chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIED; This spontaneous report received from a consumer via a company representative via social media concerned multiple (unspecified number) patients of an unspecified age, sex, race and ethnicity The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients died. It was reported as "I could tell you about a 2hole bunch of people who died not too long after their covid vaccine". On an unspecified date, the patients died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221247101 and 20221247073.; Sender's Comments: V0: 20221247130- died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
The patient received the Pfizer covid-19 vaccine and lost consciousness after the vaccine. The EMT was called and administered assistance to the patient. She came to  minutes later and  was monitored for side effects. She went home with her mom after feeling ok.
Left arm deltoid @ site of injection of H1N1 vaccine 4 cm x 5 1/2 cm indurated, swollen erythematous minimally tender + warm area measured + treated with topical antibiotics.
Received by vaccination Friday evening.  Following day, Saturday, starting around 12pm I developed headache, body aches, fatigue, fever, and chills. Also developed arm pain and a large red rash around vaccine site. Symptoms lasted for the rest of the day. Sunday was back to normal except for the arm pain and rash around vaccine site.  As of today, the arm pain has mostly dissipated,  but I still have a red rash on my arm.
Information has been received from a physician concerning a 75 year old female who on 29-NOV-2007 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot# unknown). There was no concomitant medication. On 29-NOV-2007, the patient developed redness, swelling, warmth at injection site and pain at injection site after first immunization. Medical attention was sought. At the time of reporting the patient had not recovered. No other information was available at this time. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruised left arm injection site since day of vaccination, starting to fade) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE BRUISING (bruised left arm injection site since day of vaccination, starting to fade). At the time of the report, VACCINATION SITE BRUISING (bruised left arm injection site since day of vaccination, starting to fade) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Unwell; Headache; Tired/exhaustion/fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Unwell), HEADACHE (Headache) and FATIGUE (Tired/exhaustion/fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Unwell), HEADACHE (Headache) and FATIGUE (Tired/exhaustion/fatigue). At the time of the report, MALAISE (Unwell), HEADACHE (Headache) and FATIGUE (Tired/exhaustion/fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-408578 (Patient Link).
Patient describes fever and chills, headache, body aches, pain in your back especially where the kidneys are located. Site injection soreness. Patient report nausea, but also says he hadn't eaten all day
Lumps in arm; Arm all bruised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lumps in arm) and CONTUSION (Arm all bruised) in a female 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 VACCINATION SITE MASS (Lumps in arm) and CONTUSION (Arm all bruised). At the time of the report, VACCINATION SITE MASS (Lumps in arm) and CONTUSION (Arm all bruised) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (when she was younger). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter said that her nurse at the physician's office told her that one of her friends had shingles after getting the SHINGRIX vaccine. However, the shingles that the patient experienced after getting the SHINGRIX vaccine was a mild case of shingles. The reporter did not have additional information. This case was considered as suspected vaccination failure case as the vaccination schedule, time to event onset and laboratory results were unknown at the time of reporting.
Information has been received from a physician via a company representative reporting on a male patient of unknown age. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient received an unspecified dose of GARDASIL 9 for prophylaxis (strength, anatomical location, route of administration, lot number and expiration date were not reported). On an unknown date (reported as "several weeks ago"), the patient was diagnosed with psoriasis after receiving GARDASIL 9. The outcome of the event psoriasis and its causal relationship with GARDASIL 9 were not reported.
This spontaneous report received from a registered nurse referred to a 4 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with M-M-R II (lot number: M004305), dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830: same reporter US-009507513-1609USA013814: same reporter US-009507513-1610USA004339: same reporter.
This spontaneous report was received from a pharmacy student and refers to an unspecified amount of patients (reported as a "few") of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On an unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23 (lot #, expiration date, route of administration and dose were not reported). The pharmacy student reported that, on an unknown date, a vial of PNEUMOVAX 23 was cloudy and went through an unspecified temperature excursion and after it had been left out of the refrigerator for a couple of hours. The product was not supported as to whether it should be used because the reporter did not have the proper product information to be checked. The pharmacy student reported the product was placed back into the fridge and it was no longer cloudy, it returned to its normal color. Product quality complaint (PQC) was filed. Additional information is not expected, as there are no contact details.
Alternating feelings of chills and hot flashes for 8-9 hours.  Patient did not report temperature readings. Resolved without treatment.
Within 2 days of vaccination, patient reported experiencing  dizziness, stumbling/wobbly, numb left arm from shoulder to ankle, vision disturbance, pain in head, and slurred speech. Went to Emergency Room 09/13/17. Patient reports blood pressure was 199/??. in ER. She was given fluids and a stroke was ruled out. 09/14/17- still experiencing neck/shoulder/back pain, slight headache.
On October 5th, 2022 the patient was given a vaccine with the expiration date of 09/30/22.  I was notified of the error.  We were also notified that the manufacture indicates the the stability data supports the use of the product through October 19 and that revaccination is not required.
I began an irregular menstrual cycle 2 weeks early. I've been extremely regular my entire life. This has never happened before
Patient developed severe redness and warmness to touch a few days after receiving the vaccine. Patient urged to contact provider about how to proceed for second vaccine.
Flare of MS occurring approximately 10 days after 1st covid vaccine. Hospitalized for 5 days as a result.
Initial misuse report received from a healthcare professional on 07 October 2013. This is invalid case as the individual patient identifiers missing. It was reported that on an unspecified date a intradermal dose of FLUZONE INTRADERMAL was administered. It was noticed that, a large amount of liquid running down the patient's arm as they remove the needle. It's a vaccine underdose. No information was provided regarding the patient. No adverse event was reported.
Post vax, skin became bright bluish-red from head to soles of feet and hot to touch, followed, immediately by dizziness, nausea, abdominal cramps, SOB, eyes burning and lips swelling. Pt took 2 Benadryl capsules and applied icepack to face and felt better within 1 hour of arriving home. Pt stated she arrived home about 5 minutes after leaving health dept.
got second dose over a year since first; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) (batch number 557b3, expiry date 24th November 2023) for prophylaxis.   Previously administered products included Shingrix (it had been over a year since first).   On 1st November 2022, the patient received the 2nd dose of Shingrix. On 1st November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.      Additional Information: GSK Receipt Date: 01-Nov-2022 Reporter's comment: The reporter reported as per chat do a person have to restart Shingrix series of second dose greater than 1 year.  GlaxoSmithKline provided yes to question regarding this inquiry involving a patient.  The patient just received the second dose. Someone told the reporter that they need to restart. The patient asked pharmacist but they declined to provide patient initials and date of birth. The reporter consented to follow up. Additional supportive information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
chills Sweats night sweats (drenching) aches, pains Scratching, itching all over body  Severe diarrhea fever
Patient given shot that was drawn into syringe 9 hours before and kept refrigerated at correct temperature (vs 6 hour recommended expiration tiime)
Developed severe tinnitus and subsequent hearing loss in right ear.  4 weeks after testing positive (asymptomatic) for COVID-19 (early December 2020), tinnitus and hearing loss was experienced over a 3-4 day period.  This hearing loss and tinnitus improved after 8 days.  Hearing loss and tinnitus gradually improved (estimated 90-95% return in hearing with tinnitus varying).  Hearing loss after receiving the vaccine was more rapid (severe loss of hearing in right ear over a two day period).
awakened aprpox 10AM 3JUN94 w/upset stomach, worsened to lethargy slept 13 hrs straight @ lines, had chills/fever; denied h/a; n/v; states arm was so sore; 6JUN94 no visible redness/swelling-mild soreness;
p/vax pt exp vertigo; dizzy spells; seen by MD dx vertigo; MD stated common sx in local area(Hawaii); tx antivert; sx stopped p/2days; sx started again 1/99, dizzy; vertigo; ringing ears; dizzy spells; given meclizine;
Temp over 99, headache,muscle, joint pain chills for approx. 36 hrs
Pain, swelling, redness at the injection site (severe, more than 5cm); fever, fatigue, headache, chills, muscular pain
sore arm; dizzy/light headed; weakness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy/light headed), ASTHENIA (weakness), FATIGUE (fatigue) and MYALGIA (sore arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039021A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced DIZZINESS (dizzy/light headed), ASTHENIA (weakness) and FATIGUE (fatigue). On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, DIZZINESS (dizzy/light headed), ASTHENIA (weakness), FATIGUE (fatigue) and MYALGIA (sore arm) outcome was unknown.            This case was linked to MOD-2021-331145, MOD-2021-330997 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-330997:Dose 1 case MOD-2021-331145:Dose 2 case
fatigue; Covid antigen; ache; fever; Redness 6 inch down injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ache), PYREXIA (fever), INJECTION SITE ERYTHEMA (Redness 6 inch down injection site), HEADACHE (Headache) and FATIGUE (fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN (ache), PYREXIA (fever), INJECTION SITE ERYTHEMA (Redness 6 inch down injection site), HEADACHE (Headache) and COVID-19 (Covid antigen). On 22-Feb-2021, the patient experienced FATIGUE (fatigue). On 17-Feb-2021, PAIN (ache) and PYREXIA (fever) had resolved. On 19-Feb-2021, INJECTION SITE ERYTHEMA (Redness 6 inch down injection site) had resolved. At the time of the report, HEADACHE (Headache), FATIGUE (fatigue) and COVID-19 (Covid antigen) 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 relevant concomitant medications were reported.  No treatment.
Petechial rash on neck and upper back within minutes of injection. This occurred after 1st injection as well, but not as quickly
Pt recvd vax 20JUN92 & a mumps titer drawn on 20JUN92 was neg; No further details were provided;
There has been no adverse event reported yet. However, we are reporting an error of administering a Moderna booster shot to a person under 18 years old.
PMH: 97.7 temp, shortness of breath at rest, incontinence, bedbound, bowel incontinence, dysphagia, COVID O2 saturation 86% on 2L, BP 94/46;  pt condition began to decline afternoon of 10/06; family requested hospice consult; pt given morphine concentrate 20mg/ml for pain or repiratory distress; pt declined all meals and O2 on 10/06; occaisional wet cough diminished lung sounds; pt passed away evening of 10/08
1 dose: Legs weaknes for 1 day, sore arm for 4 days, swollen arm, 5 days, extreme weaknes for 1 week. Treatment: TYLENOL, ICEING OF SWOLLEN AND SORE ARM, A LOTS OF RESTING AND SLEEPING. Second dose 10.11.2021-  chills body aches, fever,palpitations, chest pain, chest tightness. Swollen and painfull L arm left armpit, swollen left side of the chest, high heart rate, high blood pressure. Swollen both armpits .
0927 vaccine dose  0947 reported diffuse itching and "felling like I do when I eat nuts"  0950 BP 120/74, HR 100, SpO2 99% (CTAB, no SOB, no rash or oral swelling) 0952 reported he felt his "throat closing" the same as prior episodes of anaphylaxis so epi 0.3mg given by me via auto injector IM right vastus lateralis and called 911 0954 BP 124/71, HR 84, RR 18, 99% RA  0956 50mg IM Benadryl right deltoid 1001 EMS arrived and patient transferred to ED
1/11 "Blotchy, red" after shower 1/5/13 she states, was told by husband, 1/11 stated she had hives at hair line and were now receding, & itching decreased by 75%. Per phone call supervisor said chin & neck were "splotchy & red" on 1/7. 1/9 Hive on forehead & hand, very itchy.
Incorrect diluent volume (i.e., the vial contents were diluted with a diluent volume more than 1.8 ml, but a 0.3 ml dose was still administered)
(L) arm tender, red, warm to touch & swollen with progression of symptoms past 3 days. Pain radiating to back & up the neck.
Patient developed one red bump around injection site (look like insect bite) 2 days after injection. Very itchy - she is using antihistamine cr. on it.
Patient's husband called on 11/27/2018 to inform us they are going to the doctor for increased pain in her left harm at injection site of PNEUMOVAX 23. He states she has had pain (1 or 2 on the pain scale) in that arm since her shot, but the last couple of days it has increased to a 3 or 4 on the pain scale. Her arm is not red or hot, but she reports it is warm to the touch. She reports an "achy" pain (not burning or shooting).
fever x 3d max 105.5 tx w/Ibuprofen, red pinpoint rash on chest
FOCAL REACTION WITH SEVERE REDNESS, TENDERNESS AND WARMTH SURROUNDING THE INJECTION SITE L-TRICEP.
When patient received his Boostrix shot, patient's face went blank and he was not responsive to his name. It looked like he could have been having an absent seizure. It took patient 5 minutes to fully regain consciousness. We called the paramedics to further evaluate the patient.
Vaccine was out of range/Vaccine administered after the temperature excursion occured from 22-Aug-2022 to 04-Sep-2022; No adverse event; Administered 3 doses that experienced the excursions; Patient received 0.25 ml as a first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine was out of range/Vaccine administered after the temperature excursion occured from 22-Aug-2022 to 04-Sep-2022), POOR QUALITY PRODUCT ADMINISTERED (Administered 3 doses that experienced the excursions), UNDERDOSE (Patient received 0.25 ml as a first dose) and NO ADVERSE EVENT (No adverse event) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Aug-2022 at 7:30 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On 24-Aug-2022 at 7:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered 3 doses that experienced the excursions) and UNDERDOSE (Patient received 0.25 ml as a first dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine was out of range/Vaccine administered after the temperature excursion occured from 22-Aug-2022 to 04-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine was out of range/Vaccine administered after the temperature excursion occured from 22-Aug-2022 to 04-Sep-2022), POOR QUALITY PRODUCT ADMINISTERED (Administered 3 doses that experienced the excursions), UNDERDOSE (Patient received 0.25 ml as a first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine was out of range/Vaccine administered after the temperature excursion occured from 22-Aug-2022 to 04-Sep-2022), POOR QUALITY PRODUCT ADMINISTERED (Administered 3 doses that experienced the excursions) and UNDERDOSE (Patient received 0.25 ml as a first dose).    No concomitant medications were reported. Vaccine was stored in fridge at the time of excursion. The maximum temperature reached was 52.8 Fahrenheit and the excursion duration was 8 days, 16 hours and 30 minutes. on 22-Aug-2022 the vial was moved from freezer to refrigerator and vaccine was stored in fridge as of now. Total 3 doses was impacted from the vial. A total of 3 doses were administered with no previous excursions. On 05-Sep-2022 fridge was died and ever since the fridge went out of range that past weekend and no doses was administered. The temperature went up to 70 degree and the vaccine in that fridge were moved to another fridge. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2022: Follow up information received contains no new information.
Severe hand tremors began the morning after the second vaccine.  The tremors have gotten more frequent and lasting longer. Tremors are so severe I am unable at times to hold drinking cups/glasses or use feeding utensils.  Currently occurring almost daily and last for several hours.
pt recvd vax 4AUG93 & devel local pain & severe swelling from the site of inject to the wrist; pt had red streaking down arm, arm was warm to touch, could hardly lift arm; applied ice w/no relief went to ER; PE revealed soft tissue swelling
I went to sleep feeling nothing out the blue I looked and felt the same. No more than an hour I woke up to the right side of my face dropping, swelled, no feeling, and my right eye was dry and droopy as well. It looked as if I had a stroke. I went to the emergency room and they diagnosed me with Bell?s Palsy and told me it was caused by the booster shot. I was given Prednisone, GenTeal Tears, and Refresh Liquigel.
Debilitating migraine as well as throwing up (still having it started at 3am)
16-year-old boy with a past medical history significant for chronic rhinitis, keratosis pilaris, and migraine headaches who developed large local reaction associated with vesicles at the site of meningococcal number to vaccination on 9 April 2015. Patient denies any systemic symptoms and symptoms spontaneously resolved after several days. No long-term sequelae.