chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 4 adult patients received Monovalent vaccine 9 day after MFG expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date).    No concomitant medications were reported.  8 adult patients received monovalent vaccine Beyond manufacture Expiration Date. It was reported that expiry date of vaccine had not been extended.It was unbroken cartons. Vial size was reported as 5.5 mL. Vial was initially stored in the refrigerator 20-MAY-2022 and 28-MAY-2022. 4 adult patients on 21-MAY-2022 and 4 more adult patients on 29-MAY-2022. Vial did not undergo any temperature excursions.  No treatment information was provided.  This case contains information for the 7th of 8 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-679408, US-MODERNATX, INC.-MOD-2022-679413, US-MODERNATX, INC.-MOD-2022-679412 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679408:same reporter US-MODERNATX, INC.-MOD-2022-679412:same reporter US-MODERNATX, INC.-MOD-2022-679413:same reporter
Patient felt dizzy and fainted and fell to the floor, paramedics were called and the took her to the hospital
ACUTE PERICARDITIS, UNSPECIFIED 3/22/2023 BILAT PLEURAL EFFUSION HYPOXIA 4/12/2023 BILAT PLEURAL EFFUSION ALLERGIC REACTION, INIT 8/9/2022 BILAT PLEURAL EFFUSION ACUTE PERICARDITIS, UNSPECIFIED 3/22/2023 PERICARDIAL EFFUSION HYPOXIA 4/12/2023 PERICARDIAL EFFUSION ALLERGIC REACTION, INIT 8/9/2022 PERICARDIAL EFFUSION
Itching. Next day severe headache, itch pin prick and swelling ovals down her arem from both injection sites to her elbow.
Shingles - 3 weeks Secondary Candida infection of the skin - 2 weeks.
This spontaneous report was received from a physician referring to a patient of unknown age and gender who on an unknown date, was vaccinated with a dose of GARDASIL 9 (Lot #, dose and route not reported). Subsequently, on an unknown date, the patient had local to GARDASIL 9 for one week. This is one of three reports from the same source. Additional information has been requested.
Adult patient received dose after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received dose after its expiration date 13-Jul-2022).    This case contains information for the 42nd of 56 patients described by the reporter.  Concomitant medication was not provided.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Doses were administered after 30-day use by date or after manufacturer date of expiry. It was unknown to HCP when the vials were stored in the refrigerator and when the doses were administered. The vial did not undergo any temperature excursions.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Skin rash on arms, legs, chest and back that was itchy.  Progressively became worse over the weekend and was seen by medical on Mon 10/15/12.
Arthralgia, Rash, UrticariaPruritus, Fatigue, injection sit pain, brain fog Narrative:  Other Relevant History:
This spontaneous report as received from a registered nurse refers to currently 14 years old male patient with none pertinent medical history and none drug reactions/allergies. On 30-AUG-2012 the patient was vaccinated with his first and the only dose of GARDASIL intramuscular injection, (dose and site of administration were not reported) (lot # H010915; exp. date: 13-FEB-2015). On the same day as the GARDASIL (30-AUG-2012) the patient was also administered 2 concomitant vaccines: a dose of Hepatitis A virus vaccine and a dose of FLUMIST. On an unknown date the patient experienced facial twitching occurred off and on for a month. The patient sought medical attention via seeing at the office (30-AUG-2013), one year after the dose of GARDASIL was administered. The patient recovered from facial twitching on an unspecified date. There was no treatment given and no lab tests were performed. The relatedness between the therapy with GARDASIL and facial twitching was not reported. This is one of several reports from the same reporter (MARRS # 1309USA000780). The additional information has been requested.
Fever of 100.1, chills, headache, cramps in feet, neck stiffness, severe muscle aches, severe pain in right arm, right arm swelling, redness and tenderness. Localized arm pain started immediately after injection on 5/4 followed by chills/fever/headache at 3:30 am on 5/5. It's 10 pm on 5/5 and still suffering from side effects. Only treatment has been acetaminophen.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies were not reported. Concomitant therapies included sterile diluent (STERILE DILUENT) (lot# L030306 and expiration date: 08-APR-2018) which was properly stored. On 05-APR-2018, the patient was vaccinated with improperly stored injection VARIVAX (dose, units and frequency not reported) (lot # N021722 and expiration date: 08-APR-2018) subcutaneously at the temperature from -9 degree Celsius (C) to 8 C for 25 hours. It was reported that, the vaccines had previous temperature excursion in the range from -14 C to -10 C for 37 hours 3 minutes. Digital data logger was involved. No product quality complaint was involved.
patient stated redness and swelling for about 2 weeks post injection, then multiple weeks later sore to the touch and tender.  currently radiating to scapula humerus and shoulder for pain.
Patient had immediate excruciating pain.  Tried ice and ibuprofen.  After 3 hours went to ER where they had to give her narcotics to help alleviate the pain.  Minimal swelling and redness.
He started to notice his dark blue skin marks or discoloration at the four places in his body under his armpits, hip joints area, groin; He only noticed about it when those places started to get itchy; This spontaneous case was reported by a patient and describes the occurrence of SKIN DISCOLOURATION (He started to notice his dark blue skin marks or discoloration at the four places in his body under his armpits, hip joints area, groin) and PRURITUS (He only noticed about it when those places started to get itchy) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 001B21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 SKIN DISCOLOURATION (He started to notice his dark blue skin marks or discoloration at the four places in his body under his armpits, hip joints area, groin) and PRURITUS (He only noticed about it when those places started to get itchy). The patient was treated with TRIAMCINOLONE at a dose of 0.025 and TACROLIMUS at a dose of 0.1%. At the time of the report, SKIN DISCOLOURATION (He started to notice his dark blue skin marks or discoloration at the four places in his body under his armpits, hip joints area, groin) and PRURITUS (He only noticed about it when those places started to get itchy) had not resolved.            No concomitant product use was provided.  First dose was taken on 8 or 21-Feb-2021.  Two and half to three weeks after receiving the booster shot, the patient started to notice his dark blue skin marks or discoloration at the four places in his body under his armpits, hip joints area, groin. He only noticed about it when those places started to get itchy.  Patient seek for medical help from his internists, and two dermatologists.  Patient was prescribed and using 0.025 Triamcinolone ointment and cream and shifted to 0.1% Tacrolimus.
after 15 minutes pt. complained of racing heart dizziness and sweating , had pt. remain in seat and asked if wanted water there was no apparent anaphalactic issue  ,  pt. was in site of pharmacist entire time , rph or tech also went talked to her + checked on her symptoms every 5 minutes pt. showed slow improvement refused 911 stayed seated for total 1 hour 5 minutes symptoms per pt. had mainly subsided  and she chose to was able to leave
URINATING VERY FREQUENTLY; VOMITING; CHILLS; NAUSEA; MUSCLE ACHE; FATIGUE; This spontaneous report received from a consumer concerned a female 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced urinating very frequently, vomiting, chills, nausea, muscle ache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, vomiting, muscle ache, fatigue, urinating very frequently and chills was not reported. This report was non-serious. This case, from the same reporter is linked to 20210409934.
Approximately 10 days after I received my second COVID vaccine (Pfizer) my index fingers and thumbs in both hands became very swollen.  The swelling continued to ebb and flow over the next couple of weeks and often included swelling and inflammation in all my fingers and hand joints/knuckles, my left ankle, left toes, left elbow.  As of today (6.18.2021, my left index finger is still very swollen and painful with limited mobility and more minor swelling/inflammation is still present in all my fingers, some of my left toes, my left elbow and left ankle.
Chronic mild nosebleed; Cough; Axillary lymph node pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 24Feb2021 at 16:00(at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperhomocysteinemia, anxiety and ADHD. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and doxycycline (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 03Feb2021 at 16:00(at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 17Mar2021 the patient experienced chronic mild nose bleed, cough and axillary lymph node pain. The events resulted in doctor or other health care professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chronic mild nose bleed, cough, axillary lymph node pain was recovered with sequelae on an unknown date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient states that she has been experiencing a painful tingling sensation since receiving the vaccine and that sometimes she has to wear a sling because her arm hurts to that extent.
I started feeling a reaction 2-3 days after. I broke out in hives and my chest felt really heavy. I could barely swallow and had problems breathing, then I started vomiting. I went to Urgent Care where they ran an EKG and did bloodwork. The EKG came back normal, but my white blood cells were elevated. They gave me Prednisone and sent me home. When I got home and started taking the Prednisone my body had a reaction to it. I started vomiting and had a hard time breathing while feeling the heaviness in my chest again. This time Urgent Care sent me to their ER (same medical complex) I was a CT Scan, blood cultures, a Chest X-ray and given another EKG. They also tested me for Strep, Mono and COVID-19, and they were negative. They gave me IV fluids of Benadryl and Dilaudid. I was released and was told to stay home from work and rest for 3 days. They told me to come back if I experienced anything else. I have a checkup appointment this Monday 5/9/2022.
(R) arm pain, erythema, swelling, warmth to touch (esp to forearm, noted ecchymosis to (R) upper arm.
VARIVAX was administered 02SEP2021 following a supported temperature excursion; This spontaneous report has been received from a healthcare business professional referring to a 4-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, previous drug reactions, or allergies was provided.  On 28-JUN-2021, a temperature excursion involving varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number T038830 has been verified to be valid, expiration date reported and established as 17-NOV-2022) occurred. The vaccine was improperly stored at a temperature of 8.4 degrees Fahrenheit, during a time frame of 1 hour and 30 minutes. There was no previous temperature excursion.  On 02-SEP-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose number, administered dose, vaccination scheme, route of administration, and anatomical site of vaccination were not reported) as prophylaxis (product storage error).
Received vaccine on 6/10/11. Got site injection redness, experienced fever, malaise & arthritic condition in hands prior to outbreak of shingles, & mild itching; eruption started on 6/18 on left  shoulder & scalp. Patient sought diagnosis/treatment at medical clinic & received Acyclovir 200mg 3 p.o 5 x/day for 5 days #105 & ZOVIRAX Ointment. Patient concerned that CDC fact sheet does not give risk of getting shingles as part of vaccine administration. Still has outbreak (6/24/11) saw Dr. for treatment/diagnosis while traveling.
Patient complained of soreness/pain on right arm on FLUZONE injection site and also reported fever. I advised patient to use ice/cold compress to help the swelling and soreness and to take TYLENOL by mouth for fever and pain. I checked with patient after a few hours and they confirmed the fever/pain/soreness had improved. They decided not to go see their physician. I informed the physician of the reaction to flu shot and they advised patient come see them if symptoms do not resolve.
Fainted after leaving the clinic.  Mom took him to Hospital who transferred him to another facility for observation.  He was released the 16th.
Nerve pain and twitching in arm, upper left back, burning and pulling sensation. Diagnosed as Neuralgia by E.R.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 09Apr2021 at 18:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine, COVID-19 and allergy to quinolones. Concomitant medications were not reported. The patient previously took received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 19Mar2021 at 12:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 20:30 the patient experienced Nerve pain and twitching in arm, upper left back, burning and pulling sensation and She was diagnosed as having Neuralgia by E.R. The event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Therapeutic measures were taken as a result of neuralgia and included treatment with (unspecified) pain medications, and muscle relaxers. The clinical outcome of the event Neuralgia was not recovered.  No follow-up attempts are needed. No further information is expected.
injection site redness; 13 different patients" given Pfizer COVID vaccines for all age group "couple of weeks and some are less" after the 10 weeks beyond-use-date in the refrigerator.; 13 different patients" given Pfizer COVID vaccines for all age group "couple of weeks and some are less" after the 10 weeks beyond-use-date in the refrigerator.; The initial case was missing the following minimum criteria: (ICH- unspecified number of patients). Upon receipt of follow-up information on [06Jun2023], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 5-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Mar2023 at 11:23 as dose 3 (orange cap; booster), single (Lot number: GK1657) at the age of 5 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 20Mar2023, outcome "unknown" and all described as "13 different patients" given Pfizer COVID vaccines for all age group "couple of weeks and some are less" after the 10 weeks beyond-use-date in the refrigerator."; VACCINATION SITE ERYTHEMA (non-serious) with onset 20Mar2023 at 11:23, outcome "recovered" (2023), described as "injection site redness". Therapeutic measures were not taken as a result of vaccination site erythema.  Additional information: No Prior Vaccinations, no medical history. No Relevant tests and specific relevant test for thromboembolic events with thrombocytopenia. Bivalent COVID vaccine given outside BUD. The patient did not experience any adverse event(s) as a consequence of the error.
I am a physician and received my 3rd shot Pfizer - did well but developed LAD about 48 hours later - quite significant under my axilla and down my lateral chest wall. Was uncomfortable for 48 hours requiring NSAIDs and now I am still quite swollen but pain is subsiding.
Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016394519) on 03 Jan 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (Tetanus) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed Allergies to Tetanus (speed like response). Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of the documents held by sender: none.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 22-JUL-2013, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On 24-FEB-2015, the patient was diagnosed with Transverse Myelitis. On approximately 2015, a lumbar puncture was performed, and spinal fluid confirmed the presence of herpes zoster/shingles infection. Thereafter, the patient was diagnosed with Bell's Palsy and Transverse Myelitis/Guillain-Barre Syndrome, and at the reporting time was unable to walk. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries and suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Further, as a direct and proximate result of the Company's conduct, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The reporter considered the events to be related to ZOSTAVAX. Transverse Myelitis/Guillain-Barre Syndrome, Bell's Palsy and herpes zoster/shingles infection were considered to be disabling. Upon internal review, the events Bell's Palsy and Transverse Myelitis/Guillain-Barre Syndrome were determined to be medically significant. Additional information has been requested.