chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a physician referring to a patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported. In 2015, the patient was vaccinated with two doses of GARDASIL series, (unknown if it was GARDASIL) (dose, route, lot# and expiration date was not reported) or GARDASIL 9 (dose, route, lot# and expiration date was not reported)). On 18-JUL-2017, the patient received the third dose of GARDASIL series with GARDASIL 9) (dose, route, lot# and expiration date was not reported) for prophylaxis (inappropriate schedule of drug administration and interchange of vaccine products). No adverse effects were reported.
Lot of blisters inside my mouth and I was just miserable. I wasn't able to eat for three days, It was really difficult; Lot of blisters inside my mouth and I was just miserable. I wasn't able to eat for three days, It was really difficult; Lot of blisters inside my mouth and I was just miserable. I wasn't able to eat for three days, It was really difficult; My blood pressure was of some concern; I was so sick; mouth is full of sores; it's was an antibiotic, it's Clindamycin I didn't take it because my daughter who is in medical field thinks it probably a viral infection not bacterial.; it's was an antibiotic, it's Clindamycin I didn't take it because my daughter who is in medical field thinks it probably a viral infection not bacterial.; This is a spontaneous report from a contactable other Nurse (Patient). An 85-years-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EN6201) via intramuscular route of administration in left arm on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history included hypertension and atrial fibrillation. The patient's historical vaccine included bnt162b2 (Lot number: EL3247) with pain in extremity as reaction. Concomitant medications included alprazolam (ALPRAZOLAM), apixaban (ELIQUIS) taken for atrial fibrillation, furosemide (FUROSEMIDE), losartan (LOSARTAN) and propranolol (PROPRANOLOL). The patient was a retired nurse and stated that her first injection was just perfect, little it of a sore arm and that was all. She started that the injection that she got a week prior for the second injection she was okay until the next day, and then she got a lot of blisters inside her mouth and she was just miserable. She wasn't able to eat for three days. It was really difficult and she just wanted to know if anyone else had that kind of symptoms. She was sure had troubles with that. She stated she was so sick, yesterday at a clinic and her biggest problem was her mouth was full of sores. They did take her blood work and said it was ok. Her blood pressure was of some concern. The patient stated that they gave her four different things. They gave her Ondanse, lidocaine for pain and Valacyclovir. She did not take Valacyclovir as it was an antibiotic. She did not take clindamycin because her daughter, who is in medical field thought it probably was a viral infection and not bacterial. The outcome of the events was unknown.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Left olecranon bursitis; swelling of left elbow; inflammatory polyarthritis/Inflammatory polyarthritis; seronegative rheumatoid arthritis; Pain; Stiffness; Synovitis present over the wrists right greater than left; This case was reported by a lawyer and described the occurrence of inflammatory polyarthritis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced inflammatory polyarthritis (serious criteria GSK medically significant). On an unknown date, the outcome of the inflammatory polyarthritis was unknown.   It was unknown if the reporter considered the inflammatory polyarthritis to be related to Shingrix.  The initial information received on 29 September 2020 via medical records. As per the records date 08 April 2018, the male patient had concurrent condition of Hypertriglyceridemia and High density lipoprotein deficiency. As per the pharmacy records dated 29 September 2018, the male patient received SHINGRIX 50 mcg Injection intramuscular. As per the record dated 11 March 2019, he had been off of prednisone for about a week. At that time, he had pain is rated 1 and Stiffness of 5 min. Inflammatory polyarthritis, seronegative rheumatoid arthritis. He was on prednisone 2.5 mg a day and prednisone 5 mg per day. As per the records dated 09 January 2018 he had total knee arthroplasty and on 09 January 2016, he had joint replacement knee surgery. On 07 December 2018, he had Synovitis present over the wrists, right greater than left. On 06 September 2019 he had 1 week of swelling left elbow, causing pain, sore to touch. As per the records dated 12 February 2020, he had mild warmth noted around the left elbow and olecranon bursa.
Mother called--stated that child has a few pimple like bumps--has had fever for 3 days--as high as 101 degrees. Has loss of appetite also.
Looked and felt like bug bites, turned red with liquid inside, itchy.  After 2 weeks working with Terminix it was suggested that I had an allergic reaction to something.  Took Benadryl Allergy Diphenhydramine HCI 25 mg. and it stopped.  Right eye dialated and left one did not for several hours.  Washed eye out and took one drop of Naphcon A eye drops.  Situation corrected itself within 1/2 hour and never returned.  This occurred on 2/10/21
missed dose; 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.  Treatment information was not reported.   Reporter did not allow further contact
Period 3 days late; body aches; Fever; chills; Head ache; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 27-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Unknown dose number single for covid-19 immunization. No medical history and no concomitant medications were not reported. patient was not diagnosed with COVID-19 Prior to vaccination. On 22Apr2021 patient experienced period 3 days late, Fever, chills, body aches, headache, fatigue. Since the vaccination patient was not tested for COVID-19. Patient did not receive any treatment for the events. The outcome for the event Period 3 days late was resolved on 25Apr2021and for remaining events outcome was reported as resolved on an unspecified date in May2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recvd vax 10AM & slept all afternoon, evening had projectile vomiting 2 times & had a high-pitched scream for several hrs off & on; fussy, had been vomiting 1 x/day; MD has been switching formula; p/vax vomiting wasn't much more forceful
This spontaneous report was received from a registered pharmacist refers to 3 female patients of unknown age. On an unknown date the patients were vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). On an unknown date the patients developed potential shingles like rash around the injection site. The outcome of potentia; shingles like rash was unknown. Causality was not reported. Additional information has been requested.
This spontaneous report was received from a healthcare professional refers to a 60 years old female patient. The patient was vaccinated with a dose of ZOSTAVAX (dose, route not reported, lot # reported as H012575) on 16-OCT-2012. On 17-OCT-2012 the patient experienced baseball size around injection site, red from shoulder to elbow. The patient was advised to take BENADRYL as directed and apply cold compress. It was reported that the patient did not seek medical attention. The outcome of adverse events was reported as unknown. The relatedness for baseball size around injection site and red injection site, from shoulder to elbow is unknown for ZOSTAVAX. Additional information is not expected.
A non-serious, spontaneous report of administered expired product was received from a nurse concerning a six-year-old male, subsequent to FLUMIST. The patient received FLUMIST on 20-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause of the medication error were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information on 31-Mar-2009: included Product Complaint Investigative results.
Hospitalization 04/04/21, DISCHARGED 04/29/21. Received Remdesivir 4/6/21-4/10/21, dexamethasone 6 mg IV twice a day 4/6-4/16.
Rash to bilateral chest and left shoulder/axillary with reported burning sensation to affected area 5 days post smallpox vaccine.
Headache, fever, body aches, nausea, chills, hot flashes - from about 10pm the night of the vaccination, and still going now (130pm the next day)
Body aches, joint pain, fever (tmax 101F),  Mentally fog, fatigue  Left sided Headache, dizziness, and I couldn?t hear out of my left ear. These symptoms peaked approximately 12 hours after the vaccine. They lasted for 24 hours. The next day, the fever was gone and the only symptom I had was fatigue. 48 hours after the vaccine all my symptoms had resolved.
After receiving the vaccine, patient was observed to have muscle spasm. Patient has history of seizures.
This is a spontaneous report from a contactable pharmacist. A 38-year-old male patient received the 1st dose of BNT162B2 (Comirnaty, solution for injection; batch/lot# and expiry dates not reported), via unspecified route of administration, on unknown date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On unknown date, patient experienced metallic taste in his mouth, which lasted for 24 hours after he received the 1st dose. The patient was about to get the 2nd dose of the Pfizer-BioNTech COVID-19 vaccine. The pharmacist would like to know whether it is safe for the patient to take 2nd dose despite the reaction he had with the 1st dose. The outcome of the event recovered (at the time of report). The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
client given vaccine that had expired 12/22/21.  Vaccine given in right deltoid. client tolerated well with no signs or symptoms of adverse reactions.  Medical Director notified and advised that client should not be redosed unless directed by manufacturer. Manufacturer notified and given details of incident. Manufacturer to provide guidance from medical guidance team.
devel facial hives w/in 5 mins given DPH w/good resolution of hives; no resp distress;
Left arm -severe pain, numbness and tingling in left hand (occurred within a few hours of receiving vaccine). Left leg numbness and tingling from left hip all the way into left foot.  Woke up with this on 3/27/2021. No recent low back injury. Did have a 2-disc lumbar fusion in 2001 that I have never had a problem with. Never had any low back pain, no further injuries, no leg symptoms/sciatica ever since 2001. Left leg feels like I sat on it for a long time and it went to sleep and now it is ?waking up? with pins and needles and numbness.  It will not subside. Been going on for almost 6 hours (how long I?ve been awake).
After patient received this vaccine dose, it was discovered that the vial had been stored outside of the recommended temperature range calling into question its efficacy  After conferring with immunization experts it was determined that this dose needs to be repeated.  Patient was contacted by the person completing this form and made aware of this information.  The patient is unsure if she plans to repeat dose.
10 days after receiving my Moderna booster (first 2 doses were also Moderna), I began exhibiting symptoms of itchy, watery, swollen eyes.  The next day, I woke to find hives covering about half my body.  The following 2 days were symptomatically the worst with a very itchy red rash that would flare up in areas with even modest friction against the skin.  Over the next several weeks, the rash lessened greatly and is now almost completely gone.  I have been taking Benadryl (maximum daily dose) since the onset.
Moderna COVID-19 vaccine EUA about 1 day after receiving the vaccine, I developed chills, an elevated temperature & a headache for several hours. When I awoke the next morning the chills & temperature were gone. I still have a significant headache & I feel quite tired.
Mother misrepresented child's age by stating he was 5y/o.   Child received Pediatric dose (.2cc) of Pediatric Pfizer.
Started with Tingling in Upper Right Leg, Chest Pain and Shortness of Breath, Constant Headaches. Passing out, Light headed and dizziness. Joint Pain and All Day Headaches. More recently Been having Sharp pain in kidney areas and back pain and Constant headaches. Tingling throughout whole body at times.
Behavior changes with in 1-2 days. Aggressive, combative, argumentative with friends, staring off into space, enough that it bothered mom. Lasted 1 week.
No knowm symptoms. She never called to say she is having a reaction to the immunization that was given. Dr ordered to give a Tdap but the nurse gave her a Dtap.
Non blanchable rash on abdomen (purpura) and abdominal pain for 3 days.
about 7 or 8 (about 9pm) hours after I received the vaccine my arm started to hurt and became very, very tender, sore and painful.  In the next couple of hours I began feeling bad. Throughout the night it just got worse with severe body aches, headache, fever, dizziness, and some nausea at times.  It is 1:30 pm the day after vaccine and I still have these adverse symptoms.
About a week after receiving the booster I developed hives. My primary doctor told me take Benadryl. I was then referred to an allergist. I was allergic to pretty much everything the allergy panel tested for. I was prescribed a daily allergy medication. If I do not take the medication I would get hives again everyday. The allergist stated it might be a reaction to the booster. In about a month or so I may have another allergy panel test done.
soreness; loss of appetite; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration in right arm on 23Mar2021 (at the age of 29-years-old) as single for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies to medications, food or other products. There were no concomitant medications.The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On an unknown date patient experienced fatigue, soreness and loss of appetite. The patient did not received treatment due to the events. The outcome of events was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Within a month or so started to have hypersensitivity in both legs to vibrations wherever I am, the feeling of vibrations of items running being transferred up through my feet and legs. Shortly after that I started having  spider crawling feelings in both legs, like my muscles in my legs are moving, this has continued up to this date.
possible sinus or tooth infection; possible sinus or tooth infection; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was scheduled to take the second dose of the COVID-19 vaccine on Saturday, 20Mar2021. She was just put on an antibiotic for a possible sinus or tooth infection. She was put on Clindamycin. It was stated that she went to the dentist for her tooth infection and was prescribed clindamycin which she has taken one dose of. It was asked if there were any interactions with the vaccine and the drug. She would like to know if the antibacterial drug she took would possibly affect the vaccine effectiveness. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates the patient was vaccinated with improperly stored GARDASIL (lot # L008560 with expiration date 15-JUN-2017, lot # L019297 with expiration date 18-AUG-2017, lot # reported as L043213 with expiration date 28-AUG-2017, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 35-year-old female patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 02-Dec-2010. The patient received the expired FLUMIST on 08-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
fatigue; pain at injection site (left) arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection site (left) arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection site (left) arm). On 06-Mar-2021, VACCINATION SITE PAIN (pain at injection site (left) arm) had resolved. On 07-Mar-2021, FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  No treatment information was provided.
1.) Strong soreness in lower back and gut area. Hard to bend over. I don't typically suffer from back pain and didn't exert or do anything that might have strained muscles. Pain seems muscular in back and deep in lower gut/groin area in front.  2.) More concerning is the tinnitus or ear ringing I am experiencing. Very loud and unrelenting. Feels like ears need to be popped such as when air pressure changes. However, can't swallow hard or chew hard enough to clear ears. It's a bit flummoxing as it is unrelenting. Sounds like cicadas in my head.
The pt experienced dizziness, and hard time focusing. This will last for 2-5 minutes 2-3 times a day and 2 days a week. Blacked out yesterday while driving and 2 weeks ago noticed a lump on left side. Had upset stomach X 2 weeks. Something gave him a rash. He states he felt well yesterday morning. At about 08:00, he took his daughter to school and while driving back, his vision went away and lasted about 30 seconds; couldn't see anything. His body felt fine and slowly over 15-20 minutes, his vision came back. He went to work but felt a little dazed the rest of the day. Today, he has epigastric pain. Dx'd as symptoms most likely due to migraine, new onset and epigastric pain due to PUD or gastritis. Also, planar fasciitis discussed and info given and arch supports. Follow-up visit on 11/9/99, has some nasal congestion. I think his episode last week was vertigo and his episode last month was a migraine. On 12/22/99, here for 5 days of congestion, body aches all over and weakness. Also, has a non-productive cough with wheezing and SOB. He has a feverish feeling, sinus congestion and some diarrhea. On exam, he has right basilar crackles. Dx'd with bronchitis and URI and rx'd Erythromycin 250mg qid; Azmacort 4 puffs 1id 1X2. Seen on 6/19/00 and dx'd with HTN; fatigue; lack of sleep; cough; sore throat X 10 days and treated with Atenolol 50mg po. Continue with Thera-flu and fluids. Seen on 5/31/01 with dizziness and headaches; brief blurred vision X 2 years and neck pain. Discussed with pt headache due to tension and stress. On 7/24/01, has slight tender lump on left thorax X months, nodes on left upper extremity and back that he wants excised. Unclear if he wants left thorax lump off. He is concerned if it may be cancer. Dx'd with limpoma and moles. Dermatology referral for mole excision. Seem 8/27/01 with feeling tense, headache and anxiety attach 2 X and went to ER on 8/3/01. Treated with cyclobenzaprine; diazepam 5mg. Added Hytrin 2mg 1 po qhs 60, Serax 10mg 1 po bid.  Follow up 07/02/2001: "Dizziness and visual disturbances persist.  New onset headaches "behind head" over past 6-7 months...therefore patient has not recovered from adverse event.  Patient however, is on full duty status."
The granuloma annulare continued to spread after the booster on my face, legs and arms. My dermatologist prescribed two steroid creams for relief. In February I experienced severe knee and leg pain. I went to see my doctor and was diagnosed with osteoarthritis.
Vacciantor unpackaged syringe and needle and proceeded to given deltoid injection with out having drawn up the vaccine.  No air injected.  Patient informed of situation.  Correct Moderna dose then given.