chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LOOSE SYRINGE CAUSING VACCINE CONTENT LEAKAGE; MEDICATION ERROR; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced loose syringe causing vaccine content leakage, and medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loose syringe causing vaccine content leakage and medication error was not reported. This report was non-serious The report was associated with product quality complaint:90000181024.
The person who administered the flu vaccine injected it into the bursa of my left shoulder. It became so painful I had to have an injection of cortisone to relieve the pain two days later.
12-4-02 Seen in clinic - Dx probably contact dermeratitis. 12-7-02 returned to clinic rash (dense population of erythematous papular lesions) Dx of atypical measles secondary to MMR vaccination
Severe headache 3/15/23-3/18/23 Broke out in rash on face, neck, back, stomach, arms on 3/18/23?12 days after her vaccine. Continued to get worse morning of 3/19/23. Some itching.
She was exposed to COVID virus on 10Mar2021 but has no symptoms; This is a spontaneous report from a contactable 56-Year-old female consumer (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 05Mar2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated she received the first dose of vaccine on 05Mar2021. She was exposed to COVID virus on 10Mar2021 but has no symptoms. Her second dose has been scheduled on 27Mar2021. The patient planned to follow-up with her vaccination provider for further discussion. She was ok with further follow-up. No additional details available.   Information on lot/batch number is requested.
When she got up, complained of "itchy feet" - presented with severe hives all over legs and feet. (We haven't contacted dr yet b/c too early).
Vaccination Error RECIPIENT RECEIVED FIRST DOSE PFIZER VACCINE ON 12/21/2020. Arrived to Moderna clinic for second shot, did not have his vaccine card, provider did not tell team member his first dose was Pfizer. Team member working clinic vaccinated patient with Moderna, did not recognize provider had received first dose Pfizer until she documented the administration of the Moderna dose in the state data base.
Red "stripe" on back of arm, red "stripe" inch below injection site, R Deltoid only affected arm (Pneumovax). No treatment needed.
diarrhea, (dark, then light liquid) 9:30pm - 4:00am nausea, midnight - 0700 vomiting, midnight- 0400
Systemic: None-Fridge excursion-Mild, Additional Details: Fridge excursion 10/29/22 a few degrees too cold overnight for a few hours not detected until 1/9/2023
Apparent life-threatening event-ALTE.  Symptoms-increased episodes of periodic breathing, progressed to full code.  Tx: Coded in hospital with PPV, cardiac compressions.  03/03/2008 MR received for NICU stay beginning DOB 11/30/2007 to 2/09/2008 with DX of ALTE, possibly 2' to immunization (in addition to multiple DX due to prematurity). Infant experienced significant apnea and bradycardia on 2/3/08 requiring PPV and chest compressions. Thought to be 2' to immunizations. Re-admitted to NICU and started on IV abx. No further episodes.
A physician reported that an 18 month old male received his first injection of Prevnar, as well as Acel-Imune vaccines on 4/6/00. The next day, he developed hives. He was treated with Benadryl and recovered.
arm is painful, two red welts, pain in armpit, swelling, firm on the shoulder, pain impairs rom, hot, Neck pain and swelling
Patient's arm was tender, became red, warm and swollen.  Patient went to ER and was prescribed antibiotics.
Patient experienced seizure-like activity at home while playing video games with his brother. He apparently slumped over and became unresponsive. Seizure-like activity was noticed by mother. EMS was contacted; he was taken to hospital and admitted CT scan done. EEG and MRI ordered.
p/vax pt exp sore arm (inj site); lasted 2 days; flu-like symptoms; bloating & abdominal cramping; lasted about 2 days
About 1hr later of the vaccine on the vaccine site I had a bump of a size of a baseball it was hard to the touch, swollen, red, & itchy. I put ice on it 7 it lasted about a week.
Both injections given in the L arm. Two days after the injections, localized redness, swelling, heat and inflamed area on L arm.
I gave him vaccine, he was light headed after so I gave him gatorade. Then he said he was having bad anxiety, then some breathing issues so patient took some of his albuterol. Pt didnt need epipen or benadryl from me. I asked if he wanted me to call 911 and he told me yes.
severe nausea; A spontaneous report was received from a consumer concerning herself, who is a 61-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031M20a) via unknown route for prophylaxis of COVID-19 infection.  On Mar 2021, the patient experienced the event severe nausea that keeps going and coming.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event severe nausea was unknown.
States that the child woke from nap approximately 4:00 pm on 4/19/2000. The pt looked tired, pale, lethargic, and seemed to be running a temperature. Does not have a thermometer, so did not know how high fever was. Gave acetaminophen product 3 times since then. States child is "burning up", no nausea and vomiting. States the site of injection was red, swollen and firm.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-MAR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)(dose and strength were not reported, lot # R019235 and expiry date 04-JUL-2020) via unknown route for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent (dose, strength, route, lot # and expiration date were not reported). There was a previous temperature excursion and the time frame and temperature was unknown. Digital data logger was involved. There was no involvement of Product quality complaint (PQC). This is one of the several reports received from the same reporter.
Angioedema Narrative:  Swelling and redness of lips 3 days post-vaccination, lips then became chapped with burning sensation that has persisted >1 week.  Other Relevant History:
Day 1 within 20 minutes difficulty swallowing water felt like my throat was closing up.  Subsided after an hour.  at 2:00am woke up with sever abdominal pains, diarrhea, body aches, chills and hot flashes.  Continued till am of day 3 woke up with just headache and stiff neck.  Brain fog was really bad and a litter better today.  Eyes are a little fuzzy.
A non-serious spontaneous report of a second dose of FLUMIST given two weeks after first dose was received from a registered nurse concerning a five-year-old male. The patient's medical history and concomitant medications were not reported. On 09-Oct-2008 the patient received FLUMIST vaccine. two weeks later, on 23-Oct-2008, the patient received a second dose of FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
(times above are approximate). Received flu vaccine last year and within 1/2 hour had circumoral numbness and tingling (unreported).  This year, within minutes of receiving vaccine, mouth was flooded with metallic taste, followed by circumoral numbness/ tingling within the next five minutes, followed by fullness in ears and throat (as is typical during allergic reaction). The numbness/tingling lasted for only about 5-10 minutes.  The metallic taste and full sensation in ears and throat lasted throughout the evening.  These symptoms had just about completely resolved by 11 pm.
ADACEL given instead of DTaP.  Vaccine drawn up by one person, but given by another.  No adverse reaction reported.
patient diagnosed with Parsonage-Turner syndrome.  Symptoms of weakness and pain started on 2-10-2021; returned approximately 2 months later with significant atrophy and continued weakness and pain
Herpes Zoster Diagnosis at pediatrician in a one dose varicella vaccine recipient on 12/11/2014. Unilateral in one dermatome. Lasted less than 4 weeks. No antiviral treatment. Also had loose stool. Given amoxicillin. Rash in palm of hand to right forearm.
child lt deltoid almost to elbow had considerable swelling, redness & warmth-no pain, no fever reported;
The evening following administration of the vaccine, patient had left-sided rib 2-7 muscoskeletal pain.
Per mom, hives that started on chest (avoiding the nipple area), back, stomach and shoulders.  Took child to emergency room and given epinepherine, steroids and benadryl.  No breathing difficulties noted. Hives subsided with treatment.  Next morning, hives on shoulders,neck, face, pelvic area, thighs and legs.  Taken to pediatrician.  Given prednisone and atarax for the itching.  Pediatrician described the rash as "moderately severe urticaria covering most of his body."  Symptoms started approximately 3-4 hours after receiving first dose of FluMist.
Redness, swelling, edema, tenderness on right deltoid muscle. TX Motrin as directed. Follow up visit in 2 days.
A Puffy swelling filling on both sides of head.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the arm left on 28Jul2021 at 10:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jul2021 at 00:45, the patient experienced a puffy swelling filling on both sides of head. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event a puffy swelling filling on both sides of head was not recovered at the time of this report.
Muscle twitching; Headache; some wired discoloration on my nail; This is a spontaneous report from a contactable consumer (patient). A 24-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EA6780) as dose 1, single and dose 2 (Batch/Lot Number: EW0178) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient reported side effect that not going away from the Pfizer vaccine. Patient experienced muscle twitching and headache and there is like some wired discoloration on patient nail. The patient does not  know if the events are the vaccine. Treatment was not taken for events. The outcome of the events was not recovered.
exposed to COVID-19; positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (exposed to COVID-19) and SARS-COV-2 TEST POSITIVE (positive for COVID-19) in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (exposed to COVID-19) and SARS-COV-2 TEST POSITIVE (positive for COVID-19). At the time of the report, EXPOSURE TO SARS-COV-2 (exposed to COVID-19) and SARS-COV-2 TEST POSITIVE (positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported  Company Comment: This is a Spontaneous case concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected, non serious, and AESI event of SARS-CoV-2 test positive. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected, non serious, and AESI event of SARS-CoV-2 test positive. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
5 minutes after vaccine administration, pt had sudden onset of lethargy, decreased responsiveness, vomiting, ? jerking of limbs prior to lethargy witnessed by mom. Given Benadryl, subcutaneous EPI, NS Bolus.
Developed tingling and tightness in throat approx 15 minutes after injection. Employee had personal epipen and gave it at 0917 in her right thigh. She was then taken to the ED for evaluation. She stated she felt better. No additional complications were reported.
On the evening of the first vaccination, a pronounced ringing in my right ear was experienced. It has now persisted since the initial vaccination.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Apr2021 14:00 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single and administration date 19May2021 10:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gluten intolerance" (unspecified if ongoing); "Lactose intolerance" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 28Apr2021 19:00, outcome "not recovered", described as "On the evening of the first vaccination, a pronounced ringing in my right ear was experienced. It has now persisted since the initial vaccination.". Therapeutic measures were not taken as a result of tinnitus.  Additional information: The event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Urticaria - 10/25 - minimal urticaria, ? scrotal discomfort advised use of OTC antihistamines. Pt seen in UC 10/26 US of scrotum showed edema - not orchitis or torsion. Labs drawn, no DM, CBC normal. Pt seen by Dr 10/30 scrotal swelling resolved, 3 hives left. No follow up needed unless recurs.
The pt experienced a localized reaction to the right deltoid with 5-7cm erythema, and non-tender swelling. The child received vaccines on 5/23/01. Mother noticed the area this morning. Advised warm compresses.
Sudden unilateral hearing loss.  Undergoing treatment with prednisone at this time.
Client in today with sister who are getting vaccines.  Client had vaccines administered on 2/18/09 and started rash on her chest today mom states client has no other cause or risk for rash fuls could be related to vaccines.
Redness and swelling in (L) deltoid 10 days after Tdap injection.
Information has been received from a physician concerning a female (age unknown), who, "last week" on approximately 18-SEP-2007 was vaccinated with a first dose of Gardasil.  Subsequently, the patient experienced a hypersensitivity/allergic reaction to the aluminum adjuvant in the vaccination.  The patient developed an injection site reaction with pain and swelling.  The next day, a rash began to develop over her whole arm (arm unspecified).  The patient was treated with BENADRYL.  The reaction continued to worsen and her arm "turned colors."  The reaction continued to worsen for 2-3 days after the vaccination and then began to improve.  The patient was seen in the office multiple times.  At the time of the report the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
his wife got covid in August after completing their two doses of covid vaccine with Pfizer; his wife got covid in August after completing their two doses of covid vaccine with Pfizer; This is a spontaneous report from a contactable consumer (husband) in response to consumer letter sent via follow-up letter. A female patient (wife) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Apr2021 as DOSE 1, SINGLE and second dose of bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Apr2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter mentioned that he and his wife (patient) got covid in an unspecified date in Aug2021 after completing their two doses of covid vaccine with Pfizer. The reporter got his vaccines in Jan2021 and his wife (patient) around Apr2021. Both were fully recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Aug2021. The outcome of the event covid-19 was recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt recvd 1st dose of Engerix-B & 6 hrs later exp fever, hypermyotonia, & confusion; Hospitalization was necessary; Pt, @ time of report, still had a fever; No meds taken;
Three days after vaccination developed symmetric weakness in both legs, myalgia, difficulty walking, dysarthria/dysphagia, along with shortness of breath and right eye drooping. Also recently (4/13/2021)  treated with nivolumab/ipilimumab so immune checkpoint inhibitor toxicity is suspected.
Patient was given the flu vaccine. Upon administration into her arm, the plunger was stuck and pharmacist was unable to push the vaccine into the patient. The patient reported tingling down her arm right away and for a few hours after. We have left a message with her PCP.
Sore arm almost immediately. Within a few hours started to experience intense period pains (might not be related as occasionally get these. No actual period however). Started to feel lethargic,slightly disorientated. By evening I was not wanting to do anything but rest under a warm blanket and turned heating up. Body aching, especially around hips. At 8pm I started to get pains in my left hand which were very unusual. Sharp shooting pains. Felt like massaging my hand.   Did not have any such symptoms with first two immunisations, just a sore arm briefly. This booster has had a much stronger impact. My husband also had the vaccine this morning with me and also reports a sore arm and lethargy.
Seen 9/8 for well check, red, papular pruritic rash developed with 24 hr at time of visit 9/10 50-75 papular rash non vesicular, no crust. (+) pruritus
Pt became rigid, apneic, cyanotic, & pulseless shortly p/IM inject of DTP vax; Event was preceded by lots of crying per mom & the nurse; p/less than 1 min of CPR, pulse returned; Pt admitted for abservation; made a complete recovery;
Shingles after 1st dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The pharmacist reported that, the patient experienced Shingles after vaccination with dose of Shingrix. The reporter did not have patient information and expiry date of Shingrix at the time of call. The reporter consent to follow up.
Headaches within 45 mins  By 345pm: fatigue and tiredness. Armache By 5pm: fever of 100.4 and chills  9pm: nausea and continued fever (despite taking acetaminophen) 2am: body aches were at a 10 (scale 1-10), headache and nausea. Low grade fever 100.2  Nause, body aches, chills, exhaustion, fever (range 99.9-102.1) continued all of Saturday 4/17. (Past 24hrs of injection)   Arm soreness, redness-, tiredness, headache  - remaining symptoms on 4/18 @9:26am
Pain on injection site 7days,  headache 10days , foggy brain 11days , lightheaded  off and on 12days , extreme fatigue 5days , fatigue 12 days  and counting, weakness  in  arms 12 days and counting, heat, rash and hives on injection site 24hours, floating sensation while walking  off and on 12 days and counting and stomach cramps off and on for 2 days this is a newer symptom started 11 days after vaccine injection
Needle came off syringe during administration, unsure if patient received full dose. Revaccinated in right arm
Case denies any COVID symptoms. She tested positive when admitted to hospital on 06/12/2022 after falling and sustaining injuries.
PT developed shortness of breath and slight tingling.  Sat and drank juice and symptoms resolved after 30 minutes
This spontaneous report was received from a licensed practical nurse refers to a 4 month old male. Concurrent conditions included cystic fibrosis. On 16-JAN-2013 the patient was vaccinated with dose 1, oral, ROTATEQ (lot #, expiration date and route not reported). Concomitant medications included CREON. Approximately on 30-JAN-2013 (reported as 2 to 3 weeks after receiving the first dose) the patient experienced cough with thick mucus accompanied by some vomiting. The outcome of cough with thick mucus accompanied by some vomiting and vomiting was reported as recovered/resolved on an unknown date in 2013. The patient was treated with steroid and antibiotics for the events. The patient sought medical attention by office visit. The patient was in office at the time of this report, but it was unknown if a second dose of oral, ROTATEQ would be administered. Causality was not reported. Additional information is not expected.