chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given Moderna vaccine that was out of the freezer for 42 days. Vaccine was 12 days past the beyond use date. Parent's notified and encouraged to repeat the dose.
Febrile seizure 6/24/10 ? days after MMR #1 - fever 102 degrees.
Patient received a flu shot at the at 1531 on 10/22/10.  She reported no problems at time of administration.  .5 ml of sanofi pasteur Fluzone injection was administered in the deltoid muscle of the Left arm with a 23 X 1 inch needle attached to a sterilized syringe.  She reported no problems and demonstrated no reaction symptoms at time of administration.  At 1609 she returned to the conference room stating that she was expirencing a "metal taste in my mouth".  She also stated that she felt "warm in the arm where I got the shot and my fingers are tingling".  Patient was encouraged to drink some cool water and sit with the nurse to further evaluate her.  She drank approximately 1/2 cup of water and stated "Im fine".  She was encouraged to call her primary care doctor to inform of the problem.  She also was informed to call 911 if she experinced any further problems.  She expressed understanding and returned to work.  On 10/23/10 at 0845 I called her home number to check with her and left an answering machine message for patient to call the nurse.  At 1156 on 10/23/10 patient returned the nurses phone call.  Patient stated that she had called her primary care doctor and informed him of her condition.  She stated that he told her there were no tests available to determine if she was indeed having a reaction to the injection.  She stated that he told her if her symptoms worsen or change that she should go to the emergency room at the hospital.  The nurse restated the doctors instructions and patient again expressed understanding.  She also stated that she had researched this injection on the internet and would never again receive a flu injection.  On 10/25/10 the nurse left a message at patient's home number for patient to call if she was still having problems.  At 1423 on 10/25/10 patient phoned the nurse.  Patient explained that she was still feeling warmth in her left arm and she was also having "chest pain".  The nurse told patient that if she is having chest pain she needs to call 911 or go to the emergency room immediately.  Patient explained "I just don't have time this week to go".  Patient was again encouraged to call 911 or go to the emergency room by the nurse.
Baby "turned grey" and was non-responsive approx. 3-4 hrs after receiving 2 month vaccines at PCP. EMS was called and reported baby had HR to 45. Baby was given BENADRYL and O2 and transferred to inpatient facility. Back to baseline at admission.
Infant screamed for 20 min after PENTACEL vaccine given in left thigh IM, then fell asleep. About 1 hr later while sleeping left thigh was red and swollen and warm from lateral knee to hip. Infant difficult to console w/o being held in evening. Slept through night, ate normally. Sxs gone by morning.
This spontaneous report was received from a medical assistant and refers to a 4 year-old (reported also as 6 year-old), black, male patient who did not have any known drug reactions or allergies. There was no information about the patient's concomitant therapy or medical history provided. The patient did not have any illnesses at the time of vaccination. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (dose, frequency, route of  administration, lot# and and expiration date were not reported). On 22-SEP-2016 at 10:15 (am),  the patient was vaccinated with improperly stored second dose of VARIVAX lot # L013068, subcutaneously in the left arm for prophylaxis (dose and expiration date were not reported). The vaccination was in privates doctor's office/ hospital and administered VARIVAX was purchase with public funds. No adverse event was reported. Previous temperature excursions, the range and time of temperature excursion the administered VARIVAX experienced were not reported. It was unspecified if a digital data logger was involved. A signed informed consent form was not obtained. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1611USA014213: US-009507513-1702USA004104: US-009507513-1702USA004102: US-009507513-1702USA004103: US-009507513-1702USA004110: US-009507513-1702USA004109: US-009507513-1702USA004107: US-009507513-1702USA004106: US-009507513-1702USA004105:
a patient received improperly stored vaccine; This spontaneous report was received from the administrator from the doctor's office, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 10-NOV-2020, the patient was vaccinated with one improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (strength, dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number S027467, which have been verified to be valid, expiration date reported and validated as 02-MAR-2021) as prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature excursion of 17.2 degrees Fahrenheit (F) for 1 hour and 30 minutes, as recorded by a data logger. The previous temperature excursion reported was 12.2 degrees F for 1 hour.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2011USA013420: US-009507513-2011USA013458: US-009507513-2011USA013844:
Systemic Rash all over the body, headache, soreness, chills, aches, fever, fatigue, loss of appetite, and shortness of breath.
Patient woke up morning after getting shingrix with blisters on her upper right forehead.  She said the blisters were itchy until they popped as she was washing her face.  Patient has two separate areas on her forehead with the blisters which she now describes as painful.
Pt recv vax on 11/11/98; on 11/12/98 pt exp diarrhea x 2 day
Approximately 5 minutes after vaccination patient reported both feet felt warm and numb as though they were asleep.  Symptoms resolved in 15 minutes with no other issues reported
trouble breathing; Fast heart rate; top lip was swollen; This spontaneous case was reported by a pharmacist and describes the occurrence of HEART RATE INCREASED (Fast heart rate), LIP SWELLING (top lip was swollen) and DYSPNOEA (trouble breathing) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HEART RATE INCREASED (Fast heart rate) and LIP SWELLING (top lip was swollen). On an unknown date, the patient experienced DYSPNOEA (trouble breathing). At the time of the report, HEART RATE INCREASED (Fast heart rate), LIP SWELLING (top lip was swollen) and DYSPNOEA (trouble breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Injection site pain, swelling and redness; Injection site pain, swelling and redness; Injection site pain, swelling and redness; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration), via an unspecified route of administration in right arm on 11Jan2021 at 09:00 AM at a single dose for COVID-19 immunization.  Medical history included high cholesterol.  The patient has no known allergies. Concomitant medication included simvastatin. The patient received the first dose of COVID vaccine dose yesterday (11Jan2021) and reported that he experienced the following side effects; injection site pain, swelling and redness on unspecified date. The patient did not have other vaccine in four weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive treatment for the events. The patient is recovering from the events.   Information on the Batch/Lot number has been requested.
Swollen face and eyes. Treatment with 25mg Benadryl and referred to MD.
This spontaneous report was received from a healthcare worker concerning an unspecified number of patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were vaccinated with improperly stored dose of VAQTA (Lot # L004743; Expiration date: 01-JUN-2017) (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a consumer concerning her daughter who was vaccinated with the first dose of GARDASIL (unspecified dose). Subsequently, "shortly after initial dose of GARDASIL", the patient experienced cysts, and marks or her legs, buttocks, and groin areas. The physician felt it may be at allergic reaction to GARDASIL. At the time of the report, the AE did not improved and the patient had not recovered. Additional information is not expected.
Information has been received from a physician concerning a female patient between 18-26 years of age, who was vaccinated with her second dose of GARDASIL vaccine (yeast). The physician reported that the patient received her 2nd dose of HPV vaccine and developed migraine headaches. The patient had been taking TOPAMAX and the headache persisted. The physician reported that the patient was due for her third dose of HPV vaccine "soon" and was considering not receiving it due to her concern over the headaches. At the time of the report, the patient had not recovered. The patient sought medical attention at the physician's office. Additional information has been requested.
patient experienced soreness of the arm after getting administered Prevnar 13; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for three patients. This is the third of three reports.  A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced soreness of the arm after getting administered pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). Outcome of the event was unknown.  No follow-up attempts are possible. Information regarding the batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019548927 same drug, reporter, and event; different patient;US-PFIZER INC-2019548921 same drug, reporter, and event; different patient
Received shot about 5 hours later arm started to swell up. Had redness and itchiness to injection site - continued to swell for 3 days - Redness has gone away about 4 days later - still some itchiness and swelling 4 days later but seems to be improving.
Leg, shoulders, arms joint pain; felt very weak. Received cortisone injections from Dr. Followed up w/ another Dr. who ordered blood & urine tests.
gave a 12 year old the Flublok Quadrivalent/no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12 years old female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was reported.   On 12-Oct-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1913 via unknown route in unknown administration site.  It was of actual medication error due to Inappropriate age at vaccine administration.  It was unknown whether adverse event was reported or not.  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 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.
headache; REDNESS; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and ERYTHEMA (REDNESS) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ERYTHEMA (REDNESS). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) and ERYTHEMA (REDNESS) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant details were provided. No treatment details were provided. Consent given for safety to contact patient. Consent not obtained for her HCP.   Reporter did not allow further contact
complete loss of taste; he can not taste anything; really tired and fatigued; complaining of eye pain; Had eye straining and eye pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 08Sep2021 16:00 (Lot number: FF2588) at the age of 16 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing), notes: Verbatim: ADHD; "Gastroschisis" (unspecified if ongoing), notes: Verbatim: Gastroschisis. There were no concomitant medications. The following information was reported: AGEUSIA (non-serious) with onset 11Sep2021, outcome "not recovered", described as "complete loss of taste; he can not taste anything"; FATIGUE (non-serious) with onset 10Sep2021, outcome "recovered" (11Sep2021), described as "really tired and fatigued"; EYE PAIN (non-serious) with onset 10Sep2021, outcome "unknown", described as "complaining of eye pain"; ASTHENOPIA (non-serious) with onset 10Sep2021, outcome "unknown", described as "Had eye straining and eye pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eye pain, asthenopia.  Additional information-Reporter stated, "She had question about the Pfizer BioNTech vaccination this actually her son received it. She was looking at the calendar here, her son had 1st dose on 08Sep2021. She seem to be doing fine like for the first 3 days, 4 days and as of Monday of this week he had lost, complete loss of taste. So reporter did not know, looked up at like different reactions to it because everybody was different, how they react to it, so she guess she was little bit concerned as far as like if this was in vaccine related or she was not sure all she knew was her son lost complete taste on Monday. He cannot taste anything." Reporter stated, "Believe it or not her son was not taking anything for his ADHD, he choses not to and his doctor was fine with it as long as her son can be able to focus on study and school he does not feel like he needs to be medicated." Patient did not administered any vaccines on Same Date of the Pfizer Suspect. The AE did not required visit to Emergency Room and Physician Office. The patient did not had any vaccination four weeks prior to the first administration date of the suspect vaccine. Reporter Stated the patient had Ibuprofen when at work and the Ibuprofen was given to the patient by his supervisor because the supervisor was afraid the patient would not make it through his shift.  There is a Product Complaint. Description of complaint: Caller reported, her son received second dose Pfizer Covid 19 Vaccine and reports really tired and fatigued, complaining of eye pain and lost sense of taste. Caller questions if it is safe for caller to receive second dose Pfizer Covid 19 Vaccine. Product strength and count size dispensed: N /A , Additional lot numbers: FF2588   F/U (20Sep2021) Follow-up attempts completed. No further information expected.
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from non-healthcare professional. This case involves a two-months old patient who was vaccinated with a dose of PENTACEL (batch number: C5447AA, expiration date: 18-Oct-2019, dose and route of administration was not reported) in left thigh on an unspecified date. The patient's medical history was not reported. Concomitant medications included PREVNAR and ROTAVIRUS VACCINE. It was an actual medication error due to inappropriate reconstitution technique as the patient received PENTACEL component DTaP-IPV without the Hib component. No known reported symptoms. 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. List of documents held by sender: none.
After I got the vaccine my arm hurt. The next day I got mild flu like symptoms, Then ringing Tinnities  in my ear did NOT  have that before, heart palpitations , racing heart. than my neck, face, right lymph node swelled up. Than I got pulsating Tinnities in my ear where I heard my heartbeat. I lost my hearing in one ear (which came back after the steroids).My ear hurt. I was put on antibiotics, I think for 10 days and than steroids for 25 days . I got knots down my neck and jaw. It?s still inflamed. I still hear the pulsating and ringing in my ears. I got muscle twitching in different areas of my body. I also can feel my heartbeat in different areas of my body where I never felt that before. The arm where I got the injection you can watch the muscle move for 15 minutes. So now I need to go to the heart doctor and get a several brain scans and physical therapy. I did not have any of this before and never had ear  problems before. Scary I have pulsatile tinnites. My SCM and my jaw and other neck muscles are inflamed.
The patient jerked to the right and the needle entered the sub-dermal layer of the patient and caused it to be raised and red. A second needle was utilized the patient got scrapped by the needle tip before it even got close to the arm this was also wasted due to bloodborne pathogen risks and concerns. The 3rd attempt was done fine after the mother had a bear hug the patient with back rub support.
Severe arm pain starting at 6pm, then extreme chills, with no fever, severe acking of all joints, especially knees, hands, back and feet
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included tetanus toxoid vaccine (manufacturer unspecified; details unknown) given on an unspecified date. In1986 or 1987 the subject received 1st, 2nd and 3rd doses in the first primary series of ENGERIX B (20 mcg, unknown route, alternated between left and right arm) and experienced not responding to therapy. On an unspecified date 1 month after the 3rd dose of ENGERIX-B, the "titre" was 1 mIU/mL. On unspecified dates, the subject received 1st, 2nd and 3rd doses in a second series of ENGERIX B (details unknown) and experienced not responding to therapy. On an unspecified date a titre was drawn and was 1 mIU/mL. On an unspecified date, the subject received a booster dose of ENGERIX-B (20 mcg, unknown arm) (this was the 7th dose) and experienced not responding to therapy. On an unspecified date, a titre was drawn and was 6 mIU/mL. Follow up received from the healthcare professional who may also be the subject on 14 February 2012. For relationship to patient, the healthcare professional wrote "self", but the initials for the reporter were reported and the initials for the patient were reported as other initials. Concurrent medical conditions included "nonresponder". The currently 59-year-old subject was 35 years old when the first titer showed her not responding to therapy. The healthcare professional noted that the subject in January 1987, February 1987 and June 1987 (previously all reported as 1986), received 1st, 2nd and 3rd doses in the first primary series of ENGERIX B. The titer that was one month after the first series that showed not responding to therapy was around July 1987. In December 1988, January 1989 and February 1989, the subject received 1st, 2nd and 3rd doses in a second series (or doses 5, 6 and 7) of ENGERIX B. In June 1989, the subject received a booster which was dose 7 of ENGERIX B and December 1989, the subject received another booster which was dose 8 of ENGERIX B. On 27 June 2011, the subject reported not responding to therapy. The healthcare professional reported that the not responding to therapy after the second series and boosters were serious events, but did not select the series criteria so the events were considered as clinically significant. The healthcare professional noted that the events could have been associated with having deltoid injections. The healthcare professional corrected the after booster titer previously reported as 6 mIU/ml to 1 mIU/ml. The healthcare professional noted that the ENGERIX B series was not discontinued or delayed. The healthcare professional reported that the not responding to therapy was unresolved and probably related to the treatment with ENGERIX B.