chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to an approximately 65 year old female patient. On 11-FEB-2013, the patient was vaccinated with ZOSTAVAX 19400 plaque forming units (PFU), dose, lot number, expiration date not reported. Concomitant therapies included diazepam, tramadol hydrochloride, and baclofen. On unspecified date in 2013, within 6 months after receiving ZOSTAVAX, the patient developed shingles. The patient received unspecified antiviral medication for treatment of the adverse event. The patient sought medical attention - contacted pharmacist (way of contact not reported). The outcome of shingles was reported as recovered (date not reported). The outcome of shingles was reported as recovered (date not reported). Relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 18-MAR-2021, the patient was vaccinated with one Hepatitis A Vaccine, Inactivated (VAQTA) (lot number T014589, which has been verified to be valid, the expiration date was reported and validated as 25-OCT-2021), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014589; expirationdate: 25-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2104USA001297:
NEVER HAD SKIN REACTIONS BEFORE, ABOUT A YEAR AND A HALF AFTER SHOTS. SKIN BEGAN TO BREAK OUT WITH BUMPS, ONLY IN LOCAL AREA THAT SHOT WAS GIVEN, UPPER LEFT ARM. SAW HMO AND HE THOUGHT IT WAS STAPH INFECTION, TOOK MEDICATION, WENT AWAY AND RETURNED TWO WEEKS LATER. REPAEATED THIS SERIES AND STILL IT CAME BACK. NOW IF I SCRATCH MY UPPERARM AT ALL IT WILL RETURN. I ONLY RECEIVED FOUR OF THE REQUIRED SHOTS OF THE MILITARY ANTHRAX VACCCINE. NO DOCTOR OR ER I'VE BEEN TO CAN TELL ME WHAT IT IS.
Rash, UrticariaPruritus, SAME DAY OF INJECTION, FELT FATIGUED. ONE WEEK AFTER INJECTION, INJECTION SITE WAS ITCHY WITH RED RAISED AREA APPROX SIZE OF QUARTER, RESOLVED AFTER ONE DAY. Narrative:
A report has been received from a Pharmacist concerning a 7 year old, male subject who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. Pharmacist reported that the patient received only a half dose FLUMIST in one nostril started on 11-Nov-2013 at a mobile clinic. The out outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Got H1N1 mist and noted rash on body few hours later. Confluent pink on body, sl raised tiny papules on ext. Treated with antihistamine - No sequelae.
3/17/04 Past vaccine Exantham started 3-12-04. 3/6/04,3/5/04- erythema multiforme minor persisted through 3-11. Treated tih Orapred and Zyrtec.
Patient received the vaccination IM left arm and stood up after. She felt sick and needed to sit down. Patient thought she was going to faint. She threw up a few times and sat down for about 20 minutes before leaving.
Syncope, brief, recovered quickly after laying down, offered water and crackers, observed for additional 15 minutes, no further symptoms.
sick; Initial information was received on 18-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case is linked to cases 2020SA330568 and 2020SA357040 (reporter and Reporter's Aunt).  This case involves female patient (age unknown) who was sick (illness), when she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  No laboratory data was reported  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
sore arm; bad headache; fever of 37.9; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), HEADACHE (bad headache) and PYREXIA (fever of 37.9) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included ERYTHROMYCIN for Wisdom teeth removal.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm), HEADACHE (bad headache) and PYREXIA (fever of 37.9). At the time of the report, MYALGIA (sore arm), HEADACHE (bad headache) and PYREXIA (fever of 37.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 37.9 degree Celsius (High) 37.9 degree Celsius.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication reported  Additional information removed by the reporter was that the Patient had her wisdom teeth removed last week. Reporter wanted to know were there any risk taking antibiotics at the same time as that of vaccination.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient stated she had palpitations after her 2nd Pfizer dose. Patient heart rate trending at 120's. Diaphoretic Clammy
Hot, itchy orange-sized lump at injection site; Hot, itchy orange-sized lump at injection site; Local allergic reaction; Hot, itchy orange-sized lump at injection site; This is a spontaneous case was received on 05-Jan-2021, reported by pharmacist to regulatory authority (reference number: SEQW21-00039) and concerned a 67-year-old, female patient.  The patient's concurrent conditions were not reported. The patient's past medical history included breast cancer. The patient stated that she was not allergic to eggs. The patient's concomitant medication included Aromasin (exemestane) for an unreported indication.  On 04-Nov-2019, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical: not reported) for influenza prophylaxis. The batch number reported was 259815, expiry date: 30-Jun-2020.  On the same day, within 15 minutes after receiving Flucelvax Quadrivalent, the patient experienced hot, itchy orange-sized lump at injection. She had a very significant local allergic reaction and in half an hour post vaccination the patient was seen by attending physician. Prednisolone at dose of 20 mg and Benadryl (diphenhydramine hydrochloride) at dose of 15 mg were given as corrective treatment.   On the same day, within four to six hours, the patient recovered from the events.  The reporter assessed all events as related to Flucelvax Quadrivalent, as the patient had shown allergy to flu vaccine and stated that there must be some lingering, 'hidden', maybe trace ingredient which was responsible for the patient's allergy.   The case was assessed as non-serious.  Company comment: A 67-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same day, within 15 minutes after receiving Flucelvax Quadrivalent, the patient experienced vaccination site mass, vaccination site warmth, vaccination site pruritus and local allergic reaction. Causality is assessed as possibly related for all events.; Reporter's Comments: The patient had shown allergy to flu vaccine and stated that there must be some lingering, 'hidden', maybe trace ingredient which was responsible for the patient's allergy.; Sender's Comments: A 67-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same day, within 15 minutes after receiving Flucelvax Quadrivalent, the patient experienced vaccination site mass, vaccination site warmth, vaccination site pruritus and local allergic reaction. Causality is assessed as possibly related for all events.
Patient received expired 1st dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 55-year-old female patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th March 2022, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 9th March 2022, unknown after receiving Twinrix and Twinrix 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 details were provided as follows: The license practice nurse reported that today at the day of reporting, a patient received an expired dose of Twinrix, which led to expired vaccine used. The reporter consented to follow up.
Pharmacist on duty incorrectly mixed 3.6mL of sodium chloride with the vaccine instead of 1.8mL. Patient contacted. No adverse reactions reported.
Pt had PNEUMOVAX 5-22-14 approx 8 AM. Pt went to the gym and at 8 PM she was feeling very ill and cold. She went to bed and woke up at 11:30 feeling better but (L) upper arm was swollen, red and hot. She noticed 2 fingers (L) hand were blue. She iced her arm and took BENADRYL. 5/23 Fingers normal color. Injection site better but front and back of arm swollen over wkend. 5/26 All redness gone but arm sore with some swelling.
Persistent toothache (this happened to my brother after the 2nd dose as well) Chills Body aches Nausea
little raised bumps around both elbows, and four finger distant from the injection site. On the injections site there was no sign of redness, warmth, or irritation.  Also patient had a slight raised streak on the left upper quadrant on his chest, just above the nipple region.  Sx onset within 15 minutes.  Patient c/o itchiness. Treatment: 10 ml of Benadryl. Outcome: Decrease bumps & itchiness.
Over 48 hours, patient complained of nausea, dizziness, headache, diarrhea, and fevers. Patient was told to contact physician and continue taking TYLENOL for the fevers. Diarrhea lasted 6 hours and had ceased by the time the patient contacted pharmacy staff.
Pt. reported to the emergency room c/o DIARRHEA and SWELLING OF LEFT FACIAL CHEEK.  Informed dr. that he had received the MODERNA vaccine recently (10 days prior). their records did not acknowledge that the doctor identified the reaction as "allergic", but confirmed diarrhea as a diagnosis.  Dr.  informed pt. to proceed with 2nd Moderna vaccine, but to inform pharmacy of the incident so that he may be observed closely for a reaction.
Reporting this as this has come to my desk.  Patient received doses outside of their normal vaccination dates.  Pt parents were not contacted due to unknown adverse event.
On 11/15/01 pt felt nerve pain, numbness in left arm and hand, pain radiating across chest. 12/4/01 no numbness less pain,pain hen raising of arm over shoulder, pain when sleeping on L arm and some decreased mobility of L arm.
APPROXIMATELY 3 HOURS AFTER ADMINISTRATION, PT DEVELOPED EXTREME WEAKNESS IN THE ARM AT THE DELTOID REGION AS WELL AS PAIN. PATIENT HAS BEEN SLOWY RECOVERING. A DECREASE IN PAIN LEVEL EVERY DAY AS WELL AS INCREASE ABILITY TO MOVE LIMB. SYMPTOMS RESEMBLE A "SIRVA" (SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION) TYPE REACTION NOTED IN LITERATURE.
DIZZINESS; LEG CRAMPS/BAD CHARLEY HORSE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A,and expiry: 23-JUN-2021) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced dizziness. On 13-MAY-2021, the subject experienced leg cramps/bad charley horse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from leg cramps/bad charley horse, and had not recovered from dizziness. This report was non-serious.
Patient started to feel chills like a cold symptom; throat pain; Patient felt chilling; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Patient started to feel chills like a cold symptom), OROPHARYNGEAL PAIN (throat pain) and CHILLS (Patient felt chilling) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included VALSARTAN for Hypertension.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced FEELING COLD (Patient started to feel chills like a cold symptom), OROPHARYNGEAL PAIN (throat pain) and CHILLS (Patient felt chilling). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (Patient started to feel chills like a cold symptom), OROPHARYNGEAL PAIN (throat pain) and CHILLS (Patient felt chilling) outcome was unknown.            evening of 03Dec2021 patient felt the symptoms, noted.   Reporter did not allow further contact
3/9/10 Rash appeared on trunk, back, face, arms and legs. Fine rash, itchy at first. Used Calamine lotion. 3/10/10 patient taken to Hosp. ER and Dx Dermatitis, Hydrocortisone cream recommended and used. Follow up with PCP recommended. Appointment scheduled for pt with Dr.  3/18/10.
Guillain-Barre (Documented and Treated) (Has had Flu vaccine for past 5-10 years with no previous problems).
Initial report received from a consumer on 22 February 2011. A 73-year-old male patient received on 06 November 2010 an injection (route and site unknown) of FLUZONE, lot number U3703AA. The patient had no illness at the time of vaccination and had no other vaccinations within 4 weeks of the FLUZONE. The patient had no known allergies and his medical history was not reported. The patient's concomitant medications included a blood pressure medication, SYNTHROID, baby Aspirin and multivitamin. On 19 January 2011, the patient was diagnosed with a staph infection of the blood with an elevated temperature, the start of kidney failure and other organ failure. The patient was admitted on an unknown date to the intensive care unit (ICU) and was treated with intravenous (IV) antibiotics. The patient continues to have the infection and was going to be hospitalized starting "today" for IV antibiotic. The outcome was reported as not recovered. Documents held by sender: None.
Information has been received from a nurse concerning a patient who was vaccinated with a 0.5 ml dose of Pneumovax 23 (lot # 654982/0675F).  Subsequently on 17-OCT-2006 the patient experienced severe localized reactions which included welts and a rash on the extremity that was vaccinated, but not necessarily at the injection site.  The reaction was reported "from the shoulder to the elbow."  The patient sought unspecified medical attention.  It was reported that the lot # would not be used and there was concern expressed regarding the lot number.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released by the regulatory agency.  Additional information has been requested.
I am very tired almost all the time; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I am very tired almost all the time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (I am very tired almost all the time). At the time of the report, FATIGUE (I am very tired almost all the time) outcome was unknown.            concomitant and treatment drugs were not provided
TAKEN FROM THIS EARTH; BLOOD CLOT; This spontaneous report received from a consumer via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot and was died from unknown cause of death. It was unspecified if an autopsy was performed. As per reporter "Two dear friends TRUSTED the J& J vaccine, and were taken from this earth...One, blood clot. The other? Heart. Way before their time." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of blood clot was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20220313855.; Sender's Comments: V0: 20220313454 -COVID-19 VACCINE Ad26.COV2.S- Taken from this earth, Blood clot.  The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: DEATH
I had the same arm issues, along with an unusual feeling in my head. My BP was higher than it's ever been at 184/88. I started seeing a gray area in the eye where I had my surgery and the doctor discovered that my retina was detached. I also had a red, blotchy area on my face. He said the increased BP could?ve caused it. I had to undergo surgery twice after that. They reattached it, but I had scar tissue so it became detached again. They?re waiting for it to stop creating scar tissue before they try again.
Day 1 of getting the vaccine, i felt great, seemed to have a lot of energy.  Day 2 and since day 2 (today is 4-15-21) I have had ear infection symptoms in left ear, foggy hearing in that ear, pain, and low grade fever ranging between 100 and 99, and fatigue.  (this stayed the same even taking Acetaminophen)
Fever 100 degrees for 36 hrs Fatigue for 48 hrs  Headache for 1 week post  Menstrual cycle started 6 days early Menstrual cycle was heavier and many clots noted
The patient was given Moderna vaccine- He was under 18-  Provider notified immediately and she looked up information on up to date and CDC and the recommendation was to go forward and given the 2nd dose in 1 month. Patient had no adverse reaction Mother updated Second dose given 1 month later
Feels flushed all the time; feels weak; shortness of breath; kind of stumbles around a little bit; ittle bit light-headed; muscle pain from his fingers down to his toes; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Feels flushed all the time), ASTHENIA (feels weak), DYSPNOEA (shortness of breath), BALANCE DISORDER (kind of stumbles around a little bit) and DIZZINESS (ittle bit light-headed) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included PAROXETINE HCL, ATORVASTATIN, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), TAMSULOSIN HCL, FLUTICASONE PROPIONATE and LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced FLUSHING (Feels flushed all the time), ASTHENIA (feels weak), DYSPNOEA (shortness of breath), BALANCE DISORDER (kind of stumbles around a little bit), DIZZINESS (ittle bit light-headed) and MYALGIA (muscle pain from his fingers down to his toes). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, FLUSHING (Feels flushed all the time), ASTHENIA (feels weak), DYSPNOEA (shortness of breath), BALANCE DISORDER (kind of stumbles around a little bit), DIZZINESS (ittle bit light-headed) and MYALGIA (muscle pain from his fingers down to his toes) outcome was unknown. Not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Initial report received from a nurse on 02 Dec 2009: This patient was vaccinated with FLUVIRIN. The reporter stated that when the patient was receiving the dose, vaccine leaked down from the patient's arm. No further information available.
Information has been received from a registered nurse concerning a 61 year old female who on 15-AUG-2008 was vaccinated with a dose of PNEUMOVAX, 0.5 milliliters, intramuscularly in the right arm (lot # 659150/1348U or 658673/0990U), the office had two lots of PNEUMOVAX 23, but did not known what lot was administered. On 15-AUG-2008, the night of vaccination, the patient developed an injection site reaction with severe pain in the right arm, "shaking and chilling", dizziness and nausea. There was no swelling or redness at the injection site. The patient called the office on 19-AUG-2008 and reported that the arm was still sore. The reporter considered the events of severe pain in the right arm, "shaking and chilling", dizziness and nausea to be a significant disability of incapacity. At the time of reporting, the patient was recovering. This is one of 7 reported from the same source. Additional information has been requested.
irritability;high pitched cry/scream;fever 101-102;very inconsolable;tremors;admitted to hosp for further testing;
Red rash developed around injection site.  Itchy, hot to touch.  Pt was advised to take Benadryl and ibuprofen.  Pt was advised to contact PCP if rash did not go away or if rash got any worse.