chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extreme pain; in the arm that I got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Oct2021 02:47, outcome "unknown", described as "extreme pain; in the arm that I got the shot".  Additional information: It was reported that, I am having some extreme 'pain'. In general city time it is 02:47 in the morning and I woke up with extreme pain in my, in the arm that I got the shot within and is it ok for me to use the ice pack. My arm is killing me.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had vaccine at school administered by Health Department nurses on 03/31/2022 in AM. Woke up with rash on 04/02/2022 & took po Benadryl. No other s/s. Rash worse & large areas on shoulders, arms legs & especially on back of legs with no other s/s & went to Urgent Care on 04/03/2022 & given Steroid dose pack. Asof 04/06/2022 he is better. Mother is a nurse & says he has a lot of allergies.
Patient had vaccine on 8/18 and presented on 8/21 with mother with left arm edema, erythema and warm to touch. Left arm measured 11cm x 10cm edema and erythema noted. No pain with palpation. Denied numbness and tingling. Patient prescribed BENADRYL 8/21 and instructed to RTC if s/s persist or worsen. Mother verbalized understanding.
Case number PHEH2014US020714, is an initial spontaneous report from a nurse received on 14 Oct 2014. This report refers to an 11-year-old female patient. Her medical history and concomitant medications were not reported. On 14 Oct 2014, she was vaccinated an intramuscular dose of MENVEO (batch number: M14055) where MenA lyophilized conjugate component reconstituted with a sterile diluent (and not MenCWY liquid conjugate component). No adverse event was reported following this administration error (wrong solution used in drug reconstitution).
Cronic puratic rash  Initially at injection site, has spread to most of upper body.
warm to touch near injection site; aches and pain; felt sick; arm was painful; Hardness near injection site; itching near injection site; redness near injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm to touch near injection site), PAIN (aches and pain), MALAISE (felt sick), PAIN IN EXTREMITY (arm was painful) and INJECTION SITE INDURATION (Hardness near injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced INJECTION SITE WARMTH (warm to touch near injection site), PAIN (aches and pain), MALAISE (felt sick), PAIN IN EXTREMITY (arm was painful), INJECTION SITE INDURATION (Hardness near injection site), INJECTION SITE PRURITUS (itching near injection site) and INJECTION SITE ERYTHEMA (redness near injection site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INJECTION SITE WARMTH (warm to touch near injection site), PAIN (aches and pain), MALAISE (felt sick), PAIN IN EXTREMITY (arm was painful), INJECTION SITE INDURATION (Hardness near injection site), INJECTION SITE PRURITUS (itching near injection site) and INJECTION SITE ERYTHEMA (redness near injection site) outcome was unknown.            Concomitant medication information included Chemotherapy   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15-JUL-2021 contains No New Information (NNI)
Patient reported tingling pain from left deltoid down to finger started after getting  a flu vaccine on 11/6/2020. Patient called pharmacy on 11/9/2020 to report adverse event of shooting, tingling pain in left arm after getting a flu vaccine. The pain comes and goes several times throughout the day and the pain lasts about a few seconds. Patient stated injection site area has no redness, no swelling, and is not tender to touch. Patient did not report any shoulder/neck pain nor any joint pain, just the tingling and shooting pain down her left arm. Patient reported no muscle weakness nor any diminished strength in left arm. The patient was worried that pain started Friday night and still lasts until day reported on 11/9/2020. Pharmacist on duty recommended patient to seek medical care if pain doesn't get any better by next day. Pharmacist will follow up with patient on status of symptom and if patient seeks medical help.
This spontaneous report was received from a physician referring to a 4 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 04-AUG-2017, the patient was vaccinated with an expired dose of PROQUAD rHA lot number M004891 and expiration date of 25-JUL-2017 for prophylaxis (dose, route of administration, lot number and expiration date were not reported).
Large, red circle around injection site with swelling and pain. Pt went to MD office. Not cellulitis. MD determined topical reaction resolved on own, no treatment.
This spontaneous report was received from a register nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 08-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The register nurse reported patient experienced 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-201 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Left arm soreness present the day after vaccine injection never fully resolved, continued to go to the gym for about 4-6 weeks post-vaccine but could not use the usual weights for any exercises involving the left shoulder (0-5 lbs instead of the usual 12-15 lbs).  Exam consistent with shoulder impingement. Tried anti-inflammatory medication (Celebrex) without relief. Could not sleep through the night, woke up 2 or 3 times/night with left upper arm pain. Started physical therapy December 2021 (about 2 mos post-vaccine). Eval today showed improvement with continued decrease in range of motion. Plan to continue PT.
lichen planus/itching; This spontaneous case was reported by a patient and describes the occurrence of LICHEN PLANUS (lichen planus/itching) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 018B21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID-19 - Jan2022, no hospitalization) in January 2022. Previously administered products included for Product used for unknown indication: FLU VACCINE VII in 2021. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII. Concurrent medical conditions included Seasonal asthma.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced LICHEN PLANUS (lichen planus/itching). The patient was treated with HYDROXYZINE for Itching, at a dose of 2-3 tabs at night; LORATADINE at a dose of Once at night; DOXYCYCLINE at a dose of Once in the morning for 30 days but will need a refill and CLOBETASOL PROPIONATE (IMPOYZ) at an unspecified dose and frequency. At the time of the report, LICHEN PLANUS (lichen planus/itching) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, Biopsy: Diagnosed with Lichen Planus.         No concomitant medication was reported.  Patient had not experienced similar events in the past. It was reported that the events on some parts of the body were improving but breaking out on some. Treatment also include Fernico spray.
Vaccine recieved at 0930 am . Per nurse, patient waited 15 minutes post vaccine and left with no reported issues.  Patient called the clinic at 1000 from her car stating that the  left side of face and left arm was numb and tingly.  Patient also stated she was lightheaded and dizzy.  The nurse advised her to pull over to the side of the road and call 911.  Patient was taken to the emergency room and discharged.  Follow up call to the patient at 12:30 with no answer and at 1400.  At 1400 patient stated she was feeling much better but tingling in side of face and arm was still mildly present.  She has a roommate staying with her for the day.  Patient was advised to seek medical care if symptoms worsen or do not resolve.
pt recv vax;approx 1 wk,began itching on rt side;few days later,red "bumps" appeared in same location;N/V;d;fever;itching & rash cont;to MD;dph,PO steroids;pt scratched so much that bumps turn into open sores;PC to pt,still itching;
This spontaneous report was received from the patient's mother who is also a company representative and refers to 12-year-old male patient. The patient's concurrent conditions included haemolytic uraemic syndrome (HUS), kidney failure, dialysis, blood transfusion and asthma. On 09-APR-2018, the patient was vaccinated with the first dose of GARDASIL 9 for human papilloma virus (HPV) prevention. Concomitant therapies included probiotics (unspecified), vitamins (unspecified), ASMANEX TWISTHALER or ASMANEX HFA; reported as ASMANEX. On the same day, reported as after receiving the dose and last night, the patient experienced 4 bouts of vomiting. The patient did not seek medical attention and did not receive any treatment for the reported event. The outcome of vomiting was reported as recovering. Causality assessment was not provided. This is one of two reports refers to the same patient. Sender's Comments: US-009507513-1804USA004780.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 29-JAN-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of the patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not reported and the lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
running errands and she was shortness of breathe and chest heaviness.; running errands and she was shortness of breathe and chest heaviness.; also reported that she had a rash and hives on the day of vaccine; also reported that she had a rash and hives on the day of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (running errands and she was shortness of breathe and chest heaviness.), CHEST DISCOMFORT (running errands and she was shortness of breathe and chest heaviness.), URTICARIA (also reported that she had a rash and hives on the day of vaccine) and RASH (also reported that she had a rash and hives on the day of vaccine) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 URTICARIA (also reported that she had a rash and hives on the day of vaccine) and RASH (also reported that she had a rash and hives on the day of vaccine). On 27-Mar-2021, the patient experienced DYSPNOEA (running errands and she was shortness of breathe and chest heaviness.) and CHEST DISCOMFORT (running errands and she was shortness of breathe and chest heaviness.). At the time of the report, DYSPNOEA (running errands and she was shortness of breathe and chest heaviness.), CHEST DISCOMFORT (running errands and she was shortness of breathe and chest heaviness.), URTICARIA (also reported that she had a rash and hives on the day of vaccine) and RASH (also reported that she had a rash and hives on the day of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Left arm around injection site became sore morning of 1/21/21, small (approx 1 inch) area became red shortly after, which expanded to approx 6 inches in length and 4 inches in width appearing as a red rash on the left arm. Arm became increasingly sore throughout the day. Morning of 1/22/21, redness had spread less than 1 inch bigger, still sore and itchy.
Pt exp a head to toe rash w/generalized slight itching DEC90 following the 2nd Engerix-B vax;
Urticaria, erythematous, macular, wheals covering distal upper extremities behind right knee. Urticaria/ hives
73 y.o. male with a PMH of prostate CA, depression, anxiety, renal artery stenosis, orthostatic hypotension, and recent admission 1/11-1/12/23 for CP, dizziness, found to be covid positive. He presented 1/13/2023 with sudden aphasia. Per wife, last known well 1130. S/p TNK @ 1309.
Pt reported rash on upper arm, 6-8" long, which lasted for approximately 4 weeks.
MA administered HPV and MCV4 vaccines to patient's right deltoid. Patient tolerated well but then lost consciousness and convulsed. PCP was called into the room and assisted. Patient did attempt to sit up and experienced syncope a 2nd time. Patient was given juice and crackers and made to lie down for a few minutes prior to leaving. PCP gave instructions on after care and follow-up.
09/11/22 presents to ED for "fall". PMHx of "HTN, T2DM"
Ct. was to receive PPD 0.1cc for TB skin test on 8/16/04, instead Ct. received Adult Td 0.5cc  ID in left forearm.  This nursing staff did not visually assess Ct. Mother reports Ct. seen at Pediatrics.
The following day, the 6th, I had a fever, body aches and chills - like a flu. That lasted for about 6 hours. I had general fatigue. I took Aleve and I was fine. Then I had insomnia, and heart  palpitations  - I got those two weeks after the vaccine. This was almost like anxiety - it was like my heart was racing. I had to get up and walk around the room because of it. I don't have anxiety ever so this was a huge difference in me.   I took homeopathic stuff and drank cherry tart juice.  Those symptoms lasted from week 2 to weak three.
At 7pm, 4/22, she developed macular exanthema left lower and lateral leg from below knee to the ankle. Petechiae present, itching and burning. Gave script for triamcinolone 0.1% cream 80 mg apply BID.
This spontaneous report as received from a nurse refers to a 6 month old male patient. On an unknown date the patient was vaccinated with his first dose of ROTATEQ, (route of administration defaulted to oral, dose was not reported) at age 6 months (inappropriate age of vaccine administration). No adverse effect reported. Additional information has been requested.
I received the 2nd moderna vaccine last Friday 1/29 and around Saturday 1/30 night / Sunday morning I started getting this HORRIBLY ITCHY RASH!! All over my stomach, side of stomach, back, shoulders, mid butt, arms only to about my elbow.  Sunday and monday night took 50mg Benadryl-no improvement. Tuesday-Thursday took Zyrtec 20mg BID-no improvement or clearing of rash. Friday- consulted covering PCP who prescribed  11 day oral steroid course- Predisone. Took first dose Friday 2/5 at 1pm noticed improvement of rash  and symptoms saturday 2/6 AM.
Administration error not adverse event. Patient signed up to receive booster dose of Janssen Covid-19 Vaccine. The intended vaccine was correctly selected, verified, documented; however, upon administration the vaccine was past it's beyond use date.
Local reaction to vaccines. Cellulitis right deltoid area. Tx: Ibuprofen 100/s mL 1 1/2 tsp po q 6 hours rn on full stomach. Warm compress.
Patient presented with chest pain after exposure to COVID positive person. Person was vaccinated. EKG showed STEMI. Was taken to cath lab and found to have no blockages. Provider has deemed this to be myocarditis.
Approximately 48 hours after receiving the 2nd dose of the Moderna vaccine, I experienced extreme itching and an almost burning/tingling sensation in my back. After about 5 minutes, I was covered in hives from my neck down to my hips. The top of my head felt sensitive, but we couldn't see if there were hives under my hair or not. It appeared on the bottom half of my neck, across my shoulders down to about mid-arm, a couple splotches on my forearms, across my breasts and stomach, full back, and even the top of my pelvic area. I did not notice any major areas on my legs. I took 3 doses of Benadryl throughout the day for the reaction and ibuprofen for the itching and sensitivity. Still pink and sensitive 24 hours later, though not itchy or as red anymore. Only really remains on my chest and stomach and minimally on my forearms.
she fainted at her home; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 11-year-old female patient received BNT162b2 (COMIRNATY), on 21May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 11 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: SYNCOPE (medically significant) with onset 22May2022, outcome "unknown", described as "she fainted at her home". The event "she fainted at her home" required physician office visit.   Clinical information: The reporter reported that after receiving booster dose. The next morning, she fainted at her home. Her parents took her to the (name withheld). The pediatrician on call said it was potentially a side effect from booster. They did an overall evaluation and sent her home.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immediately after receiving vaccine injection had many PVC's in a row. Similar thing happened with the 1st dose of the covid vaccine.   After the first dose of the vaccine's increased PVC's lasted about 24 hours after which PVC's decreased to well below the baseline they had been at for the previous months. 2nd dose increased PVC's lasted about 2 hours and decreased back to the baseline prior to this dose.
This initial spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions. The nurse stated that on an unspecified dates, the patients could have received improperly stored ROTATEQ oral liquid, lot# K017575 expiration date 22-MAY-2016 (dose not provided). There was no concomitant medication described. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions and concomitant medication provided. On an unknown date in 2012, the patient was vaccinated with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot# and expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On an unknown date in 2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered the events to be related to the  ZOSTAVAX.