chrisvoncsefalvay/vaers-outcomes huggingface dataset:
instances of fainting; This serious case was reported by a nurse via sales rep and described the occurrence of fainting in a patient who received Men B NVS (Bexsero) for prophylaxis.   On 11-OCT-2023, the patient received Bexsero. In OCT-2023, an unknown time after receiving Bexsero, the patient experienced fainting (Verbatim: instances of fainting) (serious criteria hospitalization and GSK medically significant). The outcome of the fainting was unknown.   It was unknown if the reporter considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 12-OCT-2023 The nurse reported the one particular patient fainted after receiving a dose of Bexsero and appeared to be seizing and was taken to the hospital. She said she has had several in the past year. The nurse asked if there are instances of fainting after receiving a dose of Bexsero. She would also like to know if there was any data on increase of adverse events with Bexsero being given with another vaccine, especially Meningitis ACWY. This incident has been reported using adverse event reporting. The reporter consented to followup. This case is linked with US2023140641, same reporter.; Sender's Comments:  US-GSK-US2023140641:
This spontaneous report as received from a registered nurse refers to a 12 month old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 27-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot # L040961 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with public funds. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered untill 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1610USA004339: 1609USA013814-1609USA014830.
head pressure built up; sinus pressure built up; Double ear infection; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 14:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN) and pravastatin (MANUFACTURER UNKNOWN) on an unknown date, for unknown indication. The patient had no allergies to medications, food, or other products.  The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021 at 18:00, the patient experienced head pressure, sinus pressure and double ear infection. The patient reported that she had congestion began 6 hours after first dose, head and sinus pressure built up on next two days and she went to urgent care, COVID tests were performed and were negative she continued to worsen, so the patient went back to urgent care and was diagnosed with double ear infection. On 18Mar2021, the patient had COVID-19 virus test and result was found to be negative. Therapeutic measures were taken as a result of head pressure, sinus pressure and double ear infection and included treatment with azithromycin. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events head pressure, sinus pressure and double ear infection were recovered on an unknown date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
I was having a fullness in my ear. I have my ears cleaned every year at the beginning of the year, so I waited until February for that appointment. That cleaning did not help. Then I was having a ringing in my ear and then I started losing hearing in my ear. I called my doctor, and we did some testing and they did see some hearing loss and inflammation along with negative pressure behind my ear drums in both ears. They gave me a steroid to help with that and did help but it did not stop things. At this point I will be having tubes put in in May and while I do have some hearing back I am not hearing as I was. The ringing has calmed down a bit but it still present.
Mom stated to have taken her daughter to a clinic at 7:00pm she doesn't remember the name but was sent to the hospital on 09-25-10 at 10:00pm patient was admitted to the hospital, she hasn't been released but I have spoken to the attending nurse, she stated patient was diagnosed with cellulitis to the R Thigh where the vaccs were given it was noted as red, and painful. She is currently taking BENADRYL and prednisone.
Significant diffuse, raised, firm, erythemic area with increased warmth to touch. Area extended from deltoid to down lateral aspect of biceps area. Patient reported she noticed symptoms in the morning upon waking. She denied any swelling of mouth/throat/tongue, difficulty swallowing, dyspnea, nausea, vomiting, or abdominal symptoms.
HEADACHE; ELEVATED HEART RATE; POUNDING HEART; This spontaneous report received from a patient concerned a 21 year old. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808982 expiry: unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced elevated heart rate. On 13-APR-2021, the subject experienced heart pounding hard. Laboratory data included: Heart rate (NR: not provided) Elevated. On 15-APR-2021, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elevated heart rate, heart pounding hard, and mild headache. This report was non-serious.
In the afternoon of 9/11 I noted a flare of my fibromyalgia coming on.  I haven't had one in so long I can't remember the last one.  All of my old standard pain sites that hurt with a flare were inflamed, including a nerve issue in my neck, and I was exhausted.  The problem persists.
A report received from a health care professional on 12Dec02, concerning a 66 year old female vaccinee who experienced a blister at the injection site and redness 1 day after receiving Fluvirin on 17Oct02. On 18Oct02, the vaccinee experienced a blister at the injection site and redness 1 day after receiving Fluvirin. The vaccinee was treated with betamethasone dipropionate and celecoxib. At the time of reporting the vaccinee had not yet recovered. There was insufficient information to determine the reporter's causality assessment. Update 1, 30Jan03: A report was received from a health care professional indicating that Fluvirin vaccine was received on 18Oct02. The blister at the injection site continued until the end of December 2002. The event was reported as resolved.
Swelling and redness at (L) deltoid lower (L) biceps mild tenderness with itch. TX ADVIL PRN with ZYRTEC PRN.
2/16/06-Received call from Mother-C/O; having an "allergic reaction".  Has red bumps on face/neck.  Denies difficutly breathing.  Instructed to seek medical attention either physician or ER.  Chose to go to ER.  Arrived at ER.  Generalized rash on face.  Mother had used Curell Cream on rash on way to ER and Mother reports @ ER, "rash is now gone".  Client was dc'd home on Benadryl.  Contacted Mother after the incident and visit to ER and she said, "I never had to use the Benadryl-only the Curell cream-he's fine, he was fine when we got to the ER".
Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 23-MAR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 1604AA, expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sore and numbness and tingling down to fingers.  Mostly now down to elbow.
patient was 11 years and 10 months .12 year old vaccine given no adverse reactions  per parent
she got sick from the COVID 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "she got sick from the COVID 19 vaccine".  Additional information: NDC number of COVID 19 vaccine was not provided. Investigations was not provided. Reason for no lot number of COVID 19 vaccine reported as reporter unwilling to complete the report. Expiry date of COVID 19 vaccine was not provided. Other Products was not provided. The reporter has been sick for 8 months and she saw her doctor today. He told her she should call Pfizer today, but she didn't ask why. He said Pfizer could help her. She got sick from the COVID 19 vaccine, and he thought maybe Pfizer was doing a study or could help her get better. She is not up to talking right now, and she would mostly want to talk to medical information to see what Pfizer can do for her. The patient asked can Pfizer help her. The patient stated she will call back when she feels like talking.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Migraine headaches May 22 and 23 Burning stinging pain across forehead and eyes  right side Shingles diagnosed on forehead and right eye May 26
A little under the weather; A little funny; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (A little under the weather), FEELING ABNORMAL (A little funny) and MYALGIA (Sore arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A, 026A21A and 011P21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced MALAISE (A little under the weather), FEELING ABNORMAL (A little funny) and MYALGIA (Sore arm). On 10-Feb-2021, MALAISE (A little under the weather) and FEELING ABNORMAL (A little funny) had resolved. On 13-Feb-2021, MYALGIA (Sore arm) had resolved.        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.   No Concomitants and Treatment medication were reported. This case concerns a 69-year-old, male patient with no previous medical history, who experienced the expected non-serious adverse event of Myalgia and unexpected non-serious adverse events of Malaise and Feeling abnormal. The events occurred on the same day after the first dose of mRNA-1273 (COVID-19 Vaccine Moderna). The rechallenge was not applicable. Dose 2 and dose 3 related events were provided in the same source. Patient Link for dose 2 and dose 3 has been created. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.   This case was linked to MOD-2021-362098, MOD-2021-362099 (Patient Link).; Sender's Comments: This case concerns a 69-year-old, male patient with no previous medical history, who experienced the expected non-serious adverse event of Myalgia and unexpected non-serious adverse events of Malaise and Feeling abnormal. The events occurred on the same day after the first dose of mRNA-1273 (COVID-19 Vaccine Moderna). The rechallenge was not applicable. Dose 2 and dose 3 related events were provided in the same source. Patient Link for dose 2 and dose 3 has been created. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.
headache; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Historical vaccine included. It was reported that, after administration of the 2nd dose patient experienced headache on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N001528 with expiry date: 13-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
CT Scan with contrast at Medical Center on 28 APR 2021 and full lab work. At the time I could no longer take the pain in my abdomen and I had not slept for days. I felt like I was being stabbed.  Encounter Diagnosis Diverticulosis of colon (Discharge Diagnosis) - 4/28/21 Umbilical hernia (Discharge Diagnosis) - 4/28/21 Lesion of liver (Discharge Diagnosis) - 4/28/21 Abdominal pain (Discharge Diagnosis) - 4/28/21 Discharge Disposition: Home or Self Care Attending Physician:  Admitting Physician:
Developed Redness down left arm and elbow in addition to vomiting and achy all over after receiving flu vaccine and Pneumovax in Left arm. Presented to emergency department after 2 days of symptoms. Vaccines were given 2 days prior to presentation to ED.
Headache, Myalgia, Fever, Pain at the injection site AND CHILLS Narrative:
did have a sore throat for a day once more.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 05Feb2021 (Lot number: EL9269) at the age of 35 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Eustachian tube disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "benign tumor removed from salivary gland" (unspecified if ongoing); "burning throat disorder", start date: Mar2020 (unspecified if ongoing), notes: after a long bout of strep throat. Concomitant medication(s) included: NORTRIPTYLINE taken for oropharyngeal pain; DEXILANT. Vaccination history included: BNT162B2 (lot number: EL3249,  vaccine location:Left arm, dose number: 1), administration date: 15Jan2021, when the patient was 35 years old, for COVID-19 immunisation, reaction(s): "my throat became extemly sore", "burning in throat". The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "recovering", described as "did have a sore throat for a day once more.". The event "did have a sore throat for a day once more." was evaluated at the physician office visit. Therapeutic measures were taken as a result of oropharyngeal pain.  Additional information: The patient was not pregnant at time of vaccination. The patient had no known allergies. The patient had no COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination. The patient did not receive other vaccine in 4 weeks.  No follow-up attempts are possible. No further information is expected.
dizziness, shortness of breath, rapid heart rate, immediately following injection.  Lasted for about 2 hours.
Patient received vaccination of anthrax on 19 Dec 02 during first trimester of pregnancy. LMP 7 Nov 02, EDC 14 Aug 03, later changed to 25 Aug 03.
pt recv vax 16JUL98 730PM & felt weak p/lunch;had bouts of uncontrollable laughing & crying in class;no other complaints;feels different;prescribed atarax & valiumprimetime clinic;
pt parents called clinic, to report pt not wanting to bear weight on rt thigh; did not take pts temp but stated did not feel warm; pt was happy & self so the parents stated the only problem would not bear wt on rt leg;
Patient requested pfizer covid vaccine as a booster and was given moderna. Patient was informed of the error and said they were ok with receiving Moderna. Patient was observed in observation for 15 minutes before leaving. They reported no symptoms from the vaccine and reported no side effects as weel.
Patient reports severe left shoulder pain 7/10 x 2 weeks after receiving the flu vaccine. Also, she experienced a 50 cent piece bruise that occurred the next morning. She was encouraged to use ice and heat to her left shoulder. She reports the heat was helpful.
pt began  having  sharp squeezing left sided chest pain the week she received her vaccine. Currently this occurs intermittently approx a few times weekly. Each episode lasts minutes to hours.
Information has been received from RN concerning a white female with scoliosis who was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (manf unk). Subsequently, the pt developed a reaction. No further information is available. It was also reported that the pt was vaccinated with a dose of varicella virus vaccine live and a dose of hep B virus vaccine rHBsAg (yeast) (manf unk) and experienced an adverse event (WAES0402USA01468 and WAES0404USA02293, respectively).
received the first shot of Moderna Covid 19 Vaccine and Pfizer for the second dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 IMMUNISATION (received the first shot of Moderna Covid 19 Vaccine and Pfizer for the second dose) in a 39-year-old female patient 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 21-May-2021, the patient experienced COVID-19 IMMUNISATION (received the first shot of Moderna Covid 19 Vaccine and Pfizer for the second dose). At the time of the report, COVID-19 IMMUNISATION (received the first shot of Moderna Covid 19 Vaccine and Pfizer for the second dose) outcome was unknown.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-May-2021 and was forwarded to Moderna on 22-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 IMMUNISATION (received the first shot of Moderna Covid 19 Vaccine and Pfizer for the second dose) in a 39-year-old female patient 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 21-May-2021, the patient experienced COVID-19 IMMUNISATION (received the first shot of Moderna Covid 19 Vaccine and Pfizer for the second dose). At the time of the report, COVID-19 IMMUNISATION (received the first shot of Moderna Covid 19 Vaccine and Pfizer for the second dose) outcome was unknown.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
This spontaneous report as received from a other health professional refers to a patient of unknown age. In 2017, the patient was vaccinated with PEDVAXHIB lot # reported as N003968 with expiry date 31-OCT-2019, lot # N003700 with expiry date 01-NOV-2019 for prophylaxis. In 2017, the patient experienced incorrect product storage. On an unknown date, the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PEDVAXHIB. Additional information has been requested. Sender's Comments: US-009507513-1708USA013258: US-009507513-1708USA013259: US-009507513-1708USA013257.
DVT in right leg and life threatening pulmonary embolism requiring TPA (thrombolytics) to prevent death.
Mom goes to crib and picks up baby at 11:30 PM, baby stops breathing for approx 10 seconds, takes a breath then stops again; baby "very pale", not moving. Transported to hospital by ambulance. Before transporting, baby's HR 150, unresponsive, at hospital HR 97, crying, pink. Recovered okay.
2nd dose of SHINGRIX vaccine was administered 16 days earlier than the recommended time of 2 months.
Information has been received from a physician concerning a 18 year old patient who on 26-JAN-2009 was vaccinated with the third dose of GARDASIL. On approximately 26-MAY-2009 "four months later" she was sent to a rheumatologist. She developed some sort of autoimmune disease, elevated IGA levels, vasculitis and skin lesions. She was put on steroids and it was still unknown what actually happened. There is some inference that GARDASIL may have a possible connection since it was one of the things she had been on. The patient sought unspecified medical attention. The health professional contacted during telephone follow up could not supply the following information: patient name, date of birth, dates of vaccination, dose number (if applicable), lot number (if applicable), date of event, recovery status, hospital name (if applicable). Additional information has been requested.
p/vax pt devel pox & abd;approx 1wk p/pt devel 3 more pox on scalp & face;2wk later pt devel two more pox on arm & approx 11/4/98 devel 3 more on lt arm;