chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B821A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Lupus erythematosus (Tested highly positive for lupus) in April 2020. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Blood test: normal (normal) Normal.         Concomitant medications also included unspecified cultural pre and probiotic. No treatment medication was reported.   This case was linked to MOD-2021-215806, MOD-2021-215806 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up received provided patient details, medical hsitory and concomitant medications.
I received my second vaccine and in the middle of the night I woke up out of a dead sleep.. My entire body was on fire, my heart was pounding and I felt like I couldn?t breathe.. It was a very scary experience.. After that I have been have these attacks every night and I?m unable to sleep? I went to my PCP and my blood work came back normal.. I had a baby and he is now 9 months old when I got the shot he would have been 7 months? I have been fine prior to getting the vaccine and never had problems sleeping.. My dr believes it may be an effect from the vaccine but he isn?t certain as he doesn?t have information on the vaccine.. Please get this under control, this is why I didn?t want the vaccine because I?m a healthy woman in her 30s and now I have issues..
p/vax pt exp severe myalgias, neck pain ?blurry vision?, vomit x1 + S.O.B, and ketones in urine
Patient is a 24 year old, female who received her first dose of Moderna lot 037C21A exp 06/17/21 around 10:22 am. While being  monitored patient nausea and begin vomiting around 10:35 am. The vomitus was small and  clear - 3 episodes. The patient reported she had eaten since last night (05/24/21) and  went to the ER for chest pain. Her labs and discharge diagnosis is not known. The patient  is HIV+ and has taken biktarvy for the past three years. Patient reported face tingling,  "rushing" sensation in her head, back pain, headache. The patient had cold, sweaty hands,  upper extremity shaking. An cold pack was placed on the patient's neck, given sips of  gatorade. EMS called at 10:45am and arrived at 11:10am. Patient transported to ER Initial vital signs @1035 - 98.2, SpO2 92%, 106/68, 18, HR 88. Vitals @ 1047 120/95, HR 93, SpO2 95%, RR 18 Pt was AAOx4, weak, dizzy, vomiting, cool & sweaty palms. Cardio: S1, S2, no r/m/g. Resp: CTAB
Patient received only the liquid adjuvant; Patient received only the liquid adjuvant; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 3N3GH, expiry date 28th January 2023) for prophylaxis.   On 14th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 14th July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided are as follows: The reporter was the doctor. The patient received only the liquid adjuvant of Shingrix intramuscularly without the active component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The lot number of the powder vial in the box (which was not administered) was 75xa2, expiration date 28th January 2023. The reporter consented to follow-up. This case has been linked with case US2021171383, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021171383:Same reporter.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-JAN-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX, subcutaneously for prophylaxis, with lot # M035694 and expiration date 07-NOV-2017 (strength 19400 PFU, dose not reported). The administered dose of the vaccine experienced a temperature excursion that was greater than -15 degrees Celsius but less than -10 degrees Celsius for 17 minutes. Another temperature excursion in the same temperature ranges was reported for 3 minutes. There was no adverse effect reported. No product quality complaint was involved. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012977: Original Case : 1701USA012977
As described by mother, child was seen in ER 11/22/01 9 days after MMR, varivax for complained of fever & rash.
Patient became dizzy after receiving shots. Did not lose consciousness. Dizzy for next 3 day on and off.
Developed a CRVO (central retinal vein occlusion in the right eye hours after receiving this vaccine.
Patient received her flu shot between 8 and 9 am on 10/13/09.  By 10:00 AM she was complaining of itching all over and neck pain and eye pain.  Advised her she may try benadryl but to seek physician care immediately in case her reaction became worse.  She stated that she would call and go see her local physician as soon as possible.
This spontaneous report was received from an Internet article, via Sanofi Pasteur MSD, concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. The article stated that, studying case reports from national and international registries, it was found at least 20 cases of patients, children and adults, that were vaccinated with Zoster vaccine (manufacturer unknown) (reported as "chickenpox and shingles vaccine") (dose, dose number, route, anatomical location, lot # and expiration dates were unspecified). On an unknown date, within a month after vaccination, the unspecified patients experienced corneal inflammation. The outcome of the event was unknown. The article stated that there was a link between the event and Zoster vaccine (manufacturer unknown). Additional information is not expected, no contact details were provided.
Pt received COVID vaccine 1st of June at the clinic;  presented to Hospital ED on 11/8 with c/o dizziness and fever with weakness, SOB received fluids, IV decadron, tylenol and Albuterol inhaler; discharged also with home 02 and oral dexamethasone. Returned to ED on 11/9 with continued SOB, lung CT obtained, given IV bolus, albuterol neb discharged to home with Azithromycin and duonebs for q 6 hrs prn.  to continue home 02, dexamethasone and instructed on proning positioning and isolation requirements.
Pt. upset prior to HPV injection, crying 5 min after shot was given pt became clammy and dizzy-urinated self-easily aroused-Examined by Dr.,  Vasovagal event. Had pt lay for 20 min-Left office in stable condition.
I experienced pneumonia, wracking cough, severe headache, gastrointestinal problems, complete incontinence, extreme weakness, loss of appetite, loss of sense of smell. I have an issue with anemia but my issues with bruising and muscle pain were significant. At the time the only thing I did not have was sore throat and vomiting. I did not need oxygen to breathe, but it had gotten to a point that the doctor was going to order it. I was given steroids and antibiotics. I expected the sore arm which I did get. With the 2nd dose, I was sick within a 24hr period. I experienced every symptom, and nothing seemed to be responding. My decline was also much quicker. Every day did not seem to get better no matter what I did. I experienced this for 6-8 weeks. My breathing would get better but as soon as I stopped the steroids, it was back to worse again. My doctor said these symptoms were expected but the duration was not. I feel like my symptoms resurface because they will go but soon after they will reoccur.
Redness swelling around shot. Aching pain.  Then on 11/04/2011 develop severe flu like symptoms. Chills then fever, total aches & pain thru whole body, felt like eyes were going to pop out of socket. Arm rash grew to 3x4 in size & painful! Dizzy faint & severe headache. Heart rate kept going up!  Almost went to emergency room but doc visit stated minor reaction!  Patient took 2 Benadryl tablets & tossed & turned all night.  Woke up feeling 75% better.  Still aches & pain mostly in left arm & very weak.
2 month old previously healthy female born at 38 weeks via repeat C-section received immunizations at PCP's office ~10:30AM.  Was fussy at home, so mom gave TYLENOL X1.  Pt fussiness increased and about 2:30PM pt began to have resp. distress.  Mom called 911.  Pt stopped breathing ~1 min. and facial cyanosis x3 min.  Then entered a state of "sleepiness".  When EMS arrived pt limp but responsive to painful stimuli.  By the time pt got to hospital, she was sleepy but otherwise in no distress. 8/7/08-records received for DOS 7/22-7/23/08DC DX: Apparent Life Threatening Event (ATLE) possibly secondary to hypotonic hyoreponsive collapse following reaction to pertussis immunnization. Episode of dyspnea, cyanosis blanching, fussing crying.
Information has been received from a licensed practical nurse concerning an 18 year old female with drug hypersensitivity to CECLOR, ZITHROMAX and no pertinent medical history who on 12-FEB-2008 was vaccinated with a first dose of GARDASIL (lot # 655670/1459U). Concomitant therapy included LOESTRIN. On13-FEB-2008, the patient experienced a fever of 101.9 degrees Fahrenheit, nausea, and vomiting. The patient sought medical attention and was examined by her physician and was instructed to take BENADRYL, TYLENOL, and increase fluid intake. No diagnostic tests were performed. At the time of reporting, the patient had not recovered. Additional information has been requested.
Patient was walking in waiting room, passed out, fell backwards and hit his head on a chair.  When I came to the waiting room patient was actively seizing and bleeding from a laceration on the posterior part of his scalp.  Patient moved from under chair and placed in recovery position.  Active seizure time from my arrival was 30 seconds.  Patient was minimally responsive and postictal for approximately 5 minutes and diaphoretic.  Vital signs taken and oxygen placed on patient.  Color returned to normal, and VSS.  BS was 108 on glucometer.  EMS called and patient transported out of facility.  Patient is a 35 yo M with no sig pmhx presenting after syncopal event after receiving his COVID vaccine. Fell from standing, denies dizziness, SOB, CP, or other symptoms prior to the event. He hit the back of his head when he fell. He presented to the ED, at which time he felt very nauseous and per notes he was confused and perseverating.  Admitted to the SICU for R frontal IPH and R frontal SDH.
In September 2021, I started having vertigo, sensitivity to light, leg weakness and a decreased ability to stand. These continued for a week or two and I went to my primary care physician who referred me to a cardiologist. I saw this cardiologist on September 28, 2021 and he ordered alot of different tests with only my cardiac stress test showing abnormal. He started me on Crestor and baby aspirin following the stress test. He also started me on a cardiac event monitor which showed abnormal tachycardia rhythm from both chambers. He has referred me to an electro physiologist for further workup. I am currently awaiting that appointment. I am still experiencing all of these symptoms.
within 15 minutes of receiving vaccine patient complained of feeling "itchy all over".  Patient was noted to have blotchiness on bilateral temples Patient was administered Benadryl 25mg PO x1 at 1038 at Direction of NP Patient remained seated under observation under NP for an additional 15 minutes Patient stated feeling much better, less itchy and was released at 1055
Patient received covid 19 dose for ages 6m0s-12 years . Patient is 13 years old as of a month ago and should have received the 13 years old and older dose.
Systemic: Patient was unresponsive after the vaccine and then started vomiting.  She went to the ER and then perked up for a few hours and they sent her back. She was fine after leaving the hospital.-Severe
This patient has MS and is on ocrevus.  Had COVID-19 vaccination with second shot about 5 weeks before most recent ocrevus infusion.  It is well reported in the literature, now that is, that these sub section of patients (MS on CD20 monoclonal antibodies) may not produce an antibody titer to vaccination.  However, she had a breakthrough COVID-19 infection that started on 7/11/2021.  Admitted to the hospital on 7/21/2021, discharged 7/26/2021.  Severe COVID-19 that required BiPaP therapy.  Treated for secondary pneumonia as well.  Treated with ivermectin, remdesivir, dexamethasone.
Painful arm; Swollen arm; Red arm; Got the shot way below the deltoid muscle between the shoulder and elbow; A spontaneous report was received from a pharmacist concerning a 71-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) below the deltoid muscle between the shoulder and elbow/ vaccine administered at inappropriate site and developed painful arm/ pain in extremity, red arm/ erythema and swollen arm/ peripheral swelling.  The patient's medical history was not reported. Products known to have been used by the patient, within two weeks prior to the event were not reported.  On 26 Feb 2021, the patient received his first of the two planned doses of mRNA-1273 (batch number: unknown) intramuscularly way below deltoid muscle for prophylaxis of COVID-19 infection.  On the same day after vaccination, the patient developed painful and red swollen arm.   Treatment medication included with paracetamol for the events.  The action was taken with mRNA-1273 in response to the events was unknown.  The outcome of the received Moderna's COVID-19 vaccine (mRNA-1273) below the deltoid muscle between the shoulder and elbow/ vaccine administered at inappropriate site was considered as resolved. The outcome of the events painful arm/ pain in extremity and red arm/ erythema and swollen arm/ peripheral swelling were considered as unkown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Erythematous, warm, tight skin extending circumferentially from center injection site with mild blanching centrally (8 cm in diameter).
Chronic hives randomly broke out all over my body 12 days after booster shot Difficulty breathing on episodic periods for 30 days Chest muscles constricting for episodic periods   Prednisone was administered for 3 months Regiment of double daily dose Zyrtec in an 2 benedryl twice a day Two hydroxyzine twice a day  Hives stoped after 3 months  Dermagraphiga still present 6 months later
Information has been received from a nurse practitioner concerning a 5 yr old female pt who was vaccinated with varicella virus vaccine live. The nurse practitioner reported that on 30Apr05, the pt developed breakthrough, which was described as 50 lesions. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
Localized redness & swelling in right deltoid 10/2; oral temp 101.2F.  Took Aleve @ about 2:30 pm.  Cold compresses applied to site @ 6 pm.  10/3 had no fever, cold compresses on 2X by 3 pm.  Advised client to continue with cold compress to site prn.
Shortly after receiving the vaccine I developed a headache followed by muscle aches, fever, chills, nausea, joint pain, brain fog, fatigue, dry cough.
headache around 3p, went to bed at 8p couldn't sleep due to heart racing then pain in back, arms , had to urinate 5 times during night, still unable to sleep . got up 8am took tylenol for pain, valium to sleep, slept till 330pm. .2nd day still headache and all over body ache. foggy
Initial report received from a non-healthcare professional (patient's mother) on 23 May 2013. A 10-year-old male patient, whose medical history and concomitant medications were not reported, had received dose of MENACTRA (batch number: U4021AE, route of administration was not reported, expiry date: 10 May 2013) on the right arm on 14 May 2013, also received Tdap and Varicella vaccine (unknown manufacture, route and site of administration were not reported) both on 14 May 2013. It was stated that after vaccination, the patient experiences redness and swelling at the site on the right arm and presented dizziness, headache and nausea. It was reported that the patient received expired MENACTRA vaccine. Complementary investigations and laboratory data were not reported. As of 23 May 2013 it was reported that, swelling and redness at injection site has resolved and had not any further dizziness, headaches and nausea. Documents held by sender: none.
Syncope. Pt received 3rd Moderna vaccine dose in preparation for Methotrexate therapy for her Rheumatoid arthritis. Felt mylagias and "flu" like symptoms in the evening. Around 4:30 am went to the bathroom and had a syncopal event, possible seizure.
pt suffered what appeared to be a sz approx 35 mins p/receiving DTP; no hx of prev sz; became pale; pt bruised lip when fell; eyes rolled back; body was rigid; bit lip; confused afterwards;
This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received CERVARIX (batch number unknown, expiry date 21st September 2014). In November 2014, the patient received CERVARIX. On an unknown date, an unknown time after receiving CERVARIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: Pharmacist calling on behalf of a vaccination clinic with minimal information at the time of the call. Last week (exact date unknown) a patient received an injection of an expired CERVARIX vaccine (Sept 21 2014).
Vaccine received 9/25/17. She called the office 9/27/17 stating she was not responding to NSAIDS for pain after the vaccine. On 8/3/17 she returned for an office visit and had mild pain distal to injection site but decreased ROM with arm especially lateral abduction.
Narrative:  pt hospitalized with COVID infection more than 2 weeks following completed Pfizer COVID vaccination series
Swelling, Redness, sore muscle, inflammation. By Thursday, redness and swelling were spreading past my elbow. Diagnosed as Cellulitis. I am on antibiotics and prednisone.
Symptoms:  Fever 101.5, severe chills, night sweats. Treatment:  Ibuprofen (3) Outcome:  Symptoms were gone by the following morning.
Initial report received from a nurse on 10 Nov 2010: This patient was vaccinated with only the lyophilized MenA powder of MENVEO batch numbers: (lot number: 00026) after being reconstituted with saline solution on 10 Nov 2010. No adverse events had occurred following this administration.
Chest pain  episodes 1-3 days after vaccine, Cardiac MRI shows small area of acute myocarditis
32 hours after the vaccine, he suffered a massive heart attack due to a blood clot and a massive clot in the right arm. He went to the hospital and under went surgery at 12 am on Saturday. The coronary surgeon mentioned that this was not from heart disease as all vessels were clear. Rather, this was due to an embolism due to an unknown origin. A further work up concluded that he also had blood clots throughout his body (both lungs, one kidney, heart, liver, legs, arms, and possibly brain). By 12 p.m. we were asked back to the hospital as he was worsening. Treatment options included a heparin drip, which caused a brain hemorrhage. He was just at the doctors two times this week, on Tuesday and Wednesday and was fine no issues found. They went through with the 2nd dose and came to our home on Thursday.
WEAK, VOMITING, HEADACHE, SORE ARM, AND STOMACH PAIN
Dose was given from partial vial that had been continuously refridgerated at temp of 42 degrees greater than six hours after initial puncture of vial.
pt recvd vax & devel febrile convuls; had fever; er eval was unremarkable;
I saw patient 6 days after she received her vaccines. A pruritic rash appeared the day after vaccination at the location of the injections on both thighs. No pain associated with rash. No nausea, difficulty breathing, or signs of angioedema. She has been acting like herself. Parents have applied natural balm, non-medicated, to help with pruritus. On exam, I saw a papular rash, mildly erythematous, clustered on bilateral thighs. Papules <0.5cm and mildly elevated. No excoriations, urticaria, warmth, or discharge. I instructed parents to treat pruritus with Benadryl or Cetirizine.
Sudden hearing loss on the left side along with tinnitis. No vertigo, facial numbness, or pain. No known inciting event.  ENT evaluation showed on 1/13/10 moderate sensorineural hearing loss with absent L. acoustic reflexes at 500, 1000, and 2000 HZ. Tympanometry was normal as was the physical examination of the ear canal.
Pt had severe pain at injection site and soft tissue swelling without redness approximately 4 hours after immun. Erythema (L) mid to upper arm to elbow developed with edema a little over 48 hours later (on 12-11-14). Pt went to ER 12/9; PCP visit 12/11 and 12/12.
First symptoms were headache and body ache. The next morning, 9/4/2022 I tested positive on an at home rapid COVID-19 test. I then had a telehealth visit with the doctor who prescribed PAXLOVID. He advised to stop taking supplements until after PAXLOVID was finished. I began taking PAXLOVID and TYLENOL. Headache and body ache cleared up while on medication. Fatigue and breathlessness after that, lasting about 10 days to 2 weeks. Day 5 of PAXLOVID, I tested positive on an at home rapid COVID-19 test. I did not test negative until day 10, 9/14/2022.
Muscle pain below the chest, difficulty breathing and pressure in the ribs. Wrist pain that returned to pain after three days after vaccination.
Erythema, edema and itching to LUE. Tx'd with Benadryl 25mg q 4-6 PRN itchy and Motrin 800mg TID x 3d
sneezing like crazy; not feeling well for 1-2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing like crazy) and MALAISE (not feeling well for 1-2 weeks) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced SNEEZING (sneezing like crazy) and MALAISE (not feeling well for 1-2 weeks). At the time of the report, SNEEZING (sneezing like crazy) and MALAISE (not feeling well for 1-2 weeks) had resolved.            Concomitant medications were not provided.  Treatment information was not provided.  Reporter mentioned that the patient may have had delta (COVID-19). Did not get tested for COVID-19 but patient said, from what found in the internet, symptoms were similar to delta's.  Symptoms as sneezing like crazy and not feeling well for 1-2 weeks.