrome. He was discharged from hospital on Sept 1st.  On Sept 27th he had his 2nd Covid Booster.
I95.9 HYPOTENSION 5/23/2023 HEPATORENAL SYNDROME J96.00 ACUTE RESPIRATORY FAILURE 5/24/2023 HEPATORENAL SYNDROME
Alopecia on left side noticed early December 2007, probably started November 2007. Increased alopecia several months. Alopecia on right side noticed first part of July, 2008. Alopecia increasing. I've now lost 3/4 of my scalp hair and it continues to shed.
flu like symptoms; fever of 102 F; This is a spontaneous report from a contactable consumer or other non hcp.     A 46-years-old female patient received bnt162b2 (BNT162B2 Solution for injection), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. On Feb2021, The patient experienced flu like symptoms, fever of 102. Patient did not receive any treatment for events. The patient underwent lab tests and procedures which included body temperature: 102 Fahrenheit. The patient does not receive any vaccine prior to covid vaccine and post covid vaccination. The outcome of the events was unknown.   Information about Lot/Batch has been requested.
No adverse effects; Expired dose of PROQUAD; This spontaneous report was received from a medical assistant referringto a 4-year-old-child patient. Information on patient's medical history, concurrent conditions and concomitant therapies was not reported. On 18-JUN-2019 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, dose, frequency were not reported, lot # N035172 with expiration date 09JUN-2019) via subcutaneous route for prophylaxis. On 18-JUN-2019 the patient was administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (expired product administered). No adverse effects were reported (no adverse event). There was no involvement of product quality complaint (PQC).
lymph node under right arm swollen 9/23-9/29. Chest pressure 9/23-9/24 with increased blood pressure.
This 35 year old male patient experienced injection site reaction, muscle twitching and back spasm during post exposure RabAvert therapy. After the second injection, the patient experienced injection site reaction with induration, swelling and redness at the site injection. Following the third injection, he experienced back pain and muscle twitching for a short period of time after the injection. No further information is available.
SICK; WANT TO SLEEP ALL DAY; FATIGUE; TIREDNESS; This spontaneous report received from a patient concerned a 49 year old male. 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 not reported, batch number: 043a1a, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced want to sleep all day. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced tiredness. On an unspecified date, the subject experienced sick. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and tiredness, and the outcome of want to sleep all day and sick was not reported. This report was non-serious.
Pfizer-BioNTech COVID-19 Vaccine EUA 5-11 year COVID vaccine administered to a 4 year old patient.  No adverse effects known at this time.
Patient received first dose of Pfizer COVID vaccine.  10 minutes after vaccination patient reported mouth felt 'weird' and throat felt 'swollen' although no difficulty swallowing was reported.  Assessed by provider Benadryl PO administered.  After 20 minutes patient reported symptoms had resolved.  Discharged to home with husband.
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 30 patients who was given vaccines that were outside of the recommended temp range below 32f, while he/she received vaccines PENTACEL, MENACTRA, FLUZONE QUADRIVALENT and QUADRACEL. 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 DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route. It was a case of actual medication error due to incorrect product storage. The patient outcome is reported as Not Applicable for given vaccines that were outside of the recommended temp range below 32F. 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 Directive 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.
Varicella vaccine given SQ left arm 4-25-11. Went to MD 4-27-11 for c/o redness, swelling, and soreness. Assessed by Dr. and APRN. Recommended cold compresses and BENADRYL cream or hydrocortisone cream.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a female patient who received SHINGRIX (batch number G47M2, expiry date 11th October 2020) and (batch number 5NY3B, expiry date 13th July 2020). On 27th April 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 29th April 2018, 2 days after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved. The reporter considered the injection site rash to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that they had a SHINGRIX clinic on Friday (27th April 2018). Three of her patients returned to her pharmacy on reporting date with the same symptoms. All three patients were female. The reporter did not have additional details to differentiate one patient from the other. They used two different lot numbers of SHINGRIX. This case has been linked with case US2018GSK080995 and US2018075831, reported by the same reporter.
42 YO FEMALE PRESENTED WITH A C/O OF ITCHING IN HER MID FACIAL REGION THAT PROGRESSED TO A NUMB/TINGLING FEELING. PT STATES SHE HAS NEVER EXPERIENCED THIS REACTION TO A MEDICATION OR VACCINE, BUT SHE TOOK BENADRYL AFTER STARTING TO FEEL THE ITCHING FEELING.  SHE DENIES FACIAL PAIN, SOB, CHEST PAIN, OR NUMBNESS IN UPPER OR LOWER EXTREMITIES.  BP 119/53 HR 97 SpO2 100%  PT APPEARS ALERT AND ORIENTED X 3.  NO FACIAL ERYTHEMA OR ASYMMETRY PRESENT. LIPS APPEAR  NORMAL WITHOUT EDEMA. SKIN APPEARS NORMAL WITHOUT ERYTHEMA OR LESIONS.  PT REACTION RESOLVED 95%. SHE WAS INSTRUCTED TO MONITOR FOR CONTINUED  SYMPTOMS AT HOME AND TO F/U WITH HER PCP.  PT REMAINED STABLE AND LEFT THE OBSERVATION SITE WITH HER HUSBAND DRIVING.
tested positive on covid test; tested positive on covid test; This is a spontaneous report received from a contactable reporter(s) (Consumer [Pharmacy Technician who is also the patient] ) from medical information team and a sales representative. A 72 year-old male patient received BNT162B2 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive on covid test". Caller is a company Employee. Caller wanted to report an AE regarding consumers "they have gotten Pfizer covid-19 vaccine including booster" and apparently tested positive on covid test. Caller said that she feel like she's obligated to report it. Caller also added that she cannot share the consumers information to me, but she mentioned that the one she talked to is a woman and her husband, the wife age "about 66" and the husband age "about 72" (caller is not sure about the age and just tried to guess it). It was further reported that the patient tested positive for COVID after a total of 3 doses of Pfizer Covid-19 Vaccine had been administered. She thinks the test may have been taken on 09Dec2021 and she believes it was a home test. She also reported that the patient reported no symptoms, only a positive result for COVID on that test. As far as caller is aware there has not been any further testing or anything done. The patient underwent the following laboratory tests and procedures: COVID-19 test: (09Dec2021) positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A report has been received from a Health Professional, subject of unknown gender, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. The patient was administered a dose of expired FLUMIST on 09-Jan-2014. The outcome of the event of administered a dose of expired FLUMIST is unknown. The report was considered to be non-serious.
Tinnitus and Severe Case of Vertigo. Vertigo has subsided to mild case. But Tinnitus has persisted consistently and continuously since the second shot.  Hearing has also been effected and I have been diagnosed wit mild hearing loss in both ears.
Three weeks after my booster, I started having heart palpitations/fluttering. My Primary Care Dr's referred me to a Cardiologist. I was given a Stress test and an EKG, both came back normal. I was given a heart monitor for 2 weeks. They added 2 meds Magnesium Oxide 400mg, Metoprolol 25mg and they adjusted my prescription of Amlodipine from 5mg to 2.5mg
Shortness of breath exacerbated on fast walking but also present on normal walking occasionally; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) as a single dose via unspecified route of administration on 19Mar2021 at 13:00 (at the age of 54-year-old) for COVID-19 immunisation. Medical history included thrombophilia (leiden factors), parotidectomy since 1996 and subsequent regrowth (pleomorphic adenoma- benign), non-Hodgkins lymphoma diagnosed on 14Feb2013, lung scarring from 9/11 exposure and mild seasonal allergy related asthma. It was reported that the patient allergic to mango skin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had obese reading with 75 lbs and pulse rate and oxygen rate (reported as pulsox) 98 or 99 respectively. Concomitant medications included ZYRTEC, baby aspirin (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) and BENEDRYL taken within two weeks of vaccination. On 20Mar2021 at 15:30, the patient experienced shortness of breath exacerbated on fast walking but also present on normal walking occasionally. No treatment was received for the events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of event shortness of breath was not resolved at the time of reporting.   Information about lot/batch number cannot be obtained. No further information is expected.
*No adverse event noted  Medication Error: Too little diluent 1.3ml (pediatric dose) diluent mixed with adult Pfizer Covid vaccine. Patient contacted and informed of error. She was advised to contact office if any concerns arise. None noted at time of call.
The patient began to feel weak after she received vaccines. No syncope. Patient lied down and recovered well.
Immunizations provided 6/25/04. Febrile seizure on 7/19/04. Was not previously ill. Awoke 4AM on 7/19 with temperature 103.3, 45 second seizure. No fever or illness after
Client received COVID 19 Vaccine (Moderna #038k20A) at 10:00 am. She waited out in the lobby for 30 min. when she started to feel flush and dizzy. Had complaints of her throat feeling like it was closing off. Client taken to clinic room. Benadryl  50mg administered IM into the RT Deltoid. Epi administered IM administered into the RT deltoid. EPI was drawn up by the RN and Administered by another RN. Benadryl drawn up and administered by RN. RN present and assessed for lung sounds and bp. Lung sounds were clear, unable to obtain bp in clinic room.  911 was called and client was transferred via EMS to ER for observation. Client was alert and oriented x 3 upon departure.
soreness in both of her arms and at the injection site; soreness in both of her arms and at the injection site; This spontaneous report as received from a nurse via a company representative refers to a 12-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.     On 15-OCT-2019, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unknown date in October 2019 (reported as after injection), the patient experienced soreness in both arms and at the injection site. The patient's father called into office. No treatment was given to the patient and no laboratory tests were performed. The outcome of the events was unknown.  The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
severe pain in joints;12DEC95 pt stated has only body aches, no joint pains;no rash;no neurological sxs;
Within 2 hrs after vaccine, protracted screaming episode. These continued almost daily for 6 weeks. Had blistering skin lesion on right great toe within 2 days. EGD after 1 month revealed multiple gastric ulcers, and CBC showed neutrogen (ANC 200 to 800) which has persisted. Has seen GI and heme-one, no explanation found, but is asymptomatic now.
The nurse reported that a 4 year old male received an injection of Acel-Immune on 04/11/00.  The next day the patient developed an injection site reaction characterized by an area of redness, itching, and swelling, measuring 2 inches in diameter. The patient recovered. This is 1 out of 3 patients from this facility that developed an injection site reaction following receipt of Acel-Immune lot 469-396.
ive never been sicker  throwing up,diarehaa,cold/hot flashes,super tired,and basically havent felt all trhe way well since taking shot  i totally regret getting shot
Left deltoid swollen, red, warm to touch, with a hard knot underneath the redness, painful to touch. temp 99.5.
Medical Assistant gave the Varicella vaccine IM instead of SQ.  No problems noted with the patient after the injection and neither when patient was checked 3 hours later.
developed pain, redness and heat in her left wrist on 1/11/21. I saw her on 1/12 and evaluated it. It could be gout or pseudogout and just a coincidence but we need to fill out a VAERS report on it, just in case.
I have had both the zostravax vaccination in 2015, both doses of the shingrix vaccination in 2020, yet I recently developed shingles; I have had both the zostravax vaccination in 2015, both doses of the shingrix vaccination in 2020, yet I recently developed shingles; I have had both the zostravax vaccination in 2015, both doses of the shingrix vaccination in 2020, yet I recently developed shingles; This spontaneous report was received from a patient of unknown gender, who would be 66 years old at the reporting time. The patient's medical history, concurrent condition and concomitant medication were not provided.  The patient have had both the zoster vaccine live (ZOSTAVAX) vaccination in 2015 (extra dose administered), both doses of the varicella zoster vaccine rge (cho) (SHINGRIX) vaccination in 2020 (strength, dose, frequency, route, lot# and expiration date were not provided), yet the patient recently developed shingles (herpes zoster and vaccination failure). The outcome of all events were unknown.    The reporter considered vaccination failure to be related to suspect products of zoster vaccine live (ZOSTAVAX) and varicella zoster vaccine rge (cho) (SHINGRIX) vaccination. The causality between shingles and suspect products was not provided.
After taking the first shot my period came the next day and was shorter than normal . I was delayed in taking the second shot by 48days . I finally took the second shot July 13 and noticed my period came earlier on the 16 th that friday . My period was supposed to come on august 12 and never came until today august 24 th . I was spotting for days brown blood and now finally got my period late . Not sexually scribe and I have regular periods every 28 days . I believe this is vaccine related .
body aches; headache; felt like he had a fever; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), HEADACHE (headache), PYREXIA (felt like he had a fever) and VACCINATION SITE PAIN (Pain at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cholesterol since an unknown date and Hypertension since an unknown date. Concomitant products included METFORMINA [METFORMIN] for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced MYALGIA (body aches), HEADACHE (headache), PYREXIA (felt like he had a fever) and VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, MYALGIA (body aches), HEADACHE (headache), PYREXIA (felt like he had a fever) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included None. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), HEADACHE (headache), PYREXIA (felt like he had a fever) and VACCINATION SITE PAIN (Pain at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cholesterol since an unknown date and Hypertension since an unknown date. Concomitant products included METFORMINA [METFORMIN] for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced MYALGIA (body aches), HEADACHE (headache), PYREXIA (felt like he had a fever) and VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, MYALGIA (body aches), HEADACHE (headache), PYREXIA (felt like he had a fever) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included None.
4/15/2021-8:05am - Moderna shot received in right middle deltoid.  Soreness started immediately. 9:30pm - chills started and lasted until 4/16/2021-3am. 04/16/2021- general fatigue most of the day.
5 minutes after vaccine pt. fainted, bumped head moderately on fridge, and had 3-4 second seizure called 911, within 10 min. they arrived. Pt regained conscious within 8-10 seconds after fall. Nausea/light headed, low BP for 1.5-2 hours. Walked away under own power after 2 hours with wife when she arrived. Injuries suffered were minimally bit tongue on tip. No head/neck/spine injuries-EMT cleared patient to leave on own terms.