chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Wanting to pick up baby but brain would not allow her; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Wanting to pick up baby but brain would not allow her) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced CONFUSIONAL STATE (Wanting to pick up baby but brain would not allow her). At the time of the report, CONFUSIONAL STATE (Wanting to pick up baby but brain would not allow her) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment information was not provided by the reporter.
pt recv vax 15AUG97 & 25AUG97 pt devel a rash;pt recovered;
Information has been received from a consumer concerning her 13 year old son with no known drug reactions or allergies or pertinent medical history who on 06-AUG-2010, was intramuscularly vaccinated in the left arm with the first dose of GARDASIL, in the physician office. There was no concomitant medication. On 06-AUG-2010, following the administration of GARDASIL, the patient walked to the waiting room to sit with his mother. Within two or three minutes the patient fell to the ground seizing. The seizure activity lasted approximately three minutes. Emergency medical service was called because of sustained tachycardia and low blood pressure. It was noted that this resolved with a lengthening of the postictal phase of the seizure. The patient was then transported to the emergency room by his mother where blood work and electrocardiogram were performed (results not provided). The patient was then discharged to his home. According to the patient's mother he was currently very anxious. "Patient fell to the ground seizing", sustained tachycardia, low blood pressure and very anxious were considered to be disabling and life-threatening by the reporter. Additional information has been requested.
She had 5 covid shots and still got covid; She had 5 covid shots and still got covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 61 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6203, Expiration Date: Jun2021), on 21Mar2021 as dose 2, single (Lot number: EN6208, Expiration Date: Jun2021), on 09Nov2021 as dose 3 (booster), single (Lot number: FH8028) and on 23Jun2022 as dose 4 (booster), single (Lot number: FM0173) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Breast cancer, diagnosed about 12 years ago; "Kidney cancer", start date: 01Feb2022 (unspecified if ongoing); "removed 10% of her left kidney" (unspecified if ongoing); "aspiration pneumonia" (unspecified if ongoing). The patient had kidney cancer, removed 10% of her left kidney, she went in the hospital for throwing up and had aspiration pneumonia and they found a spot on her kidney. She went to a urologist and urologist told her she needed an MRI. Spot was more than 4cm and it needed to come out and was found to be stage one kidney cancer. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She had 5 covid shots and still got covid". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Spot was more than 4cm and it needed to come out, notes: found to be stage one kidney cancer; SARS-CoV-2 test: positive, notes: still got covid. It was reported that the patient had 5 covid shots and still got covid. She knows breakthrough covid happens. She has heard and thought she was going to get passed it but she didn't and was not lucky. She thinks she is passed the worst part, the night of chills and fever and once past that then she is ok and over the hump. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received treatment with Paxlovid from 19Sep2023 and ongoing (will take for 5 days).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300306774 Same patient, same product, different event, different dose;
Swelling in the arm; Pain in the arm; Scaling of skin between elbow and wrist; Itchiness in the arm; Redness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in the arm), PAIN IN EXTREMITY (Pain in the arm), SKIN EXFOLIATION (Scaling of skin between elbow and wrist), INJECTION SITE PRURITUS (Itchiness in the arm) and INJECTION SITE ERYTHEMA (Redness in the arm) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included POTASSIUM CHLORIDE (K-TAB) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swelling in the arm), PAIN IN EXTREMITY (Pain in the arm), SKIN EXFOLIATION (Scaling of skin between elbow and wrist), INJECTION SITE PRURITUS (Itchiness in the arm) and INJECTION SITE ERYTHEMA (Redness in the arm). The patient was treated with MAGNESIUM SULFATE (EPSOM SALT) at an unspecified dose and frequency and ALOE VERA at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling in the arm), PAIN IN EXTREMITY (Pain in the arm), SKIN EXFOLIATION (Scaling of skin between elbow and wrist), INJECTION SITE PRURITUS (Itchiness in the arm) and INJECTION SITE ERYTHEMA (Redness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes patient rubbed Epsom salt body cream and aloe Vera cream
A report has been received from a Health Professional concerning a female child. The relevant history patient were not reported. She was taking KEFLEX for sinus infection from 30-Dec-2013 for 10 days. The patient had been receiving FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient had FLUMIST QUADRIVALENT on 30-Dec-2013 and was tested positive for influenza B on 02-Jan-2014 when she was seen at the physician's office. The reporter did not have any expiration date or lot information for the FLUMIST administered, she was uncertain the exact date of administration. The outcome of the event of influenza B was unknown. The reporter considered the event of influenza B to be non-serious.
Patient is only 63 years old and mistakenly received the HD flu vaccine for patients over the age of 65.
inadvertent administration of IPOL that was not supported by the extended stability information post excursion with no adverse event; Initial information received on 18-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA286823.  This case involves a 4 year old female patient who had inadvertent administration of IPV (VERO) [IPOL] that was not supported by the extended stability information post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) and measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (WISTAR RA 27/3), varicella zoster vaccine live (OKA/MERCK) (Proquad) for Prophylactic vaccination (immunization).  On 12-Sep-2023, the patient received a dose 4 dose 0.5 ml of suspect IPV (VERO) Suspension for injection lot V1B891M expiry date: 01-jun-2024 via intramuscular route in the left thigh for Immunization and inadvertent administration of ipol that was not supported by the extended stability information post excursion with no adverse event (poor quality product administered) on the same day following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertent administration of ipol that was not supported by the extended stability information post excursion with no adverse event.   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.
about 12 hours after receiving shingrix pt fainted in her bathroom resulting in trauma to the patients head and a contusion fracture on patients back. patient states she blacked out and does not remember moments after she woke up and cannot recall how she got out of the bathroom. Patient subsequently went to the ER and spent 9 hours getting treated for her injuries
This spontaneous report as received from a pharmacy technician refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 20-FEB-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Information has been received from a nurse practitioner for HPV rL1 6 11 16 18 vaccine, a Pregnancy Registry product, concerning a 23 year old female patient who was pregnant after receiving a second dose of HPV rL1 6 11 16 18 vaccine (route, dosage and lot # not reported) in the last several weeks. The LMP was 19-DEC-2011, estimate delivery date is 24-SEP-2012. No further information is available.
irritability, inability to sleep x 36hrs high fever (parents do not have a thermometer)
Full body hives on day 10. Steroid treatment   Then Zyrtec and Benadryl daily. 6 weeks into it, still no better
This case was reported by a physician and described a 27 year old male pt who experienced hemochromatosis following the completed immunization series to hep B vaccine recombinant (Engerix B). On unspecified dates, the pt received a series of three doses of Engerix B. Approximately one year following the third dose of Engerix B, in 2003, the pt experienced hemochromatosis. The pt was evaluated in the physician's office. The physician reported that the pt had clinical symptoms of hemophromatosis but not the genotype. This case was considered to be serious (OMIC) because a clinically significant intervention was required. The pt had 11 units of blood withdrawn via phlebotomy over an unspecified amount of time. At the time of reporting, 11/13/03, the event was unresolved. A 15-day follow up report received 01/14/2004 adds: The pt had a medical history notable for elevated triglycerides, being moderately overweight, and alcohol consumption of "less than two drinks per week." On unspecified dates in 2002, the pt received a series of 3 doses of Engerix-B (lot numbers not specified). Concurrently, the pt received "high doses" of vitamin C (20 tablets per day), multivitamins and consumed a diet high in red meat. At an unspecified time following the 3rd dose of Engerix-B, in 2002, a routine laboratory screening revealed an elevated hematocrit of 49 and an elevated aminotransferase level of 202 and an elevated alanine aminotransferase level of 74. Iron studies indicated a high ferritin of 524, an unusual iron-to-total iron binding (TIBC) capacity ratio with normal iron of 135 and TIBC low at 144 and an elevated iron saturation at 95 percent. Tests for hepatitis B and C were negative. Genotyping for hereditary hemochromatosis revealed negative results for all 3 markers tested, including C282Y, H63D, and S65C. The pt was diagnosed with iron overload and was treated with 9 units of blood withdrawn via phlebotomy over a 3 to 4 month period. In Nov 2003, the iron overload had improved with a decreased hematocrit and normal levels of ferritin, TIBC, iron saturation, asparate aminotransferase and Engerix-B. The physician also stated that, "I suspect vitamin C was the culprit here." This case was considered to be serious because a clinically significant intervention was required.
After receiving the Covid Pfizer Vaccine I started to feel a sudden sense of blacking out, along with warm sensation through my entire body,  rapid heart rate, difficulty breathing,dizziness
ear to hurt; swelling in neck and face; swelling in neck and face; more difficulty breathing; little bit of headache; Swollen lymph nodes in her throat on the right side; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received bnt162b2 (BNT162B2)via intramuscular route, administered in right upper arm on 02Feb2021 10:00 (at the age of 64-year) (Lot Number: EM9810) as dose 1, single for covid-19 immunisation in hospital. Medical history included ongoing chronic obstructive pulmonary disease (diagnosed two years ago), she smoked for 43 years and she quit. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available was none. The patient did not receive any vaccinations prior vaccinations (within 4 weeks). The patient did not have concomitant medications. Caller was reporting on herself and her husband. This was the report for the caller herself she had the Pfizer covid vaccine. It was reported that, patient experienced little bit of headache and Swollen lymph nodes in her throat on the right side on 02Feb2021. Also experienced swelling in neck and face and have more difficulty breathing on 03Feb2021 and started ear to hurt on an unknown date. It was reported that, She did not have internet and wanted to report side effects. Stated her husband did not have any side effects aside from a sore arm. Reported she had a little bit of a headache not anything she could not deal with. She has swollen lymph nodes in her throat on the right side, making her ear hurt and has had the swollen lymph nodes since she got the vaccine. She noticed a little bit of swelling in neck and face. First dose administered 02Feb2021. She was going back for her second dose on 23Feb2021. Reported she has not had a headache since, she thought by the third day her headache was gone. Her face was a little swollen, stated that, it was nothing major. Her husband noticed her face was swollen. She already has COPD and noticed a little more difficulty in breathing since after receiving the vaccine, stated it might wear off but she noticed her breathing was a little worse after the shot. She noticed she was short winded and noticed she could not go as far as she could, she could go to mailbox and back before. She thought the difficulty breathing was from her COPD, not the vaccine. The swelling in her lymph nodes was a little worse since it was causing her ear to hurt, it was nothing she could not deal with. Treatment: declines any she was happy with the shot and could not wait to get the second dose. The patient did not visited to emergency room and physician office. The outcome of the event little bit of headache was recovered on an unspecified date in Feb2021; swelling in neck and face was recovering and not recovered for other events.  Follow-up attempts completed. No further information expected.
4 year old female patient was given a expired dose of Daptacel, no AE; Initial information received on 13-Feb-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 years old female patient who received a 0.5 mL fifth dose expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] Frequency = once for prophylactic vaccination (lot C5367AA  and expiry date: 13-Jan-2020) via intramuscular route in the left deltoid on 13-FEB-2020.  Medical history, medical treatment, vaccination and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Very tiny bit of a sore arm the next day; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 at 12:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high (reported as high blood pressure), hypothyroidism and cholesterol high. The patient had no known allergies to food, medicine or other products. The patient had received other medication (unspecified) within two weeks prior to vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced very tiny bit of a sore arm the next day on 09Apr2021. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event very tiny bit of a sore arm the next day was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
DISSEMINATED HIVES - LEGS, ARMS, BACK; FEVER, CHILLS, NAUSEA, BODY ACHES
Employee complained of arm hurting, tender to touch, red at vaccination site, approximatly 2.5 inches.
Vaccinated during 3rd trimester of 3rd pregnancy, delivered June 17th 2021, birth weight 8lbs 9oz.  Adverse events, I have had two severe sinus infections since the completion of my 2nd dose of the COVID 19 vaccine. Both sinus infections resulted in the loss of taste and smell for approx 2 weeks, and I tested negative for covid 19 9n both occasions. Prior to the vaccine I have never had a sinus infection before in my life.
Tinnitus, ringing in the ears.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 12Mar2021 at 12:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The concomitant medications of the patient included levothyroxine 88mg (MANUFACTURER UNKNOWN) from an unknown date and for unknown indications. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 03:00, the patient experienced the event tinnitus (ringing in the ears). On 22Mar2021, the patient underwent COVID-19 virus test and the result was negative. The event resulted in doctor or other healthcare professional office/clinic visit and visit to emergency room/department or urgent care. Therapeutic measures were taken as a result of the event tinnitus and included treatment with antibiotics from an unknown date. The clinical outcome of the event tinnitus was not recovered.   No follow-up attempts are needed. No further information is expected.
pt reported red area @ elbow 1" x 7", not painful swollen-same arm as pneumovax given but no problem @ inject site; DPH cream 19DEC92; 21DEC92 checked by MD faint yellowish discoloration upper arm over biceps & swelling @ elbow ulnar side;
Lump at injection site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE MASS (Lump at injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE MASS (Lump at injection site). At the time of the report, VACCINATION SITE MASS (Lump at injection site) had not resolved. Not Provided      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.   Concomitant medication list was not provided. Treatment information was not provided.
Sneezing; Nose is stuffed up, Congestion in the head; Scratchy throat; she feels like she is under the weather; Nose is stuffed up; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing), SINUS CONGESTION (Nose is stuffed up, Congestion in the head), THROAT IRRITATION (Scratchy throat), FEELING ABNORMAL (she feels like she is under the weather) and NASAL CONGESTION (Nose is stuffed up) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN N) for Diabetes, LOSARTAN for Hypertension.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced SNEEZING (Sneezing), SINUS CONGESTION (Nose is stuffed up, Congestion in the head), THROAT IRRITATION (Scratchy throat), FEELING ABNORMAL (she feels like she is under the weather) and NASAL CONGESTION (Nose is stuffed up). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, SNEEZING (Sneezing), SINUS CONGESTION (Nose is stuffed up, Congestion in the head), THROAT IRRITATION (Scratchy throat), FEELING ABNORMAL (she feels like she is under the weather) and NASAL CONGESTION (Nose is stuffed up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.