chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An medical assistant (MA) had administered the incorrect medication (Pediarix) to a patient, when the order was for Infanrix. It is understood that what occurred was that the MA pulled infanrix from the cart and gave to the doctor to confirm. Per the doctor, he saw DTaP and did give the approval to administer the medication. The MA first administered the vaccine to the patient, followed by scanning the vaccine, and learned the vaccine administered was the incorrect pne due to a hard stop upon scanning. The MA informed the doctor. The doctor notified the patient's mother that they accidentally gave Pediarix and told her that the patient received an extra Hep B vaccine. The doctor reassured her that this was at a safe interval from previous (6 months administration) and to monitor the patient for side effects of vaccine administration. The patient expressed appreciation.
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 01-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
It started in my left thumb, and it felt like it was locking up and we left the restaurant. Then I started getting cramps in my legs and I had to get out the car and walked around for 10 minutes. About 30 minutes later everything went away. Then in April I went in for a surgery and when I came out, I was ill and had symptoms like body aches, headaches, abdomen pain (due to right adrenal bleed). When they took my bloodwork my Anti-phospholipid syndrome was very, very high and my inflammation level and clotting factors were high as well, highest it's been since 2018. Nobody seemed to know why they were so high.  I've had surgery in the past and didn't have issues with clotting. I ended up back in hospital due to adrenal bleed, my blood was very elevated. I was having terrible headaches and really sick for about 10 weeks. Then the leg cramps started 3-4 weeks later where my left foot was going to the side and my toe was sticking up in the air, and I'm still on the medication for the inflammation in the body. I do have Lupus but the leg cramps and stuff like that I've never had ever and the leg cramps, toe sticking up and foot sticking to the side comes and goes. I haven't had it for a week or two as of today.
a little injection sore pain; a little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Mar2021, outcome "unknown", described as "a little injection sore pain"; FATIGUE (non-serious) with onset 26Mar2021, outcome "unknown", described as "a little tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
deceased on 02/20/2022:  had covid 12/2021  and was admitted after a fall 2/13/22 with closed fx of nasal bone, sepsis, jaundice, anemia in setting  of myeloproliferative disorder.  placed on  comfort measures and  discharged 2-16-22  to hospice
A physician reported that a 4 year old male received a 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine) vaccine on 12/11/00, when he was 3 years old. On 11/5/01, he was admitted to the hospital to rule out appendicitis. On 11/6/01, he went to the OR for presumed perforated appendicitis but his appendix was normal. He was found to have "a lot of pus" in his abdomen. A swab was sent for culture. Lab data revealed a negative culture. The child was subsequently given a dx of nephrotic syndrome. No additional information was available as of the date of this report.
I went to be that night feeling fine, and woke up the next morning around 8:30 to testicles being extremely swollen and sore, to the point where I held an ice pack on them each night before going to bed. This lasted one entire week.
Swelling & soreness of (R) arm starting evening after vaccination, resolved to minimal soreness by 11/9. Blister type presentation around injection site, filled w/ clear fluid - referred to physician no redness.
Information has been received from a pharmacist referring to 2 patients of unknown age and gender. The patient's medical history was not reported. On an unknown date the patients were vaccinated with PNEUMOVAX23 (dose, lot# and route unknown). No concomitant medication was reported. The patients did not receive the same lot #/exp of PNEUMOVAX23. On an unknown date the patients experienced cellulitis at the injection site where PNEUMOVAX23 was administered. The outcome was unknown. The patients has sought unspecified medical attention. No product quality issue (PQC) was involved. Causality was not provided. Additional information is not expected since the reporter did not allow to follow up.
Entire arm red and swelling traveling into neck area. Lethargy, dizziness, confusion. Treated with Antihistamine plus steroid
Moderate to severe pain in the middle chest and upper middle back. Pain was not a stabbing sensation, but a tense dull sensation that would come an go in waves. Elevated heart rate. Pain caused dizziness and tingling in fingers and toes. Went to the ER after 4 hours of symptoms.
By the end of the night I was shivering, with a 102+ degree fever that has responded to ibuprofen and had gotten slightly better within the last couple of days but I still have a 101+ degree fever when not using ibuprofen (when waking up in the morning) it had only been 2 days but it is still very uncomfortable and the degree of fever at first was very scary
Initially appeared to be a syncopal episode, but while unconscious, exhibited myoclonic activity and possible airway involvement/apnea. SpO2 was 79% initially during this episode, but quickly bounced back up to 100% when he regained consciousness. EMS called due to possible airway involvement.  EMS arrived,, VS WNL at that time, however patient BP did not increase with postural changes (pt showed postural hypotension), so EMS transported him to local ED.  On 4/27/2021, I spoke with patient family to check in and patient mother reports that ED doc told her he was likely dehydrated and had a "severe syncopal" episode. Reports no adverse effects or expected effects from the vaccine and will likely return for his second dose. For second dose, our staff will ensure he is lying down supine for  vaccine administration.
Headache, Myalgia, inj site sore throat, muscle aches, foggy head, shortness of breath Narrative:
Parotitis  - Primary  Very swollen face on my right side (apposite side from injection site) On Thursday 3/11/21 (after injection Tuesday morning 3/9/21) woke with swollen right side of face. Eating painful. Friday extreme swelling, externally visible and very painful. Saw Dr. who started course of rimethoprim-sulfamethoxazole (Bactrim DS) 160-800 mg TABS. Over weekend swelling and pain went down, but it was a full 2 weeks before I felt almost all of the symptoms were gone. This is not a condition I have ever had before.
Woke up completely drenched and had fever and chills on. 4/27 and 4/28
Pt reported an immediate headache that lasted 5 days, refractive to OTC treatment.  On 5th day, had a syncopal event at work, EMS took to ER on 7/31/2021.   Negative organic work up.  Developed left upper arm numbness and facial twitching day 10 (5 days after hospital treatment).  No meds given at the hospital.
mild dizziness; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (mild dizziness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, GERD and Osteopenia.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 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 DIZZINESS (mild dizziness). At the time of the report, DIZZINESS (mild dizziness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: normal (normal) Normal. On an unknown date, Metabolic function test: normal (normal) Normal. On an unknown date, Thyroid function test: normal (normal) Thyroid panel normal. On an unknown date, Vitamin D: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIZZINESS (mild dizziness) to be possibly related.    No concomitant medications were reported.  No treatment medication were reported.   This case was linked to MOD-2021-278255, MOD-2021-276754 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: follow-up information included no new information
This spontaneous case was initially received on 11-May-2016. The case report was received from a Non Health Professional and concerns a 63 year old female patient. Linked case: US-BEH-2016062653 (same reporter). Weight: 135 pounds, Height: 5 feet 6 inches. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Fibromyalgia and Migraines. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 26-Sep-2015 - 26-Sep-2015, Batch no: 11549221A, Route of administration: Intramuscular, Dose: no information provided. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 27-Sep-2015 (the next morning), the patient woke up extremely dizzy. Dizziness comes and goes. The patient underwent a sinus scan and was going for a brain scan. The outcome was not yet recovered.
Client received adult Pfizer dose (30mcg) instead of Pediatric Pfizer dose (10mcg).
While giving the AFLURIA vaccine to member is was discovered that the vaccine was partially frozen due to improper storage.
Left mid arm with 5 cm firm erythematous slightly raised warm area of skin. No vesicles or skin breakdown. Feels a little itchy, not painful. Recommend ice. Continue to observe, expect will begin to improve after tomorrow.
Headache, fever, chills, fatigue approximately 12 hours after vaccine. Followed by nausea and vomiting approximately 15 hours after the vaccine which lasted 8 hours. Fever remained for 24 hours.
VOMITING,FEVER OVER 104,CHILLS,CONGESTED,HEADACHE
nose running; shortness of breath; hot / cold chills; hot / cold chills; bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (nose running), DYSPNOEA (shortness of breath), FEELING HOT (hot / cold chills), CHILLS (hot / cold chills) and HEADACHE (bad headaches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced RHINORRHOEA (nose running), DYSPNOEA (shortness of breath), FEELING HOT (hot / cold chills), CHILLS (hot / cold chills) and HEADACHE (bad headaches). At the time of the report, RHINORRHOEA (nose running), DYSPNOEA (shortness of breath), FEELING HOT (hot / cold chills), CHILLS (hot / cold chills) and HEADACHE (bad headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported.  Treatment information included cold tablets.
Pt eyes got puffy 1/2 hr after vaccine. 1 hr. later worse puffiness with redness. By next day rash around (R) eye & neck area & hands. Slight to thighs. High fever - per mom up to 105.
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient with asthma and sulfonamide allergy who on 02-APR-2009, was vaccinated with the first dose of 0.5ml of GARDASIL (Lot#: 662229/1497X). On 02-DEC-2009, the patient was vaccinated with the second dose 0.5ml of GARDASIL (Lot#: 662229/1497X). On 29-APR-2010 was vaccinated with the third dose 0.5ml of GARDASIL (Lot#: 662529/1317Y). Concomitant therapy included albuterol as needed. The physician reported that the patient received the third dose on 29-APR-2010, and a pregnancy test at that visit was negative. She was seen in the office on 28-APR-2010, and a urine for pregnancy was positive. Last Menstrual Period (LMP) was on 01-APR-2010, Estimated Date of Delivery (EDD) is on 06-JAN-2011. Follow up information has been received from a physician. The physician stated that the patient electively terminated her pregnancy on 06-JUL-2010 due to personal reasons. The physician did not have any other information. Upon internal review, electively terminated her pregnancy was determined to be an other important medical event. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient began to felt chest pain; Patient began to vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Patient began to felt chest pain) and VOMITING (Patient began to vomiting) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Dec-2021, the patient experienced CHEST PAIN (Patient began to felt chest pain) and VOMITING (Patient began to vomiting). At the time of the report, CHEST PAIN (Patient began to felt chest pain) and VOMITING (Patient began to vomiting) had not resolved.            No concomitant drug details were reported. No treatment details were reported.  Treatment details include Diuretic.   Reporter did not allow further contact
Fatigue, chills, fever, headache, body ache, right sided chest pain, neck pain, left arm pain at site of injection.
No adverse reactions. Vaccine expired 06/31/2022 from manufactory date of October 2021. Patient was given injection 1 day past expiration date. Patient reports no adverse reactions and no problems when contacted.
Initial report received from a health care professional on 09 Dec 2009: This patient (37 months) inadvertently received FLUVIRIN 0.5 ml on 07 Dec 2009. No adverse events were noted upon administration. The outcome of the event was not reported. Following an internal review done on 11 Feb 2010 of the data received on 09 Dec 2009 following changes was made: The event coding was changed to off label use.
TACHYCARDIA; VERY HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 04321A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the patient experienced tachycardia. On 14-APR-2021, the patient experienced very high blood pressure. Laboratory data included: Blood pressure (NR: not provided) very high, Electrocardiogram (NR: not provided) tachycardia, Lab test (NR: not provided) negative, and Pulse rate (NR: not provided) 130 {beats}/min. Laboratory data (dates unspecified) included: Cardiovascular evaluation (NR: not provided) not reported, and Lab test (NR: not provided) not reported. Treatment medications (dates unspecified) included: metoprolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tachycardia, and very high blood pressure. This report was non-serious.
From notes written by responding RN on day of event: Patient appeared normal for first few minutes after vaccine administered.  Then she walked to car on her own along with her partner to wait 15 minutes in her car.  10 minutes after going to car, partner returned to report something wrong.    Partner reported he was talking to patient one minute and she was talking and the next minute she was not talking; said her face twitched a little and she looked like she had passed out.   RPh and RN responded to car immediately and reclined patient?s car seat.  Patient was awake but not fully alert.  Answered questions with one word answers; color pale; lips pale; BP 92/58; pulse slow & regular at 58.  Patient responded that her throat didn?t feel scratchy or swollen.  RN, using stethoscope, reported lungs wheezing/crackles.  No rash on face or arms.  No facial edema. Within 5 minutes of getting to car, patient was awake and answering questions correctly; she was easy to understand.  Drank a few sips of soft drink.  Color less pale; skin warm/dry.  BP 111/68; pulse 78 regular.  Suggested to patient that she remain supine.   About 10 minutes later, patient stated feeling faint again.  In response to question about what she had eaten that day, she said ?nothing?.  A package of peanut-butter crackers were provided. Patient felt better immediately. About 15 minutes later, patient continues to feel fine; allowed her to leave with partner driving.   At 6pm, called to check on patient;   reported feels fine; no more problems
Chills, nausea, headache, fatigue, fever 101.2F,  body aches, muscle cramps, joint pain, severe tinnitus.
twinges in my head; arthritis; bone pain,bones of shoulder and hip, sitting or laying down, hur; allergies in my head; knees hurt; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (twinges in my head), ARTHRITIS (arthritis), BONE PAIN (bone pain,bones of shoulder and hip, sitting or laying down, hur), HYPERSENSITIVITY (allergies in my head) and ARTHRALGIA (knees hurt) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029H20A and 013620A) for COVID-19 vaccination.     Concomitant products included LOSARTAN and LORATADINE for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced HEAD DISCOMFORT (twinges in my head), ARTHRITIS (arthritis), BONE PAIN (bone pain,bones of shoulder and hip, sitting or laying down, hur), HYPERSENSITIVITY (allergies in my head) and ARTHRALGIA (knees hurt). The patient was treated with DICLOFENAC POTASSIUM (VOLTAREN ACTI) (topical) at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (twinges in my head), ARTHRITIS (arthritis), BONE PAIN (bone pain,bones of shoulder and hip, sitting or laying down, hur), HYPERSENSITIVITY (allergies in my head) and ARTHRALGIA (knees hurt) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
I woke up with a scratchy throat and didn't feel right. The next day, I woke up and tested myself for COVID-19. The result was positive. I called my doctor's office to get medication. I don't remember the name of it. We picked up the prescription. I took it for the prescribed course. I tested positive for COVID-19 during that time. I had a hard time sleeping. I had a lot of phlegm. Otherwise, it wasn't that bad. Towards the end of 10 days, I tested negative for COVID-19, but I still felt very weak. After a few days, I tested positive for COVID-19 again. I called my doctor back. They told me to quarantine again. After 10 days, I tested negative again. A few days after that, I came down with Bell?s Palsy. I went to the hospital to confirm whether it was Bell?s Palsy or a stroke. They ran tests and prescribed more medications. It took several weeks to get over it.
Patient had swelling  "like an egg" , rash, and  fever in arm at site starting the night she received vaccination. Patient said she had same with the first dose (opposite arm) that lasted at least a week. Pharmacist recommended tylenol and benadryl for "COVID arm" symptoms.
yellow fever vaccine was mixed with a sterile diluent instead of the diluent that came with the vaccine with no reported adverse event; Initial information received on 27-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom who given yellow fever vaccine - [YF-VAX] that was mixed with a sterile diluent instead of the diluent that came with the vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included typhoid vaccine (TYPHIM) for Immunisation.  On 27-Jan-2023, the patient received 0.5 ml once (1X) (total) dose of suspect yellow fever vaccine, solution for injection (strength; not reported; lot UJ563AA; ,Expiration Date :23-May-2023) via subcutaneous route in the left arm for Immunization was mixed with a sterile diluent instead of the diluent that came with the vaccine with no reported adverse event (product preparation error) (latency; same day).  Action taken: not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.