chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Plaque psoriasis.    No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 15-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In July 2021, the patient experienced COVID-19 (COVID-19). In 2021, COVID-19 (COVID-19) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medication information was provided. It was unknown if patient was enrolled in a covid-19 vaccine trial. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna.
On 10/22/06 pt was bitten by his dog. He was seen at ER and was given a tetanus shot at midnight. The following morning 3:00am, developed left arm pain and numbness, right arm pain and numbness of both feet with calf muscle spasms. Seen at center on 10/27/06 with peripheral neuropathy symptoms and muscle spasms. 12/12/06-obtained lot #U1786AA Aventis.  02/20/07-DC DX: Parathesia secondary to Tetanus Toxoid. DOS 10/27-10/28/06 Complaint of numbness left palm pain in right upper arm and numbness of both feet after tetanus vaccine. Prior to vaccine patient was bitten by his dog. Day after tetanus shot developed numbness of left thenar eminence, pain in right triceps ara numbness of both feet and spasms of calf muscles when standing but not walking. History of stomach virus several days prior.  PE:WNL: except for palpable spasm of calf muscles bilaterally. Sensation diminished to light touch and pinprick over just the left thenar eminence.  Assessment: unexplained fleeting neurologic deficits related to side effects of tetanus toxoid.
This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 55-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included lisinopril. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was recovered/resolved. The reporter considered the dizziness to be related to SHINGRIX. Additional details were provided as follows: The patient had the SHINGRIX vaccine 5:00 PM in the left arm, approximately 2.5 months ago before the time of reporting on a Friday. The patient reported experiencing some dizziness the following day and throughout the weekend. It resolved by Monday.
The day after the vaccine, she developed severe abdominal pain w/vomiting and loss of appetite. She was fine before.
I got up in the middle of the night to go to bathroom and I was incredibly dizzy. Room was spinning and I fell down. I was nauseous and had a hard time getting back into bedroom. I needed to call someone - two people to come over and help me get back to bed. I didn't go to ER because of the amounts of COVID cases there. But I had never felt that sick before. I had a high fever, could hardly open up my eyes and threw up for two days. I couldn't work and I was super sleepy. The nausea subsided probably about Tuesday. I was really tired, and I slept until about Thursday before I could get up and move around and I had Vertigo really bad throughout those days coming and going - it was bad. I had never had vertigo before. I did that maneuver that can help with Vertigo and that didn't help at all. I was still dizzy when I got my second vaccine a month later. I had that on February 12, 2021, Lot# 006M20A. The dizziness lasted for about two months altogether, I didn't really have too much dizziness after the second vaccine. It would come and go. With both vaccines, within 10 minutes after the injection, I felt a little spacey. A month ago, I had swollen lymph nodes under my right arm. (I was vaccinated both times on my left arm.) Those are gone now. I have had a little bit of dizziness no nausea, vertigo or swollen lymph nodes though. It was about a day or so ago.
23 y.o. female  has a past medical history of Anxiety and Depression.  Who was a proceed out after receiving her first vaccine for Covid.  Patient reports a long history of of fainting with vaccines in the past. She received the first vaccine and about a minute later started to feel diaphoretic and lightheaded.  She had to sit herself down and staff at the vaccine clinic lifted up her legs.  Ended up doing repeat vitals with initial blood pressure of 60 over palp.  She was cool and clammy at that time.  She denies any nausea or flushing.  At the time of my evaluation in the bouncing clinic, blood pressure had improved to 85 over palp with 2+ radial pulses bilaterally.  Patient was then transferred to emergency department for observation.  At the time of transfer she started to feel back to baseline.  She denies any cardiac history, drug use, decreased p.o. intake, family history of cardiac disease, sudden history of cardiac death, bleeding, black or bloody stools.  She is unsure of her last menstrual period.
Soreness in arm that has persisted for 3 to 4 weeks since vaccination.  Patient went to see MD and MD says that the soreness was due to the vaccination.
Patient passed out roughly 2 minutes after vaccine. EMS was called and checked him out. He was advised not to drive and have someone pick him up.
Within 24-48 hours of receiving the COVID booster, patient states he developed acute shortness of breath.  He does not know exactly what day he received the booster.  Sometime around 7 days prior to hospitalization.  When he started needing oxygen he was sent to the hospital and was diagnosed with sepsis- this was on 12/11/2021.  Ultimately he was found to have no bacterial source.  Workup revealed a large pericardial effusion with pericarditis, elevated troponin, and pleural effusion.  He has required pericardiocentesis with drain and bilateral pleural drains.  Fluid analysis reveals inflammation but no infection.  He also developed Atrial fibrillation with RVR requiring IV amiodarone.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2013 at 11:30 ZOSTAVAX (Lot # 672476/1605AA) was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 07-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 672476/1605AA, expiration date 13-JAN-2013) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
REDNESS AND SWELLING AT SITE, VARIES IN COLOR TO PINK WARM TO TOUCH. 6.5" X 7.0".
Pt admitted with R/O Guillain Barre. Below is a list of all vaccines given for a year period.
1. Cough Wheeze. 2. CHEST PAIN.  1/8/10 Spoke w/patient who stated she did not seek any medical treatment & has fully recovered.
11/3/22:  Started developing symptoms of what was later diagnosed (11/10/22) as Shingles.  About 1 week later developed facial paralysis and was further diagnosed with Ramsay Hunt Syndrome.  Symptoms began with shooting, stabbing and burning pain inside her left ear, left side of face and left eye.  A couple days later, blisters developed inside her ear canal and her ear was swollen shut.  Dizziness, tremors and loss of appetite.  Blisters cleared up within about 1 week.  Today, 12/12/22:  Severe shooting, burning and stabbing pain inside left ear continues.  Facial paralysis is much better, but not completely gone.
2 to 3 wks p/vax-numbness lips & face sl imbalance; inc pain & pressure in hea, burning sensation in ears; inc abn sensations in head like dizziness, swollen lymph nodes;
This spontaneous report as received from a patient's daughter refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported) and experienced itching afterwards. The outcome of the event was unknown. Causality assessment for the event and therapy was not provided. Additional information is not expected.
times are in hours after vaccination: muscles aches, fatigue at 12h, chills at 23h, 101.7F fever at 33h
Pedia-rix was given 2 weeks after second dose was administered. NO adverse events occurred. Patient is medically well.
This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, less than a week after receiving SHINGRIX, the patient experienced fever, pain, chills, headache and insomnia. On an unknown date, the outcome of the fever, pain, chills, headache and insomnia were unknown. It was unknown if the reporter considered the fever, pain, chills, headache and insomnia to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient asked how long does the side effects of shingle shot last. The patient experienced fever, aches, chills, headache and could not sleep. The patient refused to provide the healthcare providers details.
Hives throughout upper body beginning within a few hours of receiving vaccine, as well as a constriction sensation in the throat. Vaccine was administered around 2:15 pm on 03/13/22, symptoms began to emerge around 4:30 pm the same day.
In some places they forget to take it out of the freezer and administer directly  to the patient. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT PREPARATION ERROR (In some places they forget to take it out of the freezer and administer directly  to the patient.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (In some places they forget to take it out of the freezer and administer directly  to the patient.). At the time of the report, PRODUCT PREPARATION ERROR (In some places they forget to take it out of the freezer and administer directly  to the patient.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications information was not reported No treatment medications were provided.
Expired Engerix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number K329E, expiry date 24-APR-2023) for prophylaxis.   On 05-MAY-2023, the patient received Engerix B. On 05-MAY-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired Engerix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 05-MAY-2023 The health care professionals reported that the patient received Engerix B on 5 May 2023 which was expired on 24 April 2023.  Patient received a dose of Engerix B on 4 May 2023 which was expired on April 08, 2023, which led to expired vaccine used. The reporter consented to follow up.
After the shot, at least 2 hours, had loss of appetite and nausea. On Saturday, 5/5/01, had redness around the injection site. Redness had gotten bigger on Sunday and experienced chills on Sunday night. Currently, 5/7/01, have a headache.
Sore arm at the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm at the injection arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 024C21A) for COVID-19 vaccination.     The patient's past medical history included Shingles (Shingles attack few years back). Concomitant products included GABAPENTIN for Rheumatoid arthritis, ESCITALOPRAM OXALATE (LEXAPRO) and ALPRAZOLAM (ZENAX) for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm at the injection arm). At the time of the report, PAIN IN EXTREMITY (Sore arm at the injection arm) outcome was unknown. Not Provided          Patient received no treatment for events that occurred due to first dose.  Action taken with the drug in response to events was not applicable.
6/26/07 1 1/2 hours after receiving vaccine patient presented back to nursing dept with a reddened raised area (5 1/2 cm x 3 1/2 cm) at injection sit - warm to touch and painful. Seen by Doctor and Ice applied. Recommended to call clinic if any other reactions occur. 6/27/07 - Injection site slightly red and still warm to touch, patient c/o HA in middle of night and now feels nauseated this AM.
THE PATIENT PRESENTED TO THE PHARMACY FIVE DAYS AFTER RECEIVING THE VACCINE COMPLAINING OF REDNESS, SWELLING, WARMTH, AND PAIN AT INJECTION SITE AND SURROUNDING AREA. THIS WAS ACCOMPANIED WITH FATIGUE. THESE SYMPTOMS STARTED THE SAME DAY THAT THE VACCINE WAS ADMINISTERED.
Bruise at the place of injection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE BRUISING (Bruise at the place of injection) 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 reporter.  No concomitant medication reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE BRUISING (Bruise at the place of injection). At the time of the report, INJECTION SITE BRUISING (Bruise at the place of injection) outcome was unknown.            Treatment information not provided. List of concomitant medication were not given.
About 12 hours after vaccine, fever 103.0, chills, nausea, major body aches/ pain, fatigue, irritation, neck and head pain, pain where injection given.  Tylenol helped bring fever to 101.0, and symptoms lasted about 36 hours. Felt like a really bad flu.
No even 24 hours after first shot my headaches became severe to the point that I am lying in bed every day with pain levels of 9 and 10.  Waited over 4 hours for help at ER but ER was overwhelmed with patients and no assistants were given.  I?ve had 2nd toradol shot followed by a course of prednisone but had to stop it after developing significant psychotic symptoms related to my schixoaffective disorder.  I?m currently on emgality injunction,  go maybe 1 or 2 days in a week with reduced pain but it comes back to high pain levels the next day or day after.  Ibuprofen or Tylenol doesn?t decrease the intensity or pain or length headache lasts.  Headaches prevent me from my activities of daily living.  Fortunately I have pets that rely on me for care and food so I manage that.  Barely driving anymore.  They usually start in early morning.  I had migraines years ago that would last for 1-2 weeks then disappear for months and months and eventually years.  Never was able to not stop a migraine with migraine medication.  Appt for neurologist was made for me by a HCF back in April 2021 but first available appt is Jan 11, 2022 which is my appointment
Case number PHEH2013US017940, is an initial spontaneous report received from a nurse on 20 Aug 2013. This report refers to a 12 years old male patient. Past medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: not reported) on 20 Aug 2013. Reporter stated that, a nurse administering MENVEO lost about half the dose, when the needle came out during administration. No adverse event was reported following this administration error.
pt reports hives, lip swelling and throat swelling 1 day after receiving COVID-19 Pfizer #1 vaccine and influenza vaccine together by unknown pharmacist at a pharmacy
13 & 12cm indurated red swelling @ rt thigh inj site of DTP;
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: rash not cleared by benadryl on trunk of body, sought medical attention and received steroids
falling down; went to the ER were they were put on an IV; body chills; body aches; This spontaneous case was reported by a physician and describes the occurrence of FALL (falling down), EMERGENCY CARE (went to the ER were they were put on an IV), CHILLS (body chills) and MYALGIA (body aches) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Cardiac disorder (con med: 4 different medication for a heart problem they had on 1990) in 1990 and COVID-19 in November 2020.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced FALL (falling down), EMERGENCY CARE (went to the ER were they were put on an IV), CHILLS (body chills) and MYALGIA (body aches). On 01-Mar-2021, FALL (falling down), EMERGENCY CARE (went to the ER were they were put on an IV), CHILLS (body chills) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included Tylenol, IV at the ER  concomitant medicines include 4 different medication for a heart problem  had on 1990  Action taken with mRNA-1273 in response to the event was unknown
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1, (dose, lot # and expiry date unknown). On 11-JUN-2013, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # H018451 with expiry date of 09-OCT-2014. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Intense stiff neck and arm. Patient reported not being able to reach the top of her head to style her hair.
Upset stoamch; did not take second shot; hasn't been able to hold down food; diarrhea; left arm had tingling; numbess in left arm and extremeties of fingers of left hand.; dizziness; Queasy feeling in the stomach all the time as if in sides are being chewed out by; soreness in arm; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PRODUCT DOSE OMISSION ISSUE (did not take second shot), FOOD INTOLERANCE (hasn't been able to hold down food), ABDOMINAL DISCOMFORT (Upset stoamch) and PARAESTHESIA (left arm had tingling) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Suspected COVID-19 in March 2020. Concurrent medical conditions included Insomnia since 2007, Polycystic ovaries since 2002, Hypothyroidism since 2010 and Stomach discomfort (Stomach issues for few months) since March 2020. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METFORMIN and TRAZODONE for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced DIARRHOEA (diarrhea), FOOD INTOLERANCE (hasn't been able to hold down food), PARAESTHESIA (left arm had tingling), HYPOAESTHESIA (numbess in left arm and extremeties of fingers of left hand.), DIZZINESS (dizziness), NAUSEA (Queasy feeling in the stomach all the time as if in sides are being chewed out by), MYALGIA (soreness in arm), HEADACHE (headache) and CHILLS (chills). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not take second shot) and ABDOMINAL DISCOMFORT (Upset stoamch). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Headache, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Stomach discomfort, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), FOOD INTOLERANCE (hasn't been able to hold down food), ABDOMINAL DISCOMFORT (Upset stoamch) and NAUSEA (Queasy feeling in the stomach all the time as if in sides are being chewed out by) had not resolved and PRODUCT DOSE OMISSION ISSUE (did not take second shot), PARAESTHESIA (left arm had tingling), HYPOAESTHESIA (numbess in left arm and extremeties of fingers of left hand.), DIZZINESS (dizziness), MYALGIA (soreness in arm), HEADACHE (headache) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For treatment patient took a bland diet   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received :  Patient demographics, medical history were added.Concomitant and treatment medications were added. New events added and outcome of all events  was updated.
Pt. is described as having full blown chicken pox as result of vaccine. (Unofficial Dx - per MD visit w/a family member). Advised pt. to seek medical attention - she declined.