chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had vaccine at 1143, hives started at 1200, c/o itching throat at 1210 which progressed to difficulty swallowing. Epi given and pt transferred to ED
This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer given on 9 December 2007. On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as "Flumist" and administered intranasally. There were no other adverse events other than "bad taste."
rash down three quarters of left arm; Arm  was hot, very itchy and red; Arm was hot, very itchy and red; Arm was hot, very itchy and red; This is a spontaneous report from a non-contactable consumer (patient) received via a sales representative. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 03Jun2021 (batch/lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included Psoriatic Arthritis. Concomitant medication included infliximab (REMICADE). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, on 13May2021 at the age of 68- years in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 06Jun2021, the patient experienced rash down three quarters of left arm, arm was hot, very itchy and red. Therapeutic measures were taken as the result of the events which included treatment with Advil and Benadryl. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were considered non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
As of 12/28/17 we had a blood work and awaiting results. Pls. read paper attached. My daughter started having reactions Friday into Saturday morning 08/25/17 - 08/26/2017, I notice her eyes were swollen. But before the end of the weekend it disappeared, and again Tuesday morning 8/29/17 I noticed her eyes were swollen again which I called the doc's office and was given an appointment. We were advised to give her ZYRTEC and a prescription of Prednisone was given too. But her reactions occurred weekly, which ended up taking her to see a specialist for skin testing and she came out negative on all test performed on her. Though the skin test proved negative, she still had an episode of swollen eyes. We had a follow up 12/27/17 and lab work was done 12/28/17 and had to do another lab work which we are still waiting for the results.
This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 14-AUG-2017, the patient was inadvertently vaccinated with expired dose of ZOSTAVAX 19400 PFU lot # N041510, expiration 27-JUL-2017 (dose and route of administration were not reported) for prophylaxis. No adverse effects reported. No further information provided. Lot number N041510 has been verified to be a valid lot number for ZOSTAVAX. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-SEP-2014 the patient was vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
At 10:35 I started feeling weird in my body like when I get either an asthma attack or flu type. It was an hour later when I first began to feel lightheaded, dizzy, chills, and then really cold. I started then coughing hard like my throat was closing up and hard to breathe. My chest got tight and had sharp pains right under my chest by my stomach side. My heart rate was fast to the point my watch alerted me at over 135. I took my rescue ProAir inhaler to help but it didn?t. I tried to settle down and not panic to make things worse on my asthma attack. I then had to lay down feel weak. Within the next 15-20 min I used my nebulizer at home to help me breathe. After one treatment it helped me tremendously but still felt tired, nauseous, fatigue, pounding headache, but no fever since I barely checked at 98.5.
On the 2nd dose, the next day I experienced redness in my left eye.  I tried a dry eye lubricant that didn't work. I wen to my optometrist who advised that I had pink eye and gave me an antibiotic
Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: PATIENT NOTICED RECURRING NUMBNESS AND TINGLING IN LEFT TOP INDEX FINGER.  THIS HAPPENED ON AND OFF THROUOUT THE DAY AS SOON AS 15 MINUTES AFTER THE INJECTION. PT ALSO FELT TINGLING GOES UP & DOWN LEFT ARM. PT HAS A HISTORY OF POOR CIRCULATION IN FINGERS BUT NOTHING LIKE THIS.
Seizures started a few hours after vaccine was given. Patient is now taking Phenobarb and DILANTIN.
no further ae reported; Temp excursion occurred on 11/22/21; This spontaneous report was received from a nurse referring to a 24 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  Temperature excursion occurred on 22-NOV-2021. On 17-DEC-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the left arm (lot U010398, expiration date 01-APR-2023) (strength and dose were not provided).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
8NOV95 pt recvd vax that evening (4-5hrs later) devel hives 9NOV95 took OTC DPH;10NOV95 diffuse arthralgia, 12NOV95 fever, chills & arthralgia, saw PMD 13NOV;also devel red blotches w/hard lumps;to MD w/URI gave Keflex;edema
Swollen lips, slight rash on my face 50 mg Benadryl upon noticing the swelling around 8:30 pm 50 mg Benadryl at 4:30 M the next morning 9:45 am lips are still swollen
received an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 vaccine) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 vaccine). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Number of doses/vials: 13 doses from 1 vial; date the vial was initially stored in the refrigerator: not sure, because the facility received the vaccine in thawed condition; date(s) and time(s) vial was first punctured: 28-Dec-2021 at 10 pm; date(s) of administration of vaccine: 29-Dec-2021 at 10:30 am - 2:55 pm; post puncture the vial was stored in RT; the vial did not undergo any temperature excursions; total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was approximately 17 hours.  The patient did not report any side effects from this dose.  No treatment information was provided by the reporter.
Shaking chills, Fever, Muscle aches and pain, joint pain, migraine
Information has been received from a registered nurse referring to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 17-AUG-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # K021935, expiration date 10-NOV-2016, dose and route were unknown) that was improperly stored. It was reported that the doses were administered following an excursion of 14F from 28-AUG-2015 to 17-NOV-2015. No adverse effects was reported. This is one of several reports received from the same source. Additional information has been requested.
Initial unsolicited report received from a healthcare professional via partner company (Pfizer) on 19 January 2016. This case involves 52-year-old female patient who was vaccinated with a dose of Flu vaccine (batch number, route and site of administration not reported) on an unspecified date in 2002. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2002, following the vaccination, the patient had experienced arm and shoulder pain. Laboratory data was not reported. The patient had received physical therapy for 6 weeks as corrective treatment. The outcome of event was not reported. List of documents held by sender: none.
Patient had a severe local reaction with pain, swelling, erythema and limited range of motion. He also had a severe systemic reaction which included fever to 39.4, hypotension to 81/54, tachycardia to 130, and a fall at home after which he could not get up. The systemic reaction was not distinguishable from sepsis thought possibly due to treatment failure of doxycycline and amox/clav for treatment of cellulitis with polymicrobial abscess due to cat scratch. However, the infected site was well healing and all cultures at the time of illness were negative. Patient improved on Piperacillin/Tazobactam.
Covid19 breakthrough.  1st Vaccine received on 02/15/2021.  75 y/o with PMHx HTN, prostate CA, BPH, TUMT, Cysto, Radiation, HLD presents to ER with c/o 5 day history of SOB/Hallucinations/Hearing things.  Rm air sat 98%.  CXR-no acute.  Started on low dose steroids and Remdesivir.
I developed a Urinary Tract Infection approximately 4 days after the vaccine.  This was very unusual; I estimate that I haven't had a UTI for about 15 years.
This spontaneous report as received from a other health professional refers to a 19 year old female patient. On 02-APR-2015 the patient was vaccinated with GARDASIL lot # L001442 dose 1 for prophylaxis. Other suspect therapies included GARDASIL 9. On an unknown date the patient experienced interchange of vaccine products, no adverse event and inappropriate schedule of drug administration. The outcome of interchange of vaccine products, no adverse event and inappropriate schedule of drug administration is unknown. The reporter considered interchange of vaccine products to be not related to GARDASIL 9 and GARDASIL. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to GARDASIL and GARDASIL 9.
Soreness; Swelling; Red; Itchy; A spontaneous report  was received on 1 Feb 2021, from a consumer concerning a 44-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness, swelling, red, itchy, swollen.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Soreness, Swelling, Red, Itchy, Swollen.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), soreness, swelling, red, itchy, swollen was unknown.
Experienced moderate tension headache that same evening; asymptomatic the following 2 days.   At 2:00 am on 1/7/21 and 1/8/21, I woke up to severe face/ears/neck/and chest itching without rash.  No trouble breathing.  Upon waking had small welts that resolved within an hour.  Contacted PCP, continuing to monitor should symptoms persist throughout the following nights. If symptoms persist for 1 week, will schedule an appointment with PCP.
No reaction - pt's wife concern heard of disease state Guillain-Barre Syndrome.
While pt was still in the building, after receiving vaccines, pt started to develop very pruritic hives all around his head and trunk. Benadryl (1.5 tsp) was given po, observed for 35 minutes. Had slight cough but had clear breath sounds bilaterally. Left stable.
Dramatic hair loss following 2nd dose.  Evaluated by PMD then referred to  dermatologist.  Scalp biopsy revealed Alopecia Areata.  Steroid injections, topical Lidex, oral doxycycline and Allegra initiated.  Ongoing significant scalp hair loss then began to manifest in other areas on body as well.  Diagnosis then updated by dermatologist to Universalis. Have been evaluated by Rheumatologist as well now for this dramatic autoimmune presentation.
Pt complained of tingling around mouth after injection.Symptoms quickly resolved. VSS 130/61 67, 99% ; observed for 30 minutes.  Counseled to call 911 for any symptoms of anaphylaxis
7:00am- 1- 24 hr zyrtec & 2 tylenol 8:07 received shot 8:10 immediate intense shooting shocks through left arm down to fingertips...  8:30- shooting shocks through left arm and starting to throb down through hand ...          shooting up through next and base of head 9:00am- random shocks throughout my whole body. shoulder pain.   10:30- shocks stopped somewhat, shoulder and arm still achy, extreme fatigue/weakness,  fogginess,  blurry vision 11:30- extreme fatigue/weakness, fogginess, kind of blurry vision, severe shaking rt hand,  had to sit down.  Needed to hang on to things to walk.  12:00pm- continued severe fatigue and  brain fogginess & still minor blurry vision,  and a few shooting shocks in arm, shoulder , neck,   1:00pm? still great fatigue/weak, body aches-more like shocks than aches Neck is especially sore? back of neck up through head 1:10pm- severe fatigue, eyes hurt, foggy vision and cannot focus? off and on?  chest pain for a period of time 1:40pm- twinges through body, still extreme fatigue? fogginess, back of neck is super sore.. Shoulder is slightly sore? 2:00pm- shoulder sore, severe fatigue but other symptoms seem to be getting less?. 2:45pm- shocks in left arm?  4:00pm- went home from work? hard to drive and focus.. severe fogginess, disorientation,  4:20- laid on the couch? slept in between nausea, buzzing in my head, severe arm pain going down into my hand, random shocks throughout my body, could not focus, brain was fuzzy,  random severe itching, neck pain, eye pain, extremely irritable, extremely thirsty, bad taste in my mouth, extremely cold, no fever, super sensitive to sound & touch, no appetite, trouble peeing, felt extremely dehydrated. Needed to hang on to things to walk.   Fri, Feb 5 6:00am- next day? better, but still buzzing, ringing in my head, extremely exhausted & weak,  arm pain radiating to hand, hard to focus, coughing, chest heaviness like an elephant sitting on it, sore, scratchy throat, drainage out of head but not stuffed up?, eyes hurt. Severe nausea & bloating, rt hand shaking badly, no appetite 9:30am- everything is a bit better, coughing & chest discomfort gone,  still bad taste in my mouth, slight nausea, bloated, eyes hurt, extremely tired, entire arm sore, buzzing in my head?random twinges or jolts in my limbs?  11:00am- still super tired, still not peeing?... weird for me who pees every 2 hrs or so? Still really bloated? still buzzing in my head,  1:30pm- feeling better, no buzzing, no zinging, super tired and drinking a lot but not much peeing?   4:00pm- home and bed.. hard to sleep because of jolts though my body..      Sat, Feb 6 Normal body aches.. finally able to pee decently, arm and hand on shot side sore (this is my good hand side), shooting pain, and hand aching. Fatigue,  This has continued into Monday.. arm and hand pain are off and on. Everything is getting better?
Headache, muscle cramps, dizziness, problem breathing, could not sleep, weak, out of balance, tired and slept a lot when I got to sleep.
Given PREVNAR (L) anterior thigh marked erythema thigh warm 8 cm diameter erythema.
tightness, pain in chest, shortness of breath, weakness, pain and tightness in left lower neck and shoulder and upper inner bicep area. Symptoms were 5-15 min duration at a time coming and going at all times of the day both with physical exertion and without. Resting pulse was around 120 with each event, symptoms came and went over the course of a week and have since subsided on their own.
On Tuesday 11/9, complaint of bad stomach ache. And rash appeared on both legs. Continued 11/10, 11/11. Evening of 11/11 , difficulty walking with severe joint pain. Called dr who thought HSP. Brought to clinic Friday. Tested positive for strep. Ran blood and urine tests. No signs of sore or irritated throat. Started cephalexin. Tummy improves. Joint pain worsens. Sunday night called pediatrician with new joint pain in arms and hands who said to go to ER. Ran blood and urine tests. Diagnosed with hsp henoch schonlein purpura at ER. Pain continues and rash continues to present. Check up at pediatrician planned for tomorrow 11/17
This spontaneous report as received from a physician refers to a female patient of unknown age. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On an unspecified date about 1 week ago (approximately in Jul-2016), the patient was vaccinated with first dose of GARDASIL (strength, dosing details, anatomical location, lot# and expiration date were unknown). The reporting physician stated that within 10 minutes, while the patient was still in the office, the patient developed weakness and syncope that has been steadily improving but has not yet resolved. On an unspecified date (approximately in Jul-2016) after receiving GARDASIL the patient developed hypoglycemia with blood sugar levels in the 40's (unit unspecified). The reporting physician stated that the patient's condition is causing her to miss time at work. Patient is being treated through her primary care physician and that her primary care physician has performed multiple unspecified tests to determine the cause of the patient's problems. The outcome of the events were reported as not recovered. Causality assessment was not provided. No product quality complaint was involved. Additional information has been requested.
No adverse effect; patients who received improperly stored GARDASIL 9 since 8/13/2019; This spontaneous report as received from a phlebotomist refers to an adolescent patient of unknown exact age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.     On an unknown date in 2019 (reported as since 13-AUG-2019), the patient was vaccinated with incorrect stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # 1602281, expiration date 21-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The temperature excursion occurred on 13-AUG-2019. The vaccine was stored in temperature 30.60 degrees Fahrenheit for 41 minutes and in temperature 56.80 degrees Fahrenheit for 4 hours 30 minutes. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1909USA004622:
100.5 fever, headache, body aches, chills, fatigue. All symptoms lasted 48 hours
Severe headache for three days.; Fatigue for three days; Muscle pain for three days; Very sore arm at place of injection and through the shoulder; Very sore arm at place of injection and through the shoulder; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 27Apr2021 at 14:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included brewers' cancer 2018 for which patient completed treatment in 2019. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included tamoxifen (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received tramadol (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 24Mar2021 at 10:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Apr2021 at 00:00, the patient experienced severe headache for three days, fatigue for three days, muscle pain for three days and very sore arm at place of injection and through the shoulder. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with OTC medication, rest and lidocaine patches (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, fatigue and muscle pain were resolved on 01May2021; while that of the very sore arm at place of injection and through the shoulder were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Shot was very painful; This is a spontaneous report from a Pfizer-sponsored program, 2020_2021 Strategy Research. A contactable healthcare professional (patient) reported that a male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 13; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for invasive pneumococcal disease (immunization). The patient's medical history and concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) and the shot was very painful on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
swelling, warm blistering, reddened & hard to the touch began 29JUN; atarax Medrol dose pack Zantac;