chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vasovagal event with lightheadedness, diaphoresis, blurry vision.   No CP, SOB, palp.  No s/sx anaphylaxis: no hives/rash, wheezing, stridor, throat closing, tongue swelling/itching, N/V/D. VS: BP 95/5Os, HR 50s, SaO2 99% RA, afebrile.  Pt clammy, bradycardic.  Lung clear, abd soft, no edema.  No focal neuro deficits, A&Ox3. Pt laid down on the floor with legs elevated with improvement in symptoms, and BP up to 120s/70s, HR 70s. After ten minutes, felt well enough to sit up, repeat BP while sitting  120/70s, HR 70s.  Given water/juice and a snack. After another ten minutes, felt well enough to stand, repeat BP unchanged. Pt monitored for another 30 minute without recurrence of sxs.  Pt went home without issue.
PT rec'd TD and Pneumococcal vaccine 9/7/06 returned to clinic 9/8 with right arm pain and swelling, early cellulitis. Started on Ancef.
ActHIB mixed/ reconstituted with diluent that expired on 22Mar2021 and administered to patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00559563) and transmitted to Sanofi on 13-Apr-2021.  This case is linked to case 2021SA124250 and 2021SA133014 (same reporter).  This case involves a 1 years old female patient who was administered with expired 0.5 mL dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ143AA and expiry date: 22-Mar-2021) via intramuscular route in the left thigh (expired product administered) for prophylactic vaccination on 08-Apr-2021.  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   No other vaccines received by patient.   It was an actual medication error case due to expired vaccine used (latency: same day).   It was reported that patient received ACTHIB in which diluent expired but the powder doesn't expire until May. Reporter states that 3 different patients received the Act-HIB on 08-Apr, 24-Mar and 02-Apr. She requests to know what they should do, should they revaccinate. Box had batch: UJ143AAA and expiry date: 22-Mar-2021.   At the time of reporting, No specific adverse event reported.   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.
VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 24-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's past medical history included two previous pregnancies resulting in normal births of two full-term live infants with no defects.  The subject had not been using contraception before becoming pregnant.  On 08 September 2011 the subject received a booster dose of Boostrix (.5 mL, intramuscular, right deltoid), and experienced vaccine exposure during the second trimester of her pregnancy.  The conception was reported to be normal.  The subject was approximately 24 weeks gestation at the time of vaccination.  Date of last menstrual period was 15 March 2011 and estimated date of delivery was 20 December 2011.  Ultrasound on 02 September 2011 revealed no evidence of a defect.   Upon internal review done on 16th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound on 02 September 2011 revealed no evidence of a defect.
Itching, rushes and hives, breaking out on a daily basis, lasting up to two hours. ALLEGRA (60 mg) causes it to subside quickly.
Persistent, inconsolable crying described as shrieking for longer than 3 hour duration.
no sense of smell; has been sleeping; has no energy; her body is shaky; no sense of taste; was not feeling good / hasn't been feeling good; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (was not feeling good / hasn't been feeling good), ANOSMIA (no sense of smell), SOMNOLENCE (has been sleeping), ASTHENIA (has no energy) and TREMOR (her body is shaky) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced MALAISE (was not feeling good / hasn't been feeling good). On 04-Nov-2021, the patient experienced ANOSMIA (no sense of smell), SOMNOLENCE (has been sleeping), ASTHENIA (has no energy), TREMOR (her body is shaky) and AGEUSIA (no sense of taste). At the time of the report, MALAISE (was not feeling good / hasn't been feeling good), ANOSMIA (no sense of smell), SOMNOLENCE (has been sleeping), ASTHENIA (has no energy), TREMOR (her body is shaky) and AGEUSIA (no sense of taste) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. List of concomitant medication were not given.  This is a Spontaneous case concerning a 66-year-old, female patient with unknown medical history,  who experienced the unexpected non serious (AESI) events of ageusia and anosmia. The event occurred approximately 1 day after the first dose of Moderna COVID 19 vaccine. The rechallenge is XXXX. The medical history of not applicable.   The Benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Added patient demography, suspect product details and added events; Sender's Comments: This is a Spontaneous case concerning a 66-year-old, female patient with unknown medical history,  who experienced the unexpected non serious (AESI) events of ageusia and anosmia. The event occurred approximately 1 day after the first dose of Moderna COVID 19 vaccine. The rechallenge is XXXX. The medical history of not applicable.   The Benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.
Patient had a seizure at home on 05/16/19 and went to the ER and was transferred to Hospital.
flushed at 12:03 pm, by 12:08 pm Benadryl 25 mg 1 tablet po x 1 for itching at injection site and slightly red 12:20 pm 140/100-64, 12:31-140/90-76; 12:36pm (L) arm heavy and then subsided. At 3:25 pm, she tc'd then RN and c/o throat lumpness." Directed her to ER immediately.
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. On 11-DEC-2006 the patient was vaccinated with her first dose of GARDASIL (intramuscular, injection 120 Y, lot#, dose/frequency, route and duration were unspecified). Her second dose of was on 31-JAN-2008 and third dose on 19-MAY-2013. No adverse effects reported. The outcome was unknown. Additional information has been requested.
Rash reaction; This spontaneous case was reported by a physician and describes the occurrence of RASH (2 or 3 other people, women, patients of their doctor had this rash reaction) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (2 or 3 other people, women, patients of their doctor had this rash reaction). At the time of the report, RASH (2 or 3 other people, women, patients of their doctor had this rash reaction) 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 concomitant medications were reported. It was not reported if any treatment was administered in response to the events.   This case was linked to MOD-2021-030985 (Patient Link).
I went to the emergency room because I started having extreme abdominal pain. They told me that I had pancreatitis. The pain started moving to my back. They started me on some antibiotics and put me on morphine for the pain, but when I got home later that night the pain started back. The medication they sent me home with was Ciprofloxacin, Metronidazole, Dicyclomine, and Ondansetron ODT. They gave me Metronidazole, and Cipro through an IV and the hospital. When I went to the other emergency room, that doctor told me that they don't prescribe Cipro for Pancreatitis, and I told him that that this doctor did.  They told me they didn't see any Pancreatitis there and told me that the problem is that my kidney had shrunk. He told me to follow up with my primary care.
No antibodies detected in Spike Protein (IGG) semi-quant tests performed 5 weeks (4/21) and 6 weeks (4/28) after the shot.
the first time the HIB was administered, pt slept over 12 hours. This second time the HIB was administered he slept, without food and water intake, for over 20 hours. Sleeping did not occur with any of the other immunizations.
"Janssen COVID-19 Vaccine EUA"  This patient's wife called me on 06/14/21 after the patient being in a hospital all weekend in another state.  She stated the patient had a blood clot in his lung and had passed out due to lack of oxygen.  Patient is improving now but their MD at the hospital told patient to report this to me, vaccine provider, since this blood clot occurred within 6 months of receiving  the covid vaccine on April 1, 2021.
5days p/vax pt devel severe swelling upper & lower extremities; dx w/lymphedema; p/seeing many, many MDs was dx w/RA & Raynauds disease; aggravated
LIGHT HEADED/DIZZY; SORE ARM; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced light headed/dizzy. On 11-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced headache.  On 13-APR-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from light headed/dizzy, headache, and sore arm. This report was non-serious.
On 7/7/21, PT came to get a first dose of Moderna Vaccine. (Vaccinator) confirmed that this was her first dose and she never got any other Covid vaccine before. educated PT about the Moderna Covid Vaccine, went over potential ADR and gave her the vaccine. Later that afternoon, (technician) created a batch for the vaccine and got a rejected claim from the insurance. Upon calling the insurance, found out PT got Pfizer vaccine at Walgreens on 5/8/21. The staff pharmacist  reached out to the patient but couldn't get a hold of her on 7/6/21 evening. Next morning (today),  was able to talk to the patient, and the patient initially claimed that she never got the Pfizer vaccine. She gave her insurance card and signed a consent form at Walgreens but she had to leave for work then called the Walgreens to confirm, but the technician there said she did get a vaccine there. called PT back to call that Walgreens to sort this issue out. And later talking to PT again, she said she then remembered getting Pfizer Vaccine at Walgreens. She apologized for her mistake and said because she is pregnant and has been getting so many different vaccines, she didn't remember getting a Covid vaccine,  asked PT to reach out to her doctor immediately and explained that for now, she does not need another dose of Moderna Vaccine based on CDC recommendation (Pt is considered fully vaccinated if 2 different mRNA vaccine is given at least 4 weeks apart).
Pt reported a knot, redness and swelling near the injection site of the ZOSTAVAX immunization.  She has taken a benadryl and will use hydrocortisone and keep area cool.
WE WERE NOTIFIED THIS LOT # HAD EXPIRATION OF 9/30/22 HOWEVER RECIEVING IT PERSON MARKED IT AS 10/31/22 DUE TO 10 WEEKS EXPIRATION IN FRIDGE BASED ON 8/22/22 SHIPMENT RECEIVED; MFR GUIDANCE SAID IT IS OK TO USE UP UNTIL 10/19/22 PATIENT RECEIVED 10/10/22
LEFT EYE REDNESS, ITCHY EYE, SWELLING LEFT EYE, FATIGUE ALL BODY, NEXT DAY AFTER VACCINE AND ONE DAY AFTER VACCINE THE RIGHT EYE START TO BE RED, ITCHY, SWELLING RIGHT EYE
finger twitch starting within the 15 minute waiting period,   expanded to muscle twitch and tremor to left leg and head.
The day immun recvd pt presented w/local pain, malaise, dizziness, h/a, nausea & muscle ache;
hurt; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of injection site reaction (1st dose received on an unknown date, refer case US2021AMR250998).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles shots and that hurt. Follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR250998:same patient/ different dose
Patient's father reported that patient developed a fever and vomiting during the evening of the same day after receiving vaccine.  States patient vomiting morning of following day, temp. 101.4.  Dr. was informed. Advised to observe; symptomatic treatment.
This spontaneous report as received from a pharmacist refers to a female patient of approximately 58 year old at the vaccination time. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. In July 2015 (reported as one and half years ago), the patient was vaccinated with ZOSTAVAX intramuscularly (dose, lot # and expiration date were not reported). On an unknown date, after administration, the patient experienced the injection site swelled into a large knot, that lasted for several days. The symptoms resolved after several days (unspecified date). No product quality complaint was involved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Pain moving from injection site up through shoulder joint and left side of neck.  Approximately 1"-2" site of reddness working way down upper arm remained sore and red for 2 days.
3 days after H1N1 shot developed headache, chills, full body aching + swollen painful bilateral knees.  Information received January 18, 2010. This was not administered in our office. It was done in a walk-in clinic. We just saw her due to reaction.  We don't know manu/lot #.
This spontaneous report as received from a pharmacist refers to an 83 years old female patient with drug allergy to penicillin. On about 25 days ago, approximately on 17-AUG-2012, the patient was vaccinated with ZOSTAVAX (lot# reported as 0364AE, exp 16-MAR-2013). No other co-suspects were reported. No concomitant medications were reported. the Pharmacist reported that patient called the pharmacy and complained of rash around her bra strap on her trunk and burning sensation around rash after receiving ZOSTAVAX about 25 days ago. Patient noticed rash started appearing yesterday, 10-SEP-2012. There were no treatment and no laboratory information for the event. The patient had sought medical attention by spoke to the pharmacist. The outcome was reported as not recovered. Additional information is not expected.
This spontaneous report as received from a registered nurse refers to a 5 year old female patient. On 02-NOV-2011 the patient was vaccinated with her first dose of MMR II, and her second dose on 09-AUG-2012 (strength, route, lot# not reported). No adverse effects reported. The outcome of event was unknown. Additional information is not expected as we could not contact physician.
Unconsolable crying for 2 hr 45 min, 4 hrs after receiving vaccines. Rash onset next morning prompting office visit. Dr recommended BENADRYL for pt and return to clinic if worsening.
patient presented to emergency department on 10/26/21 with shortness of breath patient was admitted for further management of acute respiratory failure with hypoxia patient was found to be covid-19 positive on 11/21/21 patient did require treatment for symptoms associated with covid-19 infection. treatment included: dexamethasone and remdesivir patient condition worsened requiring transfer to the intensive care unit on 11/27/21 until 12/19/21 patient required intubation on 11/27/21 patient expired on 12/19/21 due to acute respiratory failure with hypoxia
Patient states she has had on and off left arm pain at the injection site for the past 4&1/2 months.
Injection in left arm on 5/26/21.  On the following day, 5/27, my hand was in excruciating pain and my index and ring finger were not able to be extended from my palms. The next day, the middle left finger knuckle rendered useless and in excruciating pain.    Two days later, the pain was back to just the middle finger in the knuckle joint closest to my palm.  To date, I am experiencing pain in my left middle knuckle closest to my palm. The pain in my ring, and index fingers have subsided. There is still a painful sensation but I have been able to resume everyday activities. However I am unable to specifically use my left hand at 100% capacity and the symptoms have remained the same for about one week neither improving or becoming worse.
5 min after MMR administration right arm, child developed large hive at site. Hives and redness developed on back administered 12.5mg Benadryl.
pt recvd vax & immed collapsed; was responsive; pulse dec; BP about 100 systolic; N/V; resolved w/epi 0.3 cc SQ; 1 hr later nausea recurred; systolic BP 70; given epi 0.3 cc SQ again & admitted to hosp;
Redness; Pain along left nasolabial fold with soreness; Nodule; Firmness; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (Redness), NASAL DISCOMFORT (Pain along left nasolabial fold with soreness), NODULE (Nodule) and INDURATION (Firmness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Skin cancer and Surgery (The vulva area removed due to skin cancer). Concurrent medical conditions included Rosacea.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced ERYTHEMA (Redness), NASAL DISCOMFORT (Pain along left nasolabial fold with soreness), NODULE (Nodule) and INDURATION (Firmness). The patient was treated with PREDNISONE at a dose of 1 dosage form; AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID]) at a dose of 1 dosage form and HYALURONIDASE (VITRASE) at a dose of 1 dosage form. On 24-Jun-2021, ERYTHEMA (Redness), NASAL DISCOMFORT (Pain along left nasolabial fold with soreness), NODULE (Nodule) and INDURATION (Firmness) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided  Pt received 2doses of COVID-19 vaccinations but the manufacturer was unknown.   Due to skin cancer the vulva area removed two weeks prior to Lyft injection and had been on antibiotics for a vaginal infection post-surgery. Patient was injected with 1cc total of Restylane Lyft in both cheeks on 23-Apr-2021.
Muscle spasum; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle spasum) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Muscle spasum). At the time of the report, MUSCLE SPASMS (Muscle spasum) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments   Reporter did not allow further contact
Below injection site, left deltoid. Measures 12 cm x 14 cm. Red, warm to touch, surface area hardened, 8-9 on pain scale of 10 when bumped. Temp 99.8 F with TYLENOL 90 min. previous.
Headache x3 days and a small red bump on left arm close to the smallpox vaccination site.  Pain in armpit area and into his chest on the muscle.  Patient treated with Tylenol 325mg every 4-6 hours as occasion requires.
Body aches, hot and cold sweats, pounding headache, fatigue and upset stomach. Symptoms started 6 hours after receiving the shot and last for a total of 24 hours. After 24 hours only symptoms included sore right arm where shot was administered.
Pt. left  once at observation lane.  Pt. began to feel woozy and anxious.  Paramedic assessed pt. Once symptoms subsided, Pt. was released by paramedics to leave.
Symptoms began with a severe headache. I had a sinus infection and was given antibiotics. I lost my vision temporarily. A CAT scan was done on Friday without contrast and was negative. On Sunday I began bleeding from my crotch and was sent to the emergency room. Second CAT scan Sunday on head without contrast and abdominal CAT scan with contrast. I was admitted and discharged on Sunday.
Long standing problems with allergies to molds and pollens previously under control came back with higher intensity than in the past.
Nurse was giving pt the vaccine and pt was replying to questions well before the injection. After injection, pt rolled his eyes back and head went back. Dad came in and stated that this was normal and that it occurs sometimes from injections. Nurse rubbed pt's back and propped his legs up on a chair. Pt drank water and rested and slowly felt better. After about 20 minutes, pt felt fine and was able to walk out.