chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd dose has not yet been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that second dose of shingrix has not yet been administered, which led to incomplete course of vaccination. The reporter stated the first dose was given at a different facility so reporter does not have lot number, expiration date, or exact date of dose. The reporter could not provide patient initials. The reporter consented to follow up.
Fatigue,,low grade fever, body aches ,itchy rash and redness right upper arm.
Pt became slightly fussy after vaccines but about 4 hours later had an episode where mom feels that he was fairly limp in the limbs with eyes open but less responsive and decreased respirations. He became more pale and some bluing of the lips. No shaking or tremors or lip smacking or eye movements. Episode lasted about 10 minutes and then he slowly improved over the following 20 min. He was taken to the ED where he was back to his normal self and took bottle. He was admitted overnight to the hospital and had normal asleep and awake EEG. He also had blood work drawn in the ED.
approx 1 1/2 hrs p/receiving vax, pt vomited, crying & turned very pale; was seen in MD office 1/2 hrs later; very pale, eyes not focusing; WBC 31200, fever 101.2;
Family of four came in for flu vaccines. Gave FLUMIST to all four. The adult was over 49 yrs. old and ineligible for FLUMIST- phone call to client was made notifying of error - no adverse reports. E-mail to CDC who replied to count as valid dose.
after vaccine experienced very sore arm couldn't hold anything, body aches and joint pain felt like I had a fever but did not, extreme fatique
Pt. c/o soreness L deltoid area extending to L axilla & L side of chest & extending up L side of neck.  Injection site sl. red, sl. warm to touch; bruising.  Sx's severe 6/14-6/16.
Symptoms started out like an allergy within a week. Extreme tired, headache, congestion and overall feeling unwell. Made a video appt. with Dr. describing sinus infection symptoms.   Took antibiotic for a week, but symptoms worsened. Three weeks after the vaccine went to urgent care and was in AFIB. Estimated that the AFIB had started two weeks ago.  Was now in congestive heart failure. Shocked into sinus rhythm and sent home. Was told it was fine to get the second vaccine. Within hours of the second vaccine, passed out at home and was back in AFIB. Ultimately, a pacemaker had to be installed and oxygen now required permanently. Stress test done in 2018 showed that the heart was fine. No prior history of AFIB or congestive heart failure.
Pt reported "shaking and shivering" evening after being vaccinated and feeling extremely tired the following day (today).
Fever. Sleeping more than normal. Acne all over body. Vomiting.
3 days after 2nd dose of moderna patient presented to our er in cardiac arrest; lacking extensive cardiac history other than a-fib; he had reported anginal like symptoms to his wofe during the day and then collapsed in v-fub and was unrecusitatble;  no autopsy or further information; unclear if vaccine is contributory but within 3 days i agreed with patient's wife in that the temporal relation should be reported
Narrative: Immune Thrombocytopenic Purpura (ITP) associated with Pfizer COVID-19 Vaccine: Patient had received both doses of Pfizer COVID-19 Vaccine (dose #1: 4-12-21; dose #2: 5-3-21). Around May 10, 2021 patient began to notice bruising on her legs bilaterally and also developed numerous bruises on upper quadrant of her abdomen, forearms, and petechiae on her chest. Denied hematochezia, melena, vaginal bleeding, epistaxis, or oral mucosal bleeding. Routine labs noted platelet count of 3,000 (6-14-21). Was admitted to medicine team and given high dose Dexamethasone 40mg IV daily x 4 days and IVIG (1 gm/kg) therapy (2 doses) with prompt resolution of thrombocytopenia (platelet count on day of discharge = 153,000). Platelet Antibody, IgG: positive
Patient received MMR vaccine on 4/13/15. 3-4 days after the vaccine was administered, developed red spots on abd. 4/22 developed diffuse rash and fever. Rash was red, pimply, no blotches, no drainage or scabbing. Spread to neck, back and entire body excluding palms of hands and soles of feet. No oral lesions.
I suffered from a miscarriage.  12 weeks  along.  It had been a healthy pregnancy otherwise.
12:01PM Dizzy HR 76, BP 120/90.  12:29PM  SPO2 95, HR 76, RR 16, BP 112/90, T 96.9.  Pt verbalized understanding and signed a note stating that Pt will contact PCP.
Since my J&J shot on 3/20/2021 around11:45am at the drive up parking lot. I had swelling in in ankles. My PCP changed my blood pressure medicine to correct those symptoms. But I've had a tingling sensation in my right arm, starting under my arm pit and goes straight down to my fingers. My right thumb, index, and middle finger is numb at the tips since my J&J vaccine shot.
COVID 19 TEST POSITIVE; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0U2A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-DEC-2021, the patient experienced covid 19 test positive. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid 19 test positive was not reported. This report was non-serious.
Lot of spots on body; splotches into small bumps was drying them all over body; Splotches into small bumps was drying them all over body; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Lot of spots on body), DRY SKIN (splotches into small bumps was drying them all over body) and RASH MACULAR (Splotches into small bumps was drying them all over body) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no.  4782589) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced SKIN DISORDER (Lot of spots on body), DRY SKIN (splotches into small bumps was drying them all over body) and RASH MACULAR (Splotches into small bumps was drying them all over body). At the time of the report, SKIN DISORDER (Lot of spots on body), DRY SKIN (splotches into small bumps was drying them all over body) and RASH MACULAR (Splotches into small bumps was drying them all over body) outcome was unknown.            No concomitant product was reported. It was unknown if patient was enrolled in COVID-19 vaccine trial. No treatment information was reported.
Patient developed plaque-like rash post vaccine. Rash is full body and pruritic.
Initial report received on 18 March 2008 from a health care professional. A 30 year old female patient received on 13 March 2008 an intramuscular dose of ADACEL (lot # C2842AA) in the left deltoid. The patient had no illness at the time of vaccination. After an unspecified period following vaccination, the patient developed a cough, body aches, a sore throat, and low grade fever. Additionally, the injection site was very tender and had an area of induration measuring approximately 2.5 cm by 4.5 cm. The number of doses of ADACEL is unknown. The patient had an allergy to penicillin and BACTRIM, no medical history, and concurrent medications were not reported. At the time of the report (18 March 2008), the patient had not recovered.
No additional AE information provided.; Nurse reporting AE for improperly stored PROQUAD administered.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-AUG-2022, the patient was vaccinated with one improperly storage dose of measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) rHA (valid lot #W002783, expiration date: 24-JUL-2023) (strength, anatomical location and route of administration were not provided) for prophylaxis. Temperature excursion was at -12 degree Celsius (C) for 40 minutes. Previous temperature excursion occurred (temperature (Temp): -14.5 C for 10 minutes; Temp: -14.2 C for 40 minutes). No additional adverse event was reported.; Sender's Comments:  US-009507513-2208USA004029:Case #  02220598 US-009507513-2208USA004112:
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 01-MAR-2018, the patient was vaccinated with one dose of (wistar ra 27-3) M-M-R II (rHA) lot # N009799 with expiration date 24-MAR-2019, for prophylaxis (route of administration was not reported). Other suspect therapies included TYPHIM VI lot # M15722M with expiration date 24-OCT-2018 and sterile diluent(STERILE DILUENT) lot # reported as M030846 with expiration date 26-APR-2020. On 06-MAR-2018, the patient was vaccinated with another dose of (wistar ra 27-3) M-M-R II (rHA) lot # N009799 with expiration date 24-MAR-2019, TYPHIM VI lot # M15722M with expiration date 24-OCT-2018 and sterile diluent(STERILE DILUENT) lot # reported as M030846 with expiration date 26-APR-2020. Lot number M030846 is an invalid lot number for sterile diluent.
DROOPING LEFT EYE LID, WEAKNESS IN BOTH HANDS AND LEGS. NEUROLOGY DIAGNOSED WITH GUILLAIN BARRE SYNDROME PATIENT PLACED ON IVIG THERAPY FOR 5 DAYS.
Left elbow tendinitis onset approximately 48 hours after administration. Occurred with first and second dose.; This is a spontaneous report from a non-contactable physician. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number:EL1284, via an unspecified route of administration on the left arm on 08Jan2021 09:00 at a SINGLE DOSE and (Lot number: EH9899), via an unspecified route of administration on the left arm on 17Dec2020 20:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced left elbow tendinitis onset approximately 48 hours after administration which occurred with first and second dose on 10Jan2021 07:00 with outcome of recovering.    No follow-up attempts are possible. No further information is expected.
Elevated heart rate, led to arrhythmias on Sunday 5/16 - 48 hours after my 2nd dose. Apple Watch indicated AFib several times that day. Went to sleep and heart arrhythmia woke me out of my sleep at 4am on Monday 5/17/21, so I went to the ER to get checked out. In the hospital, I was diagnosed with myocarditis, was held there for 4 nights for monitoring and am still taking medication to keep it under control.
Flu-like symptoms, heat come up my back from bottom of spine, hallucinations with seeing wall move or bubble up then seeing tree branches come out of the side of the wall, sleep-walking, could not walk up or down steps, nauseous, flushed cheeks of face, dizzy, drowsy,
lightheadedness immediately, muscle aches that required trigger point shots 3 days later due to tightness of musches, difficulty walking
FELT A LITTLE UNDER THE WEATHER THE NEXT DAY AFTER VACCINATION FOR THE DAY; ARM HURT FOR A COUPLE OF DAYS; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: high blood pressure, and high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805108, and expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced arm hurt for a couple of days. On 15-MAR-2021, the patient experienced felt a little under the weather the next day after vaccination for the day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt a little under the weather the next day after vaccination for the day on 15-MAR-2021, and arm hurt for a couple of days. This report was non-serious. This case, from the same reporter is linked to 20211241901.
This spontaneous report as received from a medical assistant refers to a 13 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 24-JUN-2014 the patient was vaccinated with second dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # J009788, expiry date: 17-MAR-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Left arm very swollen, red, hot to touch. Weak, feverish, severe headache, diarrhea. Missed afternoon of 8/14, 8/17-8/21, tried to return to work 8/24 & only lasted 1/2 day, missed 8/25, 8/26. 8/27. Skin peeling around injection site, scar on arm. Stated on 9/3 that she was gradually seeing better. Couldn't get out of bed those 2 wk. Never went to the OR/Hosp/ or doctor. Didn't take temperature.
Significant pain at shot site extreme on morning after and continued for three days, significant debilitating and ongoing muscle pain, extreme muscle craps in neck muscles, significant pain in joints, minor but consistent multiple day headache, feeling of severe dehydration, significant upper back pain, all of these symptoms have been severe and consistent for three days and continuing post vaccination and I am unable to return to work, I had very mild Covid early January confirmed with multiple tests
Nerve demyelination, Optic neuritis, disk edema, visual loss in both eyes, pain. Treatment ongoing through ophthalmologist and neuro ophthalmologist.  It have been nearly 3 months. I still have yet to return to normal vision. Optic neuritis and disk edema still present. And as an added fun fact, I failed a work physical which led me to not having a job. Eyesight apparently is rather important is critical safety roles.
Unresponsive to verbal stimuli for about 2-3 minutes.  Vomited about 100 cc of injested food.  Diciphoretic, felt dizzy.  Checked vital signs.  Monitored for one hour.
10/7 at 0500 severe nausea, diaphoresis, arm burning from shoulder tip to elbow. At 0630 con't nausea, diaphoresis, burning arm, no redness, induration 10 x 12 cm. At 0745 nausea, burning to forearm, induration from shoulder to elbow, hot to touch, no redness, left hand numb, headache starting. Took BENADRYL 50mg. At 2100 slight nausea, arm very painful but able to lift arm now, all joints ache, headache. 10/8 next AM. Slight nausea, mild headache, all joints ache, arm hurts, induration decreased 1/2 size. 10/9-10/11 no nausea, arm very sore, no headache, mild joint pain. Unable to work 10/7 due to reaction.
I didn't have a reaction to the vaccination itself, but I started having COVID-19 symptoms on November 28, 2022. They were mild and included a sore throat and body aches. The next morning, my symptoms were a little worse, but they were still mild. In addition to the sore throat and body aches, I had some congestion. I took a Binax Now COVID-19 test. The result was positive. I isolated and stayed in bed. I called my doctor on November 29, 2022. He wrote a prescription of PAXLOVID. I took my first dose that night and continued the 5-day course as recommended. After 3 days, my symptoms were much better. I continued to isolate, but I was able to do my normal things. On December 6, 2022, I took another Binax Now COVID-19 test. The result was negative. On December 8, 2022, my symptoms started again. I tested positive for COVID-19 again. I was sick in bed for another three days with essentially the same symptoms. On December 11, 2022, I felt better, but I still tested positive for COVID-19. On December 14 and 16, 2022. I tested negative for COVID-19, but I continued isolating for three more days.
After the 2nd dose I experience common flu like symptoms for 12 hours  2/5 beginning of a 2.5 month ordeal- low grade fever fatigue itching and burning Medications or vaccines caused shortness of breathe and rapid heart rate
like a lump; Rashes 1-2 inch below the injection site; swollen; injection site irreregular; A spontaneous report was received from a consumer a female patient who experienced rashes 1-2 inches below the injection site, an irregular in shape and swollen lump-like injection site.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter  On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number not provided by administration site, per patient) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the events was not provided/unknown.   The outcome of the events rashes 1-2 inches below the injection site, an irregular in shape and swollen lump-like injection site were unknown/not reported.; Reporter's Comments: This case concerns a female of unknown age who had NS events of unexpected vaccination site mass and expected vaccination site swelling, vaccination site induration, vaccination site rash.  Event onset 2 days after first dose mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the Vaccination site mass, vaccination site swelling, vaccination site induration and vaccination site rash, a causal relationship cannot be excluded.
Patient stated had elevated temp 101 for 2 days had rash on lower legs-none at injection site. Felt tired-rash appeared on 5/31/10.
Patient was seen in ER on 9/12/08 with c/o green drainage to smallpox vaccination site with swelling and pain. SMV given approximately 20 days earlier, sx began one previous to ER visit. Culture obtained, Demerol and Vistaril given for pain, Cephalexin ordered with orders to follow up. Seen on 9/16/08 with improvement in sx. noted. Given order for Levaquin and Keflex.
Site: Pain at Injection Site-Mild, Systemic: Seizure-Medium, Additional Details: Patient sitting on chair post vaccine (waiting area) she reported (after seizure and fall) that she was feeling dizzy.  She doesn't remember after that and was awake on the floor.  Customer reported witnessing a seizure for 4-7 seconds BEFORE the fall.  She has an abrasion on her left temple post fall.  EMS called and patient refused to go to the ED.  She said she would go with her friend.
Developed a cold sore the day after the vaccine. Of course it might not be related but it is rare for me to get cold sores and I've read about people possibly getting shingles activated.
This case was received from a health professional on 25 May 2007. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. A nine-year-old male patient received an intramuscular right deltoid injection of Typhim Vi on 16 May 2007 and six to eight hours later experienced hallucinations, in addition to fever (102 degrees), headache, and fatigue. He was seen at an urgent care facility and was treated with "routine antipyretics". He had no known pre-existing conditions, and was not ill at the time of vaccination. The events were considered to be recovered.
Pt recvd vax & w/in 24 hrs of vax pt had a t103.8, body aches, & h/a; treated w/APAP;
(Pneumonia) Having problem breathing, 2 days after having shots. Went to hospital 3 days after having shots. Was in the hospital for 4 days and 3 nights. Went home on antibiotics for 2 weeks and on nebulizer for a month. I then switched his doctor and he put him on more antibiotics. He then recovered in mid-March.
The patient inadvertently received a dose of 0.51 to 0.52 ml as opposed to 0.5 ml. The manufacturer instructed us to reach out to the patient to let them know they have received a higher dose which may have the potential for increased local and or systemic side effects. No serious adverse reactions were experienced or reported by the patient.
ACUTE ST ELEVATION MI, UNSPECIFIED ACUTE NON ST ELEVATION MI HYPOXEMIA
called in regards to his sister who received her second Pfizer dose on Friday 03/26/2021 @1100. reported that his sister developed fever, congestion, runny nose, sore throat, arm hurts. reported that his sister have no allergies and no medical history, patient was instructed that she can take tylenol for the headache and the fever. patient was instructed that she can apply cold compress to help with the arm soreness. patient was instructed to seek medical attention if the symptoms got worse. Adverse events experienced and are they still occurring now: fever, congestion, runny nose, sore throat, arm hurts What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these):   they called us