chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient's parents and patient came to the Health Department 02/06/2020 approx. 4:30pm to talk to a nurse regarding the patient's injection site on her right arm. Patient's father stated Tuesday (02/04/2020) the patient cried throughout the night and he was unsure what was causing the crying and that he and his wife did not see the patient's arm until they gave the patient a bath on Thursday (02/06/2020), noticing the right arm was red and swollen, and brought her to the health department. This nurse and RN, noted the patient's right arm from the shoulder to the elbow had circumferential swelling, erythema, and warm to touch; branchial and radial pulse strong and capillary refill under 2 seconds. Raised erythema noted on right arm measuring 5 inches length with a girth of 3.5 inches. Patient's temperature was 98.7 tympanic and patient did not appear to be in distress. Patient's father denies any fever or respiratory distress since receiving the vaccine. Encouraged the patient's parents to take the child to her pediatrician or urgent care/ER.
Pt. reports skin pinched right medial deltoid lateral side and needle inserted quickly. That night pain started - pain stil there since 10/9/17 when vaccine given. So bad pt. not using arm at all. Pt. has tried NSAIDS, heat, ice and rubbing it but not getting any better. No fevers, no erythema, discharge, no nausea/vomiting, no respiratory issues.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 27-JUL-2010, the patient was inoculated with ZOSTAVAX at a clinic as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 28-SEP-2016, the patient was treated at a clinic by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed "Valacyclovir" for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Massive fever blisters.  Had 2 with the first shot and thought nothing of it and not even shot related.  Got 2nd injection and in 3 days woke up with 7 fever blisters that continued breaking out for almost 4 weeks.  I have NEVER done this.  I have had fever blisters in my nose, all around my mouth, on my lips etc, every since I received this second injection. I am concerned enough if a booster is required I would have to think long and hard if I would even get it as these have been horrible and very painful.   I also have a HUGE swelling under my right arm into my breast.  It almost could be a third breast.  I asked my PCP about this and he said to wait 3 months after last injection for mammogram as he thinks the swelling is shot related as I received both injections in my right arm.
Patient tested positive for COVID-19 after completing the full Moderna vaccine series, 56 days after 2nd dose.   Patient received 2nd dose of COVID vaccine on 1/24/21 .   Tested positive on 3/21/21.   NOT hospitalized. "Symtoms reproted: loss of taste and smell symptoms onset: 3/21/2021"  Exposed by husband. He was unsure how he was exposed. He started showing symptoms of COVID on Thursday March 18th in the morning
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted for about 30 seconds and was responsive afterwards. She was laid flat on the ground on her till the EMT arrived
Post vax, L deltoid area was swollen immediately, larger than a tennis ball. Became flushed and jittery, faint, devel ascending hives both arms, chest and up neck.
chills,  fever 99.5 F - 101.4 F,  headache, facial burning, body aches, joint pain, fatigue,  burning ocular orbits,  teeth pain, hot/cold,  These symptoms lasted approximately 7 -8 days; it felt like I had an actual influenza infection.
IgA Nephropathy; This literature-non-study case was reported in a literature article and describes the occurrence of IGA NEPHROPATHY (IgA Nephropathy) in a 40-year-old female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IGA NEPHROPATHY (IgA Nephropathy) (seriousness criterion medically significant). At the time of the report, IGA NEPHROPATHY (IgA Nephropathy) outcome was unknown. Related      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IGA NEPHROPATHY (IgA Nephropathy) to be related.    Company comment: This is a literature-non-study case concerning a 40-year-old female patient with no reported medical history, who experienced the serious (medically significant) unexpected event IgA nephropathy, on an unknown date after receiving the second dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.  No concomitant and treatment medications were reported.  Glomerular disease to vaccination is rare, although it should be monitored as a potential adverse event.   This case was linked to MOD-2022-539890, MOD-2022-539891, MOD-2022-539892, MOD-2022-539893, MOD-2022-539894, MOD-2022-539895, MOD-2022-539896, MOD-2022-539885, MOD-2022-539898, MOD-2022-539899, MOD-2022-539900, MOD-2022-539901, MOD-2022-539902, MOD-2022-539903.; Sender's Comments: Company comment: This is a literature-non-study case concerning a 40-year-old female patient with no reported medical history, who experienced the serious (medically significant) unexpected event IgA nephropathy, on an unknown date after receiving the second dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Chills, excessive shaking, headache, exhaustion all approximately 11 hours after administration.
syringes of vaccine that were pre-drawn yesterday/They were in the refrigerator overnight/a nurse utilized one of those syringes/. This was the recipient's first dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (syringes of vaccine that were pre-drawn yesterday/They were in the refrigerator overnight/a nurse utilized one of those syringes/. This was the recipient's first dose of the vaccine) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (syringes of vaccine that were pre-drawn yesterday/They were in the refrigerator overnight/a nurse utilized one of those syringes/. This was the recipient's first dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (syringes of vaccine that were pre-drawn yesterday/They were in the refrigerator overnight/a nurse utilized one of those syringes/. This was the recipient's first dose of the vaccine) had resolved.        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.   no concomitant medications are provided. treatment to the events not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: follow up information received on 20-may-2021, it dose not contain any new information.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the 2nd dose of the Moderna Covid-19 vaccine which has expired.) and NO ADVERSE EVENT (No adverse events were reported by the patient.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 038A21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 06-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the 2nd dose of the Moderna Covid-19 vaccine which has expired.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse events were reported by the patient.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with the 2nd dose of the Moderna Covid-19 vaccine which has expired.) and NO ADVERSE EVENT (No adverse events were reported by the patient.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse events were reported by the patient.) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered with the 2nd dose of the Moderna Covid-19 vaccine which has expired.). No concomitant product use was reported.  No treatment information was provided.
Excess Fatigue Reduced Stamina Cognitive Problems - Memory, Organization Hearing deficit  Severe Allergic Reaction to Poison Oak
I have not had a period for 5 years because of naxplanon birth control but have been having periods every 3 weeks since I got the vaccine.; This is a spontaneous report from a contactable consumer or other non-hcp reported about herself (patient).    A 22-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration, administered in right arm as dose 1, single on 25Feb2021 17:45 (at the age of 22-year-old) for covid-19 immunisation. The patient had no medical history and known allergies. Patient's past drug history included naxplanon for birth control. The patient's concomitant medications were not reported. Patient did not have a period for 5 years because of naxplanon birth control but have been having periods every 3 weeks since she got the vaccine (23Mar2021). Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and other medications within 2 weeks of vaccination. No treatment was received for the event. At the time of this report, outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 dose 1 (route, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient was administered the first dose of GARDASIL 9 and then experienced a swollen arm that spread down her arm. The outcome of the patient's arm swelling that spread down her arm was unknown. Causality assessment was not reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
can't drive today; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Jul2021 16:45 (Lot number: GA7484) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing), notes: From: 5 years ago.; "Blood pressure high" (ongoing), notes: From: over 10 years ago.; "Prostate, unspecified/sometimes it is difficult to urinate" (ongoing), notes: From: 3 years ago.; "Covid-19", start date: Apr2021 (unspecified if ongoing), notes: he was in the hospital Apr2021, and discharged on 05Apr2021 and received antibodies. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing); GLIPIZIDE taken for diabetes mellitus (ongoing); INDAPAMIDE taken for hypertension (ongoing); TAMSULOSIN taken for dysuria (ongoing); LISINOPRIL taken for hypertension (ongoing). The following information was reported: DIZZINESS (non-serious) with onset 20Jul2021, outcome "not recovered", described as "Dizziness"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 21Jul2021, outcome "unknown", described as "can't drive today". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, loss of personal independence in daily activities.  Additional Information: History of all previous immunization with the Pfizer vaccine not considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered on same date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). The AE(s) did not following prior vaccinations. Family Medical History Relevant to AE(s): not provided. Caller stated that he was a surgical assistant. Patient was between 162 to 170 pounds. Patient had just changed family practitioner. Caller confirmed that he had Covid, before he got the vaccine. He asked when he could get the vaccine, after receiving IV antibodies, and he was told to wait 90 days. Vaccination facility type was pharmacy. Vaccine was not administered at military facility. Caller stated that he wanted satisfaction and protection from the vaccination, and re-clarified that as better protection from the Covid virus. Anatomical location was left upper arm muscle. The time for dizziness between 4 and 6 PM. He did not think any of the medications contributed to his dizziness. Caller stated that he did not need treatment, and might be felt better a day after. The AE(s) did not required to visit to Emergency Room, physician office. No relevant test done.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100930714 same reporter/product/event, different patient
The patient received 0.2 ml of undiluted vaccine. The diluent was not added.
I did not have an adverse reaction to my vaccine but test positive for COVID 19 on May 25, 2022. I felt "knocked out" on May 25th. Telehealth visit with a provider in my doctor's office and prescribed the anti-viral medication. I started taking in on May 26th started the 5-day course of anti-viral medication.
Received PCV-7 in (R) thigh and PENTACEL (DTaP-IPV-Hib) in (L) thigh on June 5 in PM. Increased sleepiness rest of June 5, 2009. On 6-6-09 noticed hard red area on thighs and low grade temp and fussiness. Diffuse visit PM 6-8-09. had less fussiness. (R) thigh 1/2" induration with redness center, (L) thigh, 1/4" induration with slight pink center.
level of Vitamin D went up a little bit; decrease in her TSH level to 0.408; booster dose; Off label use; This is a spontaneous report from a contactable consumer (patient).   A 73-years-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 3 via an unspecified route of administration on 02Nov2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation (Booster) and thyroid (THYROID), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for an unspecified indication.  The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY, solution for injection), dose 1 and dose 2 via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE and DOSE 2, single for covid-19 immunisation. Reporter stated on 02Nov2021 she got the booster dose. Also she said that she was not sick after getting the booster. Reporter stated on 08Nov2021, a week later, she got her blood test done, that showed that her level of Vitamin D went up a little bit and a decrease in her TSH level to 0.408, and her doctor said that "It could" due to the vaccine but was not sure. Reporter asked if the vaccine could take her TSH level to go down. Patient underwent lab tests include blood test done, that showed that her level of Vitamin D went up a little bit and a decrease in her TSH level to 0.408 on 08Nov2021. At the time of this report, the outcome of event was unknown.  The lot number for the vaccine, (BNT162B2) was not provided and will be requested during follow up.
first dose of Rotarix around 17 weeks of age. Patient still has not received a 2nd dose.; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2 dose of Rotarix, which led to incomplete course of vaccination. The patient had still not received the 2nd dose.
Chest pain that is worse with any movement. This is the same reaction I had with Moderna and was unable to move around for six months and with the Pfizer later for three or four months. There has been no treatment in the past when I was hospitalized with this. Rest is the treatment as far as I know. So rest.
Nausea; body aches; heat sensation on chest; mouth blisters; fever; sore throat; headaches/migraines; headaches/migraines; This is a spontaneous report from a contactable other hcp (Nurse) for herself. A 44-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 09Jul2021 (age at vaccination: 44-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included migraine, asthma and vitamin D deficiency (recently vitamin D deficiency) all from an unknown date and unknown if ongoing. Concomitant medication(s) included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfa (sulfanilamide) and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. She received the vaccine at pharmacy or drug store. On 09Jul2021 the patient experienced nausea, body aches, heat sensation on chest, mouth blisters, fever, sore throat, headaches/migraines (headache, migraine). AE resulted in Doctor or other healthcare professional office/clinic visit. On 20Jul2021, the patient underwent lab tests and procedures which included negative COVID-19 with nasal swab. The patient had not received any other vaccine within 4 weeks. No covid prior vaccination. Therapeutic measures were taken as a result of events which included oxycodone, toradol, muscle relaxer and otc ibuprop. The outcome of events was recovered/resolved with sequel (on an unspecified date in 2021).  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
On 4-4-21 my left arm at injection site started to suddenly itch and instantly a red spot the size of my fist appeared.  It became hot the next day, and lasted for 2 days. It is 4-9-21 and I can still see the faded area on my arm.  Three days before, 4-1-21, I had a headache on the left side of my head from the ear down to my shoulder blade that lasted for a week.
Pt. stated she started feeling a burning sensation 5 minutes after getting vaccinated, the burning sensation moved to her chest and then to her legs and it went away on its own.  At 10:47 am pt. stated she is feeling OK and wants to go home.
Arm Soreness lasting for multiple days, begins as very tender and gets slowly better each day, still sore after 3 days Fatigue on and off for the next few days
Myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 22 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 22 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose: 1), for COVID-19 Immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis".The patient's mother reported that her son suffered a severe case of myocarditis after getting the second dose of our vaccine. Even so, he wants to get our booster as it was required for him to go back to college in January. She asked whether he should still get our booster or switch to another brand like J&J.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.