chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Local reaction where vaccine was administered.  Rash and scabbing. Fever the next day.
Information has been received from a physician and a 22 year old white female certified medical assistant with latex allergy, drug hypersensitivity to pertussis and iodine allergy and a history of unspecified adverse reaction after first dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (at less than 1 year of  age. On 05-OCT-2006, at 4:00 PM,. the patient was vaccinated, into the right arm, with a first dose of HPV (lot # 653978/0955F). On 05-OCT-2006, at 4:00 PM, the patient experienced burning "as if the arm was cut with razor blade and alcohol was poured on cut," and it "hurt really bad." The patient also developed dizziness, numbness in her lower arm, fever, fatigue, and malaise. She reported that her arm swelled up 2 times the normal size and was red. She developed a dime size lump and redness at the injection site that was itchy when touched or pressed on. Unspecified medical attention was sought. At the time of the report, the dime size lump, redness and itching at the injection site persisted. No further information is available.
Patient's left hand is purple, as if bruised.  There is no loss of sensation,pain, or hot/cold feeling and has normal function.
This spontaneous report was received from a pharmacist refers to a 66 year old female patient with percocet allergy and hypertension. On 25-OCT-2013, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX, (lot number, expiry date and route was unknown), subcutaneous in the left arm. Concomitant medications included unspecified blood pressure medication. On 29-OCT-2013, (reported as today) the patient experienced bump underneath her left arm where her bra line comes across almost like a mosquito bite. The pharmacist stated that she does not think it was a lesion nor a beginning of a rash. The outcome of the event was reported as not recovered. The patient sought medical attention. Additional information has been requested.
Information has been received from a physician concerning her 14 year old female daughter was vaccinated on an unspecified date with her first dose of GARDASIL vaccine (yeast). A week later she the patient experienced fever of about 103 degrees, had a headache and her left arm had pain and difficulty moving. Subsequently, the patient recovered. No further information is available.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-NOV-2015 23:27, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 11.2 and 2.6 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Chest pain on inhalation of breath and shortness of breath, along with neck pain. Went to ER and was treated as either heart attack or embolism. Ruled out embolism but EKG showed some minor abnormality and was transferred by ambulance to another hospital for heart catheterization. No blockage was found. Meanwhile blood pressure remained unstable overnight but an echo cardiogram came back normal.
worsening of symptoms, flu like; worsening of symptoms, flu like; chills; fever; tired; achy; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 01Apr2021 at 10:00 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma, chronic obstructive pulmonary disease (COPD), hypothyroid and known allergy to penicillin. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT), tiotropium bromide monohydrate (SPIRIVA), levothyroxine sodium (SYNTHROID), losartan (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date. The patient previously took prednisone (MANUFACTURER UNKNOWN) for unspecified indication from unknown date and experienced drug allergy.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 11Mar2021 at 10:00 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 15:00, the patient experienced chills, fever, tired and achy. On 06Apr2021, in evening, the patient experienced worsening of symptoms, flu like and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, fever, tired and achy, worsening of symptoms, flu like symptoms were recovered on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Patient received the first dose of Adacel on 11/23/2021. The second dose was given in error on 12/7/2021.  The physician alerted the patient she had been given an extra dose of Adacel. Patient was counseled by physician.  Patient did not experience any adverse reaction.
Information has been received from a director of nursing at the facility concerning a male with spinal cord injury and quadriplegia who in the past (on unspecified date) was vaccinated with a dose of PNEUMOVAX 23. It was reported that on 02-NOV-2009, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose not reported, lot number: 663935/0528Y, expiration date 26-NOV-2009). The nurse stated, the patient developed 7 cm induration that was warm and hard to touch (approximately on 02-NOV-2009). The patient had a temperature of 102 degrees F for 3 days. The patient was seen by the physician and given antibiotic. No laboratory tests were performed. The symptoms resolved on 09-NOV-2009. The patient sought medical attention by visit the physician. This is one of several reports received from the same source. Additional information has been requested.
Shortly after my third dose, I have my annual physical.  Routine lab work showed blood glucose  in diabetic range of 221.  Since then, I have been on metformin and daily blood testing.
Nausea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old-non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7553), via an unspecified route of administration in the left arm on 26Mar2021 at 14:30 (at the age of 43-years-old) as a single dose for COVID-19 Immunisation. Medical history included paroxysmal supraventricular tachycardia. Concomitant medication included propranolol (MANUFACTURER UNKNOWN) from unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19.  On 26Mar2021 at 16:00 (within one and half hour after receiving the vaccination), the patient experienced nausea and headache. The patient reported that the events nausea and headache and It had been just over five hours and these symptoms persist. The patient did not receive any treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the nausea and a headache was not resolved.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse practitioner refers to a 12 month old male patient. On 10-MAR-2014, the patient was vaccinated with M-M-R II lot# H017027, expiry date 14-SEP-2014, 0.5 ml, subcutaneous. Other suspect therapies included VARIVAX (Merck) (lot # J007021 expiry date 05-JUN-2015) and MENACTRA (lot # U4418BA, expiry date 21-MAY-2014). On 10-MAR-2014, 1 day after onset of therapy the patient received M-M-R II and VARIVAX that were inadvertently reconstituted with MENACTRA. In March 2014, the patient experienced no adverse effect. The outcome of patient received M-M-R II and VARIVAX that were inadvertently reconstituted with MENACTRA and no adverse effect were unknown. The reporter did not assess the relationship between the events and M-M-R II and VARIVAX (Merck). Additional information has been requested.
Developed Oral Lichen Planus about a week after injection. Have tried various treatments with no success. Still suffering from it unfortunately and I am told there is no cure.
injection dates 11/22/21, 2/23/21, 3/19/21 pulmonary embolism, became short of breath on the morning of admission, presented to the ER and found to have a right sided PE. He was treated appropriately and admitted to hospital for further treatment and evaluation. taking Eliquis
the young man had received both doses of Comirnaty primary series as well as a booster dose; after a while his penis shrunk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose: 1), for COVID-19 immunization, reaction(s): "after a while his penis shrunk"; Comirnaty (Dose: 2), for COVID-19 immunization, reaction(s): "after a while his penis shrunk". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "the young man had received both doses of Comirnaty primary series as well as a booster dose"; PENIS DISORDER (non-serious), outcome "unknown", described as "after a while his penis shrunk".  Additional Information: A consumer reported for a male patient. Caller states he was calling regarding a side effect of the Covid-19 vaccine and stated he was not calling for him. He stated that he was calling for someone else that was really upset and bashful, stating that it seems his penis has shrunk. When caller was asked if he could complete report, he stated that the patient was not there, and he stated that he just found out about it about an hour ago. All he knew was that the young man had received both doses of Comirnaty primary series as well as a booster dose, and after a while his penis shrunk. The caller stated that the patient said he was really embarrassed and did not want to talk about it. Then, he finally did. Clarified that the caller had no further details to provide to complete the report.  Caller asked if there were other men that might have these problems with the vaccine. Investigation assessment was not provided. The event was reported as non-serious.  The lot number for bnt162b2 was not provided and will be requested during follow up.
14 year old boy presented office for administration of HPV#3. Patient subsequently after given vaccine to right deltoid area about less than a minute fainted, unresponsive, generalized pallor observed. After frequent stimulation about 30 sec regained consciousness, cooperative, pallor resolved. Given water, felt better. No O2 given.
getting lightheaded; Excessive hypertension/ 180/88 to 94; This is spontaneous report from a contactable nurse reported for herself. A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 21Mar2021 (Batch/Lot Number: ER8727) as 2ND DOSE SINGLE for covid-19 immunisation. Medical history included hypertension, paroxysmal atrial tachycardia, stroke when she was 40, had COVID in Mar2020 (Her cardiologist believes she had COVID too but never did a test) and broke her ankle. Concomitant medication included warfarin sodium (COUMADIN) because she had a stroke and broke her ankle and got a clot from her ankle to her groin; ongoing diltiazem hydrochloride (DILTIAZEM HYDROCHLORIDE) taken for paroxysmal atrial tachycardia and hypertension; Chlorthalidone taken for polyuria and hypertension; verapamil hydrochloride (VERAPAMIL) taken for paroxysmal atrial tachycardia for years. Patient received first dose of bnt162b2 on 28Feb2021 in left upper arm. Patient was a retired nurse and stated about a month after the second dose of the vaccine she started getting lightheaded, she went to Urgent Care because her daughter who is a nurse insisted. Her blood pressure at Urgent Care was really, really high, she was having excessive hypertension. Before the vaccine she was on a blood pressure medication for several years and had no issues. She went to see her cardiologist and they moved her from one medication to 3 medications (then add Losartan, Diltiazem) to get this controlled. In the morning she was lightheaded and her blood pressure is high before her morning medication. Diltiazem is 24 hours. She gets up at 3AM and once she takes the medication it seems to be ok. Her blood pressure is reasonable now. It is not like it was initially when elevated. Initially it was 180/88 to 94 when she first went to see the cardiologist after second COVID19 Vaccine. Currently her blood pressure in the morning is usually 154/ 77. That was when she first takes it when she gets up. Later in the morning it is running 110/77. The event outcome was unknown. She was feeling that it had to do with the second injection. Patient considered it was medically significant for high blood pressure and lightheaded, and considered both events related to COVID19 Vaccine.; Sender's Comments: Based on the known drug profile, there is a reasonable possibility of casual relationship between the drug BNT162b2 and the events Dizziness and Hypertension. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Welts - three small, raised, non-itchy welts on left arm, noticed at 5pm on date of dosage (5/9/2021), gone by 9pm.  Red marks on and around left breast noticed on 5/10/2021 around 7:30A. Still present but not raised.
I felt really cold and could not stop shivering starting at 8:00 pm.  Went to bed and woke up very dizzy with a headache.  General weakness / soreness for 24 hours (next day @ 8:00pm).
My sister got blood clots in her legs all three weeks after they got the modernist shot; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THROMBOSIS (My sister got blood clots in her legs all three weeks after they got the modernist shot) in a female patient of an unknown age 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) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (My sister got blood clots in her legs all three weeks after they got the modernist shot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (My sister got blood clots in her legs all three weeks after they got the modernist shot) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history who experienced the unexpected serious (medically significant) AESI of Thrombosis (blood clots in legs) which occurred unknown days after administration of a dose of mRNA-1273.222 bivalent vaccine. Other details are not reported for medical review. The benefit-risk relationship of mRNA-1273.222 bivalent is not affected by this report   This case was linked to US-MODERNATX, INC.-MOD-2022-689938 (Linked Report).; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history who experienced the unexpected serious (medically significant) AESI of Thrombosis (blood clots in legs) which occurred unknown days after administration of a dose of mRNA-1273.222 bivalent vaccine. Other details are not reported for medical review. The benefit-risk relationship of mRNA-1273.222 bivalent is not affected by this report US-MODERNATX, INC.-MOD-2022-689938:Daughter case
Have red, warm to touch, itchy and hard area where injection site is. Almost feels like a bad mosquito bite. Maybe fist size area.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administered vaccine underwent temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
This case was reported by a consumer via patient support programs and described the occurrence of bronchitis in a 67-year-old female patient who received Seasonal Influenza vaccine. Co-suspect products included Pneumococcal vaccine and ADVAIR inhalation powder for asthma and pneumonia. In 2015, the patient received Seasonal Influenza vaccine and Pneumococcal vaccine. On an unknown date, the patient started ADVAIR 500/50 ug 500 ug at an unknown frequency. In 2015, an unknown time after receiving Seasonal Influenza vaccine, Pneumococcal vaccine and ADVAIR, the patient experienced bronchitis, inflammation localized, feeling abnormal, respiratory disorder and sickness. The patient was treated with azithromycin. The action taken with ADVAIR was unknown. On an unknown date, the outcome of the bronchitis, inflammation localized, feeling abnormal, respiratory disorder and sickness were unknown. It was unknown if the reporter considered the bronchitis, inflammation localized, feeling abnormal, respiratory disorder and sickness to be related to Seasonal Influenza vaccine, Pneumococcal vaccine and ADVAIR. Additional details were provided as follows: This case was received from the healthcare provider via the vaccine patient assistance program. The patient was so sick with bronchitis and she came down with that like 2 weeks ago from reporting date. Around 14th December 2015, the patient saw her doctor was given a Z-pack-Azithromycin. It was 5 day pack that worked like she had taken that for a month. The patient also had inflammation in her chest and she felt yucky. In 2015, the patient had been pretty sick with upper respiratory stuff. No other dates or specific details were provided by the patient and she could not recall how long she was taking the ADVAIR 500/50 mcg. The patient also did not have diskus she was taking, she just had a box available and no batch number and expiry date were found.
15 yo F , previously healthy, received the Pfizer covid vaccine on May 15. within a week, she developed non-tender swelling in her L UOQ  of chest. the swelling worsened and became painful after second covid vaccine on June 5. seen first by me for this on June 8. recommended symptomatic care and saw her again for f/u appt today, June 14. clinically pt is back to baseline. no swelling and tenderness has resolved.
pt recvd vax & exp shoulder tenderness then could not lift arm; was shaking & had fever of 104; to er; tx w/ meds; admitted to hosp;
Vaccines administered 6-4-18 8:45 AM. Symptoms started 6-5-18 AM - C/O abdominal pain, muscle ache/cramps in calf right one mostly. 6-8-18 rash started on upper arms and abdomen. Rash is still present 6-13-18.
(L) arm swollen, red, painful. Warm compresses, antibiotics, CT scan.
Slight dizziness; A spontaneous report was received from a consumer concerning a 73-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events slight dizziness/dizziness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the event(s) slight dizziness.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 12 Feb 2021 the outcome of event(s), slight dizziness was resolved.
Patient dizziness, diaphoretic, syncope, nausea taken to room to lay down.  Vitals taken, water given per patient request, ice pack to neck.  Pt. discharged stating they feel better.
Left arm soreness within hours of injection of second dose. Starting the following morning systemic flu-like symptoms: weakness, headache, body aches, dizziness, and extreme fatigue.  Symptoms resolved in appx. 24 hrs.
pt recv 2 doses of vax 11SEP95 & 12OCT95 & 13NOV95 lab eval revealed varicella antibody 1.31, which was noted to be a low positive;repeat lab eval 11DEC95 was neg for varicella antibody;
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with improperly stored doses of doses of GARDASIL 9 lot number N004799 and expiration date of 15-NOV-2019 for prophylaxis (dose and route of administration were not reported) and M-M-R II rHA lot number L040960 with an expiration date of 16-OCT-2017 and lot number M045402 with an expiration date of 14-NOV-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006363: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006373: US-009507513-1710USA006357: US-009507513-1710USA006355: US-009507513-1710USA006356:
Fever, Tachypnea, HYPERtension, Tachycardia & HYPERglycemia Narrative:  Was inpatient overnight in a telemetry until. DC with diagnosis of DM and CHF