chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a 91 year old male consumer who was also a retired physician reporting on himself. There was no pertinent medical history, concurrent conditions, or drug allergies/drug reactions described. In approximately 2013 reported as "approximately two years ago", the patient was vaccinated with ZOSTAVAX injection (in the buttock; dose, route, lot# and expiration date were not provided). There was no concomitant medication described. In approximately 2013 reported as "one to two months later", the patient experienced itching at the injection site (on an unspecified buttock). He presented a rash (injection site rash) approximately one and one half inches long; this rash persisted for approximately one year; the rash began regressing but then on an unknown date an ulceration (ulcer) approximately 3 centimeters in length appeared. That was treated (with unspecified antibiotic cream) and healed on an unspecified date. The patient stated that currently there was a bilateral feeling of "sunburn" on both buttocks; he had no pain as long as he was standing, but when seated there was an uncomfortable feeling as if the area was "sunburned" (burning sensation). The patient was also currently unable to sleep on his back due to the painful sensation (musculoskeletal pain). There was no clinical sign of redness on the buttocks, and the skin appeared like "normal tissue". The pain in the buttocks had lessened over time, but had not abated. The patient also reported a sensation of "feeling an eyelash" on his inner eyelid of an unspecified eye (ocular discomfort), but an unspecified ophthalmologist could find nothing that would caused this sensation. The patient sought medical attention (went to the physician). Product quality complaint (PQC) was not involved. At the time of the report, the outcome of injection site rash and ulcer was recovered. The outcome of burning sensation was reported as not recovered, musculoskeletal pain was recovering and the outcome of ocular discomfort was unknown. Additional information is not expected as there is no consent to follow-up.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (dose, route, lot # and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that patient fainted shortly after receiving the GARDASIL vaccine on unspecified date. It was unknown which injection (in a series of three) the fainting was occurred. The patient was assisted back to an upright position and had no additional side effects. No treatment was given for the event. At the time of the report, the patient's outcome and the relatedness between the event and suspect therapy were unknown. This is one of several reports received from the same source. Additional information has been requested.
Atrial fibrillation; feeling weak; Dizzy; Nauseous; chronic fatigue; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01May2021 (Batch/Lot number was not reported; at the age of 61-years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included gabapentin (NEURONTIN); famotidine (PEPCID [FAMOTIDINE]). On 01May2021, it was reported that the patient had horrible symptoms with the Pfizer Covid-19 Vaccine. Patient stayed there out of the place because they thought she was drunk, but she slept all weekend long basically and later found out that she went into atrial fibrillation because of that. On the same day, patient also was  feeling weak and dizzy; was nauseous and had like chronic fatigue. The patient was advised not to take the second dose. The outcome of the events was unknown.  Information about lot/batch number has been requested.
This serious case was received on 27 April 2009 from a health care professional. A female patient (age not specified) with a history of high blood pressure and no known allergies inadvertently received 0.5 ml of DECAVAC (lot number not known) intradermally on 24 April 2009 instead of 0.1 ml of TUBERSOL. Concomitant therapy included FLONASE, LORATIDINE, ZOLOFT, hydrochlorothiazide, and BENZOPRIL. On 24 April 2009, the patient appeared to have cellulitis with a possible abscess and approximately 4 finger breadth area of erythema with a hard knot. The patient was not recovered at the time of the report. List of Documents held by Sender: none.
Complaining of tingling to injection site after 10 minutes. Also complaining of light numbness to left thigh.  All symptoms resolved after 20 minutes.
Pt woke up with red cheeks and hoarse throat on 10/14/2016. He contacted his primary doctor via phone and was advised to take Benadryl and go to ER if having difficulty breathing. Patient's symptoms were resolved after taking Benadryl. Phamacy was notified of ADR on 10/17/16 and all signs and symptoms resolved. Protocol doctor was notified by pharmacy of ADR on 10/17/16.
Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 040A21A, 038B21A and 067F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, the nurse had discovered temperature excursions of the Moderna COVID-19 vaccine. The temperature in the refrigerator that the Moderna COVID-19 vaccine reached 13.1 degrees Celsius on 28-Jun-2022. Further nurse stated that, none of the vaccine in the refrigerator underwent two different temperature excursions.  Later, the patient received Moderna COVID-19 vaccine that underwent a temperature excursion. The temperature excursion was not known of at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna COVID-19 vaccine was stored in. The nurse had used the online temperature excursion tool and was comfortable that her patient's doses were valid and that the affected vaccine was viable for future doses.  It was unknown if patient had side effects after any dose.  No treatment medications were reported.
12/03/21 presents to ED for "shortness of breath". PMHx of " hypertension, high cholesterol, flank pain, kidney stones"
On Saturday night, April 10th, at bedtime I started to feel muscle pains in my hamstrings. The pain subsided a little during the day of Monday, April 12th, but the pain returned in the middle of the night.; extremely difficult to fall asleep; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm left on 08Apr2021 at 11:15(at the age of 50-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included vitamins nos (MULTIVITAMINS), red yeast rice (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN). Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 Saturday night at 01:00 at bedtime, the patient started to feel muscle pains in hamstrings, extremely difficult to fall asleep. The pain subsided a little during the day of Monday 12Apr2021, but the pain returned in the middle of the night. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event on Saturday night, at bedtime started to feel muscle pains in hamstrings not extremely difficult to fall asleep the pain subsided a little during the day of Monday, but the pain returned in the middle of the night were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Pt received 2nd dose of moderna vaccine at 21 days. No adverse events or outcomes observed.
chest pain with mild physical exertion. Admitted 7/7, started colchicine and ibuprofen per peds cardiology, feeling better on 7/8 and ready for discharge 7/8.
This spontaneous report as received from a healthcare worker (office manager) refers to an unspecified number of unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored PROQUAD (dose and route unknown, lot# K011314, exp 14-FEB-2016). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
+3 hours after injection: severe fatigue +5.5 hours: Chills, Shaking/Shivering and body temperature 97.2 +7 hours: Severe joint pain in entire Right Arm, everything from shoulder to each finger joint +10 hours: Sore ribs, Right side, temp @97.4 +16 hours: Wake up in morning feeling relatively fine, Temp @97.4, joint pain in Right hand/fingers still present, chills and rib pain have subsided +20 Hours: Chills/Shivering returned worse than previous day, Fever of 100.6 Currently +27 hours: Chills, Shaking, Fever 100.8, and significant joint pain in right hand/fingers still persist   Does not feel serious enough to warrant medical intervention at this time
Diarrhea; 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 DIARRHOEA (Diarrhea) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were not provided.
Hives developed inside thighs and chest that was noticed about 24 hours later.  At 36 hours, entire torso, front and back, neck, scalp and arms covered in hives. No additional hives below waist, inside thighs still present.  Treated with Benadryl and generic Allegra antihistamines. No changes to severity of hives. Visited urgent care clinic, received prescription antihistamine and steroids, some small improvement after on days dosage but hives still present. No other adverse effects present.  No fever, no pain, no sore throat, no swollen lymph nodes, no hives on face, no issues breathing. Minimal discomfort and itching even without medication.
Patient received and dose from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received and dose from an expired vial) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21B, 036a21a and 019b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received and dose from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received and dose from an expired vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The date the vial was initially stored in the refrigerator was 9-Mar-2022. The vial did not undergo any temperature excursion. It was reported that patient had no allergies (medications, food and other products) It was unknown whether patient  had ever COVID positive test or diagnosis. It was reported that no other vaccines given within 1month prior to Moderna COVID-19 vaccine (type,brand, lot,route, dose #) It was unknown whether Adverse event caused patient to seek medical care (office visit, Urgent care, ER, hospitalized) It was unknown whether patient  had experienced a similar event in the past. It was reported that death was not the cause and autopsy was not done. No treatment medications were reported.
Discomfort, soreness and pain in neck area, as well as change in voice.  Internal sore throat.
Initial report received from a consumer who is the patient on 25 August 2011. A female patient (age not reported) who has a history of cold sores, had received "4 shots" of IMOGAM Rabies-HT (lot number not reported, indication not reported) and 2 doses of IMOVAX Rabies (lot number not reported, indication not reported) on 22 August 2011, and at an unspecified amount of time later, the patient developed cold sores. She had no concurrent illnesses at the time of vaccinations. The patient did not require medical evaluation, and it was not reported whether the patient self treated the cold sores. At the time of this report, the patient had not recovered. Documents held by sender: None.
pt recvd 1st dose of Hep B in MAY91; w/in 2 to 3 days of vax devel flu like illness consisting of myalgia, severe ha/ & vomiting which persisted for approx 7 days; no further details were provided;
Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a pt who experienced rash after receiving vaccines. The pt received the third dose in Mar 2005. The pt also received a dose of Hib Vaccine (manf unk) in Mar 2005. The pt's concurrent illness includes latex allergy. Indication for Prevnar was immunization. Product was administered in Mar 2005. Dose regimen was 1 dose. Concomitant medications were not reported. The pt experienced a rash after receiving vaccines on an unspecified date in Mar 2005. No additional  information was available at the time of this report.
brain stroke and blood clot; brain stroke and blood clot; patient collapsed; This is a spontaneous report from a contactable consumer.     A 79-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 31Jul2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation (Age at vaccination 79 years).  The patient medical history was not reported.     There were no concomitant medications.  The patient experienced brain stroke and blood clot  on 31Jul2021 22:00. patient collapsed (fall) (hospitalization, disability, life threatening) on 31Jul2021 22:00 with outcome of not recovered.  The patient was hospitalized for brain stroke, blood clot and fall  for 58 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on Sep2021 (Nasal Swab).  Unknown therapeutic measures were taken as a result of brain stroke and blood clot  and fall.  The patient died on an unspecified date because of stroke and clots.  It was not reported if an autopsy was performed.  Course of the event. Patient received the 1st shot of Pfizer Covid-19 vaccine on July 31st 2021 at 4 PM and at 10 PM patient collapsed due to blood clot and due to Brain Stroke and Patient died few weeks later due to the damage from the blood clot and brain stroke.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Ischaemic stroke; blood clot
He had acute ischemia to his left lower extremity he due to a thrombus to the left SFA that required Thrombectomy At hospital a month after his first moderna dose.
Left thigh IM injection of 2nd Hep A given 3/22/11 rash developed 3/23/11. Red blotchy rash with central area hard & red at injection site, 5" circumference. Improving slowly as of 3/25/11.
Within minutes of recieving the vaccine pt had an upset stomach felt light headed turned pale and was shaking
Sometime in 02/2022, after receiving my third COVID-19 vaccine, I began getting headaches and migraines. Right after receiving the vaccine, I got the normal side effects that I expected, but as days went on my headaches were getting worse. By March, I decided to see a doctor about the headaches who put me on topiramate. I've had migraines after receiving each dose of my COVID-19 vaccines and after having COVID-19 in 2021. I usually treat them with TYLENOL, but it wasn't helping enough. The doctor advised that I take topiramate at night, but it wasn't really helping either. In May of 2021, my headaches went away. I received my fourth dose of the COVID-19 vaccine, and then five weeks later, the headaches have returned.
Pt recvd 1st dose Hep B vax 1OCT91 & on 12OCT91, pt exp pain in lt pelvic bone; by 24OCT91 pt could not lift leg & presented to MD; lab eval revealed an elevated level of WBC between 10,000 & 14,000; pt placed on therapy w/med & exp pain;
Had tenderness at injection site for several days and then it dissipated.  On the evening of Day 7 post injection experienced mild itching and small area of redness 5 inches below shot site.  On Day 8  the red area had expanded completely around the outside of the arm, with swelling, increased tenderness and thickening, and increased temperature. I was feeling sick. Doctor prescribed Amoxicillin for coverage in case of cellulitis.  Day 9 redness was decreasing but itching increased and I was feeling sick.  Took  Benadryl and it is resolving.
Numbness tongue, face, neck, right side numbness going down, twitching hands, chest pain, sharp pain throughout the right side of my body, headaches constantly, body pain, weakness, dizziness, lack of energy, itchiness, small itchy bumps, itching throughout body, pain in right hand, half my body is hot half cold, SOB.
Feeling bad 2 days after shingles vaccine #2 on 12/10/2020.  +HA +eye pain +redness of face . Patient reported feeling like her eyeballs were going to explode out of her head
Within hours of the DTP shot, Pt pitched a high fever accompanied by an ear piercing cry.  He cried for over four hours, would not eat and could not be consoled. He slept for excessive periods of time and seemed "o.k." after about 48 hrs. I noticed he stopped eye contact and seemed stoic.  He was also very sensitive to light and visual stimuli.  He was diagnosed with a minimal brain damaged manafested as a profound visual processing disability along with sensory integration disorder at age 6. Informatin from 60 day follow-up report states patient has a profound visual processing learning differences along with sensory integration disorder - a math and writing disability. Visually hypersensitive, non-verbal learning disabled.
Hair started falling out 2 1/2 weeks after 2nd vaccine  And keeps on falling out
Pt was disoriented, extremely nauseous and  feeling warm form head to toe.  It started around 6:08pm  It passed within 20 minutes.  EMS checked her out and BP, pulse and BS was fine  She walked out of store just fine and drove home.  I called pt later around 7:15pm, she was still nauseous but otherwise feeling much better
On day 6 he woke up feeling very weak. Needed help getting out of bed. He has a degenerative muscle disease (Inclusion Body Myositis) so is already very weak, wheelchair bound. House is set up with all lift chairs or elevated (Bed, Toilet) so he can get out of them with very weak legs. By mid morning he was not able to use legs or arms at all to get up and had difficulty holding head up (usually no problem). By afternoon temperature went to 103.6. and he ached all over. After 2 - 3 hours with dose of 2 extra strength Tylenol temperature came down to 100.6 and then another hour later he became very sweaty all over body and temp returned to normal. Continued very weak for a few days. Gradually regained strength and back to normal strength for him over 6 days.
tastes different; swelling of lymph nodes under arm/swelling of lymph nodes in neck; 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 AGEUSIA (tastes different) and LYMPHADENOPATHY (swelling of lymph nodes under arm/swelling of lymph nodes in neck) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21 and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGEUSIA (tastes different) and LYMPHADENOPATHY (swelling of lymph nodes under arm/swelling of lymph nodes in neck). At the time of the report, AGEUSIA (tastes different) and LYMPHADENOPATHY (swelling of lymph nodes under arm/swelling of lymph nodes in neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant and treatment information was reported by reporter.
Approaching 5 hours after receiving the second vaccine the patient developed acute encephalopathy that has not resolved since 3/29.  He was found to have group B Strep bacteremia with suspected skin/soft tissue cause however encephalopathy did not resolve with treatment.  Lumbar puncture negative for other etiology including autoimmune work up.  CT head negative for acute abnormality, unable to do MRI due to agitation/confusion.