chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NECK PAIN; SWELLING OF LYMPH NODES ON LEFT  SIDE OF FACE UNDERNEATH EAR  NEAR JAW LINE; LITTLE BIT OF TENSION ON NECK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 1802070, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced little bit of tension on neck. On 13-MAR-2021, the subject experienced neck pain. On 13-MAR-2021, the subject experienced swelling of lymph nodes on left side of face underneath ear near jaw line. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neck pain, swelling of lymph nodes on left side of face underneath ear near jaw line and little bit of tension on neck was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
HYPOTENSION 3/27/2023 CUSHING DISEASE, PITUITARY DEPENDENT
Rapid increase/onset of bilateral tinnitus on the morning after my second COVID-19 booster
Tasted metal in mouth right after injection.Later that day felt dizzy, nauseated,sweaty, clammy, and feverish. She also started vomiting and having diarrhea. Her right arm was hurting and painful but it was not red or swollen.
EMS called-unable to communicate with pt. language barrier. EMS ? H.A. Pt. with cough and itching all over-started tonight. Pt. on meds for TX x almost 3 months. cool mask applied
Covid Booser.  Minor swelling & soreness at injection site first day, then low-grade fever 2nd day (treated with Tylenol & went away), extreme tiredness first 3 days. On 3rd day, swelling spread across upper left arm & started creeping down (included pain, redness & very warm to touch). Did not go completely around arm, but halfway around, with injection site in the middle. By 4th day, had spread down close to elbow & stopped. Swelling, pain, redness & warmth continued until 6th day, then started to subside. By 8th day, all symptoms were gone.  Took Tylenol at first, but had little effect, and stopped taking it. Had very little reaction to 1st 2 Pfizer doses, with minimal swelling/pain at injection site, and some tiredness. E-appointment, which diagnosed it as Delayed Cutaneous Hypersensitivity ("COVID" arm), with no follow-up needed.
Blood in stool; 36 hours after receiving his first dose of the COVID-19 Vaccine (at 4:00PM), he had massive diarrhea; This is a spontaneous report from a contactable consumer (patient). An 80-year old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 13Jan2021 07:00AM (vaccine location: Arm, Left Upper) at single dose for COVID-19 immunisation. The patient's medical history included ongoing parkinson's disease (probably had Parkinson's disease for 8 years, but was formally diagnosed 6 years ago) and peripheral neuropathy. The concomitant medications was reported as sinemet for parkinson's disease and gabapentin for peripheral neuropathy, about 6 years. Patient said 36 hours after having his first COVID-19 Vaccine dose, he had massive diarrhea on 14Jan2021 at 04:00PM. He said the diarrhea only happened one time. He said he went on a BRAT diet for a few days and then back to a regular diet. He clarified the diarrhea was brown. He said he had 1 incident of blood in his stool after that on 15Jan2021. He said he couldn't get an appointment with his doctor, so he went to emergency room. He said he was at the emergency room from 8:00AM-4:00 PM. He said the emergency room doctor told him he probably didn't have any recurrence of blood in his stool, because the blood was caused by his episode of diarrhea the day before. He said the emergency room doctor postulated that his diarrhea was caused by the COVID-19 Vaccine because there was a 36-hour delay between receiving the COVID-19 Vaccine and having diarrhea. The outcome of diarrhea was recovered on 14Jan2021. The outcome of blood in stool was recovered on 15Jan2021.  No follow-up attempts are possible. No further information is expected.
On the day of the vaccine, I experienced numbness in my face which only lasted one day. My arm was sore for about 36 hours after the vaccine and then fine. 7 Days after the first dose, my left arm is swollen, red and sore at the injection site.  I am reporting this because it appears to be unusual.
Mom reported that patient did not feel "himself" in evening of 10/18 and all day on 10/19. Reports a fever on Friday, no temperature taken, complained of pain in arm and vomiting. Complained of sore throat over the weekend and vomiting.
Patient states that since he had the vaccine he is feeling more dehydrated than normal, cramps all of his body in various joints/muscles, a persistent cough without phlegm, and that his face/lips "feel heavy".
Per inpatient note-developed lesions on his elbows that spread up and down the bilateral arms, on his mouth, and lastly on his legs. Notes the lesions are pruritic in nature.
Patient experienced frequent urination thoughout the night after receiving the vaccination. She also reports a fever of 100 degrees, body aches, muscle aches, fatigue, upset stomach and headaches starting early this morning and throughout the day. I referred the patient to her primary care provider for evaluation.
Face swelling; Lips swelling; Leg cramps; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via an unspecified route of administration in the left arm on 23Jul2021 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not have any concomitant medications. On 23Jul2021, after1 hour of vaccination the patient experienced face swelling, lips swelling and leg cramps. Therapeutic measures were taken as a result of events and included treatment with prescribed steroids and Benadryl. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 29Jul2021, the patient underwent nasal Swab, SARS CoV-2 test and the result was negative.  Since the vaccination, the patient had  been tested for COVID-19. The clinical outcome of face swelling, lips swelling and leg cramps were recovered on Jul2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Adverse Event: rash on upper back/shoulder.   Uncontrollably coughing, tightness of throat treatment: benadryl, coffee, and washing the affected area
skin rash, described as hives, that has continued to become worse and "doesn't seem to be going away; skin rash, described as hives, that has continued to become worse and "doesn't seem to be going away; skin rash, described as hives, that has continued to become worse and "doesn't seem to be going away; This is a spontaneous report from a contactable consumer (Caregiver reported for his daughter).   A 20-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and expiration were not reported), via an unspecified route of administration on 18May2021 (at the age of 20 years) at single dose for COVID -19 immunisation.   The patient medical history and concomitant medications were not reported. The patient had earlier received first dose of BNT162B2 (Batch/Lot number and expiration was not reported), via an unspecified route of administration on unspecified date as first dose, at single dose for covid-19 immunisation.   Reporter (mother of the patient) had called on behalf of his 20 year old daughter, (name withheld), who received the, the patient had a skin rash, described as hives, that had continued to become worse and "doesn't seem to be going away." Reporter stated that he reported her reaction to their dermatologist online and read online that reaction was rare, but some people had experienced it. Re-porter had enquired about for any resources regarding the side effect that she is experiencing. The outcome for both the events was unknown.   Information on the lot/batch number has been requested.
autoimmune vitamin deficiency; vitamin B12 deficiency; This case was reported by a consumer via interactive digital media and described the occurrence of autoimmune disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles a lot).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced autoimmune disorder (serious criteria GSK medically significant) and vitamin b12 deficiency. The patient was treated with cyanocobalamin (Vitamin B12). On an unknown date, the outcome of the autoimmune disorder and vitamin b12 deficiency were unknown.   It was unknown if the reporter considered the autoimmune disorder and vitamin b12 deficiency to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient get shingles a lot and received shingles vaccine which helped for a while. After vaccination the patient had autoimmune B12 deficiency and ran across B12 shots as treatment for shingles. The patient stated that, B12 repaired myelin. Note: from the narrative it was not clear if the patient had autoimmune B12 deficiency as current condition or experienced after shingles vaccination, hence coded as event conservatively.
Shingles out break - rash/blisters right upper back and right upper chest & right axilla; pain, itching; headache.
This spontaneous report was received from an office manager refers to a 4 year old patient of an unknown gender. Medical history was not reported. On 06-MAY-2014 the patient was vaccinated with M-M-R II also reported as (M-M-R-B) lot number: K000712, expiration date 16-JUL-2015, strength, dosage and route were not provided. Concomitant therapy was not reported. The reporter also stated that the vaccine was involved in the 10 hour temperature excursion. This is a several reports received from the same reporter. Lot number K000712 is an invalid lot number for M-M-R II. Additional information has been requested.
bilateral foot rash, the rash eventually spread to her upper and lower legs/ankles / pt diagnosed with lichen planus; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 14-SEP-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient developed a bilateral foot rash. The rash eventually spread to her upper and lower legs and ankles. The patient was referred to a dermatologist and diagnosed with lichen planus, a T-cell mediated auto-immune reaction, following a punch biopsy on 15-MAR-2018. Since her diagnosis, the patient continued to suffer from the effects of her skin condition and received triamcinolone acetonide (KENALOG) injections when her lichen planus flared. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered not recovered/not resolved.  The event was considered related to zoster vaccine live (ZOSTAVAX).  The event of lichen planus was considered to be disabling.
Pediarix/Hib/Prevnar given simultaneously by two staff nurses per protocol. Initial appropriate scream with subsequent limp/pallor, eyes rolling back in head following blank stare. Transferred to ER via ambulance.
Employee reports symptom 24 hours post vaccination of headache, body aches, malaise, fever and pain, soreness and redness at site of injection.
ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 12/1/2021 CONFUSION  ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 12/1/2021 CONFUSION  ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/1/2021 CONFUSION  ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 12/1/2021 DELIRIUM  ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 12/1/2021 DELIRIUM  ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/1/2021 DELIRIUM  ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 12/1/2021 LATE EFFECT OF STROKE  ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 12/1/2021 LATE EFFECT OF STROKE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/1/2021 LATE EFFECT OF STROKE
Since injection I have had continued localized pain in the left arm between elbow and shoulder of left arm. First 4+ days arm was extremely painful with very slight swelling. No rash. Painful to move the arm. The actual administering of the vaccine was extremely painful. Pain has continued off and on every day since. The pain ranges from mild (but certainly aware it is there) medium level discomfort. At worse there is a burning sensation and the pain feels like someone is pinching an area of my arm and holding the pinch. The pain is not always in the exact spot. But it is always located as described in first sentence.  The second vaccination on 4/4/21 there was very little pain when administered. I did not have the same level of pain in my arm as in the first 4+ days after the first injection. But the arm pain has been daily since first injection .
In early November I started having low back pain that is constant that feels like bone on bone. There are times it hurts so bad I have to use a cane to even get out of bed. It will ease up and I can do daily activities and then there are days I cannot do anything. Now I am having pain after I eat. Thirty to forty minutes after I eat, I start getting pains as if I have not eaten, a burning sensation, gurgling sounds, some diarrhea. I have had an endoscopy and colonoscopy they only showed polyps that I had removed, the pains still persist. I have been given PRILOSEC to help. I just started this medication; it is helping with my cough.
A non-serious spontaneous report of ataxia and mental confusion has been received from a health professional concerning a 32-year-old female, subsequent to FLUMIST. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient received FLUMIST on mid Sep-2011. After 15 minutes of receiving FLUMIST, the patient experienced ataxia and mental confusion which for lasted three hours. The outcome of the events ataxia and mental confusion was recovered.
Patient experienced redness, swelling & soreness. Redness was spreading down patients arm. Patient went to urgent care & was diagnosed with cellulitis & is currently on a course of antibiotics.
Patient reported complaints of palpitations, dizziness, twitching eye. Also reporting acute onset of tingling in arm of vaccine administration at 30 mins post-vaccination.   VITALS: HR 68, RR 14, BP 132/84, O2 94% Patient was supervised for 45 mins and given water and gatorade with resolutions of complaints of palpitations and dizziness.   No complaints of progression of issues with twitching eye, soft tissue swelling. Patient denied dermatological changes. No loss of range of motion or function of right arm despite reports of tingling sensation.  Symptoms of tingling in arm did resolve prior to leaving site.
Pt received DTaP, IPV, Comvax and 6 hrs later developed fever to 103 deg F and seizures. No rash. Was taken to hospital and then admitted to hospital. The hospital discharge summary received on 4/5/04 states infantile spasms.
APPROXIMATELY 8 -10 MINUTES AFTER THE VACCINE MY HEART RATE INCREASED, KIND OF SUDDENLY - SHORLY AFTER THAT I FELT A 'RUSH' FROM HEAD TO TOE.  ALL OF THIS HAPPENED OVER MAYBE 20 SECONDS - THEN MY HR DECREASED TO NORMAL AND I FELT FINE.
patient collapsed while on a walk/jog 2 days after secondn dose of covid vaccine. Ended up being transported via ambulance to ER.  Symptoms were short of breath, tachycardia, couldn't move left side of body, could not respond to questions being asked of her although she could hear people and understand. (she told me later that she couldn't move to answer the questions.) Eventually came out of it, ER doc said she had a vasovagal syncope episode and that it was completely normal. The very next day at school, she had another episode and then multiple within the next couple of weeks. 9 months of unexplained symptoms... In May of 2022, after several dr. visits, specialists, etc. it was determined she developed dysautonomia/POTS due to the vaccine.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 30-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX, (dose and lot number not provided) subcutaneous. On 01-OCT-2014, the patient experienced a red ring around the site of ZOSTAVAX injection. No treatment was given for this event. The patient had not recovered/not resolved. The patient went to see the pharmacist for seeking medical attention. Additional information has been requested.
Hemorrhagic cyst; New cyst on ovaries; 4 hours after vaccination had menstrual cycle 2 weeks early; This spontaneous case was reported by a patient and describes the occurrence of HAEMORRHAGIC CYST (Hemorrhagic cyst) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced HAEMORRHAGIC CYST (Hemorrhagic cyst) (seriousness criterion medically significant) and OVARIAN CYST (New cyst on ovaries). January 2021, the patient experienced MENSTRUATION IRREGULAR (4 hours after vaccination had menstrual cycle 2 weeks early). At the time of the report, HAEMORRHAGIC CYST (Hemorrhagic cyst), OVARIAN CYST (New cyst on ovaries) and MENSTRUATION IRREGULAR (4 hours after vaccination had menstrual cycle 2 weeks early) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant product was provided. It was reported that 4 hours after vaccination, the patient had her menstrual cycle 2 weeks early. Since then patient had her period every 2 weeks for over a year, as well as new cyst on ovaries and a hemorrhagic cyst as well. No treatment information was provided.  Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected serious (medically significant) event of Haemorrhagic cyst, unknown days after receiving the first dose with mRNA-1273 vaccine in the COVID-19 vaccination series. The patient also had her menstrual cycle 2 weeks early and new cyst on ovaries. No further information on risk factors, detailed clinical course and management of the event was available in the report. The event was not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-594000 (Patient Link).; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected serious (medically significant) event of Haemorrhagic cyst, unknown days after receiving the first dose with mRNA-1273 vaccine in the COVID-19 vaccination series. The patient also had her menstrual cycle 2 weeks early and new cyst on ovaries. No further information on risk factors, detailed clinical course and management of the event was available in the report. The event was not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Seizure A follow up report received 8/27/2002 adds: No fever noted with seizure activity.
Hands in great pain, pain in arms, shoulders, hips and inner thighs.    These lasted two weeks.   Mostly bothered when lying down.
3 cm round macular patch, slightly swollen, inflamed and tender to touch. No drainage or changes in skin texture. Skin pigment unchanged surrounding area.
Injection area swallow and pain  hot area 3 inches  got worse day 5-12th still painful and hot
Dose 1 - 10:45 a.m.  3/19/2021 - two days later, period cramping and heavy spotting. Dose 2 - 1:45 p.m. 4/16/2021 - two days later, like clock work, period cramping, heavy spotting. Dose 1 - spotting lasted 14 days, stopped the morning of my pelvic ultrasound to determine if there was something serious going on. Dose 2 - spotting started two days after vaccine, counting the days to see how long this lasts, with cramping. I am 59, no kids, never been pregnant, last period at age 39, menopause at 42 and still in menopause.  What is going on Moderna? A vaccine should not interfere with hormones or hormone replacement therapy. A vaccine cost me additional procedures  - still waiting on the bill for the ultrasound and several doctor appts, and lab work.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies. On unknown dates from 01-FEB-2017 to 18-APR-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot#: M031574, expiry date: 11-NOV-2018 (dose and route of administration not provided) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 8 hours 10 minutes. Data logger was not used to capture temperature excursions. There were no previous excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA008219: US-009507513-1705USA003083: US-009507513-1705USA003081.
3RD DOSE PFIZER COVID VACCINE GIVEN 12/20/21, LOT #33030BD; 8/15/22 pt was seen by NP for c/o weakness, cough, body aches; tested positive for COVID; given Azithromycin to take x 6 days; went home where he passed away on 8/24/22