chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received immunizations approx. 2 pm 6/18/07.  Mother reports right upper arm red & swollen next morning (6/19/07) when child awoke.  Mother had given Tylenol to child immediately following vaccine administration & again at bed-time (6/18/07).  Mother attempted to place cold compresses to injection site throughout the day & night of 6/19/07 & warm compresses after 24 hrs.  Child uncooperative - no fever reported.  Swelling resolving by 6/20/07.
feel like flu today; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th April 2020, the patient received Shingles vaccine. On 21st April 2020, 1 days after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient got shingles vaccine the day before reporting and feel like flu the day of reporting.
pt exp nausea, SOB, diaphoresis w/paleness that occured; approx 2-3 minutes; 911 called & responded @ 1123AM; prior to the arrival of EMS;
Pt. contacted clinic and stated that on the second day of vaccination he developed fever 101.2, chills, lethargic, pulse was 96 and BP 131/79.  His stomach felt uncomfortable.  The third day his heart went up and felt his heart pounding.  After the fourth day symptoms tapered off and he feels okay today on 11/09/2009.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 15-NOV-2013, the patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 15-NOV-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J00681 and expiry date: 14-SEP-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Patient started to feel nauseas after vaccine. When asked if having other sxs patient unable to express. Vitals taken and provider came to assess patient. Patient complained of nausea and arm burning, but unable to answer questions well. Not able to tell us if mouth felt swollen. Due to patient unable to express sxs, provider had us call EMS, as could not tell if patient would or would not have anaphylaxis reaction. Patient brought to hospital/ER for further evaluation.
Information has been received from a certified medical assistant concerning an 11 year old female with an absent left kidney and an allergy to sulfa ear drops who on 31-AUG-2006 was vaccinated SC with a dose of MMR (lot# 649811/0491R). There was no concomitant medication. On 31-AUG-2006 the patient experienced injection site pain, redness and swelling. The patient was treated with ice and BENADRYL. On 31-AUG-2006, the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Severe joint pain in every part of body, more than ever had before during a ?normal flare up? of joint pain. Uncontrollable shaking and chills. Muscle pain in every part of body. Sensitivity to touch, just as when I am sick with some type of cold virus.
myalgia; Fever 102.8 F Ear; Swollen axillary lymph nodes; This is a spontaneous report from a contactable Nurse. This 48-year-old female Nurse reported for herself in response to HCP letter sent in cross reference case. A 48-years-old female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot number: EL3248), dose 2 via an intramuscular route of administration into left arm on 12Jan2021 at 17:00 as DOSE 2, SINGLE for covid-19 immunization (at the age of 48-Yeras-Old). The patient's medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number EL0140), dose 1 via an unspecified route of administration into left arm on 23 DEC 2021 at 13:00 as DOSE 1, SINGLE for covid-19 immunization. The patient took vaccination at hospital. On 13jan2021 at 09:00, the patient experienced Myalgia, Fever 102.8 F Ear and swollen axillary lymph nodes. The patient underwent lab tests and procedures, which included fever 102.8. The adverse events did not result in Emergency room and Physician Office. The outcome of the events was recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sudden onset of tinnitus and significant hearing loss, predominantly in left ear 24 hours after receiving flu vaccine (Fluzone High-Dose IM Susp. Lot# UI453AA) and pneumococus vaccine (Prevnar 13 IM Susp. Lot# m16258). Saw Dr. who administered vaccine on Monday 11/23/15. Saw an ENT Dr. on Wed 11/25/15. Prescribed high dose oral prednisone for 10 days. Subjectively much improved after 36 hours of treatment. Follow-up hearing evaluation on 12/17/15 showed return on hearing to "normal". Tinnitus gone with 36 hr of prednisone.
Received vaccine mid afternoon. By 11:00pm had severe pain in right arm, could not use the arm. Next day pain was less severe but arm was red and heat was felt in the arm. By 3rd day redness had extended to the elbow and heat still felt.
On day 7 post vaccine arm became red, itchy, swollen, hot to touch, and painful at injection site and left su clavicular lymph node enlarged. Symptoms still present on day 8
2 doses of Bexsero given in the same day; Intended to administer MCV-4 (MenQuadfi) but grabbed the Bexsero accidentally instead; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO).   On 22nd February 2023, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 22nd February 2023, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device and BEXSERO, the patient experienced overdose and wrong vaccine administered. On an unknown date, the outcome of the overdose and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-FEB-2023 Reporter's Comment: The reporter reported that a patient was administered two doses of Bexsero on the same day in each arm. The reporter mentioned they meant to administer an MCV-4 (MenQuadfi) but grabbed the Bexsero accidentally instead. The reporter unable to provide any vaccine lot and expiration details. The reporter did not consent to follow-up. Additional supportive information: The patient was administered two doses of Bexsero on same day instead of MCV-4 (MenQuadfi) which led to overdose and wrong vaccine administered.
event: 10 minutes after receiving vaccine, gaurdian reported patient was feeling lightheaded and dizzy treatment: had patient sit, take off her mask, bend forward with her head between her knees and guided her breathing. after patient felt better, she had some water and animal crackers.  outcome: after 15 minutes of additional observation, patient felt better and could stand without dizziness, nausea, or fatigue. Caregiver took patient home.
Narrative: 93 YO M with hx of CKD, BPH, GERD and pulmonary HTN, knee OA, depression, HLD received moderna covid-19 vaccines on 03/08/2021 & 04/05/21. Pt passed away on 08/16/2021 at his home. Due to age and comorbidities, vaccines are likely not related to death.
Patient received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and advised vaccine maintained activity necessary to protect against covid 19  on date vaccine was administered.  Also patient did not call to complain of adverse event.  This is administration error without adverse event.
Pulsating headaches; Blurry vision; nausea; 102.2 fever; body aches; hand tremors; dizziness; joint pain; Cough; feeling of exhaustion; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 09Jan2021 11:00 at single dose for Covid-19 immunization. Medical history included asthma and hypertension. The patient received an unspecified medication in two weeks. The patient previously took codeine and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced pulsating headaches, blurry vision, nausea, 102.2 fever, body aches, hand tremors, dizziness, joint pain, cough, and feeling of exhaustion on 09Jan2021 (12:00 PM). There was no treatment received for the events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
maculopapular rash began on face trunk, hands & feet red, swollen, painful, rash on thighs todya, less swelling of hands & feet; c/o mild achey feeling in hands;
I had immediate shoulder pain at the site of injection that I still have, plus swelling.  about 12 hours after the injection my entire body started to hurt so badly I could only lay in bed.  Every joint, bone and muscle hurt so bad I spent several hours crying on 2/19/2020.  My fever got as high as 103 degrees about 4pm on 2/19/2020. I alternated bewtween shivering and sweating. I took advil for the pain and fever.  The pain stayed constant.  My fever has varied from 103 to 100.   Today my full hurts about 80% less than yesterday and my temperature is 100.  I had the same reaction after my first dose, but I also got a flu shot and the nurse told me the reaction was from the flu shot.  She was mistaken.  I can't remember ever having a fever this high in. my entire life, except for the day after I got the first dose of this shingles vaccine.  It's 2/2/2020 and I can still barely life the right arm where I got the shot.  But symptons are subsiding
Moderna vaccine EUA.  Fever, headache, chills, fatigue, muscle aches,nausea. Happened 18 hours after vaccine
woke up at night and was freezing; shaking; put a jacket on and curled up next to her husband; acid indigestion really bad; been sleeping off a lot; dizzy; sore all over; all joints hurt; This spontaneous case was reported by a consumer and describes the occurrence of FREEZING PHENOMENON (woke up at night and was freezing), TREMOR (shaking), FEELING COLD (put a jacket on and curled up next to her husband), DYSPEPSIA (acid indigestion really bad) and SOMNOLENCE (been sleeping off a lot) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), BUPROPION, BETAMETHASONE DIPROPIONATE, CLOTRIMAZOLE (LOTRISONE), CITALOPRAM, EZETIMIBE (ZETIA), FEXOFENADINE, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), HYDROXYZINE HCL, LATANOPROST, LEVOTHYROXINE, METFORMIN, METHOCARBAMOL, MUPIROCIN, OMEPRAZOLE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and TRAZODONE for an unknown indication.    On 05-Mar-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 FREEZING PHENOMENON (woke up at night and was freezing), TREMOR (shaking), FEELING COLD (put a jacket on and curled up next to her husband), DYSPEPSIA (acid indigestion really bad), SOMNOLENCE (been sleeping off a lot), DIZZINESS (dizzy), MYALGIA (sore all over) and ARTHRALGIA (all joints hurt). At the time of the report, FREEZING PHENOMENON (woke up at night and was freezing), TREMOR (shaking), FEELING COLD (put a jacket on and curled up next to her husband), DYSPEPSIA (acid indigestion really bad), SOMNOLENCE (been sleeping off a lot), DIZZINESS (dizzy), MYALGIA (sore all over) and ARTHRALGIA (all joints hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient take TUMS as a Treatment medication.
Pt had swelling, redness and fever started soon after immunization. On 9-30-14 went to clinic and given KEFLEX 500mg take for 10 days.
Head cold; abdominal pain; This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) dose via an unspecified route of administration on an unspecified date as Dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced head cold that lasted over a week. The head cold was not COVID as he tested negative, and he stated he reported the abdominal pain that night to. A 70 year old male consumer was due for his second dose of Pfizer's COVID vaccine tomorrow, 26Feb2021. After his first dose, he had pretty intense abdominal pains and aches the night of the first shot and lingering. He stated it even came back now a little. Caller also stated he read that some of the 35 hospitalizations from the vaccine were due to abdominal pain. Caller also stated he just got over a head cold that lasted over a week. The head cold was not COVID as he tested negative and he stated he reported the abdominal pain that night to (App name withheld). Caller also stated he knows of 2 other people that had a head cold 2 weeks after receiving the vaccine and would like to report that. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
After the flu shot was given the patient always had a bump at the injection site. On 4-4-18 inflammation of the site began. When she came to the pharmacy on 4-25-28 the site was inflammed and purple.
Administered the vaccine on 5/24/17. Patient called me today: 6/6/17, stating that she has rash all over her body from last Friday 6/2/17. Also bruised at injection site.
Dizziness/lightheaded-comes and goes throughout the day; "brain fog" can't think clearly; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02Feb2021 13:45 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. There was no medical history. The patient was not pregnant at time of vaccination. Age at vaccination was 35-year-old. The patient's concomitant medications were not reported. On 03Feb2021 13:00, the patient experienced Dizziness/lightheaded-comes and goes throughout the day, "brain fog" can't think clearly. No treatment was given for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Muscle pain; tiredness; Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th April 2019, the patient received the 1st dose of Shingrix. On 17th April 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, tiredness and muscle pain. On an unknown date, the outcome of the injection site pain, tiredness and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, tiredness and muscle pain to be related to Shingrix.  Additional details were provided as follows:  The patient received 1st dose of shingrix shot two days ago from the date of reporting and experienced muscle soreness around shot area. The patient felt a little tired the next morning. The reporter did not consent to follow-up with your physician at this time unless side effect lingers.
05/04/2021 around 8:30 AM I started feeling effects like nausea and fatigue. The typical symptoms. They lasted for about a week and a half. It lasted until about 06/14/2021 and then I noticed the lymph node protrusion on Sunday and I went to the urgent care  Clinic on Monday  06/14/2021and they just said it would go away. At the Doctor they did blood pressure test and an EKG and they did EKG because I had vasovagal response after touching lymph node. There was a few nights in a row about a week after the vaccine, where I had insomnia and I couldn't fall asleep at all and had to take sleep aid. Lymph node swelling did go down and isn't inflamed anymore.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 11-OCT-2012 13:46, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
03/30/2021- 6:41 Vaccine; 07:01 PM weird taste in my mouth , 07:02PM arm soreness, 10:15PM immune system activation, a weird feeling in my body that I started feeling sick, feeling like my immune system was revving up, sickening in my throat and a slight headache. On 03/31 occipital headache, inferior frontal headache, run down arm soreness was 2 x2 inches of swelling in the deltoid area. Later that day the swelling went from 2 x 4 inches. I was having joint pain , one joint pain going to another joint. 04/01 my energy was returning to normal, but I was having sweats for no clear reason, arm soreness. One 04/02 arm soreness, headache and sweats . On 04/03 arm soreness. 04/05 arm swelling  was down and not swollen any more . 04/05 and 04/06 unusual headaches. 04/07 still having sweats.  I started alternating my thyroid medication on 03/ 12/2021.  In August, I had headache and nausea when I woke up , stomach problems, not clearly defined no diarrhea, bloating, just nausea , 08/04/2021 skin sensitivity to touch on forehead and scalp. and stomach problems 08/04 nausea, headache, skin sensitivity was still on my scalp and moved to my right arm 08/06 decreased energy, 08/7 more area of skin sensitivity like on the buttocks. 08/08 decreased energy headache skin sensitivity, migraine pain. 08/09 I did not feel good 08/10 fleeting sharp pains, fatigue  08/11 skins sensitivity  and low energy. 08/11 I got a COVID AND flu test-both negative 08/12 started feeling little better. 08/13 I was having a little bit of tremors. 08/14  getting better and skin still sensitive. The skin sensitivity is gone. I am clearly back to normal.  I got a lot of mosquito bites and ticks in my yard. I don't know if the symptoms were from  a tick, mosquito bite, or a virus.
Arm pit tenderness in same arm  of vaccination; Swollen lymph nodes in same arm of vaccination; A spontaneous report was received from a Nurse concerning a 59 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Arm pit tenderness in same arm of vaccination (Tenderness) and Swollen lymph nodes in same arm of vaccination (Lymphadenopathy).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28 Dec 2020, approximately five days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 02J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 2 Jan 2021, the patient experienced Arm pit tenderness in same arm of vaccination and Swollen lymph nodes in same arm of vaccination. No laboratory details were provided.  Treatment information for the events provided by the reporter included Aleve.  Action taken with mRNA-1273 in response to the events was unknown.   On an Unknown date, the outcome of the events, herpes zoster infection and overloaded immune system, were considered resolving.; Reporter's Comments: This case concerns a 59-year-old female who had nonserious expected events of lymphadenopathy, tenderness.  Event onset occurred 6 days after the first dose of mRNA-1273. Treated with Aleve. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the lymphadenopathy and tenderness, a causal relationship cannot be excluded.
Shortness of breath and chills/fatigue onset night of vaccination; no treatment sought or received; alleviated naturally by 1/21/2021
Patient was under the age requirement  to receive booster (15 years old), but was accidently given the booster dose for Pfizer.  It had been 6 months since the patient received their second dose, given on 06-06-21
Swollen, red, warm arm 2 inches below injection site. Antibiotic as treatment. Outcome TBD
Rapid test and is positive; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Rapid test and is positive) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Rapid test and is positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Rapid test and is positive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Pt went limp immediately after vaccine administer. Seconds later head was shaking and pt returned to normal. Pt was observed by pharmacist and NP from clinic. Quad was called, pt was determined to be safe to go home with mother's observation.