chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Listed in chronological order and ranked by severity (0 = no pain, 5 = moderate, 10 = excruciating, need to go to ER) 1) Sore and achy left arm = 6 2) Skin sensitivity and pain from light touch (i.e., lightly brushing against bed sheets and airy clothes) = 8 3) Painful body aches = 8.5 (had trouble moving,  pain kept me awake at night and during the day when attempting to sleep) 4) Fever (up to 101.4F, with acetaminophen), sweat and chills = 7
Pt recvd 3 doses of Engerix-B & titers were checked 6 months p/the last dose & titer result was 7.5, indicating a low pos response;
pt recv vax 7SEP95 & DEC96 pt devel a mild case of chickenpox;it was noted that a sibling devel chickenpox 2wk later;pt recovered;
swollen neck, very limited head mobility (but improving), excruciating headaches;  diagnosed at Emergency Department as bilateral posterior neck pain.  The question I need answered is, IS IT WISE TO TAKE THE SECOND SHOT on 3/1?????
First 3 days (sat-mon) felt like I had a cold then about the Tuesday it was a little worse. From Wed to 2 weeks later, I was in bed and not really conscious for most the time. I had severe fatigue to the point I had to crawl to the bathroom. I wasn't eating and felt like shit and was sleeping most of the time. I remember sleeping for a lot of it and not remembers much else. I was hot and cold most the time and was sweating. My roommate had it at the same time. I may have taken Tylenol and drank water. My sense of taste and smell that was lost during covid and it's come back but things don't smell like it should...and sometimes smells like the opposite. Or sometimes I lose the sense again. Like lavender sometimes smells like rotting flesh. Before Covid I wasn't having a lot of fibromyalgia flare ups, since I had been taking my meds. Maybe every 2 months. But now after Covid I have pain everyday nonstop and I'm walking with the pain, even with the medication I've been taking. Adding Tylenol will dull the pain but it's still there.
HPI: Received above flu vaccine 10/6 at 2:13 pm in L arm. Felt immediate spasm and pain and states "injection felt low." Reports swelling in L arm, redness, heat, and pain at injection site; denies adverse reaction to flu vaccine or injections in past. Seen in urgent care 72 hrs after injection on 10/9. Provider in UC states she could see puncture from injection over anterior biceps. Treated for phlebitis with ice and Motrin and limited shifts to 8 hrs, which EE states helped. States no change and continued to have pain in L arm. Seen by PCP this Mon. 11/2 and prescribed Bactrim DS BID via since possible cellulitis or abscess. PCP instructed to completed abx course, apply heat and massage area. Today, 11/4 , reports throbbing 7/10 pain from just distal to shoulder and proximal to elbow over anterior bicep; denies joint pain. Painful with ROM and with work or by end-of-day, states L arm feels fatigued; denies weakness. + sleep disturbances and reports "jolting, shocking pain" waking her from sound sleep. Unable to lie on L side d/t pain. Also reports difficulty with ADLs like dressing or anything with arms overhead. Continues to use q4-6hrs ibuprofen and tylenol for pain, but "doesn't like taking pills without any relief." Denies paresthesias, radiating pain, fever, chills. PMH includes RC repair in R arm.  EXAM: L ARM: 3" x 1" vertical flat patch of erythema over anterior biceps. Hot to touch. +TTP over area with skin changes. Decreased sensation to light touch around periphery of erythema and absent sensation in center. FROM of shoulder and elbow with discomfort at movement endpoints. Limited IR compared to R caused stated discomfort and grimacing.  5/5 BUE with L biceps testing causing stated discomfort and grimacing.  A/P: Referral to ortho. Ordered MRI. Complete bactrim as directed by PCP. Limited work shift to 8 hrs.
MAGNET STICKS TO HER ARM; This spontaneous report received from a consumer concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced magnet sticks to her arm. The action taken with covid-19 vaccine  was not applicable. The outcome of magnet sticks to her arm was not reported. This report was non-serious.
tired; restless; out of sorts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (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 FATIGUE (non-serious), outcome unknown; RESTLESSNESS (non-serious), outcome unknown; MALAISE (non-serious), outcome unknown.  The vaccine more than 21 days after the first dose. She got her first dose of the vaccine last 09Mar2021. The facility was scheduled her second dose on 02Apr2021.     No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), MYALGIA (Muscle pain), PYREXIA (Fever) and FATIGUE (Feeling tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (pain), MYALGIA (Muscle pain), PYREXIA (Fever) and FATIGUE (Feeling tired). At the time of the report, PAIN (pain), MYALGIA (Muscle pain), PYREXIA (Fever) and FATIGUE (Feeling tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
1) LS of head heated up, then pulsated 30 min. 2) LS of head's artery (from left eye lid to left-side of back of neck) heated like boiling oil for 30 min. 3) Left chest (heart) felt strange and started to hurt, following shortness of breath for approximately 15 - 20 min. 4) Sudden intense pain & pressure on left temple area. 5) Memory fog issue. 6) Dyslexia 10-15: Weird sensation over left breast/heart. 10-18 thru 20: Type-O's, dyslexia and hard to focus (work), didn't sleep good all week. 10-20: work (see above 1 thru 3 & 5), got home felt flu and drain symptoms with sinus problems. No fever. 10-21: Called out sick, slept. 10-25: work (see above 4) went to hosp. 10-28: Sudden sore throat.
Muscle aches are so intense that I can't stand for long; fever doesn't stop.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches are so intense that I can't stand for long) and PYREXIA (fever doesn't stop.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle aches are so intense that I can't stand for long) and PYREXIA (fever doesn't stop.). At the time of the report, MYALGIA (Muscle aches are so intense that I can't stand for long) and PYREXIA (fever doesn't stop.) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.
Redness, pain, itching, swelling and warmth at the site of injection after 24 hrs. Swelling existed and got bigger after 48 hrs.
The upper shoulder swelling pain all the way down the arm past the elbow. This lasted over a week.
Extreme itchiness and dermatographia starting approximately 10 days after vaccination. Has not resolved 5 weeks later.
This spontaneous report was received from a healthcare worker and refers to a 14-year-old patient. The patient's gender, medical history, concurrent conditions, drug reactions and allergies were not reported. On 24-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (dose, route of administration, anatomical location, lot# and expiration date were not reported). No adverse events were reported. This is one of the two reports received from the same source. Additional information has been requested.
The morning after his vaccination, his left elbow swelled up and was tender.  The elbow gradually decreased in size.  Patient wants to get his next dose in his right arm.
Pt vaccinated with DTP experienced inconsolable irritability, and screaming on & off x 24 hrs individual episodes lasting up to 3 hrs with 10-15 minutes calm behavior between episodes.
Single small pimple under her left breast; Single small itchy vesicle or pimple; Single small vesicle under her left breast; This case was reported by a consumer via call center representative and described the occurrence of pimples in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 30th August 2021, 2 days after receiving Shingrix, the patient experienced pimples, pruritus and vesicles. On an unknown date, the outcome of the pimples, pruritus and vesicles were not recovered/not resolved.   It was unknown if the reporter considered the pimples, pruritus and vesicles to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter. The patient received Shingrix on an unknown arm. Two days after the vaccination, on Monday; the patient noticed a single small, itchy vesicle or pimple under her left breast (small pimple or vesicle) which had not resolved till the time of reporting. The reporter consented to follow-up.
Nausea starting at 1330 12/25/2020, severe nausea with forceful projectile vomiting every half hour beginning at 2330 through 0800.  Nausea for next 5 days. Low grade temp 12/26. Severe diarrhea beginning 12/26 afternoon through 12/17 am.  Muscle aches through New Year's Eve. Mod to severe dehydration. Lost 10 pounds I had chemo 9 years ago and I don't recall ever being that sick
pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Serve migraine,  chills, joint pains, trouble walking, hip pain, pain all over body
Small irregularly shaped rash to the side of the injection site.  About 1-1.5 inches, very slightly raised (almost imperceptibly raised), and slightly itchy.  Also very slightly harder than surrounding skin.
This spontaneous report as received from a registered nurse via a company representative refers to an 11 year old male patient who on an unknown date was vaccinated with dose 1 of GARDASIL, 0.5 ml, intramuscular for prevention of HPV. It was reported that the patient had received his vaccination, felt faint, fell to the floor and "hit his head on the way down". The office staff assisted the patient to the exam table and laid him down, the patient was examined and found to have no injuries. After a short period of time the patient felt better and was sent home. At the time of the report the patient was recovering from the events. Relationship between felt faint, fell to the floor and "hit his head on the way down" and therapy with GARDASIL was not reported. Additional information has been requested.
Patient began to feel very dizzy and lightheaded. She felt her heart racing and thought she might pass out. Pulse regular at 120, BP 140/80. respirations 26, SPaO2 99. Denies shortness of breath. No stridor, no vomiting, no hives. EMS activated. Transported to Hospital.
The patient has a history of diabetes and PVD s/p bilateral BKA. He was seen in the ED on 10/25/23 for evaluation of weakness and altered level of consciousness. In the ED, his wife reported that the patient has had a cough, weakness, altered LOC, and flu-like symptoms for the past week. He was found to have a fever of 101.7 F. A COVID PCR test resulted positive in the ED. Ultimately, the patient was admitted 10/25/23 - 11/2/23. Discharge diagnoses include COVID-19 infection, among other diagnoses. He did not require oxygen during hospitalization.  Of note, the patient is s/p bilateral BKA, and discharge diagnoses also included left stump wound infection.   Of note, the patient has received the Pfizer Monovalent COVID vaccine (given 5/3/21; 5/22/21; 2/17/22; 7/7/22).
nurse administered the expired vaccine to six month old patient, no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00311934) and transmitted to Sanofi on 10-Nov-2020.  This case involves a 6 months old patient (gender unspecified) was administered the expired HIB (PRP/T) VACCINE [ACT-HIB] vaccine (Lot no: UJ060AAA and expiry date: 04-Oct-2020) via unknown route in unknown administration site for prophylactic vaccination on 12-Oct-2020 (expired product administered)  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.  It was a case of an actual medication error due to expired product administered (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt administered PNEUMOVAX 23 L deltoid 6/14/18. Within few hrs, pain/tenderness at steroid site of injection progressed to shoulder/exam/neck/ (L) mid back used MOTRIN sparingly (pt with H/O intolerance to prednisone) slowly improving Sx's. Had no RXN to PREVNAR 13, Tdap. Saw allergist 6/18/18 Dx'd with Adverse RXN to vaccine, but not hypersensitivity RXN.
Information has been received from a registered nurse concerning a 12 week old female with a diary allergy and no other medical history who on 14-DEC-2006 was vaccinated with an oral first dose "single-dose tube" of Rotateq. There was no concomitant medication. On 17-JAN-2007, four weeks after vaccination, the patient developed colitis with blood in stool. As of 22-FEB-2007 the patient had not recovered. The physician suspected that the patient's colitis and blood in stool was an allergy to dairy product. There was no product quality complaint involved. Upon internal review the patient's blood in stool was considered to be an other important medical event. Additional information has been requested.
pt recvd vax & the following day devel a fever of 101.6, was little hot, 2" x 2" edema described by MD as a huge 12 x 12 cm induration @ inject site; also swelling 13x12 cm red area, itching @ inject site; arm was tender & hot;
Fever 105 deg, chills left arm swelling 4 to 5 times and redness. Joint pain, Face swelling.
Pt called on 6/5/09 c/o pain in (L) arm with swelling and pain radiating to upper scapulae area. This occurred when he awoke. T-102 in am. Seen at clinic T-102.8 (L) arm -no swelling no redness.
Vaccine given on Thursday 2/4/21 4:30 PM.  On Saturday  2/6/2021 starting  about 2 am excessive itching on shot site and developed a hard lump which wasn't there day before.
Information has been received from a physician, and the patient's husband, concerning a 62 year old female consumer with hypothyroidism and osteoporosis and a history of allergy to cats and chickenpox as a child who on 01-OCT-2007 was vaccinated SC in the left deltoid with a first 0.65 ml dose of ZOSTAVAX (Lot#658085/0882U). Concomitant therapy included SYNTHROID. There was no illness at the time of vaccination. On 10-OCT-2007 (previously reported as 06-OCT-2007) the patient developed shingles. The patient had muscle pain and a red rash on the right flank, back and waist with vesicles and lesions. Medical attention was sought. A viral swab culture specimen was performed. The patient was prescribed VALTREX and LYRICA. No further information was provided. At the time of reporting the patient had not recovered. There was no product quality complaint involved. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on 16-OCT-2007. The patient had multiple lesions on right T8 dermatome. The patient had no recent exposure to chickenpox or shingles. The patient's rash occurred 12 days after vaccination. The patient rated her pain 8 on a scale from 0 to 10 with 10 being the highest. Other systemic symptom was fatigue and headache. The patient recovered on an unspecified date. A direct fluorescent antibody test was done which was positive for zoster. The strain was identified as a wild-type. No further information is expected.
redness & swelling @ inject site from shoulder to elbow, red, hot, swollen;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: soy" (unspecified if ongoing); "known allergies: salmon" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Postive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 28Jun2023 to 02Jul2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300270875 same patient, different drug, different event;
Erythema, edema, warmt, L triceps region.  Also had inject sore area day prior.  Took Keflex and Benadryl.
LINGERING HEADACHE, FEVER 100 TEMP, STIFF NECK SINCE DAY AFTER DOSE. PATIENT IS TAKING ADVIL FOR HEADACHE AND NECK STIFFNESS. LOW GRADE FEVER IS STILL PERSISTING
Patient received Hep A shot in AM that evening, developed urticaria, swollen lips.  Mild urticaria next day.
This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myopericarditis) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced MYOCARDITIS (Myopericarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myopericarditis) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This was my 4th shot.  Chills and shivering temporarily night of 2/7/22.  2/8/22, severe fatigue, minor body aches, slept all day and night.  2/9/22, continued fatigue, minor body/joint aches, awake about half the day.    I had the same reaction to my 3rd shot back in August 2021.
This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. The reporter wanted to receive SHINGRIX, but heard about the side effects, known by several people who had bad events. The reporter stated that, it seemed that some doctors in the area were advising the patients to wait awhile. Even the local drug store had a list to get on, since they received little SHINGRIX each week and then all of a sudden, they tossed out their wait list. The reporter was suspicious of the issues, side effects. The reporter asked if their concerns were real or what exactly was happening with the vaccine.
Legs hurt so bad after 1st dose/pain in legs; Couldn't walk after 1st dose; Pain worse in right leg after 1st dose; Given a medication intravenously; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs hurt so bad after 1st dose/pain in legs), GAIT DISTURBANCE (Couldn't walk after 1st dose), PAIN (Pain worse in right leg after 1st dose) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Given a medication intravenously) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025b21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID-19 in January, as reported.) in January 2021 and Device implant NOS (Patient has bolts and screws in her left arm). Concurrent medical conditions included Neuropathy. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and ASPIRIN [ACETYLSALICYLIC ACID] for Clot blood, GABAPENTIN for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Legs hurt so bad after 1st dose/pain in legs), GAIT DISTURBANCE (Couldn't walk after 1st dose), PAIN (Pain worse in right leg after 1st dose) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Given a medication intravenously). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. On 06-Apr-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Given a medication intravenously) had resolved. At the time of the report, PAIN IN EXTREMITY (Legs hurt so bad after 1st dose/pain in legs), GAIT DISTURBANCE (Couldn't walk after 1st dose) and PAIN (Pain worse in right leg after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown.       Other Concomitant product includes Parkinson's Medication