chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx 27hrs after 2nd dose I felt my heart suddenly started irregular beats, arrhythmia with dizzy feeling, flush on face which lasted a minute or 2 followed by very rapid / hard beating of my heart (I could see my shirt move on my chest from the beating). This lasted for almost 10 minutes. Very scary. Paramedics were called about 5 minutes into the episode.  (I had a similar reaction of dizzy, flush with rapid and hard heart beat reaction after 1st dose about 5 minutes after it was given which lasted couple minutes then subsided).  When the paramedics arrived, I was laying down in my bed trying to relax and breath. By then the rapid and very hard beating of heart was calming down but was still elevated pulse for a resting position...~128bpm.  My BP was measured at 154/87.  They connected the 12point electrodes and the reading came back normal...only elevated pulse.  Paramedics ran 3 more scans during the  20 minutes they were there for...all came back normal.  My O2 was 100%. I elected to no go to ER since we live only 2 miles from the local hospital and I was feeling much better by then...but would go if I had another heart episode.  I have had none since.  Only other strange side effects was sore arm for 2 day and I notice is constant ringing in my ears all the time...strange.  I hope that will go away soon...very annoying.
I couldn't breathe while talking on the phone. I couldn't catch my breath. I called EMS and they took me to the hospital. I stayed for 3 days and they ran multiple tests including COVID-19 tests, CT scans, MRI, and lung x-rays and discovered I had congenital heart failure.
This spontaneous report as received from a registered nurse refers to a 50 year old patient who was scheduled to receive MMR II. On 23-APR-2014 the patient was inadvertently vaccinated with one dose of PROQUAD (Merck), 0.5 ml (dose number, route and lot # not reported), due to an error on the part of the staff at the physicians office. There was no error in the product labeling and no confusion about what was listed on the label. No PQC and no adverse effects reported. Additional information has been requested.
"re infected" with COVID; "re infected" with COVID; heart issues; This is a spontaneous report from a non-contactable consumer. A 17-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. Medical history included "COVID naturally" over one year ago. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced "re infected" with COVID and now he has heart issues. He sees a cardiologist as well as a lung specialist. The patient underwent lab tests and procedures which included sars-cov-2 test: infected with covid on unspecified date (as reported). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Almost three months after my booster shot, I suddenly developed unilateral tinnitus, which I precisely noticed began on 1/15/22. To my knowledge I did not encounter any "noise" events during that time. I had an audiogram conducted which showed no hearing loss. Because it has almost been three months since the onset of this, I believe this is about to be considered permanent.
Caller reports a study that shows that the Moderna Covid-19 vaccine crosses the placenta in a pregnant woman; No adverse event; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Caller reports a study that shows that the Moderna Covid-19 vaccine crosses the placenta in a pregnant woman) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Caller reports a study that shows that the Moderna Covid-19 vaccine crosses the placenta in a pregnant woman) and NO ADVERSE EVENT (No adverse event). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Caller reports a study that shows that the Moderna Covid-19 vaccine crosses the placenta in a pregnant woman) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (Caller reports a study that shows that the Moderna Covid-19 vaccine crosses the placenta in a pregnant woman).    Concomitant and treatment medications were not reported.  Caller reports a study that shows that the Moderna Covid-19 vaccine crosses the placenta in a pregnant woman. Company comment This spontaneous case concerns a female patient of an unknown age with no medical history reported, who experienced the unexpected, non-serious, event of maternal exposure during pregnancy and no adverse event was reported. The patient received the first dose of mRNA-1273. The event onset date was not provided, thus, exact latency between vaccination and onset of the events could not be assessed. Last menstrual period and estimated date of delivery were not provided. No further clinical information was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
A report has been received from a literature source concerning an adult, subject of unknown gender, who had been receiving FLUMIST (intranasal). FLUMIST started on an unknown date. The patient experienced nausea. The outcome of the event nausea is unknown. The report was considered to be non-serious.
My face got red and warm.  A single hive developed on my left jaw.  After a few minutes later my throat and tongue started to feel numb like I had gone to the dentist and gotten a novacaine shot.  We went to a pharmacy immediately and got some Bennedryl which took the symptoms away within the hour.
Large amount of swelling from shoulder to elbow, with redness within 24 hours of injection.  Swelling only noted at site of Hep A injection.  All symptoms cleared by 4 days post injection.  No treatment needed.
Hiberix mixed with sterile water; Hiberix mixed with sterile water administered; 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 3-month-old female patient who received Hib (Hiberix) (batch number FY4E9, expiry date 20th June 2023) for prophylaxis.   On 8th July 2022, the patient received Hiberix. On 8th July 2022, 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 Information: GSK Receipt Date: 08-JUL-2022 Reporter's Comments:  The clinical manager reported that administered Hiberix mixed with sterile water to a pediatric patient on 8th July 2022.  After uncovering the vaccine was reconstituted with sterile water rather than the appropriate saline diluent. This reporter wanted to know if they need to contact the patients parents to get revaccinated due to saline diluent not used to reconstitute. This adverse event was reported even when another GSK representative was first to hear about it. This exact scenario and patient could already be reported by another instance. The reporter consented to follow up. Additional Supportive Information: The patient received Hiberix vaccine, which was reconstituted with sterile water rather than the appropriate saline diluent, which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. This case was identified as duplicate of case US2022104931. All future correspondence would be added in case US2022104421, which stands as case of record for this patient and the case US2022104931 would be deleted.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022104931:duplicate case
Pfizer COVID19 Vaccine  Hospitalized with aspiration pneumonia then struggled with fluid volume deficit and then overload. 18days in hospital
Patient warned me prior to administering the shot that he had a phobia to needles.  He did very well during the shot, but while waiting in the observation area he was speaking to another customer about needles and after she described a bad experience with an iv he went pale and slumped in his seat.  The other customer brought this to my attention and I checked on patient, who had dropped all this things on the floor by the chair and he said he was having a panic attack.  He said he felt very hot so we got him a bottle of water and fanned him until he started feeling better.  After about 15 minutes he said he was feeling much better and said he thought he might have blacked out for a moment because he didn't remember dropping his things.  He said he had rushed here after work and was hot and tired and that may have contributed to the panic attack.  His mother came and drove him home.
Patient is 15 years old and Moderna Covid vaccine is currently approved for 18 years and older
Bitter taste in mouth that happened immediately & subsided in 1/2 hr. Lightheadedness/dizziness, slightly nauseous.
Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD( lot # M022402 with expiration date 01-NOV-2017, once; dose was unknown), subcutaneously. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Dr states, "viral exanthem, hypertonic movement patterns, intelligent but ritualized behaviors."
The pt experienced a rash all over her body. It was reported that the first two doses of the vaccine were Hep B vaccine and that the pt had developed a reaction following each dose. Unspecified medical attention was sought. It was reported that the rash resolved within several days. Additional information has been requested.
Had vaccine on Feb 19. On  22nd my arm became sore and itchy and developed a red rash. Up until then my arm had not been itchy, only slightly sore.  The area is very warm and itching became worse on the 23. On the 24 the redness is worse and the level of itching has not changed. The red rash is about 3 inches long and from 1? to 2? wide.
The next day after I have the second vaccine, Saturday my arm was sore, I started to feel very fatigue, very tired, my whole body was achy in the afternoon nd had sore throat that night. I slept all day Sunday. Saturday afternoon around 2pm I was driving I started to have heart flutters, I ignored it because I thought it was nothing. Sunday I started to have more heart flutters and palpitations, last for 30minutes to an hour, now since then every day I have heart flutters and heart palpitations with slight back chills, its scaring me, because I do have a heart stent. I use to very seldom get palpitations, but not the heart flutters. Now every day, I get the flutters and lasting for hours, specially in the afternoon. Should I go to the ER and get look at. Please advise. Thank you.
My arm is so sore and painful I cant lift my arm up at all it?s so weak  I can?t even pick up my toothbrush
My left arm, where I had the shot, is hot; My left arm, where I had the shot, is red; My left arm, where I had the shot, is hard; My left arm, where I had the shot, is tender; My left arm, where I had the shot, is bigger than the palm of my hand; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (My left arm, where I had the shot, is hot), VACCINATION SITE ERYTHEMA (My left arm, where I had the shot, is red), VACCINATION SITE INDURATION (My left arm, where I had the shot, is hard), VACCINATION SITE PAIN (My left arm, where I had the shot, is tender) and VACCINATION SITE SWELLING (My left arm, where I had the shot, is bigger than the palm of my hand) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A, 024M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2022, the patient experienced VACCINATION SITE WARMTH (My left arm, where I had the shot, is hot), VACCINATION SITE ERYTHEMA (My left arm, where I had the shot, is red), VACCINATION SITE INDURATION (My left arm, where I had the shot, is hard), VACCINATION SITE PAIN (My left arm, where I had the shot, is tender) and VACCINATION SITE SWELLING (My left arm, where I had the shot, is bigger than the palm of my hand). The patient was treated with MENTHOL (BIOFREEZE [MENTHOL]) at an unspecified dose and frequency and TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (My left arm, where I had the shot, is hot), VACCINATION SITE ERYTHEMA (My left arm, where I had the shot, is red), VACCINATION SITE INDURATION (My left arm, where I had the shot, is hard), VACCINATION SITE PAIN (My left arm, where I had the shot, is tender) and VACCINATION SITE SWELLING (My left arm, where I had the shot, is bigger than the palm of my hand) had not resolved.            Concomitant medications details were not reported by the reporter.  Patient had received first booster.  it was reported patient not seek medical care for adverse event.  patient not experienced similar events in the past  patient adverse event ongoing also symptoms worsened   This case was linked to US-MODERNATX, INC.-MOD-2022-611797 (E2B Linked Report). This case was linked to MOD-2022-611860 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-611797:MOD22-019253 (reporters brother case)
4/7/2023 I woke up with a stuffy nose. I felt like crap, it felt like when I had COVID, but my test was negative that day. I tested again on 4/8/23 with an at home COVID test and it was negative. I spoke to my doctor that day and she said it was a sinus infection with a cold. I was very congested. I was prescribed amoxicillin and was told to stay off my LIPITOR. I suffered for ten days and I still have a stuffy nose, just not as bad.
Headache, nausea, 99.5 fever, mouth sores, knee pain
Patient is fully vaccinated and boosted 10/10/2021.  Tested COVID + 1/3/2022 at ED visit.  Patient presents with shortness of breath.  Patient with a h/o poorly controlled asthma presentw with a cough with green sputum for the past 2 days.  No fevers or chills. Patient referred for monoclonal antibody treatment.  Discharged, stable.
Fever; chill; swollen glands including my left ampit; Booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: FH8030) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Lower back pain" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; METFORMIN HYDROCHLORIDE; TRIAMTERENE/HYDROCHLOROTHIAZIDE. Past drug history included: Capoten for drug allergy. Vaccination history included: Bnt162b2 (Dose Number: 2, prev dose lot number=EW0164 , prev dose  administration date=04Apr2021, prev dose vaccine location=Left arm), administration date: 04Apr2021, when the patient was 63 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, prev dose lot number=Pfizer ER8732, prev dose administration date=03Mar2021 , prev dose vaccine location=Left arm), administration date: 03Mar2021, when the patient was 63 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster dose"; PYREXIA (non-serious) with onset 18Nov2021, outcome "recovered" (2021), described as "Fever"; CHILLS (non-serious) with onset 18Nov2021, outcome "recovered" (2021), described as "chill"; LYMPHADENOPATHY (non-serious) with onset 18Nov2021, outcome "recovered" (2021), described as "swollen glands including my left ampit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, lymphadenopathy.  Additional information: No other vaccine was given to the patient in four weeks. The patient did not have covid prior vaccination and was not tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
In joint pain-skin sensitivity-muscle pain starting in shoulder (L) moving down arm bicept. Then into lower arm-back of hand muscle. strength loss starting to recede -gaining ability to life without pain-still reduced ability to lift (pain)
Four lesions consistent with inadvertent inoculation developed over the next few days after vaccination. Three on shoulder/back, one on L chest. On day eleven he developed upper lip lesion which proved to be HSV 1 on PCR testing.
Chills, muscle aches, and fatigue that lasted about 32 hours; additionally, these symptoms were accompanied for the initial 18 hours by headache and insomnia. Aspirin and fluids were the treatments. Lingering, mild body aches exist after about 34 hours. These symptoms were similar to the symptoms I experienced after my first SHINGRIX shot, which I received in early March of 2018, but at that time I recovered fully and resumed normal activities after less than 24 hours had passed. I have not yet resumed normal activities, but I plan to do so later this morning.
Shingle spots starting popping out 5 days after injection; started on acyclovir 800 mg 5 x daily x 10 days.
Severe Vertigo the day after both shots lasting around 4 hrs. Headache all day following second shot.
pt recvd vax; mom states  about 1 1/2 hrs after vax pt became fussy w/ high pitch shrill screaming that lasted 5-6 hrs; low grade t recorded & fussy;
Begun vomiting 9/20/02. Acted normal 9/21/02. 9/22/02 6am had seizure lost consciousness and transported by ambulance to hospital. Diagnosed with mild ear infection. Told to give Tylenol-child afebrile at that time. Before left ER had another seizure. CT scan of head normal spinal tap normal. Started on Tegretol 9pm 9/22/02. Per 60 day follow up: Pt has recovered. Off seizure meds. No further seizures.  Follow up on 11/05/2003: "Vaccine recipient did recover from adverse event.  No further seizures as of 09/28/2003."
hx of thyroid disease, HTN, arthritis; presented to ED with productive cough, SOB, fever; diagnosed COVID positive 6 days before at a clinic, condition worsening; admitted to hospital where hypoxia worsened with increased work of breathing, patient died in the hospital
Narrative: Patient received two doses of COVID 19 Pfizer vaccine in Feb/Mar with COVID pneumonia and dizziness with a fall. The patient was treated with dexamethasone and remdesivir.
Information has been received from an 81 year old male with knee problems, hypothyroidism, an allergy to amitriptyline hydrochloride (MSD), and a history of bypass surgery who on 22-FEB-2007 was vaccinated SC with a dose of Zostavax. Concomitant therapy included metoprolol succinate (TOPROL XL TABLETS), levothyroxine Na (SYNTHROID), corticotropin (ACTON), ezetimibe (MSD), atorvastatin calcium (LIPITOR), ramipril (ALTACE), esomeprazole magnesium (NEXIUM), morniflumate (FLOMAX), butenafine HCl (MENTAX), and caltipotriene (DOVONEX). On 03-MAR-2007, the patient experienced a headache, general malaise, discomfort, back pain, and neck pain. His symptoms have caused sleeping problems. Unspecified medical attention was sought. His symptoms were improving but he had not completely recovered. A product quality complaint was not involved. No further information is available.
Felt coldness when needle was pulled out; Felt fluid running down her arm; Felt fluid running down her arm; Felt fluid running down her arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE COLDNESS (Felt coldness when needle was pulled out), UNDERDOSE (Felt fluid running down her arm), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Felt fluid running down her arm) and EXPOSURE VIA SKIN CONTACT (Felt fluid running down her arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE COLDNESS (Felt coldness when needle was pulled out), UNDERDOSE (Felt fluid running down her arm), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Felt fluid running down her arm) and EXPOSURE VIA SKIN CONTACT (Felt fluid running down her arm). On 04-Feb-2021, UNDERDOSE (Felt fluid running down her arm), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Felt fluid running down her arm) and EXPOSURE VIA SKIN CONTACT (Felt fluid running down her arm) had resolved. At the time of the report, INJECTION SITE COLDNESS (Felt coldness when needle was pulled out) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-033798 (Patient Link).; Sender's Comments: This report refers to a case of Product administration error for mRNA-1273, lot #  029K20A  with associated AE of injection site coldness. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Area below the injection site became red, warm and swollen on Sun 5/9. Today is Tues 5/11. I am still experiencing the symptoms and it has now started itching.
Patient developed moderate measles like rash and fever to >103 that required office visit and nmerous phone calls.  Rash was morbilliform red papules that began on face and progressed to rest of body.  Fever began on 8/5 ans rach on 8/7/07
chest pain about 2 weeks after second dose. pain around both sternum and outer chest (near arms).
3 days after receiving booster shot heart palpitations started (premature heartbeats). Initially, every 10-15 minutes and then progressively getting more intense and more frequent (every 30 seconds by day 2). Less intense and frequent (one per every two minutes) sustained for 3+ weeks after. Ongoing monitoring and treatment with no resolution so far.
Runny nose, itchy water eyes, swollen upper lip. Symptom onset 5 minutes after receiving YF vaccine. Tx with 50 ng/dl Benadryl IM. Immediately relieved symptoms.