chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 22-FEB-2021, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number S028916, expiration date 16-SEP-2021, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000266: US-009507513-2108USA000267: US-009507513-2108USA000268: US-009507513-2108USA000269: US-009507513-2108USA000270: US-009507513-2108USA000261: US-009507513-2108USA000260: US-009507513-2108USA000263: US-009507513-2108USA000259:
soreness at sight of injection, 2 days chills, 24 hrs sweats, 12 hrs muscle aches, 36 hrs
developed left-sided facial rash, itching and swelling about 24 hours after vaccination; progressed to left side of neck and left ear over the next
patient called in the morning after getting the vaccine in the same arm (got moderna bivalent in other) and said his arm was swollen and red. he did not have a fever but it was a little hot
Had shot on 7/31 in the AM. Woke up the next morning with a fever of 99.6 F.
6days p/vax pt was seen in ER where a dx of intussusception was made; surgery 7/19; intussusception & a duplication cyst were noted at surgery; cyst was resected
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 25-OCT-2018, the patient was vaccinated with an improperly stored doses of PROQUAD per subcutaneous route (dose was not provided) lot # R002932 expiration date 29-JUL-2018, for prophylaxis. On an unknown date, digital data logger registered a temperature excursion for 15 Fahrenheit degrees to 46 Fahrenheit degrees, for 1 hour.
On 12/23/04 I stumbled and fell on my sidewalk which had raised up about 4 or 5  inches. Fell on my face, cut my eye and bruised myself. Went to ER at hospital. Dr saw me, checked me, x-ray back, face and satured my eye. Gave prescription for pain and made nurse given me a tetanus shot. Many years since I had one. The next day my left arm and shoulder began to ache and hurt, enough to keep me awake at night. I used a heating pad. Went to chiropractor 3 or 4 times. He gave heat treatment and muscle stimulation. Did not help. Arm and shoulder had intense, floor walking, crying pain for 2 weeks. Still hurts but is better. I went to my Dr who gave me more pain medicine. I have never had anything to ache and hurt so badly in my life and I've had 2 babies. Intense aching pain.
Noticed a tingling sensation in her left arm radiating down to her fingertips on 12/31/2020. Redness at the injection site and hives on the left arm where injection was given. Patient went to ER on 01/01/2021 due to numbness and tingling. Received Benadryl at the ER.
This non-serious initial spontaneous case was received from consumer on 12-Oct-2017, concerning a female pregnant patient of an unspecified age. On an unspecified date, the patient was administered with FLUCELVAX QIV (dose, batch number, expiry date, route of administration and anatomical location: not reported). The patient received the vaccine during the pregnancy. The patient did not give the permission to enroll in the pregnancy registry.
This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (strength, dosing details, anatomical location, lot# and expiration date were unknown). There were previous temperature excursions but, no information was provided on previous excursions. The temperature excursions were detected by a data logger. No product quality complaint was involved. Additional information has been requested.
Next day fever up to 100.8 with Tylenol, joint aches and pain, fatigue, injection site pain radiating 2 inches out in radius. At 48 hours woke with tenderness and swelling of underarm on injection side (lymphadenopathy).
had a generalized afeb 5min sz went to hosp ER;seen by neurologist; exam nl;
Resident received Pfizer COVID vaccine 30mcg/0.3ml dose instead of the Pfiizer Covid (5-11yo) vaccine 10mg/0.2ml
At first, arm pain, fever, headache, fatigue, loss of appetite and then cough began then leading to an exacerbation of my asthma  that kept worsening over the course of the week
Mild dizziness; Headache; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration on 23Mar2021 at 09:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) for unknown indication from an unknown date and unknown if ongoing. 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 24Mar2021 at 14:00 the patient experienced headache and mild dizziness. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild dizziness and headache was recovered on an unknown date in 2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration on 13Apr2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Rise in blood pressure, extra heart beat, thickening of heart muscle. Cardiomyopathy.
Erythema, edema & acute tenderness to palpation extending from L deltoid to L elbow. This was seen following night after DTaP #5 injection. Mother states that symptoms began to be noticed the night following the injection. 2 days after injection, fluctuance noticed on elbow & on small weeping vesicle on posterion left upper arm.
COVID-19 breakthrough case. HISTORY: This is a 71 year-old male who is a direct admit from the psych unit due to testing positive for COVID-19 and needing a higher level of care.  Patient initially seen by ED physician on 7/25/21 for suicidal ideations.  Patient seen by neurology and psychiatry and was to be transferred to a HCF but tested positive for COVID so transferred to COVID unit. Admitted 8/24/21. tested positive for covid on 8/24/21.  Note: patient previously received J&J COVID-19 vaccine on 3/14/21. No respiratory symptoms or hypoxia. Did receive medication on 8/25. Stable, discharged 8/27/21. Admitted 8/24/21. Covid vaccine on 3/14/21. tested positive for covid on 8/24/21. No respiratory symptoms or hypoxia. Did receive medication. Stable, discharged 8/27/21.
kicked my butt; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient just received dose of Shingles vaccine and felt it's kicked his/her buttock but worth it. The patient stated that seen patients with it and hoping to not get it. Additional supportive information: The follow-up would not possible, as no contact details were available.
Patient went to Doctor due to headache and swelling and pain under both arm pits around brachial artery.  Shots were given on March 21, 2007 at 4:45 p.m.  Doctor instructed patient to use cold compresses under arms and take Motrin.
Breakthrough case admission after 3 vaccines Moderna 4/16/21 Lot# 017B21A;  Moderna 5/14/21 Lot# 017B21A; Moderna 12/20/21  Lot# 939903
No additiona AE reported; Administered an additional dose of PEDVAX HIB to a patient; Administered an additional dose of PEDVAX HIB to a patient; This spontaneous report was received from a nurse, concerning a 4 year old male patient. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 10-JAN-2022, the patient was accidentally administered an additional dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose for prophylaxis, lot # T037651 and expiration date 20-JUL-2023 (strength and route of administration were not provided). No additional adverse event was reported.
high fever (103.2-104.5), controlled only with both motrin & tylenol & baths; decreased appetite (appetite symptom actually began on 11/11 or 11/12); fever decreased 11/18 but still running 100.4-101 w/o motrin, motrin brings to normal. increased liver size (discovered 11/18)
pt says she developed fever, was shivering, and was very weak and tired.  She went to bed.  She woke up to use the restroom.  Next thing she remembered was waking up on the bathroom floor.  She didnt know where she was or what had happened.  She was finally able to reach her son to come help her get up and get back into bed.  She was extremely weak for a couple of days.  She contacted her PCP and was told to file a VAERS report. She no longer has any symptoms.
Body pain. 101/103 temp for 3 days; consistent diarrhea for 17 days; lethargy, mental and physical fatigue for 21 days.
Vomiting; weakness; pain; numbness in hands; aching neck; chills.  On 10/11/2014 rash on front of chest in AM.
Fever (101.0), Chills, Headache, Insomnia, Pain At Injection Site
Off label use; had 2 shots of the Moderna; She is just concerned that she made a terrible mistake getting a Pfizer booster when she got her first two shots with Moderna. /Afterwards she had some dizziness and when she lays down she's dizzy.; Booster; This is a spontaneous report from a contactable consumer or other non-healthcare professional. An 85-years-old female patient received bnt162b2(COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included that the patient received covid-19 vaccine (MODERNA COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1 and dose 2, single for COVID-19 immunisation and she got flu shot on an unspecified date. The patient experienced off label use and booster on an unspecified date and had 2 shots of the Moderna on an unspecified date she was just concerned that she made a terrible mistake getting a Pfizer booster when she got her first two shots with Moderna or afterwards she had some dizziness and when she lays down she was dizzy on an unspecified date. The patient stated that she has been relayed dizzy when she lays down at night the bed was moving and right now she was a little dizzy. The outcome all the events was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Pt recvd DPT/HIB vax 19Jun91.Around the site of inject it was swollen, inflammed + warm to the touch, size 5 X 8cm.Advice warm compress BID + APAP for pain + recheck next wk.
Stated not feeling well, waited a few days took him to Dr. on Wednesday 11/27/2013 went back to Dr. several different times until December 7, 2013 admitted to medical center.
pt was exposed to varicella & on 4/10/97 was vax w/1st dose of varicella virus vax live then on 3/28/98 pt devel 10 pox over body, 3/31 had 30 pox
No adverse event; vaccinated again with a second Moderna Bivalent booster with in a month; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated again with a second Moderna Bivalent booster with in a month) and NO ADVERSE EVENT (No adverse event) in a 42-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Sep-2022, 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 27-Oct-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated again with a second Moderna Bivalent booster with in a month). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated again with a second Moderna Bivalent booster with in a month) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated again with a second Moderna Bivalent booster with in a month).    No concomitant medication information was provided. It was reported that patient again vaccinated with a second Moderna Bivalent booster.  No treatment medication were provided.
Fever of 101.1 degrees Fahrenheit; rigors; body and joint aches; body and joint aches; headache; fatigue; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (pregnant: No) received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: Ek4176), via Intramuscular on right arm on 16Jan2021 at 10:00 AM at single dose for covid-19 immunisation. The relevant medical history and concomitant medications were reported as none. The patient previously received first dose of BNT162B2 at the age of 29 years old on 25Dec2020 (first dose, Lot number=EH9899, 10:00 AM, Intramuscular on Right arm) for covid-19 immunisation. The patient experienced fever of 101.1 degrees Fahrenheit, rigors, body and joint aches, headache, fatigue 12 hours after vaccination on 16Jan2021 at 10:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination. The patient underwent lab test included COVID 19 PCR on 17Jan2021 (covid test result: Pending). The outcome of the events was recovering.
ABDOMINAL PAIN, CHILLS, SWEATING, HOT, FELT VERY TIRED, TENDERNESS, HARD NODE ON VACCINE SITE.
ED doc notes in 10/10/10 ED note: erythematous tender wheal on left delt, decreased ROM secondary to pain but no joint involvement, distal arm neurovascularly intact. Erythema, flushing, swelling. Diphenhydramine 25 mg once, ranitidine 50 mg once, methylprednisolone 125 mg once.
3 Patients administered the dose of the Moderna after the 20th punctured from a vial.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (3 Patients administered the dose of the Moderna after the 20th punctured from a vial.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (3 Patients administered the dose of the Moderna after the 20th punctured from a vial.). On 25-Oct-2021, ACCIDENTAL UNDERDOSE (3 Patients administered the dose of the Moderna after the 20th punctured from a vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
received expired vaccine, pt reports no adverse effects. Pt will go to pharmacy for this years flu vaccine.
Patient received two bivalent vaccine; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received two bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     The patient had no medical history/conditions, allergy, concomitant diseases and risk factor.    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, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Patient received two bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received two bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patient received two bivalent vaccine).    No concomitant medications were reported.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medications were reported.   Reporter did not allow further contact
wrote: Pt advises that she had her 1st covid shot Friday. Pt advises that her neighbot was around her on Sunday, who got tested yesterday and it came back positive.  Pt advises that she started with symptoms yesterday Cough yes -Deslym (Yesterday afternoon)- taking Musinex runny nose  Headache  98.1 temp Can taste everything   Contact with and (suspected) exposure to covid-19
Headache, Myalgia, Arthralgia, Fever, UrticariaPruritus & Diarrhea Narrative:  Other Relevant History:
high pitch screaming episode for 10 1/2 to 11 hrs day of 2nd series;
Case number PHEH2015US020362, is a combined initial and follow up spontaneous report received from a healthcare professional via GSK via phone from management (reference number: 392182) on 14 Sep 2015 and 16 Sep 2015 respectively. This is also a quality complaint report (QA reference number: 397898). This report refers to a patient of unknown age and gender. Past medical history and concomitant medications were not reported. The patient vaccinated with MENVEO (batch number: M15015 and expiry date: not reported) on an unknown date. It was reported that, bottom of MENVEO vial broke and cut health care professional on the hand. The outcome, seriousness and causality of the event hand injury was not reported. No further information was available. Batch review report (reference number [392182] received from quality assurance department on 13 Oct 2015: Based on the document review, it was stated that the concerned MENVEO batch number (M15015) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information from quality assurance department received on 13 Oct 2015: Updated investigation summary report.
Eye swollen, red and he keeps blinking. Pt had/has twitching, headache, body ache.
Vaccine breakthrough.  Had varicella vaccine on 06/22/2000. Diagnosed in office on 06/04/2005 with varicella.  Developed rash on trunk, face, arms, and legs on 06/03/2005.  No fever.  Rash was itchy, red papules.  Exposed to chickenpox at school.  Rash completely crusted by 06/06/2005.  Less than 50 lesions.
Light Headed; Pain; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light Headed), PAIN (Pain), FATIGUE (Fatigue) and CHILLS (Chills) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced DIZZINESS (Light Headed), PAIN (Pain), FATIGUE (Fatigue) and CHILLS (Chills). On 16-Mar-2021, DIZZINESS (Light Headed) outcome was unknown. On 21-Mar-2021, PAIN (Pain) and FATIGUE (Fatigue) outcome was unknown and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicine was reported.  No treatment was reported.
7 hours after shot, felt pain at injection site and slight weakness. 8 hours after shot, experienced significant muscle aches and pains in upper torso - both shoulders, upper and mid back, and neck. Shooting / pins and needle-like pains randomly down both legs and in hands. Pain in my big toe where I have a pin from a previous surgery. Day after (day 2) I woke up with all the pain gone, except for some minor injection site pain. Day 3, I started to feel dizzy, like I would fall over, in the late afternoon. That went away after about an  hour, but then I continued to experience nausea and a slight feeling of swaying  That persisted into Day 4 and Day 5. Also experienced a swollen lymph node in my neck on the opposite side of my body Day 4 and 5. On day 5 now.