chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received HPV #2. 3 hours later, pt started have difficulty breathing, rash; lip & tongue edema. Seen at ER for anaphylaxis. S/P epinephrine, methylprednisolone, and diphenhydramine. D/C home on oral prednisone and EPIPEN.
got Covid; got Covid; This is a spontaneous report from a contactable consumer (patient).   A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number: unknown) as DOSE 2, SINGLE and (batch/lot number: unknown) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got Covid". The patient reported that had both vaccines he/she got Covid again like two days before he/she supposed to get the booster shot, thought they should change the requirement on the 6 months because if had sooner he/she thought wouldn't have the Covid.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient got vaccines at clinic at 9:45AM on 1/15/19. Our clinic does not carry VFC vaccines. Then at about 12pm on 1/15/10, patient was complaining of itchiness of the right thigh. Mother also noticed the right thigh was red and swollen. She called clinic which advised her to call primary doctor, our clinic.
RECEIVED VACCINES ON 02/21/07.  ON 03/03/07 NOTED A HARD RED SWOLLEN AREA AT INJ SITE ON R THIGH, 1.5CM X 3CM AREA OF ERYTHEMA AND INDURATION WITH NEEDLE MARK IN CENTER, AFEBRILE.  TX'D AS CELLULITIS WITH CEPHALEXIN 250 MG TID X 10 DAYS. PROGRESS REPORT ON 03/05/07 - DOING FINE, ERYTHEMA GONE BUT INDURATION REMAINS.
a 41 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/22/2021. The patient experienced the following reaction(s) during the immediate   of observation: 2:26pm Patient vaccinated. Patient was treated/managed as follows:    2:28pm Bruising noted at vaccinated site, left deltoid. Patient denies taking blood thinner. Patient c/o soreness to site, and numbness/tingling to left arm. Ice pack provided and applied. 2:45pm Patient reports numbness and tingling improving. Patient given educational material regarding vaccine and advised to continue to self-monitor per guidance. Patient returned to observation area with family.
My big toe is like really painful and like swollen; My big toe is like really painful and like swollen; It's a little red and it's painful; joint of my big toe is really red and very painful; This is a spontaneous report from a contactable consumer (patient reported for herself). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EP6955 and Expiration date: 30Jun2021) via intramuscularly, in left arm on 29Mar2021 (at the age of 61-years-old) as dose 1, single for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had 1st COVID shot on Monday the 29th (29Mar2021). On 01Apr2021, the patient experienced big toe that was like really painful and like swollen. Big toe was like red, and that was not really swollen. It was a little red and painful. Patient stated the joint of his big toe was really red, very painful. The patient was still experiencing the adverse event and it had worsened than it was on last day (09Apr2021). The patient enquired if that was a normal reaction from the COVID shot. Patient just wanted to know if other people had that reaction. Patient received no treatment for the events. Patient stated due date of her second shot was on 19Apr2021. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Within minutes of receiving the Pfizer vaccine, my heart rate began to increase. My normal resting heart rate is around 60-65 bpm.  Within minutes, I could feel it increasing and pounding in my chest. I checked my Fitbit, and saw it was up to 90 by about 10 minutes. It was over 100 within 15 minutes while at rest and while I was actively trying to bring it down by breathing deeply and slowly.  I checked with a nurse who asked a number of questions related to anaphylaxis, then suggested I drink water and stay for observation. I stayed for 1 hour, but it never went below 90 while at rest, even with me actively trying to make it slow down.  It remained this way for about 4 hours, when it finally returned to my normal resting heart rate. However, when I do anything, even non-strenuous things like walk a short distance, wash dishes, pull weeds in my yard, water my flower pots, etc., my heart rate spikes up to 115, 125, 135 for no valid reason. I can usually bring it back down quickly if I sit down, drink water, relax and breathe deeply for a few minutes. But it is very disconcerting to have my heart go ?wild? for no valid reason when doing normal activities. This did not happen before I had the vaccine.
Within few hours, child became irritable, mild fever, cried about 24 hours.  Had swelling at injection site for 1 week.
Red arm; 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   In September 2021, the patient received the 3rd dose of Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced erythema of extremities and extra dose administered. On an unknown date, the outcome of the erythema of extremities and extra dose administered were unknown.   The reporter considered the erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was reported. The pharmacist stated that, the patient received a 3rd dose of Shingrix this past week, which led to extra dose administered. The reporter stated that, the patient had a really red arm from the vaccine. The health care professional did not have the exact dates of vaccination for any of the doses administered as they were administered at another pharmacy. The reporter did not have any lot numbers or any additional information to provide at the moment, but stated that she might be able to gather additional information. The reporter consented to follow up.
Information has been received from a physician concerning a female patient who in August 2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # unspecified by reporter) (dose and route not reported). In August 2011, the patient still developed shingles a week after getting ZOSTAVAX (Merck). The patient sought unspecified medical attention. And on an unknown date the patient recovered. The reporter considered the event to be disabling. Additional information has been requested.
Patient received Janseen COVID vaccine. The first 1/2 of the vaccine was given easily IM to the left deltoid and then the patient complained of severe arm pain, tensed her muscles, and the last 0.25ml was difficult to inject. Then the patient became hypotensive 90/45, dizzy, and felt like she was going to pass out. She was laid in the supine position, given a cool cloth for her forehead and monitored for approx. 45 minutes. Her blood pressure remained 90/60, 96/56 at discharge. Her heart rate ranged from 55-65, regular. Her son came to take her home as we did not feel comfortable with the patient driving. The patient was continuously monitored by the NPs and APCT. She ambulated without difficulty and was discharged home. She was given information for V-safe to report her reaction and advised to follow up in the ER for any SOB, difficulty breathing, difficulty swallowing, syncope, CP, etc.
Runny nose, achy, headache. It lasted 7 days and running a fever.
Swelling, redness, itching, pain and muscle aches at injection site and down the arm one week after receiving the shot.
The patient had Prevnar vaccine and both legs turned blue, form hip to ankle.  The leg the injection was given in was worse.  The symptoms were resolving by the time the MD saw the patient, who was stable. No treatment except observation.  The patient also had a fever of 103.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On 28-JUN-2016 the patient was vaccinated with ZOSTAVAX (lot #, dose and frequency were not reported), intramuscularly (product use issue). No adverse symptoms were reported. Additional information has been requested.
2:17 states teeth are hurting and suddenly feels very tired and sleepy. Taken via w/c to private observation with EMT in attendance. Denies dizziness or lightheadedness. No redness, itching Denies throat problems. State arm sore. No swelling or redness noted.  BP 128/84; HR 98; O2 97% on r/a 2:27 states she has a metal taste in mouth. Denies having fillings. Still feels sleepy. Denies dizziness.  BP 130/85; HR 84; O2 99% on r/a 2:33 states she feels fine. EMT offered ambulance and patient declined. Patient declined lightheadedness, dizziness. States she didn't eat much for breakfast and plans on going home to rest for the day. Encouraged water intake, gave water and tolerated well. Stood, gait steady. Self ambulated to private vehicle.
Weakness in left index finger and thumb, followed by complete immobiliy of left hand, followed by no improvement for months, followed by EMG and cubital tunnel release on 8-16-2022 with no improvement in hand mobility, followed by patient of Neurosciences Clinic 10-5-22, followed by MRI and EMG at Univ. Utah on 10-28-22, followed by diagnosis of probable ALS, sent to Neurosciences ALS Clinic 11-30-2022.
Receive varicella vaccine 2/18/14. After vaccine (15 min) pt stated she had a burning feeling around her mouth and itching on face. Pt had no difficulty breathing. There was no redness or swelling at injection site. When pt left problem had resolved. Pt was instructed to call 911 if problem occur again. 2/20/14 pt left message that shot site was raised and red and itching. No other problems. T.C. to pt to go to MD or ER. 2/21/14 T.C. from pt went to express care. Dx with cellulitis - taking Cipro bid "arm red and swollen advised her to if further problems occur.
Incidence of myalgia with the Pfizer vaccine is between 38.3% to 42.2% and typically at the injection site. This patient developed myalgia and polyneuropathy 2-3 weeks prior to inpatient admission and attributed the symptom onset with the administration of the first COVID vaccine. Vaccine administered 5/19/2021 and admitted 6/8/2021. Patient also has diabetic neuropathy for which she takes gabapentin and the symptoms may be related to the that. MRI thoracic & lumbar spine showed no central cause of symptoms. Added this pain to the allergy list for the patient as the etiology is unclear. Reported to VAERS.
-lower extremity edema, pitting. started 5 days post vaccine. currently still present. -heart palpitations not related to caffeine intake or other reasons -irregular heart beat -intermittent chest pain and overall weakness
given expired vaccine; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given expired vaccine) and NO ADVERSE EVENT (No Adverse Event) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2022 at 10:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given expired vaccine) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given expired vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (given expired vaccine).    No Concomitant medication was provided by reporter.  There were Individual vials with Vial size 5.5ml and on 29Nov2022 the vial was initially stored in the refrigerator.   No Treatment Drug was provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2022: Live-Significant Follow-up received with No New Information
Patient states he experienced bicep and deltoid pain that night and a scratchy throat. He states he awoke in the morning with a fine erythematous papular dermatitis to his chest, back, neck, face and arms. A few lesions may have been pustular. He has no lesions to his legs, groin, palms or soles.
inflammatory response in my eyes; couldn't keep them open; My eyes hurt/bright lights, heat or any stress causes them to hurt; severe migraines for 24 of the next 28 day; my eyes still are very sensitive, the sun can cause pain then migraine; Couldn't hardly see vision still isn't as it was before; This case was reported by a consumer and described the occurrence of eye inflammation in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced eye inflammation, eyelid function disorder, eye pain, migraine, eyes sensitive to sunlight and visual impairment. On an unknown date, the outcome of the eye inflammation, eyelid function disorder, eye pain, migraine, eyes sensitive to sunlight and visual impairment were not recovered/not resolved.   It was unknown if the reporter considered the eye inflammation, eyelid function disorder, eye pain, migraine, eyes sensitive to sunlight and visual impairment to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 2nd dose of Shingles vaccine and had an inflammatory response in his/her eyes, his/her eyes hurt so bad that could not keep them open, had severe migraines for 24 of the next 28 days.  A year later, the patient's eyes were still very sensitive and the sun could cause pain and  then migraine.  The patient's vision was not still as it was before, bright lights, heat or any stress causes them to hurt so bad and get migraines with the vaccine. The patient stated that his/her eyes mean more to him/her and could take recommended supplements and went to a doctor that would treat him/her. The patient stated not taking another vaccine. The patient stated that month as was going to lose eyes. The follow up could not be possible as no contact details were available. The case was linked with case US2021AMR186978 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186978:same reporter
This case was reported by a healthcare professional and described the occurrence of cough in a 42-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history included allergy to IVP dye, allergy to Keflex, allergy to seafood, darvocet allergy and latex allergy. On 12 December 2006 the subject received 1st dose of Engerix-B. On 12 December 2006, less than one day after vaccination with Engerix-B, the subject was seen in an emergency room. The healthcare professional considered the events were clinically significant (or requiring intervention) (OMIC). At the time of initial reporting, 12 December 2006, the events were improved. The healthcare professional considered the events were possibly related to vaccination with Engerix-B.
large welt that is itchy, raised, hot; large welt that is itchy, raised, hot; large welt that is itchy, raised, hot; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (large welt that is itchy, raised, hot), VACCINATION SITE PRURITUS (large welt that is itchy, raised, hot) and VACCINATION SITE SWELLING (large welt that is itchy, raised, hot) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     The patient's past medical history included Intra-uterine contraceptive device insertion since an unknown date. Concomitant products included LEVONORGESTREL for Prevention, ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE WARMTH (large welt that is itchy, raised, hot), VACCINATION SITE PRURITUS (large welt that is itchy, raised, hot) and VACCINATION SITE SWELLING (large welt that is itchy, raised, hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (large welt that is itchy, raised, hot), VACCINATION SITE PRURITUS (large welt that is itchy, raised, hot) and VACCINATION SITE SWELLING (large welt that is itchy, raised, hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt had R arm pain , redness, swelling & itching with 1/2 baseball lump size under her R arm, 1 day after her 2nd Moderna shot on 04/24/21. Per Urgent Care notes: "Redness from shoulder to elbow with streaking  across R breast, warm to touch, non tender." Pt was prescribed cephalexin 500mg every 6hrs x 5 days. Pt  fully recovered from vaccine reaction with no issues.
Nausea, vomiting, stomach pain reported by mother and patient. Patient directed to exam room. Notified doctor who advised for monitoring. Obtained vital signs which were within normal limits. Gave Gatorade, crackers. Monitored patient for 30 minutes. After monitoring patient stated that he felt better, symptoms where no longer present. Allowed to leave facility with mom.
Fever, chills, severe nausea, vomiting, fatigue, moderate/severe body aches
Waves of hot/fire/acid burning throughout the whole body. Skin flushing and hot to the touch with waves of burning pain.
C/O SOB, dizziness, rash and itching. Throat itchy. Benadryl 50 mg given and Epi 1ml (1mg/ml). PREDNISONE 20 MG PO 3 TABS PO DAILY X 5DAYS. Rantidine 150 mg PO ONE TAB TWICE A DAY.
See office note. Patient was in parking lot  02/25/2021 Office Visit Subjective: Chief Complaint:PT WAS HERE FOR VACCINES-PCV AND VARICELLA AND HAD UNUSUAL REACTION.  Present Illness: PT WAS HEADING OUT THE DOOR AND THEN GRANDMA NOTICED HER TO BECOME VERY PALE WITH FIXED GAZE WITH LIMP FEELING. SHE APPEARED DUSKY.  NO JERKING MOTIONS. UNSURE IF SHE WAS BREATHING.  PICKED HER BACK UP OUT OF SEAT AND RUSHED INTO CLINIC. 'CAME TO' ON WAY BACK INTO CLINIC AND STARTED SCREAMING. FOUGHT EXAM.  VITALS ASSESSED THEN. REDNESS NOTED ON LEFT THIGH TRAVELING UP ENTIRE BACK. 1.25ML BENADRYL GIVEN. GRANDMA THOUGHT MOM MAY HAVE GIVEN ZYRTEC THIS AM.  HAS SEEN ALLERGY VIRTUALLY BUT NOT IN PERSON.  SPOKE WITH MOM. PT HAD SIMILAR PALE, ALTERED MENTAL STATUS, LIMP REACTION WHEN SHE HAD HER FOOD ALLERGY TO EGG.  IN THE PAST WITH VACCINES, PATIENT HAS DEVELOPED INCREASED REDNESS AT INJECTION SITE AND FATIGUE.  PT HAS A SLIGHT RN/COUGH SINCE LAST WEEK. NO FEVER. FEEDING OK. Objective: Vitals: HR: 150  Resp: 20  GENERAL: No acute distress.  Smiling. Playful. HEAD: Symmetric head shape. No lesions. EYES: Conjunctiva clear. PERRL.  EOM-I. No periorbital erythema or edema. EARS: TMs clear bilaterally.  EAC clear bilaterally.  NOSE: DRIED discharge.  Pink mucosa.  THROAT: Moist mucous membranes. No pharyngeal erythema, exudate, or drainage. MOLARS ERUPTING. NECK: Supple with full ROM.  No significant cervical LAD.  CARDIOVASCULAR: Regular rate and rhythm. No murmur. RESPIRATORY: Clear to auscultation bilaterally. No wheezes, ronchi, or rales.  ABDOMEN: Soft. Nondistended. Nontender. No masses or HSM.  EXTREMITIES: well-perfused. No clubbing, cyanosis, or edema.  SKIN: 10-15 CM OF ERYTHEMA AROUND LEFT THIGH INJECTION SITE. CONFLUENT ERYTHEMA NOTED UP LEFT SIDE OF BACK.  Assessment: Diagnosis: ALLERGY TO MEDICATION Z88 ALTERED MENTAL STATUS R41.82 VACCINE Z23 BRIEF ALTERED MENTAL STATUS W/ PALLOR AND INJECTION SITE ERYTHEMA AFTER RECEIVING PREVNAR. VARICELLA SITE NOT INFLAMMED. Plan: Procedures: Varicella 90716 MFR: MERCK LOT:          EXP: AREA GIVEN:          VIS DATE: 08/15/2019 GIVEN BY: PREVNAR 13 90670 MFR: WYETH LOT:          EXP: AREA GIVEN:          VIS DATE: 10/30/2019 GIVEN BY: IMMUN. ADMINISTRATION: 1ST 90471  IMMUN. ADMINISTRATION: EACH AD 90472  Other treatment: OBSERVED PATIENT FOR ABOUT 30 MINUTES AFTER REACTION AND 15 MINUTES AFTER RECEIVING BENADRYL. LAUGHING AND PLAYING WITH GRANDMA. ERYTHEMA STILL PRESENT BUT STARTING TO LESSEN. MOM TO CALL ALLERGY WITH NEWEST REACTION HAS ONLY BEEN SEEN VIRTUALLY SO FAR.  WILL CONTACT NEURO TO SEE IF EEG IS WARRANTED.  CONTINUE BENADRYL 1.5ML Q6-8 HR TODAY. Follow-Up: IF ANY NEW/WORSE SX Date Created:  02/25/2021 Date of Service: 02/25/2021
Spikevax for ages 11+ administered to 6-year-old in error.
This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was reported. On unknown dates, the patients received improperly stored doses of RECOMBIVAX HB (dose and route of administration were not provided) lot # M037248, expiration date: 21-FEB-2019. No adverse effects were reported. The vaccines were stored for 2 hours and 30 minutes in the temperature between 9 and 25 degrees Celsius. There were no previous temperature excursions. Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013230: US-009507513-1704USA013231: US-009507513-1704USA012451: US-009507513-1704USA013737.
It was reported that a 49 year old female patient received a Fluzone SV 2001-2002 vaccination, administered on 12/26/01. That evening the patient developed pain in her deltoid shoulder area. Patient has limited range of motion due to the pain--unresolved. (Not sure which lot # - U0711AA or U0592AA exp 6/20/02).
headache overnight into the next day; dry mouth; 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 1, single for covid-19 immunisation. Relevant medical history included: "high levels of stress" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache overnight into the next day"; DRY MOUTH (non-serious), outcome "recovering", described as "dry mouth".  Additional information: It was reported that prior the vaccination, the patient (reported age: 50, unit: unknown) was overall unhealthy and leads an unhealthy lifestyle consisting of poor food choices including little to no vegetables or fruit intake, lack of exercise, and high levels of stress. It was reported that dry mouth subsided the next day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.