chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Provider:  Primary Care Provider :  Admission Date: 9/10/2022 Discharge Date: 09/13/2022  PRESENTING PROBLEM: COVID-19 virus infection   HOSPITAL COURSE: 81 y.o. male presents after fall with head injury complaining of weakness and noted to be covid positive. CT head obtained in the ER showed no acute intracranial abnormalities. Pt reports that he believes his sx started 3 days ago. He is otherwise a poor historian and reports that he does not remember much about his past medical history. He has not been to see his PCP in awhile. He denies taking any medications at home for the past two years but daughter states he was taking when she visited in June 2022. Of note he lives by himself at home and reports being able to walk around on his own and up and down flights of stairs without assistance.   Hypoxic with ambulation; initiated on Decadron as well as remdesivir for management of COVID infection to prevent severe illness.  Chest x-ray is clear. Improved and patient requested discharged on 9/13. Will complete 10 total days of decadron currently on day 4 of 10 today; completed 3 days of Remdesivir. Per nursing no longer hypoxic with ambulation.    Of note spoke with patient and daughter regarding indication of Eliquis for stroke prevention in a.fib with elevated chads2vasc score of 3; explained risks benefits of Eliquis including stroke rest and benefits; patient and daughter expressed understanding; patient refusing to resume Eliquis at this time and states that he "stopped taking 4-5 years ago given bloody urine"; he also stated that he will "talk to his primary care provider regarding restarting Eliquis." Daughter also aware of this plan.    Patient in agreement with HHC (nursing, PT/OT) as advised by PT/OT; care manager arranged HHC prior to discharge.
Woke up on 5-12 feeling fine went to work by 10 AM started to feel sick, nausea, chills, maybe fever (patient had no thermometer) left work went home around 4:30 threw up.
Sore arm; Received second dose in 23 days window; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose in 23 days window) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) and ATOMOXETINE HYDROCHLORIDE (STRATTERA) for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-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 PAIN IN EXTREMITY (Sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose in 23 days window). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose in 23 days window) had resolved. Not Provided          No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received included reporter contact details (email ID updated).
Well child visit-pulled immunization from stock-HepA-HAVRIX-Failed to read age on box and gave adult dose which is twice the vaccine amount.
erythema, swelling, pruritus, warm to touch, in appex 2.5 - 3 inches radius from injection site on left deltoid area
2 inch x 2.5 inch bruise around the injection site.  Darker bruise at the actual site (1 inch x 1.75 inches) and fanning outward, lighter in color.  Minor discomfort only on the day after injection.  Sleepy for a couple of days, but feeling fine. No pain there now.  I wouldn't have noticed it if I hadn't looked. The only concern is that it has been 6 days since the injection.
Site was red and swollen for about 4 weeks, and it was hurtful to lie down on that side of the arm. She took tylenol and ice to help. The site was red and swollen like a ball per patient.
Measles-like rash on right arm (injection arm).; Raised bumps or spots; Itchy; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8737) via an unspecified route of administration in the right arm on 30Mar2021 at 10:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to a number of foods. Concomitant medications included the second dose of varicella-zoster vaccine rge (SHINGRIX) on15Mar2021 for Varicella 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. On 30Mar2021 at 14:00, the patient experienced a measles-like rash on the right arm (injection arm). 30 itchy, raised bumps or spots. The patient did not receive any treatment for the reported events. Events did not result in doctor or other healthcare professional office/clinic visits and the emergency room/department or urgent care. The clinical outcome of the events measles-like rash on the right arm (injection arm, itchy and raised bumps or spots was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Prolonged period, lasted 5 months non stop. Had to be put on multiple birth controls at once to correct issue
Couldn't take a full breath for about an hour or two. Went to urgent care where they noted acute bronchospasm, administered Dexamethasone 10mg and Duo nebulizer treatment. Didn't have any other reactions after being discharged but was told to go to the ER if bronchospasm returns.
After receiving / vaccine / I suffer from systematic outbreaks monthly; Acyclovir for prevention is no longer working; This case was reported by a consumer and described the occurrence of herpes simplex reactivation in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included acyclovir unknown for herpes simplex.   Previously administered products included Shingrix (1st dose received in June 2019). Concurrent medical conditions included herpes simplex (was managing it since from past 30 years).   In September 2019, the patient received the 2nd dose of Shingrix. On an unknown date, the patient started acyclovir 400 mg once daily (400 mg daily). On an unknown date, less than a month after receiving Shingrix and not applicable after starting acyclovir, the patient experienced herpes simplex reactivation and lack of drug effect. Acyclovir was continued with no change. On an unknown date, the outcome of the herpes simplex reactivation and lack of drug effect were unknown.   It was unknown if the reporter considered the herpes simplex reactivation to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient stated, she had been taking Acyclovir (400 mg daily) for suppression or prevention of Herpes simplex for 30 years and was able to manage outbreaks to a minimum. However, after the final vaccination, she was suffering from systemic outbreaks of HSV monthly and acyclovir was no longer working. She needed to increase dosage of acyclovir. The patient asked if, the GlaxoSmithKline have any similar findings on similar situation and asked recommendations.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR058851:Same reporter
Information has been received from a physician concerning a 12 month old pt who was vaccinated SC once with a 0.5mL dose of varicella virus vaccine live. The physician reported that the pt broke out with shingles one week later. No other details were provided regarding the adverse event or the pt's outcome. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
Initially on Friday onset of diarrhea, followed by fever to 101 if I remember correctly maybe slightly above that, cough, debilitating fatique and bone aches and chills and headaches lasting  until almost 5 January. Second shot administered 01-18/2021 Pfizer Lot #EL3249 - again, significant fever, terrible chills and bone aches lasting  approx 4-5 days.
This case was reported by a healthcare professional and described the occurrence of rash in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 November 2008, the subject received a dose of FLULAVAL (unknown). In November 2008, more than 48 hours after vaccination with FLULAVAL, the subject experienced rash. The healthcare professional reported a female subject experienced a rash (not at the injection site) after receiving FLULAVAL. The rash occurred more than 48 hours after receiving the vaccine. The reporting healthcare professional did not believe the rash was related to the FLULAVAL vaccination. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was not related to vaccination with FLULAVAL. The healthcare professional reported five other subjects adverse events with FLULAVAL. See cases, A0759344A, A0759347A, A0759349A - A059351A. Follow-up information received on 06 January 2003 indicated that about one week after receiving FLULAVAL the subject developed a rash described as 2 or 1 spots on the arms. The spots were diagnosed as ring worm and resolved an unspecified amount of time later. The events wer not ocnsidered related to treatment with FLULAVAL.
This case was reported by a pharmacist and described the occurrence of expired vaccine used in a 27-year-old female patient who received BOOSTRIX (batch number unknown, expiry date 21st June 2014). In July 2014, the patient received BOOSTRIX. In July 2014, an unknown time after receiving BOOSTRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information: Per HCP: an expired dose of BOOSTRIX was administered to a patient back in July.
Single hive on bettly/Hive an inch below injection site/Hive on face above eyebrow; Intense itching above injection site; Splotchy rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Single hive on bettly/Hive an inch below injection site/Hive on face above eyebrow), VACCINATION SITE PRURITUS (Intense itching above injection site) and RASH (Splotchy rash) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Single hive on bettly/Hive an inch below injection site/Hive on face above eyebrow), VACCINATION SITE PRURITUS (Intense itching above injection site) and RASH (Splotchy rash). At the time of the report, VACCINATION SITE URTICARIA (Single hive on bettly/Hive an inch below injection site/Hive on face above eyebrow), VACCINATION SITE PRURITUS (Intense itching above injection site) and RASH (Splotchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-090160 (Patient Link).
rash; This spontaneous case was reported by a nurse and describes the occurrence of RASH (rash) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 immunization.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash). At the time of the report, RASH (rash) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported. Treatment medication not reported.   Reporter did not allow further contact
Information has been received from a registered nurse concerning a female (age unreported), with no specified medical history or drug allergies, who on unspecified dates was vaccinated with the first and second dose of GARDASIL.  On 14-MAY-2008, the patient received her third dose of GARDASIL, (lot # not reported).  On 15-MAY-2008, the patient developed a temperature of 101 degrees Fahrenheit, a headache, and body aches.  The patient went to the emergency room on an unspecified date and her temperature reached 104 degrees Fahrenheit.  On an unreported date, she had laboratory tests to check for meningitis, no results were provided.  No treatment information has been provided.  At the time of this report the patient was recovering.  Additional information has been requested.
STARTED THE DAY RECIVED RED , PUFFY , ITCHY . THURSDAY IT STARTED AS A SMALL RASH. LATER THAT DAY ARM BROKEN OUT IN BIGGER RASH. SUNDAY MORNING RASH WAS ON FACE MORE SO EYES, EARS , AND CHEST. WENT BACK SUNDAY THE 16TH TO RECIVE STERIODS. CALMED DOWN ON 17TH OF JANUARY.
Pediatric dose (0.25 mL) of FLUZONE QUADRIVLANET was administered to adult patient instead of full dose (0.5 mL). Patient will return to the clinic later the same day to receive an additional 0.25 mL dose.
Patient was light headed she was given the option to be seen at hospital and she refused. She was given water and crackers and watched until she felt better. Family friend drover her home.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 13:00 as dose 5 (booster), single (Lot number: gj3277), in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: el9265), in right arm, on 18Feb2021 as dose 2, single (Lot number: en9581), on 19Nov2021 as dose 3 (booster), single (Lot number: fe3596) and on 15Jul2022 as dose 4 (booster), single (Lot number: fm0173), in right arm for covid-19 immunisation. The patient had no relevant medical history. No Known allergies. Concomitant medication(s) included: MULTI VITAMIN ELITE; CALCIUM CITRATE; CO Q10; BABY ASPIRIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment included Paxlovid from 01Sep2023 to 05Sep2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300299746 Same patient/drug, different dose/AE.;
Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female pregnant patient with no pertinent medical history and no drug reactions or allergies, who on 31-AUG-2010 was vaccinated with the first 0.5 ml dose of GARDASIL intramuscularly (lot number not reported). Then on 09-NOV-2010 and 19-MAY-2011 she received her second and third 0.5 ml doses (lot numbers not reported), respectively. There was no concomitant medication. It was stated that on 13-JUN-2011, the patient reported that she was pregnant. A monoclonal pregnancy test was performed on an unspecified date. Follow-up information has been received for GARDASIL, a Pregnancy Registry product, in which the estimated due date was reported as approximately March 2012. Last menstrual period (LMP) was approximated to an unknown date in 2011. Additional information has been requested.
Axillary arm pain on side of administration of second dose; Itchy on arms and side; This is a spontaneous report from a contactable other hcp (patient). A 41-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 25Mar2021 at 09:15 AM (at the age of 41-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no 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 did not receive any other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 04Mar2021 at 09:15 AM as dose 1, single for COVID-19 immunization and experienced diarrhea. On an unspecified date in Mar2021, the patient experienced axillary arm pain on side of administration of second dose, itchy on arms and side. Verbatim and Event description: axillary arm pain on side of administration of second dose, itchy on arms and side. First dose diarrhea. The patient did not receive treatment for the events. Outcome of the events was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Difficulty breathing, swelling, fever,  tiredness, headache, muscle pain, chills, joint pain, fever, nausea
Moderna COVID- 19 Vaccine EUA  There is no adverse event at this time.  After the client left, it was discovered that he had a Shingrix on 01/20/2021, 13 days before the Moderna vaccination on 02/02/2021.  He had told staff doing the scheduling the wrong date of the immunization.  The client did call us today.  He did not sign up for V-Safe.  He is not having any side effects from the Moderna immunization.
arm went sore but was not indicated whether it was on her first or second shot; On her first shot, she experienced increased heart rate (reached 133) and stomach ache; On her first shot, she experienced increased heart rate (reached 133) and stomach ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "blood disorder " (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm went sore but was not indicated whether it was on her first or second shot"; HEART RATE INCREASED (non-serious), ABDOMINAL PAIN UPPER (non-serious), outcome "unknown" and all described as "On her first shot, she experienced increased heart rate (reached 133) and stomach ache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated that she was on a blood thinner. On her first shot, she experienced increased heart rate (reached 133) and stomach ache. Caller also stated that her arm went sore but was not indicated whether it was on her first or second shot. Caller said that she was on a blood thinner and has been for 2 years and they never mentioned anything about it when they gave her the vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient got left arm swollen with blisters, severe bleeding itching and pain. Also was affected almost whole body back and head. she saw MD and was given DOXYCYCLIN 100 mg BID for 10 days and MUPIROCIN 2 % ointment to apply on the body.
1/24/22 presents with Covid exposure, and having cough and headache since Friday. No fever.  Review of Systems  Constitutional: Negative for activity change, appetite change, chills and fatigue.  Respiratory: Positive for cough.   Neurological: Positive for headaches.  Constitutional:      General: She is not in acute distress.    Appearance: Normal appearance. She is well-developed. She is obese. She is not ill-appearing, toxic-appearing or diaphoretic.  HENT:     Head: Normocephalic.     Nose: Congestion present. No rhinorrhea.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear. Uvula midline. No oropharyngeal exudate or posterior oropharyngeal erythema.  Eyes:     Conjunctiva/sclera: Conjunctivae normal.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No decreased breath sounds, wheezing, rhonchi or rales.  Skin:    General: Skin is warm.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal. Behavior is cooperative.
Pt came in to clinic was down for Tdap, FLUZONE, meningococcal and varicella. After pt left and I was logging vaccine I noticed I had given ZOSTAVAX instead of varicella. No symptoms.
a rash above and below the injection site with hives on the arm of the injection site; arm itchy; hives on her shoulder above and below the injection site; red; sore arm/pain in the left site; rash in her hand; a rash above and below the injection site with hives on the arm of the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (a rash above and below the injection site with hives on the arm of the injection site), INJECTION SITE URTICARIA (a rash above and below the injection site with hives on the arm of the injection site), PRURITUS (arm itchy), URTICARIA (hives on her shoulder above and below the injection site) and ERYTHEMA (red) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM and VITAMINS NOS for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE RASH (a rash above and below the injection site with hives on the arm of the injection site). On an unknown date, the patient experienced INJECTION SITE URTICARIA (a rash above and below the injection site with hives on the arm of the injection site), PRURITUS (arm itchy), URTICARIA (hives on her shoulder above and below the injection site), ERYTHEMA (red), VACCINATION SITE PAIN (sore arm/pain in the left site) and RASH (rash in her hand). At the time of the report, VACCINATION SITE RASH (a rash above and below the injection site with hives on the arm of the injection site) and INJECTION SITE URTICARIA (a rash above and below the injection site with hives on the arm of the injection site) outcome was unknown and PRURITUS (arm itchy), URTICARIA (hives on her shoulder above and below the injection site), ERYTHEMA (red), VACCINATION SITE PAIN (sore arm/pain in the left site) and RASH (rash in her hand) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Benadryl and cortisone cream.  Concomitant medication included thyroid pills.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: Route of administration, patient details, treatment information and events updated.