chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she felt some nausea; while studying for exam, the patient was unable to concentrate or focus, her head is space; vertigo feeling; her head is spacey, fogginess in her head; She state it feels like her equilibrium is off; Arm hurt a little afterwards; Initial information regarding this unsolicited valid non-serious case via Medical Information (MI) (reference number: 00317693) was received from a consumer and transmitted to Sanofi 15-Oct-2020.  This case involved a 49 year old female patient who experienced she felt some nausea, while studying for exam, the patient was unable to concentrate or focus (disturbance in attention), her head is space, feeling fogginess in her head (feeling abnormal) and had vertigo feeling and stated that it felt like her equilibrium was off (balance disorder) while she received vaccine INFLUENZA VACCINE and her arm hurt a little afterwards (pain in extremity).  Relevant medical history, past medical treatment, vaccination and family history were not provided.   On 14-Oct-2020, the patient received a 0.5 mL dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot UT7049KA, expiry date: 30-Jun-2021) via intradermal route in the arm not otherwise specified (nos) for prophylactic vaccination and her arm hurt a little afterwards (pain in extremity).  On 15-Oct-2020, the patient nausea, while studying for exam, the patient was unable to concentrate or focus (disturbance in attention), her head is space, feeling fogginess in her head (feeling abnormal) and had vertigo feeling, 1 day following the administration of INFLUENZA VACCINE. She stated that it felt like her equilibrium was off (balance disorder).  The patient said it was different than she ever had before.  Especially when moving quickly.  Relevant tests included No laboratory data was provided.  Final diagnosis was arm hurt a little afterwards, her head is spacey, fogginess in her head, kind of like a vertigo feeling, while studying for exam, the patient was unable to concentrate or focus, her head is space, she stated that it felt like her equilibrium was off and she felt some nausea.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.
upset stomach , diarrhea , muscle pain, soreness & stiffness at site of injection in left arm  upset stomach started around 11:00am & went away after having bowel movement, it returned  again around 2:00pm & again went away after bowel movement,  it returned for a third time around 3:00pm & that is when the diarrhea occurred.  That was the last time of any signs or symptoms.   I drank 2 cups of ginger tea afterwards which seem to help settle my stomach.  The muscle pain, soreness & stiffness in left arm at injection site started at bedtime around 9:00pm on the day of receiving vaccine & still continues today but is improving
Information has been received from an 81 year old female patient with no pertinent medical history and no known drug allergies, who on approximately 31-MAR-2009 ("last Tuesday") was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not provided). Concomitant therapy included (REQUIP), (LYRICA) and (PROTONIX). Subsequently the patient experienced injection site reaction and a little bit of a headache. Her injection site is a little sore and there is a red streak under the skin running from the injection site to the elbow. No lab diagnostic studies were performed. At the time of the report the patient had not yet recovered. No further information is available.
Feeling under the weather; Nausea; Headache; Muscle ache; This is a spontaneous report from a contactable other healthcare professional (HCP), who is also the patient.  This 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140) via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunisation. Relevant medical history included hypertension (hypertensive for years and takes medication for that), muscle aches (she got muscle aches once in a while) and headaches (she got some headaches from wearing a mask). Concomitant medications included unspecified drugs for hypertension. On 21Dec2020, the patient experienced nausea; in Dec2020 she experienced headache and muscle ache and on 22Dec2020 she experienced feeling under the weather. The patient specified that she has had light symptoms of nausea, headache, and muscle ache. Nausea was the most prevalent symptom. She said she got some headaches from wearing a mask, and the headaches she has experienced since receiving the COVID-19 Vaccine could be related to her mask wearing, and not the vaccine. She said she was at the age where muscle aches are not uncommon, and she got muscle aches once in a while, so she was unsure if her muscle aches were from receiving the COVID-19 Vaccine. She further specified that the she had a little nausea, saying the nausea was not very noticeable. The nausea was a little heavier at the time of the report, and she had some toast and some things to help settle her stomach. She said she was feeling "blah." She clarified she was feeling under the weather, like she just wanted to get in bed and sleep. The patient reported that the symptoms she was experiencing could be stress, and she just wanted to get the rapid COVID test to make sure she doesn't have the virus. She would take the rapid test as a requirement for travel. Treatment: the patient took 2 Extra Strength Tylenol 500mg (Lot Number: SHA086, and Expiration Date: Jun2024). The patient had not recovered from nausea and feeling unwell; the outcome of the headache and muscle ache was unknown.
Pt came in for 2nd covid shot. She was with 2 other family members, one of which was also getting a covid booster shot.  I drew up 2 syringes of the 12yr and older covid vaccine. I administered both vaccines. I had the pts wait 15 min and during this time I started documenting the injections and realized that the one pt was only 9. I, at the time I drew up the vaccine, thought she was 12. I discussed this with pts PCP and then notified the family while they were still in the exam room. Family did not have any concerns after I spoke with them and there were no reactions noted prior to pt leaving the clinic. I sent an email to my supervisor notifying her of this error. I attempted to start and occurrence report with facility, but have been unable to find the form on our intranet. I contacted my supervisor about this and she is looking into this issue with the occurrence report so that I may complete it.
Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, and seeing dark spots (date/time of onset symptoms 1/13/2021 at 3:00PM)  Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, swollen lymph nodes, and hard to swallow ( date/time of onset symptoms 1/13/2021 at 4pm and still ongoing).
Dizziness, Headache, NauseaVomiting & Tachycardia Narrative:  Employee had the vaccine around 1:30p and by 3:30p when she went back to work she was severely dizzy, nauseated, and had a headache. The symptoms lasted for about 10-20 minutes and did improve. The patient had a blood pressure checked at the time and was 124/83. She did develop headache, body aches and nausea around 7pm as well-I spoke with her at 9:00a 3/2/21 and this has not resolved. She will seek treatment if not improving
Initial information received on 19-Jun-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case involves a 82 years old female patient who experienced injection site reaction including mostly redness and swelling of the upper arm., while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medication was not reported. On an unknown date in 2017, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number: UI824AB, via intramuscular route in the upper arm. On an unknown date, the patient developed a non-serious injection site reaction which included mostly redness and swelling of the upper arm (inflammation localized, vaccination site reaction) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient's past vaccination(s) included Fluzone HD in Jun-2015 and Fluzone HD in Jun-2016, both on an unknown dates. Final diagnosis was injection site reaction including mostly redness and swelling of the upper arm.. Lab tests was not reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for injection site reaction including mostly redness and swelling of the upper arm.
Face became flushed after approx. 15 mins.  Also had slight tingling in left arm (arm of the injection).  No flush or rash on the body.  Symptoms subsided with a couple of hours
Site: Redness at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Visual Changes/Disturbances-Medium
Headaches; Nausea; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 45 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 09Apr2021 10:30 (Lot number: ER8734) at the age of 45 years as dose 2, single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1, Lot Number: ER6199, Anatomical location: Right arm, Administration time: 10:30), administration date: 19Mar2021, when the patient was 45 years old, for covid-19 immunization, reaction: "some headaches". The following information was reported: HEADACHE (non-serious) with onset 09Apr2021, outcome "recovered" (09Apr2021), described as "Headaches"; NAUSEA (non-serious) with onset 09Apr2021, outcome "recovering", described as "Nausea". Therapeutic measures were not taken as a result of headache and nausea.  Additional information: The patient reported between one 22 hours she started receiving headaches and nausea, the headache went away and the nausea has been consistent for about eight hours so far. With the first dose that she received on 19Mar2021, she didn't receive the nausea side effect although she did have some headaches probably within that first week. The patient had not received any other vaccine within 4 weeks or any other medications within 2 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient was not allergic to any medications, food or other products and was not diagnosed with other illness, medical history and chronic health conditions.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021402734 same reporter/patient, different vaccine dose with partial same AE
This spontaneous report was received from a registered nurse concerning a currently 4 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# N035177, expiration date: 09-JUN-2019; N028447, expiration date 09-APR-2019 or lot#N025929, expiration date: 18-MAR-2019) (dose and route of administration were not provided) as prophylaxis following temperature excursions of 15°F to 46°F (-9°C to 8°C) (19F). The previous temperature excursions were 6°F to 14°F (-14°C to -10°C) (12.7F) for 55 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. The nurse did not indicate which lot#/expiration date of PROQUAD was received by the patient. No adverse effects were reported. This is one of several reports from the same source.; Sender's Comments: US-009507513-1805USA007511: US-009507513-1805USA007507: US-009507513-1805USA007508: US-009507513-1805USA007509: US-009507513-1805USA007504: US-009507513-1805USA007510: US-009507513-1805USA007505: US-009507513-1805USA007506:
Brought to ED on 8/3 from skilled nursing facility for altered mental status and Covid +. Had been admitted to Medical Center in July with septic shock, cholangitis requiring ERCP/biliary stenting and bacteremia. There was concern for Cholangiocarcinoma but unable to peform EUS and was to f/u OP. He was then sent to facility. On arrival to ED he was hypotensive. Labs- creatinine 1.4, alk phos 976, AST 224 and ALT 224. WBC s elveated at 26. Hemoglobin 8.7. Had  UTI with blood cultures positive for kebsiella. Underwent CT of thorax , abdomen and pelvis showing cholelithiasis with gallbadder distentions concerning for cholecystitis. Biliary stent appeared in good position with dilatation concerning for cholangitis. General surgery consulted. After discussion with wife she decided to transition to comfort care. Palliative care and hospice were consulted. Comfort measures were initiated .
THe client contracted COVID-19 even after receiving both doses in the series of a Vaccine. The client experienced a runny nose and loss of taste and smell
Dec 2000 - Pituitary tumor hemmorhaged  Jan 2001 - Surgery to remove "dead tissue" ( Diseeases diagnosed with: Addison's Disease, Adrenal Insufficiency, Pashypothyroidism, Microprolacnomia, Hypertension, Acid Reflux, Diabetes Insipidus   Most common symptoms experiencing (not limited to): chronic "continuos" headaches, constant fatigue, sleep disorders, body temperature changes, joint aches, weak immune system, skin rash (arms/chest/recently feet), memory loss, flu like symptoms (last up to five days at a time), nausea, chronic pnuemonia, body sweats, recent notice of increase hair loss, no testoserone level and low/no sex drive  Current treatments involve follow up visits to specialists: PCM/neurosurgeon/endocrinology/pain management/neurology/yearly MRI  Nurse follow up on 06/14/04 states: "Complete."  Nurse follow up on 06/18/04 states: "Complete."
Child given routine MMR, Varivax, Prevnar on 03/23/2005.  Varivax in left thigh.  Child presented to urgent care 06/07/2005, crash left leg, prescription with calamine lotion and benadryl.  Seen by MD on 06/11/2005 with classis Herpes Zoster in left leg in dermatoma pattern, child in no distress, put on Acyclovir by mouth.
Sore throat; Chills; Body aches; Like the flu; Not feeling too good, felt bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling too good, felt bad), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills), MYALGIA (Body aches) and INFLUENZA LIKE ILLNESS (Like the flu) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K0A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus and Blood pressure high.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced FEELING ABNORMAL (Not feeling too good, felt bad), MYALGIA (Body aches) and INFLUENZA LIKE ILLNESS (Like the flu). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Not feeling too good, felt bad), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills), MYALGIA (Body aches) and INFLUENZA LIKE ILLNESS (Like the flu) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications reported included medications for type 2 diabetes and high blood pressure.  Treatment for the events included one Tylenol  500 extra (acetaminophen).   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Additional info on events.
Pt observed during her time of Nausea and released, Vitals in normal range.
Information has been received from a nurse concerning a 64 year old female patient with hypertension, hypothyroidism, paroxysmal atrial fibrillation, microscopic haematuria, penicillin and amiodarone allergy who on 18-JAN-2010 was vaccinated SC with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapies included "thyroid medication", enalapril maleate (manufacturer unknown), furosemide (manufacturer unknown), potassium supplement (manufacturer unknown), diltiazem HCL (manufacturer unknown), atenolol (manufacturer unknown), simvastatin (manufacturer unknown), calcium (unspecified), warfarin (manufacturer unknown) and propafenone HCl (manufacturer unknown). On 18-JAN-2010 within one hour of the vaccination the patient experienced shortness of breath while driving home from the office. She drove herself to the medical center and was evaluated in the emergency room and was found to have a widespread rash, low pulse, hypotension, and laryngeal edema. The patient was administered oxygen and unspecified medication and was scheduled to be admitted to the hospital. At the time of report the patient's status was not recovered. The patient's shortness of breath, widespread rash, low pulse, hypotension and laryngeal edema were considered to be immediately life-threatening, significant disabling, hospitalization and other important medical events. Additional information has been requested.
C/O hives both arms, face and inner wrist (B/L). Hives are intermittent.
Narrative: 69yo pt in home hospice died on 7/25/2021 with Hospice DX: Chronic Obstructive Pulmonary Disease, Secondary DX: Hearth failure, ischemic Cardiomyopathy. Pt had received 2 covid vaccines on 4/2/2021 (from facility) and 5/11/2021 (unknown where received) both Moderna. Death not related to covid vaccinations.
My arm hurt a little bit for an hour; it hurt where the needle was after the second shot.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm hurt a little bit for an hour) and VACCINATION SITE PAIN (it hurt where the needle was after the second shot.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (My arm hurt a little bit for an hour) and VACCINATION SITE PAIN (it hurt where the needle was after the second shot.). In March 2021, PAIN IN EXTREMITY (My arm hurt a little bit for an hour) and VACCINATION SITE PAIN (it hurt where the needle was after the second shot.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 antibody test: 0 antibodies after 5 months (abnormal) produced 0 antibodies after 5 months..         No concomitant medications are provided. Patient Regular med: Diabetes medication. Patient doctor recommended him to get an antibody test and it returned with 0 antibodies. Patient would like to know why he has produced 0 antibodies after 5 months.   This case was linked to MOD-2021-294841 (Patient Link).
Magnets or metals can stick on my arm and i feel tingling down my arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15May2021 13:45 (Lot number: EW0171) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset 18May2021 12:00, outcome "not recovered", described as "Magnets or metals can stick on my arm and i feel tingling down my arm". Therapeutic measures were not taken as a result of paraesthesia.  Additional Information: The patient did not treated for event. There was no known allergies. Since the vaccination the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU) vial, (dose, route of administration, lot # and expiration date were not reported). On 02-NOV-2017, the patient missed a dose of ZOSTAVAX, lot # N024561 with expiration date on 05-DEC-2018, because the sterile diluent used for reconstitution was "not available". No adverse effects were reported.
in and out of consciousness; got very sick; vomiting a lot after taking alcohol; chills; fever (102.4); cold; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (in and out of consciousness) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced FEELING COLD (cold), CHILLS (chills) and PYREXIA (fever (102.4)). On 08-Apr-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (in and out of consciousness) (seriousness criterion medically significant), ILLNESS (got very sick) and VOMITING (vomiting a lot after taking alcohol). On 06-Apr-2021, FEELING COLD (cold), CHILLS (chills) and PYREXIA (fever (102.4)) had resolved. On 09-Apr-2021, ALTERED STATE OF CONSCIOUSNESS (in and out of consciousness), ILLNESS (got very sick) and VOMITING (vomiting a lot after taking alcohol) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Body temperature: 102.4 (High) fever.         No relevant concomitant medications were provided. He was taking acetaminophen.  Company Comment: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
FEVER, ARM STIFFNESS, HIGH BLOOD PRESSURE, PULSE ACCELERATED, SWOLLEN LYMPH NODE, SHIVERING, INSOMNIA
Information has been received from a Pharm.D concerning a 38-year-old female who in approximately 1998 was vaccinated with Hepatitis B vaccine recombinant (yeast) (manufacturer unknown). The patient was given her first shot in the deltoid muscle. Subsequently, she experienced muscle atrophy at the injection site. The atrophy resolved on its own. The third shot was given in her gluteal muscle. The patient reported that she again had deltoid muscle atrophy even though the shot was given at a different site. At the time of the report, the atrophy resolved. The patient sought unspecified medical attention.  Addi tional information has been requested.
Got the shot around 6pm on the 23rd. Pain at injection site and arm within 5-10min. 1st night, just sore arm, a bit tired. 2nd day developed a headache, very fatigued and a slight fever. Went to bed early. Woke up feeling fine on 3rd day.
At injection site, erythema left thigh 6 X cm, induration left thigh 3x3 cm, 1-2 d post injection