chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in left arm; Arm has been getting sore/right arm, that's the one that is sore all the time; Arm got sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm has been getting sore/right arm, that's the one that is sore all the time), PAIN IN EXTREMITY (Pain in left arm) and PAIN IN EXTREMITY (Arm got sore) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012-M20A and 039-k204) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Blood pressure.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm got sore). On 07-May-2021, the patient experienced PAIN IN EXTREMITY (Arm has been getting sore/right arm, that's the one that is sore all the time). On 20-May-2021, the patient experienced PAIN IN EXTREMITY (Pain in left arm). On 10-Feb-2021, PAIN IN EXTREMITY (Arm got sore) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm has been getting sore/right arm, that's the one that is sore all the time) had not resolved and PAIN IN EXTREMITY (Pain in left arm) outcome was unknown.            Concomitant medications provided include cholesterol, blood pressure and prostate medications. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient stated that the pain moves around in the right arm and may be a little higher up than the injection site. The pain in the left arm is mild and kind of goes away and this seems to bother him when he reaches up.   This case was linked to MOD-2021-161382 (Patient Link).
Severe flare up of dysautonomia. However, for 1st time in her life ever experienced complete paralysis/numbness of her Left Arm.  And also including severe temp imbalance with chills. Severe hyperhidrosis. Exacerbation of her muscular skeletal pain.  Took X 2 weeks and daily PT to resolve.    Had second Moderna vaccine on 3/21/2021 at 3:12 PM Lot 045A21A, again in her left deltoid. Had similar adverse reactions. Describes experiecing only partial paralysis and "pins and needles" sensation of left arm. Great difficulaty moving arm. All of the above also occured. In addition, she had severe vomiting and diarrhea.
Patient received Pfizer vaccine (dose 2) at 11:55am, started to feel hot/sweaty/nauseated at 12:05pm.  Gave patient ice pack at 12:06pm, checked BP at 12:10pm 134/96 Pulse 80. Checked BP again at 12:23pm 106/74 Pulse 84.  Patient is pregnant.  Did not have any issues after 1st dose. Patient felt okay to go home.
Headache for 15 hours now.; Some nausea.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 30Mar2021 at 13:30(at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccination four weeks prior to the COVID-19 vaccination. The patient had no known allergies. On 31Mar2021 at 10:00, the patient experienced headache and vomiting. It was reported that the patient was experiencing headache since 15 hours. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event headache and vomiting was resolving at the time of the report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
mom stated pt had t105 for 2 wks p/vax; pt taken to MD who prescribed Ceclor, Pediaprofin & APAP; MD found pt to have bilateral SOM;
The patient said she developed boils on her inner arms, rash on her stomach, rash on armpits & on inner arms of injection site.
On Friday, 8/26/22 pharmacist was trying to verify remaining IPOL doses in multidose vial, due to miscount in system. Inserted sterile syringe into vial, drew up remaining 1.5mL vaccine into syringe and returned vaccine to vial without removing syringe from vial, process took approximately 30 seconds to a minute. Vial was returned to stock.  During the two days, Monday and Tuesday, it took to contact the vaccine program to discuss missing dose from inventory, a dose was given to the above patient on Monday 8/29/22. Vaccine program recommend contacting the manufacture to see if measuring remaining vaccine counted as a pre-drawn dose.  Sanofi determined that this would be considered a pre-drawn dose, once vaccine is drawn into a syringe it is considered prepared or "activated". Pediatric team physician was informed of vaccine error and patient will be contacted to be revaccinated per program recommendation. Pharmacist did not realize this would be considered a pre-drawn dose, as there is usually a small amount of vaccine exchanged between the vial and the syringe when drawing each dose from a multidose vial, either due to the provider pulling past the dose then coming back to the exact dose or by trying to get rid of air bubbles by injecting them back into the vial and pulling the remaining dose. Syringe contained no vaccine when remove from the vial and no vaccine was stored in the syringe.
Systemic: Fainting / Unresponsive-Severe, Systemic: The patient passed out 2 times-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: The patient passed out 2 times after vaccination while waiting her 15 minutes. i called 911. emts came and her vitals were fine. the emts advised she not go to the er. emts called dr at hospital who advised she not come to er unless it happens again or she starts to feel unwell. emts thought she was nervous about getting the vaccine.
sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced SOMNOLENCE (sleepy). At the time of the report, SOMNOLENCE (sleepy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Received immunizations listed below at routine well check. Presented to ED with fever/seizure activity approximately 10 hours after vaccination. Initial w/u negative, d/c'd home. Returned 12 hours later with 2-3 more episodes of seizure activity.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age who on an unknown dates, were vaccinated with an unspecified number of doses of VARIVAX (doses, route and lot numbers not reported) that were exposed to a first excursion of -12C for 15 hours on 17-FEB-2014 and then an additional excursion of -12C for 19.5 hours beginning on 01-MAR-2014 which were supported as long as the overall average temperature remained between -50C and -15C. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (LOSS OF APPETITE), DRY MOUTH (DRY MOUTH), PAIN (GENERAL BODY ACHES), INSOMNIA (INSOMNIA) and THINKING ABNORMAL (IRRATIONAL THOUGHTS) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (LOSS OF APPETITE), DRY MOUTH (DRY MOUTH), PAIN (GENERAL BODY ACHES), INSOMNIA (INSOMNIA), THINKING ABNORMAL (IRRATIONAL THOUGHTS), FATIGUE (FATIGUE), PYREXIA (FEVER) and HEADACHE (MILD HEADACHES). At the time of the report, DECREASED APPETITE (LOSS OF APPETITE), DRY MOUTH (DRY MOUTH), PAIN (GENERAL BODY ACHES), INSOMNIA (INSOMNIA), THINKING ABNORMAL (IRRATIONAL THOUGHTS), FATIGUE (FATIGUE), PYREXIA (FEVER) and HEADACHE (MILD HEADACHES) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Consent given to Safety *Case Crosslinked to MOD21-072559 (Argus # MOD-2021-072801)*** Consumer returning call; from Safety. Consumer left voicemail by Safety referencing Argus # MOD-2021-072801. Consumer asked to provide additional contact information. Consumer does NOT have email or fax. Consumer provided physical mailing address. Consumer prefers Safety contact him via physical mail. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Non-significant Follow-up Appended on 3-jun-2021 as No new information provided.
Per patients wife; his right eye began blinking uncontrollably; drooping on right side of mouth; noisy while eating.
Pt was given an entire thawed vial (all 6 doses) of Pfizer covid vaccine at one time in one injection.  Provider has been in contact iwth him and pt has reported no se, illnesses or concerns at this time other than an elevated glucose on a blood draw and not sure that is r/t to the Pfizer Covid vaccine.
Asked to assess Patient who had received the COVID-19 Moderna vaccine approximately 15 minutes prior.  He complained of pressure and tightness in his sinuses.  He had no other respiratory complaints and no difficulty swallowing or changes in his voice.  His exam was remarkable for no acute distress but noticeable pressure/discomfort of his frontal sinuses.  His SPO2 was >97%.      He has a history of allergic reactions in the past and good response to self treatment with Benadryl.  As he had an hour and a half drive home, he requested that he take a dose of Benadryl (25 mg) until he could get home and take his usual medications.       We administered Benadryl 25 mg and monitored for an additional 30 minutes.  patient reported some improvement and was released with instructions to seek medical help should the symptoms worsen.
Myositis.  Left vastus medialis rupture.  Left L4 - 5 disc herniation.
I didn't have any reactions after the 1st or 2nd Pfizer covid vaccination at all. I didn't have any reactions either after this Pfizer booster, the shot spot on my arm didn't even really hurt much. But now day 11 after the booster I woke up with my eyes spinning out of control and couldn't focus. I closed my eyes and spinning stopped and I stayed in bed. I got up at 7am and slightly nauseous and dizzy.  I ate toast and drank Gatorade in case I was dehydrated. Took my usual morning 1 tab Excedrin, 1/2 tab 4mg chlorpheniramine maleate. Nausea went away and dizziness seemed to. But then I dried my hair after shower, upside down as usual, bad idea. Got super dizzy and have been unsteady since. Thankfully, the nystagmus hasn't returned and pray it doesn't.
Narrative: COVID infection following COVID vaccine series 01/08, Pfizer, dose #1 02/08, Pfizer, dose #2 12/1 COVID swab, result: detected 12/1 pt cc: exposure: unknown 12/1 TROPONIN : <0.016 NG/ML 12/1 MAGNESIUM: 2.0 12/1 CXR IMPRESSION:IMPROVING PNEUMONIA 12/1 pt currently in patient
tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient's parent) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 23-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: ER8735) via intramuscular route, administered in Left Arm on 05May2021(23-year-old at vaccination) as Dose 1, single and via intramuscular route, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0171), administered in Left Arm on 27May2021, (23-year-old at vaccination) as Dose 2, single, both doses for Covid-19 immunization. The patient's medical history was reported as none. The patient had no known allergies. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was reported as Other. The 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 had been tested for COVID-19. On 06Aug2021 at 10:00 AM, the reporter stated that, the patient had experienced a loss of smell today after attending a wedding this past weekend and tested positive for Covid this afternoon. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal swab): positive on 06Aug2021. No treatment received from the resulted events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
accidental third Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received 3 years ago from the date of reporting).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 6-APR-2022 Reporter's Comment: The consumer reported this case via (Shingrix GSK) interactive digital media. The reporter asked an accidental third Shingrix shot given three years after the first two going to be a problem. Additional supportive information:  The patient received 3rd dose of Shingrix, which led to extra dose administered. The follow-up would not possible, as no contact details were available.
following rubella vax @ 1wk: swollen posterior nodes, all over rash;@ 9 days swollen rt knee, transient joint pain;as of 10AUG98 sx resolving;
Pt stated morning after vaccine extreme soreness in arm. After 2 weeks, still tender near injection site.
Medical Assistant called for TE evaluation and said that MMR II was administered to a patient after the TE. Patient has not reported any signs/symptoms of adverse effects. Permission to contact HCP was granted. No additional AE/no PQC; Medical Assistant called for TE evaluation and said that MMR II was administered to a patient after the TE. Patient has not reported any signs/symptoms of adverse effects. Permission to contact HCP was granted. No additional AE/no PQC; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 12-MAY-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (albumin status recombinant Human albumin (rHA)), lot #W034593, expiration date: 10-MAY-2024, administered for prophylaxis (strength, dose, route of administration and anatomical location were not provided) after temperature excursion (TE) (product storage error). Patient had not reported any signs or symptoms of adverse effects. There was no additional adverse event (AE) reported, and no additional information provided.
Patient received dose 1 of the Moderna SARS-CoV-2 vaccine while working.  Approximately 2 hours post administration, patient experienced onset of multiple symptoms.  The most significant symptom was that of a headache which was sharp and throbbing in quality, and was severe enough that patient did not willingly eat, drink or speak for its duration.  Additional symptoms were those of severe body aches and joint pain, stiffened neck, labored breathing, and a restrictive sensation in the throat.  Patient remained on bed rest for a 24 hour period.
9/18 administered, 9/28 body pain starts; 10/1 rash observed; 10/2 start FAMVIR 500 mg t.i.d. for 7 days; treatment for shingles is on going.
chills; body aches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (body aches) and PYREXIA (low grade fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced CHILLS (chills), MYALGIA (body aches) and PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (chills), MYALGIA (body aches) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Chest pain Found to have myocarditis Cardiology consulted Received IVIG on 1/31
A report was received from a health care professional on 11/25/03 concerning a 6 month old female vaccinee who inadvertently received Fluvirin on 11/04/03. On 11/4/03 the vaccinee inadvertently received 0.25ml of Fluvirin. At the time of the report, no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/11/04: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received.
patient presented to clinic with a positive case of chickenpox. She did get a varicella vaccination
Ninety minutes after injection, face and lips tingled and went a little numb, lost some feeling.  Throat went tight and tongue tingled and lost some taste.  Throughout the three weeks since it started it comes and goes in severity but has not stopped.  One dose of Benadryl was taken and the symptoms did not go away.
1st dose 2 years ago, didn´t get 2nd dose /Suspects pt didn't get 2nd dose within recommended interval due to pandemic.; This case was reported by a other health professional via sales rep and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the physician's assistant. The age at vaccination was not applicable for this report. The reporter was inquired about 2nd dose of Shingrix administration 2 years after the 1st dose. The health care professional declined to provide further information because she wanted to get patient consent first. The patient was scheduled to get 2nd dose of Shingrix November 2021 (specific date not shared). Till the time of reporting, the patient did not receive 2nd dose of Shingrix, due to pandemic, which led to social problem. The reporter suspected patient did not get 2nd dose within recommended interval due to pandemic. The reporter did not consent to follow up.
Sudden rise in temp from 98 to 99.8 in five minutes Flushing, mild  SOB, tachycardia. BP is 128/88. Transported via ambulance to hospital. Did state that she had previous anaphylaxis to food allergies. Allergic to eggs. Always has EpiPen on hand. Positive for Covid in June 2020.
I feel like I am dying. I really do not wish to take the second dose.  This is scary!
COVID-19 virus infection; Elevated brain natriuretic peptide (BNP) level; Elevated troponin; Acute on chronic combined systolic and diastolic congestive heart failure; Hypoxia
From initial Shingrix dose, I develpoed Verigo. Doctor perscribed chropractic exercises and vertigo went away after 5 days
He had an adverse reaction; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported; Expiration Date: Apr2021) via an unspecified route of administration on 04Jan2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient had received the Pfizer COVID vaccine back in Jan2021 and he had an adverse reaction (Allergic reaction-hypersensitivity) on an unspecified date in 2021 and he believed that he had documented this with Pfizer on an incident report back then and he was wondering if it was possible to get any documentation on that or not. Later he confirmed that he has had no new events since his original report, he said he was pretty well within about 4 to 5 days. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around November 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered neuropathy. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered as not recovered/not resolved. The event was related to zoster vaccine live (ZOSTAVAX).   Upon internal review, neuropathy was considered to be medically significant. The lawyer considered neuropathy to be disability.
Patient faked DOB to get vaccine-listed DOB as 03/31/2005.was underage at vaccination.