chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My face started to get numb, my throat started to get scratchy, cheeks got red, lip tingle
Severe pain in injected arm (unable to move), low-grade fever (100 degrees F), headache, body aches, chills. Pain in arm began 3 hours after injection; the rest of the symptoms gradually worsened over the next 8 hours. I took ibuprofen. Symptoms gradually abated beginning the next morning (24 hrs after injection), and disappeared after about 36 hrs following injection.
This spontaneous report was received from a physician and refers to a multiple unspecified patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates between August 2016 and November 2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M023718 with an expiration date 09-AUG-2016 (strength, doses, route of administration and anatomical location were not reported). No adverse effect was reported. Administered doses of RECOMBIVAX HB experienced temperature excursion of 0 degrees Celsius for 285 hours and 20 minutes in August 2016, 285 hours an 20 min in September 2016, 223 hours and 20 minutes in October 2016 and 200 hours in November 2016. There was no previous temperature excursion. Digital data logger was involved. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Covid symptoms included: slight fever, severe fatigue, nasal congestion, coughing and sneezing.
red itchy rash inside elbow, red itch bumps on a couple fingers and on inside of right wrist
Patient woke up from nap warm with a fever, also with nasal discharged, and irritability.
A non-serious spontaneous report of inadvertently sprayed into eye was received from a Physician concerning a male child. Neither medical history nor concomitant medications were provided. Per the reporter, FLUMIST was inadvertently sprayed into a child's eye during administration. There were no symptoms to report. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Redness/swelling of (R) shoulder deltoid area post vaccination (subcutaneous injection) given 2/26/08. Infected skin, Keflex 200mg PO QID x 10 days.
Lower-than-authorized dose volume administered (e.g., leaked out). Patient requested administration of additional dose. Per CDC recommendations "If less than half of the dose was administered or the proportion of the dose cannot be estimated, administer the authorized dose immediately (no minimum interval) in the opposite arm." Additional dose administered 3/11/2021.
Ongoing headaches, severe at times along with nausea and dizziness.    Some days it is completely debilitating.    These started about a week after second shot.  They have continued with some days being less present.   I also have been learning to cope with symptoms.
& fever, aches, chills, swelling at injection site, itching, redness, soreness METHYLPREDNISOLONE
Pt c/o body aches, headache, minor fever, and "pressure all over body."
Death 1/23/2021 Autopsy says cause of death is SUDDEN UNEXPLAINED INFANT DEATH
Heart pain one month after, severe dizziness, on day after, brain fog, trouble walking,fatigue all one week later. Rapid heart rate for several months. Currently have enlarged heart with no pain. Have been unable to get medical care from several Doctors. Scheduled appointment with Long Haul covid clinic at a hospital May 12,2022 and then at anither hospital.  Both clinics had no answers or follow up.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 18-MAR-2019 the patient was vaccinated with ROTATEQ, lot # R002805, oral for prophylaxis. On 18-MAR-2019, 1 day after onset of therapy the patient experienced product storage error. On an unknown date the patient experienced no adverse event.
Red Rash on her Chest.  Patient felt a tickle feeling in her throat.  She was alone and did not feel comfortable driving home.   Pateitn requested transport to Hospital ER for further evaluation.
Pt. describes increased fatigue & leg weakness with exercise starting with 2 wks after YF vaccine.
got the shot, have shingles/suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and had shingles now. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Got 0.5ml (the administrator thought she was getting the first dose); This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Got 0.5ml (the administrator thought she was getting the first dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 18-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (Got 0.5ml (the administrator thought she was getting the first dose)). On 18-Dec-2021, ACCIDENTAL OVERDOSE (Got 0.5ml (the administrator thought she was getting the first dose)) had resolved.        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.
Nausea; Vomiting; Diarrhea; Rash; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting), DIARRHOEA (Diarrhea) and RASH (Rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension.    On 16-Feb-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 NAUSEA (Nausea), VOMITING (Vomiting), DIARRHOEA (Diarrhea) and RASH (Rash). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting), DIARRHOEA (Diarrhea) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
Headache, red, swollen and hot at vaccine area, muscle weakness throughout my body, fatigue, nausea. Starting with the pain in my arm the night of the vaccine, I developed a headache. The next day started with the weakness in my body and the day after, nausea as well. It took a full week to recover.
No additional AE information provided; HCP called to report a TE for VAXNEUVANCE (Lot #W039033; Expiration 10/01/2024; current excursion (49.1F) for 34 minutes; with two previous excursions at (35.9F) for 2 minutes and again at (35.9F) for 2 minutes) which was also administered to a patie; This spontaneous report has been received from a medical assistant referring to a 12-month-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 12-JUN-2023, the patient was vaccinated with improperly stored pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) 0.5 milliliter (mL) injection (0.5mL, once, lot# W039033, expiry date 01-OCT-2024) via injection in left thigh for prophylaxis. It was reported that the suspect vaccine was underwent a current temperature excursion at 49.1 degree Fahrenheit (F) for 34 minutes. The suspect vaccine also underwent two previous temperature excursions at 35.9F for 2 minutes and again at 35.9F for 2 minutes (product storage error). User of the device was a health care professional (HCP) and product was not available to obtain. No adverse side effects were reported with the administration of the vaccine. No additional adverse event information and no product quality complaint (PQC) were provided.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2307USA004472:
13 days after vaccine: woke up today and all day my vaccine-arm bicep feels weak and sore; my vaccine-arm elbow and wrist joints are extremely painful. No clear immediate cause for this.
Prolonged, inconsolable crying. Afebrile and drinking ok. Mom tried Tylenol and bathing and it didn't help.
3 female patients had a spike in blood sugar number after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (3 female patients had a spike in blood sugar number after receiving the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high, Fibroids, Stenosis and Drug allergy (Loratad allergy).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced BLOOD GLUCOSE INCREASED (3 female patients had a spike in blood sugar number after receiving the vaccine). On 10-Jan-2021, BLOOD GLUCOSE INCREASED (3 female patients had a spike in blood sugar number after receiving the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood glucose: 200 blood sugar spike about 80 points- went 120 to over 200.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment of the event included, metformin twice daily.  No concomitant medications were reported.
Redness and Swelling of right arm. Redness spreading to other side of arm.
After pharmacist administered Moderna vaccine within 5 minutes patient complained of feeling hot all over, throat and chest tightness and feeling like they were going to pass out.  Pharmacist had technician put an ice pack behind patients neck and had them sit on floor because patient did not want to lay down.  Patient did not want to be injected with epipen but did take 10mls of Benedryl.  After about 10 minutes patient said they were feeling better and did not want an ambulance called.  Patient had mom come and picked them up and seemed a lot better when she left the store.
On 9/25/2022, I had a cough, chest congestion, and sinus congestion, runny nose, and some trouble breathing. On 9/25/2022, I took a COVID-19 home test and it was positive. I gave it 3 weeks to run its course. After 3 weeks I was not better. I continued to have the same symptoms. Around 10/12/2022, I went to see my doctor. I have a history of pneumonia. I did not have pneumonia yet, so the doctor prescribed an antibiotic and a steroid, prednisone. It's started to see improvement in about a week. As of today, 10/28/22 I still have congestion, lots of mucous, a little bit of hearing loss, but no loss of taste and smell.
I had Moderna for both of my Covid vaccine shots; both times had moderate side effects (nausea, aches, chills, 'Covid arm rash') for about 12 hrs. It also affected my menstrual cycle for over 6 months. This, however, is in reference to the Pfizer booster I received. Side effects began 12 hrs. after shot and initially included severe headache, body aches and then swollen lymph node under arm that grew from golf ball size to larger. The weird symptom that I haven't seen listed in the side effects is that one side of my mouth (the side that I received the shot on) is extremely sore, both bottom and top gums/teeth are sore and swollen.
On 1/30 I woke up to an itchy injection site.  My arm hurt and soon followed tingling in the area.  About 3 days later I called my Dr.  he asked me all kinds of questions and thought the man who gave me injection, which really hurt might have gotten a nerve, but I told him I?d gotten the shot on the 11th.  He eliminated that theory. He then asked if it went all the way down my arm to my hand, I said yes. Asked if there was any weakness, I said no. Other symptoms? No I said fever? No.  It still tingles as of today when I got my 2nd shot in my other arm.
Low grade fever; Night following injection and kidney pain the following day; Night following injection and kidney pain the following day; This is a spontaneous report from a contactable consumer (patient).  A 28-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in right arm on 03Mar2021 14:15 (at the age of 28-years-old) as dose 1, single for covid-19 immunization. The patient medical history included allergy to sulfa drugs. Concomitant medication included vitamin d [vitamin d nos] (VITAMIN D) taken for an unspecified indication, from an unknown date. Other medications the patient received within 2 weeks of vaccination included Vitamin D pill. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, on 04Mar2021 the patient experienced Low grade fever night following injection and kidney pain the following day. He lacerated his kidney several years ago and a day following the first dose both of his kidneys are in pain. Patient received the vaccine on 03Mar21, woke up with a fever around 1 am 04Mar2021, and had sharp kidney pain from approximately 6:30 am to 7 pm 04Mar2021. Patient did not receive any treatment for the adverse event. The outcome of the events was not recovered.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
As described by Client, "Itchy rash on day 3, both legs, thigh to ankle."
Case number PHEH2013US024198 is an initial spontaneous report received from a consumer via a claim examiner on 18 Nov 2013: This report refers to a patient of unknown age and gender. She was vaccinated with MENVEO (batch number: A13011 and expiry date: Sep 2014) on 07 Nov 2013 and experienced allergic reaction on an undetermined date. No further information about outcome, seriousness and causality was reported.
headache; nausea; diarrhea; vomiting; backache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 (Lot number: ER2613) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number:01, Lot Number: EN6198), administration date: 02Mar2021, when the patient was 66 years old, for Covid-19 Immunization, reaction(s): "no side effects". The following information was reported: HEADACHE (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "headache"; NAUSEA (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "nausea"; DIARRHOEA (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "diarrhea"; VOMITING (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "vomiting"; BACK PAIN (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "backache".  Additional information: Patient report not related to a study or programme. Patient not had any investigation assessment. Stated that a local newspaper article stated that Pfizer is looking to give the vaccine to ages 5-11. Stated that after reading it she thought her dad who is 91 years old and had no side effects. Stated that he is a lot heavier than her. Stated that she is 67 years old and only 5 foot and does not even weigh 100 pounds. Stated that if they did not think of fact that different there are weights of people that she would not have reacted if given a lesser dose like children. Stated that getting sick for one day versus Covid is okay. Stated that when one is sick that they do not think about this is better than Covid. Stated that they should think about how much a person weighs instead of the dosage. Stated that she wrote down all the symptoms she had second and third time. Stated that maybe other people her size are having a hard time should be given a lesser dose. Stated that children will be given 1/3 of dose and she should have to. Stated her husband got Moderna and had no reaction but weighs more than she does maybe 175. Clarified that this is for the Pfizer Covid vaccine. Stated that she got the flu shot on the same day as her booster. Stated that she has gotten the flu shot for many years so she knows that her symptoms were not from the flu shot. Later clarified that it all of this was for the Pfizer BioNTech.  No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist concerning a 22 month old white female with no allergies and no medical history who on 09/02/2004 was inadvertently vaccinated intramuscularly with a second dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Concomitant therapy included a dose of pneumococcal (prevnar), a dose of varicella virus vaccine live and a dose of Hepatitis B vaccine, recomb.  There was no other concomitant medication.  There was no illness at the time of vaccination.  On 09/04/2004, 48 hours post-vaccination, the patient developed a fever of 100.6 to 101 degrees, a red, itchy raised rash over her chest, and a cough.  The fever lasted for 2 days.  The rash lasted 5-6 days and was treated with hydrocortisone 1% ointment on day 4.  The cough was gone by day 6.  Unspecified medical attention was sought.  No diagnostic lab tests were performed.  No product quality complaint was involved.  It was also noted that neither the patient nor her sibling developed adverse events following prior vaccinations.  No further information is expected.
11/28/01 @ 1:35 came in for swollen,painful L arm after flu shot. Ice packs and advil tabs po q 6 hrs, prn. 12/3/01 pt called, doing fine now.
Swelling of arm and itching, large lump, very warm to touch. Body aches, headaches, eye pain, racing heart.
Flush feeling; tingling in the face, hands and feet; swelling of the tongue and lips; swelling of the tongue and lips; dizziness; This is a spontaneous report from a contactable other healthcare professional (patient). A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN5318) intramuscular on the left arm on 01Feb2021 10:45 at a single dose for COVID-19 immunization. Medical history included high BP and allergy sulfa drugs. Concomitant medication included losartan, acetylsalicylic acid (BABY ASPIRIN), colecalciferol (D3), zinc and ascorbic acid (VIT C). On 01Feb2021 11:00 AM the patient experienced flush feeling, tingling in the face, hands, and feet, swelling of the tongue and lips and dizziness. Diphenhydramine (BENADRYL) was used to control. Events were reported as non-serious, did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The events resulted to a doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was recovered on an unspecified date.
likely from his Xeljanz supressing his immune system; had the Pfizer COVID vaccines but they did not work; Xeljanz suppressing his immune system; This is a spontaneous report received from a contactable Other HCP and consumer (patient) and a consumer. A 70-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at age of 70 years on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation; tofacitinib citrate (XELJANZ) strength: 5mg, via an unspecified route of administration from 10May2017 (Batch/Lot number was not reported) to 25Jul2021, at 5 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient said he had the Pfizer COVID vaccines but they did not work (likely from his Xeljanz suppressing his immune system). He said he's done multiple antibody tests and they are showing none developed. He wanted to get the COVID vaccines again, and not just the booster. He stopped taking his Xeljanz 8 days before in anticipation for this. He said his MD could not provide him any recommendations. The action taken in response to the events for tofacitinib citrate was unknown.  The lot number for the vaccine, [Pfizer/BioNTech COVID-19 Vaccine], was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently provided, the company deems there are no evidence or arguments of any relatedness between BNT162b2 and Xeljanz administration and the reported drug interaction and drug ineffective that, therefore, are assessed as unrelated to both study drugs. Similarly, the reported drug immunosuppression is evaluated as unrelated to BNT162b2, whereas it cannot be excluded as related to Xeljanz.  The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Unknown vaccine information - Given at the Pharmacy 24 hours after the immunization patient had "puffy eyes" and hematoma at injection site 6 days after the immunization he developed urticaria which has persisted.  Unsure which brand of immunization pt was given as it was at a different facility.
weakness, cough, feeling ill, myalgias, nausea, not eating much and diarrhea