chrisvoncsefalvay/vaers-outcomes huggingface dataset:
like a mass that was just like a few mass break; really bad hives; she can't do her job and it's ruining her; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration administered in right arm on 03Mar2021 (at the age of 38 years old) as DOSE 2, SINGLE for COVID-19 immunisation; patient received dose 1 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration administered in right arm on 10Feb2021 (at the age of 38 years old) as DOSE 1,SINGLE for COVID-19 immunisation. Medical history included ongoing thyroid disorder. Concomitant medication included levothyroxine sodium for thyroid disorder. The patient experienced really bad hives on 11Mar2021, she can't do her job and it's ruining her on 2021, like a mass that was just like a few mass break on 28Mar2021. The patient reported that she developed really bad hives since in 11Mar2021 had gone through 6 different doctors was on antihistamines, Pepcid, lupus meads, was already took thyroid medication. They were telling her that probably Chronic Urticaria and people are getting this from the vaccine and that was how it's going to be from now on. The patient also reported that she is a teacher, and she could not do her job and it's ruining her, she thought it would go away in a few months, but she was still dealing with it. The patient had broken out in massive hives; she never had anything like this before and that had been her reaction since she got the vaccine. She had dislocated her ability to do pretty everything much that she could easily do. She reported that on her 'cab' and they were just like bug bite or something and they had migrated up all over her body little by little. They created themselves anywhere and everywhere they wanted to at least three weeks out of four weeks months and it had like 'face to face' and dislocated her ability to do pretty everything much that she could easily do. So, she did not know what to do at that point she never had anything like this before and that had been her reaction since she got the vaccine, so she guess she was looking for advice and next step where she was supposed to go. It like a mass that was just like a few mass break on 28Mar2021. The patient received Antihistamines, Prednisone, Xolair, Zyrtec, Allegra, Claritin, Pregamet, Pepcid combination and mucous medication for treatment of hives. Outcome of events were unknown.  No follow-up attempts are possible. No further information is expected.
Client presented on 1/29/2022 for a first dose of Moderna. At 11:08 AM, client was vaccinated (Lot 084J21A exp 2-12-2022). Upon review of participation form, it was discovered by database that client was vaccinated with a booster dose of Moderna (0.25ml) rather than a full dose of Moderna (0.5ml). RN notified of medication error. PHN called client, explained error, and advised client to return within 24 hours. Client was vaccinated at 1635 with 0.25ml of additional Moderna to equal the full 0.5ml amount. (Lot 084J21A exp 2-12-22). Client did not experience any adverse reaction during observation period and left with stable gait.
injection site pain; woke up with fever to 101; chills; nausea; headache; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2021, the patient received Shingrix. In January 2021, 14 hrs after receiving Shingrix, the patient experienced injection site pain, fever, chills, nausea and headache. On an unknown date, the outcome of the injection site pain, fever, chills, nausea and headache were unknown.   It was unknown if the reporter considered the injection site pain, fever, chills, nausea and headache to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had the Shingrix booster shot a day before reporting and did fine except injection site pain. During the night, the patient woke up with fever to 101 degree F, chills, nausea and headache. The patient asked if it was common for these reactions to be delayed, it was about 14 hours after the shot.
2 1/2 hrs p/DTP given pt had short episode (less than 1 min) stiffening, stopped breathing;
On 11/8/15 pt complained of "not feeling well" since 10/8/15 when she received the second HPV vaccine - 1st HPV 4valent - 2nd HPV 9, and joint pain most painful in knees. 12/31/15 mother states pt reports 2 months of knee pain and fatigue. Ortho diagnosed tendinitis, but mom not sure of dx. No apt ever scheduled for follow up, even though recommended.
Patient stated she had new onset metallic taste in her mouth. Within 5 minutes patient complained of lightheadedness and "feeling weird." Moved patient to cot and patient complained of nausea. Offered patient snack, which she ate before complaining of tightness in chest with difficulty in breathing.  Oxygen applied at 2L per nasal canula. Vital signs normal. AMR was called at 1035. Patient developed dry cough. AMR arrived at 1042, ambulance arrived at 1047. Patient was sent with AMR.
Pain in arm; Redness around the injection site area; Felt bad for about 2 days; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling bad, pain in arm and injection site erythema. In September 2019, the outcome of the feeling bad was recovered/resolved. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad, pain in arm and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 58 or 57 years old at time of vaccination. The patient received 1st dose of Shingrix and she felt bad for about 2 days and that resolved. In September 2019, the patient experienced pain in arm that had improved but not totally resolved. In September 2019, the patient also experienced redness around the injection site area that had not cleared up yet. The reporter did not consent to follow-up. The reporter declined to provide demographics. This case has been linked with US2019164588, having same reporter.
Fever, sore muscles, sore joints, headache, fatique, nausea & chills.   I had a positive Covid 19 test on September 9th.  The symptoms I've had from the shot are pretty much the same as when I was sick.  I was fortunate not to have any respiratory symptoms either time as confirmed by my oximeter.  I had two Antibody tests.  One on Nov. 23rd, which was positive for both  IgG and IgM.  I had my second anti-body test on 1/17/2021, the day of my injection which was positive for IgG and negative for IgM.  I have not contacted my doctor concerning this and I am taking Advil for the fever and ached and pains.  Today i feel better than yesterday.
woke up hurting all over; This case was reported by a consumer and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unspecified date).   On 8th December 2020, the patient received the 2nd dose of Shingrix. On 9th December 2020, 1 days after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and woke up hurting all over and no problem with the first dose.
This spontaneous report as received from a physician via a company representative refers to an approximately 2.5 year old male patient. The patient's medical history included "hyperplastic left heart" and multiple unspecified heart surgeries. There was no information about the patient's concurrent conditions or concomitant therapies provided. On 19-OCT-2015, at 12:30, the patient was vaccinated with a dose of M-M-R II, subcutaneously (lot # and expiration date were not reported), a dose of VARIVAX (Merck) (route of administration, lot # and expiration date were not reported) and a dose of an unspecified flu vaccine. On 19-OCT-2015, at 12:50, the patient was brought back to the provider's office, apparently in cardiac arrest. The reporter stated they began performing cardiopulmonary resuscitation (CPR) on the patient and called for an ambulance. The ambulance took the patient to an emergency room. The reporter stated they received a call from the coroner's office at 15:00, and was informed that the child died (on 19-OCT-2015). The event of cardiac arrest was reported as life threatening. The outcome of cardiac arrest was reported as fatal, however the cause of death was not provided. The relatedness between the adverse event and suspect therapies was not reported. Upon internal review, the event of cardiac arrest was considered to be medically significant. Additional information has been requested.
administered an expired dose; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 30-year-old male patient who received HAB (Twinrix) (batch number P9LT9, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 2 doses on an unknown date).   On 30th January 2023, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 30th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 30-Jan-2023 Reporter's comment: A physician reported at the time of reporting, the dose has not been repeated. The reporter gave permission for follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
PATIENT WAS GIVEN PFIZER (12 YEARSAND UP) VACCINE INSTEAD SCHEDULED FOR MODERNA VACCINE. PATIENT WAS TOTALLY OK WITH IT AND NO CONCERNS OR ADVERSE REACTIONS WITH THIS.
High fever- 104, stomach cramps, diarrhea, green mucous in diarrhea, blood in stools, lethargic, dehydration, slept alot, cranky.  Got shot Thursday a.m. got signs by afternoon, peak of the worst hit Friday evening.  Went to the hospital and was given an I.V. because of her dehydration and her lethargic behavior.  Gave her an antibiotic in her I.V. and went to the doctor the next 48 hrs. and they gave her an injection of an antibiotic as well as put her on amoxicyillin.  She still seems to be in stomach discomfort and her sleeping pattern is disturbed.  She had the same symptoms at her 2 and 4 month old shots, blood in stool, green, mucousy diarrhea, and a fever.  Only she didn't get hospitalized.
Positive on rapid test; Positive on rapid test; Caller indicated booster dose 04DEC2021; 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 83 year-old male patient received bnt162b2 (BNT162B2), administration date 04Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single and administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 04Dec2021, outcome "unknown", described as "Caller indicated booster dose 04DEC2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021, outcome "unknown" and all described as "Positive on rapid test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
Started breaking out; Arm to shoulder to elbow turned bright red/redness from elbow to shoulder.; Arm soreness; Had a lot of itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Started breaking out), ERYTHEMA (Arm to shoulder to elbow turned bright red/redness from elbow to shoulder.), PAIN IN EXTREMITY (Arm soreness) and VACCINATION SITE PRURITUS (Had a lot of itching at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included No adverse event (medical history not provided). Concomitant products included FLUTICASONE for Allergy NOS, ROSUVASTATIN for High cholesterol, MACROGOL 3350 (MIRALAX) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced FEELING ABNORMAL (Started breaking out), ERYTHEMA (Arm to shoulder to elbow turned bright red/redness from elbow to shoulder.), PAIN IN EXTREMITY (Arm soreness) and VACCINATION SITE PRURITUS (Had a lot of itching at injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 05-Feb-2021, FEELING ABNORMAL (Started breaking out), ERYTHEMA (Arm to shoulder to elbow turned bright red/redness from elbow to shoulder.), PAIN IN EXTREMITY (Arm soreness) and VACCINATION SITE PRURITUS (Had a lot of itching at injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: initial additional. On 10-Jul-2021: Contains no new information.
Missed miscarriage  Baby passed a week before I knew she had passed (11 weeks)
Expired dose of ACTHIB given. Vaccine expired on 8/18/2013.
This spontaneous report was received from a physician via a company representative refers to an 86 year old female patient. On 01-DEC-2011 the patient was vaccinated with ZOSTAVAX (dose, lot # and route of administration not reported). On 03-SEP-2014 the patient experienced shingles on the forehead and eye area. The patient started an unspecified antiviral medicine on unknown date. She went to see her physician on unknown date. The outcome of the event was reported as recovered/resolved on unknown date in September 2014. Additional information has been requested.
This spontaneous report as received from a physician refers to a male patient of unknown age. Information regarding the patient's pertinent medical history was not provided. On an unknown date the patient was vaccinated with a single dose of ZOSTAVAX (lot number not provided), subcutaneous. Information regarding concomitant medications was not  reported. The ZOSTAVAX was administered in the subcutaneous tissue of the waist line. The patient did not have enough fatty tissue in the deltoid region of the body. No further information was provided. additional informations is not expected.
extreme lower-body aches as if the patient had restless leg syndrome for 2 days; collarbone top chest area hurt so bad it felt like it was punched in the collarbone; cold-like symptoms; runny nose; watery eyes; sore throat; cough; rash in anus and perineum that simulated a child's diaper rash; rash in anus and perineum that simulated a child's diaper rash; extreme fatigue where the patient could barely keep eyes open for 12 days; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the arm left on 15Apr2021 at 09:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis, sciatica, scoliosis, eczema, multiple allergies (year-round allergies), sensitive skin and allergy to topical drugs (sensitive to topicals). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC), probiotics (MANUFACTURER UNKNOWN), multi-Vitamin (MANUFACTURER UNKNOWN) from an unknown date for unknown indications. The patient previously took sulfa (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 15:00 the patient experienced extreme lower-body aches as if the patient had restless leg syndrome for 2 days, collarbone top chest area hurt so bad it felt like it was punched in the collarbone, cold-like symptoms which included a runny nose, watery eyes, sore throat and cough for 12 days and also the patient experienced rash in anus and perineum that simulated a child's diaper rash (anal rash and perineal rash) and also the patient experienced extreme fatigue where the patient could barely keep eyes open for 12 days. The clinical outcome of the event extreme lower-body aches as if the patient had restless leg syndrome for 2 days was recovered with sequelae on 17Apr2021. The clinical outcome of the event cold-like symptoms which included a runny nose, watery eyes, sore throat and cough for 12 days and extreme fatigue where the patient could barely keep eyes open for 12 days were recovered with sequelae on 27Apr2021. The clinical outcome of the event collarbone top chest area hurt so bad it felt like it was punched in the collarbone, rash in the anus and perineum that simulated a child's diaper rash (anal rash and perineal rash) were recovered with sequelae on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
First day couldn't move arm  2nd day temperature shivers sore throat headache aching nerve twitching shaking all over pins and needles in hands and feet  3rd day as above  4th day headache aching  5th day headache  6th day headache and feeling sluggish and confused  7th day hives on arm small lumps on the skin and aching arm antihistamines advised began taking them  8th day burning arm red patch itching lumps bigger red patch  9th day itching constantly patch bigger redder hotter  Day 10 no better red hot to the touch spread all round arms
No additional AE reported; a 14 year old patient received a dose of PROQUAD inadvertently on 8-JUL-2021; Information has been received from a physician referring to a 14 years old patient of unknown gender.  The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On 08-JUL-2021, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (a dose; albumin status, route, lot number and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse events or product quality complaint (PQC) were reported.
Information has been received from a physician concerning a 15 year old female who in April 2007, was vaccinated with Gardasil. There was no concomitant medication. In April 2007, the patient fainted after receiving the vaccine. It was reported that the patient's blood pressure was taken. No further details were provided. Additional information has been requested.
Patient received first dose of Pfizer and started having tingling in her hands and feet. EMS responded and took Vital Signs, BP 130/80, O2 sats 99, HR 105. Patient had taken her personal albuterol inhaler prior to EMS response she stated. Patient refused any further treatment and had recovered within few minutes.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 24-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
at 48 hours initial nausea and chills, temperature rose to between 101-102 and stayed at that level for 36 hours even with ibuprofen, extreme diarrhea for 24 hours and an additional 5 days of persistent diarrhea, nausea for 3 days
Pt received vaccine (outside clinic) and complained of sweating and slight SOB and feeling anxious at 2:45 pm. Pt alert and talkative, and requested use of his own albuterol inhaler. Pt was given one does of Benadryl 25 mg also. Pt calmed after spoken to. BP and pulse ox attached, monitored, attached. Pt improved and then watched for an hour.
Information has been received from a physician concerning an 18 year old who on 14-AUG-2006 was vaccinated (yeast).  Concomitant therapy included an unspecified therapy ("ESTRASTEP").  On 14-AUG-2006 the patient experienced profuse nausea, vomiting, low grade fever and myalgia.  The patient sought unspecified medical attention.  At the time of this report, the outcome of the events were unknown.  Additional information has been requested.