chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; body aches; headache; The nurse administered the Bivalent dose without diluting the vaccine first.; The nurse administered the Bivalent dose without diluting the vaccine first.; This is a spontaneous report received from contactable reporter(s) (Nurse and Physician).  An 8-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Jan2023 at 08:30 as dose 4 (booster), single (Lot number: GK1657) at the age of 8 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, Route of administration: Intramuscular, Batch/ Lot number: Not available/ Provided at the time of report completion, Got at another facility), administration date: 04Nov2021, when the patient was 8-year-old, for COVID-19 immunization; BNT162b2 (Dose: 2, Route of administration: Intramuscular, Batch/ Lot number: Not available/ Provided at the time of report completion, Got at another facility), administration date: 26Nov2021, when the patient was 8-year-old, for COVID-19 immunization; BNT162b2 (Dose: 3, Route of administration: Intramuscular, Lot: FL8094), administration date: 24May2022, when the patient was 8-year-old, for COVID-19 immunization.  The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 04Jan2023 at 08:30, outcome "unknown" and all described as "The nurse administered the Bivalent dose without diluting the vaccine first."; CHILLS (non-serious), outcome "recovered"; PAIN (non-serious), outcome "recovered", described as "body aches"; HEADACHE (non-serious), outcome "recovered". Therapeutic measures were not taken as a result of product preparation error, overdose. Therapeutic measures were taken as a result of chills, pain, headache.  Additional information: The patient had no other vaccine in four weeks. The patient had no known other medications in two weeks. The patient had no known allergies and no known other medical history.  Follow-up (04Mar2023): Follow-up attempts are completed. No further information is expected.  Follow up (20Mar2023): This is a spontaneous report from a contactable Physician. This Physician reported in response to HCP letter sent which includes that:  Updated information included: Reporter information (2nd reporter updated to true reporter, middle name added, suffix, email address added, and occupation updated to Physician from Other HCP) and event details (added AE: Chills, Generalized aching, and Headache)
rheumatoid arthritis flare- joint pain, fatigue dexamethasone subq injection- only provided temporary relief still suffering these symptoms
The patient called the pharmacy to report that she begin breaking out in an itchy rash about one month ago.  She said it started on her chest and spread quickly from neck to groin to legs and arms.  She visited her primary care physician who first diagnosed her with poison ivy.  It continued to get worse so she went to an urgent care clinic.  There was still symptoms, so she contacted her insurance and found a dermatologist.  The dermatologist (who she saw today) said that the rash was caused by the vaccine.  The dermatologist gave her a "stronger cream" (she did not know the name) and is hopeful that it will resolve.
Got the shingle shots last year. Got shingles this year/Suspected Vaccination Failure; shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported as follows: The age at vaccination was not reported. The patient got the Shingles shots last year (in 2020) and got the shingles this year (in 2021). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter  It was mentioned that the date place in refrigerator vial was 05-Dec-2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events.  No treatment medication was provided by the reporter.
Starting within a couple of weeks, my husband began having nosebleeds.  He has never in our 50 years of marriage had them.  I knew he was taking a blood thinner and Eliquist do I didn?t think much about it.  And once he evident bit his inner lip and got a huge blood blister. On 4/19 he got a nosebleed that we could not stop and ended up going to the ER.  Had to wear a nose pack for 3 days, went to have it removed but it still bleed uncontrollably.  Had to wear a pack for another week.  After the cardiologist reduced his eliquist, it seemed to quit bleeding.
Periods became extremely heavy around the time of the vaccine. I didn't immediately make any connection but saw a few stories about women reporting similar symptoms. My periods have been consistently and extremely heavy since my shots. Previously they were sporadically heavy. This is extremely heavy bleeding that lasts for 2 or 3 day then stops. My periods used to last 5-7 days. Multiple times I have bled through clothing and had to drive home from work to change clothes. I've discussed this with my OB. They did a sonogram then a sonohysterogram (late 2021) and found no issues other than a Nabothian cyst. That cyst was removed, it was sent to pathology with no issue. My periods continue to be extremely heavy.
Within approximately 3 days (12/15-12/18), intense left-arm pain at site of injection (normal flu-like symptoms resolved within 2 days). Persistent pain, reduced ability to lift, firmly grasp items, rotate the arm, or reach above my head still today (2/5 - nearly 2 months after). One moment a few days later of elevated heart rate and hypertensive blood pressure (this also occurred following COVID-19 infection 5 months prior to vaccination around 7/4).
On 21 June 2000, 22, July 2000, and 15 December 2000, the vaccinee received his first, second, and third doses of Engerix-B, respectively. Routes/sites were unspecified. Subsequently he was found to be a ronresponder. As of 6 March 2001, the outcome of the event is unknown.
This spontaneous report as received from a pharmacist refers to a 64 year old female patient without pertinent medical history. On 18-OCT-2014, the patient was vaccinated with ZOSTAVAX lot # K009769, expiration date 09-OCT-2015, 0.65 ml, subcutaneous. Secondary and concomitant therapies were not reported. Pharmacist reported that the patient developed redness at the injection site after receiving ZOSTAVAX (on an unknown date 2014). The outcome of redness at the injection site was reported as not recovered/not resolved. The patient went into the pharmacy on 20-OCT-2014 and showed the pharmacist the redness at the injection site. No treatment was given for the event. No labs diagnostics studies were performed. Additional information has been requested.
Swollen indurated area right thigh with moderate tenderness. Umbilicated rash - trunk/extremities, blanching rash.
Leukocytosis with blast cells - concern for heme malignancy  Jaw swelling with lymphadenopathy, confirmed with CT - ?2/2 to new heme malignancy vs adverse reaction to vaccine
Head cold symptoms: Runny nose and cough for ~3 days concluding with a sinus headache on the last day.
Vomiting, localized reaction red/swollen hard area on upper left deltoid. Treatment at E.R. ORAPRED 15mg/5mL 60 mg P.O. BENADRYL 25 mg PEPCID 20 mg tab P.O.
2nd Moderna vaccine accidently administered at 22 days spacing -vs- 28 days.
COVID Breakthrough. Patient took an at home test for COVID on 11/2/21 which resulted positive. She experiencing ongoing and worsening symptoms for which she went to the hospital on 11/9/21 and tested positive again.
Continuing to have difficulty breathing and coughing when I get short of breath; Continuing to have difficulty breathing and coughing when I get short of breath; Some tightness in chest; This is a spontaneous report from a contactable consumer, the patient. A 46-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 left arm on 14Apr2021 at 10:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. 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 in left arm on 24Mar2021 at 10:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient previously received diclofenac (VOLTAREN) and experienced drug allergy. On 15Apr2021 at 14:00, the patient experienced going on week two continuing to had difficulty breathing and coughing when she gets short of breath and some tightness in chest. The clinical outcome of the events continuing to have difficulty breathing and coughing when she get short of breath and some tightness in chest was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
injection site pain; sore arm; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that he has experienced pain at the injection site and sore arm with Bexsero.
Information has been received from a nurse practitioner concerning a female patient who on approximately 15-APR-2010 was vaccinated with a first dose of GARDASIL (lot # not reported), 0.5mL, intramuscularly.  On approximately 15-APR-2010 after getting the first dose of vaccine the patient experienced body aches, blurred vision and upset stomach.  The patient sought unspecified medical attention.  The outcome of body aches, blurred vision and upset stomach was unknown.  Additional information has been requested.
102-103 temp for 2 nights, 1 days;rash around inj site;hives on rt arm;
fever, chills, headache, nausea, fatigue, body aches Tylenol and fluids 48 hours
On April 16th, I started having heart palpitations. Racing of the heart. It?s bothersome when I eat.  Pain in the upper back. Discomfort in the chest.
Intense pain started in shoulders and joints. then spread 5 hours after shot that lasted through the night and subsided 9:00 am next morning. Took TYLENOL arthritis and used cold pack on arm.
Administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) in a 78-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. It was reported as unknown when the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: The follow-up document includes non significant information.
I had fatigue, malaise, and fever of 100.4. I tested positive for COVID-19. I talked to my doctor, and they prescribed me PAXLOVID. I started to feel better and tested negative on the 12/11/2022. Then I rebounded and tested positive for COVID-19 again on 12/13/2022. I had a cough, fatigue, low-grade fever, nasal congestion, loss sense of taste and smell.
Constant shoulder pain up near shoulder joint. Limited  range of motion, can?t hold arm up as high. Nerve pain down arm. Stiff shoulder joint at times.
no adverse effects; The patient was administered an expired dose of VARIVAX.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 11-APR-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneously, lot # N009768, expiration date 24-MAR-2019 for prophylaxis (dose and route of administration were not reported) (expired product administered).The vaccine was reconstituted with sterile diluent MRK lot # R025519, expiration date 28-NOV-2019. No adverse effects reported. The outcome of expired product administered was not reported.
Felt like she had a "brief relapse of Covid"; Hard time getting in air; Not able to sleep; This spontaneous case was reported by a nurse and describes the occurrence of INSOMNIA (Not able to sleep), DYSPNOEA (Hard time getting in air) and MALAISE (Felt like she had a "brief relapse of Covid") in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2020.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced INSOMNIA (Not able to sleep), DYSPNOEA (Hard time getting in air) and MALAISE (Felt like she had a "brief relapse of Covid"). On 31-Mar-2021, INSOMNIA (Not able to sleep) had resolved. At the time of the report, DYSPNOEA (Hard time getting in air) and MALAISE (Felt like she had a "brief relapse of Covid") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.    This case was linked to MOD-2021-065537 (Patient Link).
A report has been received from a Health Professional concerning an adolescent, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT. The patient's concurrent disease(s) included asthma and bronchospasm. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced pneumonia. The outcome of the event of pneumonia is unknown. The report was considered to be non-serious.
Initial report was received 10 August 2011 from a health care professional. A 16-year-old pregnant female patient with no known pregnancy history, had received a first dose intramuscular left deltoid injection of MENACTRA, lot number U3542AA on 30 July 2011. The patient's date of last menstrual period was 10 February 2011 which calculates to 24 weeks gestation at the time of vaccination. According to the reporter, the patient had not experienced any adverse events since receiving MENACTRA. No additional information was provided. Follow-up information was received on 12 March 2012 from a health care professional. Based upon the new information, this case has been upgraded to serious. The patient had a human chorionic gonadotropin (hCG) blood test on 12 August 2011 and the result was 0.0 which was non-pregnant. The patient had a urine pregnancy test on 09 September 2011 and the result was negative. The patient was diagnosed with missed abortion. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Laboratory records.
Vaccine given on 3/5/01. Symptoms of fever to 102.6F; itching and pox appeared on 3/8/01 PM. Initial 72 pox with 4 in mouth area, 17 blisters and red spot on remaining. Child broke out worse and was seen by PMD on 3/9/01. Used Tylenol, Benadryl and Motrin for discomfort. Mother reports has pox everywhere; over 1,000 in mouth, ears, throat, nose. Had difficulty urinating.
Discharge Summary     Risk of unplanned readmission within next 30 days: N/A (0-12 low risk, 12-21 moderate risk, 22-28 high risk, 29+ extreme risk)  Reason for Admission:  Present on Admission: ? Acute chest pain  Final Diagnosis:  Acute chest pain  Myopericarditis  Hospital Course:  Patient is a 21 y.o. Caucasian male who presents with acute onset of fever, headaches, chest/back pain and rapid heart rate after having received second dose of Pfizer Covid vaccine on 5/21/2021. Chest pain with oppressive character (pressure-like, squeezing) that is associated with palpitations, sweating, SOB, not nausea, exertion, dizziness. +cardiac risk factors (smoking, and +FH).  Patient evaluated by cardiology. Echocardiogram with normal left ventricular ejection fraction no pericardial effusion. Troponins downtrending. Patient diagnosed with myopericarditis pericarditis as per cardiologist: "discharge him home with plans for a repeat echocardiogram in 1 month and follow-up with a cardiologist. I do not feel strongly that we need to start cardioprotective medications or any anti-inflammatory medications as he is feeling better."  Once symptomatically improved and repeat troponin downtrending patient was cleared for discharge by cardiology in stable condition  Significant Medication/Changes this Admission: See MAR  Follow Up Recommendations: PCP   Problems Addressed During this Admission: Acute chest pain  Elevated troponin  Engages in vaping  * No resolved hospital problems. *  Consults:  Consultants below were obtained for their respective expertise as needed (Please refer to their consult and progress notes for details). Discharge Disposition: Condition at discharge: Stable. Discharged to Home
Dizziness sweating,  Narrative: 1/14 onset of headache and sore arm 1/15 -had a "vaso-vagal" type response - room spinning and sweating. She laid down on the floor for 20 min and the sweating and dizziness went away. Her headache has been on and off today. She has decreased appetite and fatigued. General malaise. 1/19 - ongoing mild headache off and on.
had small blistery patch on her arm on the right wrist almost like poison ivy; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (had small blistery patch on her arm on the right wrist almost like poison ivy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced BLISTER (had small blistery patch on her arm on the right wrist almost like poison ivy). At the time of the report, BLISTER (had small blistery patch on her arm on the right wrist almost like poison ivy) had resolved.            No Concomitant medications were provided  No Treatment medications were provided   This case was linked to MOD-2021-240459 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: No new information was received.
No additional adverse event or product quality concern; Patient received PROQUAD on 06/11/2021 and had received MMRII and VARIVAX in July of 2020; Information has been received from a nurse prescriber concerning a 5 years old male patient. Information of concurrent condition, medical history and concomitant therapy was not provided.   On ??-JUL-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, route, lot# and expiration date were unknown) and varicella virus vaccine live (oka/merck)(VARIVAX) (dose, strength, route, lot# and expiration date were unknown) both for prophylaxis.      On 11-JUN-2021, because the nurse prescriber was unaware of he had received  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, route, lot# and expiration date were unknown) 0.5 milliliter once for prophylaxis (wrong vaccine administered). No additional adverse event or product quality concern.
This case was received from a health professional, via another manufacturer, on 13 March 2008.  SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  A nurse reported that a patient experienced Guillain-Barre syndrome following administration of a Tetanus vaccine.  No other information was available.
patient said hand was swollen and side the shot was given, also other joints swollen and blood blisters formed on hands
pt recvd vax & mom noticed the pt lt arm was sl red @ the inject site on Thurs; AM the arm was red, swollen, warm to touch the redness went from the inject site to 4" down the arm;