chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client presented to the vaccine site for 2nd dose COVID Pfizer vaccine on 1/20/2022. Client received 1st dose COVID Pfizer vaccine on 12/30/2021 and reported that she experienced "sharp chest pain" rated 9/10 3 days after receiving the vaccine. Client described the pain as "sharp and heavy" and explained that she continues to experience this intermittently, approximately 2-3 times per week lasting for 2 minutes at a time. Client reported to Lead RN that she had not followed up with her PCP. Client disclosed that she had an IUD inserted on 12/29/21. Client reported NKDA and no chronic health conditions.  Lead RN submitted medical consult for guidance on administration of 2nd dose COVID Pfizer vaccine. Vaccine Operations Lead forwarded guidance from MD with approval for Pfizer 2nd dose and recommendation for "f/u with provider re other health issues". Lead RN advised the client to follow up with PCP regarding chest pain. At 1348 client received the 2nd dose COVID Pfizer vaccine (lot #FJ6369) in the L deltoid. No adverse reaction was reported by client during her 15 minute observation. Client left vaccine site with a steady and symmetrical gait at 1405.
Cold urticaria, induced within 5 minutes of cold exposure. Resolves after two hours.  Intermittent unilateral vision blurriness, resolves after 15 minutes.
right middle lobe pneumonia; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 26-OCT-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered difficulty breathing and was diagnosed with right middle lobe pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events right middle lobe pneumonia was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the event right middle lobe pneumonia to be disability.  Upon internal review, the event right middle lobe pneumonia was considered to be medically significant.
HYPOTONIC/VENTILATED TIME FIVE DAYS, RULE OUT SEPSIS ? RELATIONSHIP TO VACCINE.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 20-JUL-2010, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot number and expiration date were not reported). On 27-JUN-2012, the patient was vaccinated with the second dose of GARDASIL (dose, route of administration, lot number and expiration date were not reported). The third dose that was administered was GARDASIL 9 (dose, route of administration, lot number and expiration date were not reported) given on 17-AUG-2015. Concomitant therapy was not reported. No adverse effect were reported. Additional information has been requested.
patient was feeling faint, improved with laying down. No dizziness, no difficulty breathing, given orange juice and oreos. patient felt better and released on his own.
The patient reported that the site of the SHINGRIX vaccination was red and hot to the touch with swelling. The patient was chilled and achy the day after the vaccination was administered but this only lasted one day. The swelling and redness persisted for approximately two weeks. The patient did not report pain at the site of injection.
Dx with COVID 1 week PTA, arrived with worsening symptoms and failed OP treatment (medrol zofran, cefdinir). Admitted for hyponatremia and AKI w/ COVID infection. Received O2, singulair, zinc. DC home on RA.
Body aches; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced MYALGIA (Body aches). At the time of the report, MYALGIA (Body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.
Swollen redness, like hives that appeared 8 days after injection.  Area is !4" x 2" and itches.  First discovered today, did not notice prior to today. Taking antihistamines, have not been able to see medical professional yet.
Fluzone High-Dose Quad Injection; Red, bumpy, itchy rash 3" irregular around injection site.  Lasted approximately 1 week.  Scabbed over in approximately 1 week.
Patient received Pfizer COVID-19 bivalent booster on 09/30/22. She reported for a Medicare annual wellness visit on 10/04/22 and noted some tenderness in a vein on the back of her right calf that started on 10/02/22. Patient reported no injury to the site and no traveling recently. She does have a history of bilateral varicose veins in her lower extremities. Ultrasound completed and revealed DVT in right lower extremity. Patient started on Eliquis 10/04/22.
Fluzone QIV administered during pregnancy no adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 23 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] in context of fluzone qiv administered during pregnancy no adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Fluzone QIV administered during pregnancy no adverse event occurred at 13 weeks of pregnancy and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE at 13 weeks of pregnancy, during first pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE.  The date of last menstrual period was reported as 14-Jun-2022. The estimated due date is 21-Mar-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2022, the patient received a  dose 1 of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection  (lot UT7682KA)  via intramuscular route in the left deltoid for prophylactic vaccination.  On 07-SEP-2022 the patient developed a non-serious event fluzone qiv administered during pregnancy no adverse event (exposure during pregnancy) (latency same day)following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (exposure during pregnancy).  At time of reporting, the outcome was Unknown for the event. Additionally, at time of reporting, the pregnancy is still ongoing.
I started feeling covid symptoms of headache, body aches, fatigue, and nasal symptoms 06Jun2022; I started feeling covid symptoms of headache, body aches, fatigue, and nasal symptoms 06Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 at 16:00 as dose 3 (booster), single at the age of 27 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: 01Jun2019, stop date: 16Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, outcome "unknown" and all described as "I started feeling covid symptoms of headache, body aches, fatigue, and nasal symptoms 06Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jun2022) Negative; (13Jun2022) Negative; (15Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient started feeling COVID symptoms of headache, body aches, fatigue, and nasal symptoms 06Jun2022. Was given Paxlovid due to her asthma history. Took Paxlovid 07Jun-11Jun. Symptoms went down. Was asymptomatic and almost negative 12Jun (small line on home test. Tested completely negative 13Jun with no symptoms. No symptoms at all 13Jun-14Jun. Woke up feeling sick 15Jun and tested postive. Feeling worse symptoms now into 16Jun- extreme fatigue, dizziness, heart palpitations, nauseous, painful body aches, fever, stuffy, shortness of breath. Symptoms are now worse than before Paxlovid.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 21-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Information has been received from a consumer about her daughter, a 17 year old female who on approximately 26-FEB-2008 was vaccinated with her first dose of GARDASIL (lot number unspecified). Concomitant therapy included WELLBUTRIN. On approximately 26-FEB-2008 the patient experienced her arm hurting on that day. The patient said she experienced itchiness on her face, lips, and arms. The patient's arm hurting and itchiness on face, lips, and arms persisted. No further information is available.
No additional AE; the patient was given a dose of VAXNEUVANCE after the dose was stored improperly; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was not provided.  On 02-MAY-2023 the patient was vaccinated with 0.5 milliliter of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) lot # W027275 and expiration date 09-JUL-2024 for prophylaxis (frequency and route of administration were not provided) (product storage error and no adverse event). The reporter stated that the temperature excursion occurred on 02-MAY-2023 lasted for 7 hours, and the temperature measured was 34 Fahrenheit degree.
Shot was administered on 1/20/2021. By that Friday, my upper right arm (over my bicep) developed a red patch, which I had attributed to dermatographia.  Over the weekend, it began to raise up a bit from my skin and swell, and became warm to the touch. By Monday, 1/24/2021, the swelling had stopped, but the redness was noticeable on other parts of my upper arm, but not around the shot location. There is a bruise there from the shot, but no redness. The redness and warmth changes throughout the day, and at times is "itchy below the skin's surface", where I'm not able to scratch.
One itchy red hive developed underneath left eye, within 4 hours of receiving vaccine dose 1
Redness, warm to touch area at imm. site. Afebrile. 3x4 cm area non tender.
COVID-19; Lower back pain; Inflammation around entire body; Joint pain; Headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), BACK PAIN (Lower back pain), INFLAMMATION (Inflammation around entire body), ARTHRALGIA (Joint pain) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 45B21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced BACK PAIN (Lower back pain), INFLAMMATION (Inflammation around entire body), ARTHRALGIA (Joint pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). On 05-May-2021, the patient experienced COVID-19 (COVID-19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), BACK PAIN (Lower back pain), INFLAMMATION (Inflammation around entire body), ARTHRALGIA (Joint pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, SARS-CoV-2 test: (Positive) No other results are reported..         No concomitant medications were provided.  The action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received on 17-May-2021 contains information regarding additional event COVID-19.
Joint and muscles aches/Joint and muscle pain lasting over a week/progressivenly worsening/Pain worsened; Joint and muscles aches/Joint and muscle pain lasting over a week/progressivenly worsening/Pain worsened; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EW0176) via an unspecified route of administration, administered in left arm on 28Apr2021 12:15 (age at vaccination 33 years) as dose number unknown, single for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD). The patient had no known allergy. The patient was not pregnant at the time of vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient experienced joint and muscles aches/joint and muscle pain lasting over a week/progressively worsening/pain worsened over the course of a week and seems to get worse daily on 28Apr2021 13:00. This was still occurring 7 days after receiving vaccine. The patient was not taking any treatment for events. Outcome of events was not resolved.   No follow-up attempts are needed. No further information is expected.
he tested positive for COVID-19 / (probably infected by a family member); runny nose; dry cough; flu-like symptoms; he tested positive for COVID-19 / (probably infected by a family member); he tested positive for COVID-19 / (probably infected by a family member); This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient stated that the next dose is scheduled for the time of the report, however he tested positive for COVID-19 on 05Jan2021 (probably infected by a family member). Representatives at the administration site are not sure if he should get the second dose. The patient reported minor symptoms "flu-like symptoms, runny nose, dry cough, no major symptoms". The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Pt complained of swollen and painful arm. Prescribed Benadryl by on-call MD. Improved by AM of 11/21/01.
Vasovagal response after administration of injection Monitored for greater than 2 hours, unable to get blood pressure to regulate Patient had to go to ER for additional IV fluids Mom was with patient in clinic- dad came after to help transport patient (family was aware it would be safer to have EMS pick patient up, and bring to hospital- family declined.)  Intervention in the clinic including  ice packs, monitoring, apple juice unfortunately patients BP was not responding appropriately, probably due to need of fluids, need IV hydration per Doctor H.  Patient arrived at ER at 12:37pm
pt rcvd vax; pt exp burning & swelling at inject site; tx w/ ice; RN switched to a different lot num of vax & symptoms did not occur;
Upon getting home on 9/18/16, patient's arm began to swell (the size of a baseball, burn, and become red at the injection site). She went to her PCP, who diagnosed her with cellulitis and gave her a 10 day course of antibiotics.
Patient received 0.25 mL of Moderna Covid-19 vaccine, bivalent; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 vaccine, bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 vaccine, bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 vaccine, bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 vaccine, bivalent).    No concomitant medications were reported.   No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up information included patient's age group updated.
A report has been received from an office manager concerning a 15 year old, male patient who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) was administered on 15-Jan-2014. The office manager reported that they gave expired FLUMIST QUADRIVALENT which occurred on 15-Jan-2014. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Mildly swollen, red area on upper left arm site measures 15cm vertical x 13 cm horizontal. Pt c/o headaches on 10/26/2005 pm. Pt c/o no itching.
Joint stiffness; Joint pain; Mobility decreased; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not applicable). The reporter is the patient. Other Case identifier(s): 22K-163-4257540-00 (Agency).  A 57 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at daily (unknown, daily (cf)) for rheumatoid arthritis. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "recovering" and all described as "COVID-19"; MOBILITY DECREASED (non-serious) with onset 17Feb2022, outcome "recovering", described as "Mobility decreased"; JOINT STIFFNESS (non-serious), outcome "recovering", described as "Joint stiffness"; ARTHRALGIA (non-serious), outcome "recovering", described as "Joint pain". It was reported that events of non-serious difficulty to move in the morning when it was cloudy and cold outside, Joint stiffness, Joint pain and COVID-19 with Humira (Adalimumab). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken for adalimumab was unknown.  Causality for Humira (adalimumab): The reporter's causality for the event(s) of Difficulty to move in the morning when it was cloudy and cold outside, Joint stiffness, Joint pain and COVID-19 with Humira (Adalimumab) was no reasonable possibility.  Causality for Pfizer BioNTech COVID-19 Vaccine: The reporter's causality for the event(s) of Difficulty to move in the morning when it was cloudy and cold outside, Joint stiffness, Joint pain and COVID-19 with Pfizer BioNTech COVID-19 Vaccine was not reported.  The reporter's assessment of the causal relationship of the covid-19, vaccination failure, Joint stiffness, Joint pain and Mobility decreased with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded.
Patient was admitted for lower extremity pain, swelling, and development of a blood blister. Hematoma was drained and pt was found stable for discharge
Rash starting on abdomen day of vaccine spreading to the chest and neck,non-pruritic, now self resolving
swelled elbow, very sore, hot, nausea, vomiting, chills;