chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 75-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes and AFib. Concomitant products included FLECAINIDE for AFib.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.            It was reported that patient experienced sore arm for a couple of days.  Patient had 5 shots of all Moderna brand vaccines, up to date with vaccinations including the new Bivalent version  Treatment medications were not reported.   This case was linked to MOD-2023-704772 (Patient Link).
This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. No information regarding their concurrent conditions, pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection (lot# reported as M033210, expiration date: 09-JAN-2018; lot# M031944, expiration date: 27-DEC-2017; doses and routes of administration were not provided). There were no adverse effects reported. Administered doses of vaccine experienced the temperature excursion of -13.5 degrees Celsius for 1 hour and 13 minutes. There was no previous temperature excursion. Digital Data Logger was involved. This is one of two reports received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1612USA008696.
Patient was supposed to be given their second dose of pfizer Monovalent vaccine to complete the initial series. But was given bivalent instead.
This spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc vaccine underwent first temperature excursion with Tmax 8.2 degree centigrade for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree centigrade for 23 minutes (explicitly coded as incorrect product storage). On an unspecified date, two temperature excursions were identified after an audit. On 31-Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252672 and expiry date :30-Jun-2019) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse events after administration. This case is linked to (201805262) due to same reporter.
Individual was given Moderna vaccine per mothers request. It was child's first covid vaccine. Child had no adverse symptoms. Told mother to follow up with their pediatrician. Called mother on December 26, 2021 to follow up and let her know that the second vaccine should be the Pfizer vaccine. Mother did not answer. Left Voice Mail.
pain, soreness and redness at the injection site immediately, soreness and redness lasted for 2 days  low grade fever, achy muscles, chills started a few hours later and lasted for 3 days
Pt became light headed and dizzy 25 minutes after vaccine administration, 40 minutes after vaccination reported feeling heat and tingling on L side of face, neck and arm.
After receiving  her 2nd COVID-19 vaccine at 1448. The  employee reported at ~ 7-8 minutes after receiving the vaccine her eyes, ears, head and chest began to itch.    o2sat was 100% on ra, b/p 113/51, 67 bpm and RR 16. The employee denied any SOB, no swelling in the throat and no swelling of the tongue.  The employee's  chest was red. She stated she felt she had "ball of phlegm in throat" . Benadryl 50 mg po x 1 . The employee  spoke in clear concise sentences and had no sign of distress. After 40 minutes of observation the symptoms improved.
Pt. reports that she noticed her left arm where she received Moderna COVID- 19 Vaccine EUA was red, swollen and itching this morning (01/06/2021) at approximately 7:45 AM. Pt. also states that she started taking Bactrim on 01/05/2021 for a UTI and she took only one dose prior to the event. Reports taking Amoxicillian for stye last week and was switched to Bactrim on Monday for a UTI but did not take first dose of Bactrim until Tuesday 01/05/2021. Pt. also reports all over itching including legs and face it red and blotchy on both cheeks that also began today. Pt. came into clinic on 01/06/2021 at 1:54 PM for visual evaluation of arm. Upper outer left arm (left deltoid area) has red rash 55MM Length & 30 MM Wide Area is also warm to touch. Pt. used cool compress for the redness, swelling and Benadryl for the itching.Pt. reports that swelling and redness has improved but itching continues along with aching.  Reports a numb feeling in the area of the shot on left deltoid. Pt. also reports left axillary tenderness but states that started shortly after vaccination. Patient's mother notified primary care provider due to current use of Bactrim but no actual visit to doctor was made. Pt. instructed to continue to monitor for side effects and to contact HD and primary healthcare provider if symptoms worsen.
This spontaneous report as received from a consumer refers to a 61 years old female patient with drug allergy to CYRPON. On 06-DEC-2012 the patient was subcutaneously vaccinated with ZOSTAVAX (dose and lot number not reported). No other co-suspect products were reported. Concomitant therapies included FLONASE, ZYRTEC and ZANTAC. On 06-DEC-2012, the patient had gotten eczema, nasal wheezing, headache, throat closing, dizziness, stabbing pain in left ear and insomnia. On 06-DEC-2012, she had gotten hives, but this she stated was not shingles and she also had swollen lymph nodes. PULMICORT inhaler, steroid creme were given as treatment for the adverse events. There were no laboratory diagnostics studies performed. She was referred to her doctor. The outcome of eczema, nasal wheezing, headache, swollen lymph nodes, hives, insomnia, stabbing pain in left ear, dizziness, throat closing and eczema was unknown. Additional information has been requested.
My son had severe facial tics that included prolonged closing of the eyes, grimacing, and uncontrollable jaw movement (opening and then closing  the mouth). These occurred approximately every 15-60 seconds for 3 days. He had a history of mild tics such as eye closing after a long day at school previously, but nothing to the magnitude that he experienced from 8/2/2019-8/4/2019. The tics stopped after 3 days. They were mild on day 4 and stopped by day 5 after the vaccine. They were gone by 8/6/2019.
Patient is 12 years and 7 months of age and was administered the pediatric Pfizer vaccine. No signs or symtoms
Recalled Lot  Product was administered; Recalled Lot  Product administered; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error 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: 26-May-2022 Reporter's Comments: The vaccine coordinator reported a dose of Engerix-B from recalled Lot Product was administered to patients. The patients were administered this lot number but no adverse event reported. The reporter inquired what information should they send to patient regarding Engerix recall from back in October 2021. The reporter did not consent to follow-up. Additional Supportive Information: The patient received engerix B from recalled Lot which led to recalled drug administered and drug dispensing error. This is one of 10 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR085028:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085026:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085029:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085030:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085025:Same Reporter US-GLAXOSMITHKLINE-US2022084603:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085027:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085032:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085033:Same Reporter
After filling out forms, reading about side effects and process, indicating that I had no known allergies, and wasn?t on blood thinners, I received my first of two series yesterday.  The required post injection 15 minute wait expired without incident and I got in the car to drive home. Ten minutes into the drive my face started tingling, my lips went numb and throat started hurting. At NO time did I have breathing difficulties.  I got home, called the site where I got the vaccine, and reported the reaction.  Over the next hour, I developed a headache, my ears were itching and my tongue went completely numb and my throat felt numb when swallowing. It was progressing enough that I took 50mg of Benadryl and within the hour my reaction completely resolved.
Mildly erythematous and mildly swollen. Seen by MD on day of reaction and was prescribed KEFLEX.
Patient received vaccine at 14:15 and was in the observation room when at 14:30 reported feeling dizzy, warm, hear raising and not feeling right.  A team alert was called and at 14:30 healthcare team arrived to provide assistance.  Patient's blood pressure was up and was taken by team to medical office for further evaluation.
This spontaneous report was received from a nurse and refers to a 13-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On 27-FEB-2019, the patient was vaccinated with PROQUAD intramuscularly in the right thigh, lot # N025924, expiration date 18-MAR-2019 (exact dose was not reported) and VARIVAX intramuscularly in the left thigh, lot # R017641, expiration date 20-JUN-2020 (exact dose was not reported) for prophylaxis. No adverse effects were reported.
Rash, papular with some(?) clear top on abdomen / legs and arms. About 10-20.
On 5/28/2012 began having diarrhea. On 5/29/12 am, he was a little fussy in the morning - mom gave gripe water and baby oragel.  The babysitter called dad in the afternoon saying that the patient was not himself.  When the dad picked him up he said the child was "out of it".  Went to grandfathers house and called EMS. On EMS arrival patient had pulse in the 140's and RR in the 30's, by the time patient arrived at the ED patient was apneic and asystolic with bag valve mask ventilation being performed.  Resusscitation was unsuccessful and the patient passed away.  Upon attempt at a rectal temperature, bloody stool was noted in the diaper.  There was also a palpable mass in the abdomen.  The medical examiner confirmed the presence of intussusception on the autopsy.
DELAYED SYNCOPE IN OBSERVATION - LAYED PATIENT SUPINE ELAVATED LEGS GAVE WATER - AND APPLIED ICE PACKS LEFT ON OWN RECONNAISSANCE 30 MINUTE LATER.
Patient was being  seen  by  Dr with cough,  congestion, fever weakness x 2 days. Medical  assistant gave  flu vaccine  with  no  MD  order. The  Dr had  ordered  the  rapid BinaxNow test. No negative outcome, no  adverse reaction  noted.
patient came down with COVID; patient came down with COVID; This is a spontaneous report received from a non-contactable consumer from a Pfizer-sponsored program, regulatory authority. This consumer reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot numbers and expiry dates were reported) dose 1, single and dose 2, single; both via unspecified routes of administration, on unknown dates, for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter was trying to make booster shot appointment but the patient came down with COVID on an unspecified date. The outcome of the events was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101368206 same reporter, same drug, same events, different patients
Nov 13, 2007 Flumist vaccination. He stated no problems with past IM flu vaccinations.  Following the Flumist, he remembers "not feeling well" for the next 12 hours as corpsmen advised. Within 1 days post vaccination he noted increasing "blurry vision" with elevation of BP >150 systolic. He described the blurry vision while reading and having difficulty focusing having to move his eyes about to refocus. Approximately 2 1/2 days post vaccination while working as correctional officer at a brig he passed out.  He was transferred to Hospital where he was monitored for 4-5 hours and sent home.  There he complained of a severe headache but cannot remember details. He does remember eyes were sensitive to light as was his hearing. He experienced intermittent episodes of headaches and visual blurry over the next two months before symptoms resolved. He stated eating "lots of garlic" which made these symptoms resolve.
"arm pain"; Three doses were left out at ambient room temperature past there beyond use date; "slight fever"; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY ("arm pain"), EXPIRED PRODUCT ADMINISTERED (Three doses were left out at ambient room temperature past there beyond use date) and PYREXIA ("slight fever") in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY ("arm pain"), EXPIRED PRODUCT ADMINISTERED (Three doses were left out at ambient room temperature past there beyond use date) and PYREXIA ("slight fever"). On 12-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Three doses were left out at ambient room temperature past there beyond use date) had resolved. At the time of the report, PAIN IN EXTREMITY ("arm pain") and PYREXIA ("slight fever") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.   This case was linked to MOD21-075527, MOD21-075517, MOD21-074055, MOD21-075351, MOD21-075500, MOD21-075532, MOD21-075544, MOD21-075549 (E2B Linked Report). This case was linked to MOD-2021-076892 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up reported: After following up with the patient she is believes that she received a viable dose. No follow up needed at this time. VAERS with significant info On 28-Jul-2021: Follow-up information received on 28 Jul 2021 contains non-significant information.; Sender's Comments:  MOD21-075527:Cross linked case MOD21-075517:Cross linked case MOD21-074055:Cross linked case MOD21-075351:Cross linked case MOD21-075500:Cross linked case MOD21-075532:Cross linked case MOD21-075544:Cross linked case MOD21-075549:Cross linked case
Information has been received from a nurse concerning a 4 year old child, over the past month, in approximately July 2006, was vaccinated with MMR. Concomitant therapy included PEDIARIX. Unspecified medical attention was sought. About 2 days after injection, in approximately July 2006, the patient experienced cellulitis at the injection site. About five days after injection, in approximately July 2006, the patient recovered. The reporting nurse also reported the experiences of 4 other patient with MMR (WAES # 0609USA00641, 0609USA05076, 0609USA00643, 0609USA00644). Additional information has been requested.
Can?t lift arm; muscle aches from neck to butt and sometimes down leg; headaches; fatigue; weakness; fever (101.5); nausea.
Arm was very red and swollen after the 2 day mark. It was hot to touch. The redness lasted 4 days.
I advised nurse to administer FLUMIST to this patient, after admin. she noted she is 51; and thus >49yoa.
Tingling, pins and needles in right arm extending from elbow down to fingers, has not subsided.
First gums were red and inflamed.  Was prescribed antifungal lozenge's and dexamethasone mouth rinse.  As it progressed my lips were extremely swollen red and dry.  The corners of my mouth were cracked and oozing.  Using Vaseline only made it worse.  .  Now a month later I am finally getting some relief from an antibiotic cream given to me and coconut oil.   I did my own research and came up with Angular Cheilitis.
On right anterior thigh, pt developed a 16 cm diameter area of redness, increased warmth and mild swelling. He was started on Keflex for 7 days.
Left sided parietal, left temple down to auditory area, and left lower occipital region with pulsating and intense throbbing . The symptoms aggravates by bending and sudden movement . This had been worsening. The Pfizer first dose HA was brief at the same site. After the second dose of pfizer covid vaccine the above symptoms continues and intolerable. left sided piercing chest pain(CP) front through the back. This is different from CP I had. I was going to the hospital -i took my Imdur, ASA and benadryl - these relieved the symptoms
Headache, Muscle aches, nausea, chills and patient has been taking acetaminophen 500mg  2 q12h and then ibuprofen 200mg 2 q12h
pt vax'd w/hepatitis B and developed wheal, arm soreness & fatigue. after 2nd dose pt developed fatigue, fever & wheal, hot to the touch @ injection site.
Experienced anxiety while driving; Generally he does not feel good; A little bit of blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Experienced anxiety while driving), FEELING ABNORMAL (Generally he does not feel good) and VISION BLURRED (A little bit of blurred vision) 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 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, 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 experienced ANXIETY (Experienced anxiety while driving), FEELING ABNORMAL (Generally he does not feel good) and VISION BLURRED (A little bit of blurred vision). At the time of the report, ANXIETY (Experienced anxiety while driving), FEELING ABNORMAL (Generally he does not feel good) and VISION BLURRED (A little bit of blurred vision) outcome was unknown.            No concomitant and treatment information were reported by the reporter.
"70-year old woman was recommended by her dermatologist to receive GARDASIL 9. She is here now to be administered GARDASIL 9. She will not be administered GARDASIL 9; "70-year old woman was recommended by her dermatologist to receive GARDASIL 9. She is here now to be administered GARDASIL 9. She will not be administered GARDASIL 9; No additional adverse effect reported; "70-year old woman was recommended by her dermatologist to receive GARDASIL 9. She is here now to be administered GARDASIL 9. She will not be administered GARDASIL 9; This spontaneous report was received from a pharmacy technician refers to a 70 year old female patient. The patient's pertinent medical history, concomitant medication, drug reactions and allergies were not reported. On 20-MAY-2020, the patient was prescribed with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength and dose was not reported) of lot # R017624 with expiration date of 17-MAR-2021 via intramuscular route for prophylaxis by her dermatologist (product prescribing error). The patient went to get administered the vaccine but the reported stated that she would not be administered with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (circumstance or information capable of leading to medication error, no adverse event and product administered to patient of inappropriate age). No clarifying information provided. No additional adverse effect reported. The outcome of product prescribing error, circumstance or information capable of leading to medication error and product administered to patient of inappropriate age was considered as unknown. No product quality complaint (PQC) was involved with this report. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R017624; expirationdate: 17-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This is a spontaneous report from a contactable other healthcare professional (HCP) (Patient). A 34-year-old female patient not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 08Jan2021 12:00 PM as a single dose for COVID-19 immunization, lot number: unknown. Medical history and concomitant medications were not provided. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. Patient had not been tested for COVID-19 post vaccination. On 10Jan2021 09:00 PM patient experienced severe itching that started in lower extremities and has moved up into trunk. Event was treated with diphenhydramine hydrochloride (BENADRYL). Patient was recovering from the event, at the time of the report.  Information about Lot/Batch number has been requested.
Severe febrile systemic reaction 103.6. Myalgia. Erythema at the site of the injection (10 by 5 cm) tender, no fluctuant.
Patient reports with 1st shot had arm pain described as mild and not interfering with daily activities.  Patient reports with second shot, within 5 hours had arm pain, malaise, headache, and nausea. At 7 hours symptoms increased in severity limiting activity. Also had chills and body aches. Unable to sleep overnight, felt feverish. On day 2 had difficulty working due to migraine headache, unrelieved by migraine medication. On day 3 migraine remained present but was less severe, modifications needed to continue working. On day 4 had worse migraine and nausea, unable to work. Developed itchy blisters, at least 12 to inner thighs, also on belly and back. Took OTC allergy medication, no worsening or additional spread of blisters following this.