chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 74 year old female consumer with allergy to sulfa, reporting on herself. The patient's medical history included skin cancer, cataract operation and a mild case of shingles on the auditory nerve on the left side of her face. In approximately 2007, (reported as "9 years ago"), the consumer stated that in this time the rash appeared did not blister and it looked like an allergic reaction and after two weeks she recovered from it. In June 2016 (reported as "about one month ago"), the patient was vaccinated with ZOSTAVAX 1 shot, subcutaneous (strength, lot # and expiration date were not reported). Concomitant therapies included SINGULAIR.. The consumer reported that on 29-JUN-2016 (reported as "last Wednesday"), she developed another rash on the cheekbone, she described it as looking like a bug bite. However, on 04-JUL-2016 (reported as "yesterday"), developed another bump around her eye, after which she visited her physician The physician performed an eye stain after confirming shingles (herpes zoster) and stated that the optic never and eye was not infected. Furthermore, the patient added that the rash was milder than her previous case, and that it did not hurt or feel inflamed, but rather the spots themselves were sore. The patient was given Acyclovir and was recovering. Additional information has been requested.
Headache, Fever, Muscle Aches, pain where shot was given, tired, weak.
Information has been received from a medical assistant concerning a 9 year old male with autism, behaviour disorder, adopted child, anxiety and impulsive and a history of cardiac murmur (2005) who on 21-NOV-2001 was given the first dose of VARIVAX (Merck) and on 12-AUG-2009 was given the first dose of VAQTA. On 02-JUN-2010 was vaccinated with a second dose of VARIVAX (Merck) (lot # 0064L which is valid for famotidine IV, exp: January 2012) in the left arm and VAQTA (lot # 667827/0416Z, exp: February 2013). Other concomitant therapy included "respivadol", "medferman", lithium and CELEXA. On 04-JUN-2010 the patient experienced large, red, warm area on the left arm at the injection site. Shortly after the patient developed spots all over the body. On "16-APR-2010", the mother reported he was still weak but recovering. On 04-JUN-2010, the patient was given BACTRIM DS. At the time of the report, the patient was recovering. The patient sought medical attention by office visit. Additional information has been requested.
61y.o. male who presents for the above issues. Patient is confused during exam with poor recall. Had recent admission for confusion related to covid-19 in setting of cirrhosis. He was managed supportively. He is stable for discharge to SAR with close outpatient follow-up. Discussed management plan with patient at bedside and wife over phone.
Nerve pain on injection side; Headache; Low grade fever; Site pain; Spontaneous report received on 19SEP2019.  A female consumer reported that she experienced nerve pain on injection side (PT: Neuralgia), headache (PT: Headache), low grade fever (PT: Pyrexia), and injection site pain (PT: Injection site pain), following immunization with BioThrax. On 17SEP2019 at 01:30 PM, she received a dose of BioThrax by intramuscular route in the left arm. On the same day, at 2:15 PM, she experienced low grade fever (101 degree Fahrenheit), which lasted for 18 hours, along with a headache which was also lasted for 18 hours. In addition, she also had nerve pain on injection side. She recovered from the reported events headache, low grade fever, and site pain on 18SEP2019 at 08:00 AM, while she did not recover from the event nerve pain on injection side.  Treatment medication included oral Naproxen (400 mg).  Medical history included fever/ pain post vaccination with diphtheria tetanus and pertussis (Dtap), at age 29 years and fever/ arthritis post vaccination with measles, mumps, and rubella (MMR) vaccine, at age 31 years.  Company comment: The described events "headache, low grade fever and injection site pain" are known effects of Biothrax, and therefore are considered to be causally related to the administration of Biothrax. The event nerve pain on injection side is likely due to the local reaction at injection site and causally related to the vaccine.; Sender's Comments: Company comment: The described events "headache, low grade fever and injection site pain" are known effects of Biothrax, and therefore are considered to be causally related to the administration of Biothrax. The event nerve pain on injection side is likely due to the local reaction at injection site and causally related to the vaccine.
Patient received 12 yrs old and up Pfizer vaccine instead of 5-11 yr old Pfizer.
severe adverse reactions such as swelling of the arms and legs; This is a spontaneous report from a contactable Physician.  A patient of unspecified age and gender received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient had severe adverse reactions such as swelling of the arms and legs. The patient had seen every type of specialists and none of them can't find any reason for the swelling (visit of physician office). Caller is needing some guidance and information on what to do with these allergic reactions. At the time of this report outcome of event was unknown.  Lot number for the vaccine, was not provided and will be requested during follow up.
A spontaneous, non-serious report of type B influenza has been received from a certified medical assistant concerning a four-year-old female patient subsequent to FLUMIST use. Medical history and concomitant medications were not reported. On or about 27-Sep-2009, the patient received FLUMIST. On 30-Sep-2009, the patient presented to the doctor's office with a fever of 101 degrees Fahrenheit. She tested positive for type B influenza. No further information was available.
Increased nasal drainage and stooling throughout the course of the day of 5/27/07 - received vaccine the morning of 5/24/07. Sudden onset of full-body rash (with the only exceptions being the hands and feet) at 1830 hrs following diaper change, bath, and dressing since 1800 hrs. Red spot appeared at the spine in the low back at 1900 hrs; we are watching for more. I believe this is a rare reaction to the Varicella - this is reported over Memorial Day weekend; not all information is available at the time of submission.
8 days after shot woke up with an itchy injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (8 days after shot woke up with an itchy injection site) in a male patient of an unknown age 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (8 days after shot woke up with an itchy injection site). At the time of the report, VACCINATION SITE PRURITUS (8 days after shot woke up with an itchy injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information on concomitant or treatment medications was reported   Reporter did not allow further contact
Initial and follow-up information has been received from a pharmacist concerning a 3 month old patient who was vaccinated with a dose of Pneumovax 23 instead of Prevnar. The pharmacist reported that the event was a mistake in dispensing by the pharmacy. A new pharmacist filled the order for Pneumovax 23 instead of Prevnar unaware of the difference in the products. The nurse on the floor did not check the order carefully, just seeing "pneumococcal vaccine." The pharmacist stated that in response to the event, the vaccines are now stored at opposite ends of the pharmacy and that the new pharmacist and nurse were provided with more education on the products. The patient sought unspecified medical attention. There were no problems were noted. Additional information has been requested.
Patient wife received call from me stating that they were both due for their follow up vaccines in the shingrix series. She stated that her husband should have never received both the shingles and flu shot and that due to receiving both on the same day he then the next day passed out and was hospitalized.
The pt woke up in the middle of the night screaming with a hoarse voice. The pt experienced hives on face with swelling and on abdomen. Mother called ER in the afternoon and was advised to give him Benadryl.
Initial report received from a health care professional on 11 February 2011. A 58-year-old male patient received on 01 September 2010 a right deltoid injection of FLUZONE 2010-2011, sanofi pasteur Inc. lot number U3567BA. The patient had an allergy to sulfa drugs. He had no illness at the time of vaccination, no other vaccinations within 4 weeks of FLUZONE and took no concomitant medications. The patient had received yearly doses of INFLUENZA in the past. In mid November 2010, the patient was seen in the Emergency Department (ED) for flu like symptoms of chills, fever, congestion, cough and runny nose. The patient had an influenza test performed from a nasopharyngeal swab. The patient was discharged from the ED on antibiotics (name not provided). The patient reported that the influenza test was positive for influenza type A but no sub strain information was provided. The outcome was reported as recovered. Documents held by sender: None.
8 days after injection developed erythema (approx. 9cm) and itching at site
I experienced a sore throat, congestion, muscle aches, fatigue, and malaise more than a month after the booster shot.  I was tested for covid and strep throat and both came back negative. My doctor prescribed fluticazone nasal spray to help clear the congestion.  My symptoms abated after 4-5 days.  I think this was simply the common cold, unrelated to the booster shot
Nasal passage swelling,  dizziness,  nausea, headache. First 3 symptoms were within 10 minutes of vaccine. Headache was 4 hours later. Vitals were checked onsite
pt recvd vax 315PM presented to hlth dept 30MAR94 @ 8AM w/raised, red, confluent rash on both arms only; also c/o h/a & being lightheaded; didn't appear in distress; next 2-3 days also told that rash was results of an allergic react to HBV;
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The patient's husband reported the case. The age at vaccination was not reported. The patient got the shingles shot last year and went to doctor, the day before reporting day because she had the shingles. The patient was not happy. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.
Patient had seizures two days after receiving vaccines. Hospitalized & released. Dr will not give this pt DTaP again.
I'm afraid I'm not going to be able to do this, as I'm dealing with a severe health challenge; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION COMPLICATION (non-serious), outcome "unknown", described as "I'm afraid I'm not going to be able to do this, as I'm dealing with a severe health challenge".  Additional information: I'm afraid I'm not going to be able to do this, as I'm dealing with a severe health challenge that has appeared this year (not unrelated, I believe, to the mRNA vaccines, as it happens).   The lot number for bnt162b2 was not provided and will be requested during follow up
testing positive for COVID; testing positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Oct2021 as dose 3 (booster), single (Lot number: EW0175) at the age of 69 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "emphysema" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; LISINOPRIL; HYDROCHLOROTHIAZIDE; ATORVASTATIN; XHANCE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "testing positive for COVID". The patient underwent the following laboratory tests and procedures: COVID-19: (Apr2022) Positive; (11May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Swollen lymph node in armpit under left arm. (I'm guessing it's a lymph node, as I'm not a doctor.) Can feel a bump when I press on the area, pain is minimal but there. Hasn't gotten bigger, but is pretty decent in size. Wasn't there until yesterday afternoon.
One week after vaccination pt. called H.D. and stated her arm (below injection site) became swollen and red on Sunday- 5 days after vaccination. Pt. became alarmed and went to ER last night and also saw MD today.
Pt was fine during vaccination. instructed pt to wait in waiting room for 15 min for observation.  Within about 5 minutes pt had passed out. Another pt in the waiting room alerted us to it.  I went out and pt came alert very quickly.  I asked how he was feeling.  He said shaky and a bit warm.  I called 911 and also asked advice from Clinic.  We put his feet up and gave him water.  Pt was more alert and talkative.  He then said it did happen once before as well.  It appears pt had a vasovagal syncope.  The fire dept came and checked him out. Mom and Dad came and took him home.
The baby received the DTaP, Hib, IPV, PREVNAR, rotavirus, FLUZONE in the am. By night, he developed at a temp of 104.8 degrees and was fussy. He was seen at local ER.
ear infection; Sore neck; Hoarse voice; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR INFECTION (ear infection), NECK PAIN (Sore neck) and DYSPHONIA (Hoarse voice) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced NECK PAIN (Sore neck) and DYSPHONIA (Hoarse voice). On an unknown date, the patient experienced EAR INFECTION (ear infection). At the time of the report, EAR INFECTION (ear infection) outcome was unknown and NECK PAIN (Sore neck) and DYSPHONIA (Hoarse voice) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The patient took Tylenol as treatment medication.  The patient went to see the doctor, and his doctor diagnosed him with an ear infection. His doctor reported his sore neck and hoarseness were due to ear infection.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Patient diagnosed with ear infection.
This spontaneous report as received from a physician who was also the patient's mother via company representative and refers to a male patient of unknown age. The patient's medical history and current conditions were not provided. On an unknown date approximately in 2015 (reported as "a few weeks ago"), the patient was vaccinated with a dose of ROTATEQ (lot #, expiration date and dose were not reported), orally. Secondary suspects and concomitant therapies were not reported. On an unknown date approximately in 2015, the patient "went from 1-2 poopy diapers a day to 6-8 poopy diapers per day" after therapy with ROTATEQ. It was unknown if ROTATEQ series was complicated. The outcome of adverse event was unknown. The patient did not seek medical attention. The relatedness between adverse event and ROTATEQ was not reported, Additional information is not expected due to a lack of contact reporter.
This spontaneous report received from a patient concerned a 70 year old female. The patient's weight was 250 pounds, and height was not reported. The patient's concurrent conditions included sinus problem: seem to have a lot since covid discovered and need to stay in, sulfa, and levaquin, and other pre-existing medical conditions included the patient had allergies to things outside (different trees, shrubs, and plants.).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 17:15 on Right arm for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced worse sinus headache. On 05-APR-2021 01:00, the subject experienced dizziness. On 06-APR-2021, the subject experienced something black spot left eye. On 06-APR-2021, the subject experienced white spot corner of left eye. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from something black spot left eye on 06-APR-2021, was recovering from dizziness, and the outcome of worse sinus headache and white spot corner of left eye was not reported. This report was non-serious.
Fourteen-year-old patient was inadvertently given pediatric Pfizer BioNTech which is indicated for ages 5-11.
Pt. got very nauseous about 2 hours after eating supper. He vomited for several hours on and off. we got a RX from our General practitioner's office for Ondansetrton ODT 8 mg tablet. and gave it to him Sat. morning. He quit vomiting after that but wasn't hungry and mainly took liquids His blood sugar #s were higher than normal. Sunday he was rather lethargic and his appetite was still nill. Drank some liquids and sucked on chipped ice. Monday he was dead when I woke up.
(R) arm very swollen, red, painful, itchy and warm. Stiffness in neck muscle on right side and headache.
a few blisters near the injection site; Arm soreness; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced a few blisters near the injection site in addition to arm soreness on 20Dec2020. Outcome of events was unknown.   information about lot/batch number has been requested.
Upon administering Spikevax into patient's L arm, some liquid from the vaccine began to leak out of the injection site. Unknown how much was administered. Contacted CDC who instructed that unknown amount or less that full amount administered the dose should be repeated. Communication shared with patient. Waiting on patient's response and if the decide to repeat dose they will need to follow up with their PCP.
Patient was given 2nd dose of shingrix subcutaneously instead of intramuscularly.  Caused a large, itchy rash on patients arm that spread to their back and required prednisone.  By the time they needed prednisone, 4 days after injection, swelling was reduced but still spreading and less itchy
sinusitis; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinusitis) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Fibrillation, Angioma (angiomas of head.) and Splenectomy.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SINUSITIS (sinusitis). At the time of the report, SINUSITIS (sinusitis) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Around 5:30pm two days after my vaccine, I experienced extreme nausea which led to vomiting. After, I experienced ringing in the ears which has continued until now. Dizziness has also continued.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-035984 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Reporter did not remember reporting adverse event for her sister. States that she does not have time to discuss as she was at work at the time of the call. Declined to provide email address or complete ADR form but states "everyone's doing fine".; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-035984:2nd dose case