chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No symptoms reported; patient received unspecified dose of either a V ARIVAX or a PROQUAD dose that was improperly stored; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 10-FEB-2020, the patient received unspecified dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # S025610, expiration date 18-AUG-2021) (strength, dose and route were unknown) or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA) (lot # S017250, expiration date 01-DEC-2020), (strength, dose and route were unknown) both for prophylaxis, diluted in properly stored sterile diluent. The vaccine was exposed to temperature excursion at 7.5 degrees Fahrenheit for 15 minutes (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No symptoms were reported.; Sender's Comments:  US-009507513-2003USA006861:
This spontaneous report as received from a Licensed Vocational Nurse refers to multiple unspecified patients of unknown age and gender with no pertinent medical history, drug reactions or allergies reported. On unknown dates, the patients were vaccinated with doses of PROQUAD (Merck) (dose, route and lot number were not provided) which was stored improperly. No adverse effect was reported. This is one of two cases received from the same source. Additional information has been requested.
Information has been received from a registered nurse concerning a 14 year old male patient with amoxicillin allergy and a history of osteosarcoma s/p chemotherapy who on 26-SEP-2009 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 IM into his left upper arm (lot # 661527/0112Y). On the same day, the patient also received a dose of FLUZONE in the left upper arm about 1 inch from the injection site of PNEUMOVAX 23. Later that night on 26-SEP-2009 the patient developed fever of 103-104 F and myalgia. The patient then developed soreness and an urticarial rash 5 cm distal to the injection site of the left upper arm. The patient also experienced emesis. On 29-SEP-2009, the patient was seen in the office. At that time, the patient was afebrile, while taking TYLENOL, and the urticarial rash had progressed but was still localized. The patient was scheduled for a follow up office visit on 30-SEP-2009. No lab or diagnostics studies were performed. At the time of reporting, the patient's adverse events persisted. Additional information has been requested.
local irritation in my left arm; little headache; Body aches; fatigue; sore throat; give mouth-to-mouth resuscitation to a person who was covid positive 48 hrs ago; dizzy; off-balanced; low-grade fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE IRRITATION (local irritation in my left arm), DIZZINESS (dizzy), BALANCE DISORDER (off-balanced), OROPHARYNGEAL PAIN (sore throat) and EXPOSURE TO SARS-COV-2 (give mouth-to-mouth resuscitation to a person who was covid positive 48 hrs ago) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 041M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced DIZZINESS (dizzy), BALANCE DISORDER (off-balanced) and PYREXIA (low-grade fever). In March 2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and EXPOSURE TO SARS-COV-2 (give mouth-to-mouth resuscitation to a person who was covid positive 48 hrs ago). On an unknown date, the patient experienced VACCINATION SITE IRRITATION (local irritation in my left arm), HEADACHE (little headache), MYALGIA (Body aches) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE IRRITATION (local irritation in my left arm), DIZZINESS (dizzy), BALANCE DISORDER (off-balanced), OROPHARYNGEAL PAIN (sore throat), EXPOSURE TO SARS-COV-2 (give mouth-to-mouth resuscitation to a person who was covid positive 48 hrs ago), HEADACHE (little headache), PYREXIA (low-grade fever), MYALGIA (Body aches) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 09 Mar 2021 patient had to give mouth-to-mouth resuscitation to a person who was covid positive.  The action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.
A 5cm in diameter area of redness and warmth at site of Pneumovax on left upper arm.
2nd dose two weeks after 1st dose; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comment: The patient received 2nd dose of Shingrix in 2 weeks after receiving the 1st dose. The patient made an appointment at the same place and got the second dose. The patient was told that, he/she should have waited at least a month. Additional Supportive Information: The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule. The follow up would not possible as no contact details were available.
I started having a fever about 12 hours after - and chills and body aches. Fever 102.1 - because I work in the hospital - I had to call employee health and they didn't allow me to return to work the next two days. I had to get COVID tested. The fever and body aches lasted about 48 hours and I also had diarrhea which went away in 48 hours too. Tylenol and Ibuprofen to treat symptoms.
Swelling and pain under left arm, lymph node Came on suddenly 4 days after injection Swollen and painful for 3 days and counting (7 days after injection) Day 7, pain is extending into left arm/bicep causing pain and difficulty using left arm and lifting anything
Had mild fever; Chills; Her left leg went numb, swollen, and painful; Her left leg went numb, swollen, and painful; Her left leg went numb, swollen, and painful; Sensitive to cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 29Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sciatica", start date: Aug2021 (unspecified if ongoing), notes: She was experiencing sciatica earlier in August and felt recovered prior to the 2nd shot. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Had mild fever"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; PAIN IN EXTREMITY (non-serious), HYPOAESTHESIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "Her left leg went numb, swollen, and painful"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "Her left leg went numb, swollen, and painful"; TEMPERATURE INTOLERANCE (non-serious) with onset 2021, outcome "unknown", described as "Sensitive to cold".  Additional information: Patient was middle aged and healthy but said she was experiencing sciatica earlier in August and felt recovered prior to the 2nd shot. Upon receiving the 2nd injection on 29Aug, she said she had mild fever and chills and that her left leg went numb, swollen, and painful. She said it was sensitive to cold, when she tried icing her leg with the cold causing pain. She said the numbness and pain continue to the present but are much more bearable.   Follow-up (05Oct2021): 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.
Patient received his second Covid vaccine booster on 4/5/2022.  On 4/6/2022 around midnight, he fell at home.  He experienced left hip pain and was unable to get up off the floor.  Approximately 12 hours later, a friend found him and he was transported to the hospital.  He had a left hip fracture and had hip repair with a gamma nail on 4/7/2022.
My blood pressure has been elevated since the vaccination. Doctor has increased medication dosages and added another prescription hydrochlorothiazide. I do have a follow up appointment with my doctor next week.
Passed out in traffic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out in traffic) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out in traffic) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 07-Apr-2021 to 09-Apr-2021 due to LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out in traffic) had resolved.            No relevant concomitant medications were provided.  No treatment medication was provided.  Patient also went to emergency room on 10 Apr 2021 and was examined for stroke and heart which came normal. No treatment information was provided. He wanted to know if Moderna can pay bills for the incurred loss.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-142984 (E2B Linked Report).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. MOD-2021-142984:dose 1 case
Information has been received from a RN concerning a 75 yr old female who in 1999 and on 02Nov04 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine, respectively (second dose lot 649696/0490P). Concomitant therapy included levothyroxine Na (Synthroid), estrogens, conjugated (Premarin), atorvastatin calcium (Lipitor), atenolol and fluoxetine HC1 (Prozac). Within two hours of the vaccination the pt developed an injection site reaction described as swelling and pain at the deltoid muscle. Unspecified medical attention was sought. The pt has not yet recovered and was still experiencing pain at the site. No product quality complaint was involved. Additional information has been requested.
yellowing and pale skin on both arms; fever of 101 degrees; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PALLOR (yellowing and pale skin on both arms), PYREXIA (fever of 101 degrees), CHILLS (chills) and FATIGUE (fatigue) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PALLOR (yellowing and pale skin on both arms), PYREXIA (fever of 101 degrees), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, PALLOR (yellowing and pale skin on both arms), PYREXIA (fever of 101 degrees), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included None.
I continue to experience sharp shooting pain in my leg and arms on the left side. It truly is terrible pain after I got the vaccine.
Patient was given Hep A/Pediatric instead of Hep A/Adult dose. Pt. is 19. This was his second Hep A , the first was given at correct age. Pt. has been called and has an appointment tomorrow to get the correct Hep A/adult.
Became dizzy,BP100/50--laid down, BP 112/60.  Dizziness lasted about 15 minutes before sustained BP upon standing.
Leg muscles drastically weakened. within 12 hours.  Unable to get out of bed easily.
pt recvd vax & approx 3 months p/vax exp elevated liver enzymes;
Headache, Fever, CoughWheeze, Fatigue, Pain Narrative:
PHARMACIST PERFORMED AN OUTSIDE CLINIC AND GAVE A DOSE TO PATIENT WHO WAS ONLY 16 YEARS OF AGE.  SHE WAS AN EXTRA DOSE .
1) loss my concentration, befor the vaccine I was able to concentrate in my school studies for 3 hours and up, and efter that I wasn't able to do that even for an half hour!!!  for the following 4-5 years. 2) very hard to wake up in the morning, befor the vaccine was my daily schedule for waking up at 5:00 - 5:30  AM  and efter that (until now) even 8:00 - 8:30  is very hard for me to wake up!!!!  still ongoing (as of AUG. 22, '21)
Information has been received from a registered nurse concerning a female between the ages of 14 to 21 years old who was vaccinated IM into the deltoid region with a first 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced extreme pain during injection. No medical attention was sought. About 15 to 20 minutes after injection, the patient was improving. No product quality complaint was involved. Additional information has been requested.
Trouble breathing, tightness in chest, feeling of throat closing up. Started during intense cardio activity 2 days after receiving 1st dose of vaccine
pt called 17NOV98 & c/o lt arm soreness/pain that kept getting worse on Wednesday p/vax;c/o welts w/itching from shoulder down to elbow;SOB 1st couple of days-went to ER on Sunday afternoon 15NOV98;lt arm sore;
Fatigue; low grade temperature; joint pain; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration, administered in Arm right on 26Mar2021 15:15 (at the age of 57 years) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included Pantoprazole sodium DR 20mg QD. It was reported that the Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8731) via intramuscular administered in Right left on 16Apr2021 15:15 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had known allergies NKA. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. On 03Apr2021 08:00 the patient experienced fatigue, low grade temperature between 99.5 and 100.3 degrees and joint pain. It was reported that I was the patient and became aware of the AEs in 14Apr2021. Patient had no treatment received. The patient underwent lab data and procedure which include low grade temperature between 99.5 and 100.3 degrees on 03Apr2021.The outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
volitile diarrhia for3 days;  a few nighttime hours of pressure on chest ( 7/ 27), and had to consciously pracitce deep breathing to feel I was not going to suffocate. i am very healthy and never got flu  or other recommended shots due to  my stong immune system. i had one case of food posioning in 1973, and that was only vomitting.  NEVER have had such diarrhea as on 7/26, 7/27, and 7/28! And I alway eat the same way- organic/no fish/ rarely beef/never pork/never poultry/ always clean organic veg and fruit.  NEVER  had the feeling of chest pressure- like something sitting on  my chest to compress the air out....until I pushed back - long slow in/out breathing.  I do not think I  will risk the second shot next week!!
Pain and swelling at vaccination site left thigh that started 8-1-17. Tender to the touch. Fever of 100.3. Otherwise behaving normally.
Evening of vaccine: fussy, fever to 100.5, lethargic - fever to 102 F next day. Periodic cyanosis, rigidity, posturing, poor feeding, irritable, very uncomfortable to being touched/moved. Diarrhea & emesis on D #3 post vaccine. Hosp x2d, r/o sepsis, IV fluid.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 23-JUL-2014 the patient was inadvertently vaccinated subcutaneously with a second dose of ZOSTAVAX (dose 0.65 ml, lot# and expiration date were not reported). The patient had received the first dose of ZOSTAVAX about 8 years ago (approximately in 2006, dose, route, lot# and expiration date were not reported). The patient had forgotten that he had received ZOSTAVAX in the past so he requested it at the pharmacy on 23-JUL-2014 and was vaccinated.When he got home his wife reminded him that he already received ZOSTAVAX about 8 years ago (approximately in 2006). No symptoms were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
After receiving the Dtap vaccine on the morning of 3/9/15, Sage became very tired and went home to nap. After waking, we noticed she was lethargic and running a low grade fever. By bedtime that night, she wouldn't eat and would not stop crying. Her fever increased, and she continued crying for 4 days. She was clearly uncomfortable and was not the happy, calm, baby we knew. She barely ate or drank, barely slept, and when i brought it up to her pediatrician, they told me it was normal. Shortly thereafter I left that doctor's office to find one that would believe me when I told them about her adverse reaction to the vaccine. She began getting recurrent ear infections after never having one before. They were so severe they would rupture her eardrum.She also started having severe anxiety that would inhibit her normal day to lay life. We have since collected medical history and allergy information from our families and discovered autoimmune diseases, anyphalactic allergies, thyroid disease, and MTHFR gene mutations that are all contraindicated for further vaccines.
Beginning the next day, she had a low grade fever and body aches. Over the next several days (over a week) she felt extreme fatigue falling asleep frequently and not being able to participate in school and daily activities and had to miss school. In addition to fatigue, she was pale, had abdominal pain, back and body pain, lost appetite, and had low grade fevers.
This spontaneous report was received from a medical assistant refers to a 11 month old patient(gender unknown). On 28-APR-2000, the patient was vaccinated with a dose of M-M-R II(lot#, expiry not reported). No adverse event reported. Additional information has been requested.
This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. It was reported that improperly stored doses of VAQTA lot number reported as L042660, expiry date 15-MAR-2017 (dose and route were not reported), were given to unspecified multiple patients on 07-APR-2016. No adverse effects were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Lot number L042660 is an invalid lot number for VAQTA. Additional information has been requested.
10 minutes after shot c/o "tingling", then felt faint.  Vitals monitored, discharged 1:40 by MD.
Besides having dizziness, back/hip pain and fever (99.6 F) all other times, this time THE INJECTION SITE BECAME RED, HOT AND PAINFUL.  THE REDNESS INCREASED OVER TWO DAYS AND THEN BECAME ITCHY. DAY 3 AFTER INJECTION, RED CIRCLE IS LESS BUT ITCHING, HEAT AND PAIN CONTINUE.
kind of sick/felt sick; slight temp; headachey; pains in rib cage; sharp pains/really hurt; arm got sore/arm hurt; felt really flu-like/kind of sick/like got the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt really flu-like/kind of sick/like got the flu), ILLNESS (kind of sick/felt sick), MUSCULOSKELETAL CHEST PAIN (pains in rib cage), PAIN (sharp pains/really hurt) and PYREXIA (slight temp) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K214, 051F21A, 013A21A and 028220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Glaucoma (When she was around 55-56 years old). Concurrent medical conditions included Pollen allergy.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient experienced INFLUENZA LIKE ILLNESS (felt really flu-like/kind of sick/like got the flu) and PAIN IN EXTREMITY (arm got sore/arm hurt). On 05-Apr-2022, the patient experienced MUSCULOSKELETAL CHEST PAIN (pains in rib cage) and PAIN (sharp pains/really hurt). On an unknown date, the patient experienced ILLNESS (kind of sick/felt sick), PYREXIA (slight temp) and HEADACHE (headachey). At the time of the report, INFLUENZA LIKE ILLNESS (felt really flu-like/kind of sick/like got the flu), ILLNESS (kind of sick/felt sick), MUSCULOSKELETAL CHEST PAIN (pains in rib cage), PAIN (sharp pains/really hurt), PYREXIA (slight temp), HEADACHE (headachey) and PAIN IN EXTREMITY (arm got sore/arm hurt) had not resolved.            Patient took vitamin D as Concomitant drug. She was amazingly healthy; her vitals were perfect. She was shocked that she was sick.   This case was linked to MOD-2021-367368 (Patient Link).
w/in 10min of vax pt devel gen rash & an inj site rxn characterized by redness, swelling & warmth;pt was seen in ER & nurse dx allerg rxn;this is 1 of 2 reports from this facility;
1/22/2021 6:30pm dizziness, fell over, vertigo, suspected stroke at 3am, brain stem stroke, released 2/19 to other facility, limited mobility in eft arm, dysphasia, cognitive skills in tact