chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   No treatment was given to the patient.   The vaccines were stored in freezer, were taken out one to two vials and placed in fridge each day as needed.
Initial report received from a consumer who is also the patient on 05 October 2012. A female patient, whose age, medical history and concomitant vaccinations were not reported, had received a dose of FLUZONE (Lot number UH720AD, dose number and route of administration not reported) in left upper arm on 03 October 2012. On 03 October 2012, about 2 hours after receiving vaccination, the patient's left upper arm became bright red, hot, hard to touch, very swollen and the patient felt really sick. The patient reported that the patient cannot lift the left arm up all the way because it hurts badly to do so. The arm was still swollen and slightly red and it hurts to touch. The patient is not feeling very well and is currently just resting. The patient was taking BENADRYL twice a day and also rubbing BENADRYL lotion on the irritated injection site as corrective treatment. Laboratory details were not reported. As of 05 October 2012, the patient was not recovered from the event. Documents held by sender: None. Follow up of information received on 25 December 2012: Patient's demographic details (age and date of birth) updated. It was reported that the patient recovered from the events after one month. Reporter did not know the vaccine details including dose number and route of administration.
Patient presented at the pharmacy requesting a nasal flu vaccine. FLUMIST Quad was administered without regard to the patient's age. No adverse effects were noted.
vaccine had a temperature excursion of 0.5 degrees above recommendation for 1 hour during storage
3/10/2021 SHE WENT TO A FACILITY 155 MILES FROM OUR LOCATION AND RECEIVED JANSSEN VACCINE  WITH LOT NUMBER 1082028. ON 4/28/21 SHE CAME TO OUR LOCATION AND RECEIVED THE 1ST OF 2 PFIZER VACCINE, THE 2ND ON ON 5/19/2021.
Left upper arm cellulitis/lymphangiitis (?). Treated Keflex po by ER.
This spontaneous report was received from a registered nurse refers to a multiple unspecified patient's of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an multiple unspecified dates, the multiple unspecified patient's were vaccinated with improperly stored doses (incorrect product storage) of ROTATEQ (lot, expiry date and dosage regimen was unknown) for a year. No adverse effects reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
mom states pt became very lethargic progressing to unconscious (unable to arouse)&was very pale,lasting for 1-2hrs;also devel t103.9 ax;pt then awoke w/piercing screaming&crying for 1-2hrs;fever came down w/APAP but pt remained irritable
This spontaneous report as received from a phyisican refers to a 29 year old male patient. Concurrent conditions and medical history was reported as none. The physician reported that the patient showed an immune response to hepatitis B titers which were drawn on unknown date of May 2011. The patient was firefighter and exposed to blood during the extraction of a person who was negative for the hepatitis B surface antigen on unknown date of October 2014. The physician reported that his patient's hepatitis B titers were drawn on 25-OCT-2014 following his blood exchange and the titers were negative. On 28-OCT-2014, prophylaxis dose of RECOMBIVAX HB (lot # J006511, expiry date: 28-JAN-2016) through intramuscular route was administered. Concomitant medications were not reported. The patient's titers drawn again on 12-DEC-2014, and they were positive and showed a quantative hepatitis B surface antibody of 52. On 10-FEB-2015 blood levels were drawn and IgM core antibodies to hepatitis B were positive and on 19-FEB-2015 his hepatitis "BE" antigens were negative. The physician stated that polymerase chain reaction (PCR ) testing has been conducted on unspecified date and the results were pending. The patient sought for the medical attention and had occupational health visit. The outcome of the reported event was considered as recovered on 12-DEC-2014 and the causality assessment was not provided. No product quality complaint (PQC) was filed. No further information has been provided. Additional information has been requested.
Pt. states that after receiving the 3rd dose of Booster Phizer 10/04/2021, started experiencing symptoms 10/05/2021 of swollen  Lymphoid (experiencing pain) under right arm towards chest along with flu-like symptoms. No noted Primary visit.
infection with SARS-CoV-2 Omicron; infection with SARS-CoV-2 Omicron; This is a literature report for the following literature source(s):  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "infection with SARS-CoV-2 Omicron".; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event drug ineffective based on the known safety profile and temporal association ,Linked Report(s) : US-PFIZER INC-202200256250 Same article/drug/events, different patient
B cold feeling (like stepping on cold water or ice ) at the arch of the foot/cold feeling at the R deltoid, R biceps and triceps, and R upper leg; B cold feeling (like stepping on cold water or ice ) at the arch of the foot/cold feeling at the R deltoid, R biceps and triceps, and R upper leg; Feeling less energetic but able to do ADL; This is a spontaneous report from a contactable other HCP (health care professional, who reported for herself). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot Number: EN6203, expiration date unknown) 1st dose, via an unspecified route of administration administered in Arm Right on 28Feb2021 at 11:00 am, as single dose for covid-19 immunization. Medical history included B peripheral neuropathy post op (L5- S1), urinary retention postoperative, superficial melanoma (excision required, no treatments) and seasonal allergies. Concomitant medication included estrogens esterified, methyltestosterone (ESTRATEST); progesterone (PROMETRIUM [PROGESTERONE]); tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]); cyanocobalamin (B12 [CYANOCOBALAMIN]); collagen (COLLAGEN) and Biot. The patient previously took IV Infed on which experienced anaphylaxis) and IC Feraheme on which experienced hives. The patient had not received prior covid vaccination and had not tested covid post vaccination. The caller stated that after receiving the first dose of vaccine on 03Mar2021 she experienced B cold feeling (like stepping on cold water or ice) at the arch of the foot, cold feeling at the R deltoid, R biceps and triceps, and R upper leg and was feeling less energetic but able to do ADL. The patient had not received any treatment to treat the event. The outcome of the events was not recovered.  No Follow-up attempts are possible. No further information is expected.
no adverse event; patients received improperly stored vaccines; This spontaneous report was received from a nurse and refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. Their concomitant therapies included properly stored sterile diluent.  On unknown dates in 2019 (reported as between 01-JUL-2019 and 02-AUG-2019), the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # R030612, expiration date 23-OCT-2020 and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot # S002490, expiration 23-JUL-2020 (doses, routes, vaccination sites and concentration were not reported) for prophylaxis. The temperature was from -14°C to -10°C (-14.2 C) for 6 hours. Previous temperature excursion was from -14°C to -10°C (-14.2 C) for 30 minutes. Digital data logger was involved. No adverse events were reported.   This case was considered to be non-valid due to lack of patients' identifiers.  Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received.  Follow-up information was received from the nurse on 27-AUG-2019 and refers to ten children patients at the age between 3 and 5 years old. On an unknown dates in 2019 (reported as between 01-JUL-2019 and 12-AUG-2019), the patients were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) lot # S002490, expiration 23-JUL-2020. There was no reactions or problems with the patients. The freezer was defrosted on 08-AUG-2019 (reported as last Thursday). On 12-AUG-2019, the temperature was -14.9°C for 30 minutes. The clinic manager was checking into getting a lab grade/ vaccine grade freezer. Total hours of excursions was 6 hours and 30 minutes at -14°C.  This is one of 4 cases received from the same reporter.; Sender's Comments:  US-009507513-1908USA004659: US-009507513-1908USA010527: US-009507513-1908USA010528:
PATIENT HAD MULTIPLE BRUISES OVER HIS BODY-1CM AND BACK OF HEAD, CHEST AND MIDDLE OF FOREHEAD, LEFT EAR. WE SENT HIM TO THE EMERGENCY ROOM. HIS PLATELETS WERE LESS THAN 0.4K/cumm.  HE WAS ADMITTED FOR OVERNIGHT OBSERVATION WAS GIVEN IV IMUUNE GLOBLIN AND LABS REPEATED IN THE AM WERE  0. 7K/cumm. HE SAW HEMATOLOGY TODAY AND HE WAS UP TO  107K/cumm. HEMATOLOGY CLEARED HIM  TO RECEIVE ALL FUTURE VACCINATIONS.
Lightheaded, pale, sweaty - about 5 minutes after vaccines given. Pt. was helped to a bed, feet elevated, and fluids. Mom in room at all times. Gradually sat up, then stood. Escorted out  by mom. Episode lasted 15 minutes.
swollen lump at injection site; itchiness at injection site; he had injection arm pain for two days; v shaped marking that is 4 or 5 inches around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (swollen lump at injection site), VACCINATION SITE PRURITUS (itchiness at injection site), VACCINATION SITE PAIN (he had injection arm pain for two days) and VACCINATION SITE ERYTHEMA (v shaped marking that is 4 or 5 inches around the injection site) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (v shaped marking that is 4 or 5 inches around the injection site). On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (he had injection arm pain for two days). On 06-Apr-2021, the patient experienced VACCINATION SITE MASS (swollen lump at injection site) and VACCINATION SITE PRURITUS (itchiness at injection site). On 02-Apr-2021, VACCINATION SITE PAIN (he had injection arm pain for two days) had resolved. At the time of the report, VACCINATION SITE MASS (swollen lump at injection site), VACCINATION SITE PRURITUS (itchiness at injection site) and VACCINATION SITE ERYTHEMA (v shaped marking that is 4 or 5 inches around the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
booster doses administered after expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided. HCP called to ask about stability of expired vaccine given to patients. HCP said that 80 patients (may be less) received an expired booster dose. Vaccines were given on 8, 9, 10, 11, 12, 15, 16, 17, 18, 19 and 22 of November. HCP did not have # of doses given each day but said that on average, 6-7 doses were given per day. HCP also stated that it is possible he had used 2 vials in the same day. All booster doses were injected intramuscularly in deltoid muscle.
1022am- Observed patient abruptly stand up and fall to floor, landing face down.  Turned patient over on back with neck support.  Patients legs elevated.  Patient was unresponsive to voice, performed mild sternal rub and became responsive immediately after stimulation.  Pulse strong and regular, respirations WNL - VS BP 126/82, Sp02 99% RA, P122, Temp 98.2 Infrared, AAO to person, place and time.  Observed ~1" laceration above right eye, treated with bandage and bleeding controlled.  EMS and parent called to scene.  EMS arrival at 1033, I gave patient report and they assumed care and assessed patient.  VS @1038- BP 120/68, SpO2 99% RA, P101, R17 AAOx4, Patient c/o headache. EMS sat patient up on floor, then to chair.  EMS had discussion with parent and it was agreed that parent would take patient to Urgent Care for treatment and parent signed off for no EMS transport.  Patient walked out with parent and EMS on own power to vehicle and left approximately 11:00 AM.
This spontaneous report was received from a Nurse Practitioner refers to a 11 year old female patient. On 13-SEP-2012, the patient was vaccinated with first dose of GARDASIL (lot #, expiry not reported) 0.5 ml, intramuscularly and on 01-JUL-2013, the patient was vaccinated with GARDASIL (lot #, expiry not reported) dose 2, 0.5 ml, intramuscularly. No adverse effect reported. Additional information has been requested.
Patient has erythematous indurated lesion on (R) thigh that measures 12 x 11 1/2 in. area was warm to touch.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 at 19:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 09Mar2021 at 16:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 11Nov2021 at 16:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 05May2022, outcome "not recovered", COVID-19 (medically significant) with onset 05May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I tested negative one day after finishing Paxlovid with only symptom being a slight cough; (unspecified date) Positive, notes: 2 days after finishing Paxlovid, I started testing positive again. Cough became more persistent. ; (unspecified date) Positive, notes: Cough became more persistent. Day 3 I began experiencing fatigue. I have been testing positive everyday; (unspecified date) Positive, notes: Day 4 fatigue got worse. I have been testing positive everyday; (unspecified date) Positive, notes: Day 5 (after finishing Paxlovid) woke up with a sore throat, cough and headache. Feeling very tired. Feeling COVID symptoms again and testing positive; (05May2022) Positive, notes: I tested positive for COVID in Thursday 05May. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Believe patient was rebounding. Patient tested positive for COVID in thursday 05May and began treatment on Friday 06May. Last day of treatment was Tuesday 10May. Patient tested negative one day after finishing Paxlovid with only symptom being a slight cough. 2 days after finishing Paxlovid, patient started testing positive again. Cough became more persistent. Day 3 patient began experiencing fatigue. Day 4 fatigue got worse. Patient has been testing positive everyday. Day 5 (after finishing Paxlovid) woke up with a sore throat, cough and headache. Feeling very tired. Feeling COVID symptoms again and testing positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 08Jan2021 as dose 1, single (Lot number: EL 3246), in left arm, on 29Jan2021 as dose 2, single (Lot number: EL 8982), in left arm, on 31Aug2021 as dose 3 (booster), single (Lot number: EW0191), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Neopsporin, reaction: "Allergy"; Bicitracin, reaction: "allergy"; Polysporin, reaction: "allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.
on Feb 1,2021 my rt arm stated itching and felt a llittle heavy..  Feb2   still itching I noted redness in area of vaccine injection it measured 3 x3.5 inches.
After the second dose I had fever, body aches and swollen lymph nodes. I went to the doctor and got antibiotics. Nine days after the vaccine I got Bells Palsy and I have not been able to work since then. I noticed when I gargled that night the water was coming out. The following day was a holiday and everything was closed. I was able to see my doctor. My left eye was not closing and I had difficulty eating because the left side of my face was effected. I had to tape my eye shut at night.  It is very sad and upsetting because I don't know if it will get better. I have seen a Neurologist. It has been four months and I am still getting therapy for the Bells Palsy.  Physical therapy since 04/19/2021 with electrical stimulation. My eye closes a little better and my smile is a little straighter.
Within five minutes I experienced a hot wave, rapid heart rate, syncope, dizzy, light headed, dip in pulse, headache, nauseous, chills, shaking, body ache especially back, fatigue, out of it/dreamlike, worse standing/sitting up.   Was kept for monitoring at facility for three hours then sent home.  Next day I had my opposite arm from the shot and neck itching, rash on chest.  Felt ill for many days afterwards.
Within several weeks my hair began to fall out in general, not patches.; This is a spontaneous report from a contactable consumer.  This 68-year-old male consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ENG205), dose 1 via an unspecified route of administration, administered in Arm Right on 04Mar2021 (at the age of 68-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hiv infection from an unknown date and unknown if ongoing Other medical history: HIV, rubber sensitivity from an unknown date and unknown if ongoing Known allergies: Latex, drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: Penicillan.      The patient experienced alopecia (within several weeks my hair began to fall out in general, not patches) on 30Mar2021 with outcome of recovered with sequelae.  Adverse events was classified as serious: Disability or permanent damage  Follow-up attempts are completed. No further information is expected.
Fatigue for about 24 hours. One week later awoke at 3am with dizziness. Almost a vertigo type feeling except there was no nausea.
Starting within 30 minutes of receiving 2 dose of moderna vaccine I began to have intense sporadic migraine-like headaches, random fever & extreme photosensitivity & blurred vision which continues to this day. It is effecting my job since I work in an outdoor profession.
Sudden onset of prostration lasting 48 hours followed by severe fatigue.  Needed to stay in bed for 48 hours. Headache during first 48 hours.  Intermittent burning nerve pains in hands and feet started after 48 hours.  Marked fatigue persists with cloudy sensorium. Today, 96 hours post vaccination there is a  sense of general malaise and brain fog.
24 hours post injection: Chills, fever (102 F), pain at injection site, nausea, fatigue, body and joint aching, Side effects gone after 36 hours, except sore arm, which lasted 2 days.
Nausea, fevers, sweating, shakes, arm extremely sore, headaches.
Massive coronary blockage. Required emergency triple bypass surgery. Had no previous reports or labs of any kind of issues. Excellent numbers in BP and cholesterol before and after event.
The day after her 2nd COVID vaccine, patient began experiencing intermittent episodes of tingling in her bilateral hands and feet.  The episodes last about 5 minutes at a time.  She has no associated weakness or other concerning symptoms.
Patient developed swelling on thigh the size of an adult's hand, redness covering whole front of thigh, warmth, pain. Temp 100 F at highest.  Sx resolving now.