chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 unspecified patients experienced syncope/3 of the unspecified patients were male; This spontaneous report was received from a physician via a company representative and refers to 2 female patients, at the age range between 11 to 16 years old. The patients' medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, site and route of administration, lot# and expiration date were not provided) for prophylaxis. After administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patients experienced syncope.  The outcome of the event was unknown. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was reported as dose not changed. The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of syncope was determined to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA003299:
The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022; The patient received vaccine past its 30 days of an expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2022 at 10:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2022 at 10:50 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had received the vaccine dose number as booster.  No Concomitant medication reported.  It was reported that a series of approximately 540 patients had received lot 066H21A past its 30 days of an expiry date. The vaccine was administered up until its manufactured expiry date of 04-Apr-2022 and this lot number was no longer possessed.  No Treatment medication was reported.
Extreme Fatigue - fighting to stay awake Chills Dizziness Rash on entire body except face ( this progressed a week later into skin peeling) NO itchyness Dehydration Weakness, difficulty walking Went to the ER the Tuesday, when I was not feeling any better, was fearful that I had covid on top of getting the booster Treatment : - diphenhydrAMINE (Benadryl) - sodium chloride 0.9% bolus
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 27-Oct-2021 at 1:13 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 1:13 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Batch number 035C21A underwent temperature excursion on 27-Oct-2021 with temperature range of 29 and 32 degrees Fahrenheit at 09:00 AM to 10:00 AM. This vial was moved to fridge on 29-Sep-2021 and 05-Oct-2021, beyond use date for the vial was reported as 29-Oct-2021 and 04-Nov-2021. Product moved to clinic on 27-Oct-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a brand traceable temperature monitor at every hour.  Treatment information was not provided.   This case was linked to MOD-2022-566976 (Patient Link).
Fever and flu-like symptoms started within hour of receiving his FLUARIX AFLUA578AC GSK.
I got completely numb on the right side of my face. I called a hotline nurse and she told me it could be bells palsy. My eye started to droop. Got worse and then got better. Face still a little numb
5-10-12 - got shot. 5-16-12 - Hosp. ER. Weakness not walking, short of breath. Sore muscles.
Patient in observation. Patient complaining of cottonmouth, tongue numbness, difficulty swallowing, numb lips, and throat swelling.  Vital signs BP-153/97, HR-88, RR-18.  Benadryl 50mg give orally by EMT. Patient AOx4, lung sounds clear bilaterally, no hives notes, no injuries noted.  Patient monitored. Patient reports feeling better after receiving Benadryl. Vital signs BP-164/45, HR-82, RR-16.  Patient reports no more symptoms. Patient educated about adverse reactions and when to seek medical attention. Patient verbalizes understanding.
Post vax, pt experienced altered mental status per parents. Pt was admitted with possible encephalopathy associated with the vaccine. Per discharge summary pt went to sleep after leaving the office (from receiving vax) and had not awakened except briefly and incompletely to feed. She had not let anyone know of this previously. No vomiting, diarrhea, congestion, coughing, or fever.
Left arm swollen (inflamed) pt went to convenient care. Was given prednisone.
Had foot surgery and was in the hospital and now she is past the 42 day limit; Past the 42 day limit interval between the first and second vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FOOT OPERATION (Had foot surgery and was in the hospital and now she is past the 42 day limit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced FOOT OPERATION (Had foot surgery and was in the hospital and now she is past the 42 day limit) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past the 42 day limit interval between the first and second vaccine). At the time of the report, FOOT OPERATION (Had foot surgery and was in the hospital and now she is past the 42 day limit) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Past the 42 day limit interval between the first and second vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This report refers to a case of Product dose omission issue for mRNA-1273, lot #066B21A , and an AE of Foot operation. Based on the current available information and temporal association between the use of the product and the start date of the event of Foot operation, a causal relationship cannot be excluded.    .; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot #066B21A , and an AE of Foot operation. Based on the current available information and temporal association between the use of the product and the start date of the event of Foot operation, a causal relationship cannot be excluded.  However based on reporter's causality (is past the 42 day limit) the event is assessed as not applicable to mRNA-1273.
Around five or six weeks after the vaccine, I started to get a sore throat, swollen lymph nodes, and fatigue. EBV was shown reactivated after a blood work test. Doctor said it was from an immune response from the vaccine.
My extremities broke out in itchy hives (near knees, calves, elbows).
Pfizer 1/31, 2/21, and 8/16. Positive on 12/2
Slight fever and chills 24 hour after booster.  28 hours after booster i started getting  Upper adominal pain , pain when deep breathing.  felt pain right side under ribs when deep breath.  Pain when twisting or in bed adjusting when trying to sleep.  kept getting worse for few days.   Pain started to reduce by the time I saw my PCP on 12/09/ 21
Headache, Myalgia, Arthralgia, rADIATING PAIN MOVING UP TO THE SHOULDER AND NECK, AND DOWN THE LEFT ARM Narrative:  Other Relevant History:
to ED c/o SOB, cough, congestion, + COVID 10 days prior, now with low O2 and confused; tested + again with pneumonia and req TX: rocephin, decadron, mucinex, singulair, remdesivir, zinc; develops AMS, toxic metabolic encephalopathy; pt transitioned to hospice care 2/16/22 and pt expired 2/23/22
VACCINE WAS GIVEN BEYOND USE DATE. VACCINE WAS RECEIVED IN REFRIGERATOR ON  03/07/2022 AND KEPT IN REFRIGERATOR IN APPROPRIATE TEMPERATURE (2-8 CELSIUS). VACCINE WAS GIVEN TO PATIENT 2 DAYS PAST THE 30 DAY TIME IN REFRIGERATOR.
At the site of the pneumonia shot, the reaction began with itching, tenderness.  When I looked at the site, it was whelped, red, sore and the size of a large egg (ovoid). I called my doctor on Sunday 11/7.  He suggested Benadryl and ice. The site was painful for the first three days. It remained the same shape, but over the next five days it grew to about 3" wide to almost 6" long.  It was the length of the distance between my thumb and forefinger.  On Nov. 11, I found that the tenderness, redness, swelling was lessening from the center outward.  Today is 11/14/2010 and the only remaining symptom is itching.
A report has been received from a Pharmacist concerning a 47 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 11-Nov-2013. The patient experienced administration of only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
inadvertently administered to a 6 month old patient on 02Aug2019; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old female patient who experienced inadvertently administered to a 6 month old patient on 02aug2019, while she received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomintant medication included PCV13, Hepatitis B.  On 02-Aug-2019, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5248AA via intramuscular route in the right thigh.  It was of actual medication error due to  inappropriate age at vaccine administration..  It was unknown if adverse event was experienced.  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.
Typically symptoms plus those out of the ordinary: numb lips and face to cheeks, extreme ear pain, headache, dizziness, light headed, difficultly swollen for short periods of time.
Swelling right side of neck, shoulder, upper trapezius and tracheal area Slight rash Soreness in the swollen areas
shingles; nerve pains; She felt that there were pins sticking out of her whole body for 24 hours; fever; chilling; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (shingles), NEURALGIA (nerve pains), PARAESTHESIA (She felt that there were pins sticking out of her whole body for 24 hours), PYREXIA (fever) and CHILLS (chilling) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 041L20A and 037K20A) for COVID-19 prophylaxis.     No Medical History information was reported.  Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced HERPES ZOSTER (shingles), NEURALGIA (nerve pains), PARAESTHESIA (She felt that there were pins sticking out of her whole body for 24 hours), PYREXIA (fever) and CHILLS (chilling). At the time of the report, HERPES ZOSTER (shingles), NEURALGIA (nerve pains), PARAESTHESIA (She felt that there were pins sticking out of her whole body for 24 hours), PYREXIA (fever) and CHILLS (chilling) had resolved.             No treatment information was reported.
Night of vaccine, patient experienced weekness, dizziness, nausea/vomiting, felt "odd". prolonged symptoms, tinnitis, continues to get dizzy and fall. One fall resulted in hitting head leading to ER visit. continued vertigo to this day, new onset of headaches. has reported this to pcp.
Whole body aches, chills, headache, fatigue and fever of 101 degrees...had to call into work the next day
This spontaneous report as received from a physician refers to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported). During the same visit, the patient was vaccinated with hepatitis A vaccine, inactivated (manufacturer unknown) and MENACTRA (lot #, expiration date, dose, route and site of administration were not reported for both). The patient did not wait the recommended 15 minutes, he just got up to leave immediately administration and he passed out. An ambulance was called. The patient's mother decided that the patient would not receive any further vaccinations. The outcome of syncope was unknown. The relatedness between the syncope and GARDSIL 9 and hepatitis A vaccine, inactivated (manufacturer unknown) was not reported. Additional information is not expected, because the physician cannot be contacted.
Information has been received from a physician concerning a 15 year old female with sulfonamide allergy who on 11-AUG-2007 was vaccinated with a first dose of Gardasil (lot # 658100/0525U).  Concomitant suspect vaccine on 11-AUG-2007 included Varivax (MSD).  Other concomitant vaccine included MENACTRA.  Gardasil was the last of the three vaccines given that day.  On 11-AUG-2007, a second after the vaccines, "the patient got pale, weak, slumped to her side and her eyes went back for a second."  The patient then got up real quick and the physician gave her water.  It was reported that "the patient was fine."  On an unspecified date, the patient recovered.  Additional information has been requested.
This spontaneous report as received from an Medical Assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates the unspecified number of unspecified patients were vaccinated with unspecified doses of improperly stored oral ROTATEQ injection (lot number not provided) (strength, dose, frequency and route not provided). No adverse effect was reported. The outcome of event was not reported. This is one of 4 reports from the same source. Additional information has been requested.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/14/2021 and 2/4/2021. Telehealth visit 1/21/2022 c/o sore throat and persistent cough, declined COVID testing, given prescriptions for azithromycin and guaifenesin AC syrup. Presented to ED 1/30/2022 c/o of SOB, fatigue, fever and positive home COVID test on 1/24/2022. On presentation respiratory rate of 24 with an SpO2 of 81%. Admitted for acute hypoxic resp failure 2/2 Covid PNA. Treated with methylprednisolone, tocilizumab, and Max HF of 60L 95% FiO2 with O2 sat down to 86%. 2/4/2022 expressed desire to cease all Covid treatment, remove HFNC, w/comfort measures only. Expired 2/5/22.
7/11/12: Syncopal episode after immunizations. LOC about 30 secs placed supine, BP/color back to baseline about 25 minutes. 7/18/12: Sinus headache, fever - sinusitis by history/exam, started AUGMENTIN. 7/25/12: headache, decreased energy, pale, nauseated, feeling faint, decreased HR.
This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown. It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was concerned about the side effects of Shingles vaccine. The reporter's mother got shingles infection in eye after getting the vaccine. The reporter was afraid if the same would happen to him or her. This case was considered as suspected vaccination failure as status of primary vaccination schedule and time to onset for the event were unknown.
Breakthrough COVID case. CG received 2nd pfizer covid vax 2/4/21. Became symptomatic 5/5/21. Tested positive 5/11/21
Chills; Aching; Nausea; Fatigue; Weakness; This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received Shingrix. On 10th September 2019, 1 days after receiving Shingrix, the patient experienced chills, pain, nausea, fatigue and weakness. On an unknown date, the outcome of the chills, pain, nausea, fatigue and weakness were not recovered/not resolved.   It was unknown if the reporter considered the chills, pain, nausea, fatigue and weakness to be related to Shingrix.  Additional details were provided as follows: Information obtained via webchat. The reporter was the wife of this patient.  The age at vaccination was not reported. The patient received Shingrix and was currently experiencing chills, aching, nausea, fatigue and weakness. The reporter did not consent to follow up. The reporter did not provide any demographic details and disconnected chat when asked for any demographic information to complete safety reporting.
Severe body aches, chest pain, sweating, chills, slept all day, very uncomfortable, haven't felt this sick in over a decade, unlike any ?flu?, nauseated. Weak, no energy, no appetite. Husband had same shot as me, had same reactions, terrible feeling
Pain at injection site; Muscle soreness in buttocks, legs,back; Right eye swelling lower lid; Tiredness; Feel unwell; This is a spontaneous report received from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number:Unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 17:30 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included Celexa (MANUFACTURER UNKNOWN), Zinc (MANUFACTURER UNKNOWN), Magnesium (MANUFACTURER UNKNOWN), Calcium (MANUFACTURER UNKNOWN), Vitamin D (MANUFACTURER UNKNOWN), Vitamin C (MANUFACTURER UNKNOWN), Vitamin B (MANUFACTURER UNKNOWN), and Clari (MANUFACTURER: UNKNOWN), all from unknown dates for unknown indication. The patient was not allergic to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested positive for COVID-19. The patient underwent lab tests and procedures which included COVID-19 virus test on an unknown date and tested negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 18Mar2021 at 09:30, the patient experienced injection site pain, muscle soreness, swelling of eyelid, tiredness and feeling unwell. The Patient did not receive any treatment for the events. The clinical outcome of the injection site pain, muscle soreness, swelling of eyelid, tiredness and feeling unwell was not recovered.   Information about lotnumber cannot be obtained. No further information is expected.
Swollen, red, warm to touch Deltoid. Recommend Dr. visit for antibiotic.
Eight days after receiving the first dose of vaccine, I developed an itchy spot at the site of injection.  The spot is swollen, warm to the touch/burns and is about the size of an egg. I took an extra dose of Claritin and put hydrocortisone cream on the area which helped with the symptoms. It is day 2 of these symptoms and the area is still inflamed and itchy/burning but improving.
Break through COVID-19 infection symptoms began May 5, 2022.  Scratchy throat, little tickle in my throat.  The following days I had lack of energy and fever most of the day Friday and Saturday, highest temp was 102.  As of I am feeling a lot better because the doctor gave me steroid - Methylprednisolone and antibiotic Azithromycin.  I only have a residual cough.