chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Asthma attack; Asthma attack; ringing in ears; arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 10:30 (Lot number: EW0158) at the age of 63-year as dose 2, single for covid-19 immunisation. Relevant medical history included: "Ringing ears" (ongoing); "Asthma" (ongoing), notes: Asthma severe in myself; "Reflux" (ongoing); "Eczema on skin dryness" (unspecified if ongoing). Family history included: "Thyroid issue" (unspecified if ongoing); "cancer" (unspecified if ongoing), notes: Mother cancer; "Heart attack" (unspecified if ongoing), notes: Father Heart attack. Concomitant medication(s) included: DEXILANT taken for gastrooesophageal reflux disease (ongoing); FLOVENT HFA taken for asthma (ongoing); PROAIR HFA taken for asthma (ongoing); CLOBETASOL 0.05% taken for skin disorder (ongoing). Past drug history included: Estrace for Balance of body hormones. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: ER8727, Anaomical location: Right Arm, Time: 10:30), administration date: 25Mar2021, when the patient was 63-year old, for COVID-19 immunization, reaction(s): "Asthma attack", "Ringing in my right ears", "Dizziness", "Arm pain". The following information was reported: ASTHMA (medically significant), DISEASE RECURRENCE (medically significant), outcome "not recovered" and all described as "Asthma attack"; TINNITUS (non-serious), outcome "unknown", described as "ringing in ears"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain". The events "asthma attack", "asthma attack (disease recurrence)", "ringing in ears" and "arm pain" were evaluated at the physician office visit. Therapeutic measures were taken as a result of asthma, disease recurrence. Clinical course: Patient received bnt162b2 on 18Dec2021 02:30 (Lot number: ED7218) via an unspecified route of administration administered on right arm as DOSE 3 (BOOSTER), SINGLE.   No follow-up attempts are possible. No further information is expected.
began exp diarrhea & low grade fever day p/vax; sx worsened to sz, following apneic episode requiring resuscitation; temp on admission to hosp was 105.3 R & pt was adm to hosp
Shoulder immediately sore and has been for 8 months and three weeks.  In the past month, I have developed pain in my forearm and right hand (shot was administered in right shoulder)
Breakthrough case admission after 4 vaccines Moderna 3/6/21 Lot# 030A21A;  Moderna 4/3/21 Lot# 018B21A;  Moderna 12/22/21 Lot# 032H21A;  Moderna 6/15/22 Lot# 060A22A
woke @ 130AM-very listless, floppy, fussy;t100.5a given APAP;woke @ 7AM extremely listless & floppy;t99.4 a 9AM;taken  to MD 11AM t101 ear;beginning to gain strength, but devel hives over entire body;tx w/DPH & Ibuprofen;
In the setting of profound immunocompromise, he has reactivated his VZV Oka strain (confirmed by sequencing). He has a rash and possible intestinal manifestations.
3/02 As the vaccine was given in my left arm, I felt it travel down inside my arm and toward my hand.  i waited at Pharmacy for 20 minutes with no reaction.  I returned home and within the hour I began to feel "very tired' and lay down in my bed.  Within minutes, my left thump had spasms and painful cramping and "froze" I massaged my thump for about 5 minutes and the pain subsided.  I then had painful cramping in my left calf and then the entire leg which then followed by Muscle pain and cramping in both legs.  I was told that I should exercise, so I went for a long walk.  When I returned home, i felt even worse so I went back to bed. Headaches began. I had flu-like symptoms (chills and discomfort) I covered my self with two blankets and drank lots of water and took an Aleve.which upset my stomach.  3/03 (the next morning), my usual sinus stuffiness was Gone! and I could breathe better than i have in a long time (by days end my sinusitis had returned) and so had my headache. Today 3/04 I still feel exhausted and I have swelling, puffs under my eyes (not usual) and occasional headaches.  My Left Arm (area of the inoculation) Has Never Been Painful!!!!!!
Information has been received from a nurse referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot # N000336, expiration date 03-JUL-2018, dose and route were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent (lot # and expiration date were unknown). The vaccine was exposed to temperature excursion -9 degrees Celsius to 8 degrees Celsius for 6 hours and 18 minutes and the data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010812:
Pt recvd DTP/OPV/HIB on 30JAN93 & pt was adm to local hosp ER @ 215AM on 21JAN93 w/grand mal seizures; ER dx was a general seizure disorder;
Fever from 99.7 as high as 101.1 for 36 hours s/p vaccine - Treated with acetaminophen and ibuprofen Clogged ears. - treated with Mucinex
This spontaneous report as received from an approximately 63 year old female patient without any pertinent medical history or drug reactions/allergies. About seven years ago, in 2006 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not reported). Concomitant therapies included LYRICA. About six years after getting the vaccine of ZOSTAVAX, in approximately 2012 the patient was diagnosed with shingles after receiving the ZOSTAVAX vaccine. The patient experienced pain and lesinos on the right side of her buttock. The patient stated, "Within four to five weeks, the lesions on buttock were gone". Three weeks after that episode, the patient developed a burning, stabbing pain in the fold of her left breast. Physician told her it was post-herpetic neuralgia (PHN) from having the shingles. The patient had visited many physicians (names not provided) and had tried many pain medicaitons (VALTREX and prednisone mentioned but others not specified) for relief but still continued to have pain. There were no lesions present at this time. There was Magnetic resonance imaging (MRI) and bloodwork performed without results. At the time of reporting, the patient had not recovered from adverse events. The patient sought unspecified medical attention. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Pt fainted after receiving the shot.  BP was stable.  Pt was conscious and responsive and rested on the floor for a while and then went home with father.
Fatigue, headaches, body aches, slight chill, very painful injection site, pain in underarm of the injected arm Lasted until about 48 hours after the shot
9/14/18- day of vaccinations, one shot bled a lot. Symptoms: hot, sweaty in the evening, fussy; 9/15/18- large size of half dollar, possibly bigger, hot, swelling and lump under skin on left leg where shot was on upper thigh, fever of 100.6; called nurse line at clinic about lump, they stated it was normal, apply ice pack and give TYLENOL. I did not give TYLENOL. 9/16/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8; 9/17/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8; 9/18/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8, runny nose and wet cough starts; 9/19/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8, slight runny nose still; 9/20/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8; 9/21/18- the day his demeanor changes, large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8- very tired and fussy, cries every time I move him, nurses from 7p-11p- does not want to come off, cries when not nursing, doesn't smile today; 9/22/18- wakes at 2am or 3am crying in sleep, just keeps crying cannot get to nurse, finally able to get him to nurse by 8am/9am, falls back asleep, will only sleep on me, cries if I move him. Call nurse line at clinic, she recommends we go to the ER based on his symptoms and age, fever of 101 at ER, TYLENOL given, lump still present under skin on left leg, looks more like a large bruise now, still size of half dollar.- We spend 6 hours in the ER, they run blood at urine. No UTI, No bacteria in blood but did not get all results prior to being discharged. They recommended TYLENOL and diagnosed as a virus. No smile today. If he wasn't sleeping, he was awake and crying or staring lethargically; 9/23/18- lump still present under skin on left leg, looks more like a bruise now, still size of half dollar, fever 100.5, still no smiles today, give TYLENOL dose at 7:30pm, got slight smile with bath time; 9/24/18- lump still present under skin on left leg, looks more like a bruise now, still size between half dollar and quarter, no fever today, wakes up with red rash all over body, we go to his primary care physician, rash- diagnosed as viral rash, given antibiotic for possible infection from shot- DID NOT GIVE antibiotic. Smiles today, slight wet cough present, diagnosed with virus. 9/29/18- bruise and lump still present quarter size on left thigh. Has been back to normal self since 9/25/18. 10/2/18- bruise and lump still present- quarter size.
3min p/vax hive 15mm, 140HR, crying, BP 82/50, no LOC or change of consciousness;no wheezing, no swelling of throat or large welt;induration resolved in 30 min;
Patient collapsed onto ground, whole body, was in tremors, eyes rolling in the back of his head. Patient was out for 1 minute and came to and was fine.
Vaccines Rotateq, PRX, Hib, PCV7 adm at 1630, rash noted at 1650 only upper body. Seen by PAC, Benadryl 1 ml adm PO as ordered. Rash decreased. Sent home with topical cream HC 1%.
Myalgia, Fever, NauseaVomiting, Site pain Narrative:
Had significant increase in vomiting leading to being admitted to the hospital for dehydration on 9/18.  Vomiting lessened after rehydration and child sent home then 2 days later vomiting restarted again with significant increase in diarrhea -- there is no bloody or bilious emesis, there is no blood in stool. Still afebrile.  Being giving IV Fluids again today.
Information has been received from a physician concerning an adult male who on an unspecified date was vaccinated with a dose of zoster vaccine live (Oka/Merck).  A few days later the patient developed shingles on the head.  The patient had never had shingles before.  It was unspecified if medical attention was sought.  The outcome was not reported.  No product quality complaint was involved.  Follow-up information received indicates that the physician is interested in the VZV identification program.  Follow-up information indicates that the patient is a 67-year-old male with allergies to atorvastatin calcium (Lipitor) and ezetimibe (+) simvastatin (MSD) and has a past history to childhood chickenpox, colon polyp, depression, high lipids and hypertension.  On 16-Nov-2007 he received a "unit," his first dose of zoster vaccine live (Oka/Merck) (lot #658361/090U) in the left arm.  On 18-Nov-2007, the patient developed a herpetiform rash with approximately 30 lesions on the back of the skull, face, dermatome II and V and had pain.  He had a maximum temperature of 98.6.  It was reported that there was no recent exposure to chickenpox.  The outcome was reported as not recovered.  The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the OKA/Merck vaccine VZV strain.  The sample lesion was collected on 27-Nov-2007.  The sample was taken from a crusted vesicle from the scalp.  Additional follow-up information was received.  The PCR results for the sample from a crusted vesicular lesion from the scalp site identified the presence of WT VZV.  Additional follow-up information from the reporting physician indicated that the 67 year old white male developed the onset of herpetiform rash on the forehead, back of head and the face on the morning of 19-Nov-2007 (also reported as 18-Nov-2007).  There was no illness at the time of vaccination.  The patient was not recovered at the time of this report.  The physician considered shingles to be disabling and an other important medical event (medical/surgical intervention).  Additional information has been requested.
mom states that pt cried continuously for 7 hrs following vax; pt was not able to be comforted; t101 sl swelling & redness @ DTP inject site;
Patient has hx of syncope. Patient was lightheaded and dizzy HR 42.  Epi given.  Vasovagal likely.  Called EMS however patient refused.
Soon after the vaccine, I had nausea and sinus/cold symptoms for about 2 days, then had a rash and still do have a rash.  Went to a doctor after a month of the rash and he diagnosed me with a viral rash of pityriasis rosea.
Patient had a very sore arm with large areas of bruising covering most of outer arm from injection site to above elbow.  Patient was cautioned about the rare side effect of thrombocytopenia and advised to reach out to her md.  Md does not believe this is the case as bruising was just on the one arm but ordered a CBC anyways.  Patient states bruising is improving.
pt recvd 1st vax of Hep B 03DEC90 & devel fever,h/a & body aches which lasted 5-6 days.
first dose in March and hasn't received second dose yet; 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 PRODUCT DOSE OMISSION ISSUE (first dose in March and hasn't received second dose yet) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose in March and hasn't received second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose in March and hasn't received second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Patient developed a disseminated pustular eruption consistent with VZ infection after receiving VZ vaccine 3 weeks prior. He was on prednisone 20-60 mg for one week prior to vaccination.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 02-OCT-2013 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # and route not reported) that expired on 08-SEP-2013. No adverse effects reported. Additional information has been requested.
After Vaccination client was waiting in observation area when he complained of ?feeling dizzy? approximately 15 mins into his observation. Client was placed in anti-gravity chair by EMT. Vital Signs were taken at 1115am BP 132/86 HR 61 RR 14 02 96%. Client stated he has a history of syncope and anxiety prior to shots. Client has a history of high blood pressure. Client reported not having breakfast in the morning and was given a snack at 1115am. He was recommended to stay an additional 30mins for observation, client complied. Vital Signs 1120: BP 186 HR 66 RR14 02 96% at same time client stated he ?felt better.? Client continued to be in anti-gravity chair in no apparent distress. He was able to answer all questions with no issues. Vitals 1125: BP 132/J80 HR 62 RR 14 02 95% 1130: BP 129/ HR 62 RR14 02 95%. Client was alert and oriented throughout the entire observation. No further interventions were necessary, and client was ready to head home. Emergency Precautions were given by EMT, if his symptoms worsened to seek emergency care. He was also recommended to follow with his Primary Care Provider.
large amount of liquid ran down arm during vaccination with FLUZONE HIGH-DOSE QUADRIVALENT, No AE; large amount of liquid ran down arm during vaccination with FLUZONE HIGH-DOSE QUADRIVALENT, No AE; Initial information received on 09-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 74-years-old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination, and large amount of liquid ran down arm during vaccination on 09-Sep-2020 for prophylactic vaccination.  The patient's past medical treatment included ENBREL for last 12 years. The patient's medical history, past vaccination(s) and family history were not provided.  Concomitant medications included SECUKINUMAB (COSENTYX).  It was a case of exposure via skin contact and vaccine underdose (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  There will be no information on the batch number for this case.
Hives on UE and scalp. Itchiness. Anxiety. Received flu shot. Present 5 minutes later with hives, itching and anxiety. Throughout UE. Vitals increased on presentation (2:30 pm vitals 140/86 P-75) no difficulty breathing. Pt was given 50 mg BENADRYL PO. Hives and itchiness decreased slightly 15 minutes later. Vitals after 15 minutes have returned to normal. Stable. Pt given 50 mg BENADRYL to take 6 hours later. Advised to see PCP.
Had 5 scattered tiny single pustules, scabbed over with erythema on right shoulder, right and left chest wall, right hip and left ankle, that developed approximately 03/31/2003.  Rash not pruritic.  Temperature 99 degrees F, 122/61-HR 74, Respiratory Rate 18.
Started with dizzyness around 11PM, went to bed. Woke up at 6:30AM with a very painful constant sharp headache, then had a sudden onset of nausea and went to bathroom and puked for around 10 minutes (emptied stomach and had dry heaves after). Checked my temperature and it was at 102F. The whole day it was around 100-102, it went lower after taking Tylenol and Advil. Had chills and sweats all day. As of 8PM its down to 100F and the headache isn't so bad but is still present.
Child presented with rash on face, stomach, arms and legs since 05/24/2004 in arm. Fever two days ago up to 102.
Headache, Myalgia, Arthralgia, Fever, Palpitations & HYPERtension Narrative:
I had symptoms of a call like congestion, coughing and a headache. I completed a COVID-19 Home test which was positive. I called my doctor and they prescribed Paxlovid which I started taking it the next day. My symptoms improved in about 2 days. The symptoms improved with some lingering symptoms like congestion and coughing. I was symptom free about 5- or 6-days in. I do feel that I have completed recovered from the symptoms of that infection.
This spontaneous report was received from a medical assistant refers to a one unspecified patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot number reported as M003703, for prophylaxis. The vaccine was exposed to a temperature ranges between 47°Fahrenheit (F) to 77°F, during a time frame of 30 minutes which was call by a data logger with no previous temperature excursions. Lot number M003703 is an invalid lot number for GARDASIL 9. This is one of several reports from the same source. Sender's Comments: US-009507513-1708USA004846: US-009507513-1708USA004847.
redness at the injection site; soreness, pain at the injection site; terrible pain beyond my leg/terrible pain behind the knee that went down to her foot\Soreness; PAIN BEHIND KNEE; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2020 12:00, the patient received the 1st dose of Shingrix (intramuscular). On 9th October 2020 05:00, 5 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site pain, leg pain and knee pain. The patient was treated with non-drug therapy (Hot Compresses). On 12th October 2020, the outcome of the injection site erythema, injection site pain, leg pain and knee pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, leg pain and knee pain to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix vaccine around noon. At 5 pm after vaccination, the patient experienced terrible pain behind the knee that went down to her foot it lasted for a couple of days.  She also reports experiencing soreness, pain and redness at the injection site. All symptoms became mild and resolved on 12th October 2020. The patient used hot pot, EMU machine and massages to help relieve the symptoms.  The patient states health care professional did not know about the event but was told by patient's daughter to report it. The patient was due for the 2nd dose in December and plans on getting it.  The reporter did not consent to follow-up.
Pt got 1st COVID vaccine on 1/13 @1309 (Moderna 012L20A) and reported had throat scratchiness, tightness and tongue fullness within 15min of administration.  Shortly after then got a headache. Generalized itching, nausea, stomach upset was also reported. Took benadryl and pepcid and states itching has improved but not resolved. Has a few bumps on outside of thighs which she thinks is from scratching, no rash. Throat swelling sensation somewhat improved from prior once seen in ED.  Patient was appearing well in ED but continued to have mild sensation of throat swelling, itching and nausea. Was observed in ED for 4 hours and discharged with prescription for prednisone
Red, swollen. Hard lump at injection site radiating into shoulder (Right). Mother was giving TYLENOL and BENADRYL and applying ice to site.
Information has been received from a 63 year old female consumer referring to herself with concurrent condition of allergic to sulfa. There was no pertinent medical history. On 07-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # K023007 is an invalid lot number for ZOSTAVAX) (dosage and route were not reported) 1 time injection. No concomitant medication was reported. On the same day the patient experienced swelling and redness 2 inches below injection site. No lab diagnostic studies were performed. The patient didn't seek medical attention. There was no treatment given. At the time of the report, the outcome of the event was not provided. Additional information is not expected as there is no contact information reported.