chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The COVID-19 vaccine administered through a vaccine administrator, between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
Cellulitis; This case was reported by a physician via sales rep and described the occurrence of cellulitis in a 4-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, 2 days after receiving Kinrix, the patient experienced cellulitis (serious criteria hospitalization and GSK medically significant). The patient was treated with antibiotics nos. On an unknown date, the outcome of the cellulitis was unknown.   It was unknown if the reporter considered the cellulitis to be related to Kinrix.  Additional details were reported as follows: The age at vaccination was not reported however the patient was atleast 4 years old. The patient received KInrix and 48 hours later, the patient came back to physician's office with cellulitis. The patient was hospitalized for 2-3 days and treated with unspecified antibiotics.
Had SOB during the noc. Did not wake parent. In the AM (8/18/10) woke up with swollen face, lips & tongue. Had fever 100.0 degrees, c/o stomach ache - backache. Had a sports physical this AM with M.D. Symptoms improved as the day went on.
soreness around injection site; redness around injection site; Skin being hot around the injection site; feeling weird; tired; feet and lower legs feeling cold; headache; dizziness; lips tingling; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th August 2020, couple of hours after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth, weird feeling, tiredness, coldness of lower extremities, headache, dizziness and tingling lips. On 31st August 2020, the outcome of the weird feeling, tiredness, coldness of lower extremities, headache, dizziness and tingling lips were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, weird feeling, tiredness, coldness of lower extremities, headache, dizziness and tingling lips to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm.  After receiving Shingrix, the patient felt weird, tired, feet and lower legs were cold, headache, dizziness and tingling in lips.  The patient also experienced soreness around the injection site, redness around the injection site that looked like a circle and skin had been hot around the injection site. The reporter consented to follow up.
Information has been received from a physician concerning a pediatric patient with celiac disease who on unspecified date was vaccinated with the series for Hep B (manufacturer unknown) but was not seroconvert. It was unspecified if the patient sought medical attention. At the time of reporting the outcome of the patient was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports from the same source. Additional information has been requested.
Covid vaccine was given on 8-31-21 that had been drawn up and stored in refrigerator on 8-30-21 which made it over the 6 hour time frame of administration.
erythema @ site of inject w/an inc temp lasting 1 wk; used heat & APAP for pain & ince temp;
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The agency consulted with the Dept Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The agency is working with the public health dept on a compliance improvement plan and has been reinstated vaccination privileges.
18 hrs after administration of vaccine, she woke with pain, redness and swelling around injection site. Treated with ice/heat and Midol. On 8/21/06 observed induration and erythema 13cm x 4 cm L deltoid.
with the second dose got sick; This is a spontaneous report from a contactable nurse and a contactable consumer (Patient). A 50-years-old female patient (Pregnancy unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 2, single for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Historical vaccine included first dose of BNT162B2 on unspecified date via an unspecified route of administration on an unknown date as dose 2, single for COVID-19 immunization. The patient's concomitant medications were not reported. On an unknown date, after second of BNT162B2 patient experienced sickness. The event outcome was unknown.  Information about lot/batch number has been requested.
The day after the shot, I had a severe  headache, my right arm swelled up and turned red.  It itched  a lot and I was very tired.   This continued for 5 days.  The last 2 days, I was sweating  and I had a fever.  I think I am better now.
Redness in arm at the site of injection, spreading toward shoulder. No pain or any other discomfort. Redness didn't start immediately and got worse after day 5 of receiving both vaccines. No treatment needed.
I was pregnant when I got my second dose vaccine. I was on my first trimester when I had a miscarriage. I also had high fever which I took Tylenol for pain medication even though I had hard time bringing my fever down, I also do not know if it was related to the Modena vaccine or my miscarriage.  On 05-12-2021 I found out I was 11 weeks pregnant. I underwent  a radiology ultrasound where it showed my fetus died at 8 and half weeks.
Golf ball sized bump at injection site; Soreness at injection site; red itchy rash at injection site; red itchy rash at injection site; red itchy rash at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 27Mar2021 at 08:15 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 06Mar2021 at 08:15 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 10:00, the patient experienced golf ball sized bump at injection site(vaccination site lump), red itchy rash at injection site and soreness at injection site. The patient did not receive any treatment for the reported events. The clinical outcome of the events bump at injection site, red itchy rash at injection site and soreness at injection site were recovered on an unknown date in 2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I did have positive covid four months after my second dose; I did have positive covid four months after my second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I did have positive covid four months after my second dose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The patient wanted to know when can they apply the third dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
After 15 minutes of receiving the shot the patient was preparing to leave when she developed a sharp pain that began in her upper left back then radiated to her mid chest. Chest pain lasted about 2 minutes before dissipating. Bp 133/71  heart rate in the 70's and O2 sat 97%
fever to 100.4, headache, neck pain for 10 hrs then 3 days later developed fever 100.6 and abd pain, diarrhea,
Red macular rash to forehead, raised red rash to chest. Vital signs= 1515 HR 168, RA sat 94%, LCTA, no wheeze, no increase work of breathing noted; 1525 HR 154, RR 48, RA Sat 98%, LCTA bilat, no wheeze, no increase work of breathing; 1550 HR 144, RR 44, RA sat 96%, assessment unchanged.
pt recv vax; 5mo later devel a rash & to MD, dx w/ chicken pox; MD felt chicken pox related to vax;
There were incredible headaches like hypertension headaches that lasted for two days after the vaccination (04/27/2021). The headache was throbbing and was mostly around the neck and back of head area. There were not much body ache following the vaccination. Two days after the vaccination on 04/29/2021, I experienced something similar to Visual Migraine. Part of my vision was blurry with lights induced in the blur and the reality was distorted. It lasted around 40 minutes and I spoke to a Telemedicine who advised me to go to ER if I dont feel safe. I rested my eyes for a little bit and the vision disruption finally went away.
Slight itching at injection site immedicately after administration, left upper outer arm.  Within a few hours the site was still itching, also slightly painful and redness noted approx. 3mm x 3mm. which felt warm to the touch,  About 24hrs later redness extended to approx 10mm x 10mm and was warm to the touch, left upper arm was slightly swollen with an area of approx. 4mm x 4mm of subcutaneous firmness. I treated with a cold pack to site with temporary relief of itching and pain.  I also felt as if I was getting a "cold."  I felt tired and my nose was runnning slightly.  I took 325mg of acetaminophen one time only.  Within 72 hours my symptoms were abating.  My generalized symtoms were gone, the redness was fading, the subcutaneous firmness was resolving, the pain was diminished and there was still slight itchiness at the injection site.  I continued to improve each day and the final symptom of itchiness resolved completely in 6 days.  All other symptoms had completely resolved within 4 to 5 days.  I did not seek medical advice since I had read that most of these side effects were not uncommon, but I would have contacted my physician if my symptoms had not begun to resolve within 72 hours.
Severe allergic reaction with itchy hives all over the body but particular along legs and arms. Onset of allergic reaction was about 24 hours after receipt of vaccine. Treatment taken includes OTC allergy medicine
Temp 102.1 for 24 hours, swelling of both thighs, hot to the touch, slight redness. 7/27/04-Client recovered- Mom states fever and swelling gone after 7/21/04.
H1N1 vaccine given in right deltoid on 10/27/09. Noticed on 10/29/09 enlarged nodes (3) armpit.
Day 6 post vaccine: nausea, vomiting, diarrhea, chills, body aches, fever.
No adverse Events currently reported. This is being filled out because the patient received a second dose 11 days after recieveing the first. The Patient transferred facilities and due to dementia was unable to communicate. New Facility did not report prior vaccination.
Injection site pain; Injection site swelling; Fever; Feeling unwell; Swollen lymph nodes in the left axilla; This is a spontaneous report from a contactable other health care professional (nurse), the patient. A 59-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0164), via an unspecified route of administration, administered in arm left on 09Jun2021 09:00 as dose 2, single (at the age of 59-years-old) for covid-19 immunization. The patient was non-pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. There were no known allergies. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0172), via an unspecified route of administration, administered in arm left on 19May2021 09:00 as dose 1, single for covid-19 immunization. On 10Jun2021 06:00, the patient experienced injection site pain, injection site swelling, fever, feeling unwell and swollen lymph nodes in the left axilla. The patient did not receive any treatment for the events. The patient did not receive any other vaccine in four weeks and not received other medications in two weeks. The patient did not had any other vaccine prior to the vaccination and did not test for covid post vaccination. The outcome of the events was not recovered.  Follow-up attempts were completed. No further information was expected.
Pain in arm, radiates up and down  at times into neck and forearm.  Started 3 days after receiving vaccine, has gotten progressively worse each day since.
spoke with patient. no adverse effect reported. error being reported because patient revieved second bivalent booster. no indication for second bivalent booster on date of administration.
Information has been received from a consumer concerning her daughter, a female who in approximately 1998 (about 10 years ago) was vaccinated with a dose of VARIVAX (Merck). Recently, the patient had blood work and it showed that she did not have any immunity. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. No further information is available.
no adverse affects; improperly stored MMR II was administered; This spontaneous report has been received from a pharmacy technician and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported.  On 14-AUG-2019 the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, (recombinant human albumin (rHA)) (M-M-R II), for prophylaxis, subcutaneously (strength, dose, dose number, frequency and anatomical site of vaccination were not reported; lot number R027063 and expiration date on 20-SEP-2020)  The doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) were exposed to a temperature excursion of above of  70 degress Fahrenheit (°F) for a timeframe of 4 days, which was recorded by a digital data logger. There was not a previous temperature excursions. In addition, no adverse effects or product quality complaints were reported.
pt recv vax 10APR98 12PM & went to MD for hives on feet-itching-red put on DPH;oatmeal bath;11APR98 noon huge red areas to back of legs, stomach area hives, itching, crotch, ears, hands, feet;put on steroids;
102 F fever; chills; body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102 F fever), CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PYREXIA (102 F fever), CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (102 F fever), CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 102 °F High.         No relevant concomitant medications were reported.  Additional treatment details included sports drink.
Patient presents today post VARIVAX 4/12/13. Right arm with 8x11 cm induration and redness. Afebrile without itching and pain at site.
the patient did not have any adverse events after administration of GARDASIL 9; The first dose was administered on 11/6/2020/ The second dose was administered on 12/4/2020; The caller said a patient received a fourth dose of GARDASIL 9 on 12/1/2022; This spontaneous report refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 06-NOV-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #s020254, expiration date not reported, but established as: 09-DEC-2021, administered for prophylaxis (strength, and route of administration were not provided). On 04-DEC-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (inappropriate schedule of product administration), lot #1687292, expiration date not reported, but established as: 25-AUG-2022, administered for prophylaxis (strength, and route of administration were not provided). On 06-APR-2021, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #t024831, expiration date not reported, but established as: 18-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided). On 01-DEC-2022, the patient was vaccinated with the fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (extra dose administered), lot #1780878, expiration date not reported, but established as: 02-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided). No further information was provided. No other adverse event reported.
From telephone contact received at manufacturer on 6/4/02, it was reported that a 4 year old female received Tripedia vaccine. Patient developed redness at injection site. Patient treated with Zyrtec 2.5mg. Reaction resolved.
Client ran fever of 102 deg. F. am of 03/09/2002. Responded to Tylenol. 99 deg. F mother stated that right leg thigh area was swollen, red and hot area size of a soft ball. Mother stated MMR was given in right leg. Actual immunization administered in right leg was DTaP. Child was seen in ER on 03/09/2002 placed on Dunicef 125 mg/5ml. Referred to family physician and seen 2 times 3/11/2002 and 3/16/2002.
Information has been received from a physician concerning a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 30-APR-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
day of vax pt devel wheel & flare react adjacent to inject site;given DPH & observed for 20min;no apparent systemic rxn;wheel was subsiding p/20min;
Patient was inadvertently administered the vaccine. The patient is currently too young to receive the Moderna Covid-19 vaccine under the current Emergency Use Authorization. Patient has not experienced any symptoms out of the ordinary.  He has a headache and slept most of the next day following vaccination.
Soreness in right arm at injection site; This is a spontaneous report from a non-contactable consumer (patient). A 56-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EL3247) via an unspecified route of administration in arm right on 24Feb2021 (age at the time of the vaccination 56 year) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included VITAMIN D, in two weeks. No other vaccine in four weeks. The historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EL3247) via an unspecified route of administration in arm left on 03Feb2021 age at the time of the vaccination 56 year as dose 1, single for COVID-19 immunization. On 24Feb2021, the patient experienced soreness in right arm at injection site. Did not require admission due to the event and no treatment was received for adverse event. The outcome of the event recovered on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
Never received second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 02nd December 2021).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Never received second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 08-MAY-2023 The reporter reported that the patient was not immunocompromised and received first dose of Shingrix but never received second dose. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Patient felt like she might faint, tightness in chest, tingling in fingertips and like it was hard for her to breathe. Provided water, checked oxygenation with pulse oximeter (100%), elevated pulse at 95bpm, BP-142/95. Through talking and deep breathing patient was able to calm down. Patient reports history of events similar to panica attack but has never been formally diagnosed. After ~10 minutes, patient reported feeling improved, pulse ox remained steady and heart rate within normal limits. Second BP reading 132/80. Patient comfortable to leave clinic without EMS evaluation.
Intermittent unilateral tinnitus. Completely resolved after 3-4 weeks.