chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse reaction noted with patient; Temperature excursion in freezer, was instructed vaccines were okay to use; This spontaneous report was received from a certified medical assistant, concerning a 6 months old male patient.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 19-AUG-2020, the patient was vaccinated with first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose or anatomical location were not reported) with lot # reported as T007359 with expiration date on 29-AUG-2021, administered subcutaneously, for prophylaxis; he also received fist dose of hepatitis A virus vaccine inactivated (HAVRIX) (strength, dose, anatomical location and indication were not reported) lot # 7595K with expiration date on 30-DEC-2021, administered intramuscularly (IM); both at a public clinic, with public funds, by a trained operator. It was reported that there was nothing wrong with the vaccines which were used according to the instruction leaflet; however, they underwent a temperature excursion in the freezer before administration and the vaccine provider was instructed that the vaccines were okay to use (product storage error). No digital Data logger was involved. No adverse reaction was noted in the patient.  Lot number T007359 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA001768:
Hives, on 10-1-08, Vaccinated on 9/20/08, adverse reaction same day wife came down with Shingles.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with GARDASIL vaccine (lot# unknown). On an unspecified date the patient developed a fever and nasal congestion shortly after her vaccination with GARDASIL vaccine. Medical attention was sought, no other symptoms were noted. No other information was available. On an unspecified date the patient had recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. Initial and follow-up information has been received from a physician concerning a 20 year old female with a history of bladder exstrophy and slight cold at the time of vaccination who on 25-JUN-2007 was vaccinated with a second dose of GARDASIL vaccine (lot# 0469U) in the right arm at 3:50 PM. On 25-JUN-2007, the patient developed a fever and nasal congestion shortly after her vaccination with GARDASIL vaccine. Medical attention was sought. No other symptoms were noted. No other information was available. On an unspecified date the patient had recovered. Additional information is not expected.
LEFT EYE SWOLLEN; PUFFINESS IN LEFT EYE; RIGHT EYE WAS REDDIDSH BUT NOT SWOLLEN/REDNESSS IN LEFT EYE; BAGGY LUMP IN LEFT EYE; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Generally healthy, saw physician for checkup in 2020 routine. Patient had no drug or non-drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, expiry: UNKNOWN) dose was not reported, administered on 01-NOV-2021 07:20 for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021, the patient experienced left eye swollen. On 02-NOV-2021, the patient experienced puffiness in left eye. On 02-NOV-2021, the patient experienced right eye was reddidsh but not swollen/rednesss in left eye. On 02-NOV-2021, the patient experienced baggy lump in left eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left eye swollen, puffiness in left eye, and right eye was reddidsh but not swollen/rednesss in left eye, and the outcome of baggy lump in left eye was not reported. This report was non-serious.
Two reactions, post TDaP: 1) I know it's 'inactivated,' but within six hours of the TDaP vaccine, I developed--and still have--a peppery-stinging sensation in my mouth/larynx. It has yet to go away. This is why I write, to notify you of this symptom. 2) The next morning, post-vaccine, and for 3-4 days hence, I actually had lockjaw on the opposite side. Vaccine given on the left; temporary lockjaw in the right jaw x 3-4 days--now resolved.
11JUL98 exp febrile sz;11JUL98 pt devel classic chickenpox;awoke w/fever 104.6 & dozens of lesions in a gen distribution;had @ least 100 very large lesions, described as red vesicular bumps;12JUL98 devel secondary staph infect;
Pt became faint. Possible vasovagal. After several attempts pt did was not able to sit up or stand without becoming diaphoretic again. Observed over 60" then with Fathers consent called medix to transport to local hospital. Vital signs remained stable, pt was alert and oriented but was pale weak and diaphoretic. Unable to ambulate. Neuro check was negative. Blood sugar was 104. We had given pt juice prior to inj and then following the second near syncope episode.
COVID- 19 symptoms started 07/01/22; tested positive on 07/05/22. Friday morning I woke up with a stuffy head, congestion, sinus problems, and took some ibuprofen and tested and it was negative. I had basically a fuzzy head and I went out of town and the next morning my head was fuzzier and I took SUDAFED and ibuprofen that seemed to help. Later that night, the flood dates opened and I had so much snot. I took NYQUIL and felt OK and the next morning I took TYLENOL and SUDAFED and symptoms were better by Sunday. I had drainage from sinuses causing a cough but nothing unusual and typical allergy symptoms for me. Sunday night I took more NYQUIL and came home on Monday and symptoms were getting better and on Tuesday morning I tested positive. I had a little stuffy head after but no cough, no fever, no fatigue. Basically I just had allergy symptoms. I went to urgent care and they said at that point it was too late to take antiviral an it might be worse than symptoms I had.
I have lost significant range of motion in my arm/shoulder; vaccine was given to high in my shoulder; Pain; A spontaneous report was received from a paramedic who was also a male patient of unknown age, who was administered Moderna's COVID-19 vaccine and experienced that the vaccine was given to high in shoulder (vaccine administered at inappropriate site), pain and lost significant range of motion in my arm/shoulder (injected limb mobility decreased).  The patient's medical history was not reported. No relevant concomitant medications were reported.  On 02 Feb 2021, the patient received the second dose of mRNA-1273 through an unknown route in an unknown arm for COVID-19 infection prophylaxis.  On 02 Feb 2021, the patient reported that  the vaccine was given to high in his shoulder and was injected into the bursa space and he had lost significant range of motion in his arm/shoulder and the pain was severe. The patient immediately obtained medical care within six hours of receiving the vaccine. The patient was admitted to an emergency room after the initial care in less than twenty-four hours and then eventually to the hospital floor. The patient's treatment  included medical care.  The action taken for Moderna COVID-19 vaccine was not applicable.  The outcome of the events, lost significant range of motion in arm/shoulder and the pain were considered as unknown.The outcome of the event vaccine was given to high in shoulder was resolved.; Reporter's Comments: This case report concerns a male patient of unknown age who vaccine was given to high in shoulder (vaccine administered at inappropriate site) and experienced pain and  lost significant range of motion in arm/shoulder for mRNA-1273, lot # unknown. The event of pain and lost significant range of motion in arm/shoulder are temporarily associated with the product use and a causal association cannot be excluded. The event of vaccine was given to high in shoulder is assessed as not applicable.
1/6/21 - 3pm. Experiencing chills, headache, heart rate at 103/min sitting.                  - 10:06 pm, chills, headache, fever 99.6                  - 10:38 pm, chills headache, fever 100.1                  - 11:05pm, chills headache, fever 101.5                  -
Felt fine after injection, walked 5 miles home & assured loved ones before going to bed that vaccination went fine with no side effects. After midnight I woke in the dark with many of the same symptoms as when I had COVID in March/April 2020: extreme allover body aches, terrible thirst, extreme weakness.  Next day (Wednesday) symptoms continued; too weak & achy to watch all but the core parts of the inauguration; too uncomfortable to read or to concentrate on music or anything else.  Absolutely no appetite so I didn't eat.  Wednesday night I tossed & turned all night with a chill that I couldn't lose even with the heaviest down comforter & supplementary blankets.  That night & the following day I also noticed a distorted sense of time, where hours seem to pass v-e-r-y  s-l-o-w-l-y.  On Thursday night two more symptoms appeared: a tremendous cough that I couldn't stop or assuage with the normal remedies (e.g., lozenges, tea with honey), and that kept me from falling asleep till dawn; and diarrhea (which was limited because I hadn't eaten since Monday dinner so I didn't have much food in my system).  The cough felt like it might develop into a sore throat (which had been my first symptom when I had COVID) but it never did.  Yesterday (Friday) I felt as if my symptoms (other than residual weakness) were abating, and Friday night I got a full night of unbroken sleep.  I awoke on Saturday morning with no symptoms, and felt well enough to challenge myself by attempting my usual 90-minute yoga/stretch workout, which proved to be no problem.  Now, at 4 pm on Saturday--about 100 hours after my shot--I feel fairly normal & seem to have no further symptoms.  I do plan to lie low & take things easy, and to have as little outside contact as possible between now and my second shot (scheduled for 2/16) in order to minimize the possibility of re-infection.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient with asthma, blood pressure abnormal, penicillin allergy, unspecified ACE inhibitors allergy. on 24-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H021941, expiration date: 11-JUL-2014, intramuscular, dose not reported). On the same date the patient was vaccinated concomitantly with a dose of FLUZONE (lot number, dose and route not reported) in the opposite arm than PNEUMOVAX23. Other concomitant therapies included PROAIR and SYNTHROID and unspecified blood pressure medication. On 24-SEP-2013, the patient experienced chills, swollen and arm area on her arm about 3 inches below the PNEUMOVAX23 injection site, fever, malaise and has been in bed since the injections due to not feeling well. No other lab diagnostic studies were performed. The patient called pharmacy. The outcome of swollen and warm area on her arm about 3 inches below the PNEUMOVAX23, injection site, fever, chills, malaise and has been in bed since the injections due to not feeling well, was reported as recovering/resolving. Additional information has been requested.
SUSPECTED COVID-19 INFECTION; ADMINISTRATION OF EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned an 80 year old female of unspecified race and ethnicity. Initial information was processed with the additional information received on 20-JAN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 07-OCT-2021 for prophylactic vaccination (administration of expired vaccine and off label use). No concomitant medications were reported.  On an unspecified date, the patient passed away due to positive COVID-19 (coronavirus disease of 2019) (suspected covid-19 infection). The reporter did not know the date of death or when the patient was confirmed to have a positive case of COVID-19. The reporter also did not know if the patient was confirmed to be positive for COVID-19 by PCR (polymerase chain reaction) or by another type of test. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from suspected covid-19 infection and outcome of the administration of expired vaccine and off label use was not reported. This report was serious (Death). This report was associated with product quality complaint: 90000212906. The suspected product quality complaint has been confirmed to be voided (did not meet criteria as vaccine was already expired when the consumer received the vaccine) based on the valuation/investigation performed. This case, from the same reporter is linked to 20220136322.; Sender's Comments: V0 20220136393-COVID-19 VACCINE AD26.COV2.S-suspected covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: SUSPECTED COVID-19 INFECTION
2x unknown children who were administered GARDASIL 9 were listed as 'compromised'; This spontaneous report as received from a health care business professional refers to a child patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), lot # S020255, expiration date: 09-DEC-2021 for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  It was reported that the child was listed as 'compromised' (Ill-defined disorder) within registry, on an unknown date; Immunization registry entry was entered incorrectly as confirmed by Healthcare Business Professional at call time. Healthcare Business Professional was not able to further clarify the meaning of 'compromised' (Ill-defined disorder) on unsuccessful clarification attempt at call time. The healthcare business professional had extremely limited information.Health care business professional requested a  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) expiry check.  No additional adverse event. The outcome of ill-defined disorder was unknown.  The causal relationship between the aforementioned event and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.  This is one of several reports received from the same reporter. 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: S020255; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-0095075132106USA001252:
DIZZINESS; HEADACHE; NAUSEA; This spontaneous report received from a consumer 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 not reported) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 25-MAR-2021, the subject experienced dizziness. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, dizziness and nausea was not reported. This report was non-serious.
can't sleep; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (can't sleep) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (can't sleep). At the time of the report, INSOMNIA (can't sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not reported.   Treatment information was not reported.   Reporter did not allow further contact
Pt reported area she received injection become painful, swollen and red 48 hours after injection.
Anaphylactic reaction; Burning sensation in eyeballs; Wheezing; Rales; Airways were closing; Can't breathe; A spontaneous report was received from a consumer concerning a 22-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction, burning sensation in eyeballs/abnormal sensation in eye, wheezing, rales, airways were closing/obstructive airways disorder, and can't breathe/dyspnoea.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Feb 2021, within 5 minutes prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 05 Feb 2021, within 5 minutes after receiving her second dose of vaccine, the patient reported a burning sensation in her eyeballs, followed by wheezing and rales in her lungs.  She was given epinephrine and taken to the emergency room via an ambulance.  She was given a second dose of epinephrine. Her airways were closing and she could not breathe. She was given a steroid, diphenhydramine, H2 antagonist and albuterol. Consent given for follow up calls.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, anaphylactic reaction, burning sensation in eyeballs, wheezing, rales, airways were closing, and can't breathe, was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Full blown flu; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA (Full blown flu) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Full blown flu). At the time of the report, INFLUENZA (Full blown flu) 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.   No concomitant medications were provided by the reporter.  No treatment information was provided.    Reporter did not allow further contact
Vaccine was at room temperature of 72 degrees F and administrated past 12 hour post puncture time.   Patient had similar reactions to booster as first and second Pfizer vaccine including  fever, headache, chills and fatigue 12 hours after vaccine and lasting 16 hours then resolving.
5/9/11. Patient administered 4 vaccines on this date, 2 vaccines on each thigh, anterior, lateral vastus lateralis. On 5/19/11 patient here for OV to evaluate left thigh (+) cellulitis 1.5 by 2 cm, warm, firm, slightly bruised, slight pustule at center (PREVNAR 13 area).
Case number PHEH2013US003979 is an initial spontaneous report from the health care professional received on 13 Feb 2013, with a follow-up received from a physician on 30 Apr 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M12013) at a dose of 0.5 ml intramuscularly into left arm on 12 Feb 2013. On the same day, few hours after vaccination, he experienced a large swollen area on his left upper arm. On 13 Feb 2013, he consulted the physician and noticed swelling and redness of the left arm with size 164/6 cm. It was reported that swollen area was warm to touch and approximately 50mm across was painful. He received treatment with ATARAX and prednisone for the events. On 14 Feb 2013, the swelling and redness were barely visible. The final outcome of the events was reported as recovered. The seriousness and causality of the events were not reported. Follow-up was received on 30 Apr 2013: Patient demographics, vaccine information (batch number, vaccination dose, site of vaccination, events (swelling/ redness of left arm), treatment medication and outcome of the events were updated.
So about 6-7 days after my whole arm got swollen but injection site was raised a good inch from my skin and there was a rash around it. This lasted for about 4-5 days before it went away/ It was hot to touch, itchy and painful.  I called my Doctor and she had no idea what to do and told me to call the vaccine person who did the vaccine. And he informed me  the injection may have been given wrong. I called Moderna and they basically gave me stats on the vaccine and I fell in the 1% and I was ok to get the second dose.
The night of 10/04/2019 patient's wife states that he had a rash that started on his back and "wasn't that bad" .  The next day it was also on his chest and belly and that night he had a 99.7 temp with sweating. He had slept in the morning and afternoon that day which is more than his usual.   On the 7th it was mostly on his belly.  On the 10th the hives were no better and benadryl did not help and steroid and prednison helped briefly. Friday patient went to the ER for worsening hives and was given a stronger dose of prednisone and steroid.  Today 10/14/19 patient is still not much better. He will be seeing his doctor this evening and may be having lab work.
Given the vaccine on day 31 days of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication were provided.
in the middle of the night i noticed my arm was sore. when i got up this morning my arm was swollen. And then the swelling has gone down some.