chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-valid spontaneous report was received from the vaccine coordinator who reported about multiple unspecified patients. There was no information about the patients' concurrent conditions, medical history, drug reactions, allergies or concomitant medication. On 11-JAN-2019, 14-JAN-2019, 28-JAN-2019, 08-FEB-2019 and on 07-MAR-2019 the patients were vaccinated with improperly stored doses of M-M-R II (lot # N009172 and expiration date 20-MAR-2019) for prophylaxis (strength, dosage schedule, and route of administration were not reported) and on multiple unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # N013868 and expiration date 04-MAY-2019) and (lot # N025894 and expiration date 19-SEP-2019) for prophylaxis (strength, dosage schedule, and route of administration were not reported); ROTATEQ orally (lot number R012957 and expiration date 11-JUN-2019) for prophylaxis (strength and dosage schedule were not reported); and with LIQUID PEDVAXHIB (lot # R005114 and expiration date 26-NOV-2020) for prophylaxis (strength, dosage schedule, and route of administration were not reported). No adverse effects were reported. The vaccines LIQUID PEDVAXHIB and ROTATEQ were exposed to 11.63 degree Celsius for 5 hours and 31 minutes on an unknown date; M-M-R II (lot # N025894 and expiration date 19-SEP-2019) was exposed to 11.63 degree Celsius for 5 hours and 1 minute and (lot # N009172 and expiration date 20-MAR-2019) (lot # N013868 and expiration date 04-MAY-2019) were exposed to 11.63 degree Celsius for 5 hours and 54 minutes on an unknown date. The vaccines did not have a previous temperature excursion and the call was done due to a data logger. However, it was also reported, that from 19-APR-2018 to 15-OCT-2018, M-M-R II (lot # N009172 and expiration date 20-MAR-2019) experienced 22 excursions. The lowest temperature excursion for M-M-R II (lot # N009172 and expiration date 20-MAR-2019) was 8.45 degree Celsius (on 30-MAY-2018) and the highest was 13.01 degree Celsius (on 11-OCT-2018).
18 year old received adult vaccine; This case was reported by a pharmacist via other manufacturer and described the occurrence of adult product administered to child in a 18-year-old female patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced adult product administered to child. On an unknown date, the outcome of the adult product administered to child was unknown.  Additional details were provided as follows: The patient inadvertently received adult dose of Havrix, which led to adult product administered to child. This case had been linked with case US2022AMR032529, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR032529:Same reporter
It started at first as pain in my thyroid area and it was tender and painful. Sore throat and hard time swallowing and were painful. I went to see my doctor about pain and was instructed to watch after all the different things going on. The doctor said it should get better and go away on its own. I actually felt a lump up under my arm I thought it was naturel, but it wasn't on both sides which made me think twice. Then made me want to get a mammogram. I had a script for a yearly mammogram, so I used it then. Finding was something found in the breast but nothing under my arm. I had to go back for a close look at the thing under my arm. I was told they didn't think I had breast cancer, so they just wanted to remove it just to be safe. Enlarged lymph knots with lymphocytes.
Low grade fever (99.8F), local rxn, rash other than @ inject site, adenophy generalized, abnormal crying >4 hrs, vomiting; c/o coughing x 10 days;
patient missed her third dose in the GARDASIL 9 vaccine series; This spontaneous report was received from a nurse and refers to a 19-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in August 2022, the patient missed her third dose in the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine series (Vaccine dose omission).
CLient was given this dose (second dose) only 2 days after the first dose as given.
This case was reported by a healthcare professional and described a 14 yr old female subject who was vaccinated with hep A vaccine inactivated (Havrix) for prophylaxis. There were no concurrent medications. On 07Jun05 the subject inadvertently received the adult dose of Havrix (lot AHAVA031BB) for the 2nd dose in the immunization series. At an unspecified time after the administration of Havrix, the subject experienced soreness at the injection which resolved in one day. The adult dose of Havrix is recommended for immunizing individuals older than 18 yrs of age. In the reporters opinion, the event were unrelated to vaccination with Havrix.
woke up at 11 pm sunday feb 28 restless which developed into super restless body--almost squirming- then maniac headache and aches all over, then fever... getting up to 102.4 ( i only took it twice). lasted full bore thru the next day and night. subsided somewhat on tuesday but still strong. woke up wed much better but not great. no executive function. bloody nose added to teh list... sneezes and some cough. NO energy.
Symptoms started approx 12 hr after dose (duration below) nausea -5 hr fatigue-36h headache-36h myalgia- 24h fever- 8h. Patient was unable to perform any physical or mental tasks and remained inactive the day following dosing. Note: none of the above were seen on first dose.
Raised, red warm to touch. Tender lesion approx 3 cm in size, round at site of injection.
Increased heart rate, prolonged chest pain, radiating pain on left side of upper body, shortness of breath, heart palpitations
pt recv vax; no adverse events noted in 36 hr p/ vax;DTAP rt deltoid, MMR sc lt deltoid, polio po; same 3 immun adm 8 days earlier
Checked into ER at temperature of 102.2, severe muscle pains, developing cough, abdominal pain, headache, muscle cramping. Given two bags of saline, morphine, Tylenol, toradol, Zofran. Left hospital after 6hrs with pain reduced and fever down to 100.4. Still on bed rest the next day.
Anaphylactic reaction: approximately 30 minutes after shots. The pt was brought back to office due to rash over body and face. Face and lips were slightly swollen. No respiratory distress or wheezing. Epipen Benadryl was given. Pt was observed for about 2 hrs and was sent home on Benadryl  pacone.
This spontaneous case, initially received on 27-Nov-2017, from a consumer, concerns a female pregnant patient of an unspecified age. The patient's medical history and concomitant medications were not reported. On 26-Nov-2017, the pregnant patient was administered with FLUCELVAX QIV (dose: less than 0.5 ml (as reported), route of administration, anatomical location, batch number, expiry date: not reported), at 34 weeks of pregnancy and the vaccine was expelled twice from the pre-filled syringe before administration. The reporter considered the events as non-serious. Significant case correction received with IRD 27-Nov-2017: Added classification "Special Case with No AE" in relevant field.
eczema; itching; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 70-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Feb2021 12:00 (Batch/Lot Number: EM9809, Expiration date was not reported) (at the age of 70-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included eczema from an unknown date and unknown if ongoing (verbatim: had eczema a few years ago). The patient concomitant medications were not reported. All previous immunization with the Pfizer vaccine considered as suspect were reported as none. There were no prior vaccinations within 4 weeks. There were no additional vaccines administered on the same date of the Pfizer Suspect. On 02Mar2021, the patient experienced itching and on an unspecified date, the patient experienced eczema. It was reported that, the patient received the first dose of the Covid-19 vaccine two weeks ago. He was scheduled to receive the second dose on 11Mar2021. A week ago, his skin was very itchy. He had eczema a few years ago. This usually happens in Jun or Jul but not in Mar. The doctor gave him Triamcinolone and Zyrtec yesterday. His doctor was not able to tell him if it was ok to get the second shot or not because it is too new. The events resulted in physician office visit. There were no relevant tests provided. The clinical outcome of the event itching was recovering, and eczema was unknown. No follow-up attempts are possible. No further information is expected.
no adverse event; got Moderna Bivalent for 1st dose of series, instead of Moderna Monovalent; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (got Moderna Bivalent for 1st dose of series, instead of Moderna Monovalent) and NO ADVERSE EVENT (no adverse event) in a 65-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. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Nov-2022, 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 27-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (got Moderna Bivalent for 1st dose of series, instead of Moderna Monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (got Moderna Bivalent for 1st dose of series, instead of Moderna Monovalent) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (got Moderna Bivalent for 1st dose of series, instead of Moderna Monovalent).    Concomitant medication was not reported. Treatment drug was not reported.
Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history was not reported. On 01-JUN-2015, the patient was vaccinated with the first dose of VAQTA (strength, lot# and expiration date were unknown, 0.5 ml) intramuscularly. On 06-JUN-2015, only about 5 weeks after his first dose, the patient was vaccinated with the second dose of VAQTA (strength, lot# and expiration date were unknown, 0.5 ml) intramuscularly. No adverse effects reported. Additional information has been requested.
she wanted to pass out; Sweating; she felt weak; middle of her stomach it hurts/Stomach ache; This is a spontaneous report from a non-contactable consumer. This consumer reported for a female patient (daughter).   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Jun2021 (As reported: lot number: 'E06180', or 00180; Expiry Date of Covid-19 Vaccine: Unknown) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.   The patient experienced she wanted to pass out (syncope) on 06Jul2021 with outcome of unknown , sweating (hyperhidrosis) (non-serious) on 06Jul2021 with outcome of unknown , she felt weak (asthenia) (non-serious) on 06Jul2021 with outcome of unknown , middle of her stomach it hurts/stomach ache (abdominal pain upper) (non-serious) on 06Jul2021 with outcome of unknown.   No follow up attempts are possible. information about lot/batch number cannot be obtained.
This case was reported by a nurse and described the occurrence of an allergic reaction in an 8 month old male who received hepatitis B vaccine recombinant (Engerix B). On March 19 2005, the patient received the third dose of Engerix B in the right arm (lot AHBVA0588AA). Concurrently the patient received the first dose of inactivated poliomyelitis virus vaccine (Ipol). The site of injection of IPOL was not provided. On March 21 2005, two days post immunization, the patient experienced urticaria, swelling of his hands and feet, and crankiness. The patient was seen in the ER and was diagnosed with an allergic reaction. The events resolved on March 24 2005. The nurse considered the allergic reaction to be related to vaccination with Engerix B.
Got HPV 2 weeks ago and at first the arm did not hurt (really the other arm hurt from the meningitis vaccine) but now sore at the spot and hard to lift her arm. Nothing done except an ice pack right after the vaccine, not since. Mother says that she isn't driving like normal and not raising the arm well. Not hot or red, no bump palpated at the site. So to summarize was a little sore at first and resolved and then 3 days ago the soreness started and now harder to move.
Almost 2 years ago I have had a flu shot, and I have been in pain since. I went thru a lots of pain. They gave me medication, cortisone shot, therapy for months and now they are talking about a surgery. What can I do please.
Headache, vertigo, weakness, postural hypotension. Lasted 7 days so far. Today almost better; still vertigo with turning head fast or standing fast.
ON 31 DECEMBER, I EXPERIENCED ACUTE SYMPTOMS OF WHAT WAS EVENTUALLY DIAGNOSED AS PERICARDITIS. I SPENT THE EVENING OF 31 DECEMBER IN THE HOSPITAL EMERGENCY ROOM, WHERE IT WAS NOT DIAGNOSED. ON 2 JANUARY, I SPENT THE AFTERNOON IN THE HOSPITAL, WITH ACUTE SYMPTOMS. BEFORE GOING TO HOSPITAL ON 2 JANUARY, I WENT TO URGENT CARE, WHO SENT ME TO HOSPITAL BECAUSE AN EKG WAS ABNORMAL. DR. CONFIRMED THE DIAGNOSIS OF PERICARDITIS.
On 1/26/16 pt was given HPV #2. She waited in pt room approximately 10 min with her dad, stated felt ok and left to go to scheduling window to schedule HPV #3. Was standing behind dad and fainted - fell back and hit head.
20 hours after vaccine, felt weak and fever of 100. Then 48 hours after vaccine, got rash on one arm. The rash got worse and spread out to both arms, thighs and feet. Went to urgent care and doctor gave me a steroid shot and some allergy medicine. Now wait and see when the rash will go away.
Pt reported about 10 PM she began shaking, spiked 104 degrees F Temp, had headache, pain and swelling at site, joint pain weakness, dizziness and insomnia. Temp went down to 99 04/19/13 in the AM. Returned to normal 04/19/13 about 10 PM. Patient continues to have pain and mild swelling at injection site.
43 days out from 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (43 days out from 1st dose) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (43 days out from 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (43 days out from 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information about medical history and concurrent conditions were reported for the patients. On unspecified dates, another nurse vaccinated the patients with VARIVAX (unknown strength, route and anatomical location) which had been removed from the freezer and thawing it at an unspecified room temperature for 20 minutes prior to administration. Concomitant medications were not reported. No adverse symptoms were reported. The outcome of the event was unknown. There was no product quality complaint involved. Additional information has been requested.
Discharge summary "41 YO female with a PMHx of renal artery stenosis s/p R renal artery stenting (4/2021), left renal artery atrophy in setting of total left renal artery occlusion, and resistant hypertension who presented to the Niles ED with nausea/vomiting and headache found to have acute kidney injury superimposed on chronic kidney disease stage 3 in setting of restenosis of her right renal artery stent (angiogram, 6/13) likely compounded by hypovolemia.  Kidney function continued to improve daily with initial IV fluids followed by increased oral intake with ballooning of restenosis of right renal artery.  Hypertension urgency and headache/migraine hard to control, but notable improvement with escalation of antihypertensives (with addition) and migraine management.  Questionable etiology of resistant hypertension with previous hyperaldosteronism workup negative and negative sleep apnea test.  Suspect due to renal artery stenosis with totally occluded left renal artery in the setting of persistent headache.  Negative corkscrew appearance on angiogram inconsistent with fibromuscular dysplasia.  Consider pheochromocytoma given headache and tachycardia with plasma metanephrines added upon discharge.  Patient was discharged in a stable condition to home with close appropriate follow-up and strict return precautions. "
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 09-DEC-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J014002 and expiry date: 13-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck),  nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
The night of my shot I developed chest pain, left arm, forearm and hand/finger numbness and tingling along with twitching in my left forearm. I continues to have chest pain and numbness and tingling in my left arm. Twitching has moved all throughout my body.
Partial blindness both eyes, nervous problems, HBP. Legs pain, acid reflux cramps, loss appetite, muscle and joint pain.  2/8/07 Received medical records from VAMC which reveal patient experienced: Chronic low back pain with muscle spasm, osteopenia, DDD L5-S1, LS radiculopathy since 2003 during active duty deployment; HTN; GERD; hyperlipidemia; smoker; cataracts; presbyopia; hypermetropia; Vit B12 deficiency; elevated LFTs; fatty liver; hematuria; dermatitis; Consults: PMR; PT; Urology; dental/optho; MRI of LS spine.
Last night I had some bad diarrhea; Today I feel nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Last night I had some bad diarrhea) and NAUSEA (Today I feel nauseous) 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Last night I had some bad diarrhea) and NAUSEA (Today I feel nauseous). At the time of the report, DIARRHOEA (Last night I had some bad diarrhea) and NAUSEA (Today I feel nauseous) outcome was unknown.            Patient stated that the diarrhea may have been caused due to the food and patient was active before the events occurred.  No concomitant information was reported. No treatment information was reported.
Pharmacy was notified of the adverse event on 12/26/2013.  Patient had redness, swelling, and heat approximately 24 hours after administration of vaccine.  Now, patient is asymptomatic with a red oval shaped rash.  It is not raised or hot to the touch.  Patient stated that it has reduced in size.
Sore arm, swollen lymph nodes, rash by left hear/hairline, general fatigue and malaise, sore throat pain on left side of throat
On November 4, 2015 I had the ZOSTAVAX injection. On Fri. 11/06 and 11/07 I started having slight upset stomach with a fullness feeling. Then on Sunday 11/8 starting having a heaviness feeling to chest area. And by Monday 11/09 the heaviness of chest area was joined by joint pain in left shoulder and left elbow and area between the two was a heavy feeling then on to left hand being numb. Also early Monday morning had fever then chills. About noon on Monday had a bout of nausea. About 8 p.m. Monday night decided it was time of the ER. Was admitted to the Hospital on Tuesday morning 11/10. Had a heart catheterization, all by-pass grafts are still working great, no other blockage. So Wed. 11/11 a CT scan was done. All look the same as last CT scan done 4 or months before. So with that we determined that the problem was caused by the ZOSTAVAX shot.
Body aches Chills Fever of 101.3 F Joint pain Headache Dry cough
This spontaneous report as received from a registered nurse refers to a male patient of 6 years with no reported medical history. On June 2009 the patient was vaccinated with hepatitis B vaccine (manufacturer unknown) dose 1 (exact date, route, dose and lot number unknown). On July 2009 the patient was vaccinated with hepatitis B vaccine (manufacturer unknown) dose 2 (exact date, route, dose and lot number unknown). On August 2009 the patient was vaccinated with hepatitis B vaccine (manufacturer unknown) dose 3 (exact date, route, dose and lot number unknown). On August 2009 the patient experienced received first dose on 06/2009, 2nd dose on 07/2009 and third on 08/2009 (Inappropriate schedule of vaccine administered). The nurse reported that 2 unspecified patients, one female and one male, had received vaccines that were given outside of the vaccine schedule. The female patient also received an unspecified HPV vaccine, GARDASIL could not be ruled out, on June 2009, the 2nd dose on July 2009 and the third on August 2009. This female patient also received an unspecified HPV vaccine, GARDASIL could be ruled out, on June 2009, the 2md dose on July 2009 and the third on Octobre 2009. This case was linked to 1303USA012014 (same reporter link). Additional information is not expected.
Patient received a lower than age appropriate dose, receiving the 10mcg dose instead of 20mcg dose of Engerix-B. Patient is aware of incorrect dose, and will return to the pharmacy for an adult dose in the coming days as recommended by the clinical team contacted for GlaxoSmithKline