chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Medical Assistant administered Infanrix to a 8year old female patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa (Infanrix) (batch number YA259, expiry date 03-MAR-2024) for prophylaxis.   Previously administered products included Dtap vaccine (on an unknown date receive 1st dose) and Dtap vaccine (on an unknown date receive 2nd dose).   On 08-NOV-2023, the patient received Infanrix. On 08-NOV-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Medical Assistant administered Infanrix to a 8year old female patient). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-NOV-2023 A registered nurse reported that one of her medical assistant administered Infanrix to a patient. 8 years old patient received Infanrix which led to inappropriate age at vaccine administration. The reporter did not consent to follow-up.
28OCT97 pt recv vax & 48hr later devel stinging rash w/vesicular eruptions on rt posterior neck rt lower jaw/inner cheek & 4cm spot on chest;5 days later saw ED for sx;on sx was chills 48-72hr p/vax;
chills, body aches began 8 hours after shot and lasted approximately 6 hours; fever began 10 hours after shot and lasted approximately 4 hours   Headache and fatigue lasted for 24 hours   Nausea and tightness of chest began 3 days after shot and are continuing
The spontaneous report as received from a Medical Assistant refers to a patient of unknown age. The patient was vaccinated with VARIVAX (Merck) (dose, lot# and expired date were not reported) in error on 13-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. No known adverse effects. No further information is available. Additional information has been requested.
This spontaneous report as received from a female patient of unknown age reporting on herself with not known case of chickenpox. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route, lot # and expiration date were not provided). On an unknown date, after receiving ZOSTAVAX, the patient experienced 3 separate cases of herpes zoster as shingles in her throat. The patient also experienced, dysphagia as she had difficult swallowing and post herpetic neuralgia (PHN). At the time of the report, the outcome of herpes zoster, dysphagia and post herpetic neuralgia was unknown. Additional information is not expected because the reporter did not provided contact details.
Extremely bad lung infection twice second time was approximately 3 weeks after first surgery second surgery was very intense I was cut open and Doctor had to scrape my lungs by hand to try to get all the infection off the lung.
Within 5 min of Pediarix #2 (21936A2), Hib #2 (Pasteur UE275AA), PCV7 #3 (Lederle 945928), IM Thigh. Blotchy rash at forehead and superior periorbital started clearing within 10 min of event and within 5 min of Benadryl. Resolved 15 in after event and 10 min after Benadryl.
The patient fainted in the pharmacy 5 minutes after her second shot. She was conscoius back in 30 seconds and had a racing heart.  we gave her gatorade and she started to feel a  little better. She was seated in the pharmacy for about an hour she started to feel much normal then left the pharmacy with her friend driving her home.
Worst headache ever - intense pain when walking or moving head, nausea. Dr told me to take 4 ibuprofen 3 times per day. I took 2 3 times per day. The headache and nausea lasted 4 days. Headache is milder but still present, especially with head movements. Ringing in ears, moderate tinnitus from the day I got the shot and it still remains.
Patient received dose on 6/8/21 and developed redness and swelling below the injection site (between the injection site and elbow of arm) on 6/10/21.  Patient went to urgent care for the reaction and received an Rx for Keflex to treat any possible skin related reaction.  Patient informed the pharmacy of the reaction and will monitor her symptoms.  Explained to patient to inform her primary care doctor of the reaction to the vaccine.
Patient was administered only half dose (0.25 milliliters) of the recommended (0.5 milliliters) moderna bivalent dose. No adverse reactions reported.
Local erythema, pruritis, tenderness at injection site. Started w/in 1 hour of injection.
The evening of September 16, my joints began to ache.  The only time I experienced pain like this before was following the second Covid vaccine and the booster.  Then the pain was not relieved with Tylenol but lasted only 24 hours.  The discomfort lasted much longer this time and began to increase over the next week.  Then most joints improved, lingering mostly in my hands, feet and knees.  My knees were the worst, making it difficult to sleep and go up and down stairs.  Although I show signs of osteo arthritis in my knees, I NEVER have pain like this and negotiating stairs is not a problem at all.  By the end of the 3rd week the pain subsided.  When I found a pdf version of the insert sent to health care providers with the vaccine, I learned that 10% of the trial group experienced joint pain.  Sounds like my experience.  Even though I am older than that group, it is the same vaccine I received.  "ADVERSE REACTIONS  In adults 18 through 49 years of age, the most common (?10%) injection-site reactions were tenderness  (48%) and pain (37%); the most common (?10%) solicited systemic adverse reactions were headache  (20%), fatigue (17%), myalgia (13%), and arthralgia (10%) [see Clinical Trials Experience (6.1)]. "
Information has been received from a physician concerning a female in her 60s with pulmonary problems who on 8/9/05 was vaccinated SC with a dose of pneumococcal 23v polysaccharide vaccine. On the same day, the patient developed a severe local reaction to pneumococcal 23v polysaccharide vaccine including swelling, edema, erythema, localized urticaria, fever, and severe pain. Medical attention was sought. At the time of the report, the patient had not yet recovered. The reporting physician considered the events to be disabling. Additional information has been requested.
Tenderness/Stiffness in injection arm. Red and hot to the touch, also feels hard to touch. Was not aware I was pregnant at the time of injection. Found out a week later (4/6/21). Estimated Due Date is November 28, 2021.
No additional adverse effect reported; M-M-R II that underwent a temperature excursion was administered; This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided.  On 11-MAY-2021, the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) vaccine lot number S037497 and expiration date of 20-NOV-2021; underwent a temperature excursion and was administered to the patient for prophylaxis (route of administration, dose and anatomical location were unknown). Previous temperature excursions were reported as follows: 2°C to 8°C (1.7°C) for 37 minutes; 2°C to 8°C (1.8°C) for 25 minutes and 2°C to 8°C (1.5°C) for 32 minutes. No additional adverse effect reported.
Son is Health Care Worker who also received 1st dose of covid vaccine, had tested positive for covid after 1st dose.; Son is Health Care Worker who also received 1st dose of covid vaccine, had tested positive for covid after 1st dose.; This is a spontaneous report from a contactable consumer (parent) reported that a male patient (son) of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The reporter stated that son is health care worker who also received first dose of covid vaccine, had tested positive for covid after first dose. The patient underwent lab tests and procedures which included covid: positive on an unspecified date. The outcome of the events was reported as unknown.   Information about lot and batch number was requested.
Bad h headache, stiff arm, sore arm, sick to my stomach, pain in muscles and joints
This spontaneous report as received from a medical assistant refers to an unspecified patient of unknown age. On 11-MAR-2015 the patient was vaccinated with a dose of VARIVAX (Merck) that was improperly stored. No adverse effects reported. Additional information has been requested.
accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; this is 1 fo 30 cases reported from this site; no adverse effects noted;
Mother reported that 5 days post vax, pt developed a rash on his left thigh which spread to his right thigh. By 9/13/01, the rash had spread to his belly, back, and face. He was seen by MD and a diagnosis of erythema multiforme was made.
Following 2nd dose of COVID 19 injection (lot EP6955) localized soreness around injection site; Dizziness; Low grade fever of 99.1; Joint soreness; Mild headache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration on an unspecified date (at the age of 51-year-old) (Lot Number: EP6955; Expiration Date: 30Jun2021) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration on an unspecified date (Lot Number and Expiration Date was not reported) as dose 1, single for COVID-19 immunization. The patient experienced localized soreness around injection site, dizziness, and by evening low grade fever of 99.1, joint soreness. Next morning the patient continued to have localized soreness around injection site, milder joint pain, mild headache, and fatigue. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
pt passed out while sitting in waiting area after vaccination, hitting head on can display.  Was unconscious for approx. 5-10 sec. Paramedics called and evaluated pt.  Pt had not eaten today and had BG=65.  BP normal x3.  Pt was given water, OJ and a candy bar to elevate BG.  Wife picked up pt per paramedics suggestion.  Pt recovered and reports no injuries or other side effects
Gave a patient a Moderna vaccine today. ( 03/15/2021)  Patient stated before I gave then vaccine to her that she had felt dizzy after receiving her flu vaccination previously.  Patient became dizzy and lightheaded after I gave her the Moderna (10:40am). Patient was concerned that her blood sugar was low and took a glucose gel packet from her purse.  She stated that she thought she might faint, so moved the patient to the floor with her feet elevated.  I took the patient's blood sugar, it was 211. I monitored her pulse, it was strong and not racing. Placed a cool wet rag on the patient's forehead. Patient remained lying down for 10 minutes and said she was feeling better and asked to sit up.  I assited her in sitting up on the floor. Had her sit on floor for 5 minutes more before helping her to a chair.  Continued to monitor patient for an additional 10 minutes.  She stated she felt better and had her companion escort her to his car and drove home.  Followed up with patient an hour later, she stated that she felt much better and had eaten lunch and was taking it easy.  She thanked us for assisting her. I will follow up with her tomorrow.
some liquid leaked out; some liquid leaked out and she is not sure that patient got enough dose or not?; A spontaneous report was received from a Pharmacist concerning an unspecified age and gender patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and some liquid leaked out/ device connection issue and she is not sure that patient got enough dose or not/ underdose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 March 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 045A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 17 March 2021, the patient received mRNA-1273 but had some liquid leaked out and underdose. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.  On 17 March 2021, the outcome of the events was considered as recovered.
Patient's wife called around 12:30pm and stated that her husband had been vomiting nonstop since receiving his vaccination. The vomiting began about an hour after receiving the vaccine and had occurred about five or six times. The patient's spouse was advised to have him drink plenty of fluids to replenish electrolytes and to monitor the patient for continued vomiting. The spouse was told if the patient continued to vomit and could not keep any fluids down to report to an urgent care facility for further evaluation and treatment if necessary.
Patient reports having a cough and lower blood sugar than usual since 2nd dose of vaccine. Encouraged patient to contact PCP to report and have physician determine if what patient is experiencing is related to vaccination.
TRUMENBA was given as an alternative to MENACTRA or MENVEO. No adverse reaction reported to this facility.
4" welt on back side of right arm swelling and red at varicella site SC. Instructed to use cool compress dose of BENADRYL. If symptoms do not improve call for appt. Mom called Dr. office 3-19-12.
Presented to ER via EMS from home for evaluation of shortness of breath.  He lives with his brother, both were battling COVID-19 infection for the last few days. Tx w/abx, remdesivir, zinc, O2. Due to requiring high flo O2 still, pt dc'd to LTAC
Mycolonus and elevated heart rate/tachycardia 8-weeks following vaccine.
No adverse effects reported; The patient inadvertently received an expired dose of PROQUAD; This spontaneous report was received from a registered nurse referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug allergies and reactions were not reported.  On 01-MAY-2020, the patient was inadvertently vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R026722 with expiration date on 17-MAR-2020 (strength, dose, anatomical location, and route of administration were not reported) for prophylaxis, which was reconstituted with sterile diluent (MERCK STERILE DILUENT).  The nurse also reported that the patient's twin brother was also received an expirated dose of vaccine (MARRS#2005USA000636).   No adverse effects were reported. This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2005USA000636:
Long cycle/delayed period. Cycle was 40 days long and is usually 32-34 days; Long cycle/delayed period. Cycle was 40 days long and is usually 32-34 days; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 21Apr2021 at 15:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 COVID-19 vaccine. On an unknown date in Apr2021, the patient experienced long cycle/delayed period, cycle was 40 days long and was usually 32-34 days. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. 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 long cycle/delayed period, cycle was 40 days long and was usually 32-34 days was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Left anterior thigh red, swollen, warm to most of anterior thigh with parts of lateral and medial thigh.
Employee reports fever ranging from 100 degrees F - 103 degrees F and vomiting starting 4/3/09 through 4/4/09.  Also reports body aches.  No treatment needed.
Patient endorsed an 'odd' and 'scratchy-like' feeling in her throat @ 1520.  Famotodine 40mg , Diphenhydramine HCl 50mg, and Cetirizine HCl 10mg given PO after No contraindications determined @ 1530.  VSS : SpO2 99-100% on RA, HR 64, NIBP 90s/50s (62-67) - 'baseline' per Patient w no c/o orthostasis.  Feeling better by 1550. Was released to home w f/u phone call @ 1726 to find her at home and feeling 'much better'. She will report this to her PCP.
Upper left arm red, warm to touch, edematous, ice, Benadryl and Motrin
2 weeks after 2nd shot I experienced arm pain from the elbow down for about a week until the pain changed to pain at the injection site followed by pain radiating down my entire right arm.  Pain type changed from a more general pain type to a "pins & needles" tingly pain that radiated down my arm.  Tingly nerve type pain.  Pain was intense & primarily occurring when  my arm was bent at a right angle.   Did not see physician.   Symptoms lasted 3 weeks & then faded away.  Have not had any issues with this pain until now.   On 8/10 the lower arm pain came back briefly followed by slight tingly nerve pain.  I've been having slight nerve pain for a couple days so far.  I also am having cold symptoms now with runny nose, headache, sore throat.  Wondering if this could be Covid Delta virus & its brought back some mild symptoms from the vaccination last year.
None were reconstituted or administered; This non-serious case was reported by a nurse via sales rep and described the occurrence of intercepted product storage error in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient did not receive Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced intercepted product storage error (Verbatim: None were reconstituted or administered). The outcome of the intercepted product storage error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  GSK Receipt Date: 13-MAR-2023 Reporter's Comments:  The reporter was a GlaxoSmithKline representative stating a temperature excursion was reported to him. He stated a nurse manager reported that the Priorix vaccines were stored in the freezer (for hours) and would like to know if they were viable. None of the vaccines were reconstituted or administered. Medical information phone number provided. Consented to follow up.
On August 8, 2015, general malaise. August 15, altered gait and visited prompt care. August 17, saw PCP. Aug 19, went to ER due to falling and sent home. Aug 21, weak, falling, return to ER and hospitalized, put in ICU and diagnosed by neurologist for Guillain-Barre Syndrome and immediately treated with immunoglobulin (6 treatments). Went to rehab at same hospital for 6 weeks and then transferred to another rehab center and was released December 28 and currently doing outpatient therapy.
Sore effect with first dose of vaccine; Lump just above the collarbone of the same side of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore effect with first dose of vaccine) and MASS (Lump just above the collarbone of the same side of injection) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Sore effect with first dose of vaccine) and MASS (Lump just above the collarbone of the same side of injection). At the time of the report, PAIN (Sore effect with first dose of vaccine) and MASS (Lump just above the collarbone of the same side of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by reporter.   Reporter did not allow further contact
This spontaneous report was received from a pharmacist, referring to a 89 year old male patient. The patient's medical history or concurrent conditions were not reported. It was reported that the patient had no drug reactions or allergies. Concomitant therapies included torsemide, clopidogrel, metoprolol, pantoprazole, nitroglycerin (manufacturer unknown), metolazone, simvastatin (manufacturer unknown) and tamsulosin hydrochloride. On 06-JUN-2017 (reported as "administered today"), the patient was vaccinated with a dose of ZOSTAVAX lot number m037014 with expiration date on 22-NOV-2017, dose 1, (therapy route reported as "injected vaccine") (anatomical location, administration route were not reported) for shingles. Subsequently, on the same date that the patient was vaccinated, he called the pharmacist stating he was experiencing back pain. The pharmacist reported that the patient was evaluated by his physician regarding his back pain, but no details of the physician office visit were provided. At the time of the report the outcome of the back pain was unknown. The pharmacist did not mention the causality assessment between the back pain and therapy with ZOSTAVAX. There was no product quality complaint involved.
fainted; feeling horrible; dizzy; ringing in ears; nausea; chills; fever; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0175), via an unspecified route of administration, administered in Arm Left on 04May2021 09:45 (58-years-old) as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. Facility where the most recent COVID-19 vaccine was administered was Clinic (Public Health Clinic/Veterans Administration facility). Concomitant medication included levothyroxine sodium (SYNTHYROID) and multivitamin. The patient previously took first dose of bnt162b2  (lot number: EW0164) , on 13Apr2021 01:30 PM at 58-years-old, on Left arm for COVID-19 immunization. The patient was fine until 17 hours after the second dose. She woke up around 3 am feeling horrible, got up to go to bathroom.  She was very dizzy, had ringing in ears, nausea, then fainted. She had chills and fever for the next ~ 12 hours. Events started on 05May2021 03:15. No treatment was given. The outcome of the events was recovered.
Mother called 8/3/12 am to report swollen, painful, bright red area on (R) arm "about the size of a hand," Pt subsequent office visit 8/6/12 mother reported onset of dizziness - temp to 104 "off & on all weekend" with complaint of nausea, decreased appetite, sore throat & cough. Fever was still 101.6. Exam - normal including (-) strep test.
Pt c/o swelling, redness, red streaks. Call pt today 10/16/08 pt. states doing much better. No redness/swelling or streaks much better.
Localized hives at site of injection, treated with OTC BENADRYL, hives resolved overnight, residual numbness in L arm.