chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client presented at a booster clinic where booster doses of Pfizer and Moderna were being administered to employees who had completed their primary series.  Client did not have immunization record.  Stated she had received Pfizer dose previously.  Instructed client that she would be receiving a booster dose of Moderna since it had been determined that Moderna could be given to people who had previously received a Pfizer dose.  After the 0.25 dose of Moderna administered the client stated that she had only received one dose of Pfizer previously.  At that point I offered to administer either a dose of Pfizer vaccine or the other half of the Moderna vaccine to complete her series.  The client refused both.
Fever up to 103, chills, night sweats, fatigue/exhaustion, nausea.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 29-APR-2010 the patient was vaccinated with the 1st dose of GARDASIL, (lot # and expiry date not reported). Then on 29-SEP-2010 the patient received the 2nd dose of GARDASIL (Inappropriate schedule of drug administration). No adverse effects reported. Additional information has been requested.
Sore arm, left axilla pain, body aches, leg cramps, headache, fatigue, neck pain. Started 12 hours after vaccine
9/29/1999 Reactive Exanthem to vax area to, rt thigh. Benadryl given and ice advised. Seen again 9/30/1999, dx right thigh cellulitis. Treatment Cephalexin, this began after rec vax.
Approximately 4 hours post injection, pt developed a full-body rash; fine red pruritic.
In First 24 hours itching swelling redness upper arm around injection site with superficial loss of feeling outside arm.  Area. Approx 5? in diameter.  No weakness.  Concerned about second vaccine and a worse reaction if condition has not resolved by that time.
I have a confirmed case ulcerative colitis, with associated problems of arthritis and fatigue; I have a confirmed case ulcerative colitis, with associated problems of arthritis and fatigue; I have a confirmed case ulcerative colitis, with associated problems of arthritis and fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Colitis ulcerative" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Mesalamine, reaction(s): "Known allergies: Mesalamine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: Feb2021, when the patient was 57 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: Jan2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: COLITIS ULCERATIVE (medically significant), ARTHRITIS (non-serious), FATIGUE (non-serious) all with onset Oct2021, outcome "unknown" and all described as "I have a confirmed case ulcerative colitis, with associated problems of arthritis and fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Feb2022) negative. Therapeutic measures were not taken as a result of colitis ulcerative, arthritis, fatigue.  Additional Information: There were no other vaccine administered within 4weeks. There was no COVID prior vaccination. The patient had not been diagnosed COVID tested post vaccination. The Nasal Swab test had been performed.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Hearing noise wind blow in my ears and pain in my bone joints.  i dont know if i have to go see a doctor or is normal.
No adverse event; First dose on 23-JAN-2020 and second dose on 23-APR-2020; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 23-JAN-2020 and second dose on 23-APR-2020) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy.   On 23-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2020, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 23-JAN-2020 and second dose on 23-APR-2020). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 23-JAN-2020 and second dose on 23-APR-2020) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     No concomitant medications were reported. Patient received Pfizer vaccine from 17-Nov-2022 to 21-Nov-2022 for treatment of COVID-19. On 03-Dec-2022 at 09:00, patient had difficulty breathing upon exertion of activity, Cough, Sore Throat, Muscle aches, Hoarseness, Fatigue, Not sleeping well and Chills. All events were recovering. It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that the patient previously received a COVID-19 Vaccine. Device Date was given as 08-Dec-2022. No treatment information was provided.
I woke up in the morning with stroke like symptoms, slurred speech, right side facial droop and paralysis, and I had trouble finding words. I went to the ER and they did a cat scan with contrast and did not find signs of a stroke. The symptoms started to come and go over the next 24 hours. They admitted me and did an MRI and still no sigh of a stroke. The working theory was TIA's or a migraine. I was also having very high blood pressure. In my follow up after being discharged the neurologist thinks the TIA is unlikely because the symptoms were the same were every time. I am being treated as if it were a TIA though and am on medications now for blood pressure and cholesterol and an aspirin regimen. However, they think it was a hemiplegic migraine and have new migraine medications as well.
Information has been received from a pharmacist referring to 3 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 02-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was not product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Chills, headache, diarrhea, muscle aches and fever.  Date 02/06/20121 @ 9:00 am
This spontaneous case was reported by a consumer and describes the occurrence of DEATH NEONATAL (Three babies died in her hospital last week/one was sent to the ICU) in a  neonate of an unknown age and gender exposed to mRNA-1273 (Spikevax), while the mother received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during pregnancy. No Medical History information was reported. On an unknown date, the mother received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the neonate was diagnosed with DEATH NEONATAL (Three babies died in her hospital last week/one was sent to the ICU) (seriousness criteria death, hospitalization and medically significant) and FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy). The neonate was diagnosed with DEATH NEONATAL (Three babies died in her hospital last week/one was sent to the ICU) and FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. The neonate died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy) had resolved. No concomitant and treatment information were reported. Company comment: This spontaneous case concerns a neonate with no reported medical history, who experienced unexpected, fatal (hospitalization, medically significant) event of Death neonatal which occurred at an unknown time with regards to the mRNA-1273 vaccination. Fetal exposure during pregnancy was also noted. The caller inquired if mRNA-1273 has trials with pregnant women. The caller also claims that people are dying, and three babies died in the hospital, with two still born and one was brought to the intensive care unit. The cause of death is unknown, and no autopsy report was given. No further information was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-586147 (Patient Link). Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a neonate with no reported medical history, who experienced unexpected, fatal (hospitalization, medically significant) event of Death neonatal which occurred at an unknown time with regards to the mRNA-1273 vaccination. Fetal exposure during pregnancy was also noted. The caller inquired if mRNA-1273 has trials with pregnant women. The caller also claims that people are dying, and three babies died in the hospital, with two still born and one was brought to the intensive care unit. The cause of death is unknown, and no autopsy report was given. No further information was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reported Cause(s) of Death: Unknown cause of death.
No adverse outcomes were noted by nurse or reported. This VAER is being completed because when we went into system to put in the FLU vaccination pt. received on 12/4/2022 we saw that he had received a FLU vaccine on 11/6/2022.
BRAIN FOG; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced brain fog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of brain fog was not reported. This report was non-serious.
My arm started to hurt at the injection site at about 7PM.  It hurt to touch and put pressure on it.  I woke up around 1AM on the 31st feeling cold and went back to sleep, but I couldn't lay on the arm that had the injection due to the pain in my muscle.  I woke up again at 3AM with chills, cold sweats, and body aches; it felt like I had a fever but I don't own a thermometer so I can't say for sure.  Later in the day on the 31st, I did not have an appetite and when I tried to eat, I experienced nausea.  Even the slightest touch to the injection site caused pain and I couldn't raise that arm.  My fatigue, aches, loss of appetite, nausea, and chills lasted until January 1st.  The pain in my arm lasted for another week or so before I could lay on it or touch it.  To this day, if I scratch the injection site or accidentally bump into it in the exact spot I received the shot, it will cause pain that I did not experience before.
Per phone call received from pt's mother on 1/18/2007: Taken to the ER 1 or 2 days after receiving the Pneumovax vaccine with a red raised area on her right deltoid with a surrounding rash, welts and blisters.
Joint pain; This case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was unknown.   The reporter considered the joint pain to be possibly related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The reporter wanted to know how long it would take before the joint pain goes away from Shingrix shot.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR253490:same reporter
Sore arm, fever, chills, pain in back and hips, severe stomach ache, extreme confusion, anemia
rash around the area of the injection site; rash around the area of the injection site. She stated it itches all the time; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 03Apr2021 single dose for covid-19 immunisation. Medical history included rash before the vaccine due to bed bugs. The patient concomitant medications were not reported. Patient reported that did not receive a reaction on the site where she took it. She gets bit during the night. she waited one hour at the facility because she read that severe allergic reactions happen for one minute to one hour after the vaccine. She had clusters of red bumps and itchy bumps but it could possibly be from bed bugs. She stated this happened a week or so after the vaccine. The difference after the vaccine is that some were redder. She now has rash around the area of the injection site. She stated it itches all the time. She rubs it with soap. The events assessed as non-serious. She stated some feel like they do not itch. She is seeing HCP Monday. She has not had any swelling. Some rashes have gone away. She asked if rash is a reported side effect specifically rash all over the body and does it go away. She asked should she get the second dose. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient's mother reported firmness, redness, slight edema & pain at injection sites via phone call. Call took place 10 PM on 03/08/2023; approx. 12 hours after patient's receipt of DTaP/IPV and MMRV vaccines.  Mother's concerns were triaged, and she was advised to have the child assessed at ER / Urgent Care. When the child had workup at ER, he was diagnosed with mild injection site discomfort that had evidently resolved. Tylenol/motrin and continued observation by parent at home recommended by ER. When further contact w/ mother was sought by clinic after this visit (on 03/13/2023), calls were refused due to invalid number / lack of voicemail.
Insomnia night after second shot Covid arm day after second shot. Covid arm one week after first shot
Temp > 103 for 2 days, some site pain (no swelling or edema).
I started scheduled period on  4/15/2021 the day before second covid vaccine. It lasted about a eight days; which is normal for me. My next scheduled period should not be until the middle of May, but on 5/4/2021 I started spotting. On 5/5/2021 I started having bleeding consistent with light to medium period.  The bleeding has not subsided.
significant erythema & induration @ site of inj 2.5 inches in diameter;
No adverse event; an expired dose of MMR II was administered to a patient; This spontaneous report was received from an other health professional referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant therapy was included sterile diluent (manufacturer unknown).  On 05-MAY-2022, the patient was vaccinated an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant Human albumin (rHA) 0.5 milliliter once, (lot #T007234, with expiration date: 27-FEB-2022), for prophylaxis (strength, and route of administration were not provided) (expired product administered). No additional adverse effects were reported.
Approx 6 hrs p/receiving immun pt had fever 104 followed by 3 febrile convulsion & tachycardia;
extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included Hypersomnia since an unknown date. Concomitant products included LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced FATIGUE (extreme fatigue). The patient was treated with AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) at an unspecified dose and frequency. On 14-Feb-2021, FATIGUE (extreme fatigue) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-063561 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-063561:Dose 1
h/a, fever, eyes, face, cheek warm & hurting lot of pressure on eyes, h/a severe;
Patient's girl friend reported he fainted and bumped his head on the floor. He fainted and was awake by the time the pharmacist came out to the aisles.
On 7/14, two days after her vaccine she had a fever of 104 degrees and was unable to bear weight or walk on her right leg. On 7/15 we took her into the ER at hospital. Her fever came down with medicine, continued to be unable to walk or stand on right leg. Doctors ruled out fracture. On 7/16 they diagnosed her with transient synovitis and we were discharged from hospital and told to give her Motrin for the pain and they would continue to monitor her bloodwork. On 7/17 she was able to put some weight on her right leg. Her walking continued to improve over the next few weeks and on 8/1 she was walking normal again. Her blood work continued to show low neutraphils with little improvement. She was referred to a hematologist-oncologist. On 9/11 she was diagnosed with severe neutropenia.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration, lot# and expiration date were not reported). There were no adverse symptoms reported. The temperature excursion and its time for administered doses of vaccine was unknown by the reporter. It was unknown if data logger was involved. There was an unspecified number of multiple ongoing excursions since April 2017. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA011849: US-009507513-1709USA011988: US-009507513-1709USA011986.
Had not taken Vivotif according to the recommended schedule; Spontaneous report received on 07FEB2020.  A nurse reported that a consumer "had not taken Vivotif according to the recommended schedule" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for immunisation. The consumer had not taken Vivotif doses according to the recommended schedule. The doses were taken on Tuesday, Saturday, Monday, and Wednesday (dates unspecified). Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif doses on Tuesday, Saturday, Monday and Wednesday (Inappropriate schedule of product administration) instead of taking Vivotif on every other day. The causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took Vivotif doses on Tuesday, Saturday, Monday and Wednesday (Inappropriate schedule of product administration) instead of taking Vivotif on every other day. The causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
pt recv vax 7JUL97 & 11JUL97 pt devel a high fever 99-104 & a rash;12JUL97 pt went to ER & was dx w/OM;pt was treated w/APAP;
triple bypass surgery; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 68 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing); "Blood thinner" (ongoing); "Coronary bypass surgery" (unspecified if ongoing), notes: . Concomitant medication(s) included: LIPITOR taken for coronary artery bypass (ongoing); CLOPIDOGREL taken for coagulopathy, start date: 15Feb2022 (ongoing); METOPROLOL taken for blood pressure measurement, start date: 15Feb2022 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EN6205, Exp: Unknown, Dose and Route: Unknown), administration date: 09Mar2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (DOSE 2, SINGLE, Lot: EN6202, Exp: Unknown, Dose and Route: Unknown), administration date: 01Apr2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: VASCULAR GRAFT (medically significant) with onset 07Feb2022, outcome "unknown", described as "triple bypass surgery". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Aug2022) Positive.  Clinical course: Additional vaccines administered on same date of the Pfizer Suspect was reported as with one of the vaccines he might have gotten his flu shot also, but he was not sure. He knows he has had his flu shot. Prior vaccinations were reported as none.  Follow-up attempts are completed. No further information is expected.
Several months after receiving one dose of varicella virus vaccine live the pt developed chickenpox.  Two other family members reportedly had similar experiences.
Evening of shots, extreme nausea from 8:00 to 10:00 PM. Then uncontrollable violent shaking, cont 'd thru night, around 1:00 AM 99.8 fever, 5:00 AM 99.3 fever, still shakes, 8:00 AM 98.6 fever and ok.
Patient experienced "pounding headache" during the 15 minute post-injection observation period. Patient was taken to the Emergency Room, treated, and released. She complained of continued symptoms the following day, noting improvement in severity.