chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; body aches the first full day after; chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th November 2019, the patient received the 1st dose of Shingrix. On 13th November 2019, 1 days after receiving Shingrix, the patient experienced fever, general body pain and chills. On an unknown date, the outcome of the fever, general body pain and chills were unknown.   It was unknown if the reporter considered the fever, general body pain and chills to be related to Shingrix.  Additional details were provided as follows: It was reported that, as warned, the patient experienced fever and chills, body aches the first full day after receiving Shingrix. The patient was supposed to receive a booster dose of Shingrix in two to six months after the 1st dose.  The patient asked if the she should expect the same sickness after the 2nd dose of Shingrix.
It is bubbling with pus bubbles and weeping; It is bubbling with pus bubbles and weeping; Two large patches of itchy skin started day after shot- on left arm/elbow area and right knee/Still itchy and irritated and inflamed/ Skin continued to be itchy and hot; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3182), via an unspecified route of administration in left arm on 08Sep2021 09:30 (at the age of 57-years-old) as dose 2, single for COVID-19 immunization. Medical history included none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FA7485), via an unspecified route of administration in right arm on 18Aug2021 15:30 (at the age of 57-years-old) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient experienced two large patches of itchy skin started day after shot- on left arm/elbow area and right knee, skin continued to be itchy and hot on 09Sep2021. Five days later, it is bubbling with pus bubbles and weeping on 13Sep2021. It was Still itchy and irritated and inflamed from 09Sep2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with antibiotic and steroid. Since the vaccination, patient has not been tested for COVID-19. Outcome of events It is bubbling with pus bubbles and weeping was unknown. Outcome of remaining events was not resolved.  No follow-up attempts are possible. No further information is expected.
10x9 cm erythematous, warm, firm rash over the left thigh surrounding injection site.
Moderate aches/chills/pains and fever (100.2 when taken axillary) starting around 2100 3/24/21, progressing to severe aches/chills/pains from 2200 3/24/21 to 0900 3/25/21. Tylenol 1000 mg taken and decreased symptoms. Fatigue was also present.
Patient was administered the concentrated dose of Pediatric(5-11 yrs) Pfizer.  Per conversation with parent, No adverse effect experienced  at time of reporting.
Presented to ED w/ fever, flank pain, dx w/UTI 2 days prior; COVID+ on 12/16, cxray showed multifocal pna; pt admitted for tx of pyelonephritis and COVID-19 pna; tx w/ abx, steroid, and O2 therapy; cold ot wean off of O2; Pt DC on home O2
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 12 years old male patient who was vaccinated with a suspect vaccine IPOL lot number N1K931M, via unknown route and administration on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that an opened vial of IPOL reached 32 F were given to patient. It was not reported that the patient had any adverse event. 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. List of documents held by sender: none.
Shot at app 2pm. Red cheeks at 3 (1 hr pr) hot face (a little). 8pm very blotchy face (6hr pr) 1am very red swollen face (11hr pr). 10/11/02 dermatologist prescribed 20mg preomsone.
Pt was an inpatient on a psych unit and was negative on admission over a month ago, but due to exposure was retested and found to be COVID positive.
About 5 minutes after receiving the vaccine, I was checking out at the front desk of the doctor's office and I turned around and saw my daughter sitting in a chair convulsing - it looked like she was having a seizure. My daughter was non responsive and I yelled for help. The nurse came out and we helped my daughter back to a chair and my daughter started saying that she couldn't see.  The nurse took her blood pressure and it was 60 over 30 in contrast to 120 over 80 when we arrived at the office. My daughter was cold and clammy - kept saying she was freezing and couldn't see. They layer her down and after about 15 minutes her blood pressure started coming back up.  She is still feeling tired and has a headache. This was a very scary incident - she has not had issues previously with any other vaccine and has no heath issues at all.
102 fever, body chills, body aches for 12 hours starting 11pm on Sunday, April 11th (about 8 hours after vaccination).  Continued pain in sight of injection and body aches for third day now.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient with no drug reactions/allergies. The patient's medical history included history of shingles. On 17-MAR-2014 the patient was vaccinated with ZOSTAVAX lot # J011338, dose 1, subcutaneous in the left arm. On 21-MAR-2014 the patient called the pharmacy to report she developed redness and soreness at the injection site. The patient was advised to apply cold compresses and take BENADRYL. The outcome of redness at injection site and soreness at the injection site was reported as recovering/resolving. The causal relationship was not provided. No consent for follow up. Additional information is not expected.
Mother called clinic on 06/07/2010 to say that pt,'s right leg has been red and swollen since vaccination. Pt. seen in clinic on 06/08/2010 with a dime size circle of induration on right lateral thigh. Pt. guarding limb. Mother states pt. itches site frequently and that pt. was moving a great deal during vaccination.
Rash red, swollen, tender, warm at left arm injection site; fatigue Narrative:
Day 1 feeling a bit spaced out, vision is slightly blurry, sudden onset of nearsightedness - have to hold phone away from face to see it clearly. Depersonalization sets in.  Day 2 woke up severely depressed, still having vision issues, started developing a slight fever, sore arm. Day 3 still depressed, having vision issues, full blown fever, and sore arm. Started having chest pain and difficulty breathing last night before bed. Been taking Tylenol every 6 hours. Still very spaced out, I do not feel like the same person I was before the shot.
Cutaneous hypersensitivity reaction with macular circumferential rash around injection site with associated pruritus, improving at day four after presentation
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-JAN-2019, the patient was vaccinated with improperly stored dose of PROQUAD (lot # R017800, expiration date: 19-DEC-2019, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported. Administered dose of PROQUAD experienced temperature excursion between -14 to -10 Celsius degrees for 30 minutes. There was no previous temperature excursion reported. Digital data logger was involved. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1901USA009536.
Site: Swelling at Injection Site-Medium, Additional Details: Swelling of left arm after injection at site of injection
No other AE reported at this time.; gave an MMR II injection IM instead of SubQ; This spontaneous report has been received from a medical assistant referring to a 36 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided.      On 06-AUG-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S023654 with expiration date 30-JUL-2021) for prophylaxis via intramuscular instead of subcutaneous (incorrect route of product administration). No other adverse event was reported.
I felt tired, I had like a frog in my throat, a little bit of a cough, and a stuffy nose.
Patient reported headaches, fever of 102 to 103ºF, chills and dizziness. Symptoms lasted for approximately 36 to 48 hours, then faded away.
Immediate symptoms of slight swelling and soreness at injection site resolved within 48 hours of receiving vaccine. Approximately 10 days after injection minor swelling, heat and redness occurred over a 3? x 4? area of the upper R arm at location of injection lasting now at 72 hours and perhaps mildly diminished. No other bodily symptoms. No evidence of hives or other rash
Fatigue appeared 3 days after first dose. Fevers, chills, headache, abdominal pain, rash appeared 5 days after first dose and 2 days after second dose.
I developed hive on my left wrist at approximately 0600 on 09/21/2022.  At approximately 1900 on 09/21/2022. I developed new hives on my right forearm
Rash under breasts to belly button starting 12/14/21-12/17/21 Flu like symptoms 12/14/21-12/17/21
Narrative: Symptoms:  Myalgia & at injection site and redness to site Treatment:
Test (+) 6/19/2023; hospitalized 7/26/23-8/2/23; Hospice 8/2/23; expired 8
(L) thigh vaccine admin 9/29/10. On 09/30/10 mother noticed small area of erythema and induration, has been giving pt MOTRIN q 12 hours as needed. On 10/1/10 noticed redness progressed, induration persists. Pt denies pain in (L) leg. Normal level of activity.
61 year old female who presents today(5/20/2021)  for evaluation of her left shoulder. Reports atraumatic left shoulder pain x 2 months. Pain to localized to lateral deltoid. Worse with reaching/lifting. Associated with stiffness. Unable to reach her bra. Denies prior surgery. Pain started after she got the moderna vaccine - not sure if it is related, but did not have any problems with her shoulder prior to this.  Reviewed exam findings and US findings with the patient. Passive ROM generally intact and seems to be pain that is affecting range of motion, but could be early frozen shoulder. Could be related to the recent vaccine, if some of the medication could have gotten into the bursa. I do not see any evidence of rotator cuff tear on US, but I do see diffuse tendinosis of rotator cuff.  patient received injection of kenalog into left subacromial bursa.
Broke 0ut Gradually over a few days  on various parts of body with Hives_raised (bumpy).  I did not scratch. The hives are still  there. I am taking an allergy pill daily and applying 3times a day a cream  generic fo Kenalog.
Extreme fatigue, temperature of 100.8°, all over body aches, severe headache - lasted 24 hours. Injection site very tender and swollen to a diameter of 4 inches.
INCREASED BLOOD PRESSURE; BONE PAIN IN LEFT ARM; DIZZY; This spontaneous report received from a patient concerned a 73-year-old male. The patient's height, and weight were not reported. The patient's past medical history included heart stent for heart attack. The patient was non-alcohol user, and non-smoker. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, administered on 10-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-MAR-2021, the patient experienced significant increase in blood pressure (200/110)/headache and bone pain in left arm (vaccine was administered on right arm). On the same day, he also experienced headache and felt dizzy. Laboratory data included: Blood pressure (NR: not provided) 200/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy on 10-MAR-2021, and had not recovered from increased blood pressure, and bone pain in left arm. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210430234-COVID-19 VACCINE AD26.COV2.S- Increased blood pressure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.
injection site pain; chills on and off yesterday; stomach hurting; feels cruddy and doesn't feel well / Feels cretty and does not feel well; feels cruddy and doesn't feel well / Feels cretty and does not feel well; nausea; diarrhea; This is a spontaneous report from a contactable other HCP (patient). A female patient of an unspecified age (age: 59; units: unknown) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL3246), via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she received the first dose of the Covid vaccine on Saturday (16Jan2021). Saturday night (16Jan2021) she experienced nausea and diarrhea, in which she was still experiencing diarrhea this morning. The patient also reported injection site pain, chills on and off yesterday (17Jan2021), and her stomach hurting. She stated that she felt cruddy and didn't feel well on 17Jan2021. The treatment reported as No. The outcome of event diarrhea was not resolved, outcome of other events was unknown.   Information on the Lot/Batch Number has been requested.  Follow-up (18Jan2021): New information received from a contactable other HCP included: patient weight and height, lot number of vaccine, no treatment.
Client was in post vaccine monitoring and reported feeling lightheaded/dizzy, Reports she had a headache with her 1st dose but did not feel this way before. No other symptoms reported. VS: HR 72, RR 20, BP 108/68 O2 sat 98%. Client placed on extended monitoring, no additional symptoms developed and her current symptoms began to improve. @ 0930 VS:  HR 72, RR 20, BP 114/68 O2 sat 98%; client reported symptoms have completely resolved at this time. Assisted client to walk in monitored area, no dizziness reported and gait was steady. Client denied need for additional monitoring or intervention, family was waiting in the car to drive her home. Instructed client to seek medical attention if symptoms return/worsened. Client left with family at 0940am.
The same day of vax, the child developed hives. Mom took child to ER, child was given Benadryl. Hives quickly disappeared.
allergic reaction; This is a spontaneous report from a contactable pharmacist based on the information received by Pfizer from Merck & Co., Inc.   A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced allergic reaction on an unspecified date with outcome of unknown.    No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 11-DEC-2014, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (lot # reported as L5MN2 exp date 02-SEP-2016) instead of GARDASIL in error (wrong drug administered). The patient received the first dose of GARDASIL on 30-OCT-2014 and did not receive her second dose of GARDASIL at this time due to the error. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Pain behind eyeballs; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Pain behind eyeballs) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced EYE PAIN (Pain behind eyeballs). At the time of the report, EYE PAIN (Pain behind eyeballs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Is this one of the side effects? Ibuprofen taken as a treatment.
My Mom is not doing well. SOB. No pain anywhere. Extremely fatigue, cannot walk very far, no temp, could this be from that pneumonia shot.
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 10th May 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, joint pain, muscle pain, nausea and chills. On an unknown date, the outcome of the injection site pain, joint pain, muscle pain, nausea and chills were recovered/resolved. It was unknown if the reporter considered the injection site pain, joint pain, muscle pain, nausea and chills to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Around 10th May 2018, the patient received SHINGRIX. The patient experienced pain at the injection site, chills, nausea, muscle pain and joint pain.
Fever (100-101.2), chills, body aches, large swollen lymph node in left arm pit starting at 4am. Fever continued to get higher throughout the day. I had a headache first thing in the morning but it didn?t return. Lymph node was sore to touch or lay on.
I am having extreme neck pain. My neck is frozen. Can't turn head from side to side or up and down. Any movement at all is causing me pain. Having a difficult time swallowing due pain. Need help getting in and out of bed intermittently.
11/12th rash on face from nose to mouth noted by grandparent and daycare teacher. No fever.
@1345 Pt with family walked in the room. Pt looked pale. About to check with pt, when mother directed pt to the trash can. Redirected pt back to sitting down and gave an emesis basin for safety. Pt was diaphoretic, really pale. Nonpharmalogical interventions provided to relieve nausea. Elevated feet. Fanned pt for cool air to face. Pt is started to get better.    @1355 Pt is starting to feel better. Color is starting to come back. Pt still feel nauseous but better to earlier. Encourage to take a couple of deep breaths and to continue to fan pt.    @1405 Pt denies feeling nauseous. C/O slightly dizzy. Encourage intake of fluids and food. Apple juices and crackers provided. Tolerated PO intake.    @1415 Pt denies any dizziness, nausea. Pt is feeling better. Skin WNL. Pt is moving around better. Pt stated that he is ready to go home.    @1418 VS sitting 120/67 (80) 94 100%. @1419 VS standing 124/70 (83) 97 100%. Denies dizziness. Trial ambulation done. Tol well. Asymptomatic. Talked to mother and sister re: pt. They feel confident in taking pt home. Instructed to follow up with PMD and to bring pt back to ED for worsening or new symptoms. Pt, mother and sister verbalized understanding.    @ 1420 Pt walked out of the clinic with family. Gait stable. No distress. Resp even and unlabored.
I received the shot on 8/17/20 about 4:15pm in my left shoulder. When I went to bed at 11pm, there was no significant pain in my left shoulder. When I woke up at 6am, my left shoulder was very painful. It hurt to raise my left hand above my waist, and the pain made it impossible to raise my left hand above the shoulder. I could not grasp things or pick up things. For about the next 4 hours my left arm was not usable, I did everything with my right arm. Gradually the pain abated, and I was able to get some movement out of the left arm. When I awoke the morning of 8/19/20 most of the pain was gone and my arm felt almost back to normal. I did not discuss this with the doctor because I wanted to give it some time to recover.
This spontaneous prospective pregnancy report as received from a physician refers to a 17 years old female patient. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with the first dose GARDASIL (lot number not reported) on 25-SEP-2008. The physician reported that the patient received the third dose in the GARDASIL immunization series on 03-OCT-2012, while she was 14 weeks pregnant. No adverse effect reported. Physician reports that the patient is due on 03-APR-2013. The patient had sought medical attention, the AE occurred in provider's office. Additional information has been requested.
Fatigue beginning 4-5 hours after injection. Nausea, aching muscles, headache, stomach cramps, pain at injection site, chills, and fever beginning 12 hours after injection.
No adverse reaction; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (No adverse reaction) and FATIGUE (Tiredness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (History of allergies).   On 25-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced NO ADVERSE EVENT (No adverse reaction) and FATIGUE (Tiredness). At the time of the report, NO ADVERSE EVENT (No adverse reaction) and FATIGUE (Tiredness) outcome was unknown.            Concomitant product use was unknown by the reporter. Treatment information was not provided.
Extremely itchy at injection site radiating to entire left upper arm.  no redness or swelling noted treatment-benadryl 25mg 2 tabs
Local redness/rash on areas of vaccine injections. Treated on 1/4/14 with prednisone and antihistamines at urgent care.
Pt received vaccine and was waiting in observation area. After 20 min., pt reported to observation nurse that her tongue and throat were itchy and she had "an unusual feeling in her throat." Pt denied SOB, WOB, was able to speak normally and answer questions appropriately. Pt was escort by observation nurse and on-site EMT to quiet AE observation area. VS and spo2 were recorded, all were WNL (SP02 98 on room air). Pt states she had a similar reaction to shellfish 2 years ago, which resolved on its own w/out treatment. After 30 min of observation, VS were rechecked and were again WNL (SPO2 99 on room air). Pt stated she no longer had symptoms and felt well and ready to leave. Pt was advised to seek emergency care if sx return or worsen. Pt stated understanding and agreed w/ plan.