chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; This is a spontaneous report from a contactable female consumer (patient), of an unspecified age reported that she received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 06Feb2021 (reported as Saturday), as a single dose for COVID-19 immunization. The patient previously took first dose of BNT162B2 vaccine for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, her 2nd dose of Covid vaccine on Saturday and had chills on 06Feb2021 (Saturday) and Sunday. She wants to know if the chills mean the vaccine was working. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Started with small bump, turned very red and hard, warm to touch. Made markings on her arm to see where it was at 6:00pm. No other symptoms at that time.  Next day (4/24/19) nothing suspicious during the day, around 6:00 pm noticed the redness moved past the marking lines, and it was still warm to the touch as well as hard.
I have a new nodule on the outer edge of my collarbone that is quite sore. I have never had this before. The soreness is approximately 1 inch diameter. It hurts when I touch it/press on it. It is not unbearable but it is sore. Very strange.
Eczema get out of hand; gave injection and it hurt very bad; Lot of medication ran down hand; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (Eczema get out of hand), INJECTION SITE PAIN (gave injection and it hurt very bad) and ACCIDENTAL EXPOSURE TO PRODUCT (Lot of medication ran down hand) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Prophylactic vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On 14-Oct-2022, the patient experienced INJECTION SITE PAIN (gave injection and it hurt very bad) and ACCIDENTAL EXPOSURE TO PRODUCT (Lot of medication ran down hand). On an unknown date, the patient experienced ECZEMA (Eczema get out of hand). At the time of the report, ECZEMA (Eczema get out of hand) was resolving, INJECTION SITE PAIN (gave injection and it hurt very bad) had resolved and ACCIDENTAL EXPOSURE TO PRODUCT (Lot of medication ran down hand) outcome was unknown. Not Provided    For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was not reported if the patient received a corrective treatment for the events.
Redness at site, heat at site, muscle pain in left arm, vomiting, headache
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 37-year-old female patient (not pregnant) 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; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: nsaids, reaction(s): "Known allergies: NSAIDS". The following information was reported: DRUG INEFFECTIVE (medically significant), 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. Clinical course: The patient was treated with Paxlovid from 31Jul2023 to 05Aug2023. The patient experienced rebound COVID-19 on 08Aug2023 at 1:00 PM treated with Mucinex.   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.
Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-May-2021 and was forwarded to Moderna on 02-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication listed.  No treatment information provided.
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Vials were moved to fridge on 06-Oct-2021.  Treatment details was not reported by the reporter.
Following vax, patient was crying and developed a fever of 102F. Patient has a red area, approx. the size of a dime, at the injection site. ER doctor prescribed Motrin. The follow up confirmed site was at left upper thigh site Varivax-no other AE. Hx no other vaccination previous 4 weeks.
Ct hx of vaccination (-) titer requiring MMR - Ct stated on AUGMENTIN for URI finished antibiotic couple days ago. Since completion arm has been sore, warm and swollen - Encouraged to see provider for flu  by medical director
17 year old got vaccinated; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got vaccinated) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got vaccinated). On 19-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got vaccinated) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment medication was not reported.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 046A21A) with no associated AEs.
pt exposed to varicella vax strain through contact w/a sibling (WAES97052819) who contracted chickenpox via secondary transmission through contact w/an individual WAES97052772 who recv vax;2wk post exposure pt devel vesiculopustular rash
Two weeks after shot, I began to go numb in my left arm and leg. Numbness spread to right side. Cramping in right leg. I went to doctor and then ER.  MRI normal. Still feeling numb and tingling in all limbs. Also weak and fatigued.
J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/9/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/9/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
pt recv vax 12JUN98 & mom described child w/eyes rolling back in  head & child w/jerky movements to body;child was taken to MD-observed & given meds;
some weird response; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (some weird response) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (some weird response). At the time of the report, FEELING ABNORMAL (some weird response) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
5 seconds after vaccines, patient had 30 second seizure, eyes rolled back, hit head on wall, and had upper body jerking for < 30 seconds, was then responsive, had some facial sweating.  Subsequent normal neuro exam with perrl, eomi, normal gait, and alert and oriented x 3.
Information has been received from a mother concerning her 3 year old male son with no known drug allergies and a history of cellulitis of cheek and eye five times who was vaccinated with a dose of MMR II. Subsequently at three years of age, in approximately 1997, the pt was diagnosed with autism. The mother reported that 2 other siblings received MMR II without adverse symptoms. *Follow-up report on 7/29/02: Conflicting info. has been received from an MD's assistant. The MD's assistant reported that the PT was first seen in the practice at the age of 10-11 mts, and in 98, the PT was referred for psychological counseling due to behavioral issues. In March 99, the PT was diagnosed w/a speech delay and social skill problems. In 99, the PT was diagnosed w/Asperger's Syndrom. It was reported that the PT attended a special school and was receiving speech therapy, occupational therapy (OT), and psychological counseling. The MD's assistant reported that the PT's MD felt that the PT's Asperger's Syndrom was not related to the MMRII.* Upon internal review, autism was considered an other medical event (OMIC). Additional info has been requested. The mother also reported that her other son also developed autism at 17 months old after vaccination with MMR II (WAES0207USA00696).
Child received his first GARDASIL 9 dose at the age of 8 years and 8 months; No symptoms reported; This spontaneous report was received from a nurse, referring to an 8-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated at the age of 8 years and 8 months with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age). No symptoms were reported.
1) Shortly after receiving the vaccine I noted a metallic taste in my mouth. It lasted for 3-4 days 2) Within a day or two of receiving the vaccine I noted a sense of heart fluttering/ palpitations 3) I was very tired for 4 days
pt recv vax & 5 days post vax pt devel fever, enlarged lymph nodes, conjunctivitis, & pustule like rash on face & ears; rx gentamicin on Duricef;
10/19/12 Headache muscle aches. 10/22/12 Felt run down. 10/23/12 Fever 100 degrees F. 10/25/12 Palpitations, fever 101.5. Went to ED. CXR, labs. Started on antibiotics for bilateral pneumonia.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 14-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000928: US-009507513-1907USA000936: US-009507513-1907USA000923: US-009507513-1907USA000862: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000925: US-009507513-1907USA000924: US-009507513-1907USA000937:
Client presented at the vaccination clinic and reported that he had never received any doses of Covid vaccine. He received a first dose of Pfizer vaccine today without any obvious incident. In checking through our state database this afternoon, it was noted that the client had actually had a dose of Johnson and Johnson vaccine on 3/6/21, about which he had neglected to mention.
About two weeks after the shot, bad rush on hands, shoulders, back, legs/knees, constant itch all aver
it hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In FEB-2023, the patient received the 1st dose of Shingles vaccine. In FEB-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: it hurt). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by patient via interactive digital media. The patient received shingles vaccine this week and it hurt like a son of a gun and he/she was not looking forward to get the second shot of shingles vaccine. The reporter stated that he/she would take it over shingles any day. The follow up would not possible as no contact details were available.
Soreness at injection site and radiahy redness down arm and on left side of chest. Injection site on left arm. As of 9/25/2017 Pt says its much better.
Very sore arm for days.  Over a week later a red scab formed at the injection site
Contracted Covid-19 with symptoms first appearing January 9th. Medical interventions: monoclonals, immunity infusion, rest, Advair, prednisone, a second round of steroids, albuterol. Also 3 x-rays, 1 ER visit, 1 urgent care visit. After recovering from the acute phase of the illness at the end of January, have developed symptoms: mild cognitive impairment, sensitivity to light and patterns, blurry vision, dimming vision, nausea, feeling like I am falling/dizziness.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (unspecified date) Negative; (15May2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient treated with Paxlovid from 06May2023 to 11May2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
headache; body ache; chills; freezing cold; potential fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 15th October 2020, 1 hr 30 min after receiving Shingrix, the patient experienced headache, general body pain, chills, feeling cold and fever. On an unknown date, the outcome of the headache, general body pain, chills, feeling cold and fever were recovered/resolved.   It was unknown if the reporter considered the headache, general body pain, chills, feeling cold and fever to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced headache, body ache, chills, freezing cold and a potential fever and all were resolved within 24 hours.   This case was linked with case US2021AMR008919, reported by the same reporter.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR008919:same patient, 2nd dose
I had problems in my left eye and it was diagnosed as posterior vitreous detachment. I was having flashing in my eye and a lot of floaters. I ended up testing positive for Covid  after my 3rd dose on 01/03/2022. I had cold symptoms, slight fever, congestion, back pain, achiness. I had the same thing happen to my right eye after the second dose.
Patient reports redness, warmth and swelling  to both injection sites. Sites are also painful.
Slurred speech and tongue swelling at 4:35 PM. Reported to ER at 5:11 with tingling of extremities, but slurred speech had resolved.
This spontaneous report was received from a 55 year old male patient, reporting on himself. It was reported that the patient was a survivor of HPV cancer. "About 6 months ago" in approximately November 2014 the patient was vaccinated with the third dose of GARDASIL (route and lot# not provided). It was reported that the patient completed the 3 dose regimen (dates of doses 1 and 2 were not reported). The patient reported that he received GARDASIL after being "cancer free" for two years, which is other than indicated in the prescribing information. Additional information has been requested.
As I washed up in the morning, about 8 a.m., I noticed my underarm was sore.  As I examined the area several times during the next couple of hours I noticed a lump.  The lump was moveable, but seemed about the size of a nickle.  It scared me even though it was not actually in my breast.  The doctor told me since it was moveable and felt smooth he thought it to be a reaction to the Covid vaccine, but ordered a mammogram.  I called for the mammogram and was told I could not have one until 4 weeks after the 2nd shot.  I have a mammogram scheduled 3/26/2021.
temp 101.4 axillary ,   nausea ,without emesis HR   108  . weakness fatigue
1.  First COVID vaccine was received on Dec 30, 2020. 2.  COVID symptoms begin on January 6, 2021. 3.  Positive COVID PCR test on January 7, 2021 4. Moderately sick from January 8 through January 19. 5.  Cleared by employee health division to return to work on  January 22.  I inquired as to whether or not I should receive the second dose of the vaccine  as scheduled, on January 22.  I was told that it was safe.   6.  Between 4-5pm on January 22, 201, I received my 2nd COVID vaccine. 7.  At approximately 1am on January 23, 2021, I awoke dripping w/ sweat, fever of 102.2, and severe body aches.  I took 800 mg Ibuprofen and  1g Tylenol at 4am.  Neither helped w/ symptoms.  At approximately 11am, I took 60 mg  prednisone.  Approximately 1 hour later, fever broke and body aches began to resolve.  Mild soreness and fatigue persisted for approximately 24 hours.
Charlie horse began 10 days after vaccine, leg felt full with cramping  not allowing motion, went to ER diagnosed with blood clot in left calf