chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a non health care reporter refers to 10 patients of unknown age. On an unknown date, the 10 patients were administered with the PNEUMOVAX 23 with lot # K010466 and expiry date 23-MAR-2016 (strength, dose, route not reported) that were exposed to temperatures outside of the required temperature range on 24-NOV-2014. The efficacy of this product outside the temperature range has not been established. It was reported that the customer purchased on 10 pack of the vaccine, therefore, it has been administered to 10 patients. The outcome of the event was unknown. The ages and gender of the patients were unknown at the time of this report. Additional information has been requested.
Rash in the injection site; itch in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash in the injection site) and VACCINATION SITE PRURITUS (itch in the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE RASH (Rash in the injection site) and VACCINATION SITE PRURITUS (itch in the injection site). At the time of the report, VACCINATION SITE RASH (Rash in the injection site) and VACCINATION SITE PRURITUS (itch in the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated 1st dose on 9-17-21 .Some itch and rash in the injection site. It last for 48hs then goes away by itself.  No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-355778 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: follow up document received on 20-Oct-2021 contains Non significant Follow up information.; Reporter's Comments: Per SO, please obtain email address for SO follow up Agent made outbound call 20Oct2021 at 2:19 PM ET and spoke to patient who states she never gave follow up consent for Safety initially although consent was granted as per original case and does not want to be followed up with regarding original adverse event case.
swelling, redness, itching at injection site. "size of nickel. little red bumps around it; red spots; Swelling arm; swelling, redness, itching at injection site. "size of nickel. little red bumps around it; swelling, redness, itching at injection site. "size of nickel. little red bumps around it; swelling, redness, itching at injection site. "size of nickel. little red bumps around it; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration on 22Feb2021 (at the age of 67-year-old) as dose 1, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient previously took ace inhibitors and experienced drug allergy. The patient had no concomitant medications. Caller got dose on 22Feb2021 approximately 12 noon, the following symptoms began Tuesday night was swelling, redness, itching at injection site. Size of nickel. Little red bumps around it. Caller asked, should I be taking any action on this. Caller voices concerns about going to be evaluated by a health care professional since this was a new vaccine with limited information. Caller believes health care professional will not know how to evaluate and treat her symptoms. She was called about the vaccine for COVID. She has concerns, she took it last Monday, and experienced mild side effects. She had swelling on the arm. As the week progressed, she began to itch and have red spots, it still persists. She was just wondering was this an issue that will dissipate or should she be concerned. The Swelling started the same day as receiving the vaccine on 22Feb2021 it now gone but there was a little hard skin around the area, harder than the other skin. She has recovered with lasting effects. The Itch and red spots started approximately on 24Feb2021, it was still ongoing vacillates, it was more intense at time yet less at times, it was fluctuating up and down. Regarding COVID vaccine card, she just stated her name and birthday. Her second dose schedule, which she was recalled from her memory, was on 15Mar2021 at about 10 she thinks. She was just taking her normal stuff, she takes lotions and vitamins, she was nothing new. The outcome of red spots, swelling arm was recovered with sequelae and rest all the events was unknown. No follow-up attempts are possible. No further information is expected.
Today client complained of feeling of tiredness on left arm and lack of strength to life objects, minimal weight.  Client states only mild local reaction following injection.
Booster Pfizer dose was to be administered.  Upon injection of dose, liquid from syringe ran down patient's  arm. No active bleeding or injury noted.  Full dose of vaccine wasn't believed to be given.  No additional doses given. No symptoms besides arm soreness 24 hours later.
He received DTaP and varicella. Twenty-four hours later he woke with rash on buttocks and inner thigh, pink-red, that spread to sides. Later in day, he was noticed to have raised pink welps under arms and on chest and upper arm as well. Red rash in diaper area and inner thigh faced. He also developed an area of erythema, warm and induration around DTaP in left thigh the size of two fifty-cent pieces.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 92-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "enlarged prostate" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE, start date: 01Jan2020; DOXAZOSIN, start date: 01Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient had no known allergies.  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.
CHILD'S AGE WRITTEN AS 12 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS MOTHER. CHILD IDENTIFIED IN MEDICAL RECORD. CHILD IS TOO YOUNG TO RECEIVE VACCINE ON 09/24/2021. SEE PREVIOUS REPORT FOR 1ST DOSE.
At 1015AM Client  arrived at Vaccination Center requesting Janssen Covid Vaccine.  Ancillary staff registered walk-in client.  Ancillary staff was not notified History of Moderna Trial. Client  notified Vaccinator that he had participated in the Moderna Trial.  He states he received his 1st dose 4-7-2021 and 2nd dose 5-5-2021.  Client  states his employer is requesting vaccination status and due to blind trial is unable to provide proof.  At 1022AM PHN  notified and sent text to Vaccine Operations Leads and were directed to send a request for medical consult.  Client was interviewed for information.  At 1053 Medical Consult was sent via text.  At 1101 PHN received confirmation of approval for Janssen dose 1 with 30minute observation and at 1104 received approval for Flu vaccine from the Medical Consult team.  At 1110 Vaccinator  administered Janssen dose 1.  Client was observed for 30 minutes.  At 1140 Client  completed observation without complaints and left vaccination center with steady gait.
Mitral valve replacement. exhibited acute hypoxic respiratory failure due to history of emphysema, postoperative atelectasis, hospital-acquired pneumonia, and bilateral pleural effusions.  He was treated with a 7-day course of cefepime for respiratory cultures that noted growth of Pseudomonas aeruginosa and moraxella catarrhalis.  He was also treated with scheduled nebulizer treatments and an aggressive pulmonary toilet while in the hospital. Hospital admission within 6 weeks of receiving the COVID vaccine.
Tested + for covid at home on Saturday 2/26. Had fever  but no cough or sob. Pulse ox at home was reading 93-94%, then over the weekend developed really bad cough, pulse ox went down to 89-90%. Says only has sob due to cough Denies muscle aches, GI sx, HA" Cont improving,Now walking around on 2 L/min , no fever
Information has been received from a nurse, via company representative, concerning a female patient (age not specified), who on approximately 14-SEP-2007 ("two weeks ago") was vaccinated IM with the first dose, 0.5 ml, of Gardasil (lot # not specified). There was no concomitant medication. On the day of vaccination, the patient called the physician and stated she had a small rash on her chest, about the size of a quarter. Treatment was not specified. At the time of this report, the outcome of the event was unknown. No further information was available. Additional information has been requested.
Received vaccine approximately 10:00 on 12/01/05. That evening at about 19:00, broke out in hives, especially over face, neck, and back. Pruritic. Given Benadryl tid for 3 days. Rash waxed and waned over that time.
This case was reported by a physician via sales rep and described the occurrence of malaise in a 19-year-old male patient who received Bexsero for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis. In September 2017, the patient received Bexsero .5 ml and Influenza vaccine Quadrivalent 2017-2018 season. On an unknown date, unknown after receiving Bexsero and Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced malaise, influenza-like symptoms, injection site erythema, injection site swelling, injection site induration and injection site warmth. On an unknown date, the outcome of the malaise, influenza-like symptoms, injection site erythema, injection site swelling, injection site induration and injection site warmth were recovered/resolved. It was unknown if the reporter considered the malaise, influenza-like symptoms, injection site erythema, injection site swelling, injection site induration and injection site warmth to be related to Bexsero and Influenza vaccine Quadrivalent 2017-2018 season. Additional details were provided as follows: The age at the vaccination was not reported. The flu shot was given at the same time as Bexsero. After vaccination, the patient experienced malaise, flu like symptoms and had large red swollen induration on arm at the injection site. The induration was warm to the touch. The symptoms lasted for 4 to 5 days.
Test: Nasal Swab, Result: Positive; Test: Nasal Swab, Result: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL9262), in left arm and on 16Feb2021 as dose 2, single (Lot number: EL9267) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Reaction Allergy" (unspecified if ongoing), notes: Reaction: Allergy. Concomitant medication(s) included: SERTRALINE; ZOLOFT. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14May2022, outcome "unknown" and all described as "Test: Nasal Swab, Result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Positive.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.
Got the nasal mist next day started running a fever, throwing up about every 2 hours laying around and crying stomach hurting.
Caller reported an expired diluent that was administered with PROQUAD.; This spontaneous report was received from a medical assistant referring to a 4-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medication and drug reactions/allergies was not provided.  On 24-AUG-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (strength, dose, route were not reported; lot # S017255, expiration date 01-DEC-2020) reconstituted with an expired sterile diluent (MERCK STERILE DILUENT) (strength and dose were not reported; lot # S018821, expiration date 22-AUG-2020) for prophylaxis (expired product administered).
Pt states she developed redness and swelling at the site of the pneumococcal vaccine, 24 hours, post vax. She was seen at Urgent Care 72 hours, post vax, and treated with steroids and antibiotics. She states that her husband, who received the vaccine on 11/2/01, had a similar reaction and was treated for the same.
No Adverse effects. Resident received expired Moderna vaccine, expired on 10/13/2021.
He was giventhe vaccine on 10/30/18 and came back into the clinic on 11/1/18. At the second visit, patient had swelling/redness/warmth to R AC and medial upper arm (half way up arm from AC) and rash all over body except to face. He was a given a MEDROL DOSEPAK and KEFLEX, he was also advised to take BENADRYL. Patient was called the next day for update and reported symptoms were improving but not yet resolved; admitted to only starting oral steroids and not KEFLEX as of that time.
sore arm after both injections.; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer-sponsored program.  A male patient of an unspecified age (Age: 60; Unit: Unknown) received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on 25Jan2021 as single dose and first dose via an unspecified route of administration on 04Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included paracetamol (TYLENOL). It was reported that caller was calling on behalf of her husband who works in healthcare and has received both doses of the Covid vaccine. Caller had question on behalf of her husband. Caller stated that her husband took Tylenol prior to receiving both doses of the vaccine with the intention of pre-medicating and wanted to know if that was okay. Caller then clarified husband only took Tylenol before first dose. Caller stated that he was unaware of the guideline to not take Tylenol prior to receiving the vaccine and did not take Tylenol after receiving the vaccine. Caller stated that her husband experienced a sore arm after both injections on Jan2021. Caller was asking if her husband needs to take a booster due to him medicating with Tylenol prior to receiving either dose. Caller stated, it was her fault on telling him to do that. They used to tell her to do that with their kids. Caller asked if Tylenol would lessen the effectivity of the vaccine and if need to take any other shot of the vaccine again. Precautionary AE. Seriousness of the event was non serious. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained.
Rash started on forehead, then face, then injection site (L), forearm (both), back, armpit (L), neck, chest (R).   Different patches appear over the course of the past 3 weeks.   Per dermatologist, try antihistamine, clobetasol (which had already been prescribed for Morphea skin condition)  and emollient lotions.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka-Merck) PROQUAD (Lot # K007799, expiration date 29-NOV-2015), (dose number, route, dosage and frequency were not provided). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
excruciating pain in her left shoulder after waking up today; This is a spontaneous report from a Pfizer sponsored program from a contactable female consumer reported (patient). A 70-year-old female patient received second dose of bnt162b2 (Pfizer-BioNtech Covid-19 Vaccine, Solution for injection), via an unspecified route in the right arm on 15Feb2021 as a single dose for covid-19 immunization. Medical history included left shoulder surgery on 15Jan2021. Concomitant medications included Tylenol which she has been taking and doing physical therapy without issues. Historical vaccine included first dose of bnt162b2 (Pfizer-BioNtech Covid-19 Vaccine, Solution for injection) as a single dose for covid-19 immunization. On an unknown date in Feb2021, patient experienced excruciating pain in her left shoulder after waking up today and no pain at injection site (right arm) was reported. Patient confirmed that the vaccine was given in opposite arm as shoulder surgery, and she was experiencing post-operative shoulder pain before 2nd dose. Patient wanted to know if she is able to take hydrocodone, that was prescribed for shoulder pain after surgery. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Slight pain in arm the evening of injection that ran up into neck.  Next morning, arm very sore, tired, went back to bed. had a fever of 100.8 (my normal temp registers 97.5) by afternoon. a cough, a runny nose, arm became so sore it was impossible to move, (no redness or inflamation at shot site). Severe body aches, headache sore joints all from my head to the sole of my foot on the right side. Slept most of the day and that night. Woke up the next day and had soreness every place mentioned above but to a lesser degree. I tool an extra strength Tylenol around noon and was completely back to normal with no pain within 30 minutes.
Developed painful, itchy rash, allergic reaction, atopical dermatitis above upper lip and below nostrils
Less than 24 hours after the vaccine, "I" got "my" period early. "I" am very regular, and this is not normal for "me".; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Aug2021 at 17:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The medical history included COVID-19 and allergic to neoprene.  Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the COVID-19 vaccine. The concomitant medications included lisdexamfetamine mesilate (VYVANSE) for an unknown indication from an unknown date and unknown if ongoing. On 12Aug2021 at 15:45, less than 24 hours after the vaccine, the patient got her period early. The patient reported that she was very regular and this was not normal for her. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event got period early was resolved on an unspecified date in Aug2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a female physician, who in 2007 ("about a couple of months ago" in 2007), after administering RotaTeq vaccine to one of her patients, believed she developed rotavirus. She reported that although she washed her hands, she thought that some residual vaccine from her hand was ingested during food consumption (sandwich). She reported that she was sick and stayed home for one week. Specific medical attention and current patient status was not reported. A product quality complaint was not reported. No further information was available. Additional information has been requested.
Moderate left deltoid pain the day after vaccine - pain is persisting through today 4/8/21 - a month later. Olecranon Bursitis in left arm - same as vaccine - 4/2/21 - seen at ER and given IV antibiotics, then outpatient oral antibiotics
pt was given 5 HIB vaccines maximum number being 4-this dose given 6mo p/4th dose-no rxn reported by mom;
This spontaneous report as received from a nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with GARDASIL (lot #, expiration date, dose, frequency, route unspecified) that were improperly stored. No adverse effect was reported. This is one of several reports from same source. Additional information has been requested.
Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On 09-SEP-2015, the patients were inadvertently vaccinated with improperly stored doses of RECOMBIVAX HB (lot# L010595, expiration date 12-NOV-2016, lot # L001456, expiration date 22-OCT-2016, strength, dose and route unknown). No adverse events had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Felt terrible worse than the COVID shot; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's father had it on face and suffered till he passed). Previously administered products included Covid vaccine (received COVID shot on an unknown date).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient for himself/herself. The patient received 1st shingles shot  and felt terrible worse than the COVID shot. The reporter asked that the 2nd shingles shot was worse or not as bad. The follow up would not be possible as no contact details were available. The case was linked with case US2021AMR180720 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR180720:Same reporter
Syringe mallfunction, vaccinje didnt full administer, consulted medic, readminstered
I received the shot September 5th.  On  September 12th my Watch alerted me I had atrial fibrillation.  My watch continued to give me daily alerts. I was on a vacation and went to my doctor when I got home on September 13th.
swollen, achy joints, gen malaise, h/a lasting over 1mo cont;