chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHHY2013US116690 is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (reference number: 496557) website on 15 Oct 2013. This report refers to a male patient of unknown age. His medical history included anaphylaxis (anaphylactic reaction anything related to amoxicillin in when he lost consciousness and had atrial fibrillation in 2002, he was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) into arm (unspecified date). On an unspecified date, after vaccination with influenza vaccine (unknown arm), he experienced injection site soreness. The injection site soreness resolved two days after receiving the vaccination. He reported that he did consult his health care provider regarding the event. He again received flu shot in 2003, 2004 and another in unspecified year where he also experienced events with these vaccinations (see cases PHHY2013US122590, PHHY2013US122591 and PHHY2013US122592. No seriousness and causality was reported by the reporter.
This spontaneous case was initially received on 28-OCT-2015. The case report was received from a(n) Health Professional and concerns a(n) 65 years old female patient. Weight: 160 pounds, Height: 64 inches. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Neomycin allergy and Potassium allergy. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 17-OCT-2015 - 17-OCT-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: no information provided. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 17-OCT-2015, after starting/treatment with AFLURIA the patient experienced Site injection pain/Pain at site (injection) (non serious, outcome: Not Recovered/Not Resolved). On 18-OCT-2015, after starting/treatment with AFLURIA the patient experienced Tiredness/Felt very tired (non serious, outcome: Not Recovered/Not Resolved), Felt very sleepy (non serious, outcome: Not Recovered/Not Resolved). On 19-OCT-2015, after starting/treatment with AFLURIA the patient experienced Felt feverish (warm to touch) (non serious, outcome: Not Recovered/Not Resolved). Redness at the site (injection (non serious, outcome: Not Recovered/Not Resolved). Action taken: discontinued. Event treatment: 21-OCT-2015 applied topical diphenhydramine cream. For relevant test results see appropriate report section.
Blood sugar level rose after the 1st dose by 65mg/dl; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar level rose after the 1st dose by 65mg/dl) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes mellitus. Concomitant products included METFORMIN.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 04-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar level rose after the 1st dose by 65mg/dl). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar level rose after the 1st dose by 65mg/dl) outcome was unknown.            Treatment details was not reported by the reporter.
A report was received from a health care professional on 12/8/03 concerning 5 children of unspecified sex and aged between 8 months and 3 years of age who inadvertently received Fluvirin on 12/6/03. On 12/6/03, five children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Follow up information received from a health care professional indicated that a 2.5 year old male vaccinee inadvertently received Fluvirin on 12/6/03. No adverse events have been reported to date. No follow up pending. All information received.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 18-OCT-2012 15:53, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 16-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was unknown by the reporter. Treatment information was not provided.
Approx 26 hours after injection, noticed large circular rash on both armpits. Very painful.
p/vax pt devel hives & swelling of lips;sx temporarily relieved w/antihistamines;next day pt devel low grade aches & pain which got worse;pt had muscle aches, h/a & by 6/14/99 pt presented to MD office vomiting;
Throat - burning, hot, heart beat - faster, chills, Muscle pain - around rib cage, legs, No fever. 4PM Meningococcal vaccines administered. After 6PM he started complaining, lastt 4-5 days
A couple weeks after my fourth vaccine I started developing acute muscle spasms in my leg, which persist. Two days ago I started having numbness and lost of strength and muscle use in right arm.
Information has been received from a registered nurse referring to a currently 5 year old child of unknown gender. There was no information about concurrent condition, medical history or concomitant medication. On 04-FEB-2013 the child was administered a first dose of M-M-R II (lot number, expired date, dose and route were not reported) and a first dose of VARIVAX (Merck) (lot number, expired date, dose and route were not reported) on 16-SEP-2013. This child was then administered a second dose of both M-M-R II  (Lot number J002934; expired date 14-MAR-2015) and VARIVAX (Merck) (lot number reported as J009999; expired date 12-AUG-2015) on 14-APR-2014. Then the child was administered a third dose of both M-M-R II (Lot number L026550; expired date 16-JUL-2017) and VARIVAX (Merck) (Lot number L026410; expired date 15-FEB-2017) (extra dose administered) on 18-JAN-2016. This was outside the labeled recommendations in both the M-M-R II and VARIVAX (Merck) prescribing information (Off label use). No adverse effect reported. Lot # J009999 was not valid for VARIVAX (Merck). Additional information has been requested.
Vaccine @ 12:10p Left site and came back- feeling numbness in the mouth and fingers- Seen by EMT
Patient had extensive bruising covering entire upper arm and spreading down to the forearm after the injection. Spreading of bruising continued for 4 days after vaccination. Started to improve 7 days post vaccination.
Information has been received from a physician concerning a pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot #647272/0664N). Subsequently, "in the past few weeks", in approximately 11/03, the pt developed cellulitis with redness and induration. The pt was treated with ice and ibuprofen. Subsequently, the condition has resolved.  It was also reported that 5 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and also developed cellulitis (WAES #0309USA01513, 0309USA01722, 0309USA01723, 0309USA01724, 0311USA02365).  It was also noted that of the 6 total pt's 5 received a booster dose and one had the first vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ibuprofen for drug used for unknown indication. On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced pain to touch. On 11-MAR-2021, the subject experienced had a knot. On 11-MAR-2021, the subject experienced redness. On 11-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, pain to touch, redness, itching, and had a knot. This report was non-serious.
This case was reported by a other health professional via sales rep and described the occurrence of generalized urticaria in a 19-month-old female patient who received HARVIX. Co-suspect products included INFANRIX, PEDVAXHIB and PREVNAR. On 6th February 2017, the patient received HAVRIX, INFANRIX, PEDVAXHIB and PREVNAR. On 7th February 2017, 1 days after receiving HAVRIX, INFANRIX and PREVNAR, the patient experienced generalized urticaria. On 8th February 2017, the patient experienced facial swelling. The patient was treated with MOTRIN, BENADRYL, DECADRON, dexamethasone and prednisone. On an unknown date, the outcome of the generalized urticaria and facial swelling were unknown. The reporter considered the generalized urticaria and facial swelling to be probably related to HARVIX and INFANRIX. Additional details were provided as follows: This case was previously reported to manufacturer. The reporter, pharmacy operations manager, stated that the patient received all four of the vaccines at the same time. The next day, the patient broke out into hives. On 7th February 2017, the patient had hives all over the body and on the head. He was taken to the emergency room and was treated with MOTRIN, BENADRYL, DECADRON and prednisolone and was released. On 8th February 2017, 2 days after receiving HARVIX, the patient had hives again as well as swelling in the face and hence was taken back to the emergency room and was treated with BENADRYL and dexamethasone. The patient was improving once again with treatment. The patient did not have a fever and was discharged. Before the patient left the emergency room, she was able to eat and drink.
adult accidentally received INFANRIX; received INFANRIX instead of BOOSTRIX; This case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 59-year-old female patient who received DTPa (Infanrix) (batch number 7ec55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd June 2022, the patient received Infanrix (intramuscular) and Infanrix Pre-Filled Syringe Device. On 22nd June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced adult use of a child product and wrong vaccine administered. On an unknown date, the outcome of the adult use of a child product and wrong vaccine administered were 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: 22-JUN-2022 Reporter's Comments:  The nurse stated that an adult patient accidentally received Infanrix instead of Boostrix. The reporter gave consent to follow up. Additional supportive Information: The patient accidentally received Infanrix instead of Boostrix which leads to Wrong vaccine administered and adult use of child product.
1/30/08 patient was given her 3rd Recombivax at 08:40.  Patient stated approximately 9pm she had small hives on bilateral arms, maybe some on inside bilateral thighs.  Denies fever.  Took Benadryl for itching with relief.  Took Benadryl this morning also.
High fever, nauseas, Pain, located swelling, redness, arm was hot and hard.
Injection site is inflamed and very painful. There is numbness throughout the arm, into the hand. Advised-10' ice tid and Ibuprofen 400mg qid x 2d. Report if sx are increasing in RUE.
A report has been received from a Health Professional concerning a patient. Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 05-Dec-2014. The patient was given expired FLUMIST. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.
One small hive appeared on lower back and did not grow or change throughout the day.  Woke up next morning 2/6/12 with dozens of hives on various parts of body (back, legs, arms).  Had minor reaction the day of the immunization - localized swelling, redness, and irritability and then no adverse signs until six days later.  In 2011, major hives breakout 14 days after HepA immunization, so suspect allergic reaction to the vaccines.  Pediatrician disagrees.
Left upper arm cellulitis - Swollen, red, warm site of HepA vaccine. Treated with KEFLEX 250mg/5ml BID for 7 days.
shingrix vaccine administered in imms clinic 05/23/2023 Tuesday05/23/2023. On Wednesday he threw up and felt general body aches. Progressed to a dry cough but did travel on a plane. Took a home test on Saturday that was negative. Overall lethargy, body aches and dry cough have cont similar but not as severe to a covid infection he had previously. Reports no sick contact. Mild night sweats on Sat/Sun. Using OTC advil/tylenol/ASA. No rash or localized pain at injection site. Requesting VAERS report and CBC. Pt denies previous adverse reaction to vaccines in his past. No abd paib/ST/COB/CP/HA. No emesis since Wed but still having slightly decreased appetite.
Adverse symptoms began about 9 am. on 3/27.  symptoms were low grade fever, chills, headache, muscle aches, very tired, cough. Symptoms subsided sometime after going to bed at 7:30. I felt ok when I woke up at 5:00 am.  I did not feel 100% but symptoms were gone. Felt a little off all day 3/27 but by #/28 felt fine
Patient received J and J vaccine on 03/31/2021 started feeling sick with a sore throat tested positive for covid on 04/30/2021
Pt, received vaccines on 12/03/2018, pt returned to clinic on 12/06/2018, with complaining of fever of L upper later arm after getting injections. Pt. Left lateral arm lesions erythema, warm to touch, flat surface, tenderness to touch, Pt received Keflex 500mg one cap po q 8hr  for 10 days. Ibuprofen 600, per pt symptoms improved in about 10 days.
11/12/21 pt in transitional care facility in for rehab; urinary retention with acute on chronic bladder obstruction; right upper lung with infiltrate and left lower lung cavitary lung lesion; s/p COVID pneumonia (positive COVID test 11/6/22); pt had worsening productive cough, with some SOB; on O2 supplementation; gross hematuria in setting of anemia; AHRF secondary to recent COVID pneumonia; family interested in hospice; comfort is primary priority; pt's condition worsened and he passed away in the facility
Dizziness, Headache, headache, dizziness, tender skin all over Narrative: Day 2 - headache, dizziness, tender skin all over
Excruciating pain in arm of injection; A spontaneous report was received from a consumer (reporting on self), concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events excruciating pain in the arm of the injection (Injection site pain)  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 027L20A) in the left arm for prophylaxis of COVID-19 infection.  On 24 Jan 2021, the patient experienced the events excruciating pain in the arm of the injection. She had to call EMT (emergency medical technician) and she had taken aspirin and it got better. On 02 Feb 2021 it was worse than it was when she first received the first dose.  Action taken with mRNA-1273 in response to the event was not reported.   Outcome of events of excruciating pain in the arm of the injection was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Worst headache I ever had.  I very rarely get any headache, this was a whole different kind of pain.  I did not have access to a fever thermometer.  Very low energy, I could barely complete my walk and had only done half the usual 10,000 steps a day.  I fought the pain with the only available medication, aspirin and a can of Coke.  Pain lasted ten hours, then I managed to get to sleep and was OK next day.  I already had 5 Pfizer Covid shots and don't recall an effect like this.
No side effects to report; Per nurse a patient was given an expired VAQTA on 8/9/2021.; This spontaneous repot was received from a certified medical assistant (also reported as a nurse) and refers to a patient of unknown age and gender. No information regarding the patent's medical history, concurrent conditions or concomitant medications was provided.  On 09-AUG-2021, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot # T014836 was confirmed to be valid, expiration date 17-JUL-2021, (dose, route and site of administration were not reported) for prophylaxis. No side effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T014836; expirationdate: 17-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
After administering Covid Vaccine, the pharmacist realized that the beyond use date given from the Retail location was 2/12/22.
vax given afternoon 18OCT91 evening 18th fever (mild) headache, diarrhea, threw-up, not feeling well for two day 19th-20th;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EK5730), on 12Jan2021 as dose 2, single (Lot number: EL1284) and on 29Sep2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "history of asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: sulfa and erythromycin. Concomitant medication(s) included: YAZ. Past drug history included: Known allergy: erythromycin, reaction(s): "allergy", notes: Known allergies: sulfa and erythromycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Aug2022) Negative, notes: On 19Aug2022 I tested negative for the first time after having covid; (20Aug2022) Positive, notes: On Saturday 20Aug2022 I developed a mild sore throat again and tested faintly positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Member complains of swelling to her neck left side and left arm and shoulder.  This was also the site where vaccine was adminstered.