chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at injection site; large raised rash injection site, 2-3 inches; large raised rash injection site, 2-3 inches; slight fever; light muscle pain; light body pain; severe lower back pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 22nd April 2022 11:30, the patient received the 2nd dose of Shingrix. On 22nd April 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site rash, raised rash, fever, muscle pain, general body pain and low back pain. On an unknown date, the outcome of the injection site pain, fever, muscle pain, general body pain and low back pain were unknown and the outcome of the injection site rash and raised rash were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site rash, raised rash, fever, muscle pain, general body pain and low back pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-Apr-2022 Reporter's comments: This case was reported by the patient. The patient received Shingrix. Later that evening, between 6 pm-7 pm the patient started having pain at the injection site, slight fever, light body and muscle pain. The patient stated that those were the normal side effects but what really bothered her was the severe lower back pain and large raised rash around injection site. The rash was raised about 2-3 inches, rash was still present but was resolving. The patient needed no further information regarding adverse event. The adverse event was reported to healthcare professional. The consent to follow up was given.
no adverse event Vaccine given after expiration date, no expiration date on vial or box.
Cellulitis in arm, arm was red/swollen/seeping, treatment: antibiotics (unknown), unsure of outcome as it was just reported
Vaccine area was hard, swollen, red, hot to the touch and the redness was spreading.
Patient reports about 12-24 hours after vaccination she is experiencing severe flu symptoms. She is having low grade fever, body aches, sore throat, cough and bronchial symptoms.
grown pustules, was really red and itching; grown pustules, was really red and itching; grown pustules, was really red and itching; Rash under left eye; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), dose 1 via an unspecified route of administration, administered in Arm Left on 24Jan2021 (age at vaccination: 72 years) as dose1, single for covid-19 immunisation. Family history included patient's daughter and patient's father were Diabetic. Patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 28Jan2021, in the morning the patient experienced a rash under her left eye and the next day on 29Jan2021 it had grown pustules, was really red and itching. Treatment includes she applied alcohol and started using Neosporin ointment applied to the rash about twice daily and the rash is improving, going away, but it is still dark, and feel the roughness where the rash is; but the pustules are gone that she has and it is going away. Relevant lab tests included- on Dec2020 she had a tuberculin skin test that was negative for her job. The outcome of all events was resolving.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from a practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 09-JUL-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N022728 and expiration date 31-MAY-2020) for prophylaxis. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018  was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterated that because her facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the local Health Authority at that time. It was reported that no adverse reactions were reported by any patient. Reporter confirmed that patients had administered doses while the temperature excursion assessment was ongoing.  No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2022-501575 (Patient Link).
Back and body aches. Next day: back and body aches, groggy, headache, tired -- didn't feel well enough to go out as I had planned.
VACCINE GIVEN AFTER VIAL WAS OPENED AND LEFT AT ROOM TEMPERATURE FOR MORE THAN 3 HOURS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021,the subject experienced vaccine given after vial was opened and left at room temperature for more than 3 hours. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccine given after vial was opened and left at room temperature for more than 3 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210540069 and 20210540110.
first two weeks, daily and all day fatigue requiring multiple naps. General sense of not well. Elevated temperature, three days mid first 2 weeks.  Intermittent brain fog. next weeks, ongoing to today, intermittent fatigue, intermittent need for naps, intermittent brain fog.
Bad taste in mouth (mild; soap/detergent/metallic like taste) 1 week after first vaccine that got worse after second vaccine
Patient complains about pain at injection site and down the left arm at time of vaccination. Pt. states that in the afternoon she became fatigued and is experiencing malaise. She had a severe headache yesterday that is only a mild headache today. Pt. also complains of hives that started yesterday. She has taken oral BENADRYL tabs last night, oral liquid BENDADRYL today as well as, applying BENADRYL lotion. Pt. was given Rx for prednisone and informed on when to go to the ER. She was also advised on the use of OTC antihistamine medications.
achiness and throbbing around left shoulder and chest; Sore arm; sensitive skin around left shoulder and chest; sore joints in knees and elbows/shoulder PAIN; This case was reported by a consumer and described the occurrence of chest pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th December 2020, 1 days after receiving Shingrix, the patient experienced chest pain, pain in arm, sensitive skin and soreness of joint. On 20th December 2020, the outcome of the soreness of joint was recovered/resolved. On an unknown date, the outcome of the chest pain, pain in arm and sensitive skin were not recovered/not resolved.   The reporter considered the chest pain, pain in arm, sensitive skin and soreness of joint to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of Shingrix and about a day later, he began to experience a sore arm, achiness and throbbing around left shoulder and chest, sensitive skin around left shoulder and chest and sore joints in knees and elbows.  The sore joints in knees and elbows lasted about 2 days.  The patient  reported that he was still experiencing the achiness, throbbing and sensitive skin in his left shoulder and chest area and that it actually may be worsening.  No LOT number or EXP date was known.   The reporter did not consent to follow up. The case has been linked with the case US2020AMR255588 reported for wife.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR255588:same reporter
pt recvd vax & 20mins post vax pt passed out while driving & was involved in an auto accident (fender bender);MD believes that pt may have had a vasovagal episode;pt eval in ER for bruises;
Swollen, red & hot lt leg. Fever & difficulty walking. No known allergies, 4th DTP, no prior problems. No family hx of allergies or rxns to vaccines
This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age with no drug reactions or allergies. The patient was vaccinated with a dose of PNEUMOVAX 23 (Lot # H009826, expiration date 11-FEB-2014) IM on 16-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient experienced bruise at the injection site as well as reddish, swollen welts approximately 2 inches below the injection site. The patient was treated with TYLENOL. At the time of the report, the patient had not recovered. Additional information has been requested.
rash; itching; warm to touch; Injection site raised; redness; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L3PR, expiry date 11th December 2021) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 31st October 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema. On 3rd November 2019, the patient experienced injection site rash and injection site itching. In November 2019, the patient experienced injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site swelling were unknown and the outcome of the injection site rash and injection site itching were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site rash, injection site itching, injection site warmth and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient experienced some redness at the injection site and also developed an itchy rash at the injection site. The area was larger than the initial redness, raised and warm to the touch. The patient consented to follow up.
Patient Fainted few seconds after taking his first dose of the Pfizer vaccine. Pharmacy nurse was able to help patient right away where he was seated safely, patient was provided with water, orange juice, and an energy bar and within couple of minutes he regained consciousness. Patient was feeling okay after that, he was taken to the stretcher to rest where he was still monitored to make sure he is okay. Patient stayed under observation for 35 minutes.
Since day swelling redness itch tenderness at sight of DTaP. 3 days later had-15cm diameter area of redness around shot site. No sign induration, tenderness ony mild tenderness. Never fever day post immunization period.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, in Feb2022 as dose 2, single (Batch/Lot number: unknown), in May2022 as dose 3 (booster), single (Batch/Lot number: unknown) and in Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: " Hypertension" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19".  The patient received Paxlovid from 23Feb2023 to 28Feb2023. The information on the batch/lot number for BNT162B2, BNT162B2 OMI BA.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107258 Same patient, same reporter, same product, different dose, different events;
This is a spontaneous report from a contactable consumer who reported for herself, via Pfizer-Sponsored Program IBCC (Inbound Call Center for HCPs). A female patient of an unspecified age, received the second dose of PREVNAR 13, on an unspecified date at 0.5 ml single for immunisation.  The patient medical history and concomitant medications were not reported. The patient received two shots of pneumococcal 13-val conj vaccine within six months of period: the doses were administered by two different doctors and the patient thought she would not have to receive the second one. On an unspecified date the patient experienced really bad severe symptoms and reactions, she felt like she was getting weak and dying. The outcome of the events was unknown.
Information has been received from a registered nurse concerning a 27 year old female, who, on an unspecified date, was vaccinated with a second dose of Gardasil.  Subsequently, the patient developed an injection site rash and injection site soreness.  The patient contacted the physician.  At the time of the report, the outcome of the patient was unknown.  No product quality compliant was involved.  Additional information has been requested. 07/08/08 Initial and follow-up information has been received from a registered nurse concerning a 27 year old female with an allergy to codeine, who on 07-DEC-2007 at 09:30 was vaccinated in the left deltoid with a second dose of GARDASIL (Lot# 659055/1522U). There were no illnesses at the time of the vaccination. On 07-DEC-2007 at approximately 10:30 the patient experienced a weak arm, the patient developed an injection site rash, and injection site soreness. The weak arm lasted for 4 weeks after the injection. The patient could not lift a hose. Around the third day post vaccination the patient developed "blister like fever blisters" all around the injection site. The blisters lasted seven to ten days. The patient was seen by the physician and was instructed to take BENADRYL. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
Fine, red itchy papular rash on mid chest and upper abdomen. No rash elsewhere on body. No temp, no headache, no trouble swallowing, no shortness of breath.  No neurological changes, no change in consciousness. Treatment: antihistamine over the counter.
Erythema, induration overlying right deltoid with low grade fever; within 24 hours became more severe with fever of approximately 102 F and increased erythema, induration and pain.  Was seen at a Patient First and diagnosed with cellulitis and given a prescription for clindamycin.
unarovienable period 24 hr after vax; no tx necessary; seen in ER 2 h/ exam
The injection site is raised and the size of a quarter. It?s red and has a fever. My left arm is in sore.  It has felt this way since a few hours after getting my shot yesterday morning. Also I have been tired since getting the shot yesterday.
pt recv vax 4APR97 & 31OCT97 broke out w/what mom felt were chickenpox lesions;had about 10-15 total lesions, none in unexposed area of body;only 1 devel a vesicle & non truly scabbed;
Breakthrough case admission after 3 vaccines Moderna 3/13/21 Lot# 038A21A;  MOderna 4/10/21 Lot# 037B21A;  Moderna 2/17/22 Lot# 083J21A
STARTED IN APRIL COULD'T CLEAN HOUSE WITHOUT STOPPING TO REST GETTING SHORT OF BREATH. BY JUNE I WAS HAVING GREAT DIFFUCTLY BREATHING AND SPOKE WITH DR. SHE PRESCRIBE A DOSE PACK AND RESCUE INHALER. 2ND DAY I RAN A FEVER.CALLED DR AGAIN SHE STARTED IN ON ANTIBOTIC. STILL NOT WORKING,WENT IN TO SEE DR SHE DID EKG,PFT AND CHEST XRAY ALL NEGATIVE. SHE DID BLOOD TEST CAME BACK POSITIVE AND SHE STARTED ME ON PLAVIX 75 MG.AND INHALER WITH STERIODS.  STILL COUGHING AND HAVING DIFFICULTY BREATHING, BUT NOT AS SEVERE. STILL HAVE TO REST FEQUENTLY AND CANNOT ENJOY BEING OUTSIDE WHEN HOT OUT. DR WANTS ME TO HAVE SLEEP STUDY AND SEE PULMONOLOGIST. WAITING .
Information has been received from a Registered Nurse (R.N.) concerning a male patient with no medical history or drug allergies who on 26-NOV-2007, 11-JAN-2008 and 25-MAR-2008 was vaccinated IM with the first (lot# 656680/0010U), second (lot # 656680/0010U) and third (lot # 659265/1609U) 1 ml dose of RECOMBIVAX HB, respectively. There was no concomitant medication. Subsequently the patient found to have negative antibody titers. Hepatitis B antibody test was performed. The patient contacted nurse by phone. The patient's negative antibody titers persisted. This is one of several reports from the same source. Additional information has been requested. This is an amended report. Upon review of the file, the code was changed from antibody test negative to Anti-HBs antibody negative.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of GARDASIL vaccine (yeast). The patient fainted after she received GARDASIL vaccine (yeast). She became hot and sweaty after fainting. Subsequently, the patient recovered. Unspecified medical attention was sought. This is one of several reports from the same source. No further information is available.
At the time of injection, injection site immediately began to swell to approximately 2 cm diameter,  No stridor, wheezing, or other sx.  Blood Pressure  115/85, HR 60, SaO2 99%, Temp 97.7 F po.  No progression of edema or any symptoms.   Evalluated by rapid response team, patient opted to not go to the ER.  Released after observation.
While beginning my menstrual cycle  at the time of my first vaccine, and having tracked my menstrual cycle regularly, from getting the first vaccine, the second dose of the vaccine to nearly present I had a 67 day gap with no menstrual flow when my cycle averages 35days between them according to the app that I track it on. The only change to my health or routine was the covid 19 vaccine.
Itchy welt (2") first 12 hours, post vax. Welt continued to grow, painful; had fever and chills, aching joints, nausea with dry heaves. Baby vomits after nursing the next 24 hours. Welt is 4" to 5" until 11/29/00, then slowly shrinks. Still have a hard lump at injection site.
One day after PENTACEL vaccine, patient started with local reaction to vaccine = redness, swelling, small amount of pain/itching, redness measured 10 cm x 18 1/2 cm, induration measured 71/2 cm x 14 cm. Mom advised on symptom treatment.
Prior to polio vaccine I got polio I now suffer from constant pain am disabled have bad deformed left foot that is shorter than my other leg and has resulted in back surgery and back pain and am several medication and am fixing to have brace put back on foot and leg.
On 03/31/2003, vaccinee reported to her employee health that she had experienced sore transient "chest pain" on the weekend and had a resp gradiform.  She had been vaccinated on 03/12/2003.  States that she has Wolf Perkinson While syndrome had has had chest pains in the past.
Reconstituted Shingrix lyophilized powder with sterile water / and administered to a patient; Reconstituted Shingrix lyophilized powder with sterile water / and administered to a patient; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th May 2021, the patient received Shingrix. On 14th May 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient was administered reconstituted Shingrix lyophilized powder with sterile water instead of with the adjuvant suspension component (AS01b), which led to wrong solution used for drug reconstitution and inappropriate dose of vaccine administered. The reporter was unable to provide any vaccine or patient details at the time of reporting. The reporter consented to follow up.
difficulty breathing post vax, self administered own inhaler, pt called PCP who advised ER, paramedic administered albuterol breathing tx, pt transported by ambulance to Hospital