chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This patient received Pneumovax on June 1, 2007, during a routine physical examination as she had turned 65. The patient describes having severe pain at the injection site approximately 6 hours alter, and since that time she has had multiple somatic complaints of unclear etiology. She has even developed high blood pressure for which she has been started on medication. She has seen two other physicians for evaluation of these problems and has had multiple studies with minimal abnormality. One MRI did show some local tendonitis. 11/2/07-medical records included with report. Complained of injection site pain and shoulder pain. Blood pressure increased since vaccination. On date of vaccination 6/1/07- BP 144/88. HX Osteopenia, kidney stone, hyperglycemia.  11/2/07-medical records included with report. Complained of injection site pain and shoulder pain. Blood pressure increased since vaccination. On date of vaccination 6/1/07- BP 144/88. HX Osteopenia, kidney stone, hyperglycemia. Per 60 day follow up: The same previously reported though possibly not as severe. 1/13/2010 Still with severe pain and tingling thighs. improved.
Began menstrual cycle 2 weeks early, with extreme cramps and heavy period flow. Patient has normal cycles and never bleeds between periods. Bleeding started the morning after receiving the first dose of COVID-19 vaccine.
SYMPTOMS: CONSTANT STOMACH CRAMPS, LETHARGIC, HYPERSOMNIA, WEAKNESS, GI PROBLEMS (DIARRHEA, CONSTIPATION, BLOATING) LOSS OF APPETITE, FATIGUE, MENTAL FATIGUE . TIME COURSE: SYMPTOMS STARTED FEB. OF 22 AND PROGRESSIVELY WORSENED UNTIL MARCH. WHICH IS WHEN I WAS DIAGNOSED WITH HASHIMOTO'S DISEASE, AT THAT TIME I WAS SWITCHED FROM NP THYROID TO LEVOTHYROXINE. I HAVE TO WAIT 3 MONTHS WITH PERSISTENT SYMPTOMS STILL HAPPENING FOR MORE BLOOD WORK, WHICH IS SCHEDULED FOR JULY 5TH WITH THE ENDOCRINOLOGIST.
Fever of 100.4; headache; chills; This is a spontaneous report from a contactable consumer or other Non Health Care Professional.   A 23-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 01Sep2021 16:00 as DOSE NUMBER UNKNOWN, SINGLE (At the age of 23 Years) for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced fever of 100.4 (pyrexia), chills and headache. The events had took place after the use of product. The patient underwent lab tests and procedures which included body temperature: 100.4 on unknown date. On an unspecified date in 2021, the event headache was recovered. At the time of reporting, the outcome of the events pyrexia and chills were unknown.          Query: Thanks for sending this information to safety. I hope that (Name withheld) is feeling better. Kindly confirm the awareness date of 01Sep since this is being received outside of the 24-hour reporting timelines. Please copy all on your reply.  Response: She got her shot at 4 pm on the 1st. I have been out of town with no access to the app. She is better this morning. No headaches.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Gestational diabetes; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 16-Oct-2019, concerning a 32-year-old, pregnant, female subject of body weight: 117.5 lbs, height: 62.3 inches and body mass index (BMI): 21.3, enrolled in, a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.   The subject's medical history included Rhesus (Rh) D negative and insomnia. Concomitant medications included Rhophylactic (anti-D immunoglobulin) for RhD negative, Prenatal gummy (mineral not specified (NOS,) vitamins NOS) for pregnancy and Unisom (doxylamine succinate) for insomnia.  The subject had no previous pregnancies. The subject had no maternal or paternal history with major congenital malformations (MCMs). Also, the subject had no history of offspring with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was on 07-Mar-2019, the estimated delivery date (EDD) was reported as 12-Dec-2019. The type of pregnancy was singleton.   On 03-May-2019, 16-May-2019 and 13-Aug-2019, the subject underwent ultrasound and no MCMs were noted.   On 25-Sep-2019, at approximately 29 weeks of gestation, the subject was administered Afluria QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, batch number: P100118566, dose , route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an influenza immunisation.   On 07-Oct-2019, the subject developed gestational diabetes.   At the time of initial reporting, the subject was not recovered from the event of gestational diabetes.  The case was assessed as serious. The reporter did not provide causality assessment.  The subject experienced gestational diabetes after vaccination with the suspect product Afluria QIV. Reportedly, vaccination occurred during pregnancy. Chronology is plausible. Pregnant state may provide alternative aetiology for the event. Causal relationship between the suspect product and exposure during pregnancy is assessed as not related per company conventions. For the event gestational diabetes causal role of the suspect product is assessed as unlikely related.
Information has been received from a registered nurse, concerning a female patient who was vaccinated with the third dose of Gardasil (date unspecified). There was no concomitant medication. The patient developed "little bumps" that developed about 2 days after the vaccination, "mostly near the arm and neck." The nurse reported the bumps did not appear to be hives, but that some of the bumps "appeared to be vesicles." The nurse stated that the vesicles resolved "several days later." Additional information has been requested.
REDNESS, SWELLING AT INJECTION SITE. TREATED WITH TYLENOL AND COOL COMPRESS.
Information has been received from a physician concerning her 27 year old daughter who in 2007 was vaccinated with the first dose of GARDASIL (route and lot number not provided) and did not return to complete the regimen. The physician reported that in 2010 the patient was diagnosed as positive for Human Papilloma Virus (HPV) and returned for her second dose of GARDASIL (route and lot number not provided), in 2011. It was unspecified if the patient sought medical attention or received any treatment for the adverse event. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
tested positive for Covid-19 last Friday; This is a spontaneous report from a contactable consumer or other non hcp (patient) via Pfizer. A male patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 04Mar2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive for Covid-19 last Friday on 12Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Mar2021. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Red raised circle on arm (continuing 9 days past vaccine), warm to touch. Some stiffness/soreness in the muscle, no significant pain. Diameter of red, raised area is 1.5 inches. Some minor itching on skin.
Immediately following vaccine, I experienced momentary dizziness.  Later in the evening, I experienced body aches, chills, and fatigue. The next morning I experienced extreme muscle stiffness with minimal range of motion in my neck.  Over the course of the following weeks I experienced dizziness, lightheadedness, headaches, nausea, muscle aches, paresthesia, tinnitus, confusion, decreased cognitive functioning.  I was treated by various ER doctors as well as my primary doctor, an audiologist, ENT, and a neurologist.  I have received extensive testing to include an MRI, 2CT scans, blood work, allergy testing and Neuro psych testing.  It has been just over 3 months since the vaccination, and I am still experiencing symptoms of dizziness, lightheadedness, headaches, and mental fatigue.
This case was reported by a consumer via interactive via interactive digital media and described the occurrence of illness in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced illness, shingles and incomplete course of vaccination. On an unknown date, the outcome of the illness, shingles and incomplete course of vaccination were unknown. It was unknown if the reporter considered the illness to be related to Shingrix. The reporter considered the shingles to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient stated that the Shingrix vaccine caused the patient to become violently ill and 30 days later, the patient ended up with shingles. The patient refused to receive second dose of Shingrix, which led to incomplete course of vaccination. Consent to follow up was possible as contact details were not available.
This spontaneous report as received from a healthcare professional refers to a 14-year-old non-pregnant female patient with no pertinent medical history and no drug reaction or allergies. On 28-APR-2016 at approximately 10:00, the patient was vaccinated with the first dose of GARDASIL 9 lot # L045711, expiration date reported as 08-MAY-2017, 1 shot, intramuscular. There were no concomitant medications. On the same day at about 16:00 (6 hours after vaccination), the patient's parents called the office, because the patient experienced swelling in the hand on the same side she was administered the injection. The nurse practitioner recommended the patient ice and to elevate the hand that is swollen as treatment. The patient was to be seen in the office at the day of report. The outcome of swelling was reported as not recovered/not resolved. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY. At the time of the report, PAIN IN EXTREMITY outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC-MOD-2021-092706; Sender's Comments:  US-MODERNATX, INC-MOD-2021-092706: Dose 2.
Pain and itching at injection site (Left Upper Arm). Red, raised, hot to the touch skin. Ended up spreading mare and I was seen in ER on 01/18/2014 with pain radiating down arm and up into left chest and neck regions. Diagnosed with Cellulitis and given a prescription for Bactrim.
patient was exposed to COVID on 07/24, she is asymptomatic, tested positive for COVID on 7/31/2021
having an allergic reaction; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: One nurse is to latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "having an allergic reaction". Therapeutic measures were taken as a result of hypersensitivity.  Additional information: Nurse 1 (patient) was allergic to latex and when administered the Covid vaccine started having an allergic reaction which is believed to have come from the "stopper" in the vial and this was reported in VERS at the time. This nurse was given a double dose of Benadryl and no other action was needed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/ allergies and concomitant therapy were unspecified. On an unknown date in April 2016 (reported as on or after 06-APR-2016), the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L040422, expiry date: 15-OCT-2017). Nurse reported that the vaccine underwent temperature excursion at -10.2 degree Celsius for a duration of 15 hours, 37 minutes and 30 seconds. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
COVID arm.  Redness itching and swelling 3 days after receiving 2nd injection
Developed skin rash within  hours of receiving vaccine, started on the forehead and spread down the face including the ears and eyelids, a more mild rash on the arms, legs and stomach. took some Benadryl which help with the rash. rash lasted about 4 to 5 days.
Myalgia beginning 10/05/2021 at ~02:00 AM followed by shortness of breath x several days. Syncope (loss of consciousness) 10/07/2021 ~11:00 AM follows by 36 hour hospitalization.
First dose of HPV given 3/19/07 without sequelae, second dose given 09/27/07.  1 year old sibling accompanied patient to the visit and received MMR, Varicella and Hep A vaccine.  On 10/12/2007, broke out in pruritic macular/papular rash on chest, spread to arm and today 10/19 is faint, coalescent and continues to be pruritic.  Mother has given diphenhydramine without substantial decrease in itching or rash.  Mild conjunctivitis noted today as well.  No fever, no headache, no nausea/vomiting, abdominal pain. No joint pain. No urticaria noted.  Has had exposure to viral illnesses at school.  Has been provided with Atarax to see if this helps with rash.
nauseous; flu-like symptoms; few little reactions; This case was reported by a consumer via call center representative and described the occurrence of nausea in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced nausea, influenza-like symptoms and nonspecific reaction. On an unknown date, the outcome of the nausea, influenza-like symptoms and nonspecific reaction were recovered/resolved.   It was unknown if the reporter considered the nausea, influenza-like symptoms and nonspecific reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The caller asked if she could visit a patient in the intensive care unit even though she has completed the Shingrix series. The caller reported that the Shingrix made her nauseous, with flu-like symptoms and few little reactions but she was ok at the time of reporting. No health care professional information was obtained.
3 DAYS AFTER INJECTION HAD AN EPISODE OF VESTIBULAR NEURITIS AFTER NO ISSUES FOR MORE THAN 4 MONTHS. HAD VERTIGO, NAUSEA, DIARRHEA AND SEVERE FATIGUE. SX RESOLVED AFTER 3 DAYS WITH PREDNISONE, ZOFRAN AND VALIUM.
stuffy nose/nose congestion; body aches; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy nose/nose congestion), PAIN (body aches), PYREXIA (fever) and CHILLS (chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was provided by reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced NASAL CONGESTION (stuffy nose/nose congestion), PAIN (body aches), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, NASAL CONGESTION (stuffy nose/nose congestion), PAIN (body aches), PYREXIA (fever) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were included blood pressure medicine, cholesterol medicine.   This case was linked to MOD-2021-033551 (Patient Link).
Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced low titer levels. The patient received a dose on an unspecified date. The patient experienced low titer levels (antibody test abnormal). Lab results were not provided by the time of this report. No additional information was available at the time of this report.
The medication being available to clinicians could have occurred due to vaccines being left in the clinic or products being returned by the clinic and not appropriately segregated when returned to the pharmacy. This was a quick change, and we all worked to communicate as quickly as possible. The Vaccine in stock was given one day beyond date of approval to administer.
This initial spontaneous case, received on 24-Oct-2017, reported by other non-health professional and concerns a 3-year-old male child. The patient had no medical history and concomitant medications received. On 23-Oct-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml, batch number: 195236, expiry date: 31-May-2018, route of administration: intramuscular). It was reported that, the patient has not experienced any problems. Outcome of the events was not reported. The reporter considered this case as non-serious.
Neck pain; Stiff neck; Severe migraines; Dizzyness; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0151) via an unspecified route of administration in the right arm on 05Apr2021 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 19Apr2021, the patient experienced neck pain, stiff neck, severe migraines and dizziness. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events neck pain, stiff neck, severe migraines and dizziness were unknown at the time of the report.  No follow-up attempts are possible. No further information is expected.
Information has been received from a medical assistant concerning a 17 year old female patient with no other relevant medical histories or allergies who on 01-MAR-2010 was vaccinated intramuscularly with a 0.5ml dose of VAQTA (666629/1670Y). There was no concomitant medication. On an unspecified date, the patient complained of some nausea. Unspecified medical attention was sought. Ultrasound and urine test were performed. At the time of this report, the patient was "6 weeks pregnant", and her outcome was not reported. Follow-up information has been received concerning a female patient who had  no previous pregnancy. On 01-APR-2010 the ultrasound showed that the patient had a 6 weeks and 2 days old fetus. It was also reported that the patient terminated this pregnancy one week later. At the time of the report, the patient's status was unknown. Upon internal review, the patient's termination of pregnancy was considered an other medical event. Additional information has been requested.
AIOU needle and hub broke off during start of administration - all of vaccine squirted out on patients arm.  Needle and hub removed from arm.  Dose re-administered.  No adverse effect for patient.
Information has been received from a medical assistant concerning a 7-year-old female patient who on 01-MAR-1999 was vaccinated with a dose of varicella virus vaccine live.  On approximately 28-DEC-2005 the patient developed chickenpox.  Unspecified medical attention was sought.  There was no product quality complaint involved.  No further information was available.  Addition information has been requested.
left side of her face is drooping but she can move it; face is numb like she's been to dentist; tingling in left side of her face; headache; fever; This spontaneous case was reported by a physician and describes the occurrence of FACIAL ASYMMETRY (left side of her face is drooping but she can move it), HYPOAESTHESIA (face is numb like she's been to dentist), PARAESTHESIA (tingling in left side of her face), HEADACHE (headache) and PYREXIA (fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 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 FACIAL ASYMMETRY (left side of her face is drooping but she can move it), HYPOAESTHESIA (face is numb like she's been to dentist), PARAESTHESIA (tingling in left side of her face), HEADACHE (headache) and PYREXIA (fever). At the time of the report, FACIAL ASYMMETRY (left side of her face is drooping but she can move it) and HYPOAESTHESIA (face is numb like she's been to dentist) had not resolved, PARAESTHESIA (tingling in left side of her face) outcome was unknown and HEADACHE (headache) and PYREXIA (fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information mentioned.  Company Comment: Very limited information regarding these events have been provided at this time. Further information has been requested   This case was linked to MOD-2021-295432 (Patient Link).; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.
PT LEFT ARM (DELTOID AREA) BUT ENTIRE UPPER ARM HAD GENERALIZED SWELLING, RED AND WARM TO THE TOUCH. THE PATIENT ALSO EXPERIENCED PURITIS. PATIENT TREATED WITH BENADRYL