chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body ache; shaking; sore at injection site; Fever of 102; chills; A report was received from a consumer concerning a 58-year old, male patient who was participating in the mRNA-1273 and experienced sore at injection site, fever of 102, chills, shaking, and body ache.   The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported.   On 31 Dec 2020 at 1:30 pm, approximately 0 days prior to the onset of the events, sore at injection site, fever of 102, chills and 1 day prior to the onset of the events shaking and body ache, the patient received their first of two planned doses of mRNA-1273 (LOT number 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient experienced soreness at the injection site, a fever of 102 degrees and chills later in the night. On 01 Jan 2021, he experienced shaking in the afternoon and body ache. The patient was concerned his symptoms were indicative of another COVID infection. Treatment for the event included Tylenol.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
UNABLE TO USE ARM AS SHE DID IN THE PAST; ACHING RIGHT DELTOID MUSCLE/ACHING ARM AT THE SITE OF THE INJECTION; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced unable to use arm as she did in the past. On 06-MAR-2021, the subject experienced aching right deltoid muscle/aching arm at the site of the injection. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aching right deltoid muscle/aching arm at the site of the injection, and unable to use arm as she did in the past. This report was non-serious.
NAUSEA; DIZZINESS; GAGING; SORE ARM AT INJECTION SITE FOR 5 DAYS; HEADACHE; This spontaneous report received from a consumer concerned a 49 year old male. 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: 1822811, and expiry: 20-MAR-2022) dose was not reported, administered on 01-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On OCT-2021, the patient experienced gaging. On OCT-2021, the patient experienced sore arm at injection site for 5 days. On OCT-2021, the patient experienced headache. On 01-OCT-2021, the patient experienced dizziness. On 02-OCT-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm at injection site for 5 days on OCT-2021, was recovering from dizziness, had not recovered from nausea, and the outcome of headache and gaging was not reported. This report was non-serious.
Heavier than usual menstrual bleeding. Cycle doubled in length from typical 8  days to 16 days. More days with an occurrence of menstrual blood clots including later days in the cycle (12 and 13). Subsequent cycle was also unusually long 15 days with clots for 12 days.   Current "normal" periods for patient are 7 to 9 days with clots seen 3 or 4 days.
Narrative: Sorethroat for 3.5 weeks 2 days after the administrative of the 1st dose
A non-serious spontaneous report of "threw up" has been received from a consumer, patient's mother, concerning a four-year-old female subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The patient's medical history and concomitant medication were not reported. The patient received a total of one dose of FLUMIST before the onset of the event on 29-Sep-2009. The patient "threw up" mostly phlegm, about two-three minutes after FLUMIST administration of 29-Sep-2009. The outcome of the event was unknown. All follow-up attempts have been completed per company SOPs.  No further information is available. 19-Feb-2010.
Pfizer-BioNTech COVID-19 Vaccine EUA Enlarged and slightly painful axillary lymph node in the same arm (L) as the injection.
vaccine given to 15 year old; first dose is 29Jul2021. they went back for their second dose and they were sent back to their pediatrician since they were underage and should have not received it.; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 15 year old) and PRODUCT DOSE OMISSION ISSUE (first dose is 29Jul2021. they went back for their second dose and they were sent back to their pediatrician since they were underage and should have not received it.) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 15 year old) and PRODUCT DOSE OMISSION ISSUE (first dose is 29Jul2021. they went back for their second dose and they were sent back to their pediatrician since they were underage and should have not received it.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 15 year old) and PRODUCT DOSE OMISSION ISSUE (first dose is 29Jul2021. they went back for their second dose and they were sent back to their pediatrician since they were underage and should have not received it.) outcome was unknown.        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.   Concomitant medications was not provided by the reporter Treatment information was not provided
she was freezing one minute, and then she was hot the next minute; dizzy; soreness throughout body/achy; stated her eyes feel heavy; Chills; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730, expiration date: Mar2021, intramuscular in left upper arm from 21Dec2020 10:00 to 21Dec2020 10:00 at 0.3 mL for Covid-19 immunization. Medical history included COVID-19 in Jul2020. She said she had a real bad case of COVID-19, and didn't get over it until Oct2020. The patient's concomitant medications were not reported. The patient stated she received the COVID-19 Vaccine yesterday at her employer, which is a hospital. She said she got the COVID-19 Vaccine at around 10:00AM on 21Dec2020. She said she had a few chills not too long after receiving the COVID-19 Vaccine. She said last night the chills got worse, saying she had chills all night. She said the chills are not as bad now. Reported she is sore and achy, clarifying she has more of a soreness throughout her body. She stated her eyes feel heavy too. Caller asked if what she was experiencing were side effects of the COVID-19 Vaccine and how long were the symptoms going to last. The reporter stated she is not a healthcare professional. She said she works in the surgery area at the hospital, and the hospital was offering the COVID-19 Vaccine yesterday, so she got the vaccine. Reported after receiving the COVID-19 Vaccine, she noticed she felt cool at work. She said last night she felt like she was freezing one minute, and then she was hot the next minute, and kept going back and forth between freezing and hot. She said she woke up at 1:00AM and felt really hot. She said she wished she had a thermometer at the time to check her temperature because she thought she had a fever. She said her husband told her what she was experiencing was part of having the chills. She said when she woke at 1:00AM, she got out of bed to go to the bathroom, and her eyes felt heavy, and she thought she may have been a little dizzy. She said now she doesn't think she was dizzy at the time, but maybe it was because she just woke up and got out of bed. She said she hasn't had any dizziness today. Treatment: Reported she took an Ibuprofen 200mg at 2:00AM and another Ibuprofen 200mg at 8:30AM. She clarified it was Equate Brand Ibuprofen 200mg. The event chills with outcome of recovering; the rest of the events was unknown. Therapeutic measure has been given as a result  of the events.  Information about the lot/batch number and expiration date has been requested.
Site became warm and painful within 4-5 hours,  and grew up to 4 inches in 2 days. Seen at urgent care 7/21/19, prescribed doxycycline. Fully recovered.
Dose administered after manufacturer date of expiry; Received expired 2nd booster after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. it was reported that 15 dose each red cap vial. Date the vial was initially stored in the refrigerator: N/A On 25MAY2022 was moved from Freezer to Room Temperature. The vial did not undergo any temperature excursions. No treatment information was reported.
Received his Pfizer vaccinations 1/26/21 and 2/16/21; he started to have a dry cough  on 7/15/21 which has progressed to shortness of breath. He does admit to eating with friends who were not vaccinated while on vacation sometime prior to this. He had a positive COVID test at his PCP office on 7/18 and another positive COVID PCR  at our hospital 7/22
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 09-JUL-2015, the patient was vaccinated with an improperly stored dose of MMR II lot # K016154 with exp 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever 102.1 degrees F on the evening of vaccine administration and the next day, resolved in late afternoon; severe fatigue the next day, resolved in late afternoon
Cough, mild SOB, rhinnorhea  Registered Nurse Specialty:  Emergency Medicine Progress Notes    Signed Encounter Date:  10/21/2021  Patient is here for MAB Infusion O2 sats > or = 90%   Signs of potential reaction reviewed with patient.   Tolerated IV start and MAB infusion without complication.   Pt has access to pulse oximeter and thermometer for home monitoring   Discharge instructions reviewed. Patient denies any questions
chills, cough, swollen glands in neck, sore throat, just didn't feel right
Headache, swollen lymph node in armpit, debilitating muscle tension in shoulder, neck, back, rash at injection site and over upper arm. Treated with Advil and bed rest.
Fever, chills, Fatigue beginning night of vaccination until 1week later when it resulted in ER visit.
No additional AE reported; Caller reports a 2 year old male patient received PNEUMOVAX 23 instead of PREVNAR 13; This spontaneous report was received from a medical assistant referring to a 2-year-old male patient. Information of the patient's pertinent medical history, concomitant therapy, concurrent condition and drug reactions/allergies was not reported.  On 05-JUL-2022, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot# U034712, expiration date upon internal review was established as 30-JUL-2023, strength and route were not reported) for prophylaxis instead of pneumococcal conjugate vaccine (13-valent) (PREVNAR 13) (wrong product administered). No previous doses were vaccinated. No additional adverse event (AE) details available. No additional AE reported (no adverse event).
About 1 hr after started to have muscle pain/soreness.  Still sore ~40 hrs out.
15 HOURS AFTER INJECTION:  body ached all over.  Body aches lasted for about 12 hours.  48 HOURS AFTER INJECTION:  The area below the injection site, on the outside of the right arm, was red and slightly swollen.  It was hot, and ached.  The ache was stronger under pressure.   I have never reacted to an injection like that before.  MY IDIOT WORRY:  Did the entire dose of vaccine pool below the injection site and thus got nowhere to the rest of my body to do any good?    However, the same thing happened to a friend of the same age.
8 am felt arm around injection site a bit sore and found redness around injection site.  A bit sore and itchy.  No treatment.  It went away by the next day.. I have photograph.
May 15th 2019 - Left Arm - Lump and so sore couldn't Lift Arm yet in Aug. Nausia and diarea off + on. Aug 5th 2019 - Right Arm After Several days and Month Couldn't Lift either Arm + Sore. Did ultra Sound + Bloodwork  Dr visit #2 Trying 3 days of steroid than Aleve for 10 days 2 x Day 11-1-19 Dr visit put Cortizone shot in left Arm. No Longer could lift Arm At All. Right Arm wanted to Also Do Cortizone shot As had 50% use of Arm. Refused that day, Possible When I go in for physical 11-11-19. Started physical therapy for both arms 11-4-19. Doing better since Cortizone Shot.
22 hours post vaccine I started receiving tingling in my toes.  That night, sweating from my shins, clamy skin and feeling of possible passing out. 48 hours post vaccine, I start getting tingling and severe burning in my lower legs. My left cheekbone was tingling as well. My bottom lip was also numb at different times. Left calf pain. Numbness and tingling still coming and going.  Lower back pain. Today, 8/15/21 I am 12 days post vaccine.
Patient vaccinated with Zostavax on 5-15-07 in fight upper arm; on 5/17/07 patient was driving long distance and had pain in left groin region; "pinching sensation somewhat relieved by walking; 5/18/07 to developed deep bone pain in left shin - he rated it a '8" for scale "1-10," (10 being worst pain) 5/19/07 left shin pain throbbing persistent later that evening pain became sharp. Used Advil prn; 5/20/07 pain in same area and extended to 'entire leg throbbing." 5/21/07 Patient presented to Urgent Care local facility; knee (left) X-ray done but negative. Patient given Valtrex prescription for clustered blisters left shin - MD informed patient he needed 'for" shingles. (information obtained from pattern via phone).
A little tired; Given a third full dose instead of a booster (half) dose.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (A little tired) and ACCIDENTAL OVERDOSE (Given a third full dose instead of a booster (half) dose.) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced FATIGUE (A little tired) and ACCIDENTAL OVERDOSE (Given a third full dose instead of a booster (half) dose.). At the time of the report, FATIGUE (A little tired) and ACCIDENTAL OVERDOSE (Given a third full dose instead of a booster (half) dose.) outcome was unknown.  It was reported that the patient was not immunocompromised. No concomitant medication was reported. No treatment medications was reported.   Reporter did not allow further contact
reports a fever that evening up to 101.7. No rash, no trouble breathing, no skin irritation
Rapid heartbeat; like a racing heart. I had very elevated blood pressure. - 150/90 It keeps me up at night. I went to my doctor - April 22nd. She did an EKG and was alarmed and she put me on a high blood pressure medication - Lisinopril. I went back for a check-in on June 1st and it was still high and she doubled the dosage (now doing 20 mg of Lisonopril) and now my blood sugar is really elevated and my pancreas is not creating enough insulin. My blood sugar is very high. I have a follow up dr appt on Sept 1st. Note: I had my  shingles vaccine in the fall of 2020 -1st dose was  November 2020; February 2021 (early February 2021).
A report has been received from a Health Professional concerning a 17 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started on 04-Feb-2014. The patient received expired FLUMIST QUADRIVALENT. The outcome of the event of administration of expired dose is unknown. The report was considered to be non-serious by the reporter.
lost total vision in left eye, took about 2 seconds from onset. Recovered within 30 minutes. Suspect small clot. No other symptoms. No detectable lasting vision impact.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), lot unknown reason: unable to locate or read the details as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin, Other medical history: None. If vaccine received: Yes. Concomitant medication(s) (Other medication in 2 weeks) included: TRI-SPRINTEC; FISH OIL; VIT B12; VIT D [COLECALCIFEROL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Anti-viral details: Product: COVID 19 treatment. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Device date: 16Oct2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a Healthcare worker. The healthcare worker stated that their office received box of PROQUAD (lot # L017140 with expiratory date 13-NOV-2016 and lot# L016394 with expiratory date 08-NOV-2016. Due to human error, the PROQUAD that had "same coloring as box of M-M-R II)" was placed in refrigerator for storage. There was no patient affected by this but there was potential confusion based on similar package appearance. Additional information has been requested.
1.  Local swelling/moderate inflamation of entire arm and shoulder for about two weeks. 2.  Headache and moderate dizziness/light headed sensation for 1-2 days.  Headaches have continued off and on since the vaccination date. 3.  Moderate muscle and joint soreness for 2 wks. 4.  Conceived a child within several weeks of the shot that developed massive birth defects effecting both the spinal column and the head.  Severe case of Spina Bifida, and severe bi-lateral hydrocephalus.  Lost unborn child due to birth defects on 2 June 00.  Went through extensive genetic counseling and discussed probs with expert doctors.  We were told there was no apparent reason for these birth defects.  I did not tell the doctors of my anthrax shot because I did not at the time realize that this could affect the situation.  After reseaching the anthrax vaccine and how it attacks the human body and the fact that the FDA has stated that there are links to birth defects I am convinced that this vaccine played the major role in causing my unborn son's birth defects!
LEG WITH REDNESS AND SWELLING ALL THE WAY DOWN TO ANKLE. *CHILD WITH SIMILAR REACTION LAST YEAR AFTER FLU SHOT ALSO. ** SENDING A REFERRAL FOR CHILD TO SEE ALLERGIST.
patients hands became rashy looking.  patient did not experience shortness of breath or itching.  i advised her to take benadryl.  i called her about 3 hours later to check on her and she had not experienced any further reactions.
Immediately after administration of the flu vaccine, the patient started complaining of itching. She was given a BENADRYL tablet immediately following vaccination. After about 5 minutes, the patient was complaining of feeling lightheaded. She was told to take a seat and was given an EPIPEN to administer if she started having difficulty. Patient continued to decline and pharmacist called 911 and administered EPIPEN to patient. EMS arrived within a few minutes and took patient to hospital where she was given further treatment.
Redness and swelling in right leg. Painful and hot to touch-Chief complaint. 9x4 cm area of right thigh-non tender-physical exam. Pt started on BACTRIM 40mg-200mg/5ml and HYTONE 2.5% topical cream to left thigh-contact derm.
Severe chills with shaking of hands about 9:00 pm. Few hours later trying to get out of bed, extreme aching. Movement to sit up, roll over caused sharp pains. Walked to another room and legs felt like they wouldn?t support me. Some dizziness. Got back in bed. Pain all over particularly in neck and head. But any attempt to reposition myself in bed caused severe pain centered in my left buttock.  Felt like muscle pain.  By 8:00 a.m. Friday (next day) still had achy, flu like pain.  Took two ibuprofen and had some relief.  Felt progressively better throughout the day. Saturday felt almost back to normal. Never felt feverish.
Two days after the vaccination, patient experienced a burning, itching sensation on her skin and had many cysts filled with clear fluid appear on her body. The cysts first appeared inside her mouth then also appeared on her nose, corner of her mouth, left hand, thumb, torso and back.
About  a day after vaccine, I developed body aches which got worse after few days down to extreme pelvic pain, lower back pain, ovary pain and breast pain. That last about 10 days, then few days after that, I developed chest wall inflammation which lasted about a week. Then about 5 days or so after that, I developed vestibular hypofunction, and still experiencing vertigo and extreme fatigue.