chrisvoncsefalvay/vaers-outcomes huggingface dataset:
potentially received dose from expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (potentially received dose from expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (potentially received dose from expired vial). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (potentially received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concomitant medications and medical history were not reported. The patient was prescribed VARIVAX (Merck). On 25-AUG-2015, the patient was vaccinated with ZOSTAVAX, 0.65 ml once, subcutaneous instead of VARIVAX (Merck) (Wrong drug administered). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
After the vaccine on Wednesday, I was feeling fine. When I woke up on Thursday at 7:45a.m. I had an overwhelming nauseous stomach. I threw up immediately. Then I checked my temperature and had  a 101 fever. I threw up several more times throughout the day. I became extremely weak, lethargic, unable to make sentences, and disoriented. On Thursday night to Friday morning I woke up with  intense heart palpitations, chest pain, throwing up, and a 200 heart beat. I threw up blood and could not stand up. On Friday to Saturday my fever was 103.4, I could not even stand up. On Saturday afternoon my fever broke and I was feeling alittle better
Patient reported to Pharmacist on November 5th that after having the vaccine on the 3rd, she had limited mobility and pain the next day, with improvement of mobility on day 2 after vaccination.  Multiple attempts were made over the next 3 days to contact the patient for follow up, with no answer.
Patient came in one week early for 1st booster as she is traveling out of country and is needing booster 2 weeks before able to travel. Booster dose was due 4/18/2022 but states leaving on 4/28/2022.
The patient is 17 years and 9 months old. She was given Moderna; however, Moderna is currently only approved for persons over 18 years of age. The patient did not require any treatment and denies any adverse events related to the vaccination delivery.
A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 21-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half of the dose was discarded by the person administering the vaccine. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Itchy rash on legs and chest after 2nd dose; Rash all over back after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on legs and chest after 2nd dose) and RASH (Rash all over back after 2nd dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (not reported).    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash on legs and chest after 2nd dose) and RASH (Rash all over back after 2nd dose). The patient was treated with TRIAMCINOLONE for Itch, at an unspecified dose and frequency and HYDROXYZINE for Itch, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy rash on legs and chest after 2nd dose) and RASH (Rash all over back after 2nd dose) had not resolved.            no concomitant medications reported.   This case was linked to MOD21-070169 (E2B Linked Report).; Sender's Comments:  MOD21-070169:MOD-2021-068630  1st dose case
My son passed away the same night he received the shot and the pediatrician claims they have no record of him even being at the drs that day nor did they have the shot they gave him in there records. That day he received his shots he was having seizure like symptoms and he was also running a fever.
Information has been received from a licensed practical nurse concerning a 60 year old female patient with asthma and allergy to AVELOX and PERCOCET who on 20-JAN-2010 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # 665402/1339Y). Concomitant therapy included montelukast sodium (MSD), inhalers and vitamins (unspecified). On an unspecified date, the patient developed severe left arm pain that radiated down the entire arm and the underneath of the arm. No local redness or swelling was noted. The patient called the office to seek medical attention. There were no laboratory diagnostics studies performed. At the time of this report, the patient had not recovered. Follow up information has been received from the licensed practical nurse concerning the 60 year old female patient who on 20-JAN-2010, in the morning, the patient was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # 665402/1339Y) into the left deltoid. On 21-JAN-2010, the patient developed pain in left arm and under arm. On 25-JAN-2010 the patient recovered. This is one of several reports from the same source. Additional information is not expected.
Information has been received from a physician concerning a 42 year old female with a history of diabetes, and no drug reactions or allergies who was vaccinated with three doses of RECOMBIVAX HB on unspecified date. Concomitant therapy included PLAQUENIL, LANTUS, AMARYL, and metformin. Subsequently the patient titer was 0.85. The physician reports that the patient failed to adequately respond to RECOMBIVAX HB after 3 doses, noting that the minimum titer level for protection must be 0.99. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Menquadfi in the refrigerator and unmonitored for 1 week due to a provider removing the data logger and not putting it back in the refrigerator with no reported adverse event; Menquadfi was administered to 1 patient during the time the product was unmonitored in the refrigerator with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case US-SA-2022SA417024.  This case involves an unknown age and unknown gender patient who was administered meningococcal a-c-y-w135 (t conj) vaccine [menquadfi] which was kept in the refrigerator and unmonitored for 1 week due to a provider removing the data logger and not putting it back in the refrigerator with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect meningococcal a-c-y-w135 (t conj) vaccine (Solution for injection) (lot U7299AA; expiry date: 04-Aug-2024) (strength, route unknown) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date the patient was administered menquadfi which was kept in the refrigerator and unmonitored for 1 week due to a provider removing the data logger and not putting it back in the refrigerator with no reported adverse event (product storage error) (poor quality product administered).  Action taken with meningococcal vaccine was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Eyes were very irritated and they hurt.  Took out contacts and eyes continued to hurt.  Next am, eyes slightly swollen and very red.  She did not wear her contacts.  She wore her glasses.  While she was driving to work her eyes swelled shut. Had a severe HA and called her sister to get her and take her to urgent care. Was seen at Urgent care and was given Motrin 800 mg, and Nasocort nose spray.  She had to have a patch because the itching was so intense that she scratched her cornea.  By Oct 18th her symptoms subsided.  She did say she had a fever of 101 in the urgent care.  She did not have a fever before receiving the vaccine.  The doctor she saw said she may have had the H1N1 virus in her system and the vaccine made it worse.
Pt is a 76-year old with SIDEROBLASTIC ANEMIA that had been mild and  without need for treatment, and IgM MGUS. Presented to ED with newly diagnosed AML, in MDS with WBC counts ~250, 000.    He had a normal (EX ANEMIA) CBC on Jan-21. He had COVID vaccine #1 on Jan-25.  About 4-days later he developed diffuse dermititis and severe fatigue. He had an  ED visit on Feb-8 for these issues and was prescribed Prednisone and Cefalexin  (completed Feb-15).  CBC was NOT done at that ED visit. He called HEME clininc  on Feb-16 (see also the Hematology Note) stating that he was just NOT feeling  well in general with increased fatigue and DOE. He noted that the dermatitis was  mostly resolved. We rechecked CBC on Feb-17 (results available about 4-PM) that  indicated ACUTE LEUKEMIA.  Presents to the MC with MDS on FEB18.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-SEP-2017, the patient was vaccinated with a dose of improperly stored dose of PROQUAD (recombinant human albumin (RHA)) lot # N014758 with an expiration date 08-NOV-2018 (dose and route of administration were not reported). The sterile diluent used for reconstitution did not undergo temperature excursion. There was no adverse effect reported. Administered dose of PROQUAD experienced the temperature excursion between -14 and -10 (-12.2) degrees Celsius for 1 hour and 20 minutes. There was previous temperature excursion with temperatures from -9 to -8 degrees Celsius for 6 hours and 26 minutes. Data logger was involved.
I woke up with a fever of 102.9. Throughout the day, the fever increased to 104.2. My legs were very sore  which made it difficult to walk. I was extremely tired and and my left kidney area was very painful! I did not have a headache like the first injection but was very dizzy.  It lasted about 30 hours and then my fever broke.
First I had a big swelling, redness, fever in the site the first day, about the size of a golf ball or bigger, then I got weak, exhausted, achy all over, pain in site and exhaustion still going on 7 days later.
PATIENT STATES INJECTION SITE IS RED AND HAS SWOLLEN TO SIZE OF A SOFT BALL. SHE STATES THE AREA IS SURROUNDED BY A RED RASH. PATIENT STATES SHE IS HOT AND HAS AN ITCHY THROAT.
Headache; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EW0169, Expiration Date: not reported) via unspecified route of administration on 03May2021 (at the age of 59-years-old), as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EW0158, Expiration Date: not reported) via unspecified route of administration on 12Apr2021 (at the age of 59-years-old), as dose 1, single for COVID-19 immunisation. The patient experienced headache on an unspecified date. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Pt vaccinated with flu developed severe pain w/swelling of lt wrist. Injection site was sore to touch only. Saw MD; patient told he developed arthritis in lt wrist, secondary to flu vaccine. Was advised not to have flu vaccine in future.
should have gone to Dr but didn't. Arm swelled up  with large amt of fluid, redness, heat from  injection site in left arm down to forearm. Some  bruising below injection site took 10 days to recover
partial paralysis in her left arm, left hand and left leg, and left foot.; Lymphadenopathy; a severe allergic reaction to the vaccine; cardiovascular issues; tachycardia; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on (08Jul2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had a severe allergic reaction to the vaccine. She developed Lymphadenopathy that has caused partial paralysis in her left arm, left hand and left leg, and left foot. She have cardiovascular issues and tachycardia and she is taking heart medication. Patient stated it is widely known that this adverse reaction can occur based on the data Pfizer released in Mar2022. She need a letter stating this to provide workers' compensation. She has cardio appointment on 18July2022, and now she has to pay out of her pocket. The outcome of events was unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
vaccine reaction. PT reports HA. bodyaches, diarrhea and 1 episode of vomiting this morning. denies fever. reports received JJ vaccine yesterday. command requested medical evaluation. Patient is experiencing the normal side effects of this vaccine. Quarters for 24 hours given. RTC precautions given.
This spontaneous report as received from a Registered Nurse refers to 13 patients of unknown age and gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, 8 patients received improperly stored VARIVAX injection, with lot number: M040137, expiry date: 28-SEP-2018 (dose, route of administration were unknown) and 5 patients received improperly stored VARIVAX injection with lot number: M044349, expiry date: 04-NOV-2018 (dose, route of administration were unknown). Doses of vaccine were stored in temperature range from -14 to -10 degrees Celsius for 1 hour and 25 minutes. Another temperature excursion in temperature range from -14 to -10 degrees Celsius occurred and lasted for 1hour. Digital data logger was involved in recording the temperature excursion. No adverse events were reported. Additional information has been requested.
I have been sick with every shot, 2 of them 6 days, one of them 2 days - this one was terrible.  One day one, 15th, by 9 pm I was already chilled and headache set in, day 2 chills headache, fatigue and aches & pains, this went on until day 6, of which a stomach ache started, day 7 work with diarrhea, continued with stomach ache, day 8 woke 3 am which severe dizziness and headache worse, could not move, I live alone, could not open my eyes,  eventually fell back to sleep, woke, extremely fatigued and headache, day 9 extreme fatigue and headache.  I am on day 10, the headache is still present and fatigue, but not nearly as bad.  I suspect it will be a long time before I get another shot - I do question the methods that are driving your recommendations for more boosters, I suspect we are being over vaccinated due to big Pharma advocating for big money and the CDC not looking at all the data.   I would like to see the CDC act alone and look at Moderna data separated from Pfizer - I don't think that is happening well - please get to together.  I can't say I have recovered, I am waiting for the side effects to stop.
Proquad ordered/ pulled/  given in error to adult patient who needed MMR vaccine.
Approximately 12 hours after receiving the vaccine I woke up with body aches and chills and could not fall asleep. A few hours later it turned to a fever and sweating. A few hours later it turned into a bad headache with continual aches. The symptoms ended approximately 1 day later.
Patient stated she woke up 2 days after she had the GARDASIL 9 vaccine with swelling at the injection the site on the left arm the "size of an egg," with pain all down the arm, tingling in the fingers, and hives on the left arm.
feeling tired; head hurts; legs hurt/feet pain; having chills; temp went up, to 101.9 lowest 100.3 F, 100.9 still has fever this morning; body aches; nausea; she states she couldn't open her eyes had photophobia due to the headache,  couldn't tolerate light due to extreme headache.; feeling cold; complaints of joint pain; back hurting; making humming sound during night; This is a spontaneous report from a contactable consumer (Patient). A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not reported), dose 2 via an unspecified route of administration, on 24May2021 at 08:30, as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date for COVID-19 immunization. On an unknown date in May2021, around 17:00-18:00, the patient started feeling tired, head hurts and legs hurt, by 21:00 started having chills temp went up, to 101.9 lowest 100.3 F, 100.9 still had fever this morning body aches, nausea, head kilting, last night she stated that she couldn't open her eyes had photophobia due to the headache, couldn't tolerate light due to extreme headache. She took Tylenol at 16:00, 12:00, and at 04:00 took Advil, still having fevers of 100.3, 101.9, 101.7 and complaints of chills throughout the night, was feeling cold, complaints of joint pain, feet pain, making humming sound during night. also, with c/o back hurting. The patient underwent lab tests and procedures which included body temperature: 101.9 Fahrenheit, lowest 100.3 Fahrenheit, 100.9 Fahrenheit, 100.3 Fahrenheit and 101.7 Fahrenheit on May2021. The outcome of event temp went up, to 101.9 lowest 100.3 F, 100.9 still has fever this morning was not recovered and for all rest events was unknown.  Information about lot/batch has been requested.
Tested COVID positive; Fell sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Fell sick) and COVID-19 (Tested COVID positive) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dialysis since an unknown date. Concurrent medical conditions included Hypertension, COPD, Lung disorder and Kidney disorder. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), VALPROATE SEMISODIUM (DIVALPROEX) and VALPROATE SEMISODIUM (DEPAKOTE) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced ILLNESS (Fell sick). On 25-Jan-2021, the patient experienced COVID-19 (Tested COVID positive). At the time of the report, ILLNESS (Fell sick) and COVID-19 (Tested COVID positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: positive (Inconclusive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included blood pressure medication. Patient was reported to be enrolled in program where he received iv infusion of monoclonal antibodies.   This case was linked to MOD21-028165 (E2B Linked Report).; Sender's Comments:  MOD21-028165:
This spontaneous report as received from the patient's mother refers to a non-pregnant currently 17-year-old female patient with no drug allergy. The patient's medical history included low blood sugar and low iron level. Sometime in 2012, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot number and expiration date were not reported). The patient was concomitantly using an unspecified birth control and allergy medication. Sometime in 2012, the patient experienced suicidal thoughts and depression. The patient sought medical attention (office visit on an unspecified date). The patient was prescribed CELEXA as a treatment for the adverse events (10 mg/unspecified frequency and manufacturer, which has been increased to 20 mg/unspecified frequency and manufacturer, which has been increased to 20 mg/unspecified frequency and manufacturer within the last 6 months). On an unknown date, blood and hormone tests were performed (results were not provided). The patient did not recover from suicidal thoughts and depression. The relatedness between GARDASIL and the events was not reported. Upon internal review, suicidal thoughts were considered to be serious as an other important medical event. Additional information is not expected because there was no consent to contact the physician.
Pt received a dose of Pfizer covid vaccine for children 5-11 that was expired. Parent was notified and told the recommended course of action was to revaccinate as soon as possible. No other events.
Approximately 2 hours after the patient had an injection, his neck, and both arms started aching. The patient had steady aching for 4 days. The patient did not seek treatment.
Patient started to experience sharp pain in whole arm. Was unable to move arm. Took 800 mg of IBU. Followed up with patient on 1/19/17 and she is feeling better, the pain has stopped and she just feels sore.
Patient was ordered Bivalent booster and was inadvertently administered the 6year-11-year primary series which had previously been used for booster dose.  Both vials have a blue cap and both say "booster".  Patient notified of the error and was given the correct vaccine.  Counseled patient on possible adverse side effects that could be amplified by receiving both doses in office today.
Received Tripedia on 8/6/04: had redness and swelling of site right thigh that PM, which continued to increase in redness and swelling, warm to touch. Called office in AM on 8/19/04. Brought in to be evaluated by office NP. Approximately 4" lateral area  red, swollen.
4 month old getting 2nd set of vaccines - today has rash both thighs and abdomen.
reports sx of sore throat and feeling "stuffy" , reports known exposure in community from positive boyfriend- tested positive for covid 8/18/22- has had 4 doses of covid vaccine- initial series Moderna plus 2 doses of pfizer