chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the date in July, I woke up with an extreme case of vertigo. My balance was completely off and I had a ringing in my ears. I immediately went to Urgent Care facility. They checked my heartrate and all of that came back fine. Bloodwork - all was fine. They recommended I go to my ENT doctor -  and so I made an appt to go that next week. He checked everything and didn't see any reason why I was having VERTIGO - I couldn't stand up straight. I had to lean against the wall of the room would spin. He ran bloodwork, too, and everything came back fine. He gave me a medication to help my body balance - it took me almost the whole month of July to get back to semi-normal. And still have a subtle ringing in my ears. I have been to ENT doctor two my times since July and he can't figure out why I still have occasional bursts of balance not being good but then it will come back; and then the ringing still in my ears. My primary care doctor and my ENT doctor. My plan is to set up an appt with an neurologist. The same day I went to Urgent Care, I went Hospital ER too - for a test on my heart that Urgent Care didn't have. They wanted to make sure that my heartbeats per minute and the pressure with my blood was correct.
Patient was feeling  dizzy after getting her second Pfizer Covid  shot.  EMS  believed patient was having anxiety attack.  Patient felt better after about 30 min and she went home with her mother.
CHILLS; BODY ACHE; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (CHILLS) and PAIN (BODY ACHE) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced CHILLS (CHILLS) and PAIN (BODY ACHE). At the time of the report, CHILLS (CHILLS) and PAIN (BODY ACHE) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was taken. No treatment medication was taken.
Shot didn?t hurt at all but bled profusely down arm. Black & blue ,& heart beat pounding ,racing. Extreme swelling,extreme pain,in entire arm,headaches very tired to the point of sleep,,pain,chills,. Body aches,joints hurt.  Excess sleep in bed, fevering on 5/16 so taking Tylenol & trying to drink water from 5/15 and still 5/16
generalized sz consisting of stiffening, eye deviation, cyanosis lasting 5 min followed by pallor & hypotonia; no treatment;
Received vaccine from a vial that had been puctured from more than 3 weeks; Soreness at both injection sites; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine from a vial that had been puctured from more than 3 weeks) and INJECTION SITE PAIN (Soreness at both injection sites) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D25iT2D-2A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine from a vial that had been puctured from more than 3 weeks) and INJECTION SITE PAIN (Soreness at both injection sites). On 26-Jan-2021, INJECTION SITE PAIN (Soreness at both injection sites) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine from a vial that had been puctured from more than 3 weeks) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Received vaccine from a vial that had been puctured from more than 3 weeks) and INJECTION SITE PAIN (Soreness at both injection sites) to be not related.    No treatment information and concomitant medications were reported.   This case was linked to MOD-2021-079045 (E2B Linked Report).; Sender's Comments:  MOD-2021-079045:Split case
After receiving the shot patient had a vasovagal reaction a faint. Patient came back in less than a minute.
No adverse event; first dose given on 08-Mar-2023 was the Moderna bivalent, which was an error because patient never received the initial series yet, a patient came in today for a second dose of Moderna; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (first dose given on 08-Mar-2023 was the Moderna bivalent, which was an error because patient never received the initial series yet, a patient came in today for a second dose of Moderna) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Mar-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (first dose given on 08-Mar-2023 was the Moderna bivalent, which was an error because patient never received the initial series yet, a patient came in today for a second dose of Moderna). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (first dose given on 08-Mar-2023 was the Moderna bivalent, which was an error because patient never received the initial series yet, a patient came in today for a second dose of Moderna) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (first dose given on 08-Mar-2023 was the Moderna bivalent, which was an error because patient never received the initial series yet, a patient came in today for a second dose of Moderna).    Concomitant drugs were not reported.  It was reported that patient never received the initial series.  Treatment medications were not provided.
received his second Covid vaccine dose 27-Nov-2021, but just tested positive for Covid-19; received his second Covid vaccine dose 27-Nov-2021, but just tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 10 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and administration date 27Nov2021 (Batch/Lot number: unknown) as dose 2, single 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) all with onset 2021, outcome "unknown" and all described as "received his second Covid vaccine dose 27-Nov-2021, but just tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive. Additional information:  Reporter stated that 10yo received his second Covid vaccine dose 27Nov2021, but just tested positive for Covid-19. Reporter queried for are boosters being studied in 5-11yo yet. What age range was the antiviral pill tested on.   The lot number for bnt162b2 was not provided and will be requested during follow up.
8/18/21 PMH of cord compression. Underwent C3-7 posterior cervical laminectomy, and posterior fusion. Course complicated further cord compression from posterior drift of cord immediate post operatively. Returned immediately to OR for C1-C2 laminectomy with extension of fusion. Admitted to SICU for close hemodynamic and neuro-monitoring
At night on th day of the vaccination (12/10/12) the patient had increased coughing. On 12/11/12 the patient had acute shortness of breath. She went to the ED where she had tachypnea, and wheezing. She reeived epinephrine, albuterol 5mg + ATROVENT and SOLU-MEDROL. The patient went into status asthmaticus and required continuous albuterol 15mg/hr for 7 hours.
Pt into Health Department for vaccinations. Brought previous immunization records. Entered into system and determined patient needed Tdap, Ipol, 2nd Hep A, 1st HPV and 1st Meningicoccal vaccinations. Pt was administered vaccines. Approximately, 2 minutes after vaccinations patient had a fainting episode.
A day or two after vaccine administration, muscle of upper right arm became weak and numb. Patient did not seek treatment or alert provider until 4/6/2015. He states his right upper arm still feels weak, but remains functional. He states there were no other reactions.
Right side of trunk & groin area broke out in a rash & he was itching. I gave him 2tsp of Benadryl & he took a shower - it took care of the itching, & rash went down, but did not go completely away.  He woke up at 12:30 am with swollen lips, entire chest, back & groin area covered in a rash. I gave him 3 tsp of Benadryl & he took another shower & applied ice pack to his lips.  Lip swelling went down & itching subsided. In the AM, the rash was gone with exception of groin area & lip swelling was gone.  He was still itchy with no rash at 12:30pm so I gave him 1tsp of Benadryl.
redness around the injection site 3x4 spot around the injection site; hurts at night; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness around the injection site 3x4 spot around the injection site) and INJECTION SITE PAIN (hurts at night) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced INJECTION SITE PAIN (hurts at night). On 13-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness around the injection site 3x4 spot around the injection site). At the time of the report, INJECTION SITE ERYTHEMA (redness around the injection site 3x4 spot around the injection site) and INJECTION SITE PAIN (hurts at night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Based on current available information and the temporal association between product use and start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and start date of the events a causal relationship cannot be excluded.
Irregular  high blood pressure; dizzy; disoriented; loss of balance; pain in neck left side; loss of hearing; impaired blurry vision; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 09Apr2021 at 10:45 as a single dose for COVID-19 immunization.  Medical history included Bell's palsy ebv (as reported) from an unknown date and unknown if ongoing. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included lisinopril (manufacturer unknown); clarithromycin (CLARITIN); ascorbic acid (VITAMINS C); colecalciferol (D3) and fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 08:30, the patient had an irregular high blood pressure, was dizzy and disoriented, had a loss of balance, pain in neck left side, loss of hearing and impaired blurry vision. The events resulted in a visit to the emergency room and hospitalization for 2 days. The patient had an MRI, CT scan, EKG and an echocardiogram (results unknown). The patient had a nasal swab COVID-19 test on 28Apr2021 with an unknown result. The outcome of the event was recovering.   Information about batch/lot has been requested.
After 2nd DTP (3-6-90) pt had T 105, MD saw pt, Dx otitis media Roseola, pt on Ceclor, MD advised DT only. After this dose (#3) DT/OPV/HIB/TTine, pt had swollen eyelids /w bruising underneath, swollen rt cheek, MD feels vaxs caused rxns
inflammation; muscle aches; This case was reported by a consumer via interactive digital media and described the occurrence of inflammation in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th October 2021, the patient received Shingrix. On 25th October 2021, less than a day after receiving Shingrix, the patient experienced inflammation and muscle pain. On an unknown date, the outcome of the inflammation and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the inflammation and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, he/she took Shingrix vaccine on the day of reporting (in the morning) and was asking if need to take Motrin for inflammation and Tylenol for muscle aches. No further information was provided.
Had vaccine around 10:30 am, woke up next morning with sore throat and very stuffy nose which lasted about 3 days.
This spontaneous report was received from a registered nurse referring to an unknown number of patients of unknown age and gender. Nurse reported that unknown number of doses of improperly stored ROTATEQ (lot # not reported), had been administered to the patients. No adverse effects reported. This is one of several reports from the same reporter source. Additional information has been requested.
Patient called pharmacy on 4/3/13. She said shot was given too high on arm, and arm had been hurting since. She said she couldn't raise her arm up for the pain.
Patient  did not have any reaction, however an expired vaccine was administered. Moderna Vial was punctured on 9/13/21 a little after 1:13 PM. Dose was given  a little after 10:55 AM on 9/14/21
Vaccinator attempted to vaccinate client with Monkeypox Jynneos 0.1ml intradermally in L arm.  There appeared to be leakage on site.  Another successful attempt was performed on R forearm.
Patient was seen in ED at Hospital with complaint of cough, decreased appetite and generalized weakness since the morning. Patient denied any chest pain, abdominal pain, nausea, vomiting, fever or any other complaint at that time. She stated that she just had no appetite. Patient has dry cough an stated weakness that she stated started 6 to 12 hours ago. The problem occurs constantly. The problem has not changed since onset. Pertinent negatives include no chest pain, no abdominal pain, no headaches, and no shortness of breath. patient reported 2 days ago she was exposed to her husband who was positive for COVID and currently in a rehabilitation facility. Web report states patient stated she has been vaccinated and boosted x2 with last booster on July 2, 2022.  Report states she started experiencing symptoms 7/6/2022 which included dry cough, fatigue and Malaise; she went to her PCP, who prescribed Paxlovid. Stated she took 1 dose prior to coming to the hospital.  EKG showed normal sinus rhythm with a heart rate of 70 and no acute ST or T wave changes noted. She had a chest x-ray which showed no acute cardiopulmonary findings, and she had several labs including a CBC, CMP, total CK and troponin. All came back normal except for a troponin of 52 and 20 ketones in her UA. She was also treated with a liter bolus of 0.9 normal saline. Patient was admitted to hospital service for further management. Had Low grade temp 99.1. Mild hypoxia 86-88% documented as isolated incident, other recordings >90%. No oxygen needed. CRP 1.8. Chest x-ray with no acute cardiopulmonary findings. HS troponin was minimally elevated at 52, down to 46 and 48 today. Patient has been vaccinated for COVID-19. Reports 4th dose 7/2/2022. ID was consulted for further recommendations. Patient has some word finding/memory issues, forgetful. Uncertain how this compares to baseline. Patient states it is worse than usual for her. Denies cough, headache, chest pain, shortness of breath, body/muscle aches. No fevers, chills. Mild sore throat. The plan was to discharge patient home on prescription of Paxloid and resume prior medication. Health department has no further information on this patient's discharge or outcome.
1hr p/vax pt exp red swollen eyes, coughing & sl fever 100.6 was taken to hosp & keep overnoc;
This spontaneous report as received from a healthcare worker refers to a 13-year-old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 05-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # reported as L011846, expiration date reported as 16-JUN-2017) (dose, route and site of administration were not provided. Concomitant medications were not reported. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Patient presented to the ED for migraine without status migrainosus on 1/11/22. Patient presented to the ED on 1/16 and was subsequently hospitalized for sepsis. These visits are within 6 weeks of receiving covid vaccination.
Approximately 15 mins after vaccination, patient had complaints of feeling lightheaded, nauseated, with diaphoresis. RN arrival at car noted skin of patient cool and clammy.  Patient reported minimal dietary intake. Patient given OJ and gummies.  VITALS: T 97.8, HR 72 , BP 122/82, O2 97% RA, RR 20.  Lungs CTAB. No pruritis or SOB.   12:59 PM--patient reporting that symptoms resolved, patient had companion in car and did not drive home and left site in NAD.
flu-like symptoms; chills; achiness; feeling cold; arm was extremely sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th February 2019, the patient received the 1st dose of Shingrix. In February 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, chills, pain and feeling cold. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the pain in arm, influenza-like symptoms, chills, pain and feeling cold were recovered/resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, chills, pain and feeling cold to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix in his unknown arm and his arm was extremely sore.  Later in the day, the patient experienced chills, achiness and felt cold.  The patient took Aleve to treat the arm soreness. Within 24 to 36 hours, the flu-like symptoms was resolved, but the arm soreness lasted an additional 3 to 4 days.
This case was reported by a physician via sales rep and described the occurrence of angioedema in a female patient who received SHINGRIX for prophylaxis. Concomitant products included lisinopril. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, unknown after receiving SHINGRIX, the patient experienced angioedema (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the angioedema was unknown. It was unknown if the reporter considered the angioedema to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient experienced angioedema and was hospitalized after vaccination with SHINGRIX. The patient was also on lisinopril however, the patient had been on lisinopril for months without incident. The reporter stated that this was all the information I could get from the provider. The reporter requested to reach out to the office for further information. The reporter agreed to follow up from GlaxoSmithKline.
Redness (cellulitis like) on the injection site (upper deltoid muscle); Inflammation; Redness (cellulitis like) on the injection site (upper deltoid muscle); This is a spontaneous report from contactable Pharmacist via Pfizer Sales Representative.  A patient of unspecified age and gender received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced inflammation, redness (cellulitis like) on the injection site (upper deltoid muscle), non-serious,  on an unspecified date after vaccination. The outcome of the events was unknown.  The information on the batch/lot number has been requested.; Sender's Comments: Based on the information currently available, it cannot be fully excluded that vaccination with PREVNAR 13 may play a contributory role in triggering the onset of cellulitis like reaction on the injection site.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
"woozy like on a boat and unsteady/ I walked into a walk heading into the bathroom"; woozy like on a boat and unsteady; This spontaneous case was reported by an other health care professional and describes the occurrence of GAIT DISTURBANCE ("woozy like on a boat and unsteady/ I walked into a walk heading into the bathroom") and DIZZINESS (woozy like on a boat and unsteady) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     Concurrent medical conditions included Peripheral neuropathy. Concomitant products included GABAPENTIN for Peripheral neuropathy, LEVOTHYROXINE and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Nov-2021, the patient experienced GAIT DISTURBANCE ("woozy like on a boat and unsteady/ I walked into a walk heading into the bathroom") and DIZZINESS (woozy like on a boat and unsteady). At the time of the report, GAIT DISTURBANCE ("woozy like on a boat and unsteady/ I walked into a walk heading into the bathroom") and DIZZINESS (woozy like on a boat and unsteady) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took 1st dose on 01Feb2021 having lot number 028L20A and 2nd dose on 01Mar2021 having lot number 011A21A No treatment information were reported by the reporter
PT WAS GIVEN AN EXPIRED MODERNA BIVALENT LOT #...LOT EXPIRED ON 06/01/23 AND WAS GIVEN 06/20/23