chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination site warmth; Vaccination site erythema; Vaccination site pruritus; Vaccination site rash; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE RASH (Vaccination site rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE RASH (Vaccination site rash). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE RASH (Vaccination site rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported  No treatment medication was reported
This case involves Adult patient of unknown gender who had got a flu shot were the years at some point got the flu while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, route, frequency, lot number and expiry date was not reported) via unknown route in unknown administration site for Flu. On an unknown date the patient developed a non-serious event " got a flu shot where the years at some point got the flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (got a flu shot were the years at some point got the flu). At time of reporting, the outcome was Unknown for the event got a flu shot were the years at some point got the flu.
Rash at injection site; This case was reported by a physician via call center representative and described the occurrence of injection site rash in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed injection site rash, following vaccination with dose of Shingrix. The reporter did not consent to follow up.
Myalgia, Fever & NauseaVomiting Narrative: Nausea myalgia low grade fever on weekend after covid vaccination on 7/30/2021 #2
Chest pain and shortness of breath that started approx. a week after booster shot for COVID.  Patient states that she had similar issues after initial  COVID vaccination and with 2nd vaccination also.  PAtient was diagnosed with pleurisy and pneumonia. States that she was told that it was from strep but had no cultures or sore throat.
patient because dizzy and fell. She does not remember falling, so it is believed that she did faint after reciving vaccines.
Had Moderna in the mornig for second dose approximately 9:00 a.m.  About 10:00 p.m. body started to feel achy.  At around 1:00 a.m., woke up in extreme pain from head to toe, could eeven feel pain in my toes.  Felt so horrible I wanted to go Urgent Care or ER but never did.  Had an extreme headache, couldn't lay down, had to walk around body was in so much pain. Had chills and sweats.  Fell asleep sitting up and woke up about 3:00 a.m. vomitting for about 30 minutes. Next day, felt fatigued but no longer vomitting and the pain was mostly gone, just achy.
This spontaneous report as received from a physician referred to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced shingles. No treatment information was reported. The outcome of shingles was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Patient came into pharmacy 8/29/11 to show pharmacist her skin reaction to flu shot administered 8/24/11. She said that two days after injection, observed hard lump at injection site with itching. On 8/29/11 she presents with approx. 4"x4" square area of red skin around injection site, raised, with intense itching, and "hot" feeling at site.
Aches; chills; fatigue; low grade fever; injection site swelling, pain, and redness; injection site swelling, pain, and redness; injection site swelling, pain, and redness; This is a spontaneous report from a contactable other healthcare professional (patient). A 32-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), intramuscularly on 14Dec2020 at 16:45 on Left arm at single dose for COVID-19 immunization in hospital. The patient medical history included Von Willebrand disease. No known allergy, no allergies to medications, food, or other products. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced aches, chills, fatigue, low grade fever, as well as significant injection site swelling, pain, and redness on 15Dec2020 at 14:00. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.  Information on the lot/Batch and expiration date has been requested.
Soreness in arm; severe headache; body aches; tiredness; thirst; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient). A 31-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration (at the age of 31-years administered in arm left on 16Feb2021 at 13:30 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, on 26Jan2021 at 11:30 as dose 2, single for COVID-19 immunization and experienced soreness in arm. The patient did not received any other vaccine in four weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. On 17Feb2021, the patient experienced soreness in arm of injection for both shots, after second shot: severe headache, body aches, tiredness, thirst. The treatment was not received for all the events. The clinical outcome for the events was reported as recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021353701 Same reporter, patient, product/ different dose
Refusal of vaccine sign on 03/28/11. Hep B, MMR, Varicella, Hep A.
Mild itch beginning shortly after injection at injection site and surrounding area. Next day 9/27 after a jog in the evening, noticed red rash at injection site, 14 cm by 16 cm. Lateral left arm swollen. Took 50mg benadryl and went to sleep. Next day 9/28, redness slightly faded, but spread distally and arm was still swollen. Took 50mg benadryl that day. Next day 9/29, redness faded further and swelling reduced. 9/30 symptoms were gone.
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 44-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.   Concomitant products were not provided.  Reporter  states that because their facility has not been able to download the digital data logger, they have been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the State is made. There have been no power outages that would have impacted the Moderna vaccine. However, she reiterates that because her facility is unable to download the digital data logger, they will need to treat this issue as a temperature excursion. The data logger that caller is unable to download are for the months of DEC2021, JAN2022, and FEB2022. She says that they are filling out a temperature excursion assessment with the State at this time. Patients have been administered doses while the temperature excursion assessment has been ongoing.  No adverse reactions were reported by any patients.  No treatment information was reported.
Knot in deltoid persists for one month following injection; joint pain in fingers; pain in left arm (injection in left deltoid).
Queasy stomach; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Queasy stomach) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Queasy stomach) and FATIGUE (Tiredness). At the time of the report, ABDOMINAL DISCOMFORT (Queasy stomach) and FATIGUE (Tiredness) outcome was unknown.            no concomitant and treatment product was reported The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments   This case was linked to MOD-2021-038171 (Patient Link).
Patient admitted for suicidal ideation, paranoia, over taking her Adderall. Behavioral health admission for 8 days, patient discharged self. This visit was within 6 weeks of receiving the COVID vaccine.
This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19 prior to Pfizer (Z-PAK) treatment) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination. Concurrent medical conditions included Sjogren's disease and Allergy. On 12-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19 prior to Pfizer (Z-PAK) treatment). The patient was treated with AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19 prior to Pfizer (Z-PAK) treatment) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 antibody test: positive (Positive) Positive. No concomitant medication was reported. Co-suspect product included Pfizer started from 7-May-2022 to 12-May-2022 for COVID-19 treatment. Patient had not taken any medications within 2 weeks of starting COVID-19 treatment. Treatment product included steroid inhaler. Device date was reported as 27-May-2022. Company Comment: This spontaneous case concerns a 67-year-old female with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Pfizer (Z-PAK)  from 7th May to 12th May 2022 and with steroid inhaler for Covid-19. 6 days after stopping treatment she had a resurgence of COVID symptoms and tested positive with rapid test. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 67-year-old female with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Pfizer (Z-PAK)  from 7th May to 12th May 2022 and with steroid inhaler for Covid-19. 6 days after stopping treatment she had a resurgence of COVID symptoms and tested positive with rapid test. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient experienced facial drooping on the right side of his face starting on 6/17/21 and worsening over the next two days. He experienced tearing in his right eye. Patient denies any additional symptoms. Recommended patient be seen by provider asap to rule out potential stroke. Patient denies any additional symptoms.
Information has been received from an unspecified health professional referring to a baby patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. On 09-JUL-2016, the patient received two months vaccination, and was vaccinated with a dose of ROTATEQ, orally (dose and lot# were not reported). But the vaccine underwent an incorrect storage, as the hospital's fridge was off for 24 hours on 06-JUL-2016 and the maximum temperature recorded was 19 degrees Celsius. Additional information has been requested.
G5P3 mother had moderna vaccine 1 week prior to going into preterm labor.   Pregnancy was complicated by gestational diabetes.  Mom also intermittently takes atenolol for heart palpitations.  Preterm labor and delivery occurred at 33 0/7 weeks (previous children were not delivered preterm).  Infant's weight at birth was 1670g.
I never got my second/got first dose in month of jan; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I never got my second/got first dose in month of jan) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient tested positive for COVID-19.) in August 2020.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I never got my second/got first dose in month of jan). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I never got my second/got first dose in month of jan) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: follow up document received on 16-AUG-2021 contains Reporter information updated, patient demographics added and batch/lot number added.
L arm sore, as expected, thru evening of 6/14/19. Hand fell asleep when laying on left side. Stomach was queasy all the next day - ate nothing 6/15/19. Arm got much sorer from just below injection site all the way to my elbow. Left leg cramps. Arm hot to touch but didn't notice redness til Sunday 6/16/19. Daughter (PA) noticed redness - looked like cellulitis - large patch 3 inches below injection site the cellulitis-looking red elevated skin was approximately a 4 in. wide by 7 inches long patch on the left arm between elbow and top of shoulder. Ate a normal breakfast, but stayed away from coffee all day Sunday because of queasiness of stomach. I am not an wipy person - have thrown up once in the last 50 yrs from some flu bug. Felt warm but not feverish. Early Monday morning 6-17-19 had diarrhea. About 3 short bouts of that before I took 2 Imodium pills. That stopped diarrhea, but still had slightly queasy stomach for the next 4-5 days. Stool was formed, but a yellowish color like grey poupon mustard. By Friday, felt more like eating & stool turning more of a normal color. The covering physician on Monday (6-17-19) thought the redness of my arm was lightening from the pictures I had sent on Sunday. Said if my symptoms would worsen (fever, darker-red skin, etc) I could get an antibiotic from him. Nothing was prescribed that day and I left w/ a wait and see attitude. Soreness went away & feeling almost back to normal by Thurs. 6-20-19.
Headache, body aches, fatigue  Covid arm: hard painful lump at injection site, itching, tingling and rash
Had gotten the shot and it was excruciating/Suspected vaccination failure; It was excruciating; It was excruciating; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had gotten the shot and it was excruciating/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: It was excruciating) and pain (Verbatim: It was excruciating). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient's child via interactive digital media. The patient said shingles was excruciating. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
has not been feeling well; She has neither IgM or IGG against COVID; She has high timers against Epstein Barr - i. e diagnostic for mononucleosis; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 for COVID-19 immunisation on an unspecified date. The patient had 2nd PFE COVID vaccine immunization about 3 weeks ago (unspecified date). She has not been feeling well and, being a physician, sent in her blood for a litany of antibody tests. She has high timers against Epstein Barr i.e. diagnostic for mononucleosis. She has neither IgM nor IGG against COVID. The issue is how to proceed to ensure immunity against COVID. If it turns out that there are some non-responders (i.e. no AB response) to the Pfizer vaccine, the logical thing to do would be to get a different vaccine. If there is immune competition and she did not respond to the vaccine because of her ongoing mono, then it makes sense to get another single dose of the Pfizer vaccine once the mono has cleared, as she will likely have memory B cells against the Pfizer antigen and may need multiple injections of the vaccine if the antigen presentation is different between the two. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: She has neither IgM nor IGG against COVID on an unspecified date. The outcome of the events was unknown.  Information about the Lot/batch number has been requested.
Patient asymptomatic, did pre travel COVID test on 08/01/21 that was positive for COVID
day 14 post vaccine: pt presents with low grade fever, feeling "achy". day 16 post vaccine: pt report feeling better. day 17 post vaccine: pt admitted to hospital with chest pain.  EKG normal. chest x-ray shows infiltrate.  day 18 post vaccine: pt released from hospital. clinician believes hospital admission unrelated to smallpox vaccine.
W/in 15 min of immunization, pt fainted. She "came to" quickly and was able to sit up, felt light headed & nauseated. No rash, SOB, itching/swelling, etc.
March 31st to Apr. 4th)- I got the red rash on my right arm (covid arm) and it went away after 3 days (itchy and it was sore). I took bendryl and it got better.    Apr 8- noticed a rash forming on my thigh. By the next mroning its was the same red rash that was on my arm...but now it was on my thigh. My left tig toe also became kind f swollen and itched alot. I began taking benadryl like every 4 hours and  by the 10th...it started getting better. Its April 12 and the rash is still there and it itches (sometimes) but it is much smaller and not as inflamed.