chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on leg and groin; Burning on the inside of her left leg and top of vagina; Itch on the inside of her left leg and top of vagina; Burning on the inside of her left leg and top of vagina; Burning itch on the inside of her left leg and top of vagina; This spontaneous case was reported by a consumer and describes the occurrence of VULVOVAGINAL BURNING SENSATION (Burning on the inside of her left leg and top of vagina), VULVOVAGINAL PRURITUS (Itch on the inside of her left leg and top of vagina), BURNING SENSATION (Burning on the inside of her left leg and top of vagina), PRURITUS (Burning itch on the inside of her left leg and top of vagina) and RASH (Rash on leg and groin) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 306A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VULVOVAGINAL BURNING SENSATION (Burning on the inside of her left leg and top of vagina), VULVOVAGINAL PRURITUS (Itch on the inside of her left leg and top of vagina), BURNING SENSATION (Burning on the inside of her left leg and top of vagina) and PRURITUS (Burning itch on the inside of her left leg and top of vagina). On 10-Mar-2021, the patient experienced RASH (Rash on leg and groin). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and FLUOCINONIDE (topical) at an unspecified dose and frequency. At the time of the report, VULVOVAGINAL BURNING SENSATION (Burning on the inside of her left leg and top of vagina), VULVOVAGINAL PRURITUS (Itch on the inside of her left leg and top of vagina), BURNING SENSATION (Burning on the inside of her left leg and top of vagina), PRURITUS (Burning itch on the inside of her left leg and top of vagina) and RASH (Rash on leg and groin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
This spontaneous report as received from a registered nurse refers to a 5 year old female patient. On 20-MAR-2013 the patient was vaccinated with 0.5 ml expired PROQUAD (lot number 667182/1435Z, expiry date 27-MAR-2012) subcutaneously in the left arm. No adverse effects reported at reporting time. It was unspecified if the patient had sought medical attention. Additional information has been requested.
A non-serious report of administration of expired FLUMIST has been received from a nurse concerning an eight-year old male. Neither medical history nor concomitant medications were provided. The patient received FLUMIST on 13-Mar-2008. The FLUMIST had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FLUMIST on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had not adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FLUMIST was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006659; MEDI-0006672; MEDI-0006673; MEDI-0006673L MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Raised bumps ONLY in the tattoo areas near where the vaccine was given. They have been there for a few months now and are not going away. Reaction to the ink?
per mother of child, respiratory distress, eye and tongue swelling. They stopped on way home and called 911 - taken by ambulance to medical center. epinephrine and beadryl in ER, d/c 4 hours later on predisone and benedryl.
Fever starting few hours after vaccine, then fever with seizures the day after. Child was in preschool at the time of seizure, parents did not witness.
Screaming for hours, fatigue, large red lump for over a week, seizure activity (head going back and forth repeatedly for 10 seconds), lost speech ability for 18 months (had been babbling a lot with consonant-vowel-consonant sounds), staring spells which last up to 30 seconds for 5 months afterwards.
Information regarding PREVNAR was received from a mother regarding her 12-month-old female daughter who experienced swelling and redness at the injection site. At 12 months of age, the patient received a dose on 02-Sep-2008.The patient experienced injection site swelling and redness on 03-Sep-2008. The events are listed as not recovered. No additional information was available at the time of this report.
Large raised welt, at least 3" diameter.  Hard, red, painful to touch.
A non-serious spontaneous report of blocked eustachian tube has been received from a physician concerning an adult (year of birth is 1963) male, subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 06-Oct-2009. The patient received a total of one dose of FLUMIST before the onset of the event given on 06-Oct-2009. On 06-Oct-2009, the patient experienced blocked eustachian tube within 24 hours after FLUMIST administration. Another relevant etiological factor was that the patient had cold. The event was resolved on 07-Oct-2009.
Child received H1N1 vaccine at a school clinic. Denied any allergies completed by mother. Child came home itching with hives on face, chest, abdomen and arms. Given cold bath only. Resolved when awakened in morning. Mother signed consent for child to receive H1N1 # 2 but related above incident and 2nd dose not given.
My wife and I both experienced chill, aches, and a headache, but the most interesting thing is that an IR thermometer reported 104F in our ears. Our foreheads and tongue did not show an elevated temp. By the following morning the temperature in our ears was back to normal.  Additionally, within 36 hours, both of us were free of side effects.
This spontaneous report was received from a physician via company representative refers to a male patient of unknown age. It was reported that the patient who had been on an unspecified immunosuppressive medication was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and route was not reported). It was also reported that the patient did not disclose his full list of medications to the physician and that existing medication was not fully co-ordinated with the administration of ZOSTAVAX. Two days after administration of ZOSTAVAX, the patient experienced shingles rash. The patient was immediately admitted to the hospital where he was treated with unspecified drip for an unspecified duration and was reported to have improved. The outcome of shingles rash was reported as recovering at the time of this report. The patient sought medical attention (physician appointment). Additional information has been requested.
body ache/body pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache/body pain) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 17-Feb-2021, the patient experienced PAIN (body ache/body pain) and HEADACHE (headache). At the time of the report, PAIN (body ache/body pain) and HEADACHE (headache) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Soreness in injection ar; Heaviness in injection ar; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in injection ar) and LIMB DISCOMFORT (Heaviness in injection ar) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in injection ar) and LIMB DISCOMFORT (Heaviness in injection ar). At the time of the report, PAIN IN EXTREMITY (Soreness in injection ar) and LIMB DISCOMFORT (Heaviness in injection ar) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-085909.
Pityriasis rosea rash?taking Allegra and steroid cream. Rash is still there (4 weeks)
COVID Vaccine Breakthrough Case  Pfizer Dose 1 3/19/21 (EN6208) Pfizer Dose 2 4/14/21 (EW0153) COVID Positive 11/28/21 Discharged home 11/30/31 Hospitalized 11/28/21-11/30/21  12/8/21: The patient vaccinated for COVID-19, diagnosed with COVID-19 pneumonitis on November 28 and she was admitted to the hospital and observed and discharged home, for the last 3 days she had progressive shortness of breath with sputum productive cough and episodes of chills with epigastric discomfort and nausea and occasional vomiting and unable to tolerate p.o. intake last 24 hours with generalized weakness and fatigue, she does have dyspnea with minimal exertion while she is walking within her room and her home.  She is known to be asthmatic and was using her inhalers at home 2-3 times within  24 hours within the last 3 days without resolution in her cough and shortness of breath.  No wheezing noted test.  At baseline she does not use any oxygen.   At emergency she was hypoxic and require 3 L of oxygen to maintain SpO2 above 94%, her EKG show sinus rhythm with old left bundle branch block, troponin unremarkable, proBNP mildly elevated.  Chest x-ray reviewed personally and show vascular congestion and linear opacities.   At emergency she received Zofran and IV fluid.  12/10/21: She is a 79-year-old female recently admitted to hospital for severe COVID-19 infection complicated with pneumonia and hypoxia was discharged on 3 L of oxygen but came back to the emergency room on 12/08/2021 because of persistent SOB, nausea and poor appetite.  She was admitted and commenced on usual management for COVID-19 infection including restarting remdesivir, dexamethasone, IV antibiotics in addition to other supportive management.  On re-evaluation this morning she feels much better except for mild nausea.  She has a good appetite.  Her Sao2 on room air is 100%.  She will be discharged home on pre-admission medications.  She will follow-up with the PCP in 1-2 weeks.
Severe pain in whole body; headache; weakness; chest pain; This is a spontaneous report from a contactable consumer (reported herself). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via intramuscular, administered in arm left on 28Apr2021 10:30 (age at vaccination was 38-year-old) as dose 2, single for covid-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, known allergies: Walnuts from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ofatumumab (KESIMPTA) taken for an unspecified indication, start and stop date were not reported received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: unknown), via an unspecified route of administration on 07Apr2021 10:15 (age at vaccination was 37-year-old) as dose 1, single for covid-19 immunisation. The patient experienced severe pain in whole body, headache, weakness and chest pain on 28Apr2021 23:15. Post vaccination, the patient was tested for COVID test and the test result was negative on an unknown date. The treatment received for the events was unknown. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Had chest/back pain on 4/27. Thought it was a pulled muscle. Notice small rash on back on Friday morning. Thought it was due to cream used to help pulled muscle. Rash enlarged and was only on one side. Looked up "shingles" on Sunday 05/02/21. Diagnosed with shingles. Given prescriptions for valACYclovir 1 tablet by mouth 3 times a day until supply gone and Nortriptyline 1 capsule by mouth daily at bedtime.
Swollen warm injection site. Pt. c/o hurting into (R) neck and swollen glands in (R) neck and under (R) arm. Received Tdap booster in the right upper arm three days ago and since then has developed swelling and pain in that area with the pain extending to the top of her shoulder and adjacent right upper chest as well as armpit and back of upper shoulder. She does have an area measuring 7 x 6 cm of subcutaneous fullness that is not hard, but is tender to palpation, as well as the adjacent areas where she's having pain. The area of fullness is warm to touch, but the overlaying skin is not inflamed. She's able to fully range her right shoulder compared to left and her grip strength is equal bilaterally. She not have any numbness. I advised her to use over-the-counter ZYRTEC for the antihistaminic effect as well as apply intermittent heat. If she does not gradually improve she's to return to clinic. We will complete a vaccine adverse reactions form regarding this.
The day after vaccine began itching around lower legs by today 1/25/16 the itching and rash spread to arms chest etc...
No additional AE details.; Inbound all from HCP stating VARIVAX experienced a supported temp excursion and then was administered to patients. No additional AE details or PQC. Names of vaccines involved (including lot/exp) VARIVAX T031383 09/15/2022        ?    Te; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Concomitant medication included diluent. The patient's concurrent conditions, medical history, allergies and drug reactions were not reported.   On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), lot #T031383, expiration date: 15-SEP-2022 (strength, dose, dose number, route of administration was not provided) for prophylaxis. For varicella virus vaccine live (oka/merck) (VARIVAX), the temperature excursion was initially reported as 5.5 Fahrenheit degrees (F) for 10 minutes, however it was corrected (by the reporter) to temperature 9 F for 3 hours 50 minutes (product storage error). The previous temperature excursion was not reported. No additional adverse event was reported (no adverse event).
Information has been received from a RN concerning a 7 year old female child who on 12/03/97 was vaccinated with a dose of varicella virus vaccine live. Subsequently, between the dates of 10/06/03 to 12/04/03, the pt developed a "mild case of chickenpox break thru". It was noted that this case was part of 16 cases of chickenpox reported at a school, 4 of which had been previously vaccinated with varicella virus vaccine live.  The reporter also mentioned three other children who experienced similar reactions (WAES # 0312USA00810, 0312USA01001 & 0312USA01003) two of which were siblings respectively.  Additional information has been requested.
Right sided cervical lymphadenopathy; 1st dose administration date: 22Dec2020; 2nd dose administration date: 09Jan2021; This is a spontaneous report from a contactable Healthcare Professional reporting for herself. A 29-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, on 22Dec2020 at 06:45 (lot number: EK5730) at 29 years of age and the second dose on 09Jan2021 at 11:00 (Lot number: EL3248), at 29 years of age, both via an unspecified route of administration in right arm, at single dose for COVID-19 immunization. The patient was vaccinated at facility hospital and was not pregnant when she received the vaccine. Medical history included hypothyroidism and rhinitis allergic, both from an unknown date. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1.5/30), fluticasone propionate (FLONASE), levothyroxine sodium (SYNTHROID) and cetirizine hydrochloride (ZYRTEC). On 10Jan2021 the patient experienced right sided cervical lymphadenopathy, in deep anterior chain, under right sternocleidomastoid (SCM) muscle, tender to palpation, assessed as non-serious. No treatment was administered to the patient for the reported event. The patient was tested for Covid twice: once in Jul2020 via blood test (SARS COV-2 Antibody) and once in Nov2020 via nasal swab (test name: Sofia Rapid COVID antigen test) and both tests had negative result. At the time of the report the event was recovering.
25OCT93 pt recvd vax; 25OCT93 febrile reaction began & shaking (1530) exam, t104.2 ax; 26OCT93 fussy & up alot @ noc but now drinking & playing OK;
A physician reported via a company representative, that a 12 year old child received Flu Shield (2001-2002 formula) (influenza virus vaccine, trivalent, types A & B/2001-2002 formula) vaccine. At a later date, the child tested positive for influenza by an office flu test. The flu immunization was given approx. 2 months prior to dx. The child developed a "high" fever that measured 103-104F, lethargy, cough and runny nose. This is 1 of 6 pts from this office who developed influenza following receipt of Flu Shield (2001-2002 formula) lot 4078033. See case ID numbers: HQ0713214FEB2002, HQ1480025MAR2002, HQ1480325MAR202 and HQ1480125MAR2002. One pt was not identified; an additional report will be generated when identifying information is provided. No additional information was available as of the date of this report.
ADACEL given 12-15-09 in L shoulder IM by physician. Pt c/o of pain @ injection site @ least 2 wks out but it had diminished somewhat. Worse in early am but rc ROM dissipated in severity during day. ("shooting pain down arm initially").
Today she is scheduled for her 2nd dose but she is tested positive; on Monday when I went to Covid test,  I needed to take it they said that I am positive for Covid-2; This is a spontaneous report received from a contactable consumer or other non hcp (patient) via a Pfizer-sponsored program COVAX US Support. A 68-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0178) via an unspecified route of administration, administered in arm left on 15Jul2021 at 14:00 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included had sinuses and allergies from an unknown date and unknown if ongoing. Concomitant medications included tramadol, gabapentin taken for an unspecified indication, unknown start and stop dates. The patient got her 1st Covid-19 vaccine on 15Jul2021 and she was scheduled for the 2nd shot but on monday when she went to covid test, she needed to take it they said that she was positive (be-fore taking her 2nd dose) for Covid-2 on 21Jul2021. The patient did not receive any treatment for the adverse events but quarantined. The patient underwent lab tests and procedures which in-cluded sars-cov-2 test: positive on 21Jul2021.
Fever; headache; chills; Nausea; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE ( headache), CHILLS (chills), NAUSEA (Nausea) and MYALGIA (Body aches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), HEADACHE ( headache), CHILLS (chills), NAUSEA (Nausea) and MYALGIA (Body aches). At the time of the report, PYREXIA (Fever), HEADACHE ( headache), CHILLS (chills), NAUSEA (Nausea) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-017626 (Patient Link).
A spontaneous report was received on 13-JUL-2016 from a medical assistant who reported that a patient (age and gender not reported) was inadvertently administered one dose of PROQUAD (dose not reported) and one dose of VARIVAX (dose not reported), both on 13-JUL-2016 during an office visit. No adverse effects were reported. No further information was provided. Additional information has been requested.
pt received a flu shot in her Left arm on 11/16/19 and Called on 12/2/19 stating her arm was still sore and throbbing she said she was having difficulty raising her arm also.
gotten COVID; gotten COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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), COVID-19 (medically significant), outcome "unknown" and all described as "gotten COVID". The event "gotten covid" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had been vaccinated and have been, have had the extra shots, the patient had three of those, but looks like the patient still caught it. So, patient went to the doctor and the doctor gave the patient Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SOB, itching throat, complained of throat "tightening up". Provider notified 0.2 mg epi given SQ at 13:35. Pt observed for 30 min symptoms resolved.
Rash and itching on arm and shoulder in area of injection site.  Broken skin (not due to scratching)  Symptoms still ongoing