chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore right arm; Fever; Nausea; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right arm), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Muscle aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (required hospitalization) in November 2020. Concurrent medical conditions included Asthma and Adhesive tape allergy. Concomitant products included OMALIZUMAB (XOLAIR) for Asthma.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore right arm), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Muscle aches). At the time of the report, VACCINATION SITE PAIN (sore right arm), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   Reporter did not allow further contact
shoulder was incredibly painful to move (Pain travelled all the way down to the elbow); Little achiness; little feverish; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder was incredibly painful to move (Pain travelled all the way down to the elbow)), MYALGIA (Little achiness) and PYREXIA (little feverish) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced ARTHRALGIA (shoulder was incredibly painful to move (Pain travelled all the way down to the elbow)), MYALGIA (Little achiness) and PYREXIA (little feverish). On 19-Mar-2021, ARTHRALGIA (shoulder was incredibly painful to move (Pain travelled all the way down to the elbow)), MYALGIA (Little achiness) and PYREXIA (little feverish) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information included paracetamol.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: patient denied to share contact information and asked to followup via phone.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age or gender. From 15-MAY-2013 to 25-JUL-2013, the patients were vaccinated with GARDASIL (dose, frequency, route, lot # and expired date unspecified) that were subjected to multiple unsupported temperature excursions. It was reported that it was at most 20 doses. No adverse effect reported. Additional information has been requested.
Sore; Wanted to take Nap; A spontaneous report was received from a consumer, concerning a 63-year-old, female patient who who received Moderna's COVID-19 vaccine and experienced the events "wanted to take a nap" and "sore".   The patient's medical history included cystic fibrosis.  Concomitant product use was not provided by the reporter.   On 23-Dec-2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Four hours after vaccine administration, the patient wanted to take a nap and was sore. Treatment information was not provided. The patient is scheduled to receive 2nd dose January 20. Patient   Action taken with mRNA-1273 in response to the events, wanted to take a nap and sore, was not provided.   The outcome of the events wanted to take a nap and sore was unknown.; Reporter's Comments: This spontaneous report concerning a 63-year-old, female patient with medical history of cystic fibrosis who experienced the event of "wanted to take a nap" and "sore. The event occurred on the same day, 4 hours after the administration of the first dose of mRNA-1273 (lot number unknown, expiration date unknown). No treatment information was provided, and outcome is Unknown.  Based on the current available information and temporal association between the use of the mRNA-1273 vaccine and onset of the reported events a causal relationship cannot be excluded.
Nausea, swelling, redness, pain, headache, vomiting, loose stools
Patient called on 09/04/09 to report moderate swelling redness with red streak from injection site to elbow RT arm. Advised patient to apply cool cloths to site and if swelling worsens to see PCP.
I developed a red patch by the site of where i was injected.  It is red and hot to the touch.
Tested NAAT positive for COVID-19 11/7/2021 after being fully vaccinated.
no adverse event; Patient took 1st dose on 18-may-2021 and second dose on 15-jul-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 1st dose on 18-may-2021 and second dose on 15-jul-2021) and NO ADVERSE EVENT (no adverse event) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007131A and 007B21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza vaccine; for Drug use for unknown indication: Zoster. Past adverse reactions to the above products included No adverse event with Influenza vaccine and Zoster.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 1st dose on 18-may-2021 and second dose on 15-jul-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 1st dose on 18-may-2021 and second dose on 15-jul-2021) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 1st dose on 18-may-2021 and second dose on 15-jul-2021).    No concomitant medications was reported. It was reported that patient took 1st booster on 25-jan-2022 with lot number 084J21A and second booster on 25-jul-2022 with lot number 038A22A. No treatment drug details was reported.   This case was linked to MOD-2023-716927 (Patient Link).
Anxiety, sensation of breathing difficulty, dry mouth, excessive drinking of water and spitting, desire to be outside, pacing, checking heartbeat, fear of stopping breathing or heart stopping.
I experienced generalized achiness, malaise, sweats and total lack of energy.  This began within 24 hours of booster.  Within a week I had joint pain in ankles, knees and wrists.  I continued to be very tired.  I got an NSAID and advised to hydrate well.  This lasted about 3 three weeks.  I had already diagnosed previously with lime disease but this seemed to be a flare up.  This past weekend I another flare up.  I also have a cold at this time.
a little bit fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (a little bit fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 012L20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (a little bit fever). At the time of the report, PYREXIA (a little bit fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sweaty chills Headache Fatigue (had to go to bed fatigue) Feeling of unease well beyond what Others reported from vaccine of same day
On unspecified dates, the pt received his 1st, 2nd and 3rd Lymerix injections. About 2 to 3 weeks after the 3rd injection, the pt developed a low-grade fever, arthralgia, myalgia and "possible" fibromyalgia. As of 8/9/00, the outcome of the events were ongoing.
It was determined that the pt was six weeks pregnant at the time of vaccination. On follow-up the pt's husband stated that "after he and his wife reviewed the available literature that was sent to them from SKB, they decided to terminate the pregnancy. The most recent information received on 10/25/00 reports the outcome of the event as unknown.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient medical history, concurrent conditions, previous drug reactions or concomitant medications. On unspecified dates, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX lot number N020015, with expiration date on 17-JUL-2019 and Oka-Merck PROQUAD lot number N014950, with expiration date on 11-NOV-2018 for prophylaxis (strength, dose, routes of administration, anatomical locations, lot numbers and expiration dates were not reported for any of the vaccines). The MERCK STERILE DILUENT used for the reconstitution of the vaccines was properly stored. The administered doses of the vaccines experienced a temperature excursion in the range between -14 to -10 degrees Celsius (°C) for 52 minutes, as recorded by a data logger. The vaccines had a previous temperature excursions in the range between -14°C to -10°C for 67 minutes, There was no adverse events reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA008561.
12/25 Pt to ED from extended care facility with reports of altered mental status and fever.  COVID-19 infection, tolerating very well. no anti-COVID rx needed. Previous dx of diagnosed with stage 4 gastric cancer. Pt with poor prognosis from Cancer.  religious and refuses blood products as well.  12/29 Large infiltrative necrotic mass in the left upper quadrant with direct invasion of the proximal gastric body, pancreatic tail and splenic flexure of the colon as well as the anterior aspect of the spleen.  12/31 Hgb 5.6 1/5 Pt expired
A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST was given on 14-DEC-2012 later seen to be expired on 10-DEC-2012. The outcome of the event of EXPIRED FLUMIST GIVEN is unknown. The report was considered to be non-serious by reporting health professional.
body aches; night sweats; lymphnodes on my clavicle are very swollen and slightly painful; lymphnodes on my clavicle are very swollen and slightly painful; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 20Mar2021 09:15 (Lot number: EN6202) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: TRAMADOL; MELOXICAM; HUMIRA. Past drug history included: Doxycyclene, reaction(s): "Allergy", notes: Allergies to medications, food, or other products:Doxycyclene. Vaccination history included: Bnt162b2 (Dose 1, Single (lot# not provided)), for COVID-19 Immunisation, reaction(s): "swollen lymphomas". The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered with sequelae", described as "body aches"; NIGHT SWEATS (non-serious) with onset 2021, outcome "recovered with sequelae", described as "night sweats"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 2021, outcome "recovered with sequelae" and all described as "lymphnodes on my clavicle are very swollen and slightly painful". Therapeutic measures were not taken as a result of pain, night sweats, lymphadenopathy, lymph node pain. Additional Information: After first shot the patient had some swollen lymphomas and one on his left clavicle never went down. After the 2nd shot he had body aches on and off for a few days and night sweats. He also experienced the lymph nodes on his clavicle were very swollen and slightly painful. The patient did not receive any other vaccines within 4 weeks prior to the COVID Vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021320016 same reporter/patient, different vaccine dose number and different event.
Patient stated she felt like fainting post immunization. Pharmacists quickly grabbed adverse event protocol and followed directions as stated. Called code white on intercom to alert store management. Asked patient about symptoms and she reported symptoms of sweating, coldness, dizziness and nausea. Assessed patient blood pressure and asked patient if she wanted us to call 911. Patient did not want us to call 911. Patient never lost consciousness but had low blood pressure on initial reading. Instructed patient to lay down with feet elevated. We gave patient a pillow to assist in elevation of feet and gave her cold compresses to apply to neck and face. After a few minutes, patient blood pressure was normal and patient stated that she was feeling better. We requested that she sit for an addition 15 minutes before she can leave. After 15 minutes patient, patient was feeling ok and left with her boyfriend. She was exhausted from work and this was likely the main factor for the feeling of syncope.
Patient is 17  years and 7 months old and was given COVID-19 vaccine Moderna intended for 18 years and older.  Mother of patient was immediately informed by writer once error was realized.
mom called,pt shaking everywhere;denies sz;directed to MD or er;mom called,they think pt had sz;will do skin tests & give DTP under observation at MD ofc;
First vaccine 3/29/2021 Second vaccine 4/19/2021 Noticed Altered (vanished) taste and smell 5/2/2021 Taste mostly returned 5/9/2021 Thump in chest/ throat started 5/10/2021 More frequent chest/ throat thumps 5/14/2021 Thump then sharp pain in back of head 5/15/2021 Started feeling full/bloated/ difficult to breath 5/20/2021 (1 and a half days) Continued random heart thump/palpitation/scrub feeling 5/27/2021. This has been consistent since it?s start, becoming more frequent with an occasional headache accompanying. The headaches are not new, but when paired with the palpitation/PVC or whatever is happening, the headaches are worse.
Patient received the Smallpox vaccine in preparation for deployment overseas. Patient states was training and injured injection site about 4 days ago. Now has multiple satellite lesions forming around org site. Site is hot, erythemic, indurated, very tender, Fever is present, also there is weeping present. Pt was sent to the ER for further eval and tx.
Migraine headache; extreme fatigue/ tiredness; muscle ache; pain; This is a spontaneous report from a contactable Physician (patient). A 46-year-old female patient not pregnant received first dose of bnt162b2 (BNT162B2), intramuscular, administered in Arm Left on 23Feb2021 09:45 (Lot number was not reported) as single dose for covid-19 immunisation (at age of 46-year-old). Medical history included hypothyroidism, Migraine headaches, allergy to sulfa. Concomitant medications in two weeks included levothyroxine sodium (LEVOXYL); erenumab aooe (AIMOVIG). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Feb2021 03:00 patient experienced migraine headache, extreme fatigue and tiredness, muscle ache and pain. No treatment was received. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient recovered from the events. No Follow-up attempts are possible. Information about lot/batch number cannot be obtained.
There was not an adverse event, rather an administration error.  Patient was administered 0.3 ml of undiluted pediatric vaccine, instead of the adult formulation that he was supposed to receive.
Information has been received from a consumer concerning her daughter who on 18-SEP-2007, was vaccinated PO with her first dose of rotavirus vaccine live (human-Bovine). On approximately 18-SEP-2007, the child experienced "diarrhea for the last ten days and it seemed to start right after the dose." Medical attention was sought through an office visit. The patient's outcome was not recovered. The was no product quality complaint. No further information is available.
Developed a symmetrical, raised rash on each breast, each hip, and each inner thigh.  They were itchy and hive-like raised bumps.  They came on suddenly around 6pm. and were gone when I woke up the next morning at 8am.
Status migranous. Migraines lasting 3 weeks so far Had same reaction to shot number 2
Tested positive for Covid; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for Covid) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: Positive.     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.   No relevant concomitant medications were reported.    No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jan-2021 and was forwarded to Moderna on 18-Jan-2021.    This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for Covid) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: Positive.     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.   No relevant concomitant medications were reported.    No Treatment information for the event was provided.
Swelling in arm, large lump, lose of use of arm (unable to raise arm), muscular aches, pain, numbness in arm, pain in elbow. 6 weeks still with symptoms. Started with Tylenol, aspirin, cool compress. Prescribed Naproxen (no results with Naproxen). Back to Dr. and was given Prednisone to relieve pain.
Severe case of chicken pox developed in this patient, the father of a one-year-old who received VZV vaccination about 1 1/2 weeks prior to onset of illness.  Patient without other known exposure.
I have been tracking my ovulation to try to get pregnant for the past 9 months. My ovulation has come on day 14, 15 or 16 of my cycle. This time my ovulation came on day 22. I initially believed I had perhaps missed it but got a clear positive on day 22.
Patient reported fairly large volume of hair starting to come out upon brushing starting 03/22/21.  Hair loss still occurring as of 04/05/21. Patient has never had this problem in the past.  No other med changes have taken place.  This report matches a few others by word of mouth within our company.
Two days post vax, the pt developed joint pain, fever, night sweats, rash, fatigue, shortness of breath, numbness and tingling, and twitching facial muscles. A doctor visit was required. The pt was diagnosed with Lyme disease. Pt was treated with a 21 day regimen of doxycycline. Pt was tested positive for babesiosis. Pt was treated with amoxicillin, Lariam, Zithromax, and probenecid. Doxycycline was not started as consumer works outside. The most recent information reports the outcome of the event as unresolved. A 15-day follow up report received 12/26/2001 adds: Report number 2000021964-1 describes babesiosis and Lyme disease in a 34-year-old male who received Lyme disease vaccine recombinant OspA (Lymerix). This report was received from a medical office worker on behalf of the treating physician. Medical history included multiple tick bites before and after Lymerix administration. The pt had no known allergies. Concurrent conditions were not specified. There were no concurrent medications. The pt received his 1st injectin of Lymerix on an unspecified date. He received his 2nd injection of Lymerix in June 2000 (exact date not provided). Two days following the 2nd Lymerix injection, the pt experienced joint pain, fever of 104 degrees F, night sweats, five areas of bull's eye rash, fatigue, shortness of breath, numbness, tingling and twitching facial muscles. the pt reported that he "could not move from his hips down". The pt was seen by a physician. On 06/16/2000, the physician made a diagnosis of Lyme disease and prescribed a 21-day course of doxycycline. On 07/14/2000 the pt saw the physician for follow-up, at that time, he "tested positive for babesiosis." He was treated with amoxicillin, mefloquine (Lariam), azithromycin (Zithromax) and probenecid. Additional info was received from the pt on 12/17/2001. He reported that, prior to Lymerix administration, he "was tested for Lyme and it was negative." He reported that he has "been diagnosed with 2 different types of Lyme and also babesiosis." He also stated, "since then I've been depressed and on numerous medications. I was put out of work and collected for workers comp...I had meds and home IV (intravenous) Rocephin (coftriaxoac) which didn't help. I'm still receiving treatments of biocillin once a week. I have seen other doctors who also say I will have chronic Lyme the rest of my life." The Lyme disease, babesiosis, and depression were considered to be disabling because the pt was unable to work. Therefore, this report has been reclassified as serious, unexpected.
pt did not follow instructions for f/u then came in late & blisters @ site of inj, in addtl to arm reddened, warm, tender & swollen they do not regard this a bona-fide rxn to the inj because dx by MD as herpes zoster was not the company MD