chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a 74 years old male patient received a dose of Fluzone HD which had been shipped more than 2 days thus not valid/No AE; Initial information received on 27-Aug-2019 and additional received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case is linked to cases 2019SA243159 and 2019SA241338 (same reporter).  This case involves a 74 years old male patient who a 0.5 ml received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] which had been shipped more than 2 days thus not valid lot UJ221AB, expiry date: 01-APR-2020 via intramuscular route in the left deltoid on 26-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  No side effects.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  List of documents held by sender: none.
After receiving the Moderna Booster. In the morning of October 30 I experienced heart palpitations (2 hours), extreme fatigue, exhaustion, dizziness, sweating profusely for about 12 hours. I could not do anything the entire day but rest in bed.
On June 4, 2008 I started having pain in right shoulder area.  As a result I developed shingles.  I didn't think anything of this as being related to my vaccine I received on 5/12/08.  In discussing this with other nurses that I used to work with 2 of them have gotten shingles shortly after receiving the vaccine.  I was not physically around those other nurses at all.
Pain in areas where lymph nodes exist- arm pits, groin, malaise, aches in joints, and nausea.
8 days p/vax left, lateral thigh was reddened & indurated @ inj site;appeared only mildly tender;afeb;no purulent drainage;e
Information has been received from a physician concerning a 27 year old female with no previous medical history or no known drug allergies, who on 15-FEB-2008 was vaccinated IM with a 0.5 ml first dose of HPV rL1 6 11 18 VLP vaccine (yeast) (lot# 655327-1287U). There was no concomitant medication. On 16-MAR-2008 the patient experienced tingling and formication of both hands, feet, and bilateral anterior thighs. The patient was examined in the office on 21-MAR-2008. Neurological exam was normal. Complete blood count, metabolic panel, and thyroid stimulating hormone levels were normal. The patient was examined by an unspecified neurologist in early April 2008. Nerve conduction testing on the right leg and neurological exam were normal. The physician added that the patient received an unspecified steroid injection in the sacr-iliac joint 2 weeks prior to the onset of symptoms. Medical attention was sought in the office. At the time of reporting the patient was recovering. No product quality was involved. 5/27/08-records received-office visit 2/15/08-Current problems: acne vulgaris, depression with anxiety, dizziness. 3/21/08-C/O tingling sensation began 5 days ago, mild intensity, constant. Paresthesia in both hands (stocking glove distribution) both feet and both anterior thighs. Not associated with numbness or weakness just odd sensation. Two weeks prior had steroid injections in back followed by week of nocturia now resolved. Currently fighting a cold.  May likely be a side effect from steroid injections. Two weeks later seen for C/O nausea and wave of dizziness, intermittent, decrease in appetite and weight loss, diarrhea. Currently on Flexeril. Heart races when dizzy. Mild cough and chest congestion. Felt like passing out. Feet seem more cold, although hands and feet are always cold. Irregular period, 2 weeks early. spotting for 7-8 days. Skin crawling sensation intermittent 1 month after first HPV vaccine.Symptoms worsen with fatigue and when anxious. Feels worse after eating cake. Neuro consult 4/4/08-Sensory symptoms cause unknown.  This is in follow-up to report(s) previously submitted on 5/14/2008.  Follow up information received from the physician indicated concomitant medication included TAZORAC, KLARON and Brevoxyl wash.  On 15-Mar-2008 (previously reported as 16-Mar-2008) the patient experienced tingling/paraesthias/skin "crawling" sensation both hands, both feet , no numbness, weakness.  Normal reflexes, Normal exam.   At the time of reporting the patient had not recovered.  Additional information has been requested.
Left arm has large area of induration, redness, warmth, tenderness.  Pruritic.
I had what I judged to be a multiple sclerosis relapse that started about 1 day after I was vaccinated. I started experiencing pronounced Paresthesia in my feet and lower legs. This has been my most common MS symptom over the course of the disease, but it has been a few years since I had experienced it so strongly. I was able to talk the doctors out of a course of Prednisone to calm the relapse which seems to have resolved the problem. I don't suppose this will be of any interest to you, but I'll throw it out anyway. This event resonates with my own personal theory of multiple sclerosis. I think that multiple sclerosis is linked to exposure to heat-killed Paratuberculos from dairy products. The animal model of multiple sclerosis is initiated by injecting lab animals with heat-killed Tuberculosis and there is a strong correlation between the prevalence of MS and per capita milk consumption.
Pt developed mild case of herpes zoster right buttock treated with po famvir 500 tid for 7 days with one refill
No adverse symptoms reported.; The patient was inadvertently administered an expired dose of GARDASIL 9; This spontaneous report was received from a nurse referring to a male patient of unknown age. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not reported.  On 02-DEC-2019, the patient was vaccinated with the third dose in series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast )(GARDASIL 9) as prophylaxis (lot # R024264 has been verified to be a valid lot number and expiration date 29-OCT-2019 has been verified to be a valid) (expired product administered). The patient did not experienced any adverse symptoms.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On 14-OCT-2015 the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot number and expiration date were not provided). The pharmacist reported that the patient received less than a full dose of PNEUMOVAX 23 when the needle leaked and the vaccine ran down the patient's arm. No adverse symptoms or product quality complaints were reported. No further information provided. Follow up information was received on 02-JAN-2016, from the pharmacist who reported that the female patient was vaccinated with public funds. Additional information is not expected as all correspondence was received. Patient, product, event and narrative were updated.
Arm is sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: This case is reported by the husband of the patient. The patient experienced pain in arm after the 1st dose of Shingrix. The patient had received the 2nd dose in her left arm. The reporter mentioned that the arm was still hurting, 2 weeks after the vaccination that is until the date of reporting. The reporter did not consent to follow up.
Information has been received concerning an 8 year old white female with an allergy to SEPTRA who on 29-JUL-1998 was vaccinated with a SC dose of Varivax (lot # 626956/0837H). Suspect vaccination administered that day included a SC dose of MMR (lot # 627842/0798H). There was no illness at the time of vaccination. On 06-JUN-2006 the patient developed a rash. Medical attention was sought and no laboratory tests were performed. The patient's outcome was recovered on 06-JUN-2006. It was reported that the patient's brother (WAES# 0606USA04668) had as similar experience after vaccination with Varivax. Additional information is not expected.
Rash began 1 week post immunizations.  Slight redness behind ears.  Continuously worsened.  Currently on back, stomach, face, ears, buttocks, scrotum.  Red, raised whelps.  None on arms, legs, feet, or hands.  No fever, no itching, no fussiness.  Mother to call private MD.
Client came to County HD requesting second moderna vaccine , stated he was due and lost his vaccine card. Clerk could not find client  shots database so client was vaccinated with moderna, client was with relative who stated they recieved first vaccine on the same date 8/5/2021 and relative was due and was at HD to receive second moderna dose . Moderna dose was given to Marcos and clerk found client in fl shots after vaccine administration and noticed that client recieved Pfizer on 8/5/2021 and not moderna .
He had only a sore arm after each shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (He had only a sore arm after each shot) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 03-Sep-2022, the patient received fifth 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 VACCINATION SITE PAIN (He had only a sore arm after each shot). At the time of the report, VACCINATION SITE PAIN (He had only a sore arm after each shot) had resolved. Not Provided   Concomitant product use was not provided by the reporter.  Dosage text was reported as Bivalent Booster.  Treatment information was not provided.   This case was linked to MOD-2022-692275 (Patient Link).
Within 1-2 hrs after taking the flu vaccine in 2002, pt experienced diaphoresis and tachycardia; felt like she was going to pass out. Later, she experienced abdominal cramping and diarrhea. (similar GI symptoms after eating buckwheat pancakes a year ago).
When I left facility I had a mild headache.  After getting on the highway face turned beet red with mild swelling.  Throat felt tight but not closed.  An hour later the headache was worse.  Took a Tylenol and slept for an hour.  Woke up itchy.  Glands on right side of neck very sore with pain radiating to base of skull.  Swelling in face subsided after a few hours.  Later at night I was still itchy with some small red hives on my arms, legs, and stomach. Arm very sore.   Woke several times during the night with nausea.  Woke up morning of the 20th with mild dizziness, upset stomach and severe diarrhea,  Serious headache all day.  Hives subsided but was still itchy.  On the 21st felt much better but still with diarrhea.  Today is the 23rd and no diarrhea since this morning.
pt recvd vax & devel thrombotic thrombocytopenic purpura
Anxiety and jittery feeling: Started 03/19/2021 - Still occurring Pt did not take any medication or seek any medical care to relieve symptoms Pt was advised to schedule an appointment with primary doctor. SPI was consulted and Dr. was notified.
As is protocol with anyone having not received a FLU vaccine in the past year, we have them wait with us for approx 10 minutes after vaccine administration. After approx 8 minutes the client complained of feeling "dizzy" and had "tremors". Patient appeared pale, and diaphoretic. Client then was witnessed to lose consciousness and eyes rolling in back of head. Client moved with assist of 2 nurses to floor and pulse felt thready. 911 called. BP 106/60 pulse 54. Patient came to after approx 30-45 seconds and spoke coherently then again lost consciousness for approx 10-15 seconds. Bp remained stable at 107/58-56. Oxygen applied via NC at 3 l/min. At this point client awake and alert, paramedics arrived. Client refused to go to ER. Client then went to Nurses office via WC and eventually driven home by employer.
This spontaneous report as received from a healthcare worker (also reported as Healthcare Prof-other) refers to a patient of unknown age and gender. On 27-MAY-2015 the patient was vaccinated with an improperly stored dose of VAQTA 25/0.5, injection (lot # K018181, expiry date 04-JUN-2017) (route, dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. The action taken with the therapy with VAQTA was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with VAQTA was unknown. This is one of the many reports from the same source. Additional information has been requested.
Swollen and tender lymph node in left armpit near injection site; Tender lymph node in left armpit; Fatigue; Full body aches; Pain at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 11Apr2021 at 17:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021, the patient experienced swollen and tender lymph node in left armpit near injection site, presenting 26 hours after injection of 2nd dose. The events did not present after 1st dose. The patient also experienced fatigue, full body aches and pain at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen and tender lymph node in left armpit, fatigue, full body aches and pain at injection site were resolving at the time of this report.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other=Moderna, Vaccine dose number=4 / Vaccine brand=Pfizer / BioNTech, Vaccine dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 23Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: Fe3590) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Apr2022 as dose 4 (booster), single (Lot number: 059M21A), in right arm and on 01Nov2022 at 12:15 as dose 5 (booster), single (Lot number: 049022H), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Apr2022, outcome "unknown", described as "Vaccine brand other=Moderna, Vaccine dose number=4 / Vaccine brand=Pfizer / BioNTech, Vaccine dose number=3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Other medication in 2weeks: Yes, Other medication details: Other medication in 2weeks product=Losartin. Anti-viral details: Product=COVID 19 Treatment, Treatment start date=12May2023, Treatment stop date=17May2023.
Received DTaP 7-23-04, some redness around injection site following immnization. On 7-25-04 child's L arm was red and swollen from elbow to middle of top of shoulder. Father took child to ER. Doctor treated child with antibiotic and steroids. Dad states child OK and that redness around injection site about size of a dime at this time.
Student received Kinrix instead of Hepatitis A, which was what was supposed to be given.
Suspected vaccination failure; had them / mild case; painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient stated that, he/she had shingles after getting the Shingles shot. The patient said it was a mild case because of the shot.  The patient said, he/she did not ever want a bad case. It was soo painful. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided.
Information has been received from a registered nurse concerning a 35 year old male who on 17 Mar 2006 was vaccinated with a dose of Varivax (lot #652663/1032R). A few days after vaccination, on 29 Mar 2006, the patient broke out with a varicella rash. He had about 10 lesions total, mostly on his chest and back. Unspecified medical attention was sought. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
Breakthrough case admission after 4 vaccines Moderna 1/28/21 Lot# 026L20A;  Moderna 2/25/21 Lot# 031L20A;  Moderna 11/19/21 Lot# 039F21A;  Pfizer 10/13/22 Pfizer Lot# GJ3277
Pt states arm was sore on evening of 3/21/07. On 3/22/07 early am-severe arm pain prescribed with Ibuprofen. At 11am on 3/22/07 pt presented with 'Body Aches All Over", T=100.6 and headache. Prescribed with Ibuprofen. Right deltoid had 4 mm diam. erythema with 1 mm central nodule. Rapid flu test-NEG. By evening of 3/22/07 pt was "well" Pt states Hep A shots (8/30/06 + 3/5/07) give him only sore arm.
Headache; nausea; arm pain at the injection site; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ek5730), intramuscular at the left arm on 23Dec2020 14:30 at a single dose for COVID-19 immunization. Medical history included anxiety. The patient was not pregnant at the time of vaccination and had no known allergy. Concomitant medication included trazodone and fluoxetine hydrochloride (PROZAC). On 24Dec2020 6 am, the patient experienced headache and moderate nausea for about 48-32 hours with significant arm pain at the injection site. The patient was not hospitalized for the events and did not receive any treatment. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020.
Pt came to the Vaccine clinic to get the booster dose for Pfizer (3rd dose) only. However, pt was administered flu shot instead of Pfizer shot by a pharmacy intern. As a pharmacist I advised the pt what was going on. Although pt did not want flu shot, she insisted she wanted to procced in getting the Pfizer 3rd dose. We have apologized the pt for the error, we also counseled on the side effects of flu shot.  We  also have addressed with the pt that getting the flu shot is actually recommended to get for her age. Pt left the clinic fine, she was just upset that we gave her the flu shot instead of Pfizer shot.
Mother reports the child had a fever 6 days post vax. The fever was to 104 for 2-3 days. Seen by MD who diagnosed ear infection. The pt was treated with medicine (that pink stuff). The pt had a complete recovery.
a couple days after receiving the 1st dose - woke up with rash around eyes, mouth, nose and neck.  it went away with some benadryl.  1 week later it returned.  started to become worse on face, burning feeling and making her nauseaus.  consulted with doctor.  was started on prednisone & benadryl.  instructed not to receive 2nd dose
Onset, 1 hours, post vax. Chief complaints, headache, dizziness, body aches, sore arms, red eyes and slept most of the day of immunization; did not go to school on 3/20/01. Mother had to feed because arms hurt. Gave Tylenol X 1, ice to arms.
This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA005153: