chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had been administered from vaccine that experienced Temperature excursion; Patient had been administered from vaccine that experienced Temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered from vaccine that experienced Temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered from vaccine that experienced Temperature excursion) in a 67-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 17-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered from vaccine that experienced Temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered from vaccine that experienced Temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered from vaccine that experienced Temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered from vaccine that experienced Temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The temperature excursion was occurred on 10-Mar-2022. Storage condition at the time of the excursion was refrigerator; maximum or minimum temperatures reached was max temperature reached 64-degree Fahrenheit; excursion duration was 7 hours instead 5 min (previously stated); date the vial was moved from freezer to refrigerator was unknown by the reporter; upon visual inspection no changes of vaccine state was observed and at the time of excursion the vials were unpunctured.  The patient did not experience any adverse events post injection.  The reporter was yet to receive the temperature stability report.  No treatment information was provided by the reporter.
Approximately 15 min after the vaccine was given, I felt dizzy, Light headed, feeling warm and then cold, chest tightness with mild shortness of breath, heart racing. It lasted for about 30 minutes. The symptoms subsided while sitting back in a chair and drinking 2.5 bottles of water. I was able to walk out and proceed with grocery shopping slowly. Have taken it easy the rest of the day but able to be upright. Now just fatigue, muscle aches, feeling cold, abnormal teeth and tongue sensation x 2 hrs). The rest of the symptoms just described continue this evening which i attribute to the covid vaccine.
4/1 J&J Vaccine, exactly 7 hrs later, intense chills, woke up next morning a-okay 4/3 A few min after waking up, itchy wrists (bilateral), then itchy shins (bilateral), last about 20min  4/5(?) Possible tick (on back - couldn?t really see or reach, scratched at it?) 4/10 Back pain/extreme tightness (fascia from back of knee to upper back feels like sheet of hard leather, extremely limited forward flexion, maybe 50% of normal?) 4/11 Painful intermittent scalp spasms over left ear for 2-ish hours 4/17 Hypersensitive mucus membranes 4/18 Right side of face falls down - Bell?s Palsy? 4/19 Weird hard-leather back pain fading 4/20 ?Headache? - actually feels like seizing scalp muscles behind top of ears 4/20 ?Cold? spots on skin, particularly legs 4/20 Painful knot (familiar) mid/upper right side 4/20 Out of breath 4/21 Leatherback returns 4/22 Awake 3am head pain back of right ear down neck 4/22 Awake 3am - I can feel my face! (BP resolving) 4/22 Extreme pain during asana, leatherback, shakey, lightheaded, out of breath, severe brain fog (almost hallucinatory) 4/23 Awake 1am extreme head, upper right back pain 4/23 Cold spots front of thighs above knee and left foot 4/24 Weird right upper arm/shoulder pain (hours after carrying around a dozen-ish 100lb-ish rocks) 4/25 Awake 1am -6am in extreme insanely excruciating pain right arm (upper/outer/upperback-ish) paced house for 5 hrs. Tylenol & vicodan useless 4/25 Period 2 weeks early (prednisone?) 4/28(ish) Starting to feel increasingly yeasty (doxy?) 4/29 Last day prednisone (accidentally took 1 extra day, grr) 4/29 Extreme weakness and pain - right arm utterly crippled, shoulder partially paralyzed??? (acute and continuous still as of 5/19) 4/29 Very off balance 4/29 Very jittery 4/29 Emergency visit with Dr (Grrr.) 4/30 Left bicep totally dead with pain like an ice pick through it, extreme weakness (pain, limited mobility and some weakness continuous still as of 5/19) 5/1 I can see in my notes that I am switching words!?! (left for right) ?someone mentioned to me on May 2(?) that I was switching left for right? 5/3 Dr video appointment 5/5 Brain fog approaching hallucinatory (hard to explain, everything around me slightly ?fun-house mirror-esque?, judgement is vey skewed, not fun!) 5/7 Last day doxy
Eyes burning 10 min after receiving Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunisation. A patient received dupilumab (DUPIXENT), via an unspecified route of administration from an unspecified date (Lot number was not reported) and ongoing, at unspecified dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. On unknown date, the patient experienced eyes burning 10 min after receiving Pfizer COVID vaccine. The outcome of event was recovered on unknown date in 2021. The action taken in response to the events for dupilumab was unknown.  No follow-up attempts are needed. No further information is expected.
Information has been received from a 73 year old female physician referring to herself. The patient's pertinent medical history included chickenpox, asthma, stroke (happened 1 year ago), hypertension, mitral valve prolapse, depression, osteopenia, low vitamin-d, psoriasis and skin cancers. The patient's drug reactions/allergies included SULFA, BACTRIM, CIPRO, COMPAZINE and VALIUM. The patient was also lactose sensitive and latex allergy. On 06-AUG-2015 the patient was vaccinated with a dose of ZOSTAVAX (1 injection, dose, route, lot no and expiration date were unknown) in the left upper arm for prevent shingles. Concomitant therapies included PROAIR and "About 15 other unspecified medications". On 10-AUG-2015 the patient began to have some joint pain that "felt like arthritic joint pain" and within the last couple of days stated she had developed a cough, exact onset date unspecified (on an unknown date in August 2015). The patient reported that the arthritic joint pain felt like it ran from her knee to her jaw. She also reported that she had "taken TYLENOL 500mg two times, saw her Chiropractor for the joint pain and also had to use her PROALR inhaler, 2 puffs, for her cough," on unspecified dates. She then reported that her "knee is feeling better, her respiratory symptoms are getting better after using her inhaler, and her jaw pain has improved since she has taken TYLENOL 500mg two times." None lab diagnostics studies were performed. The patient sought medical attention by calling to the primary physician and pharmacy. The outcome of the events was reported as recovering. The patient also reported that when the patient took penicillin or KEFLEX she broke out in an unspecified rash. Additional information has been requested.
It was reported that a 26 year old male pt received a dose of Fluzone SV '01-'02 on 12/6/01 at noon. The dose was given in his right deltoid. The pt has been previously immunized with influenza vaccine once prior (2 years ago). At approx. 21:00, on 12/6/01, he began to feel numbness in his face and he could not shut his eye and had difficulty moving his facial muscles on one side. The pt was evaluated by an MD on 12/7/01. No dx as of yet. The pt now has slurred speech and is planning to see another physician for a second opinion.
Patient received MMR vaccine on 6/7/07, returned to office on 06/22/07 complaining of rash for 7 days.
Flublok administered to 15 pediatric patients with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2022SA402707(CLUSTER), 2022SA402396(CLUSTER), 2022SA402443(CLUSTER), 2022SA402500(CLUSTER), 2022SA402436(CLUSTER), 2022SA402514(CLUSTER), 2022SA402525(CLUSTER), 2022SA402619(CLUSTER), 2022SA402662(CLUSTER), 2022SA402704(CLUSTER), 2022SA402707(CLUSTER), 2022SA402964(CLUSTER), 2022SA402510(CLUSTER) and 2022SA402530(CLUSTER).  This case involves a 12 years old female patient who was administered Influenza Quadrivalent Recombinant Vaccine [Flublok] at inappropriate age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Sep-2022, the patient received suspect Influenza Quadrivalent Recombinant Vaccine at dose of 0.5 ml, once (formulation unknown) (lot UJ887AA, exp date: 09-Jun-2023) standard strength, via intramuscular route in the left deltoid for immunization at 12 years of age with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day).  On 15-Sep-2022 the patient was administered with flubok with no reported adverse event (product administered to patient of inappropriate age) 1 day following the administration of vaccine.  No lab data was reported  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
nothing in the syringe and had to administer it again; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (nothing in the syringe and had to administer it again) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (nothing in the syringe and had to administer it again). At the time of the report, DEVICE CONNECTION ISSUE (nothing in the syringe and had to administer it again) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.
Approximately one week after receiving my first dose of the COVID19 Pfizer vaccine, I experienced soreness, redness and itchiness at and around the injection site. All three symptoms lasted 3 days and then cleared. The itchiness was treated with a topical cortizone cream which did provide relief.
Not able to lift my right arm. Nausea, high fever, headache, chills.
Severe chills starting at 1:30 am 17Mar21 followed by fever/sweats at approximately 3:00 am 17Mar21, Headache and body aches 8 am 17Mar21, vomiting 10 am 17Mar21. Headache and body aches present until 10:30 pm 17Mar21.
The first day of injection my arm was very sore. The next day I felt really lethargic and had a fever of 99.7.  My fever was gone by the next day.  My arm remained sore for around 4 days.  On April 1st in the evening my armpit in my left arm felt really sore.  I noticed the next day that my lymph node was swollen.  It's remained that way and today my arm became red around the injection site.  It feels raised, firm and hot.  I have a low grade fever of 99.1 and feel queasy.  My arm now is sore into my shoulder and collarbone. I've also had loose bowel movements off and on since my vaccine.
5 min after vaccine; Rash on face; 1 tsp Benadryl
Initial health care professional report received on 10 Mar 2010: This patient received expired FLUVIRIN 0.5 ml intramuscular on an unknown date in Mar 2010, sometime between 01 Mar 2010 and 09 Mar 2010. No other adverse events was reported.
Had white head at injection site of rabies#1 (RabAvert), Same day of rabies#2 he had right arm tenderness (same arm as injection) sore to the elbow, HA with pressure that affected his vision, tunnel vision, light headedness, tightness in chest with difficulty breathing, partial loss of sensation in arms, legs, temp 100, joint pain, above lasted 36 hrs and resolved.
Arthralgia of elbow of injection site arm, pain in great toe metatarsophalangeal joint, pain in ankle.
7JAN94 mom had given APAP a/vax 11AM; t101, fussy, mom gave APAP; 9JAN93 fussy, fretful, wouldn't sleep, wouldn't take formual would sleep 5-10mins woke up screaming;
got redness and itchiness on both arms and legs; got redness and itchiness on both arms and legs; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program COVAX US support. The consumer reported for a female patient (mother) who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unknown date in 2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness and itchiness on both arms and legs on an unknown date in 2021. Her second dose was schedule on 19Feb2021. The outcome of both the events was unknown.  Follow-up attempts completed. No further information expected.
Received the vaccine at 1230 and felt fine.  Got home and felt tired, napped for two hours and got up for 30-45 minutes, went back to bed.  Started feeling like she was spinning  in bed and felt light-headed.  Arm felt sore when she went back to bed.   Today, April 14, 2021, woke up and looked in the mirror and was surprised to see a red raised area, sense to touch, painful.  Noticed heart was beating quickly, and "feels off."   Swelling is noted  on the left deltoid measuring 60mmx36mmx2mm elevated and red, tender to touch.
varicella type rash; This spontaneous report was received from a lawyer referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. In or around 15-DEC-2017, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (lot number and expiration date were not reported). Shortly after receiving zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff suffered a painful varicella type rash on his arm. As a direct and proximate result, Plaintiff's symptoms have resulted in physical limitations, mental and emotional distress due to resulting physical limitations and seriousness of his condition, severe and permanent personal injuries. Further, as a tragic consequence the Plaintiff 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.  Upon internal review, the event was considered as disabling.
VACCINE ADMINISTERED AFTER 6 HOURS OF VIAL PUNCTURE; OFF LABEL USE; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; This spontaneous report received from a physician concerned a 13 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: 211D21A, expiry: 08-SEP-2022) .5 ml, administered on 25-MAR-2022 for prophylactic vaccination. Age at time of vaccination 13 years old. No concomitant medications were reported. On 25-MAR-2022, the patient experienced vaccine administered after 6 hours of vial puncture, off label use, and inappropriate age at vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after 6 hours of vial puncture, off label use and inappropriate age at vaccine administration was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000233206. This case, from the same reporter is linked to 20220558436, 20220558469, 20220558475, 20220558479, 20220558482, 20220558498 and 20220558436.
Pt. had a 9/10 cm blanching erythematous rash on Right deltoid area was warm and nonfluctuant. Cold compresses, ibuprophen and keflex was the treatment. Pt. was given an Hepatitis A injection into right deltoid IM.
White ulcers (3) under right side of tongue. Developed approximately 24 hours after vaccine, and were at maximum size and ulceration 48 hours after vaccine.  At 96 hours, nearly resolved with over the counter topical treatment.
Information has been received from a consumer concerning her 70 year husband with cholesterol, anxiety and high blood pressure, and no drug reactions/allergies, who on 13-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). Concomitant therapy included simvastatin (manufacturer unknown), LEXAPRO and losartan potassium (manufacturer unknown). On 17-JAN-2011, the patient developed shingles. The patient sought unspecified medical attention. At the time of the report the patient was on treatment for shingles with Gabapentin 300mg and Valacyclovir 1g. No lab diagnostics studies were performed. At the time of the report the patient's outcome was unknown. No further information is available.
I developed a temp to 101.3, chills, headache and severe mylagias. This lasted approximately 24 hours. I then developed an area of erythema and swelling below the injection site.
Skin rash and urticaria pruritus. Hydroxyzine 25 mg QID, Ranitidine 150 mg BID.
Client returned after receiving injection of H1N1 injection at 1:30 p.m. and complained of feeling lightheaded, nauseated, and just "off". She complained of "drunk feeling" and warm feeling at the injection site and across the left side of the chest. There was no redness to the left arm or chest. The client then complained of heaviness in the chest and left arm. An ambulance was called and the client was taken to the hospital.
Initial vaccine caused fever, chills, and profuse sweating. Prior to the vaccine I have had consistent subcutaneous nodules that appear at the injection sites. After receiving 6 vaccines and have since gone from a healthy man to a disabled one. I had severe spondylosis and osteoarthritis in my lumbar spine. I was released from work due to my condition and have since been unable to work due to the pain in my spine. I had a lumbar spinal fusion in Aug. 2012 and since having the initial vaccine I have had reoccurring severe hemorrhoids that have caused me to have several surgeries as well.
Patient developed cellulitis in left upper arm at injection site requiring hospitalization, IV antibiotics for 3 days. Follow up 01/20/05: Leukocytosis resolved, likely secondary to cellulitis of left deltoid, the site of injection. Follow up 02/03/05: Patient has recovered from adverse event. Patient was on Methotrexate and it is felt it probably caused it to localize around that area.
This spontaneous report was received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, route, lot number and expiration date were not reported) for prophylaxis. The temperature involved were from 6° F to 14° F for 72 hours. It was not previous temperature excursion, and a data logger was not involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1704USA002217:Original Case : 1704USA001049; US-009507513-1704USA002218:Original Case : 1704USA001049.
for 7 hrs, pt would cry cont for 45mins until tired out;p/about 15mins would start crying again;inj site was reddened w/some swelling;
Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and HEADACHE (Headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, FATIGUE (Fatigue) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient did not took any treatment. No concomitant medications were reported.
Patient was given 0.5ml instead of 0.25ml booster 3rd dosage,  patient was called on 1/18/2022 and denied any problems since vaccination. A letter was sent informing patient of dosage given.
Sore arm / Became severe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient 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), outcome "unknown", described as "Sore arm / Became severe".  The lot number for bnt162b2 was not provided and will be requested during follow up.
should restart the SHINGRIX series, due to being two months late for the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on September 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: should restart the SHINGRIX series, due to being two months late for the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 10-May-2023 The consumer who wishes to remain anonymous asking if she should restart the Shingrix series, due to being two months  late for the 2nd dose. Spoken as per package insert and content, gave medical disclaimer, referred to health care professional offered after call survey. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.