chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Early morning stiffness; Low back pain; Injection site bruising; Pain in arm; Neck pain; Pain in hip; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Early morning stiffness), BACK PAIN (Low back pain), INJECTION SITE BRUISING (Injection site bruising), PAIN IN EXTREMITY (Pain in arm) and NECK PAIN (Neck pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bruising and Stiffness. Concomitant products included ADALIMUMAB (HUMIRA) from 22-Jul-2020 to 02-Mar-2021 for Ankylosing spondylitis.    On 30-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 MUSCULOSKELETAL STIFFNESS (Early morning stiffness), BACK PAIN (Low back pain), INJECTION SITE BRUISING (Injection site bruising), PAIN IN EXTREMITY (Pain in arm), NECK PAIN (Neck pain) and ARTHRALGIA (Pain in hip). At the time of the report, MUSCULOSKELETAL STIFFNESS (Early morning stiffness) and BACK PAIN (Low back pain) had resolved and INJECTION SITE BRUISING (Injection site bruising), PAIN IN EXTREMITY (Pain in arm), NECK PAIN (Neck pain) and ARTHRALGIA (Pain in hip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-164188 (Patient Link).
Fever of t102.9 ax on 25FEB92, seizure on 26FEB92 @ 650PM, t104.4 R in ER, rash on back; had acute ear infect @ the time of the seizure;
20min after flu shot, itching, swelling and sunburn rash.  Started with ears, face, then upper extremities.  Dermal reaction.
Initial report received from a healthcare professional on 09 May 2013. A 30-year-old female patient had received first dose of ADACEL vaccine (lot number: U4612AA, anatomical site of vaccination was not reported) intramuscularly on 08 May 2013. The patient was pregnant at the time of vaccination. The patient's medical history, risk factors (e.g.: alcohol, tobacco or recreational drugs) and concomitant medications were not reported. The patient's last menstrual period date was on 26 September 2012 and the expected delivery date was reported as 03 July 2013. At the time of this report, the patient did not experience any adverse event. List of documents held by sender: none.
Sitting at computer when I experienced excruciating pain in my right shoulder area - felt like bones were crushing.
I started feeling extremely tired about 5 hours after the 1st does of Pfizer vaccine (have not had any soreness at injection site at all).  Other symptoms presented themselves much later: Headache/Migraine onset at approximately 4:30am (15 hrs post vaccination) that lasted for about 6 hours, treated with Advil and strong coffee.  Chills set in at approximately 9:30am (20 hrs post vaccination) and lasted for about 3 hours then dissipated.  As of 1:30pm on 24 March (24 hrs post vaccination) all symptoms are no longer present.
R thigh with large area erythema, sl raised with whitish central circle-"bulls-eye" appearance, warm, non-tender. Area of erythema approx 8x5cm moving, walking well. S. pruritic. No fever. Possible cellulitis.
Elevated blood glucose symptomatic- tachycardia, dizziness, nausea, ill feeling
pt devel swelling urticarial area below area of pneumovax inj;pt denied SOB/diff swallowing;negative itching;mild pain in arm;negative fever/chills;pt to be watched for sign of further allergy & APAP as needed;
01/26/2004: t/c from client reported she had some initial right deltoid soreness after Twinrix shot. That lasted 1 day. 10 days later on 01/21/2005 client noticed a deep muscle pain occurring in right deltoid area. Also felt mildly feverish, weak, and tired. No other symtoms. Advised client measures including cold/head compresses and pain reliever and will f/u with client in one week. 02/08/2005: t/c to client. Client stated arm is better now.
Fell down while washing hands at the sink; Dizziness; Weakness; Mild feverish; Mild nausea; Vomiting; Mild pain at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell down while washing hands at the sink), DIZZINESS (Dizziness), ASTHENIA (Weakness), PYREXIA (Mild feverish) and NAUSEA (Mild nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Hypothyroidism. Concomitant products included LISINOPRIL for Hypertension, LEVOTHYROXINE for Hypothyroidism.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FALL (Fell down while washing hands at the sink), DIZZINESS (Dizziness), ASTHENIA (Weakness), PYREXIA (Mild feverish), NAUSEA (Mild nausea), VOMITING (Vomiting) and VACCINATION SITE PAIN (Mild pain at the site of the injection). At the time of the report, FALL (Fell down while washing hands at the sink), DIZZINESS (Dizziness), ASTHENIA (Weakness), PYREXIA (Mild feverish), NAUSEA (Mild nausea), VOMITING (Vomiting) and VACCINATION SITE PAIN (Mild pain at the site of the injection) had resolved.            No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Follow up received on 01 May 2021. The event outcome updated as recovered.
Pt screamed w/pain @ time of inject; cont to complain remainder day/night; fever; pt given ASA/ice pack; 7SEP92 due to extreme swelling, inflammed localized pain; Seen in ER; MD thought arm had been broken due to swelling; x-ray neg;
A report was received from a health professional on 10/21/02, concerning a 46 year old male vaccinee who experienced worsening hearing loss right after receiving the flu vaccine (brand unspecified) in September 2002. The patient was diagnosed with mild to moderate hearing loss in his right ear and moderate to severe hearing loss in his left ear in June 2002. On 10/16/02, the vaccinee was evaluated at an audiology clinic different from the one he was evaluated at in June 2002. It was noted that he had worsening hearing loss in his right ear. The vaccinee had received previous influenza vaccines in the past 4-5 years, without a similar adverse reaction. The reporter has assessed the relationship of the vaccine to the event as unrelated.
8-3-21 - Patient came in pharmacy complaining pain on the whole left arm where we gave the covid-19 vaccine injection on 6-10-21. Pt stated the pain started the day after the injection (6-11-21) n 'till now. No swelling but pain upon touching on the whole left arm. Numbness on his left hand and shortness of breath if walking too fast. Checked with MD on 7-15-21, did lab works and physical, normal per pt.  Spoke to NP, she said they did the lab works and physical exam on 7-15-21 and everything came back normal.
Patient began feeling lightheaded, describes fuzzy vision and feeling tired about 2mins after vaccination. He requested to lie down. Appeared pale. Assisted to cot by medical staff. Vital signs checked within normal limits. He began to feel better after 5mins. Accompanied by mother who drove him home after 30mins observation.
Pt. c/o redness and swelling in right upper arm between injection sights and elbow.  Mom took pt. to Urgent Care on Sunday 01/25/2015.  Pt. was seen there and placed in Cephalexin by Urgent Care Physician stating that arm was infected.
Pt presented to the ER 6 days after her vaccination with blisters and a rash on her left forearm and back.  The ER thought it might be from the vaccine and prescribed her triamcinolone cream.
Information has been received from a physician concerning a 17 year old female patient who on 10-JUL-2008 was vaccinated with the first dose of GARDASILL vaccine (yeast) 0.5 mL, IM, and fainted twice after receiving the dose. Subsequently, the patient recovered from fainted twice after received GARDASIL vaccine (yeast). The patient sought medical attention. Additional information has been requested.
rt arm became very sore, red, hot, edematous from inj site to elbow to chest;began around 5PM 7NOV96;soreness gone by 4PM 8NOV96;swelling gone by 12NOV96;did not seek medical tx;
Patient experienced a raised, 2 inch reddish area not tender to the touch. Injection site felt feverish to the touch.
no adverse event; inadvertently administered 2 doses of the monovalent vaccine which was beyond the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered 2 doses of the monovalent vaccine which was beyond the published expiration date) and NO ADVERSE EVENT (no adverse event) in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Feb-2023 at 1:15 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered 2 doses of the monovalent vaccine which was beyond the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered 2 doses of the monovalent vaccine which was beyond the published expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (inadvertently administered 2 doses of the monovalent vaccine which was beyond the published expiration date).    No concomitant medications were reported. Call warm transferred from Commercial Care line on 17Feb2023 at 12:29pm, Clinic manager reported that they inadvertently administered 2 doses of the monovalent vaccine (for 12 years and above) which was beyond the published expiration date. This report was for the 2nd patient. Patient has not reported any adverse event.  No treatment medications were reported.
11/25/21:  Arrived to ER with complaints of nausea, vomiting, diarrhea, fever, chills X3 days.  NA 130, K 3.2, HR 140, Temp 102.0, CRP 17.8 requiring 2L NC to sat 94%.  Admitted for COVID + enterocolitis.  Started on IV decadron, IV remdesivir, IV cefepime, IV Flagyl, IV NS, and Lovenox.   11/29/21:  Discharged home after uncomplicated admission.  Requiring no oxygen on discharge.  Discharged to home with daily telemedicine follow up.
Low grade fever; seizure; Passed out; syncope/ fainted; Blood pressure drop; Sore arm; This is a spontaneous report from a contactable consumer (patient's parent). A 28-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 28-years-old, via an unspecified route of administration in left arm on 07Apr2021 at single dose for COVID-19 immunization. Medical history included autism, being nervous, passed out, and anxiety. Concomitant medications included sertraline hydrochloride (ZOLOFT), quetiapine fumarate (SEROQUEL), gabapentin, bupropion hydrochloride (WELLBUTRIN), and lorazepam (ATIVAN) for being nervous. The patient received the Pfizer vaccine last Wednesday (07Apr2021) and immediately after that, at about 1:30 (unspecified), she just started having a seizure. They thought that it was more of a major response she was just having, fighting and was nervous about it, but it was kind of a different situation. The reporter has seen the patient passed out before. She did some blood test on 07Apr2021 and her sugars were fine. The reporter's concern was that they didn't know whether she should get the second one. The reporter didn't believe she got a seizure but was not sure about it. It's just that what immediately happened after she got the shot was that she passed out and they called the ambulance. After she passed out, she went to the emergency room and they did blood work on her. The reporter just did not know if they were going to let her go for the second dose because they couldn't relay if it was a seizure or a bizarre response where she just syncope and fainted. They were just thinking it was a bizarre response as it was just blood pressure drop but they were just not sure where to go from here. The patient was told to rest and intravenous fluid and something through the blood were given. The patient also experienced sore arm from 07Apr2021 for 2 days and had a low-grade fever the following day (08Apr2021). The outcome of the event sore arm was recovered on 09Apr2021 and recovered on Apr2021 for all other events.   Information about the lot/batch number has been requested.
pt recvd vax, mom reported sz type behavior 26 hrs p/vax given; stiffened arms & legs, eyes fixed, appeared to stop breathing; t101.2; hx of breath holding;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 28-AUG-2015, the patient was vaccinated with ZOSTAVAX (lot # and expiration date were unknown) (route: subcutaneous). On 13-SEP-2016, the patient was inadvertently vaccinated with second dose of ZOSTAVAX, (lot # M026874, expiry date: 19-JUL-2017) (inappropriate schedule of vaccine administered). No adverse effects were reported. The outcome of the events was unknown. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 07-FEB-2013 ZOSTAVAX (lot # H0111048/expiry date 09-MAY-2013) was reconstituted with expired sterile diluent (lot # E010687/expiry date February 2012) (subcutaneous) and administered to the patient. Dose and dose number were not reported. No adverse symptoms were reported. This case is linked to cases MARRS#: 1302USA008550, 1303USA003574, 1303USA003575 and 1303USA003576 (same reporter link). Additional information has been requested.
pt recvd vax 3MAY95;6JUN95 rt arm became red, hot, swollen, itchy & welts were present over entire upper arm;on 8JUN95 saw MD d/t t101 oral-put on Duricef; 9JUN95 temp now 99, arm swelling, less red, less itchy
This spontaneous report was received from a registered nurse refers to 11 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 02-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: L043214, dose, frequency, expiry date were not reported) for prophylaxis. The patient was vaccinated under Vaccines for Children Program (VCF). The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments:  US-009507513-1609USA014830,
On 8-8-19, 5 YOM pt accompanied by parents presented for HAV, MMR, Varicella, IPOL and Dtap vaccines. Pt and parents counseled by Clinician and vaccines on right thigh administered by Clinician assistant (CA) and on the left thigh and upper arm side by clinician per parent's request. Pt's mother called on 8-11-19 and spoke to CA and per CA's report "Pt seen 8/8/19 for immunizations, pt mother called today to let us know Pt had red knot form on right leg at injection site, mother states knot is size of her fist. Recommended to take pt to urgent care of ER. Mother highly upset. Pt given DTaP and MMR in right leg." Pt's mother was tried to be contacted on 8-11-19 by covering clinician and on 8-12-19 by clinician that saw pt. Pt's mother did not answer and a message was left. She then returned call. She reports the pt developed redness and a knot of the size of her fist (pt's mother's fist) on the right thigh on 8-9-19 (day after vaccines administered). She stated the area is not tender or hard and there is no fluid-like sensation. She reported that the pt is not having any other symptoms like SOB. However, he is having itching at the site. She has been giving pt tylenol and benadryl. She reports, pt is able to move his leg and walk normally. When she called on 8-11-19 she was instructed to take her son the the ER but she refused. Instead, she called  her son's pediatrician and an ER doctor she knows on 8-11-19, and they told her to monitor an if no improvement to take her son to his pediatrician. She also reported pt has never had a reaction to vaccines. I went over the recommendations I gave her on the date of vaccination which included to take her son the ER in the event edema and/or erythema developed at the site of the injection, rash, difficulty breathing, chest pain, SOB, swelling of lips  or any other reaction and she verbalized understanding that day and today as well, she stated she did not take him to the ER because she is an ER nurse and "I know what they're gonna do at the ER." I insisted to take him to the ER but she refused and said she will follow up with her son's pediatrician tomorrow 8-13-19 if no improvement.
restless legs; itching on the palms, soles, and torso without developing rashes; not getting enough sleep due to the earlier symptoms; a slight ache on the lower back; fever; chills; bodyache; fatigue; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported unusual symptoms related to the covid vaccine. Immediately after receiving the second dose of the vaccine she reported typical symptoms (fever, chills, bodyache, fatigue) which resolved in 48 hours. 6 days post-vaccination, she experienced what she described as horrible, restless legs, itching on the palms, soles, and torso without developing rashes. Currently she was 9 days post-vaccination and was feeling fatigued (she relates this to not getting enough sleep due to the earlier symptoms) and a slight ache on the lower back. She was looking if there were previous reports of these symptoms. The outcome of events fever, chills, bodyache was recovered in Jan2021. The outcome of event fatigue was not recovered. The outcome of events restless legs, itching, slight ache on the lower back was unknown.  Information about lot/batch number has been requested.
Fever (100.6 F max); This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 11May2021(at the age of 60-years-old) as a single dose for COVID-19 immunisation. The medical history included high blood pressure and high cholesterol (both controlled with medications). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. The concomitant medications included hydrochlorothiazide/lisinopril (LISINOPRIL/HCTZ), metoprolol (MANUFACTURER UNKNOWN) and simvastatin (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 20Apr2021 as a single dose for COVID-19 immunisation. The patient also took previously ciprofloxacin(MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. On 12May2021 at 06:00, about 18 hours after second dose vaccination, the patient experienced fever (100.6 F max). The fever ended about 24 hours after it began. The patient reported that this was the only adverse effect that he experienced. On the same day, the patient underwent body temperature test and the result was 100.6 degree fahrenheit. The adverse event did not result in doctor or other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever (100.6 f max) was resolved on 13May2021.   No follow-up attempts are possible. No further information is expected.
I am currently having symptoms and the first thing I noticed is a higher than normal temperature. Normally it's 97.5, on Tuesday it was 98.7. I'm coughing and felt a little chilly. I am taking Paxlovid, cough suppressants. I've just been having coughing that brings up small amount of mucus, and I feel wiped out.
1.  Immediately had very unpleasant metallic taste in mouth. 2.  Five to ten minutes after injection had very severe headache.  After returning to car, took 2 extra strength (500 mg) rapid release Tylenol.  Headache lasted 5/6 hours. 3.  Soreness around injection site for 2 1/2 days.
grandma & mom brought pt in 450PM pt fussy & crying cont-unusual for pt;t100.8 was given APAP since vax;has been given dimetapp & was on Amoxicillin 2 wks ago;
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media via company representative concerned a patient of an unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (unspecified manufacturer), (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose and start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer), (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection was sick for three days (Dose number in series 2). It was reported as "You people amaze me I had all the shots but the last booster and I got Covid and let tell you i am so glad I had them I was sick for three days but I could have been much worse" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection. This report was non-serious.
9MAR91 c/o hives all over body @ 9AM temp 100ax none prior to immun; Seen in ER - VS temp 103.6(R), P144, R32, Macula Papular plaques over arms, legs; Dx allergic rxn;
Info has been received from a physician concerning a 7 year old male who in 1999 was vaccinated with a 0.5ml dose of varicella virus vaccine live. "About one week ago", on approximately 3/29/05, the pt developed a mild case of chickenpox. Unspecified medical attention was sought. At the time of this report, the pt was reported as recovering. No product quality complaint was involved. Additional info has been requested.