chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning an adult patient, on dialysis, who was vaccinated with primary series of RECOMBIVAX HB in the past (dates unspecified), and is showing "negative titers". Unspecified medical attention was sought. There was no product quality complaint. At the time reporting the patient was not yet recovered. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested.
dispensed 28 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Patient has never been diagnosed or tested positive for COVID-19 No acute illness reported at the time of vaccination and up to one month before it.  Concurrent medical conditions included Peripheral vascular disease, Congestive heart failure and Arteriosclerotic heart disease.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.  The date in which vial was initially stored in the refrigerator was Unknown. It was transferred from another store. The vial did not undergo any temperature excursions. No adverse events reported. It was reported that the stability studies came back fine from Moderna.
arm sore; felt a little tired; will not receive second dose on time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), FATIGUE (felt a little tired) and PRODUCT DOSE OMISSION ISSUE (will not receive second dose on time) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CARVEDILOL and PANTOPRAZOLE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm sore), FATIGUE (felt a little tired) and PRODUCT DOSE OMISSION ISSUE (will not receive second dose on time). At the time of the report, PAIN IN EXTREMITY (arm sore), FATIGUE (felt a little tired) and PRODUCT DOSE OMISSION ISSUE (will not receive second dose on time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment  information was not provided
Symptoms first noted the following evening; arm swollen, tight and very hot to touch; splotted looking. Phoned doctors office; instructed to give Motrin and Benadryl. Child's arm was also dry, flaky, itching. Symptoms lasted approximately 6 days. Still looks blotchy.
My mother died suddenly on February 3rd. She went into shock/cardiac arrest and appeared to have internal bleeding. No autopsy has been performed. Unsure if it was related to the COVID vaccine.
patient came in to receive their 4th dose which would be the Pfizer bivalent booster.  I MISTAKENLY gave them the new COMIRNATY (Pfizer) monovalent dose.  Upon realization that evening, I called patient to follow up and let them know of the error.  I let them know the guidelines that they do not need to restart the series and advised them to return in 2 months for the bivalent booster.
Immediate burning with small amount of bleeding and bruising, severe shoulder pain radiating down into hand (pinky and ring finger).   On day 5 and is still having issues.
Within 2 minutes of receiving  the Moderna vaccine the patient fainted and had a seizure. Emergency service  arrived when the patient fainted for a second time. This time he vomitted when coming too. EMTs checked him out  and when they were speaking to his wife he fainted again and has another seizure
03/14/2009@ 11:05AM, Injection site is red, swollen, warm to the touch, and pain in elbow.03/16/2009@ 3:05Pm, No pain, no warmth, but still swollen. 04/08/2009 @ 1:00PM, Arm still swollen and aching in joints in arm and shoulder.Md visited today, will recheck in 2 weeks.  PSA shows an increase and swelling in testicles.  Patient states that MD said this may be a reaction to the zostavax vaccine.
Patient received the COVID 19 bivalent booster instead of the second (monovalent) dose of the primary series as predicted.  Bivalent dose that was administered was incorrectly diluted. Dilution used for the bivalent was .2ml 0.9% sodium chloride rather than 2.2ml. Bivalent vaccine dose given was 0.2ml.  Parent contacted and advised of med/vaccine error and s/s to monitor for.  Advised to continue series as predicted- Staff who prepped and administered vaccine was given proper procedure for COVID 19 vaccination and procedures  per facility protocols
Appendicitis, Emergency Appendectomy, in recovery : ( mild stomach pain 5/9/2021  2pm,  extreme stomach pain 5/9/2021 6pm, awoke following day 5/10/2021 Piercing pain right lower abdominal area , 630pm self transported to hospital with concern of appendicitis , admitted to hospital 5/10/2021 at 7pm. followed by emergency Appendectomy and overnight stay.
Pt. came in with nausea and vomiting and feeling unwell. Pt. is on Rocephine, pantoplazole, lovenox, tramidol Inpatient
Feeling sick; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 55 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: MALAISE (non-serious) with onset 01Apr2021, outcome "unknown", described as "Feeling sick"; HEADACHE (non-serious) with onset 01Apr2021, outcome "unknown", described as "Headache".  Additional information: The patient received first shot in the morning and in the afternoon, the patient was feeling sick and had a headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nothing at the moment (5 hours have passed). Patient came in for the Pfizer kids shot but received a dose of a booster shot of Moderna.
Large red swelling at and below vaccine site on left arm.  I have photos of the reaction if you need them.  I used an ice pack to reduce the swelling.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient fainted soon as needle was removed from arm. Laied patient down. Patient gained consciousness. Had technician call EMS. Dad laied down with patient then she vomited. Lost and gain consciousness before paramedics arrived. She was taken out on a stretcher
This is a 44 y/o male received his first Antrhax vaccine in February 2003.  Approximately, 3-4 days following the vaccine he developed soreness at the site and was not able to lift his gym bag.  One week later, he developed a lump at the site, tenderness, numbness and tingling in the left arm.  He presented to the medical clinic for evaluation and was given Motrin and an ace wrap for inflammation and discomfort.  The symptoms improved but did not resolve completely.  The lump lasted for 5-7 months, the numbness lasted for approximately 4-5 weeks and the soreness has been ongoing.  He has noticed muscle weakness of the left since his vaccination.  He is able to lift weights but notice a definite change in his level of strength.  He denies muscle atrophy and has good range of motion.  In November 2003, he was seen by Allergy/Immunology for a possible adverse reaction to the anthrax vaccine.  He underwent intradermal and skin prick testing on 25 November 03.  The results were negative. He continues to have persistent soreness and muscle weakness of the left arm.  The numbness and tingling has resolved.
Information has been received from a pharmacist concerning a 71 year old female with allergic reaction to ZITHROMAX who on 02-MAR-2009 was vaccinated with a single dose left upper arm of ZOSTAVAX (Merck) SQ, lot number 663673/1710X. On 03-MAR-2009 the patient developed lip swelling and blisters inside her mouth. The patient self-treated with BENADRYL. The patient contacted the pharmacist that the same day was coming to the pharmacist on 04-MAR-2009, the patient had a small raised area, about the size of the head of a pin on the inside of her lower lip and redness across the entire inside of the lower lip. The patient's lip swelling and blisters inside her mouth and redness across of the entire of her lower lip persisted. Additional information has been requested.
Vaccine received 2/15.  Slight soreness the next day then no further symptoms until 2/25. 2/25 Watery diarreha during night.   Light rash/itch mainly on torso and right arm.  Itch comes and goes 2/26  Light rash/itch mainly on torso and right arm.  Itch comes and goes.  No diarreha.  No bowell movement. 2/27  Watery  diarreha during night and this morning.   Took 2 Imodium tabs this morning.   Light  rash/itch mainly on torso and right                arm.   Itch comes and goes.
Chest pain, shortness of breath, fever, chills, body ache, headache, palpitations, arrhythmia, and fatigue.
Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe
Information has been received from a office manager concerning a female who in June 2007, was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). On 02-SEP-2008 the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). No adverse effect reported. Unspecified medical attention was sought. Additional information has been requested.
Information Provided by Patient's Husband Received vaccine on April 6th. April 7th: nausea and vomiting all day April 8th: fatigue, slept all day, hardly ate, mental fog when awake. April 9th: Slept 22 hours, didn't respond well to attempts to wake her up, mental fog when awake April 10th: ambulance took patient to local hospital where patient was admitted April 13th: Discharged from hospital.  Mental fog and fatigue still continuing. Husband states that mental fog seems a little worse this morning April 15th.
Information has been received on 25-JUL-2017 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration were not reported) subcutaneous on or about 04-APR-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 04-APR-2016, the patient was treated by physician at a hospital emergency department for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient was prescribed hydrocodone, acyclovir and acetaminophen, NORCO to help manage her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
discolored; opposite arm swollen; opposite arm discolored; arm has been swollen; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCOLOURATION (discolored), PERIPHERAL SWELLING (opposite arm swollen), SKIN DISCOLOURATION (opposite arm discolored) and VACCINATION SITE SWELLING (arm has been swollen) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Apr-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (discolored), PERIPHERAL SWELLING (opposite arm swollen), SKIN DISCOLOURATION (opposite arm discolored) and VACCINATION SITE SWELLING (arm has been swollen). At the time of the report, VACCINATION SITE DISCOLOURATION (discolored), PERIPHERAL SWELLING (opposite arm swollen), SKIN DISCOLOURATION (opposite arm discolored) and VACCINATION SITE SWELLING (arm has been swollen) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was reported. The reporter stated that the patient received his 4th shot of the Moderna covid 19 vaccine and the arm had been swollen and discolored. It had also traveled to the opposite arm. It was unknown if the patient experienced any additional symptoms/events.  No treatment medication information was reported.
UrticariaPruritus itching; r supraclavical tenderness and swelling began 12/28 - Narrative: reports r supraclavical tenderness and swelling begining on 12/28 for which she is taking advil.
Violent muscle aches that were not settled by medication, far beyond normal muscle aches from illness. Began exactly 6 hours following vaccine and continued for approximately 12 hours. Fever for 24 hours. Fatigue, black outs.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F. However, that is not approved by for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
12 pm PC from patient c/o hives/rash on face. Referred to PMD. 4:45pm OV pt did not got to Dr. States she does not have insurance. States the hives come and go-has them on her face, neck, arm and chest. She is taking BENADRYL. Denies swelling or any trouble breathing. Pt will go to ER if Sx worsen. Encouraged to see PMD.
Had an ache all over; Been feeling a little tired; 100-degree temperature; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Had an ache all over), FATIGUE (Been feeling a little tired) and PYREXIA (100-degree temperature) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (Had an ache all over), FATIGUE (Been feeling a little tired) and PYREXIA (100-degree temperature). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, PYREXIA (100-degree temperature) had resolved. At the time of the report, PAIN (Had an ache all over) and FATIGUE (Been feeling a little tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Pyrexia: 100 degree (plane angle) 100-degree temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
PATIENT RECIEVED 2ND DOSE OF SHINGRIX VACCINE AROUND 9:30 AM ON 1/22/2021, RECEIVED NOTIFICATION PATIENT SUFFERED FATAL HEART ATTACK MORNING OF 1/23/2021.
swelling under the armpit (left) swelling has under armpit has decreased no redness pain continues last night with right ear ache
For first 24 hours had nausea and vomiting, puffy eyes and low grade temp for 24 hours.  On 9/06 called and reported arm has been sore since shot administered-describes pain as a muscle type ache that radiates to shoulder and down to wrist.  Went to massage therapist to get deep muscle massage.
Client related Tues 09/27 fever 101-102, very achy joints, swollen tender lymph nodes, esp in axilla, Chills, urine had strong odor. Lasted through Thursday 09/29. Client was feeling better 09/30 and was off work x 2 days.
undergone several temperature excursions and was administered prior to the viability of the vaccine being known; The max temperature reached was 10.9F; poor quality vaccine administered; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (undergone several temperature excursions and was administered prior to the viability of the vaccine being known), PRODUCT STORAGE ERROR (The max temperature reached was 10.9F), POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult 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. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 PRODUCT TEMPERATURE EXCURSION ISSUE (undergone several temperature excursions and was administered prior to the viability of the vaccine being known), PRODUCT STORAGE ERROR (The max temperature reached was 10.9F), POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (undergone several temperature excursions and was administered prior to the viability of the vaccine being known), PRODUCT STORAGE ERROR (The max temperature reached was 10.9F), POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (undergone several temperature excursions and was administered prior to the viability of the vaccine being known), PRODUCT STORAGE ERROR (The max temperature reached was 10.9F) and POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered).    Concomitant medication was not reported. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Moderna product was stored in the freezer and experienced multiple warm excursions starting on 3/15/2023. Temperature data shows the vaccine was above 5F for a total of approximately 57 hours.  Two boxes of Moderna (Bivalent vaccine) Lot 066H22A was delivered on 3/15/2023 and placed in the freezer upon delivery. One box with Lot was relocated to fridge on 4/21/2023 and did not experience further excursions. This was an opened box with 9 vials. One vial was used on 4/21/2023. There was one full box impacted in the freezer that has not been relocated.   Treatment drug was not reported.
could not sleep after the shot; This is an initial spontaneous report received from sponsored program . A contactable consumer (patient's sister) reported for a male patient of an unspecified age received BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: unknown, Expiry Date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced could not sleep after the shot. The consumer stated she has not received any dose of the vaccine at all. She received a flu shot in 2013 which resulted in a three month long bed rest. She would like to contact the provider of the Covid-19 vaccine in order to ask if any component of the flu shot is present in the Covid-19 vaccine. She mentioned that her brothers received the vaccine and could not sleep after the shot. She is also allergic to several antibiotics which makes her anxious about receiving the vaccine which is scheduled tomorrow, 24Apr2021. The outcome of event was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021337286 Same drug, same event, different patient
Vomiting, diaphoresis, lethargy. Discharge Summary received on 1/27/2005 states final diagnosis was altered mental status (described as unresponsive in ER report), anaphylaxis, and congenital heart defect.
Urticaria over trunk, face, extremities.  Swelling of face & eyes.  Patient given HYDROXYINE 25 mg & .1 mg EPINEPHRINE (1.2...) SC & .2 mg Epi (1.1000 SC) + ZYRTEC 5 mg PO, oxygen (2 liters/min).  Fever of 103 12 hrs p. immunizations.
Had a terrible headache; Muscle aches; This mark was the size of a silver dollar, maybe a little larger. it lasted for around a week or so and was very painful to the touch; unusual symptom was a large, very distinct circular red spot on his arm at the injection site, size of a silver dollar, maybe a little larger/lasted around a week/ very painful to the touch; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Had a terrible headache), MYALGIA (Muscle aches), VACCINATION SITE PAIN (This mark was the size of a silver dollar, maybe a little larger. it lasted for around a week or so and was very painful to the touch) and VACCINATION SITE ERYTHEMA (unusual symptom was a large, very distinct circular red spot on his arm at the injection site, size of a silver dollar, maybe a little larger/lasted around a week/ very painful to the touch) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Immunization: Pfizer vaccine (2 immunizations with the Pfizer vaccine) and Pfizer vaccine (2 immunizations with the Pfizer vaccine). Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced HEADACHE (Had a terrible headache), MYALGIA (Muscle aches), VACCINATION SITE PAIN (This mark was the size of a silver dollar, maybe a little larger. it lasted for around a week or so and was very painful to the touch) and VACCINATION SITE ERYTHEMA (unusual symptom was a large, very distinct circular red spot on his arm at the injection site, size of a silver dollar, maybe a little larger/lasted around a week/ very painful to the touch). At the time of the report, HEADACHE (Had a terrible headache), MYALGIA (Muscle aches) and VACCINATION SITE PAIN (This mark was the size of a silver dollar, maybe a little larger. it lasted for around a week or so and was very painful to the touch) outcome was unknown and VACCINATION SITE ERYTHEMA (unusual symptom was a large, very distinct circular red spot on his arm at the injection site, size of a silver dollar, maybe a little larger/lasted around a week/ very painful to the touch) had resolved.            It was reported that reporter believes the  vaccination date was near the end of JAN 2022. No concomitant medications were reported. No treatment medications were reported.