chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have a rescue medication that I have for when my heart rate is really high. On Wednesday I had an episode of tachycardia which was four days after my COVID-19 shot. I was out shopping and my heart rate jumped up into the typical tachycardia pattern, I felt this warmth around my head and then my heart rate shot up. I had my medication for when this happens on me, I took a half of the dose at that time. That resolved and I was able to make it home and I really forgot about it. The next day I was finishing lunch around 2:30PM in the afternoon. I had another episode, and my heart rate went up to about 230-240. I was able to get it down with a half a pill, but it went back up. I then took a whole dose and did the things I am supposed to do. I put ice on my neck on my face and lay down, but this kept happening. I would get it calmed down but about thirty minutes later it would be back up. It calmed down over Friday, I did take my medication again on Friday during the episode and I had upped my regular beta blockers that night as well. By Saturday night this was still happening I had gone to bed, but it was still happening, and I ended up going up and I ended up going to the ER around 1AM that morning. They did do lab work and took a chest x-ray at the ER but they did not see anything. I am following up with a cardiologist to see if we cannot figure out what is going on. My blood pressure has been fluctuating and I did cancel travel plans because of this. I have my tachycardia issues under control with medication for the last two years and getting this last COVID-19 shot seems to have caused it flare up and have issues.
Left arm very sore about 8 hours later and the next day. Discomfort stopped around 12 noon 2nd day. Also, 2nd day, sluggish and exhausted beyond normal after my work day (PT 1:30 to 5:30 pm.)
1st dose of fluzone 3 days after shot onset of pruritic for 1 hour, lethargy and fever 1001-03 for 2 days.  2nd dose onset 4 days later similar onset and fever but also needed meds for cough and congestion. Medical records state viral infection. msv
An erratic pulse; Palpitations; Shortness of breath; Flu-like symptom; Felt sleepy; Aches; Dizziness; Chills; Had fatigue; A headache; Lots of nausea; Low grade fever; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE IRREGULAR (An erratic pulse), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), INFLUENZA LIKE ILLNESS (Flu-like symptom) and SOMNOLENCE (Felt sleepy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ventricular arrhythmia. Concurrent medical conditions included Iodine allergy.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 07-Feb-2021, the patient experienced HEART RATE IRREGULAR (An erratic pulse), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), INFLUENZA LIKE ILLNESS (Flu-like symptom), SOMNOLENCE (Felt sleepy), PAIN (Aches), DIZZINESS (Dizziness), CHILLS (Chills), FATIGUE (Had fatigue), HEADACHE (A headache), NAUSEA (Lots of nausea) and PYREXIA (Low grade fever). On 08-Feb-2021, HEART RATE IRREGULAR (An erratic pulse), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), INFLUENZA LIKE ILLNESS (Flu-like symptom), SOMNOLENCE (Felt sleepy), PAIN (Aches), DIZZINESS (Dizziness), CHILLS (Chills), FATIGUE (Had fatigue), HEADACHE (A headache), NAUSEA (Lots of nausea) and PYREXIA (Low grade fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient Take Benadryl on 07Feb2021 and Carvedilol and a low dose of Statins as a Treatment medication.    This case was linked to MOD-2021-044875 (Patient Link).
Day 2-3 (Friday - Saturday) - [ ] Random twitching throughout body in muscles? (arm, legs, head once)  (feels like something is crawling under my skin)  - [ ] Fatigue - [ ] Tight muscles Day 4 (scary night time episode) - [ ] Moderate to severe Muscle spasm with no pain in legs worse in left leg  - [ ] Sweating - [ ] Heart fluttering - [ ] Chills with moderate shaking  - [ ] High pulse  - [ ] Tight muscles  - [ ] Continuous twitching through body in muscles? (arm, legs, back, chest, butt, chest)  Day 5 (Monday) visited  Urgent Care  - [ ] Moderate Muscle spasm with no pain in legs worse in left leg  - [ ] Tight muscles - [ ] Super weak legs - [ ] Heart fluttering - [ ] Fatigue  - [ ] Continuous twitching through body (in muscles? arm, legs, back, chest, butt, chest)  Day 6  - [ ] Tight and sore muscles - [ ] random to continuous twitching throughout body  Day 7  Wednesday - [ ] random to continuous twitching throughout body (feels like a fast pulse on and off)  - [ ] A few Eye and face twitches - [ ] Tight and sore muscles - [ ] Heart fluttering  Day 8 -11 - [ ] random to continuous twitching throughout body (feels like a fast pulse on  and off)  - [ ]  Eye and face twitches - [ ] Heart fluttering
Big red spot; Very very sore arm; Lost appetite; Very achy; Chills; Fatigue; Low grade fever; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Very very sore arm), DECREASED APPETITE (Lost appetite), ERYTHEMA (Big red spot), PAIN (Very achy) and CHILLS (Chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Hypertension.   On 09-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced DECREASED APPETITE (Lost appetite), PAIN (Very achy), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Low grade fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (Very very sore arm) and ERYTHEMA (Big red spot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Very very sore arm), DECREASED APPETITE (Lost appetite), ERYTHEMA (Big red spot), PAIN (Very achy), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Low grade fever) outcome was unknown.
Information has been received from a healthcare professional concerning a patient of unknown age and gender. The concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with the first dose of PROQUAD (Merck) (lot # L046509, Expiration Date 17-MAY-2017, strength, dose and route were not provided). The PROQUAD (Merck) was improperly stored at 24.6 F for 60 hours. There was no previous temperature excursion. It was called because of a "data logger". No adverse effects reported. This is one of two reports from the same source. Additional information has been requested.
Full body rash , starting in legs/arms progressing to trunk neck and face despite taking benedryl 25mg every 6 hours. went to urgent care was prescribed atarax and zyrtec. on wednesday after monday injections. thursday rash in face neck throat, mouth lips and sore throat. went to ER thursday and recieved solumedrol im. symptoms resolving friday , minimal rash noted on monday Oct. 3.
This spontaneous report as received from a physician refers to a 4 month old patient. On 11-NOV-2014, the patient was inadvertently vaccinated with a 0.5ml (reported as "pediatric dose") of VAQTA, (lot and route were not reported). No adverse effects were reported. Additional information has been requested.
No adverse event; Some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-AUG-2023 during 2 hours and 50 minutes.; Dose were administered after the excursion happened.; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose were administered after the excursion happened.), PRODUCT TEMPERATURE EXCURSION ISSUE (Some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-AUG-2023 during 2 hours and 50 minutes.) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Aug-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-AUG-2023 during 2 hours and 50 minutes.). In August 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose were administered after the excursion happened.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose were administered after the excursion happened.), PRODUCT TEMPERATURE EXCURSION ISSUE (Some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-AUG-2023 during 2 hours and 50 minutes.) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Dose were administered after the excursion happened.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-AUG-2023 during 2 hours and 50 minutes.).    It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19. No concomitant medication was reported.  HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 for 2 hours and 50 minutes. Maximum temperature reached was 21.4°F. That was the first and only excursion. 11 doses were administered after the excursion happened. No PQC reported. No treatment information was reported.  This case contains information for patient 2 out of 11.   This case was linked to US-MODERNATX, INC.-MOD-2023-736913 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736913:Master case(Patient 1)
Pt recvd DTP/IPV 21MAY92 w/redness & swelling in both arms even fingers; also swelling in neck & cheeks-swelling & redness almost completely goen when seen by nurse; some swelling remained in cheeks; mom to take pt to ER if any further prob
Nausea, vomiting, headache, fatigue.  Started 1/7/21- ended 1/9/21.  Took zofran, compazine, and ibuprofen for symptoms, fluids and rest.  Still with fatigue and noticed swelling in lymph nodes in left underarm area.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 03-DEC-2014, the patient was vaccinated with a dose of MMR II (route, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Flat lacey red rash on inside of both lower arms and base of neck/upper chest, but clear at the injection site.  Does NOT itch. Rash fades over the course of the day but reappears the next morning but not as pronounced as the day before.  Very faint by day seven.
1/6/23 ? 11:30am immunizations. 4:30p pickup from daycare, eyes watery & red, nose runny, seems tired and sick. 1/7/23 ? fussy,  sick (runny nose, sneezing, watery eyes, no fever).  won't take a day nap but trying to get him to sleep around 2-3pm and notice first spasm. slept at night okay. 1/8/23 - still fussy, sick-ish, but no fever. still won't nap during day. finally at 10p get him to sleep for the night. 10:40p awakes with a spasm ? eyes alert, arms/legs stretched outward and stiff, crunches towards the stomach. after body relaxes cries hard for 15 minutes and then sleeps the night through okay. 1/9/23 ?  sent to daycare, picked up around 4:30p,  his right cheek is bright red (daycare says due to nap) but stays red for hours that night but observe no spasms 1/10/23 ? sent to daycare, picked up around 4:30p ? he is asleep as they hand them to me and as i get him into his snowsuit he has multiple spasms in a row ? cluster of about 6 then a minute off and another cluster. daycare said they had noticed these spasms too and thought it was colic. video tapped this called pediatrician head to Hospital ER.  after two failed attemepts at inserting an IV he is upset and has a cluster of intense body spasms (arms/legs fling out, stiffen and crunch towards stomach; eyes roll up in head but focused and alert the whole time) that last about 2-3 minutes while ER dr is in the room. EEG conducted overnight at hospital.
Severe headache; Nausea; Sweats; Fatigue; This is a spontaneous report from a non-contactable physician. A 38-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscular in arm left on 18Dec2020 08:45 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included eczema. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included cetirizine hydrochloride (ZYRTEC).  The patient experienced 'Severe headache with nausea Sweats Fatigue' on 19Dec2020 09:00.  Case was non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measures were taken as a result of events (Tylenol, Naproxen). The outcome of the events was recovered in Dec2020.  No follow-up attempts are possible. No further information is expected.
Gotten shingles three times/ Suspected vaccination Failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 20th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 01-AUG-2022 Reporter's Comment: The patient was a reporter. The reporter stated that the patient received Shingrix vaccine. Patient had both the vaccine shot on deltoid muscle of the upper arm. Patient does not recall for sure which arm she got vaccine but stated she usually uses her left arm for vaccination because she was right handed. Patient got shingles three times and currently had an outbreak right now. Patient stated shingles was not pleasant and she had to go to the urgent care to had it diagnosed treated.  Patient was not at her home at the time of report so she did not had access to the medical records . Patient may had lot numbers at home. The reporter consented to follow up. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2006, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 08-MAY-2014, the patient was treated by an optometrist for the onset of a vesicular rash, which was diagnosed as herpes zoster with ocular manifestations. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, herpes zoster with ocular manifestations was determined to be medically significant. Additional information has been requested.
Got sick after the vaccine/all over sick feeling/ felt horrible; Head hurt; Nausea; Hurt to sit up; Really bad hangover; This is a spontaneous report received from a contactable consumer (patient). This male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201; expiration 30Jun2021) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter called to obtain more information to try and figure out if the vaccine caused him to get sick or if it was something else. The reporter stated he got sick about six days after vaccination; further stating he got an all-over sick feeling, like a really bad hangover that never "let up" and lasted 6 days straight. He reported that his head hurt constantly, he had nausea, and it hurt to sit up; he felt horrible. The patient considered going to the emergency room (ER) and ended up seeing his physician yesterday (as of 03Mar2021). He reported that he had not gotten sick in 20 years. The clinical outcomes of got sick after the vaccine/all over sick feeling/felt horrible, head hurt, nausea, hurt to sit up, and really bad hangover were unknown.
This event was an administration error. The Moderna vaccine was administered to an individual under the age of 18. Patient tolerated the vaccine administration, and no adverse reactions have been reported.
Mother called 10/14/2014 stating child inconsolable during evening and night. Refuses to put weight on legs and walk as she usually does. Evaluation by MD in office showed warmth and swelling at two injection sites right thigh and one injection site left thigh but normal strength and reflexes.  Mother to continue home treatment of Advil and Tylenol with ice to site if tolerated.
muscles are sore; Injection site pain/ Injection site tender/ Injection site achy/ Hurts/ feel local soreness again; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2019, the patient received the 2nd dose of Shingrix. On 9th April 2019, 8 days after receiving Shingrix, the patient experienced injection site pain. On 19th April 2019, the patient experienced muscle soreness. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the muscle soreness was unknown.   It was unknown if the reporter considered the injection site pain and muscle soreness to be related to Shingrix.  Additional details were provided as follows: The reporter received the second dose of the Shingrix vaccine and reported that the injection site was sore for a couple of days and then resolved. Ten days later on 19th April 2019, she reports that she began to feel local soreness again, the site was achy and it hurts when she moves her arm forward or back. She cannot sleep on the arm because of the soreness at the site of the injection. She described that it hurts to the touch at the injection site and was tender in a 4 to 6 inch radius from the injection site.  When she extends arm straight out the muscles were sore.
This case was reported by a other health professional via call center representative and described the occurrence of systemic lupus erythematosus in a 80-year-old female patient who received SHINGRIX for prophylaxis. In February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, 2 days after receiving SHINGRIX, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant), widespread rash, skin plaque, blister, pruritus and pain. On an unknown date, the outcome of the systemic lupus erythematosus, widespread rash, skin plaque, blister, pruritus and pain were unknown. It was unknown if the reporter considered the systemic lupus erythematosus, widespread rash, skin plaque, blister, pruritus and pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX and 2 days later she experienced rash which began on left arm and spread to right arm and back. The patient visited physician's office on 9th April 2019, presented with scaly plaques with occasional blisters on her arms, chest, face and upper back associated with itching and pain. The biopsy was performed on same day and results showed subcutaneous lupus. No further details were provided.
2.5 hrs after the vaccine I started having a problem in my left eye. it turned out to be a detached retina which required surgery on 6-20-19