chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022; inadvertently administered expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 038B21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The reporter reported that the staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 and were not in accordance with the EUA. The vaccine in question did not experience any temperature excursions.  The patient had not reported any adverse reaction.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566648 (Patient Link).
Development of lesion at the inoculation site: Redness, swelling, and a raised, fluid filled sore that has began to scab over
My friends husband got shingles from the shot/Suspected Vaccination failure; My friends husband got shingles from the shot; This case was reported by a consumer media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter's friends husband got shingles from the shot. Te reporter stated that the patient was older then. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. No further information would be available.
BODY HURTS; CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body hurts, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body hurts, chills and headache was not reported. This report was non-serious.
Vaccines were stored after beyond use date and expiry date; 45 doses were administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (45 doses were administered past the expiration date) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 021F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (45 doses were administered past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (45 doses were administered past the expiration date) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that on 30-Nov-2021 vaccines were stored in a standard freezer maintained at 2 degrees Fahrenheit high to minus 1 degrees Fahrenheit low.  No treatment drug was reported. This case contains information for the 43rd of 45 adult patients described by the reporter.
Nausea; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (headache) and PYREXIA (fever) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, the patient experienced NAUSEA (Nausea), HEADACHE (headache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Nausea, Fever and Headache, at an unspecified dose and frequency. At the time of the report, NAUSEA (Nausea) and HEADACHE (headache) outcome was unknown and PYREXIA (fever) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had fever for 3 days after taking first dose. Even after 3 days, she was not back to normal as she had mild side effects. Even now (18-Mar-2021), she has low grade fever. Concomitant medications were not provided.
Client received a Menactra on 7/20/2009. She had a previous meningitis vaccine (type/ brand unknown) on 8/23/2007 in another county.
I was helping out provider's nurse by giving a FLUMIST. I glanced at the date and thought it was still unexpired. After documenting the eMAR, I saw that the expiration date was yesterday, 11/24/14. Because I was busy, I failed to get a second look.
The patient said she started experiencing side effects the next day which included:  "jitteriness inside", bone pain from the hips down in both legs (started the day after the vaccine and then went away the next day), and numbness inside of her lips and mouth (started the day after and improved, but was still slightly present as of 7-2-19---She said her tongue, throat and airway were not affected).
Pt devel a sterile abscess @ the inject site p/recvd DT (peds); surgery was required to treat this rxn;
28OCT94 pt recv vax; 10NOV began feeling tired & fatigued; DEC94 weakness, diarrhea, nausea, loss of appetite; JAN95 body breakdown-extremely weak (diff walking) floppy feet & hands partially paralyzed as if circulation gone; ashen color;
By after noon, into evening, I developed some not unusual side effects (fever, chills, extreme tiredness, lack of appetite). The symptoms increased through the night but by the next day Monday had started to abate. I still did not feel well enough to work but was feeling better than the night before. I improved throughout the day and in the evening, while not feeling quite normal, had definitely improved. What surprised me was that when I went in the bathroom and saw myself in the mirror I noticed a substantial rash on my neck from and bay, behind my ears, and down my chest onto my trunk. It did not itch not did it hurt but it was definitely pronounced. The rash did not worsen and about 2-3 days later was completely gone. I was not expecting to see this rash. I'm concerned it was an allergic reaction so am a little concerned about getting the booster. My new PCP suggests I wait until more data is out. I called my PCP the night and she advised me not to be concerned as she had seen this prior. I do question how often she saw this side effect since I got the vaccine pretty early upon roll out. I haven't seen anywhere that this is a typical reaction. I reported the adverse effect to Moderna after it occurred
Around 13 hours after vaccination I woke up to muscular and nerve pain all over my body. It didn't subside until the following morning.
6?x7? red  oval shaped skin rash under injection site. Very hot to the touch
patient reported submandibular lymphadenopathy as possible side effect o f cosentyx. he reported that he had moderna covid-19 vaccination on 3/18 and on 3/11 he developed right sided submandibular lymphadenopathy, then it happened again after his 2nd dose. he spoke to an internist that felt it may be due to vaccination and gave him an antibiotic. however he ha d a third case 3 days after cosentyx injection so he is not sure that is if from the vaccination. pt is a retired physician. he will speak to his rheumatologist again to see if he should keep using or if he needs to consider another treatment.no additional information or dates  provided.
Death; Respiratory failure; GBS(Guillain Barre syndrome ); This case was reported by a lawyer and described the occurrence of death in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced death (serious criteria death and GSK medically significant), respiratory failure (serious criteria GSK medically significant) and guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the death was fatal and the outcome of the respiratory failure and guillain barre syndrome were unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death, respiratory failure and guillain barre syndrome to be related to Shingrix.  Additional information: The patient had death claim involving GBS and respiratory failure.; Reported Cause(s) of Death: Unknown cause of death
pt recv vax 29JUL97 & 7SEP97 pt devel a rash, mostly in the diaper area, described as a total of 5 vesicular lesions & about 20 red spots;
Case PHEH2016US023299, is an initial spontaneous report received from a consumer on 12 Sep 2016. This report refers to a 78 years old female patient. Medical history and the patient current condition was included as neomycin antibiotic allergy. Concomitant medications were not reported. The patient was vaccinated with single dose of seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unknown date. The consumer stated that, long time ago she received a flu vaccine (not specified) and almost died because of it. The patient experienced anaphylactic reaction to vaccine. Later after an allergy test (unspecified), it was discovered that she was allergic to neomycin and antibiotics (unspecified). The outcome of the event anaphylactic reaction was reported as complete recovery on an unknown date and for other events was not reported. The seriousness of the events was not reported by the consumer. The causality of the events was not reported. The seriousness assessment of the event feeling abnormal was upgraded based on information available in the source document. The seriousness assessment of the event anaphylactic reaction was upgraded to medically significant based on the Novartis Important Medical Event list. The case is lost to follow up at initial.
One day post vax, pt had two brief episodes apnea and slight cyanosis. Infant was stimulated and immediately began breathing.
Seems to be bruising easily; More fatigued; This spontaneous case was reported by a consumer and describes the occurrence of INCREASED TENDENCY TO BRUISE (Seems to be bruising easily) and FATIGUE (More fatigued) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.        Concurrent medical conditions included Ulcerative colitis.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced INCREASED TENDENCY TO BRUISE (Seems to be bruising easily) and FATIGUE (More fatigued). At the time of the report, INCREASED TENDENCY TO BRUISE (Seems to be bruising easily) and FATIGUE (More fatigued) had not resolved.            No concomitant medications was provided. No treatment medications was provided.  It was unknown if patient was enrolled in COVID-19 Vaccine Trial.  The reporter's causality for the events seems to be bruising easily and more fatigued with Humira was a reasonable possibility.
This spontaneous report has been received from the medical assistant refers to a 12 months old male patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to them included Diluent Mrk Inj used to reconstitute the VARIVAX was properly stored. On 09-JUL-2018, the patient was vaccinated with improperly stored doses of VARIVAX (dose, units and frequency not reported) (lot# N035937 and expiration date: 18-DEC-2019), subcutaneously. The doses of VARIVAX were exposed to a temperature excursion of 6 degrees Fahrenheit (degrees F) to 14 degrees F (also reported as "9F") for a time frame of 10 minutes; and of 15 degrees F to 46 degrees F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter.
Fever, chills/heat flashes, constant body aches, headache, whole body is sore
Patient mistakenly received the Bivalent Booster without receiving the primary series of COVID vaccine. The Bivalent booster she received on 10/3/22 was her first and only COVID vaccine. Patient has reported no ill effects or issues.  Contacted Pfizer, they recommended no further vaccines at this time.
Client in observation area, nurse approached to ask how she was doing. Client stated she felt itchy all over her body, mostly on left  arm where vaccine was administered.  Nurse noted 2 welts on the left upper arm.  Took client to EMS room and administered 1 tablet 25mg of diphenhydramine.
Pain swallowing fells like something is obstructing the windpipe; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm on 26Feb2021 at 14:15 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had no known allergies to medications, food, or other products. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN), amitriptyline (MANUFACTURER UNKNOWN), potassium chloride (KLOR-CON), quinapril (MANUFACTURER UNKNOWN), furosemide (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), carvedilol (MANUFACTURER UNKNOWN) and ezetimibe (MANUFACTURER UNKNOWN); for an unknown indication from an unknown date and unknown if ongoing. On 27Feb2021 at 21:00, within 36 hours of vaccination, the patient experienced pain swallowing felt like something was obstructing the windpipe. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain swallowing was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Pt was given Adacel, Menactra + PPD. Began feeling light headed, sat in chair and became faint.
I had swollen, pain and redness in the arm at injection site, fatigue. It lasted about 7 days.
extreme nausea; vomiting; extreme vertigo; extreme dizziness; chills; a general feeling of weakness; This is a spontaneous report from a contactable consumer. This consumer (Patient's son) reported for a 71-year-old female patient (mother) who received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date as first dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced extreme nausea, vomiting and extreme vertigo to the point she could not function, extreme dizziness, chills and a general feeling of weakness. Reported enquired if these side effects were known and if she was a good candidate for the second dose. The outcome for all the events were unknown.  Follow-up (29Jan2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient. No new information found.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
arm is very sore; headache; tight/stiff neck; weak; muscle pain; achy all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm is very sore"; HEADACHE (non-serious), outcome "unknown", described as "headache"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "tight/stiff neck"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; PAIN (non-serious), outcome "unknown", described as "achy all over".  Additional information: Patient is taking ibuprofen periodically for the pain. She was asking if she can take Tylenol or ibuprofen. She spoke to a pharmacist regarding this concern but she was advised not to take the pain reliever before and after taking the vaccine shot because it will lessen the effectiveness of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient was given a Moderna Vaccine on 9/1/2021. I was unable to get into to chart the vaccine due to no access after ordereing this. He signed consent, filled out a card and prescreening done by nurse. He left jail and went to anther jail and was given another vaccine on 9/13/2021. I was unable to chart the vaccine until 9/13/2021 when I gained access to the record number. I have several jails attempting to jail access throughout this time to try to jail access. on 9/13/2021 it showed he had been given Johnson and Johnson on 9/13/2021
Redness around shot site began to expand and spread 3 inches in diameter around and patient required antibiotics, fever 100.4, nausea, fatigue.
Rash, modified chicken pox diagnosis, onset of symptoms began on 2/28/06, pt treated with Atarax, Tylenol, and Carbofed.
This spontaneous report was received from a doctor of pharmacy refers to a female patient of unknown age. On 10-SEP-2012 (also reported as yesterday) the patient was vaccinated with an expired dose of ZOSTAVAX (lot # (670980/0731AA, expiry date 17-AUG-2012) (route not reported). No adverse effects was reported. Additional information is not expected.
Extremely loud and disruptive ringing in both ears noticed 2 days after getting progressively worse. Worsening at night. Causes insomnia, inability to focus, loss of quiet. Inner ear pain.  Nothing helps.
This spontaneous case reported by a consumer, describes the occurrence of neck pain (pain in left-side of neck), pain in extremity (pain in arm), headache (sharp pain on the left-side of head) and arthralgia (pain in shoulder) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced neck pain (pain in left-side of neck), pain in extremity (pain in arm), headache (sharp pain on the left-side of head) and arthralgia (pain in shoulder). At the time of the report, neck pain (pain in left-side of neck), pain in extremity (pain in arm), headache (sharp pain on the left-side of head) and arthralgia (pain in shoulder) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant product use and treatment information not provided.
pt exp a variety of non-specific sx p/vax according to report;sx include fatigue, panic feeling, adrenalin rash, h/a, dizzy;has seen MD & psych providers on a few med for mitral valve & panic disorder dx NOV98;
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/15/2021 UTI (URINARY TRACT INFECTION)
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX (Merck) (lot#, expiration date, dose, route not reported). On an unknown date the patient experienced chickenpox. The reporter was unsure if the patient ever received VARIVAX (Merck) prior to developing the chickenpox. The outcome of chickenpox was unknown. Additional information has been requested.
Pain in entire right arm. Tingling bilateral fingers x 5min. Then tingling in bil feet x 10 min. General achiness and fatigue.  Feeling very cold x 30 min at night. Then feeling very hot. Temp 100.5F . Headache and nausea for rest of night.  Day 2 achiness and fatigue continued with temp of 99.5F. Day 3-4 sore, achy arm. Day 5 back to normal.