chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I returned to clinic after 2 weeks of PTO. I read an email that there was a change by the FDA to the Covid vaccination recommendations. Patient presented to clinic for Covid vaccine dose 2. She had previously received Moderna monovalent formula.  Before administration, I wanted to verify changes.   I referred to website. According to the new guideline overview for individuals 6 months - 5 years: "Individuals who have received one dose of Moderna COVID-19 Vaccine: A single dose of Moderna COVID-19 Vaccine, Bivalent is administered 1 month after the dose of Moderna COVID-19 Vaccine."   I proceeded to prepare the Moderna Covid-19 Bivalent original and omicron BA.4/BA.5 vaccine [80777-283-02].  I gave mom the new Fact Sheet for Recipients and Caregivers. I administered 0.2mL of Bivalent Covid vaccine in patient's right vastus lateralis.   Later in the day I was able to continue reading the Fact Sheet for Healthcare Professionals. It was then I noticed it only referred to using the Blue Cap & Grey Border for individuals 6 months and older. I continued to read until I finally found reference to "Multiple-Dose Vials with Dark Pink Caps and Labels with a Yellow Box. The cartons and vial labels state ?BOOSTER DOSES ONLY.? This presentation is authorized to provide certain doses for individuals 6 months through 5 years of age. [See Dose and Schedule (2.3)]" I now understand that this is to be used as a booster dose (3rd dose) to children age 6 months - 5 years who completed their primary series with the monovalent formula.
Pt received flu shot on 11/7/11 and about 45 min later called the pharmacy to report that her forearm was throbbing. Pt did not have any accidents in the 45 min she left the pharmacy to explain the adverse reaction.
I received the first dose around 5:00pm and finished up by 5:09. I was asked to wait 10 minutes to make sure there were no immediate reactions. I left around 5:21 or so. I got in my car and a few moments later noticed my left side of my face beginning to feel numb. Not extremely, but it felt similar to when novocaine begins wearing off after a dental appointment, but I still had muscle movement.  By day two my arm was extremely sore and very sensitive to touch. Could not lift it at all, and definitely could not move it around to stretch it out. It felt a little warm and was swollen. Unable to even put a semi-snug fitting T-shirt on because the pressure from it was painful on my arm. However I had woken up with the numbness no longer there in my face (went to bed around 12 or 1am and woke up around 8am). Day 3 now and the tenderness is still there but have subsided a bit.  Still sore but not excruciating like yesterday.
SIDS death 3APR93; autopsy performed; submission of this report does not necessarily constitute an admission that the drug was responsible for the SIDS death;
administered subcutaneous; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26-MAY-2023) for prophylaxis.   On 06-MAR-2023, the patient received Kinrix (subcutaneous). On 06-MAR-2023, an unknown time after receiving Kinrix, the patient experienced intramuscular formulation administered by other route (Verbatim: administered subcutaneous). The outcome of the intramuscular formulation administered by other route 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-MAR-2023 The pharmacist reported a patient was administered subcutaneous injection instead of intramuscular.  The health care professional (HCP) gave consent for safety team follow up. The patient received Kinrix subcutaneously, which led to intramuscular formulation administered by other route.
Bell's palsy 2 1/2 wks after immunizations persisting. Sx's started 1/10/08 approx.  1/25/08 Reviewed pcp medical records which reveal patient seen 1/21/08.  Had cold s/s w/fever 1-2 wks prior.  Developed right eye ptosis, right facial droop, neg facial/labial fold x approx 10 days prior to office visit.  Referred to ENT who saw patient 1/21/08 who dx w/left Bell's palsy & tx w/antiviral med.  DX: Bell's palsy. 1/25/08 Received vax record w/flu info.  Fluzone, SP, UT2460AA6, left thigh.
Patient is a resident at a long-term care facility.  Staff reported patient's positive status to the pharmacy on 6/22/21.  Patient tested positive on 6/18/21.  Reported symptoms include fever without fatigue.  Patient is quarantining at home for 10 days and has not seen a doctor. The likely cause of transmission was a staff member's daughter who attended a church camp from 6/7/21-6/11/21 and tested positive once returning home.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L048848 with expiration date on 09-AUG-2018; lot # M032649 with expiration date on 11-NOV-2018; lot # M006708 with expiration date on 02-JUN-2018; lot # L033343 with expiration date on 13-SEP-2017; lot # reported as M035487 with expiration date on 23-FEB-2019; lot # M034894 with expiration date on 11-NOV-2018 and lot # M020926 with expiration date on 11-AUG-2018; dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 33 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005323: US-009507513-1701USA009359: US-009507513-1701USA009357:
I got it about 10 am I went home I attempted to work from home for about an hour and had a headache, took a 3 hour nap  and felt much better after waking up, I felt like I couldn't concentrate. I felt fine this morning  12/16/2020  and I went to work just fine. I don't have a headache and don't feel like I need a nap, my arm still hurts but that is usual. I called my provider and asked if I could take Tylenol, but they were unsure so I did not take medication
Decreased appetite, general malaise that evening. Shortness of breath, pale, SA, (L) arm soreness for 2-3 days. Developed hive type rash (L) arm day 4. Arm became hand, dark purplish red color - 11/7/08 Resolved next day. All signs resolved by 6-7 days
A-Left upper chest pain, started approximately 2-4 hours after injection. B-arthralgia, myalgia to left arm, unable to lift arm,erythema, started 14 hours after injection. C-Soreness at site of injection started 96 hours after injection.
was sick as a dog for a week, got one more week of being sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follow: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient received dose of Shingles vaccine and was sick as a dog for a week, got one more week of being sick and would be vaccinated.
One dose of Ipol administered after the excursions of temperature was -2C with no adverse event; One dose of Ipol administered after the excursions of temperature was -2C with no adverse event; Initial information received on 13-Apr-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who "administered one dose of IPV (VERO) [IPOL] after the excursions of temperature was -2c with no adverse event".  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect IPV (VERO), suspension for injection (lot number, expiry date: not reported) via unknown route in unknown administration site (strength: not reported) for prophylactic vaccination (immunization).  On an unknown date the patient "administered one dose of ipol after the excursions of temperature was -2c with no adverse event" (poor quality product administered) (latency: same day) and (product storage error) (latency: unknown).  It was reported, "caller states that the units have been bad for months at a time and she is sure some of the vials has been used. Temperature was -2C. One dose of Ipol, four doses of Typhim, twenty-eight doses of Acthib and nine doses of Tubersol have been administered after the excursions."   Action taken with POLIOMYELITIS VACCINE (INACTIVATED) was not applicable.  At time of reporting, the outcome was Unknown for both the events.   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.
This spontaneous report as received from a healthcare worker refers to a 20 year old patient of an unknown gender. The patient's current conditions and medical history were not reported. On 17-JUN-2015, the 20 year old patient was accidentally vaccinated with pediatric dose of VAQTA (unknown route) at a dose of 0.5 ml. Concomitant medications were not reported. No adverse effect was reported. The outcome of the event was unknown. There was no product quality complaint involved. Additional information is not expected as the reporter did not wish further contact.
Stroke; severe allergic reaction; This is a spontaneous report from a contactable consumer (the patient's father) from the Pfizer-sponsored program. A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the Right Arm (also reported as: right shoulder) on 23Mar2021 (Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) at 16-years-old as a single dose for COVID-19 immunisation.  Medical history included heart valve operation from an unknown date and unknown if ongoing (Mechanical heart valves).  Concomitant medications included an unspecified medication, taken for an unspecified indication from an unspecified date to an unspecified date, which was reported as: "Yes she is taking other medication." On 29Mar2021, the patient experienced stroke and severe allergic reaction (medically significant). The clinical course was reported as follows: On behalf of his 16-year-old daughter, the patient's father reported that she had the first dose administer in the right shoulder on 23Mar2021. On 29Mar2021, the patient had a stroke.  The patient's father stated, "our lives have changed, completely." The patient's father reported that his daughter was receiving medical care ever since then; and was also being treated by a physician.  The patient's father was asking about compensation from Pfizer regarding his daughter's severe adverse event (AE) that occurred after the first dose of vaccine. The patient's father reported that the case had been submitted by the (Name) healthcare team "to the FDA and to Pfizer, and I haven't heard back from either." The patient's father mentioned in passing, that he "could call (Name) and have this all over the news" but that he "wants to be responsible" and doesn't want to do that.  The patient's father stated the concern, "Well my concern I am not sure that medical profession is what I really need to do, my concern is that my daughter took the Pfizer COVID vaccine on 23Mar2021 in (Name) in vaccination location. On 29Mar2021, 6 days later, she had a stroke, and that she is receiving a medical care ever since then , now  my question is like I said probably for  maybe for correlated relation type of person define as well as  for it  there is a compensation for adverse reaction to COVID vaccination being that this was only thing that was introduce in her system as far as doing that time the vaccination shot." The patient underwent lab tests and procedures which included blood test: "that's for 4/2 out of normal" on an unknown date; also reported: "Yes that's been ongoing as far as giving blood. That's for 4/2 out of normal". Therapeutic measures were not taken and was reported as "no she isn't taking anything for it." The clinical outcome of the events, stroke and severe allergic reaction, was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021411875 Pfizer
Decreased appetite day after vaccination (in a child for whom this is a very rare occurrence, even during illness). Redness and nodules at vaccination site. Child's left leg in which she was injected appeared to be painful the day after vaccination (she was dragging it when crawling).
Patients were given shots during excursions.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were given shots during excursions.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were given shots during excursions.). On 16-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were given shots during excursions.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was not reported No treatment medications were provided
This spontaneous report was received from a Registered Nurse regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 27-APR-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (therapy type digital data logger) (lot # L043213, expiry date 28-AUG-2017) dosing details unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to a temperature excursion of 31 F to 35 F in the month of April 2016 for a cumulative time frame of 200 hours. It was reported there were no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the three reports received from the same reporter. Additional information has been requested.
Whole body ached; feeling nauseated; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Whole body ached) and NAUSEA (feeling nauseated) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN (Whole body ached) and NAUSEA (feeling nauseated). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN (Whole body ached) and NAUSEA (feeling nauseated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: 101 f High.
This healthy 8 year old boy came for he second PRIORIX MMR immunization for school registration. He received the PRIORIX on left deltoid. A few hours after the injection his mother called to report that he had developed a fever and swelling on the injection site. He was complaining of headaches and multiple joint pains. I saw this boy the next day to confirm the swelling on the injection site. The swelling was severe and the boy was lethargic and still complaining of joint pains.
Pain in middle of chest from 3/18/2031 at 10:00pm until 3/19/2021 at 3:00am
Injection site turned red and swollenand hot; Injection site turned red and swollenand hot; Injection site turned red and swollenand hot also itches.; Injection site turned red and swollenand hot; This is a spontaneous report from a contactable consumer, the patient. A 56-Year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN 6203) via an unspecified route of administration in left arm on 15Mar2021 at 08:30 (at the age of 56-Year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin from unknown date. Concomitant medication within 2 weeks of vaccination included montelucast (MANUFACTURER UNKNOWN) 10 milligrams (mg) for unknown indication and since from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient experienced injection site turned red, swollen, hot and also itches on 23Mar2021 reportedly on the 9 day. No treatment was received for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of vaccination site erythema, vaccination site swelling, vaccination site warmth and also vaccination site itching was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 06-JUN-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10pk 50U/1 mL) lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 2 times with the following lowest recorded temperatures: 34F (1.111 Celsius degrees) for 64 hours and 33 F (0.555 Celsius degrees) for 16 hours. No highest reported temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cased from the same reporter. Additional information has been requested.
Presented to ED with shortness of breath. Tested + for COVID-19 at nursing home 1 day prior to presentation. Reports complaints of increasing fatigue, body aches, and respiratory difficulties. Was hypoxic on arrival to ER and required high flow nasal cannula at 45L 60% FiO2 initially. Admitted to floor for oxygen/dexamethasone treatment. Patient's oxygen was titrated as needed. The day following admission patient developed apnea/cyanosis with large amounts of thick sputum. Patients respiratory status declined rapidly and patient expired.
This spontaneous report as received from a Medical Assistant via company representative concerning female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. It was reported that on an unknown date, the patient experienced zoster-like rash after vaccination with ZOSTAVAX. The outcome of patient was unknown. Action taken was not applicable. This is one of two reports concerning the same source. Additional information has been requested.
My whole body hurts. My knees hurts real bad. They are cold. My back hurts. Both my arms hurts. Its just getting worse. It hurts when I move.
Experiencing watery stools 6-12x a day; Dizzy at time; Achy chest pains; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Experiencing watery stools 6-12x a day), DIZZINESS (Dizzy at time) and CHEST PAIN (Achy chest pains) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included Colitis. Concomitant products included TOPIRAMATE (TOPAMAX), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), GABAPENTIN, BUSPIRONE HYDROCHLORIDE (BUSPAR), DULOXETINE, LORAZEPAM (ATIVAN), LEVOTHYROXINE, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), PRAZOSIN, DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]), ESTRADIOL and IBUPROFEN for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DIARRHOEA (Experiencing watery stools 6-12x a day), DIZZINESS (Dizzy at time) and CHEST PAIN (Achy chest pains). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Loose stools, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Experiencing watery stools 6-12x a day) had not resolved and DIZZINESS (Dizzy at time) and CHEST PAIN (Achy chest pains) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Patient went to see her gynecologist around the time of her first dose. She also visited her neurologist and lost noticed she's almost 10 lbs. She has tried eating blend foods, no foods, and it just won't stop and the complaints persisted for one month. Action taken with mRNA-1273 in response to the event was no change.
SECOND NITE PATIENT HAD CHILLS AND FEELING ACHY.  NO FEVER.  NO RESPIRATORY ISSUES.  LEFT ARM WAS SORE AT INJECTION SITE.  UPPER ARM WAS RED AND WARM TO TOUCH AROUND THE INJECTION SITE