chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states shingles appeared after Shingrix vaccine. Shingrix was given Monday (4/22), & patient said a rash started on back of head/neck on Tues/Wed. The rash has also appeared on part of head, ear, & front of neck. Patient reports seeing nurse practioner on Thurs, and the diagnosis was shingles. She also reports pain associated with rash, but she denies having any other symptoms after vaccine. (NOTE: today she said she didn't have a sore arm at all, but you'll see the note below from a 4/23 follow-up that documents she said she did have a sore arm the day after the vaccine.) Dr. issued a Rx for Famciclovir 500 mg on 4/25. She is going to follow up with her regular Dr. after Dr. returns from vacation. Patient stated she did have chickenpox in the past. Patient asked me else she could use for the pain. It was recommended she follow up w/ her doctor who may choose Rx treatment for pain, but she was told that a facility recommends cool compresses, calamine lotion, and wearing loose clothing around painful areas. The CDC and facility also recommend keeping the rash covered with loose, non-stick, sterile bandages. She said the nurse practitioner did not address covering the rash. Please note the following was also documented shortly after the rash was given: "4/22/19 Pt came back ~15 min after vaccine given & said she felt "funny" and said she had a "feeling" across her forehead. She denied any other sx. I asked her to sit down, & I would check on her. 3:45-3:49, I first checked on her. She said she feels like she does when BP high. I asked her to relax for a few minute & then check BP. 3:57, Denies other sx still & reports feeling a little better. BP~ 160/80. She told me she has been taking 1/2 metoprolol tab QD as previously prescribed. I spoke to someone at Dr.'s office & they said prescribed dose of 1QD was correct. (See note on Rx.) Pt said she may be "anxious" and sat for a few more min before driving home. She said she was fine to drive home & said I did not need to call anyone for her. She was told to report any side effects lingering beyond 3 days after vaccine [multiple] times. PM 4/23/19- followed up with patient. she said the feeling she had yesterday had passed. her arm is just sore today. PM"
Fever (103), myalgias, arthralgias, fatigue, malaise, nausea ~ 32 hours (thus far)
p/vax pt exp chills while sleeping, red blotchy rash on neck & chest;poss allerg react;pt ceased taking Cleocin & Cipro & took DPH for rash;rash became more red & solid;itching;nauseous, soreness in joints, d, lightheaded, tired;
I was diagnosed bigeminy which went away on its own, I had shortness of breath and some chest pain, It resolved within 6-8 hours afterwards and was not medicated. A cardiologist diagnosed it after completing an ekg.
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 16 years old male patient who was vaccinated with two doses of FLUZONE QUADRIVALENT UT6258KA via intramuscular route in the right deltoid and left deltoid on 27-Sep-2018 and 09-Oct-2018 respectively. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This was an actual medication error due to extra dose administered. It was reported that the patient had 2 doses of the FLUZONE QIV. It was reported that the patient did not experience any adverse event. 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 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. List of documents held by sender: none.
On 5/19/2017 Patient went to urgent care for redness, swelling and pain left upper arm. Had fever for 48 hrs. Patient had a 4 cm in diameter area of induration, erythema, warmth and tenderness - no drainage. Patient required - Clindamycin and AUGMENTIN antibiotics.
This spontaneous report as received from a pharmacist refers to a  currently 61 year old non-pregnant female patient. The patient's concurrent condition included allergy to penicillin. The patient had no medical history and no concomitant medications. On 17-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiry date were not reported) for vaccination. On an unknown date in January 2017, reported as "a day or so after administration", the patient experienced swelling and redness at the injection site as well as slight headache, slight dizziness, weak and fatigued. No treatment was given for the events. No lab diagnostic studies were performed. At the time of the report, the patient did not recover from the events. The patient seek medical attention by calling a pharmacy. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
rash kind of itches,; Delayed reaction; The injection site has a rash about the size of a couple of quarters; soreness in the arm for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm for 2 days), RASH PRURITIC (rash kind of itches,), SKIN REACTION (Delayed reaction) and VACCINATION SITE RASH (The injection site has a rash about the size of a couple of quarters) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Lanolin), Allergy to antibiotic (Neomycin), Drug allergy (Pabrinex), Allergy to chemicals (MDGN), Drug allergy (balsam of peru), Allergy to chemicals (Propylene Glycol), Allergy to chemicals (Fragrance mixes), Allergy to chemicals (Compistane mix), Drug allergy (lidocaine), Allergy to chemicals (oak moss), Alcohol allergy (alcohol), Allergy to chemicals (Eugenol), Allergy to chemicals (Tea tree oil), Allergy to chemicals (sandalwood oil), Allergy to chemicals (lang lang oil) and Allergy to chemicals (hydroperoxide).    On 11-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm for 2 days). On 19-Aug-2021, the patient experienced RASH PRURITIC (rash kind of itches,), SKIN REACTION (Delayed reaction) and VACCINATION SITE RASH (The injection site has a rash about the size of a couple of quarters). On 13-Aug-2021, PAIN IN EXTREMITY (soreness in the arm for 2 days) had resolved. At the time of the report, RASH PRURITIC (rash kind of itches,), SKIN REACTION (Delayed reaction) and VACCINATION SITE RASH (The injection site has a rash about the size of a couple of quarters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Primarin Cream Twice a week. No treatment information was mentioned.
Clinical diagnosis of Bells Palsy Seemed to begin several hours after 3rd dose; along with very mild injection site pain and myalgia
A FEW SECONDS AFTER BEING GIVEN THE PREVNAR VACCINE, THE INFANT HAD A PAUSE IN HER BREATHING FOR 5-10 SECS. IT APPEARED AS THOUGH HER "EYES ROLLED BACK TOO". MOTHER THOUGHT SHE FELT LIMP DURING THE EPISODE. MA DESCRIBED HER AS BEING MORE STIFF. I WAS CALLED TO THE ROOM IMMEDIATELY AND BY THE TIME I ARRIVED, THE INFANT WAS ALERT, LOOKING AROUND AND BREATHING WITH NORMAL EFFORT AND RATE. LUNGS CONTINUED TO SOUND CLEAR.  I suspect the episode was related to the pain/discomfort of the Prevnar injection.
No adverse events, did call pt, and inform him this was his 3 dose and to see how pt is doing.  He stated that he is doing well  and has had no reaction. Will call Health Dept if any concerns, phone # provided.
08/5/21: Usual symptoms of low grade fever, generalized weakness, soreness in arm of injection 08/06/21: Arrived at work (7PM to 7AM). Around 0300 AM noticed itching, redness, swollen, and extremely painful at and around the injection site. Upper arm was swollen and warm to touch. 08/07/21: After leaving work went to Urgent Care and saw medical professional for allergic reaction. Stated that it appeared warm, red, swollen and possible cellulitis. Was given IM injection of Rocephine and Solumedrol. Also given doxycycline 100 mg x 20 pills and fluconazole 150 mg x 2. Was instructed to us ice packs and was given excuse to return to work on 08/10/21.      Notified supervisor of work provisions. 08/10/21: Visit with primary physician to follow up on reaction to Covid 19 vaccine and increase in leg weakness and small tremor development. Was given Dexamethasone 2 mg tablets with 10 tablets to suppress my overactive immune symptoms. Noted leg weakness and overall general weakness. Also measured the area of injection and swelling and redness and heat noticed. Requested use ice packs for pain. Was given a notice for work absence and to return 08/17/21. 08/12/21: Notified employee health of reaction and filled out paper work for Workmen's Compensation. Was sent to Occupational Health for evaluation for Workmen's Compensation. Saw provider NP. Noted the area was still warm to touch with redness. Requested use warm packs for comfort. Was given notice to return to work 08/13/21 to unrestricted duties. Have Follow up appointed Monday 08/16/21 with medical profession and primary physician
Narrative:  COVID infection following COVID vaccine series 02/09, Pfizer, dose #1 03/01, Pfizer, dose #2 08/13 pt cc: diarrhea, fatigue, exposure: unknown 08/19 CXR impression: Faint, streaky left perihilar lung opacities, which may be secondary to atelectasis or developing consolidation. 08/19 pt admit ED cc: severe fatigue dx: Covid positive status LOS: 1 day
9:30 am received vaccine, about 12 hrs later felt dizzy, sleepy, after 20-30 minutes of sleep awoke diaphoretic - felt hot & sweaty for about 2 hrs; no redness or swelling at injection site, recovered next am.  NOTE:  has had flu vaccine in the past (# doses unknown) without problems.
Mast cell degranulation on back and armpits; Urticaria present; Pruritus present; awoken from sleep; This is a spontaneous report from a contactable healthcare professional (patient). This 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 23Feb2021 at 13:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food or other products, and was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 24Feb2021 at 04:00, 14.5 hours post injection, the patient was awoken from sleep and experienced mast cell degranulation on back and armpits, with urticaria present and pruritis present. Cetirizine 10 mg was taken orally. On 24Feb2021 at 04:25 the urticaria and pruritis subsided. On 24Feb2021 at 05:00, the patient went back to sleep. On 24Feb2021 at 11:00 the pruritis presented again with less intensity. The events were reported as non-serious and did not require hospitalization. The events resulted in a doctor or other healthcare professional office/clinic visit. The clinical outcomes of mast cell degranulation on back and armpits, urticaria present, pruritis present, and awoken from sleep were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
The underage patient inadvertently received a Moderna Covid-19 booster (0.25mL) vaccine on 01/15/2022 after completing his initial Pfizer  Covid-19 vaccine series on 06/08/2021.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On FEB-2017 the patient was vaccinated with VAQTA for prophylaxis. On FEB-2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. Additional information has been requested. Sender's Comments: US-009507513-1707USA000481: US-009507513-1707USA000479: US-009507513-1707USA000480.
In October of 2022, I was having problems getting up out of a chair. I was having problems rolling over in bed. I was having problems with my balance and had fallen twice. My toes were curling significantly in order to keep myself upright and my handwriting had changed completely. It was much smaller and very difficult to read. I went to see the doctor; he diagnosed me with Parkinson's disease. He prescribed Carbidopa-Levodopa. I'm reacting appropriately to the medication. Almost everything has gone back to normal. My handwriting is still not ideal but is legible. I am also still having some issues with balance, but other than that, everything has disappeared.
One week after vaccine woke with large round, very itchy rash at injection site. Area was swollen and warm with a very small hard area directly at injection site.  It was very itchy for about 8 hrs and then it was only sporadic at best.  The rash was very red at beginning but has faded continually since.  The area is a very distinct oval or circular shape, approx. 4 inches in diameter.   It is almost hard to call it a rash as the itchiness, swelling and "prickly" type skin were very short lived, 2-4 days, but the discoloration is still very distinct although faded considerably since the first appearance.  I did have moderate headache and arm soreness with the first vaccine, short lived. With the second dose I had headache and then extreme axillary and neck soreness on second day. The rash did not appear until one week after the 2nd dose. It has been approx one month and the 4 inch "rash" is still apparent but faded .
Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture; No adverse event; Pediatric patient received the vaccine after more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric patient received the vaccine after more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture) and NO ADVERSE EVENT (No adverse event) in a 19-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric patient received the vaccine after more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric patient received the vaccine after more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pediatric patient received the vaccine after more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture).    No concomitant medications were reported. No treatment details were reported. It was reported that the patient had not experienced any Adverse Events after vaccination. Individual Vial size was reported as 2.5 mL. The vial was initially stored in the refrigerator on 05-Oct-2022. The vial was first punctured on 08-Oct-2022 at 09:15 am and was administered to pediatric patients on 10-Oct-2022 at 10:45 am, 11:15 am and 3:30 pm. Vial was stored in the fridge post puncture. Vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range was less than 10 minutes. This case contains information for the 2nd of 3 Patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-657574, MOD-2022-657614.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657574:same reporter MOD-2022-657614:same reporter
Patient experinced  hypotension. Onsite EMS was called vitals BP 72/46 99% O2 HR 84 BG 110. Patient treated and transported to the hospital.
PHN pulled all vaccines and pulled both the Pentacel and Polio vaccines. Child received an extra dose of Polio vaccine.
Swollen lymph node in right armpit; mild flu like symptoms; body aches; fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 5318) via unspecified route of administration on 26Feb2021 (at the age of 53-years-old) at 13:30 in right arm for COVID-19 immunisation. Medical history of the patient included pancreatectomy (pancreatic tumor (insulinoma) removed in 2016). The patient had no known allergies. The patient did not receive any other medications within two weeks of vaccination. The patient received a dose of tetanus vaccine (MANUFACTURER UNKNOWN) via unspecified route of administration on 29Jan2021 in left arm within 4 weeks of COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Feb2021 at 13:30, the patient experienced swollen lymph node in right armpit, mild flu like symptoms, body aches and fatigue for about 12 to 15 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the reported events. The clinical outcome of axillary lymphadenopathy, mild flu like symptoms, body aches and fatigue were reported as recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
My husband was exposed and got COVID-19. I had a sore throat and fever, got tested on the 27th. I had major pain in my arm, legs, when I went to the clinic they gave me PAXLOVID. I took for 5 days and the fever broke right away. I slept 20-24 hrs. the first day. Tiredness and soreness were the main symptoms.
Administered MMR/V vaccine outside of recommended guidelines. Child is over the age of 12 years. Child had no signs and symptoms to report.
Received vaccine 9/29/10 around 4pm - patient stated she went to bed (felt fine then) woke up the next morning with sweats drenched, chills, nausea, & dizziness.
1. high fever 104degrees F x 45day with irritability. 2. Measles type systemic rash as the fever resolved. 3. Negative blood cultures.
2 days after receiving my second dose I woke up to a rash on the upper arm not centrally located around the injection site. The rash wrapped around my arm in towards the armpit. It was raised, not bumpy. Very swollen and red. Warm to the touch. Could become itchy if I began to scratch it which I am avoiding. It has gotten worse towards the end of the 2nd day. I have sprayed some itch/pain relief over the counter medication. I was in the sun today, and used the arm a lot at the gym while working out. My arm is much bigger than the arm that didn't receive the shot. Very swollen. I haven't gone to the doctor because I read that this is an unusual but normal reaction to the Moderna vaccine.
received 2 pediatric doses to complete an adult dose; both vaccine administered were expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 49-year-old male patient who received HBV (Engerix B pediatric) (batch number LP724, expiry date 18-MAY-2023) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) (batch number LP724, expiry date 18-MAY-2023) for prophylaxis.   On 07-JUL-2023, the patient received the 2nd dose of Engerix B pediatric and the 1st dose of Engerix B pediatric. On 07-JUL-2023, an unknown time after receiving Engerix B pediatric and Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: received 2 pediatric doses to complete an adult dose) and expired vaccine used (Verbatim: both vaccine administered were expired). The outcome of the adult use of a child product and expired vaccine used were unknown.   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: 11-JUL-2023 It was reported that a patient received 2 pediatric doses of Engerix B to complete an adult dose but both were expired and wished to know how to proceed which led to adult use of a child product and expired vaccine used. The reporter did not wish to receive follow up and gave partial information about vaccine, event and patient.  The reporter did not consent to follow up. The vaccine administration facility is the same as primary reporter.
Severe head pain, chest and heart pain, fever, chills, body pain and joints, weakness, sleepiness, swelling in the vaccination area.
For the first 4-5 days was okay and one of days I felt my temperature go down. I felt chilled and then I got  a small case gout I got it in my right toes and a few fingers on my right and when I have gotten it in the past it was always on my left side and at first it was mild then it was got worse and the worse case of gout I have ever had. I used to get gout when I drank beer, I haven't have gout in over a  decade. I would say I have 95% recovered
The pt developed a mild generalized varicella as well as local varicella rash at the injection site appearing 10 days post vax.
VACCINE ADMINISTRATION ERROR. VACCINE GIVEN 7 DAYS EARLY DUE TO LANGUAGE BARRIER AND CLERICAL ERROR
Despite the fact that I am in perimenopause and my menstrual cycle is minimal, I began to have heavy menstrual bleeding after all three vaccinations lasting weeks at a time. Most notably, the bleeding started within hours of the third booster vaccination and became heavy the next day. Regular blood work connected with my sarcoid diagnosis showed my hemoglobin levels have been dropping ever so slightly but steadily in the weeks following the vaccines.
pt recvd vax 5OCT94 & mom informed CHW pt had high pitched screaming cont crying-started 8PM 3AUG94; cont for more than 3 hrs; pt given APAP-cont w/crying x 24 hrs; t101 ax;
Patient was given her second covid19 vaccine at approximately 1045.  She stood up and walked to a chair in the waiting room.  At 1048 she passed out and had a small seizure.  Mom said she normally passes out after a shot for a short period of time but this was the first time she had a seizure. She was moved to the floor.  She was sweating, eyes glossed over, said she felt like she couldn't breathe and couldn't feel her extremities.  She stayed on the floor until EMS arrived approximately 10 minutes later.  She was moved to a chair and once she tried to stand up she was moved back to the floor.  She left in a wheelchair and was taken to her moms car.