chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports bleeding 4-5 days after first dose of Moderna COVID-19 Vaccine. She was 19 weeks pregnant at the time, and she went to the ER. Bleeding lasted about one to two weeks. Tests were run per patient, and no reason for bleeding found.
vaccine stored in fridge over 12 hours, at approved temperature and given to patients; vaccine stored in fridge over 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine stored in fridge over 12 hours, at approved temperature and given to patients) and PRODUCT STORAGE ERROR (vaccine stored in fridge over 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine stored in fridge over 12 hours, at approved temperature and given to patients) and PRODUCT STORAGE ERROR (vaccine stored in fridge over 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine stored in fridge over 12 hours, at approved temperature and given to patients) and PRODUCT STORAGE ERROR (vaccine stored in fridge over 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment drugs were reported
When manually uploading  vaccination records into vaccination reporting website I noticed that that the incorrect vaccine was administered to adolescent.
Extremely sore arm. Headache. Fatigue. Flu like symptoms.  Extreme enough to miss a day of work. Did not have to contact doctor. Starting to subside now at 2.5 days after receiving shot.
12/15/21 presents to EC ED for "cough, body aches, nausea and vomiting". PMHx of "osteoarthritis and GERD"
I was on Day 2 of my menstrual cycle when I received my 1st shot. About 6 hours later, my period abruptly stopped. My cycle last 5-6 days, so this was very unusual. Other side effects were typical- chills (no fever), headache, body aches, and tiredness.
Anaphylaxis, throat swelling causing coughing, wheezing, chest pain, mucous drainage within 10 minutes of the shots given.  Patient recieved Epi jr., albuterol through a spacer and two tablets of benadryl. Then she had xeponex through a nebulizer. She stabilzed. Enroute to ER to be observed, Anaphlaxis occured again, with body hives, wheezing, coughing and she also had a high fever. She recieved another breathing treatment with ALbuterol and an Epi Jr once again. Oxygen was then given and she was admitted to ER. She was then give IV steroids and Motrin for fever. She was evaluated 6 hours and released. She is still running high fever and is on antihistimines.  8/31/07 Received vax record from pcp which corrected vax info.  VAERS database updated w/same.  10/26/07 Received hospital medical records which reveal patient experienced coughing, vomited, wheezing , & increased phlegm.  Seen in ER 8/27/07 from pcp office.  Had already received repeat epi pen prior to arrival along with orapred, nebs, O2 & benadryl.  Tx w/additional IV steroids & benadryl.  Improved & d/c to home from ER. FINAL DX: acute allergic reaction.
BODY PAIN; SORE AT INJECTION SITE; HEADACHE; CHEST PAIN; This spontaneous report received from a patient concerned a 32 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced chest pain. Laboratory data included: Blood test (NR: not provided) unknown, ECG (NR: not provided) UNKNOWN, and X-ray (NR: not provided) UNKNOWN. On an unspecified date, the subject experienced body pain, sore at injection site, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, body pain, and sore at injection site, and had not recovered from headache. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Pain, weakness and numbness in arm where vaccine was given.  Lignt headed, nauseous and too weak to do anything except lay down.
Following AM pt had swollen face, fine rash and irritability seen in office 3PM pt. with generalized fine rash and conjunctivitis-strep test (-) (facial swelling resolved) 5/4/07 Continued irritability-fussy, crying up to 30 minutes (inconsolably) no fever-"not himself" 5/507 seen in office tymphanogram normal  (+) preauricular nodes) Rapid Strep A (-) Dad describes pt. as having violent behavior-very abnl.
Patient was fully vaccinated (Janssen) but not boosted, admitted to the hospital with COVID-19 and associated hypoxia. Patient expired on 12/18/21.
after monitoring for almost 30 minutes, about mom noticed that child is complaining of itching.   Uppon inspection, noticed blotchy spots on back on neck,
nurse gave a flublok vaccine to a 15-year-old with no reported adverse event; Initial information was received on 03-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2022SA461738(CLUSTER).  This case involves 15 years old female patient who experienced nurse gave a influenza quadrivalent recombinant vaccine [Flublok] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Oct-2022, the patient received suspect influenza quadrivalent recombinant vaccine at a dose of 0.5 ml once (lot QFAA2231, expiry date - 30-Jun-2023) (form: unknown) via intramuscular route in the left deltoid for Immunization.  On 26-Oct-2022 the patient developed a non-serious event of nurse gave a influenza quadrivalent recombinant vaccine [Flublok] with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
For 2nd dose her husband got really tired and not feeling well during 1 day; For 2nd dose her husband got really tired and not feeling well during 1 day; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (For 2nd dose her husband got really tired and not feeling well during 1 day) and FATIGUE (For 2nd dose her husband got really tired and not feeling well during 1 day) in a 41-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Wolff-Parkinson-White syndrome (Heart condition called WPS) and Anxiety. Concomitant products included DIAZEPAM (VALIUM) for Anxiety.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (For 2nd dose her husband got really tired and not feeling well during 1 day) and FATIGUE (For 2nd dose her husband got really tired and not feeling well during 1 day). At the time of the report, MALAISE (For 2nd dose her husband got really tired and not feeling well during 1 day) and FATIGUE (For 2nd dose her husband got really tired and not feeling well during 1 day) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient received the first dose of Moderna vaccine on 09-Mar-2021, and the first booster dose on an unknown date. After first and first booster dose patient did not experience any symptoms. No treatment medications were given.   This case was linked to MOD-2023-714734 (Patient Link).
episode of fainting; dizziness; pounding headache; muscle aching; excess phlegm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10Feb2022 (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: SYNCOPE (medically significant) with onset 13Feb2022, outcome "unknown", described as "episode of fainting"; MYALGIA (non-serious) with onset 12Feb2022, outcome "unknown", described as "muscle aching"; DIZZINESS (non-serious) with onset 13Feb2022, outcome "unknown", described as "dizziness"; HEADACHE (non-serious) with onset 12Feb2022, outcome "unknown", described as "pounding headache"; PRODUCTIVE COUGH (non-serious) with onset Feb2022, outcome "unknown", described as "excess phlegm". Clinical course: Reporter received her first dose of Pfizer covid vaccine on 10Feb and her symptoms associated with the vaccine began on Saturday. Reports muscle aching (began on Saturday) ; episode of fainting (Sunday)  and dizziness (Sunday) ; pounding headache (Saturday), excess phlegm (unsure when) .asking how long should she expect the side effects to last and wanting recommendations on what OTC medication is best.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Began vomiting about 8pm 1/12/10. Felt weak, dizzy, ? fever. Vomited x 8 hrs. Patient was not seen by a medical provider during this illness. Patient feels illness due to H1N1 vaccine.
04/20/21 at 17:30 hours I received the vaccine 04/21/21 at 13:00 hours I noticed I have no taste in my palate and my mouth is numb and there is pain behind my right ear 04/22/21 at 6:09 hours upon brushing my teeth I noticed I have facial paralysis. That same day I called where they administered the vaccine (Pharmacy) and they told me to go to the doctor. I went to the medical center
Rash starting on 04/22/2002 over trunk (front and back), thighs. Ran fever of 101-102 deg. F for two days post receiving vaccines. Pt in no apparent distress, still has rash.
4 days (and still continuing) of random hives with itching, mostly on face and trunk. Given BENADRYL to help itching. Hives come and go with no obvious pattern, but do not remain gone more than a few hours at a time. Have tried environmental and diet changes in case it was contact-related or food related, but none of these changes have helped.
This spontaneous report a received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an unspecified doses of GARDASIL (route, lot numbers and expirations dates not reported) which were improperly stored at 55.9 F for 2 hours. No adverse effects reported. This is one of several reports received  from the same reporter. Additional information has been requested.
This spontaneous report as received from licensed practical nurse refers to a patient of unknown age and gender. On 06-NOV-2014, the patient was vaccinated with improperly stored GARDASIL (does: 0.5 ml, intramuscular, lot # K004205, expiration date 12-JAN-2017, anatomical location not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
My first symptom was fever and an achy feeling as well as being tired. That lasted for three days and then I took a home test on the third day. On the fifth day I went through the drive thru testing location and it was confirmed. From the fourth day on I had no other symptoms. I took ibuprofen for my fever and that went down after about the fourth day. I was on PAXLOVID on the 05/31/2022 until the 06/04/2022. I had no symptom but I still kept testing positive.
Patient had cellulitis upper left arm and elbow, went the Dr twice and urgent care twice and was given 2 antibiotic and penicillin shot.
Child returned to office today after receiving DTaP and IPV in the left upper arm 2 days ago (10-5-2004).  Since yesterday, she has had increasing redness, swelling, and warmth to touch on this arm.  The parents report no other signs and symptoms of illness.  Also, they do not report giving any medications or therapies for the reaction.---The child was alert, active, and playful during the examination.  She had erythema from the shoulder to the elbow of the left upper arm in an area that was warm to touch, tender, and extended across approximately 15cm at the widest area of the upper arm.  There was a 2cm cluster of water-filled blisters just below the area of the left deltoid.  The child had full use of the hand and arm.---Today, the child received an injection of 0.55 ml or Benadryl 50mg/ml, prescriptions for Duricef 250mg/5cc (1.5 tsp p.o. twice daily x 10 days) and Orapred 15mg/5cc (3/4 tsp p.o. twice daily x 5 days), and instructions to take Benadryl suspension (1/2 tsp p.o. twice daily for 5 to 7 days).  Also, this examiner instructed the parents to apply cold packs to the affected area twice daily prn for the swelling and redness as well as giving acetominophen prn.  The VIS statement for DTaP and IPV were provided for the parents and reviewed with them.  They were advised that an adverse event form would be sent.
Information has been received from a consumer, for the Pregnancy Registry for GARDASIL, concerning herself, a 23 year old female with a history of drug hypersensitivity to PAXIL who in December 2007 was vaccinated with a first dose of GARDASIL (lot# not reported).  On an unspecified date the patient was vaccinated 0.5mL, IM with a second dose of GARDASIL (lot# not reported).  Subsequently the patient became pregnant after her second dose (LMP approximately 12-MAR-2008, "1.5 to 2 months gestation").  On an unspecified date the patient had a pregnancy test and a sonogram.  Also, it was reported that the patient experienced soreness at the injection site after the second vaccination with GARDASIL.  The patient sought unspecified medical attention.  The patient outcome was not reported.  Additional information has been requested. Follow up information received from the registered nurse concerning the 23 year old female with depresion with a history of 1 pregnancy and 1 live birth and a history of anorexia. Concomitant therapy included ZOLOFT 50 mg in May 2008 and in October 2008 dose was swithced to 100 mg daily and prenatal vitamins since 24-APR-2008. The patient experienced preterm labor, left ovarian cyst, bacterial vaginitis (x2)  and GERD (2008). The GERD wsa treated with ZANTAC 150 mg BID, from 05-NOV-2008 to 25-NOV-2008 and PROTONIX 40 mg daily and the bacterial vaginitis was treated with FLAGYL 250 mg TID for 7 days reported on 18-JUN-2008 and 07-OCT-2008. An ultrasound was performed on 04-JUN-2008 for size and dates, the patient denied to perform a MSAFF. The patient had an ultrasound for anatomy scan on 08-AUG-2008 which was normal. On 18-DEC-2008, the patient delivered baby girl, weighing 7 pounds, 3 ounces, 19.5 inches.APGAR scores were 9/9. The patient was 39.1 weeks gestation at the time of delivery. Additional information is not expected.
pt recv vax 25FEB93 & the evening of 25FEB93 pt exp a sl sore throat & stomach cramps which lasted about 12 to 24 hr; no tx was initiated; 26MAY93 anti-HBS testing revealed neg results; No further details were provided;
just diagnosed with covid, breakthrough cases; just diagnosed with covid, breakthrough cases; some lingering fatigue; feel lousy; achy; This is a spontaneous report received from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number EL9269, Expiration: unknown) via an unspecified route of administration in arm left on 10Feb2021 in the morning (age at vaccination: 69 years) as single dose and first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number EL8982, Expiration: unknown) via an unspecified route of administration in arm left on 20Jan2021 in the morning (age at vaccination: 69 years) as single dose for covid-19 immunisation. The patient's medical history included when querying other medications and medical conditions, reports she takes a couple allergy pills and does not think this was significant, there was no family Medical History Relevant to AE. Her husband and her were both vaccinated with the second shot on 10Feb2021. There was no vaccine administered at military facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. There were no additional vaccines administered on same Date of the Pfizer Suspect. AE did not require a visit to emergency room. There were no prior vaccinations (within 4 weeks). There was no AE following prior vaccinations. On 10Oct2021, the patient just diagnosed with covid, breakthrough cases, vaccination failure. She came down with symptoms the day after her husband did, her symptoms started on 02Oct2021. She was called and asked to get tested and her positive test result came in on 10Oct2021. After the second dose of covid vac-cine she did feel lousy, fatigued and achy and needed to take Tylenol. She thinks both doses were in her left arm since she is righthanded. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 10Oct2021 her positive test result came in on 10Oct2021. Treatment included home therapy such as Tylenol. The outcome of events was recovered for COVID-19, feel lousy, achy, not recovered for some lingering fatigue and unknown for vaccination failure.  Follow-up attempts are completed. No further information was expected.
(R) deltoid pain, fever, swelling and a knot at injection site. Parasthesia in (R) hand. Erythema extended down arm from deltoid to elbow with soft fluid sac at elbow.
Patient experienced syncope and seizure for 5-7 seconds immediately after receiving injections of BOOSTRIX and HAVRIX vaccines. No trauma occured as a result of these events. EMT was called, blood sugar checked (91 mg/dL), she was taken to emergency room as a precaution. Release from emergency room with no complications within 2 hours.
This spontaneous report has been received from a healthcare worker (also reported as clinical manager) refers to a patient of unknown age and gender who on 24-DEC-2014 was vaccinated with a dose of ZOSTAVAX (strength, dose and route not reported, lot # K003597, expiration date: 12-MAR-2015), that had been improperly stored. The temperature during the excursion was unknown, as it was not monitored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
02/21/2019 PATIENT REPORTS REDNESS AND SWELLING TO RIGHT BUTTOCKS. MOM REPORTS THAT HE HAD HIS MENINGOCOCCAL VACCINE 02/19/2019. LESION TO RIGHT BUTTOCK 5X5 CM AREA WITH WARMTH AND REDNESS NOTED. DENIES TTP AT SITE. COLOR: FLESH COLOR. GENERAL APPERANCE LOCALIZED. INFECTIOUS SIGNS: WARMTH, ERYTHEMA AND SWELLING. CELLULITIS: ADMINISTERED ROCEPHIN 1 GRAM IM IN OFFICE TODAY (02/21/19). PRESCRIBED CEPHALEXIN 500MG. INSTRUCTED MOM TO APPLY WARM COMPRESSES TO THE AREA 2-3 TIMES PER DAY. MAY TAKE TYLENOR OR MOTRIN OTC AS NEEDED FOR PAIN. RTC IF S/S'S ARE NO BETTER, SOONER IF NEEDED. CARE INSTRUCTIONS GIVEN.
Monthly period is now heavier with more days of cramps/ pain, lasts a longer duration (total period time).; Monthly period is now heavier with more days of cramps/ pain; Monthly period is now heavier with more days of cramps/ pain; The bleeding is MUCH heavier and ''I'' occasionally vomit due to severe pain due to sustained cramping; This is a spontaneous report from a contactable nurse, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 18Jun2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included menstrual cramp (Before vaccine she only had severe cramping on first day of 3-4 days period) and known allergies to latex and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid (VITAMIN C), zinc (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and fish oil (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date and unknown if ongoing (not everyday). The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 22May2021 at 09:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 28Jun2021, the patient experienced monthly period that was now heavier with more days of cramps/ pain, and lasted a longer duration (total period time). The bleeding was much heavier and patient occasionally vomited due to severe pain due to sustained cramping. Then she had severe cramping for 3 days of a 5-6 days periods. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 23Aug2021, the patient underwent nasal swab test and the result was negative. No therapeutic measures were taken as a result of the events. The clinical outcome of event monthly period was now heavier with more days of cramps, pain and vomited due to severe pain due to sustained cramping was resolved with sequelae on an unknown date in 2021.
Dizziness NUMBNESS AND TINGLING AND SUBJECTIVE SWELLING OF RIGHT UPPER AND LOWER LIPS, LIGHTHEADEDNESS, DIAPHORESIS Narrative:  Received Moderna covid 19 vaccine @ 1315 however around 1330 complaining of some numbness and tingling and subjective swelling of right upper and lower lips, lightheadedness and dizziness as well as diaphoresis. Denies any chest pain or shortness of breath. He denies any periorbital or periocular edema, denies any sensation of throat closing off, no tongue swelling. Has h/o allergic reaction to nuts, environmental allergies, no reactions to vaccines but has vasovagal reactions after seeing needle for blood draw or immunizations
with 1 hour and 30 minutes-dizziness; within 2 hours-dizziness with shooting pains going up arm that had shot to the neck; within 4 hours, dizziness with shooting pains, headache and began throwing up; I threw up approximately every 10 min for about 10 hours.
Half dose of 0.25ml administered instead of 0.5.  Vaccinating staff returned same afternoon and administered remaining 0.25ml.