chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PCR confirmed Monkeypox; Case reference number US-BN-2022-004668, is a spontaneous case report initially received from a healthcare professional via Communications (reference number: USBAV22-1943) on 11-Nov-2022 and concerns a patient of unknown gender or age.  The patient medical history included human immunodeficiency virus (HIV) with CD-4 lymphocytes, at 631 (units not provided).  The patient's concomitant medication was not provided.  On unspecified date, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), at unknown dose, route of administration and anatomical location, for indication reported as to decrease the incidence of monkeypox.  On unspecified date, an unspecified amount of time after Jynneos vaccination, a polymerase chain reaction (PCR) test confirmed the patient had monkeypox. As reported, the patient received the first Jynneos dose during illness but that was not confirmed.  At the time of this report, outcome of event monkeypox was unknown.  The reporter assessed the event monkeypox as non-serious and as possibly related to Jynneos vaccination.   Additional information received from the physician via Med Communications on 11-Nov-2022: New information included seriousness and causality assessment for event monkeypox.  Additional information received from Bavarian Nordic on 14-Nov-2022 included the local BN case ID.  This case is linked with US-BN-2022-004662, US-BN-2022-004663, US-BN-2022-004664, US-BN-2022-004665, US-BN-2022-004666, US-BN-2022-004667 and US-BN-2022-004669 (same reporter).; Reporter's Comments: A patient of unknown demographics received the first dose of Jynneos, applied on an unknown date for monkeypox prevention. It was reported that the patient received this dose of Jyneos during illness, but no further details were clarified. On an unknown date, the patient developed the serious (medically significant) event of monkeypox, confirmed via PCR test. Monkeypox is unlisted per the labeling for Jynneos. Medical history included HIV, with CD4 lymphocytes level at 631. Considering that Jynneos is a non-replicating vaccine which does not contain the monkeypox, the event is assessed as not related to Jynneos. Furthermore, the patient developed the infection before being able to complete the vaccination course.; Sender's Comments: A patient of unknown demographics received the first dose of Jynneos, applied on an unknown date for monkeypox prevention. It was reported that the patient received this dose of Jyneos during illness, but no further details were clarified. On an unknown date, the patient developed the serious (medically significant) event of monkeypox, confirmed via PCR test. Monkeypox is unlisted per the labeling for Jynneos. Medical history included HIV, with CD4 lymphocytes level at 631.  Considering that the patient developed the infection before being able to complete the full vaccination course of 2 doses this case is considered not related to vaccine.
Paralysis of the hands from throwing up/ paralysis; Sweats; Chills; Diarrhea; woke up feeling off; not hungry; ended up throwing up; slept all day; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route in the right arm on 24Apr2021 at 16:00 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history included COVID prior to vaccination. Patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via unspecified route in the left arm as a single dose for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks of the COVID vaccine. Concomitant medications included bupropion hcl (WELLBUTRIN), escitalopram (LEXAPRO), and Whey Protein. On 25Apr2021 at 08:00 AM, 16 hours after second shot, patient woke up feeling off, not hungry, ended up throwing up, no fever, slept all day. Around 8:30 pm, he went to bed, got back up and threw up, sweats, chills, diarrhea, paralysis of the hands from throwing up, heart rate (HR) was 98, O2 level 98. Wife got patient back into bed. Patient stated that other than the paralysis this is exactly how COVID hit him for 14 days of non stop vomiting. The clinical outcome of the events was not recovered. The patient was not tested for COVID post vaccination.  The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Dizziness, Myalgia, NauseaVomiting,  insomnia, malaise, shoulder/neck pain-limited ROM  Narrative:
Pt recvd 1st Engerix-B vax 29MAY91 for post exposure prophylaxis; 14JUN91 exp hives, stiff neck & joint pain; tx none;
Extremely exhausted; The glands on the right side of his throat were inflamed like a miniature golf ball.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extremely exhausted) and LYMPHADENOPATHY (The glands on the right side of his throat were inflamed like a miniature golf ball.) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 02-Apr-2021, the patient experienced FATIGUE (Extremely exhausted) and LYMPHADENOPATHY (The glands on the right side of his throat were inflamed like a miniature golf ball.). At the time of the report, FATIGUE (Extremely exhausted) and LYMPHADENOPATHY (The glands on the right side of his throat were inflamed like a miniature golf ball.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information were not provided.
Pt developed Plaque Psoriasis about 2 to 3 weeks after shot. Had one spot on ankle and is now on leg and foot
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 11-year-old female patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 14-SEP-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
6pm April 2 - began feeling nauseous and chilled, began shivering. 8pm April 2 - began vomiting...bouts of vomiting every 1.5 hours from 8 pm April 2 until 12 noon on April 3. An acute stomach ache followed and continued until the morning of April 4th. After vomiting stopped, I laid in bed from about 3pm on April 3 until 9 am on the 4th...I would sleep for 45 minutes at a time and wake in a cold sweat...I physically felt very cold, but was drenched in sweat. The chills and cold sweats stopped on the morning of the 4th and gave way to a lingering but persistent headache and dull stomach ache which are continuing now (3pm on April 4), but seem to be slowly fading.
Temperature excursion. Refrigerator Temp of unmixed vaccine vial was out of range for ~ 24 hours and as high as 55 degrees F prior to being administered.; Poor quality vaccine administered; This is a spontaneous report from a contactable nurse. A 61-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an intramuscular route of administration in the arm left on 25Feb2021 at 07:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 25Feb2021 at 07:30, the patient experienced temperature excursion. The refrigerator temp was unmixed vaccine vial was out of range for 24 hours and as high as 55 degrees Fahrenheit prior to being administered. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the event temperature excursion was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Full body rash, hive like, more on arms, neck and stomach, a little on back and progressed some to legs the following day. Would sometimes increase in redness and welting looking appearance.
Information has been received from a registered nurse concerning a 28 year old female with environmental allergy and asthma who on 27-MAY-2008 was vaccinated with the first dose of VARIVAX (Oka/Merck), Lot # 657938/0848U, subcutaneous in her left arm, sometime between 1-6 pm. It was reported that the patient came to adult immunization clinic to get her second VARIVAX (Oka/Merck), but on 24-JUN-2008, she was given ZOSTAVAX (Oka/Merck), sometime between 1-4:30 pm, in error. When error was found 3 days later, on 27-JUN-2008, the patient was called and informed of same. The patient stated she had soreness at the site injection (relieved by MOTRIN), but otherwise had no other side effects. No further information is available.
At about 3PM on 10/27/2021, I received my first Moderna booster for COVID-19. About an hour and a half later, the injection site turned red and became itchy. I ran a temperature of 101 degrees. By the morning of 10/28/2021, there was a 4-to 5-inch radius around the site that was red, hot, and itchy. It itched for 6 days. By 10/29/2021, there was pain that extended from the right side of my neck to my right elbow. I had had tendonitis before, and it reminded me of this. The pain continues to the time of this writing. On 6/7/2022, I went to an orthopedist to be treated for a condition not related to the vaccine. While I was there, I asked them if anything could be done to also treat the pain in my neck and arm. The doctor advised that it sounded like I had tendonitis, and she gave me a cortisone injection in the right shoulder. The cortisone shot has helped, though it has not completely eliminated the pain, and the doctor has recommended exercises for me to do. I am to return on 7/19/2022 for a follow-up. I will also add that I received my second Moderna booster on 5/18/2022, and this exacerbated the pain.
Spoke with mother, who states patient taken to ER on 8/18. Mother states she was advised to monitor area and if worse return to Dr. Mother states it went away.
Didn't get RabAvert follow up booster on the 15th; Case reference number US-BN-2022-002258 is a spontaneous case report initially received on 01-Sep-2022 from other healthcare professional (reference number: USBAV22-1247) and concerns a 27-year-old female patient.  The patient's medical history and concomitant medication details were not provided. As reported, the patient was not pregnant at the time of this report.  On 08-Aug-2022, the patient was vaccinated with the first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number unknown), at a dose reported as one vaccine, at unknown site and route of administration for pre-exposure for school.  As reported, the patient did not get the follow up booster on the 15th (explicitly coded as 'missed dose').  At the time of this report, it was unknown if the patient experienced any adverse event due to RabAvert vaccination.  Additional information received on 01-Sep-2022 from Bavarian Nordic included local case ID.; Reporter's Comments: A 27-year-old female patient was vaccinated with the first dose of RabAvert as a pre-exposure immunization for school and as reported the patient did not get the follow up booster on the 15th, which is considered as product dose omission issue. No associated adverse events were reported. Product dose omission issue is listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A 27-year-old female patient was vaccinated with the first dose of RabAvert as a pre-exposure immunization for school and as reported the patient did not get the follow up booster on the 15th, which is considered as product dose omission issue. No associated adverse events were reported. Product dose omission issue is listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue is not related to RabAvert, but to a human factor. The case is non-serious.
Pt received DTaP on 9/1/10. Next morning site was "a little red" by that afternoon swelling and tenderness had increased. Saw PMD who Dx that he had a"staph infection" from the immunization. Today has 3mm x 8 mm area blisters. (L) upper arm swollen, red, and warm to touch. States it hurts to touch. Child is active and talkative. No change in use of arm. Full ROM. Saw Dr - this arm for poss surgery. Dr stated he had an abscess, but no need for surgical intervention at this time. Child is discontinued antibiotics and return if no improvement - Consent for pictures and ROT signed. Advised mom to notify clinic if condition worsens. Immunization program notified.
next day redness bubble @ inj site shoulder & elbow joints tender & warm rt arm-4th day abscess @ inj site painful to move shoulder & elbow & tight chest, sore throat;all joints aching-knees swelling-low back aching off & on;t100 x 4 days;
Reports developing injection site reaction about 5-7 days following vaccination, followed by fevers beginning 6/22/18. Was seen by medical provider on 6/25/18 for fevers and arm redness, swelling, and warmth, given antibiotics. Fevers resolved and arm tenderness decreased, but a hard lump remained at injection site. On 7/22/18, lump began leaking fluid. Reported to medical provider on 7/23/18, where she was told she had an abscess and would require wound care.
first dose of Shingrix in 2020 at another unknown pharmacy but then never received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2020 at another pharmacy).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of Shingrix in 2020 at another unknown pharmacy but then never received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-May-2023 The reporter stated that the consumer stated he would follow-up with his doctor of medicine (MD) for medical guidance prior to making a decision about if and when to get the second dose. Did not consent to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Started with hoarseness, then coughing with mucus, tightness of chest, headache, muscle weakness, vomiting and diarrhea. Time went on for hours. Had to go to Emergency Room and then admitted to hospital.
This time, she was found to have bilateral VFP with incomplete closure; This is a literature report.  A 45-year-old female with DM, HTN and End Stage Kidney Disease 2/2 Focal Segmental Glomerulosclerosis s/p kidney transplant that failed after 16 years (on low dose tacrolimus) requiring to start hemodialysis presented to the ED with complaints of voice hoarseness with dysarthria and throat itching that started ~30- 45 minutes after having received the first dose of Pfizer-BioNTech COVID-19 vaccine. She underwent Fiberoptic Indirect Laryngoscopy that showed widely patent airway with mobile vocal cords bilaterally. Symptoms were thought to be secondary to a reaction to the vaccine vs mild GERD. She received steroids and was discharged home within 24 hours after symptomatic improvement on steroid therapy. Her voice normalized within a week. Six months later, she received the second dose of Pfizer-BioNTech vaccine, ~30 minutes after which again developed dysphonia and dysarthria. This time, she was found to have bilateral VFP with incomplete closure. Steroid therapy was reinitiated and is slowly being tapered. Her dysarthria has improved; however, she continues to have hoarseness of voice even after 9 months of having received 2nd dose of vaccine. She has not received the booster dose of vaccine.; Sender's Comments: Based on the known the information available the Causal relation between the event Vocal cord paralysis  and suspect drug cannot be excluded completely The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Impaired cognition...fog headed, indecisive, unclear Malaise, lethargy, slept 1 1/2 days Muscular and joint aches and pains, rest Depressed, sad, tearful...cried and slept
Information has been received from a nurse practitioner concerning one of three girls in the same family who "a few months ago" in 2008, were vaccinated with GARDASIL. Subsequently, the patient became lactose intolerant after receiving GARDASIL. It was not specified whether the patient sought medical attention. The patient's lactose persisted. Additional information has been requested. This is one of several reports from the same source.
Tightness in chest, wheezing, pain in gums, swollen lips and eyes, confusion
Covid arm - rash, warmth, itch, swelling, pain sensation like "bee sting" Started 24-26h after vaccine On day 2 of rash now
Mother claims DPT & HIBTITTER given on 10/29 & 8/25/99 led to a prolonged cough, no fever in the child.
Patient received pediatric 6m-5y vaccine after the BUD; Vial was initially stored in the refrigerator on 23-Dec-2023 and dose was administered after 30-day Use By Date; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received pediatric 6m-5y vaccine after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 23-Dec-2023 and dose was administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a child 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. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    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 EXPIRED PRODUCT ADMINISTERED (Patient received pediatric 6m-5y vaccine after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 23-Dec-2023 and dose was administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received pediatric 6m-5y vaccine after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 23-Dec-2023 and dose was administered after 30-day Use By Date) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received pediatric 6m-5y vaccine after the BUD) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 23-Dec-2023 and dose was administered after 30-day Use By Date).    No concomitant medications were reported.  Total 42 Dose were administered after 30-day Use By Date. Vaccine was administrated on 26-Jan-2023, 27-Jan-2023, 30-Jan2023, 31-Jan2023, 2-Feb-2023, 6-Feb-2023,8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023.  Vial size was reported was 0.4 ml per vial. Vial did not undergo any temperature excursions. No treatment information was provided.  This case was reported for patient 40 of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:(Patient 1)
Injection site itching; Injection site aching, injection site soreness; Felt a little feverish; Feeling a little fatigued; Sore arm; A spontaneous report was received from a consumer, concerning herself, a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 22 Jan 2021 (friday), the patient experienced sore arm and felt little fatigued, had nothing else apart from this. On 29 Jan 2021, through Saturday 30 Jan 2021, the patient experienced injection site aching, injection site soreness, injection site itching and felt a little feverish. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the sore arm, feeling a little fatigued, Injection site aching, injection site soreness, injection site itching and felt a little feverish were considered not resolved at the time of this report.; 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.
was woke up by a strange noise @ 230 in the morning; pt was stiff blue not breathing, jaws locked; CPR given went back to breathing & started having a sz lasted 15 mins; pt taken to ER had 2 more sz @ hosp kept in ICU for 4 days; t103;
Muscle aches - entire body - 36 hours Jaw pain - 36 hours Headache - 36 hours  Nausea - 12 hours Vomiting - 6 hours Fever/chills - 24 hours