chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Spikevax appears to have given PMR within 10 days of being vaccinated; This spontaneous case was reported by a patient and describes the occurrence of POLYMYALGIA RHEUMATICA (Spikevax appears to have given PMR within 10 days of being vaccinated) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Osteoporosis.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced POLYMYALGIA RHEUMATICA (Spikevax appears to have given PMR within 10 days of being vaccinated) (seriousness criterion medically significant). At the time of the report, POLYMYALGIA RHEUMATICA (Spikevax appears to have given PMR within 10 days of being vaccinated) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient age was over 70.  No concomitant medications were reported.   It was reported that spikevax appeared to have given her PMR within 10 days of being vaccinated.   It was reported that patient would now had to take steroids for a year.  Company comment: This spontaneous case concerns a female patient over 70 years, with no relevant medical history, who experienced the unexpected serious (medically significant) event of polymyalgia rheumatica (reported as Spikevax appears to have given PMR within 10 days of being vaccinated), which occurred within 10 days after a dose (dose number not specified) of mRNA-1273 vaccine. Patient is having osteoporosis, now have to take steroids for a year. At the time of reporting outcome of the event is unknown. No further information on clinical course, lab data, treatment received. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient over 70 years, with no relevant medical history, who experienced the unexpected serious (medically significant) event of polymyalgia rheumatica (reported as Spikevax appears to have given PMR within 10 days of being vaccinated), which occurred within 10 days after a dose (dose number not specified) of mRNA-1273 vaccine. Patient is having osteoporosis, now have to take steroids for a year. At the time of reporting outcome of the event is unknown. No further information on clinical course, lab data, treatment received. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Flushot was given at 0330. to right deltoid IM, 0530 the site was reddened  and warm to touch, pharmacy was called and Loratadine was given. At 0540 redness was increasing and was spreading down her right side to her waist, across midback, and upper chest. She also developed itch eyes. She was taken to ER and seen by Dr and received treatment ( Pepcid IV 20 mg and Benedryl 50 mg IV and NS infusion. )
Around 9:00 p.m. the day of my shot, I developed severe tingling throughout the body. An hour later I suffered from severe chills and shaking until 3:00 a.m. or so. This was accompanied by an extreme headache in the back of my skull. Several times during the night, I felt as if I would vomit. I was unable to sleep due to the pain in my head and constant shaking.  A fever of 102 lasted until about 3:00 p.m. today, which is the day after the vaccination. I've also been extremely woozy all day, not really able to eat what's the feeling of vomiting continues. I was able to get out of bed for about an hour but laid down immediately to sleep two or three hours more in the middle of the day.
Patient was given PEDIARIX (with Hepatitis B) and additional dose of Hepatitis B instead of Hib. Vaccines drawn up and given to patient. MA was under the impression that the Hepatitis B vaccine was a Hib vaccine. When MA read the vial, she was sure she had the Hib vaccines. When MA went to enter into Vactrak, error was found. Patient's mother was informed as well as epidemiology, the provider, and office manager. Haemophilus Influenzae Type b.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 4:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 4:07 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 76.44.  Concomitant products were not provided.  On 17-Feb-2021, Excursion time was 08 AM, temperature was 20, total doses given for the day was 62, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 17-Feb-2021. 1 vial was sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.    This case was linked to MOD-2022-566976 (Patient Link).
Lymph nodes underneath my arm and side incredibly swollen and painful - on day 3 from when I got my Pfizer booster. I have been ever responded  to a vaccine or flu shot in this way. I had Covid 2 months prior.
Head ache, Body ache, chills, Temp 100.9, sweats, chest pain, elevated heart rate. Hospitalization over night. Diagnosis; Pericarditis and Aortal Flutter.
Patient fainted 5-10 minutes following vaccine administration while checking out at clinic. Patient complained of visual disturbance, headache, nausea after hitting head during fainting spell. Vital signs taken following incident and brief neurological exam performed. Patient sent to Emergency Department due to headache, nausea, visual changes.
Initial unsolicited report received from literature on 18 June 2015. This case is linked to case ID's: 2015SA090249, 2015SA090258, 2015SA090259, 2015SA090260, 2015SA090261, 2015SA090262. (Same literature, reporter and event) Abstract: Background: In October 2012, the committee recommended dose of Tdap during each pregnancy, irrespective of the woman's prior history of receiving Tdap. A retrospective cohort study to assess the safety of Tdap vaccination in pregnant women in two Vaccine Safety Datalink (VSD) sites during 2010-2012 found a small but statistically significant increased risk of chorioamnionitis. Objective: We conducted a review of the VAERS database to describe reports of chorioamnionitis following receipt of any vaccines. Methods: We searched the VAERS database for reports of chorioamnionitis after any vaccine during the period from July 1, 1990 through February 2, 2014. Results: VAERS received 31 reports of chorioamnionitis out of 3389 pregnancy reports in 24 years. The three most common vaccines in these reports were H1N1, quadrivalent human papillomavirus (HPV4), and Tdap vaccines in 32 percent, 29 percent and 26 percent of reports, respectively. Fifty-eight percent of reports had at least one reported risk factor for chorioamnionitis. Chorioamnionitis was identified in 3 reports of spontaneous abortions and 6 stillbirths, 6 reports of preterm birth (two of whom died) and 16 reports of term birth; maternal outcomes included two reports of postpartum hemorrhage and one report of maternal admission to the intensive care unit. No maternal deaths were reported. Conclusion: Chorioamnionitis was found to be uncommonly reported, representing 1 percent of pregnancy reports to VAERS. A majority of reports had at least one risk factor for chorioamnionitis. Five female patients, whose medical history and concomitant medications were not reported, had received a dose of TDAP (batch number, route and site of administration were not reported) on an unspecified date. On unspecified date, after vaccinations, patients experienced chorioamnionitis and were pregnant during vaccination. The last menstrual period and estimated date of delivery was not reported. Gestation period at exposure was unknown. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: chorioamnionitis and vaccine exposure during pregnancy. Documents held by sender: none.
A few minutes after rec. vaccine, pt started to feel lightheaded, passed out for <30 seconds, came to , reclined in car.  EMS evaluated 121/76, 79, 95%.  Had not eaten enough this am, takes metformin not for diabetes, he of lightheaded ness with blood draws.  Observed for 30 min, husband drove home, symptoms had cleared
PAIN AT THE INJECTION SITE FOR 2 DAYS; This spontaneous report received from a consumer concerned a 68 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced pain at the injection site for 2 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at the injection site for 2 days on 13-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210350479.
Got less than 0.5ml, the needle fell out by error; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 3527M, expiry date 3rd June 2023) for prophylaxis.   On 20th April 2022, the patient received the 1st dose of Shingrix. On 20th April 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.       Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: The patient received a Shingrix first dose less than 0.5ml because the needle fell out by error. The reporter consented to follow up by email. Additional Supportive Information: The patient received shingrix dose less than recommended which led to incomplete dose administered.
TEMPERATURE EXCURSION, vaccine was stored in freezer longer than manufactures recommendation. PATIENT DID NOT HAVE ANY ADVERSE REACTION TO THE COVID VACCINE
40 y/o female s/p smallpox vaccine left outer deltoid area 01Feb05; c/o vaccine area redness, swelling and heat and tenderness x 5 days, area of redness measures 14cm-16cm by 11-13cm
Child states "my intestines hurt."  Color pink.  BP 118/70.  HR 76.  O2 sat 99%.  Denies any other symptoms.  Drank orange juice & states he then feels well.
Day after vaccine admin. right thigh swollen with rash at area which spread over thigh to lower leg patchy "bumpy" red- leg swollen then rash over left knee right elbow and back of left arm- child scratching areas, fussy ?low temp (no thermon)
Initially developed pain in R arm and spreading to lower extremity with weakness, also with fever up to 102.  Residual issues with symptoms of miralgia paresthetica
Afterwards, I became ill; This is a spontaneous report from a contactable consumer (patient) received from a  sponsored program . A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on unspecified date in Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included none and prior to the vaccine patient had no underlying health issues. Concomitant medications were not reported. The patient experienced afterwards patient became ill unspecified date in Jan2021. Patient wanted to share experience with getting the COVID vaccine. Patient work at the local hospital as an MLT. Got the first shot in Jan. Afterwards, patient became ill, but got better. Clinical outcome of event was recovering.  Information about lot/batch number will be obtained during follow-up.
Left ear feels like there is water in it; Slight fever; Chills; Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 22Apr2021 at 13:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, which was diagnosed on an unknown date prior to the vaccination. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included allium sativum (GARLIC SUPPLEMENTS), hydrastis canadensis (GOLDENSEAL TINCTU) and AF compound (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8733) via an unspecified route of administration on 01Apr2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021, the patient felt like there was water in her left ear. The patient had a slight fever, chills and muscle aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left ear feels like there is water in it, slight fever, chills and muscle aches was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
For 24 hours straight he ran a fever over 103 (confirmed by three different thermometers in 3 different locations with Tylenol on board and stripped w cold compresses. Temp gradually lowered next few days. I think it?s because he?s so little.
Shots given 2/18/09. MOC called 2/20/09. On Left arm at site of KINRIX, arm was red, firm, and tender. No drainage Blotchy red rash extended down arm from inj site almost to elbow. Child had fever-temp not taken. Taking MOTRIN. Did not call pediatrician. On 2/23/09, rash mostly gone, site less sore but still red and firm, slight fever. Did not call ped.
Almost 12 hours exactly after the shot, I began shivering then started experiencing body aches that just kept getting worse as the hours progressed. Around midnight the body aches got better and the chills went away. Tiredness and slight body aches continued until the next day until about 4pm. Completely fine after that.
Fever; cold chills; Hot flashes; Nausea; Headache; increase body pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), intramuscularly on the left arm on 04Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included liver failure, mononucleosis, gallbladder disease, mitral regurgitation of the heart and fibromyalgia; patient had no known allergies. Concomitant medications were not reported. Patient did not have COVID prior vaccination, no other vaccine was given in four weeks prior and patient did not receive other medications within two weeks of the vaccine. The vaccine was given at a nursing home/senior living facility. On 04Jan2021, the patient experienced fever, cold chills, hot flashes, nausea, headache and increased body pain. Moderate side effects were also reported from 05Jan2021 to 09Jan2021. No treatment was given for the events. The patient underwent lab tests and procedures which included nasal swab COVID test: negative on 04Jan2021 and saliva swab test for COVID: pending result on 11Jan2021. Outcome of the events was recovering.   Information on the lot/ batch number has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA After two hours of injection, I felt a headache, sweaty, feverish.  Dizzy. Nauseous.   This is Sunday and I still feel nauseous.  Have a slight headache.  If not better in a couple days, I will call my PCP.
arm soreness from vaccine - Vaccine was placed in freezer upon receipt from manufacturer, then thawed prior to administration
Approximately 30 days after my second shot, I started experiencing light tingling sensations in my lower left leg and foot. 30-90 days after my second shot, the tingling sensation spread to my left forearm and hand and right side of scalp. These arm and scalp sensations come and go. However, now 120 days after my second shot, the sensations in my left leg are more constant and intensified, spreading to the inner thigh of my upper left leg.
Every weekend since then i get sick; Neck ache; Lethargic; on the right side of her lung, when she breathes in, she feels like she has a little bit of a rattle; I am like in a fog; it makes me feel ill; i get a headache; a little temperature; sometimes a little nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Every weekend since then i get sick), NECK PAIN (Neck ache), LETHARGY (Lethargic), DYSPNOEA (on the right side of her lung, when she breathes in, she feels like she has a little bit of a rattle) and FEELING ABNORMAL (I am like in a fog) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM for Anxiety, DICLOFENAC for Arthritis aggravated, DILTIAZEM for Blood pressure management, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Depression and Fibromyalgia, REPAGLINIDE for Diabetes, ALLOPURINOL, ACETYLSALICYLIC ACID (ASPIRIN [ACETYLSALICYLIC ACID]), VITAMIN D3, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) and LOSARTAN for an unknown indication.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced ILLNESS (Every weekend since then i get sick), NECK PAIN (Neck ache), LETHARGY (Lethargic), DYSPNOEA (on the right side of her lung, when she breathes in, she feels like she has a little bit of a rattle), FEELING ABNORMAL (I am like in a fog), ILLNESS (it makes me feel ill), HEADACHE (i get a headache), PYREXIA (a little temperature) and NAUSEA (sometimes a little nauseous). At the time of the report, ILLNESS (Every weekend since then i get sick), NECK PAIN (Neck ache), LETHARGY (Lethargic), DYSPNOEA (on the right side of her lung, when she breathes in, she feels like she has a little bit of a rattle), FEELING ABNORMAL (I am like in a fog), ILLNESS (it makes me feel ill), HEADACHE (i get a headache), PYREXIA (a little temperature) and NAUSEA (sometimes a little nauseous) outcome was unknown.
Every time she bends over, if her head gets below her shoulders to pick something up she will black out; fever; everything in her body ached; vertigo; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 26Mar2021 10:00 (Batch/Lot Number: ER8733; Expiration Date: Jul2021) as single dose at age of 61-year-old for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medications included methotrexate; hydroxychloroquine. Adverse event following prior vaccinations violently ill from flu shot, ended up in urgent care, 20 years. The patient experienced every time she bends over, if her head gets below her shoulders to pick something up she will black out, fever, everything in her body ached, vertigo on an unspecified date in 2021. Clinical course: The first Covid 19 vaccine she ran a fever and everything in her body ached. Every time she bends over, if her head gets below her shoulders to pick something up she will black out. She reports she has blacked out in the shower and blacked out from leaning off the sofa to pet her dog. She almost went into her coffee table trying to pet her dog. This lasted for about 5 days after she received her first Covid 19 vaccine. After about 5 days it cleared up and went away. She called the facility that gave her the Covid 19 vaccine, a drive thru facility and they told her she had vertigo. She knows she didn't have vertigo because she didn't have these problems until after she received the Covid 19 vaccines. Outcome of event black out was recovered in 2021, and outcome of other events was unknown.
pt had coughing & sneezing p/vax was given APAP q 6 hrs mom reports; t105 (under arm); T dec w/ lukewarm bath w/in 30 mins; PC to ofc next day; referred to MD for F/U; tx w/ ATB
This spontaneous report as received from a pharmacist refers to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the pharmacy has been administering ZOSTAVAX (dose, route, lot number and expiry date) into the outer tricep area of the arm rather than the indicated deltoid (drug administered at inappropriate site) to an unspecified number of patients. No adverse effects reported. Additional information has been requested.
Patients throat began swelling approximately 4 min after injection was given. Patient was given 0.3 mg epi pen in left outer thigh. EMS was contacted and came to pharmacy. EMS evaluated patient. Patient was stable when leaving by ambulance to go to  emergency room . We spoke with the patient today (3/23/2021) at 1:45 pm, and she said she was doing  fine.
none - VFC NJIIS asked us to report dose extra of IPV in 10 dose vial. Registered dose of VFC A dose given to patient and noticed was 11th dose. D/W parents during telehealth. Baby fine. Again, VFC NJIIS asked us to report dose.