chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 19 year old female, who in February 2008, was vaccinated with the first dose of (dose and duration not reported). Concomitant therapy included hormonal contraceptives (unspecified). Subsequently, the patient experienced an indentation at the injection site, it appeared that there was soft tissue or subcutaneous fat missing in an area of a centimeter and a half, and there was a little bit of swelling below that area. The patient indicated that the indentation was getting bigger and the indentation was painful at times. At the time of the report, the patient was not recovered. The patient sought medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/12/2008. Information has been received from a Licensed Practical Nurse concerning a 20 year old female with allergies and sinusitis who on 16-JUN-2008 was vaccinated with the first dose of GARDASIL (lot # 660393/0067X) IM into the left arm. Concomitant therapy included DESOGEN. 3 weeks prior to 14-OCT-2008, on 23-SEP-2008, the patient developed a dimple or indent of the skin on the left arm. There is slight pain with pressure at the injection site. The patient was seen in the office on 14-OCT-2008. The dimple had increased in size. At the time of the report the patient had not recovered. Follow-up information was received from the Licensed Practical Nurse which reported that the patient has a nickel allergy and mild asthma. It was reported that in 2002 the patient had a tetanus booster (manufacturer unknown). On 21-NOV-2008, the patient went to the doctor's office complaining of dimpling of the left deltoid. The patient had no illness at the time of vaccination. A few weeks after vaccination, the patient had noted dimpling and pain at the injection site, she had no redness or sloughing in the skin, the patient had no fever and she believed the lesion was increasing in size and wanted to have this evaluated by an specialist. Patient weight: 134, blood pressure: 124/68 and temperature 97.8 F. Medical examination showed a stable appearing dimpling size 2.5 cm horizontally and 1 cm vertically. It appeared that there was lots of subcutaneous tissue. There was no evidence of secondary infection or sensory deficits at the site. The physician reported that dimpling and pain of left deltoid likely secondary to GARDASIL. No additional information is expected.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 07-APR-2016, the patient was vaccinated with a dose of GARDASIL lot number J008423, expiration date 21-JAN-2016 (route was not provided). Concomitant therapy information was not provided. On 07-APR-2016, an expired product was administered as the patient was inadvertently administered an expired dose of GARDASIL. No adverse event was reported. At the time of the report, the patient's status was unknown. Additional information has been requested.
Reactions: dizziness, nausea, instability on feet, headache, arm pain, neck pain, muscle pain, temperature of 101.7, rectal pain, and vaginal pain. No tx taken.
Hospitalization for Acute Pulmonary embolism (recent COVID diagnosis outpatient) on dates 9/1/22-9/3/22.  Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Per mother patient first developed fever then pox rash the rash as scabbed over and since resolved. No treatment needed.
Patient experienced a thunderclap headache during a workout at about 6:00pm on 05/05/2021. She also had nausea, light sensitivity, and neck stiffness. She went to urgent care around 8:00pm and received a shot of toradol for suspected migraine. When the headache didn't resolve completely, she went to the emergency room around 11pm. On 05/06 around 5:30am, a CT scan revealed a subarachnoid hemorrhage over the right sylvian fissure. A CTA of the head and neck immediately following showed no aneurysm or AVM. The patient was admitted, and underwent a catheter angiogram later that afternoon, which also showed no aneurysm or AVM. She was admitted to the NeuroICU for one week, took nimodipine and keppra as prescribed, underwent transcranial dopplers daily to check for vasospasm, and did not develop any major complications. Patient developed worsening pain near the tailbone while hospitalized, which was attributed to nerve pain from blood in the subarachnoid space. On 05/12/2021, the patient underwent a second catheter angiogram, which also showed no aneurysm, AVM, or abnormality. The patient was discharged home on 05/13/2021, with followup with neurosurgeon for a likely third cerebral catheter angiogram.
I was feeling very tired. I had a lot of aches in my body. My arm hurt the most. I was tired with the other vaccines, but this one was the worst. It felt like I had to be in bed because I was so tired, and everything hurt. When I went to see my doctor in December, my lab work showed my VSG was high and my hemoglobin was low. My doctor told me my autoimmune condition was back. I had been in remission for a long time. He prescribed corticosteroids, etoricoxib, MYDOCALM-A, and LYRICA. He also gave me a vitamin B12 injection every other day. My lab work looked better after treatment, but I still have anemia. I have a follow-up appointment next week.
On the day of the vaccine: pain in the injection site. Next day: Body ache, Fever (100.4 to 101), chills, fatigue, and very bad headache.  I took Tylenol 1g at noon but did not make difference. I took a 600 mg ibuprofen after going to an urgent care facility after the headache became intolerable. The ibuprofen led to the relief of the headache and fever.  Two days after the vaccine: Mild fatigue and headache.
Inflammation in the thoracic spine causing pressure on surrounding nerves. Resulted in severe pain from both the spine and the abdomen, chest, and ribs.  This inflammation was a location where pain from Spondyloarthropathy  was not previously an issue.
This spontaneous report as received from a Certified Medical Assistant concerning a patient of unknown age who was vaccinated with dose 1 of VAQTA (dose, route and lot # not provided) on 17-JUL-2012 and a booster dose of VAQTA on 05-OCT-2012. No adverse effects reported. Additional information has been requested.
Patient received vaccinations on 6/28/13. He reported to the Urgent Care department on 6/30/13 at 0847 with complaints of fever, bodyaches, fatigue, redness, and swelling around the injection site. He was subsequently transferred to the Emergency Department and given ibuprofen 800mg po, morphine 4mg IV, ondansetron 4mg IV, normal saline infusion x 1 L, and 1gm of ceftriaxone.
HR 81; BP 148/96;  O2-96;  pt experiencing some sweats but not in any distress
FEVER, CHILLS, BODY ACHE, NAUSEA, VOMITING,
About 4:15pm, I had an abrupt onset of sneezing with a runny, itchy nose and cough. I also developed a very raspy voice, could not speak loudly at all. (I have never experienced anything like that with my voice.) This remained until, at 5:15pm, I developed itching around my mouth and sensation of swelling, which did not appear visually. I took 25mg diphenhydramine at that point. Within 20 minutes, the symptoms began to fade and resolved completely within 2 hours. No further symptoms.
insomnia; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 22Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced insomnia on 23Jun2021. The clinical course was reported as she received her first dose of the Pfizer BioNTech Covid-19 Vaccine on 22Jun2021. After this day she has been unable to sleep for three weeks. She has insomnia. She has seen multiple doctors including a neurologist and a therapist who prescribed her zolpidem to help her sleep. She still cannot sleep. She was not being able to fall asleep until 5:00AM. She is scheduled for her second dose of the Pfizer BioNTech Covid-19 Vaccine today. if she should get the second dose of the vaccine. The clinical outcome of the event was unknown. Therapeutic measures were taken as a result of insomnia.  Information about lot/batch number has been requested.
106 degree Fever and went to the ER; This case was reported by a physician via call center representative and described the occurrence of fever in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB28AA, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th December 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than 9 months after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 03-AUG-2022 Reporter's comments: The Healthcare Professional (HCP) reported that the patient had experienced a 106 degree fever and went to the Emegency room (ER) after receiving the 1st dose of Bexsero.  The reporter had also asked that did they had recommendations on administering the 2nd dose of Bexsero based off this reaction.  The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up however the healthcare professional was called and a voice message (VM) was left to call back the medical inquirer (MI).
On 17NOV03,6 Hours after anthrax shot # 6, patient broke out in small red hives from neck to toes and had tightness in chest.  Went to E.R. and was given Benadryl, Prendnisone, Ranitidine and Zantac.  Patient skin returned to normal about 1 hour after drug intake.  Patient continues to have a sensation of itchy skin(bugs crawling on skin.)  Patient has taken Benadryl 5 times since event to relieve itchy skin.
Patient received the first dose April 12th, second dose May 19th. She reported that she felt ill for 4 days and missed work for 4 days. She left abruptly today and stated she just received a call from her physician that she has a current pulmonary embolism and to report to the ER immediatly.
This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. Concurrent conditions, medical history and historical drugs were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD injection, lot # N009775, expiration date 20-SEP-2018, for prophylaxis (strength, dose, route and anatomical location not reported), which was inappropriately stored. The reporter stated that the vaccine had been under temperatures from -14 °C to -10 °C for 360 hours, without a previous temperature excursion. The sterile diluent (MERCK) used for reconstitution of the dose of PROQUAD was properly stored. No adverse effects reported. This call was made because of a digital data logger. This is one of several reports coming from the same source. Sender's Comments: US-009507513-1712USA013124: US-009507513-1712USA014471: US-009507513-1712USA014472: US-009507513-1712USA014468: US-009507513-1712USA014469.
Developed what looked like a spider bite on right shoulder; painful for two days, additional red spots appeared over the next 4 days with rash extending now down upper arm.   Some spots starting to blister.  Very painful.   Suspect shingles.  There is some literature that suggests the COVID 19 vaccine and shingles may be related.
Got the booster shot and flu shot at the same time. I'd been having slight menstrual cramping for a few days so when my period came i wasn't surprised. What did surprise me was the following 3 weeks of light spotting and eventually EXTREMELY heavy bleeding I've had since. I've gone through 4 boxes of pads and haven't had a moments rest on this. Took several pregnancy tests (negative) and consulted my doctor about the issue. Was told to "keep an eye on it" due to my risk of stroke from medically induced hormonal changes.   The blessing won't stop. It's exhausting.
Information has been received from a physician concerning a 5 year old female who on 11-APR-2002 was vaccinated SC with a first dose of Varivax (lot#639899/0977L). On 05-JUL-2006 the patient developed chickenpox. Subsequently, the patient recovered. Additional information is not expected.
missed dose; 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 PRODUCT DOSE OMISSION ISSUE (missed dose) 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 PRODUCT DOSE OMISSION ISSUE (missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided Concomitant medication were not provided.
Patient began losing hair in January of 2022. It was late 2022 before a scalp biopsy confirmed lichen planopilaris, an autoimmune scalp condition. Patient being treated by dermatologist who did the biopsy.  Scalp still actively inflamed in patches. Hair still falling out somewhat. Much of hair loss may be irreversible. Patient also using a functional medicine MD using diet , exercise, stress management and supplements to try and turn off the autoimmune reaction.
No adverse event occured. We realzed on 11/16/23 that we administered full vial instead of 0.25ml. Therefoer, 0.5ml was given.
Hives and itching on wrist and abdomen. Currently recovering. BENADRYL once a day was prescribed. Treatment started 07/05/2018 and is ongoing. Second SHRINGIX dose was  not advised.
flu-like symptoms (i.e.,  chills, body ache, fatigue, severe headache and slight temperature) for approximately 24 hours
Teeth felt funny; Teeth grinding; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH DISORDER (Teeth felt funny) and BRUXISM (Teeth grinding) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products LEUPRORELIN ACETATE (LUPRON DEPOT) for an unknown indication and HYDROCODONE for an unknown indication.    No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started LEUPRORELIN ACETATE (LUPRON DEPOT) (unknown route) at an unspecified dose and HYDROCODONE (unknown route) at an unspecified dose. In January 2021, the patient experienced TOOTH DISORDER (Teeth felt funny) and BRUXISM (Teeth grinding). At the time of the report, TOOTH DISORDER (Teeth felt funny) and BRUXISM (Teeth grinding) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided by the reporter. Sulfa was also considered suspect and patient was allergic to sulfa and hydrocodone.  It was unknown if patient was enrolled in a COVID-19 vaccine trial. Treatment information was not provided.   This case was linked to MOD-2022-593774 (Patient Link).
Patient presented to the clinic 7 days after vaccination. Nursing notes, arm red, itchy started 2 days after receiving vaccination. Rash localized to the arm where he receiving the injection.
4 HIV pos pts recvd 4 doses of engerix-B one mo apart; p/1 mo waiting period, pts failed to sero-convert;
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R II which had lot # L012479 with expiry: 10-APR-2017, (dosing details not reported). No adverse effects reported. The vaccine with above lot number was exposed to a temperature excursion of 72.1 degree Fahrenheit for 1 hour 42 minutes, and it had no previous temperature excursion. It was detected by data logger. No further information provided. This is one of three reports received from the same reporter. Additional information has been requested.
Adverse Event: sore shoulder, body aches, headache, chills, low grade fever, severe back pain, slight cough, malaise, weak Treatment: bed rest and OTC pain relievers Length: 48 hours Outcome: back to baseline
blister pumps / upper part of the body, chest, both shoulders / upper part of the back / on the scalp / thin, raised / elongated shape blister; They are red / Red blister; are painful; fever; When brushing my hair / blistera / "busted and have a clear liquid not blood"; burning from the shoulders up / body was on fire from the button of my shoulders up; This case was reported by a consumer via call center representative and described the occurrence of blister in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced blister, erythema, pain, fever, blister rupture and burning sensation. On an unknown date, the outcome of the blister, erythema, pain, fever, blister rupture and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the blister, erythema, pain, fever, blister rupture and burning sensation to be related to Shingrix.  Additional information were provided as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient received 1st dose of shingrix and experienced blister pumps on the upper part of the body, chest, both shoulders and the upper part of the back.  The patient reported that, it has been 10 days to 2 weeks they are mainly on the scalp, red thin, raised, and they are an elongated shape blister,instead of round.  The reporter informed that they are painful and when scratched it was busted,while brushing his hair, it had clear liquid not blood. The patient reported fever and burning from the shoulders up described it as It was like my body was on fire from the button of my shoulders up. The patient stated that he was supposed to get his 2nd dose at the beginning or mid of February 2021. The batch and lot number were unknown. Till the time of reporting , there was nothing from the male breast down and symptoms have not resolved and it was getting worse. The reporter consented to follow up via email.
On 3MAY92, exactly 2 wks p/MMR vax pt covered head to toe w/macular bright red rash, palms beet red; eyelids labia edematous; edema, cranky, sl temp;
She was told by her hcp office that because she is taking methotrexate, the covid vaccine not effective; Immune compromised; Has taken two Pfizer vaccine shots and from the antigen test, it appears as if it didn't help; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 19Jan2021 (at the age of 63-years-old) as a single dose for covid-19 immunization and the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 10Feb2021 (at the age of 63-years-old) as a single dose for covid-19 immunization. Medical history included ongoing psoriatic arthropathy she was diagnosed almost 18 years ago when she was 49 years old. It is an auto-immune disease, autoimmune disorder, immunodeficiency. Concomitant medication(s) included methotrexate. Caller states her rheumatologist gave her an antigen test before the one on 10Jun2021 but she doesn't think was as clear as the more recent test. Her internist gave her the second test and her rheumatologist gave her the first test. First test was preformed: 02Jun2021. She was told by her hcp office that because she is taking methotrexate, the covid vaccine not effective. She had antigen test done and it showed no immunity. The patient reported that they are immune compromised and take methotrexate. They got a notice from the local hospital. The notice said that the vaccine is not effective for people who take Methotrexate and that they would need to take an antigen test, which she did. Her antigen test was very very low and it's as if she never took the vaccine. Caller would like to know about taking a 3rd dose. They want to know what they can do, because of right now, she has taken two Pfizer vaccine shots and from the antigen test, it appears as if it didn't help. They heard from the news that one person took a third shot and that worked like a charm. The patient underwent lab tests and procedures which included on 10Jun2021- dna test for fragile x: 6.5, lymphocyte count: 49.9 %, mean cell volume: 100, neutrophil count: 1.44, neutrophil count: 39 %, red blood cell count: 3.80, red cell distribution width increased: 17.8, sars-cov-2 test: unknown on 02Jun2021 she doesn't think was as clear as the more recent test. She had antigen test done and it showed no immunity, sars-cov-2 test: very low on 10Jun2021. She had antigen test done and it showed no immunity. Outcome of the event was unknown. No follow-up attempts are needed. No further Information is expected.
PUFF BALL ON THE COLLAR BONE ON THE LEFT SIDE; ARM WAS SORE; RED SPOTS CAME WITHIN A WEEK OR TEN DAYS/THEN THESE LITTLE DOTS ALL OVER THE ARM/SIZE OF A PEA; 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, and batch number were not reported) dose was not reported, administered on 28-MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the patient experienced arm was sore, and red spots came within a week or ten days/then these little dots all over the arm/size of a pea. On an unspecified date, the patient experienced puff ball on the collar bone on the left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm was sore, red spots came within a week or ten days/then these little dots all over the arm/size of a pea and puff ball on the collar bone on the left side was not reported. This report was non-serious.
Information has been received from a nurse concerning an unspecified number of patients. On unknown dates, the patient(s) were vaccinated with two improperly stored doses of ROTATEQ (dose, strength and lot # were not reported, oral). No adverse events were reported. This is one of several reports received from same source. Additional information has been requested.