chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose of MENVEO was used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 15-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA701A, expiry date 28-FEB-2023) for prophylaxis.   On 22-MAY-2023, the patient received Menveo. On 22-MAY-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: expired dose of MENVEO was used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 25-MAY-2023. The patient received expired dose of MENVEO, which led to expired vaccine used. The reporter did consent to follow up.
Patient stated he had a trigger finger begin symptoms approximately 30 days after vaccination. He described the event to me on 3/5/21.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 55-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  There was no power outages that would have impacted the Moderna vaccine. However, the facility was unable to download the digital data logger and needed to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022.  No adverse reactions were reported by the patient.  No treatment medication was provided.
A physician reported that a female received an injection of Tetanus Toxoid Adsorbed, Purogenated on 3/13/200 or 3/14/2000. Pt subsequently developed an injection site reaction characterized by pain and slight redness. This is 1 of 3 patients from this facility who developed an injection site reaction following receipt of Tetanus Toxoid Adsorbed, Purogenated lot 462-809.
Pt experienced a 7 cm knot with swelling, erythema and heat at injection site (right upper anterior thigh.
Within 7 hours of receiving the vaccination I experienced significant hearing loss in my left ear. It felt like I could not pop my ear but I did not have a cold or allergy symptomw. Within 24 hours I could not hear well enough to use the telephone on the left side - barely heard the ring and could not hear a person talk. By  the afternoon of January 9th my hearing had returned to near normal.
Screaming episode (high-pitched abnormal cry w/screaming) lasting 5 hrs. Felt hot, temp not measured. Pain & increased warmth @ site, w/o swelling or abscess.
Covid19 breakthrough.  1st Vaccine received on 01/26/2022.  Pt brought to the ED for speaking incoherently, and notably decreased mental status from her baseline.  Also with fever.  Being treated with IV steroids/IV ABX and Remdesivir.
Infant received vaccinations on 2/20/08.  Next day mother saw increased swelling in lower limbs.  Continued to have lower limb swelling.  Infant was taken to PCP.  PCP diagnosed allergic reaction to vaccination.  Infant currently to receive vaccinations from allergist.
Vaccines administered after being in stored in fridge past 30 days; Patient that received first dose of primary series of Moderna Bivalent vaccine; Vaccines administered beyound 30-day use by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered beyound 30-day use by date) and NO ADVERSE EVENT (no adverse event) in a 47-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered beyound 30-day use by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and PRODUCT STORAGE ERROR (Vaccines administered beyound 30-day use by date) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and PRODUCT STORAGE ERROR (Vaccines administered beyound 30-day use by date).    No concomitant information was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730541 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:Master case
Infant developed acute hydrocephalus and altered mental status within 24 hours of immunization. Required emergency VP shunt.
Throat felt sore, then swelled, produced lots of phlegm, hard to swallow, tightening of throat. Was given prescriptions! Methylprednisolone Z-pac Took 2 weeks to recover voice Temp. 100.5 - Hard to talk - sounded like laryngitis when I spoke.
Nausea, sweating, throat sore/tightness.  - Monitor pt lungs clear.
Rash; Fatigue; Redness; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), FATIGUE (Fatigue) and ERYTHEMA (Redness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash), FATIGUE (Fatigue) and ERYTHEMA (Redness). At the time of the report, RASH (Rash), FATIGUE (Fatigue) and ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
she usually gets sore arm when she takes the Abrysvo vaccine for a day or two.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 14Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2023, outcome "unknown", described as "she usually gets sore arm when she takes the Abrysvo vaccine for a day or two.".  Additional information: Caller said that she usually gets sore arm when she takes the Abrysvo vaccine for a day or two. She took a shot on Saturday night and she doesn't feel anything. Caller is concerned and wants to know if it is normal.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Swollen upper arm, larger than a quarter knot at injection site, redness approximately 2.5 inches in diameter, excessive soreness, itching, and condition remains basically unchanged 4 days later.
Diarrhea; Colitis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea) and COLITIS (Colitis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHEA (Diarrhea) and COLITIS (Colitis). At the time of the report, DIARRHEA (Diarrhea) and COLITIS (Colitis) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported. Had diarrhea and just learned it is colitis. This started about a month after second shot.   Reporter did not allow further contact
Arm was sore; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and PYREXIA (fever) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medication were provided.
swelling and numbness in right arm; swelling and numbness in right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 08:30 (Lot number: EW0150) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hemachromatosis" (unspecified if ongoing); "Known allergies: Sulpha" (unspecified if ongoing); "Known allergies: corn and corn products and coconut" (unspecified if ongoing); "Known allergies: pork" (unspecified if ongoing), notes: Known allergies: corn and corn products, tomatoes, pork, coconut; "Known allergies: tomatoes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious), HYPOAESTHESIA (non-serious), outcome "recovered" and all described as "swelling and numbness in right arm".  Additional information: Other vaccine in four weeks: No. Other medications in two weeks: multivitamin. Covid prior vaccination: No. Covid tested post vaccination: No. Adverse event: Following first dose, swelling and numbness in right arm subsided within 12 hours.   No follow-up attempts are possible. No further information is expected.
On Oct 11th, few months after shot, body started burning up and was hot to touch, but recorded temperature stayed normal in several different facilities. Was not able to sleep for 2-3 because of body heat, and when in cold rooms or showers would shake and have chills. Few days later found that B12 helped with sleep, anxiety, and cooling down-- so continued to take supplements after and was able to sleep, heat issues went away until Nov 1st.   Nov 1st heat issues came back again and lasted for a month. Experienced anxiety attacks on and off that month-- symptoms such as chest pain/difficulty breathing, ear ringing, spotting in urine everyday, breast pain and breast cysts occurred. Took several blood tests that came up clear excepts high levels of DHEAS (600 µg/dL).  After body heat issues went away towards the beginning of Dec, experienced a day of extreme fatigue followed by pinpricks of pain all over body, especially in left side of body and left arm. Bouts of insomnia for several weeks, spotting went away, DHEAS fluctuated, anxiety symptoms went away.  No diagnosis nor treatment was prescribed by any doctors or specialist. Sought alternative treatment, afterwards experienced symptoms of hormone imbalance for several months. Might have had something to do with thyroid, but unsure. Poor sleep, poor nutrition, B12 deficiency, and chronic stress could have also contributed to factors.
Patient presented for their first dose of the Covid-19 at Pharmacy on 04/21/21, however, on 06/23/21, another pharmacy called to inform us that the patient had already received both doses of their Pfizer vaccine at their location (other Pharmacy) on 01/25/21 and 02/15/21.  We unknowingly administered a third dose of the Pfizer vaccine to the patient.  No adverse reactions have been reported by the patient or the other pharmacy.
Information has been received from a company representative concerning a patient who on 05/01/2000 was vaccinated with varicella virus vaccine live. Subsequently the patient experienced breakthrough chicken pox. It was also reported that 4 children at the patient's daycare had a similar experience following exposure to varicella virus vaccine live. Follow up information from the registered nurse indicated that  this was a breakthrough case of chickenpox. It was reported that the physician's office did not administer any of the vaccines. No further information is available.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient' medical history, concurrent conditions and drug reactions/allergies were not reported.     On an unknown date in April 2017, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX 19400 plaque forming units (PFU) lot # M001747, expiration date: 07-APR-2017, as prophylaxis (Dose and route were not reported). The patient's concomitant therapies included sterile diluent lot # reported as M019490, expiration date: 09-OCT-2018. No adverse effects were reported. Additional information has been requested.
"went from cold to hot, shoulder and back pain" "legs got so dehydrated I couldn't walk" "felt like I did when I had Covid"
blood clot in right leg; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient received the first COVID vaccine on 15Apr2021, a week later (in Apr2021), the patient experienced a blood clot in right leg. The patient is currently on blood thinners and was scheduled to receive the 2nd vaccine on 06Mar2021. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
pt recv vax 20MAR96 & 30min later pt exp earache, piercing pain in the head above the ear & dizziness, & the pt felt faint;BP inc to 161/110;by the next day BP had dec to 128/74 sx resolved;
I ORIGINALLY FILLED OUT THIS FORM ON 12/26/17 WHEN THE PATIENT ORIGINALLY CAME TO THE PHARMACY TO COMPLAIN OF THE PAIN IN HER ARM. I DID NOT FILL IN MY EMAIL OR ADDRESS AND THE FORM COULD NOT BE COMPLETED, SO WHEN I CALLED, I WAS ADVISED TO FILL OUT AGAIN SO THAT THE TWO FORMS COULD BE LINKED. Patient came in on 12/26/2017 complaining of pain in her arm that she believed was due to her pneumonia shot that she received on 8/28/2017. She said her Dr has been treating her with NSAIDS but the pain has not gotten better and she was going to go for an MRI. I asked her if her Dr believed it was due to her vaccine and she did not say yes or no. I let her know to follow up with me if her Dr decided that the vaccine was the cause and we could go from there. As of this report on 3/21/18 I have not heard either way about the official diagnosis either but I do know that she is still experiencing pain in her arm.
PATIENT FAINTED AFTER RECEIVING MODERNA COVID VACCINE. I DIDNT SEE PATIENT ACTUALLY FAINT. PATIENT WENT OUT INTO WAITING AREA. HER BROTHER WALKED OUT AND SAW HER SHE WAS LYING ON THE FLOOR. DIAPHORETIC AND SLOW TO REPOSND. ASKED IF SHE HIT HEAD AND SHE REPLIED NO. I KEPT PATIENT LYING ON FLOOR AND I ELEVATED PATIENTS FEET ABOVE HER HEAD. SHE FELT BETTER WITHIN 5 MINUTES. I HAD HER SLOWLY RISE TO SITTING POSITION. THEN AFTER ABOUT 15 MINUTES SHE WAS ABLE TO RISE TO HER FEET AND WALK AWAY.
FOGGY THINKING / OUT OF IT / FEEL LIKE BODY UNDERWATER; HIGH EOSINOPHILS; ALKALINE PHOSPHATASE LEVELS DOUBLED; INCREASED MEAN PLATELET VOLUME (MPV); HEART RACING / HEART RACING AT BEDTIME; SHAKING; DISCOMFORT IN CHEST / HEAVY FEELING /PRESSURE /TIGHT FEELING / TIGHTNESS; DIFFICULTY BREATHING DEEP; SWOLLEN GLANDS IN ARMPITS; NUMB TONGUE; GASTRO PAIN; LOOSE STOOLS; ELEVATED BLOOD PRESSURE; TONGUE SORES; EYE REDNESS; REDNESS CHEEKS WITH DRY FLAKY SKIN; HYPOTENSION (FELT FAINT/ LIGHT-HEAD/FATIGUE); INTENSE BODY PAIN; TINGLING IN CALVES; PAIN IN CHEST; ITCHY CHEEKS WITH DRY FLAKY SKIN; CHILLS; FEVER; This spontaneous report received from a patient 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced foggy thinking / out of it / feel like body underwater, high eosinophils, alkaline phosphatase levels doubled, increased mean platelet volume (mpv), heart racing / heart racing at bedtime, shaking, discomfort in chest / heavy feeling /pressure /tight feeling / tightness, difficulty breathing deep, swollen glands in armpits, numb tongue, gastro pain, loose stools, elevated blood pressure, tongue sores, eye redness, redness cheeks with dry flaky skin, hypotension (felt faint/ light-head/fatigue), intense body pain, tingling in calves, pain in chest, itchy cheeks with dry flaky skin, chills, and fever. Laboratory data (dates unspecified) included: Alkaline phosphatase (NR: not provided) Alkaline phosphatase levels doubled, Blood pressure (NR: not provided) elevated blood pressure, Eosinophils (NR: not provided) High eosinophils, and Mean platelet volume (NR: not provided) increase in mean platelet volume. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart racing / heart racing at bedtime, shaking, fever, chills, discomfort in chest / heavy feeling /pressure /tight feeling / tightness, difficulty breathing deep, swollen glands in armpits, numb tongue, gastro pain, loose stools, elevated blood pressure, tongue sores, eye redness, redness cheeks with dry flaky skin, foggy thinking / out of it / feel like body underwater, hypotension (felt faint/ light-head/fatigue), intense body pain, tingling in calves, pain in chest, itchy cheeks with dry flaky skin, high eosinophils, alkaline phosphatase levels doubled and increased mean platelet volume (mpv) was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
1122 S/p vaccination reports "mild headache" w/no additional complaints or associated symptoms; Vitals assessed: 121/90 P77 O2 sat 99% RA; po hydration given 1133 Medical monitoring in progress while client reports "feels better"; released from facility with family member
1. Blisters inside of mouth 2. High Cholesterol 3. Memory Loss 4. Thyroids 5. Sleep problems 6. Anxiety.  02/19/2007 MR received  for multiple office visits over a ~2 1/2 year period beginning 5/21/2004.   PEs: All WNL. OV of 11/08/2006 with c/o of lip blister and depressed mood.  PE showed dry lesion around lips. Depression screen (+). DXd with hypothyroidism, depression, ? Herpes Type 1, and Insomia on 11/08/06.
Redness, itchiness, urticaria- around injection site. Patient has been self medicating w/ BENADRYL, Hydrocortisone.
Fever- 4 days, headache, nausea-2 days, inflamed, itchy, rash on upper arm-started at Day 2, still experiencing Day 6. Extremely sore underarm lymph node Days 3, 4, and 5.
606 doses were given after expiration date; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication information provided. The vial did not undergo any temperature excursion. Date of vaccine placed in refrigerator was 21-Sep-2021. Patient did not experience any adverse event. No treatment information provided.
NO A/E. VACCINE WAS KEPT IN FREEZER FOR 29 DAYS.