chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 06-Jun-2018 regarding an unsolicited valid non-serious case from a Pharmacist. This case involves a patient (gender and age not reported) who received a dose of HIB VACCINE on an unspecified date (manufacturer, batch number, expiry date, route and site of administration were not reported). This is an actual medication error case as the product was reconstituted with water instead of diluent (product preparation error). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccination not reported. No adverse event was reported. Lab data and corrective treatment: not reported. 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 Directive and Module VI of the 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. Documents held by sender: none.
Patient got an extra dose of the MENACTRA with no adverse event; Patient recieved Menactra instead of the intended Bexsero with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00640413) and transmitted to Sanofi on 14-Jun-2021.  This case involves a 17 years old female patient who received 0.5 mL third dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6877BA and expiry date: 29-Feb-2022) via unknown route in right deltoid (extra dose administered) for prophylactic vaccination on 02-Jun-2021 instead of MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV [BEXSERO] (wrong product administered).  The patient's past vaccination(s) included Menactra on 08-AUG-2017 and 13-AUG-2020. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  The reporter asked when would be best to give a meningococcal B vaccine. Should they be looking for anything.  It was reported that the patient received Menactra on 08Aug2017 and 13Aug2020. She then received a third dose of Menactra in the right deltoid by mistake on 02Jun2021. The intended vaccine on 02Jun2021 was a meningococcal B vaccine, Bexsero. They told a medical assistant (MA) to give a "meningitis vaccine" and the MA chose Menactra instead of the intended Bexsero.  It was an actual medication error case due to extra dose administered and wrong vaccine administered (latency: same day).  At the time of reporting, the patient experienced no adverse event and feels fine.   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.
Parent brought pt. to vaccine clinic for 12yo and older, and pt. received Pfizer-BioNtech regular vaccine dose. Pt is only 11 and was accidentally given the incorrect dose, she should have received the child dose vaccine for 5-11yo.
Felt achy,aches; fever/feverish; headaches; swollen glands; extreme fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Felt achy,aches), PYREXIA (fever/feverish), HEADACHE (headaches), LYMPHADENOPATHY (swollen glands) and FATIGUE (extreme fatigue) 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.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Felt achy,aches), PYREXIA (fever/feverish), HEADACHE (headaches), LYMPHADENOPATHY (swollen glands) and FATIGUE (extreme fatigue). At the time of the report, MYALGIA (Felt achy,aches), PYREXIA (fever/feverish) and HEADACHE (headaches) had not resolved and LYMPHADENOPATHY (swollen glands) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Information has been received from a physician concerning a 34 month old female, who on 07-JUL-2005 was vaccinated with 0.5ml dose of varicella virus vaccine live (Oka/Merck) (lot number "0610P"). On 14-MAR-2007 the patient developed breakthrough of 20-25-lesions with a temperature of 101 degrees. Medical attention was sought. Subsequently, the patient recovered 02-APR-2007. No laboratory tests were performed. No product quality complaint was involved. Additional information has been requested.
Headache, Myalgia, Fever, Palpitations, pain at injection site, then 12/24 woke up w/freezing toes and fingers, the chills, body aches, mild temp, Narrative:
The vaccine leaked out at the time of administration and provider recommends the patient repeat the booster in two months to confirm proper vaccination.
A month after getting vaccine on October 12th began having achiness, chills, brain fog, and slight headache. Never had fever. Tested positive for COVID-19 on at home test October 13th. Still having same symptoms. Doctor ordered PAXLOVID and began taking that evening. Took TYLENOL as needed for achiness. Symptoms resolved fully by 10/17/2022.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed vaccine and advised lot 031L20A maintained activity necessary to protect against covid 19 on the date vaccine was administered. Also patient did not call in to complain of adverse event.  This is administrative error without adverse event.
Pt. showed me her arm. There was a 2.5 inch in diameter swollen red site upon injection that had prgressivly gotten worse over night.
Pt reports:  Itchy, pimply-rash started 6-10-11, approx 1-1/2 weeks after receiving Adacel vac.  Given Predisone shot and 1 week pack of Prednisone pills.  Rash resolved after completing Prednisone pills.  Rash returned 2 days later.  Described as "almost like tiny heat rash".  Had been hiking, thought environmental- but nothing noted per pt. Rash started in pelvic area, buttocks, up and down legs, arms and under arms.  Increased in warm areas. Started second round of Prednisone June 29 or 30, thru July 7 or 8. Finished x3-4 days, then bumps returned again.  No one else in family has it.
SEVERE HEADACHE, NAUSEA, ARM PAIN, PAIN THROUGHOUT BODY
L THIGH- ANTERIOR MEDIAL ASPECT WARM AND RED, SOME TENDERNESS. TX- BENADRYL CREAM, WARM SALINE SOAKS.  *** NO FURTHER DPT OR HIB PER MD**
At 5pm on day of vaccine she noticed right arm soreness, which worsened and woke her from sleep; Noticed swollen lymph node in right axilla; Took 600mg ibuprofen and pain subsided; Felt fatigued in the morning, went to her physical therapy and during therapy developed nausea, elevated heart rate to 160-170's for 20 minutes, and near syncope - was seen in the ED, EKG and labs unremarkable
crying that her heel was hurting so bad; toes were less-colored, white, pale (different from other foot); This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (crying that her heel was hurting so bad) and SKIN DISCOLOURATION (toes were less-colored, white, pale (different from other foot)) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pains in legs. Concomitant products included OXYCODONE HYDROCHLORIDE (OXYCONTIN) for an unknown indication.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced CONDITION AGGRAVATED (crying that her heel was hurting so bad) and SKIN DISCOLOURATION (toes were less-colored, white, pale (different from other foot)). The patient was treated with MAGNESIUM SULFATE (EPSOM SALTS [MAGNESIUM SULFATE]) (topical) on 22-Jan-2021 for Adverse event, at a dose of UNK dosage form (took epsom salt bath). At the time of the report, CONDITION AGGRAVATED (crying that her heel was hurting so bad) and SKIN DISCOLOURATION (toes were less-colored, white, pale (different from other foot)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Terrible Arthralgia; This case was reported by a consumer via sales rep and described the occurrence of arthralgia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was recovered/resolved.   It was unknown if the reporter considered the arthralgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with dose of Shingrix, the patient had terrible arthralgia. The reporter stated that, artralgia resolved after a couple days. The reporter did not consent to follow up.
Lasting all day: stomach pain, nausea, headache, fatigue, muscle pain, dizziness, hot flashes. At night: symptoms listed above, both hot and cold flashes, chills, could not sleep, fever.
Had the vaccination, dose #1 on January 26th and 12 days later had sharp abdominal pains just below the breast bone and they lasted for about 4 hr.   After that I had soreness in the abdominal area and back for several days. The day after the pain I was shocked to see my urine was brown.  The was Saturday  so saw by PCP on Monday February 2nd for testing.  My ALT liver test came back at 124 ul  (normal range is 0-30).  Since indicates liver problems liver follow-up testing is being scheduled.
Big rash all over the body. It came 3 days after the vaccine. Took antihistamine tablets.  Was due to start chemotherapy but can not start treatment until rash has fully cleared.
Heavy menstrual cycle occurred in morning on 5/5/21, barely 12 hours after vaccine, with cramos. Just had period 2 weeks ago, usually cycle runs later, between 35-40 days. Rash on right arm, and arm pain/swelling/redness at injection site on left arm. Headache.
16 year old was given a Moderna vaccine instead of a Pfizer vaccine.  Based on the CDC recommendations, we had the patient return for their second dose of Moderna on 05/11/2021 even though he was out of the age range.
Headache, Fever, Diarrhea, NauseaVomiting, NAUSEA, VOMITING, DIARRHEA, HEADACHE, CHILLS, SWEATING Narrative:
A 52 year old male patient, who was bitten in the calf area by a dog, received treatment for post-exposure Rabies. He began his series one month ago (approximately 3/7/02). The patient experienced flu like symptoms following his first treatment. These symptoms subsided fairly quickly. Following the second treatment, the patient developed blisters on his gums and the roof of his mouth. His gums were also swollen. He developed a quarter sized blister on his forehead that had been progressing in size. He also experienced muscle pain. The patient was treated with a tetanus shot, Zithromax Z pack, and hydrocortisone for these symptoms. No other information is available. The events were assessed as possibly related to RabAvert, but not serious.
Huge cold sore on my upper right lip; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6203, Expiration Date: not reported) via an unspecified route of administration in right arm on 27Feb2021 18:45 as 1st dose, single dose for COVID-19 immunization. Medical history included known allergies to Penicillin and other medical history was reported as none. Patient did not receive any other vaccine in four weeks and received other unspecified medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Feb2021, the patient experienced huge cold sore on my upper right lip. Patient was treated with Famciclovir. The outcome of the event was reported as recovering.  No follow up attempts are Possible. No further information is expected.
Pt 1st dose of Hep B vax on 9JUL90 & immediately pt devel arm numbness & pain; 2 to 3 hrs p/vax the pain became more severe & radiated to shoulder & neck; w/in days of the vax pt devel a flu-like synd & aching joints, fatigue, fibromyositis
Pt received HPV and MENACTRA. 15-20 mins later c/o tight feeling in throat, developed cough, became pale and dizzy. Treated w/ 50mg BENADRYL, 60mg Prednisone, 0.3mg Epi, albuterol neb then transferred to ER via EMS.
This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with improperly stored dose of M-M-R II, lot #N031294 with expiration date 21-AUG-2019, for prophylaxis (dose number, frequency, route and anatomical location were not provided).The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F (52.7°F) during 2 hours and 15 minutes. The vaccine had not had any previous temperature excursions.There were no adverse effects reported. This is one of eleven reports received from the same reporter.; Sender's Comments: US-009507513-1808USA011005: US-009507513-1808USA011006: US-009507513-1808USA011007: US-009507513-1808USA011008: US-009507513-1808USA011009: US-009507513-1808USA011010: US-009507513-1808USA011011: US-009507513-1808USA011012: US-009507513-1808USA011013: US-009507513-1808USA011014:
SWEATING; MUSCLE ACHE; FATIGUE; BODY ACHE; FEVER; SHIVERING; ARM SORENESS; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018,  expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 09:45 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced shivering. On 08-APR-2021, the subject experienced arm soreness. On 08-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced muscle ache. On 09-APR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 37.3 C, 36.9 C. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, shivering, fever, and fatigue on 09-APR-2021, and arm soreness on 08-APR-2021, and had not recovered from body ache, and muscle ache. This report was non-serious. This case, from the same reporter is linked to 20210421744.
A report has been received from a health professional via medical representative concerning a 4 year old female patient. No medical history, concomitant disease and concomitant medications were reported for patient. Patient had received FLUMIST QUADRIVALENT (intranasal) on 15-Sep-2014. Medical representative reported that nurse reported him that a patient received FLUMIST QUADRIVALENT (intranasal) on 15-Sep-2014 and had wheezing symptoms on 17-Sep-2014. Action taken was not applicable for FLUMIST QUADRIVALENT. The patient received treatment and the symptoms resolved two days later. The patient was currently doing fine. The report was considered to be non-serious by reporter.
Developed COVID symptoms on July 7, 2021 and received a positive COVID-19 test result on July 12, 2021. Symptoms: fever for 5 days, aches, chills, cough for 3 weeks, and complete loss of taste and smell for 6 days (has not fully returned)
PATIENT DID NOT REPORT AN ADVERSE EVENT, COMPANY NOTIFIED US OF ADMINISTERING VACCINE AFTER EXPIRATION DATE
The pt received the vaccines on 4/30/01/ and was presented on 5/2/01 with erythema 1 1/2 x 2 1/2 inch circular area just outside of the site of vaccine.
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: pt reported that his took benadryl immediately after the rash and hives and rash disappeared after. rash did not appear until day 2/3
After administration patient said arm was hurting and at that point eyes rolled up and clenched his mandible, then he lost tone of his body. Patient was unconscious for about 2 minutes then confusion for about 10 minutes.
1.5 weeks after my first shot I started my period 1 day early. Everything was fine the first day but by the afternoon of day 2 I was bleeding extremely heavy and several very large blood clots past in a matter of minutes. I called consulting nurse who told me to go to the ER immediately. I then went to the ER for treatment. They did some tests and sent me home and told me to watch my symptoms closely for the next few days. This was last night and I have no change today. I'm still bleeding very heavily and passing large clots. I have never in my life experienced a period of this nature.
Patient received vaccines on June 11, 2023. Patient developed bilateral blurry vision followed by gait instability on June 19, 2023. Patient was admitted to the hospital on June 20 with complete bilateral blindness. and gait instability. Patient transferred to ICU with lethargy on June 21 and got intubated for airway protection. Patient underwent MRI of orbit concerning for possible demyelinating or autoimmune process on 6/21/23. MRi brain on same day concerning for acute disseminated encephalomyelitis. Patient started on 1000mg Solumedrol on 6/22 and completed 5 days of pulse steroids. Started on IVIG for 5 days on 6/26 due to lack of response.  Patient remains unresponsive in our ICU on mechanical ventilation.
rash and scaly skin on arms, chest, legs, neck, and groin swelling in groin and legs itchiness in areas where rash was found
Information has been received from a 78 year old female with no known allergies or pertinent medical history who on 26-MAR-2008 was vaccinated with ZOSTAVAX (Oka/Merck). Concomitant therapy included LIPITOR and SYNTHROID. A few days after administration, the patient experienced a mild case of shingles on her face. It looked like a rash formed and then a few days later little blisters formed. The patient's physician prescribed her VALTREX and it cleared right up. Routine labs were performed every ninety days. A month after administration of ZOSTAVAX , April 2008 the patient recovered. Additional information has been requested.
I woke up the morning after the vaccine so dizzy that I was vomiting. I had brain fog, ringing in my ears and my eyes weren?t right.  For almost 2 days I was totally incapacitated. A person in vaccine research heard about me and suggested Benadryl. Within an hour of taking it, I felt a shift in my brain and could think clearer. By the next morning, I could get up and take a shower. I had issues with dizziness until the end of May. The ringing in my ears and the issues with my eyes lasted into June. At times,  I also felt pressure behind my right eye, left ear and in my forehead. On May 5, I went to my eye dr because of the pressure behind my right eye, she was shocked to discover my vision had changed and I now had a bad astigmatism only in my right eye. She reported to VEARS. I returned for a check on 6/21/2021 and my vision had almost returned to normal.  On 6/2/2021, I had a telemedicine visit with Dr to see why this happen to me and to see what to to in the future about vaccines.
Approx 2 hrs post vax pt eyes would not focus x 3 days, fever & lethargy x 3 days, anorexic x 3 days; Temp not measured; Parent consulted MD by phone;
Patients arm became red and warm to touch about 2-3 cm around injection site by noon. Instructed patient to take BENADRYL and report back the next day.
pt recvd vax & devel burning sensation upon inject as well as soreness & or an aching sensation in the arm; pt felt heaviness in the arm;
Information has been received from a 75 male with high cholesterol and high blood pressure who on 18-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck). Concomitant therapy included telmisartan (Micardis), Simvastatin (MSD), vardenafil dihydrochloride (Levitra) and mometasone furoate (Nasonex). On approximately 27-AUG-2007 the patient developed sensitivity reactions near the injection site (upper left arm). The area was not visibly different from other areas but the patient felt pain at the surface of his skin. It was reported that the pain was not as bad on 19-SEP-2007 as compared to few days ago. The patient also stated that he had cough that started around the time of vaccination. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient had not recovered. Additional information has been requested.
Injection site is swollen the size of a golf ball and is red about the same diameter. It is hot to the touch also and hurts to touch it.
Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 41-year-old male patient who received HAV (Havrix 1440 adult) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th February 2023, the patient received Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 13th February 2023, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-FEB-2023 Reporter's comment: The reporter was the pharmacist.  The reporter stated that a patient received Havrix Adult which was expired on 30th Jan 2023. No additional information was provided. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix adult, which led to expired vaccine used.