chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an unspecified reporter on a digital media via SPMSD on 18-NOV-2015, referring to a boy of unknown age. The patient's pertinent medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with GARDASIL (lot#, expiration date, strength, dose and route were unknown). The patient's concomitant medication was not reported. On an unknown date the patient died after vaccination. The cause of death was not reported. It was unknown if autopsy had done. The causality between the events and GARDASIL was not reported. Additional information has been requested.
Fussy; loss of appetite. No fever. Cough. "Non stop fussy/crying". Not sleeping well.
Headache fairly quickly.  Extreme fatigue about 3 hours later, slept most of the afternoon.    Muscle aches, mostly in the upper half of the back.  Overnight chills required getting an extra blanket.   Sweats later during the night.   Most symptoms resolved the following day.  Soreness at injection site, as expected.
Graves' opthalmopathy; This spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation on 31-JAN-2020. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On or around 30-MAR-2015, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, on an unspecified date, she suffered sudden onset of bulging and dry eyes, pain and blurry vision, which was diagnosed as Graves' ophthalmopathy. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, patient's symptoms had resulted in physical limitations not present prior to the vaccine, also mental and emotional distress due to resulting physical limitations and seriousness of her condition. Patient sustained severe and permanent personal injuries. Further, as a tragic consequence, patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. She also ha suffered and incurred damages, including medical expenses, loss of accumulations, and other economic and non-economic damages. At the reporting time, the outcome of Graves' ophthalmopathy was considered as not recovered. The reporters considered Graves' ophthalmopathy to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporters considered Graves' ophthalmopathy to be a disability event. Upon internal review, the event of Graves' ophthalmopathy was determined to  be medically significant.
After the second Phizer covid vaccine, I started having these red scaly itchy patches showing up on my body.  started mostly on the legs.  I have had skin cancer in the past and with my age, just assumed it was related. Or maybe a rash from the vaccine since I red that was somewhat common.  Then it just kept getting worse.
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Jun2021 (Lot number: EW0179) at the age of 48 years as dose 2, single and intramuscular, administration date 14May2021 (Lot number: EW0173) as dose1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Dec2021, outcome "recovered" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (21Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Follow up information has been requested
Allergic rash = excariations on both thighs = rough, red discrete papules eczema-like.
RN administered dose of Synagis and dose of Fluzone (1st time for Fluzone, had Synagis one month prior, no reactions). Within 5 minutes of giving injection, infant presented with hives widespread, blotchy distribution, respiratory system unaffected, no SOB or dysporia, no wheeze. Evaluated by MD, per MD, gave infant 1/2 tsp Benadryl po at that time. MD sent infant to ER for observation.
Pt was instructed to wait for observation for 30 minutes by vaccinator due to multiple drug, peanut allergies and history of hives, swelling from previous vaccines.  Pt refused to wait, stated she was going back to her office to work, patient was educated to return if she began to experience any side effects.  Pt returned at 340pm c/o itching (no hives were visible, no respiratory distress noted) patient was assessed and given 1 Benadryl 25 mg tablet PO.  Immediate Supervisor was informed via phone.
Initially muscle pain, cramps in legs, later feet and ankle became swollen , skin became darker and she experienced weight gain, tightness feeling on feet and back of it along with a dark rash.
Injection site pain; Tiredness/is just wiped out; Headache; has not been able to put anything in her stomach, as she runs straight to the bathroom; hurts so bad, her stomach and back; hurts so bad, her stomach and back; This is a spontaneous report from a contactable consumer (patient, self-reported). A 69-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EM9810 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 16Feb2021 (age at vaccination: 69 years), as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure. Concomitant medication included unspecified blood pressure medication. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization and she was fine. The patient stated that on 16Feb2021, she received the second dose of the COVID vaccine. After this dose, about two hours after, she started feel ingtired. The patient stated that she hasn't been able to get straight. The patient was having injection site pain, tiredness, headache, all of these things were going on. The patient was wondering how long these side effects were supposed to last. She has not been able to put anything in her stomach, as she runs straight to the bathroom. The patient tried to eat twice, but she didn't like the feeling of diarrhea and it was constant. The patient stated that she tried to get up and move around, but she was just wiped out. The patient was wondering if these were normal side effects, like she hurts so bad, her stomach and back and she has not had food in a long time. The patient was wondering if she was supposed to be in this situation. The patient reported that all events were still ongoing. When queried for outcome, patient stated that she would feel like her symptoms have improved but then they come back with a vengeance. She gets up and tries to function, and her symptoms shoot her back down. The patient confirmed that she had no other vaccines on the same day as her COVID vaccine. The patient took an unspecified blood pressure medication, she confirms she took it the same day as her COVID vaccine, but she was unwell the next day and the day after, and she didn't get out of bed, so she forgot to take this medicine on those days. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Yesterday during the vaccination, the patient mentioned her she felt the vaccine being administered and it hurt. The administrator was kneeling next to the seated patient and administered per protocol. The patient called the pharmacy this morning to let the pharmacist know that she experienced fever/chills and soreness in her arm last night. She said she took 2 TYLENOL twice within a 12-hour period, which seemed to help at first. Upon calling this morning, the administrator asked if the patient was sick (even though the patient stated on her vaccine form that she wasn't), and the patient mentioned she had a UTI the week prior and was on antibiotics for this, but the treatment was completed prior to receiving the vaccine. The administrator told the patient to continue to use TYLENOL for fever/chills/soreness and to ice the area while she waits to be seen from the doctor. The pharmacy left a message for the patient's PCP to make him aware of the situation, and the patient was following up with the doctor as well.
within a few hours, pt stated had pain radiating from injection site down arm to fingertips, described as nerve pain.
Pt recv vax on unknown day; 10 min post vax pt exp itchy ears & throat, nausea, dizzy, weak, positive result of Fluzone; tx=steroids Anaphylactoid reaction consisting of itchy ears and throat itching, nausea, dizziness and weak. Treated with steroids at ER. Occurred within 10 min. this Dr saw her on Oct 15th. As a follow-up allergist. Not egg allergic, did test with a different lot of FLUZONE and she had a 100mm positive result. From follow-up correspondence received at Manufacturer on 25-Apr-2000, it was reported thta the patient recovered from this experience. This case is closed.
16 years old patient received a dose; A spontaneous report was received from a nurse concerning a 16-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  the event is 16 year old patient received a dose.  The patient's medical history, was not provided by the reporter, included no known allergy and  Concomitant medications were not  reported .   On 09 Mar  2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 048A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 9 Mar 2021 the pharmacist Reported that 16 year old patient has Received his first dose of vaccine. and he want to know the patient can receive his second dose or not.  Action taken with mRNA-1273 in response to the events was not reported.   The out come of the event 16 year old patient received a dose is considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
Gradual onset Bell?s Palsy. Left side facial paralysis (partial), intermittent ear and facial pain. Onset at 39+6 days pregnant.
Administration of expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A, 032L20A and 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up document contains no new information
Following the first vaccine on 4/1/21, I had significant pain in my left shoulder and down my arm that began within the first 30 mins of the injection.  Weakness that kept me from raising my arm for 5 days.  8 days after injection pain began to subside, but weakness for another 7 -8 days.  Migraine headache for 3 days following the injection.  Following the second vaccine on 4/24/2021, I had extreme pain in my left shoulder and down my arm that began within the first 30 mins of the injection.  At 4 hours post injection I could not raise my arm.  Weakness lasted 2 weeks when pain became significantly worse and was determined by my chiropractor that my shoulder was dislocated.  5 months of recovery and care.  Migraine headache at 4 hours post injection lasting 5 days.  Exhaustion that had me asleep, waking only to use the bathroom and minimally eat/drink for 60+ hours post injection.
HPI: 62 yo with a "bad gallbladder attack" 20 years ago. She was sick for 2 weeks but had no insurance and was treated conservatively. Her pain was principally in the R post. Flank. Since then she's has occasional mild attacks associated with the same flank pain and nausea.   Two weeks ago last Friday while working at the post office, she became acutely ill with the same flank pain but this time also with epigastric and chest pain with nausea. She saw Dr. 4 days later and still felt lousey and then followed up on March 13. At that time the patient related the history as "The pain is described as aching, colicky, cramping and pressure-like, and is 5/10 in intensity. Pain is located in the RUQ, epigastric with radiation to right back. Onset was 4 days ago. Symptoms have been gradually worsening since. Aggravating factors: activity and eating.  Alleviating factors: none. Associated symptoms: anorexia, belching, flatus and nausea. The patient denies fever, hematochezia, hematuria and melena."   Subsequent blood work was normal including CBC, LFTs and lipase.   US: A 1.9 cm shadowing gallstone is visualized. It is mobile. There is no gallbladder wall thickening or pericholecystic fluid. Patient reports right upper quadrant pain during the scanning. The common bile duct is normal in caliber measuring 2 mm.   She remains fearful of eating. No CBD sx/signs.   She's had one of two Covid vaccinations
If scratched the rash area becomes red; If scratched the rash area becomes irritated; Itching right forearm; Rash on his right forearm; Itching left forearm; Rash on his left forearm (injected Arm); This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (If scratched the rash area becomes irritated), PRURITUS (Itching right forearm), ERYTHEMA (If scratched the rash area becomes red), RASH (Rash on his right forearm) and VACCINATION SITE PRURITUS (Itching left forearm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching left forearm) and VACCINATION SITE RASH (Rash on his left forearm (injected Arm)). On 02-Apr-2021, the patient experienced PRURITUS (Itching right forearm) and RASH (Rash on his right forearm). On 12-Apr-2021, the patient experienced SKIN IRRITATION (If scratched the rash area becomes irritated) and ERYTHEMA (If scratched the rash area becomes red). At the time of the report, SKIN IRRITATION (If scratched the rash area becomes irritated), PRURITUS (Itching right forearm), ERYTHEMA (If scratched the rash area becomes red), RASH (Rash on his right forearm), VACCINATION SITE PRURITUS (Itching left forearm) and VACCINATION SITE RASH (Rash on his left forearm (injected Arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Headache, Nausea, Dizziness, weight loss, Lack of appetite, Depression/Anxiety increase, No energy, Blurry vision, Off balance, and weakness. Blood test, Ultra sound, Upper and Lower Stomach, and Colonoscopy.
one patient recieved improperly stored dose of VARIVAX; no adverse effects; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R010468, expiration date: 10-APR-2020, subcutaneously for prophylaxis. The sterile diluent used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was properly stored. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 6 to 14 degrees Fahrenheit (7.9F) for 3 hours 9 minutes. Data logger was involved. There were no previous excursions reported.
Complaint of presure to chest at 5:45. Vital signs taken and BP 100/90; HR 88;RR20 Pulse ox 97%. He also complaint of mild tightness in his throat however he remained able to drink water, convers and and breath without any issues.  Over the course of the next 30 mins his symptoms decreased significantly.  Repeat vital signs: BP: 140/90; HR 79; RR 18; O2 sats: 97%. Client released to go home at 6:28 and he states the pressure in his chest was minimal.  He declined offer to call an ambulance which was offered.   He was able to stand up and walk without any issues.  Client recommended to f/u with his doctor or the ED of the symptoms returned or worsened. He said he was feeling fine and wished to leave.
01/29/2021: Near 17mo old girl who her mmr and vzv vaccine 10 days ago and who 24hrs ago developed mild lesions on trunk that have spread some more overnight. mother states neck lesions are itchy.   mother also reports mild asthenia and some diarrhea in patient for 24-48hrs too  tmax of 99.2o
Severe raised area rash on multiple locations on both sides of body with severe itching and pain and red areas. Went to Dr. and was diagnosed with Pityriasis Rosea. Prescribed oral Predisone and Hydroxyzine.   Was told he could use topical creams as well.  He has used Cortaide and Calimine lotion.
Pt. received GARDASIL dose #1, #2, & #3 - after #3 pt. experienced stomach pain, protruding stomach, trouble after eating.  Four times in the morning pt. walking to bathroom - lightheaded, fainted.  Frequent c/o HA, pain in muscle mostly R leg, hands trembling.  Pt. lost weight due to inability to eat because of pain.  ER visit -> bloodwork, check for ulcer, UA tests within normal limits.  Sxs continued.  Then went to regular Dr. - went to GI specialist/surgeon.  Scheduled upper & lower CAT scan of abd.  Test NL expect showed ovarian cysts.  Mom said news showed a story about a girl with similar symptoms.  "I'm 100% convinced it's from the shot" per mom.
Hives over general body. No swelling to face, lips, tongue, no s/s of respiratory distress. Decreased itching with BENADRYL. Pt "acting fine, normal", "looks awful". Parent instructed to continue with BENADRYL and prednisolone 15mg for 5 days.
Pt had called in yesterday(4/28/21) needing to schedule 2nd Moderna vaccine she had told clerk she go her vaccine 3/13/2021, Pt presented today for 2nd Moderna vaccine. Pt had lost her administration card from her 1st Moderna vaccine but when asked by nurse when her 1st dose was given she said the 13. Pt did reports she didn't have anything but a sore arm from the first vaccine. When looking in registry it was discovered that the vaccine was given 4/13/21.Pt was monitored for 15 minutes and notified of error and significant other understood to monitor pt for adverse reactions.
02/08/2021 onset headache, fatigue 02/10/21 fever, & diarrhea. Reports "terrible headache" & "just felt weak & tired". Took Tylenol for headache & went to bed, slept all day & night. Next day onset fever & diarrhea.
5 vaccines were administered to this chld. Immediately after the 5th vaccine,  the pt. displayed mild seizure activity lasting about 5 seconds. She awoke immediately. Was alittle dizzy and complained of a headache. She did not sustain any injuries. She layed on an exam table for about 15 minutes and seated for another 10 minutes. The family declined emergency care. Spoke to the childs mother the next day. The child felt well enough to attend school.
Headache, Myalgia,  injection site pain  Narrative:  Employee reports experiencing "arm tingling", injection site discomfort/itching, headaches, chills, body aches, sweats, fatigue, and nausea.  Reports use of Tylenol extra strength (500mg) every 4 hours x 2 days, while awake. Called in sick x 2 days. Reports symptoms have mostly resolved as of date of this report, with complaints of lingering fatigue and headaches.
patent had hives 12 days after the booster dose/ hives were all over his body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (patent had hives 12 days after the booster dose/ hives were all over his body) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0361321A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (patent had hives 12 days after the booster dose/ hives were all over his body). At the time of the report, URTICARIA (patent had hives 12 days after the booster dose/ hives were all over his body) outcome was unknown.            No concomitant medications were reported.  Patient had called to report side effects after he received Moderna vaccine. Patient reported that he had been dealing with hives since Christmas eve and stated that he had been dealing everyday and had been over a week at the time of the report. .After receiving the Moderna vaccine patient had to go to the urgent care and was prescribed steroids which he took for 2 days.   This case was linked to MOD-2022-437876 (Patient Link).