chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Painful bumps on only top pads of fingers; Area of skin was numb to touch, but painful without touching; Area of skin was numb to touch, but painful without touching; One thumb had a larger area that was raised, felt like blister, but not liquid filled; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Mar2021 16:00 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "unknown chronic infection" (unspecified if ongoing); "functional natural killer cell deficiency" (unspecified if ongoing), notes: untreated functional Natural Killer Cell Deficiency; "Mannose binding lectin deficiency" (unspecified if ongoing). Concomitant medication(s) included: FLUCONAZOLE. Past drug history included: Vancomycin, reaction(s): "rash"; Morphine, reaction(s): "rash". The following information was reported: SKIN LESION (non-serious) with onset 12Mar2021 07:00, outcome "unknown", described as "Painful bumps on only top pads of fingers"; HYPOAESTHESIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 12Mar2021 07:00, outcome "unknown" and all described as "Area of skin was numb to touch, but painful without touching"; BLISTER (non-serious) with onset 12Mar2021 07:00, outcome "unknown", described as "One thumb had a larger area that was raised, felt like blister, but not liquid filled". Therapeutic measures were not taken as a result of skin lesion, hypoaesthesia, pain in extremity, blister.  Additional information: The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with covid prior vaccination and not had been tested post vaccination. The patient had painful bumps on only top pads of fingers. Area of skin was numb to touch, but painful without touching. Not blisters, not rash. Only a few bumps on some fingertips, but not all. One thumb had a larger area that was raised, felt like blister, but not liquid filled.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Normal side effects:  Chills, Aches, Headache, but much more severe than the second injection.  I had no noticeable side effects with the first injection and very mild side effects with the second injection.  I am reporting this info because everything I've read about the side effects of the COVID 19 booster vaccination were that side effects would be similar to the first and second injections and maybe even milder.  This was not my experience.
The patient received vaccine after improper storage; No other AE; This spontaneous report has been received from an office manager concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.   It was reported the following vaccines were improperly stored and administered to multiple patients (dates of administration were unknown): varicella virus vaccine live (Oka/Merck) (VARIVAX); Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (all strength, dose, frequency, route, lot number and expiration date were not reported) for prophylaxis. The reporter did not know which vaccines the patient received. The reporter also was not sure about the previous temperature excursion details for the vaccines. No other adverse event was reported.    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003205: US-009507513-2108USA003206: US-009507513-2108USA003207:
Strong arm pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Strong arm pain) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Breast cancer (past). Concurrent medical conditions included Blood pressure high.    On 16-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Strong arm pain) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (Strong arm pain) and HEADACHE (headache) was resolving.            Concomitant medication was not provided. Treatment information was not reported.
Fatigue/Fatigued in and out; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue/Fatigued in and out) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included PHENYTOIN SODIUM (DILANTIN) for Convulsion prophylaxis.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced FATIGUE (Fatigue/Fatigued in and out). At the time of the report, FATIGUE (Fatigue/Fatigued in and out) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anticonvulsant drug level: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided. The patient thought if something happened with her Dilantin (Anticonvulsive) blood levels and consulted her health care professional for bloodwork to measure the levels. It was reported that it was higher than normal after vaccination and might be dangerous. It was reported that patient was experiencing fatigue in and out, not constant and was disturbing her daily activities, she could not finish anything that has to go to bed.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Follow up was received on 17-MAR-2021contains  concomitant medication added, lab data added, event updated.
Developed rash chest and back. No Dyspnea. Taken to ER by Unit member. Post smallpox vaccination on 9/16/09. 12/29/09 PCP Medical records received for DOS 09/29/09. Follow-up visit to Hospitalization 9/25/-9/28/09.  Skin rash resolving. On Doxycycline. 12/31/09 Discharge Summary and Hospital records received for DOS 9/25-9/28/09. Pt. presented with fever, itching and  rash on his torso and back. Admitted for observation, ID consult and placed on isolation.  Rash improved upon discharge.  DC DX: adverse reaction to smallpox vaccine; resolving rhabdomyolysis
Very hot, flushed immediately after injection. She felt panicky, lips, fingers/feet were tingling.  She cooled down and was back to normal within 20 minutes of vaccination. No other events reported thereafter.
Have had a constant dizziness/vertigo/unsteady balance since week after 2nd vaccine. Never goes away with any type of medication
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; SINUS HEADACHE; This spontaneous report received from a patient concerned a 41 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: 043A21A, expiry: 19-SEP-2021) dose was not reported, 1 total administered on 07-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 29-JAN-2022, the patient experienced body aches, chills, sinus headache and fever. On 30-JAN-2022, the patient was tested positive for Covid-19 by BiNax home antigen test (suspected clinical vaccination failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19, and sinus headache, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000214912.; Sender's Comments: V0:20220162392-Covid-19 vaccine ad26.cov2.s -SUSPECTED CLINICAL VACCINATION FAILURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Reaction delayed - self-care: Day 1 body aches, bad headache, Day 2 sore feet and heel especially, rash on right arm. Lymph nodes sore on neck on Day 2.
Day 6, woke up with swollen armpit/lymph node and pain on left side. Day 8, lump at injection sight, including red, itchy, and warm to touch
parents describe pt turning blue, not breathing in car seat; pt responded well to parent stimulation; episode occurred 5 1/2 hrs p/vax was administered; pt hospitalized for cardioresp monitoring;
pt recv vax AUG96 & in early SEP96 pt devel one pox on abd;two wk p/this pt roommate devel varicella;
A nurse reported that a 9 month old female received her second dose of Prevnar on 01/15/2002. That evening, she developed a fever of 103 d. G. and otitis media.
Headaches? nothing helps Fatigue Right side body pain?especially joints, wrist shoulder and hip and knee Two bumps on right side chest Loose stool General achiness No energy Bad sleep  Intermittent nausea Higher bp
SOB, inc heart rate, raspy & hoarse w/in 3hrs of vax;no treatment needed;resolved
approx 5 hr of inconsolable screaming following vax on 2MAR95;
facial swelling w/erythema;papular pruritic rash extending to neck & upper chest;lips swollen;local inflammation @ inj site;
RINGING ON LEFT EAR; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot number. No concomitant medications were reported. On 10-MAR-2021 around 10 AM, the subject experienced ringing on left ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing on left ear. This report was non-serious.
pt recv vax & devel frontal h/a immed;pt was treated w/APAP & the sx has somewhat resolved;
Large sporadic hives only on trunk and head and face and swelling around mouth or eyelid. Intermittent swelling lasting days at a time then recurring.  These episodes noted for approx 4 weeks.
Headache; Severely swollen lymph node in left armpit; Pain radiating down inside of left arm; Pain radiating down inside of left arm; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 51-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5381) via an unspecified route of administration in left arm on 16Feb2021 07:30 as dose 2, single (at the age of 51-years-old) for COVID-19 immunization. Vaccination facility type was reported as Workplace Clinic. Patient medical history was not reported. Patient received unknown concomitant medications in two weeks. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EN5381) via an unspecified route of administration in left arm on 26Jan2021 07:00 as dose 1, single for COVID-19 immunization and experienced sore arm and diarrhea. Patient did not receive other vaccine in four weeks. Patient had not COVID prior vaccination and was not tested post COVID vaccination. On 18Feb2021, the patient experienced headache, severely swollen lymph node in left armpit and pain radiating down inside of left arm. Patient did not receive any treatment for the reported events. The outcome of the events was not recovered.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Shingles. Small blisters on the bottom arch of both feet. More severe on the left foot
The day after the injection I was severely depressed the entire day. I was fine the day before and the day after. I happened to have an appointment with my psychiatrist that day and told her about it.
PT ALSO STATES EVER SINCE 1ST COVID VACCINE 2/19/21, PT'S EARS FILL UP WITH FLUID AND TAKES MUCINEX FOR RELIEF.
Bell's Palsy, left ear pain, left jaw pain, sharp headache, rings in ears (both sides)
Had metallic taste in mouth five minutes after shot that lasted two days. Some dizziness about thirty minutes after shot that started getting better on 7-3172021.  Severe fatigue from 7-28 to 7-31 with moderate ongoing. Vomited for about two hours on 7-28-21 from 2000 to 2200. Fever, chills and muscle and bone aches from 7-28-2021 2300 to 7-31-2021  1600. Severe sweating from 7-28 to 8-1-2021. Lid over eight eye was mildly swollen from 7-29 to 8-1. Severe headache 7-28 at 1900 to 8-2-21. Increases heart rate at times. Probably due to being so sick. I took ibuprofen and Tylenol on 7-29-2021 at 1230 am due to the pain. This reaction also flared up my arthritis from 7-29-2021 to now (8-3-2021) still fatigued and a bit pale.
Patient Called on this morning After getting Pfizer Booster 3rd dose on yesterday is having headaches body-aches diarrhea nausea and vomiting
It has been just over 24 hours since I received my first dose of the Covid-19 vaccine (Moderna). I felt fine all yesterday and early today except for a very sore arm and then this afternoon/evening I noticed a kind of tightness and tingling sensation on my face (left side and around my mouth on both sides) and a little bit in left arm that was injected.
Huge swollen arm at vaccine site; Huge swollen arm at vaccine site, red and swollen, very itchy; Huge swollen arm at vaccine site, red and swollen, very itchy; swollen throat; dry cough; hives on legs; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Sep2021 14:00 (Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization at the age of 25 years old. The patient was not pregnant at time of vaccination. Medical history reported as none. Concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL) and birth control taken for an unspecified indication, start and stop date were not reported. The patient previously had BNT162B2 dose 1 on unspecified date for COVID-19 immunization. The patient experienced huge swollen arm at vaccine site, red and swollen and very itchy on 20Sep2021 07:00. The patient also experienced swollen throat, dry cough and hives on legs on 20Sep2021 07:00. The patient was given a steroid called Dexamethason as treatment. The events resulted in doctor's office/urgent care. The patient has not been COVID-9 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The outcome of the events was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
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; Hep B; manufacturer unspecified given on 9 December 2007; Hep A; manufacturer unspecified 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 vaccination 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."
This spontaneous report as received from a physician refers to an unspecified number of patients. On unknown dates the patient was vaccinated with ZOSTAVAX 0.5 ml (lot # not reported). The patients had developed shingles at an unspecified amount of time after receiving vaccination. The patients visited physician's office for medical attention. The outcome of shingles was unknown. VZV packet faxed to physician. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
I experienced pain, swelling (left arm, at the injection site) weakness in my body, pain in both knees, lower back and I stayed in bed for one and a half days.
7/12/21 extremely painful arm lasting 2 days.  7/15/21 nausea, cramping, diarrhea lasting until 7/18/21 which caused dehydration. Still some nausea today.
Left arm swelling, redness, warmth , pain and itching. Treatment BENADRYL, warm compresses and antibiotic for possible secondary infection.
Headache for 1 month, persistent tinnitus, fatigue, muscle/joint ashiness, vision changes, stomach aches, tenderness at breast implants, tender palpable blood vessels
PT WAS ADMINISTER A SECOND FLU VACCINE IN THE SAME 24 HOURS PERIOD AT A DIFFERENT LOCATION. PT PRESENTED TO PHARMACY AFTER BEING SEEN AT THEIR DOCTOR'S OFFICE FOR LAB WORK AND AN IMMUNIZATION. PT INQUIRED ABOUT THE DIFFERENT TYPES OF FLU VACCINES AND PNEUMOCOCCAL VACCINES. PT REQUESTED A TIV FLU VACCINE. AFTER ADMINISTRATION, IT WAS LATER DISCOVERED THE PATIENT HAS ALZHEIMER'S/DEMENTIA PER THE PTS SPOUSE AND MISTAKENLY REQUESTED A FLU VACCINE. THE DOCTORS OFFICE WAS INFORMED AND PT WAS COUNSELED TO REPORT ANY ADVERSE EFFECTS TO THE DOCTOR.
circular rash size of lemon around injection site; Itchy and stingy around injection site; Itchy and stingy around injection site; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), VACCINATION SITE RASH (circular rash size of lemon around injection site), VACCINATION SITE PRURITUS (Itchy and stingy around injection site) and VACCINATION SITE PAIN (Itchy and stingy around injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On 13-Mar-2021, the patient experienced VACCINATION SITE RASH (circular rash size of lemon around injection site), VACCINATION SITE PRURITUS (Itchy and stingy around injection site) and VACCINATION SITE PAIN (Itchy and stingy around injection site). The patient was treated with HYDROCORTISONE ACETATE (CORTIZONE [HYDROCORTISONE ACETATE]) at an unspecified dose and frequency. On 04-Mar-2021, PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, VACCINATION SITE RASH (circular rash size of lemon around injection site), VACCINATION SITE PRURITUS (Itchy and stingy around injection site) and VACCINATION SITE PAIN (Itchy and stingy around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a pharmacy doctor refers to 4 patients of unknown demographics. Approximately on an unknown date in 2013 (reported as within the past 2 weeks) 4 patients were vaccinated with ZOSTAVAX (lot #, expiration date and route not reported) that was stored in a freezer which was not temperature monitored at any time. No adverse effect reported. Additional information has been requested. This is a corrected report. The encoding of "administered ZOSTAVAX stored in a freezer which was not temperature monitored at any time" was changed from "Circumstance or information capable of leading to medication error" to "incorrect storage of drug".
pts mom called 4DEC92; c/o pt had adverse reaction to pertussis pt recvd 2DEC92; states pt screamed for 6 hrs p/inject of DTP; pt eval @ ER 2DEC92
PATIENT WAS ADMINISTERED AN UNDERDILUTED PFIZER PEDIATRIC VACCINE  WHICH MAY HAVE RESULTED IN THE PATIENT RECEIVING BETWEEN 10MCG-30MCG OF DOSAGE.  AFTER THIS WAS REALIZED, THE PATIENT'S PARENTS WERE NOTIFIED ON 6/20/22 , THEY WERE TOLD TO MONITOR FOR EXCESSIVE FEVER, SORE ARM AND TO REPORT TO MD IF SEVERE.  PATIENT'S PEDIATRICIAN DR. WAS NOTIFIED ON 6/21/22 WHO INDICATED THAT THE PATIENT'S PARENTS HAD BEEN IN CONTACT WITH HER  AND THAT SHE WOULD BE MONITORING PATIENT. CONTACTED PATIENT'S PARENTS ON   6/21/22 TO CHECK IN WITH PATIENT - PARENTS STATED THAT SHE HAD A FEVER OF 100F, FELT "DULL" AND LETHARGIC AND HAS A SORE ARM
SMALL RED BUMPS ON BODY, MILD ITCHING, HANDS FEEL NUMB AND ITCHY. STARTED DAY AFTER THE 3RD DOSE OF THE ORAL TYPHOID VACCINE.  PT HAD TAKEN 1 ADDITIONAL DOSE WEEK BEFORE BUT RESTARTED SERIES BECAUSE HE FORGOT THE NEXT DOSE FOR MORE THAN 2 DAYS. HE DID NOT TAKE THE 4TH DOSE WHICH WAS DUE ON 4/16/2012 PER PHYSICIAN RECOMMENDATION.  TOOK BENADRYL FOR ITCHING WITH RESOLUTION OF ITCHING BY FOLLOWING DAY.
Office visit on 10/28 for flu shot reaction: Symptoms began a day ago. Location is L arm. Had flu shot yesterday AM  w/ in 1 hr the area started swelling and has continued to swell, Pt states area of injection is a bit sore, but remainder of arm is "okay." Does hurt w/ movement. Assessment and Plan: Reaction to influenza immunization, initial encounter. Reviewed use medications and side effect profile, use TYLENOL as needed, and give BENADRYL three times daily, emergency precautions reviewed, including numbness and/ or tingling in the left lower arm. Return for recheck with pediatric provider on Monday (no showed appt). I called mother today 11/4/16, and she said arm is back to normal.
Narrative:  COVID infection following COVID vaccine series 05/11, Pfizer,  dose #1 06/02, Pfizer, dose #2 12/21 COVID swab, result: detected 12/21 pt cc: cough, vomiting, chills, headache, myalgias, exposure: unknown
My face, neck and arms broke out in a itchy, swollen, sightly red warm rash.  Its been 3 weeks and I still have it.
Had 3 muscle spasms on her back; She was not feeling very good; Feeling that she was going to pass out; A frozen sensation; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that when she was lying on her chair, she had 3 muscle spasms on her back, she wanted to know what the cause of this could be. She mentioned that she was sitting outside in the sun and all the sudden she was not feeling very good and had the feeling that she was going to pass out and decided to go inside and sit in her reclining chair when she felt the spasms. She described the feeling as a frozen sensation, she was falling asleep when the spasms occurred. The outcome of the events was unknown.   No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.