chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Psoriasis is stopped; Fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis is stopped) and PYREXIA (Fever of 102) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis (Psoriasis stopped after fever resolved. Follow up: The moderna vaccine reset my immune system, no longer suffering from skin psoriasis).   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 10-May-2021, the patient experienced PYREXIA (Fever of 102). On 14-May-2021, the patient experienced PSORIASIS (Psoriasis is stopped). The patient was treated with IBUPROFEN at a dose of UNK dosage form. On 14-May-2021, PYREXIA (Fever of 102) had resolved. At the time of the report, PSORIASIS (Psoriasis is stopped) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) fever of 102 that lasted for 4 days..         Patient had used ointment as a concomitant as medication( name not provided).  The action taken for mRNA-1273  Moderna COVID -19 vaccine was not applicable.  Follow up: Treatment provided by doctor  was antibiotic and it took care of the infection within 4 days.   Patient stated The fever, it turned out to be a urinary infection and was prescribed medication which resolved the event. Patient also stated that the moderna vaccine reset the immune system, no longer suffering from skin psoriasis.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: The event 'Fever' turned out to be due to urinary infection. Added antibiotic as treatment for fever.The event ' Psoriasis is stopped ' turned out to be a current condition which got cured after taking vaccine as per patient's statement.
lt deltoid w/erythema & induration of 4.5cm x 2.5cm p/vax 4 days prior;tx DPH, warm compresses;
I noticed that my vision gets blurry looking at things and I'm lightheaded with no energy. My body feels weak and my legs feel numb. My knees lock up from time to time with a tingling sensation running down from my lower back to my legs. I also noticed I have hives near both of my elbows and I keep hearing a sharp ringing sound in my ears.
Spastic spontaneous involuntary movements of limbs, mainly (L) arm but randomly other limbs, (R) arm more than legs.
I got the shot on the first day of my menstrual cycle. About two hours after getting the shot, I experienced excessive bleeding for the next seven hours. For four of those hours I bled through a Tampon every half hour. In addition, to the bleeding, there was a lot of lower back pain, pain in the hips and general pelvic region.
Chills, nausea, vomiting occurred approx 24 hours after second shot and lasted several hours
10days after the vaccine my scalp was very itchy 8am the next day my entire upper body broke into red itchy hives  -still happening till this day Diagnosed  by the dermatologist with Hives today 01/28/2022
15 Minutes after second dose, patient starting feeling arm tingling and her body felt "heavy".  She was transported via wheelchair to exam table.  Was placed in a supine position.  Sensation dissipated in 15 minutes.  Was given Orange Juice and crackers.  Remained laying down for 30 minutes until all symptoms gone.  Was able to walk out of clinic with no ill effects.  Vasovagal reaction was determined to be the cause.
No adverse event; Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Sep-2022, 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 14-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL) 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 ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL).    No concomitant medication was reported.    Patient did not report any adverse events after the vaccine was administered.  No treatment information was reported.
Patient came in and requested Pfizer Covid-19 vaccine. She stated that she had discussed it with her MD. She received a Janssen Covid-19 vaccine 4/12/21. She received the Pfizer vaccine 7/22/21
CoughWheeze FATIGUE, TENDERNESS AND SWELLING AT INJECTION SITE Narrative:
an few hours after receiving the vaccination she developed tingling and numbness to feet and hands. The evening of the day she received the vaccine she developed difficulty swallowing.  Trout symptom resolved after 2 doses of benadrly and 8 hours.
About 5 minutes after the injection I get a tingling feeling all over my body.  That quickly subsides. Then my heart rate jumps from 75 to 140. My face goes flush and I feel like I am going to pass out. This happened on the first shot so I purchased a blood oximeter for my second and watched it closely. My blood oxygen never went below 96 and mostly remained at 98.  Once my pulse hit 140 it immediately began to fall back to 75. About the time the nurse I alerted got there is was back to normal. I do not feel sick at all after either shot. Sure wish I knew what this reaction I am having was.
gland swollen under injection arm; Gland under her right arm was swollen and hard. It hurt to the touch.; gland hurt to the touch; A spontaneous report was received from a consumer concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events gland swollen under injection arm, gland hard under injection arm, gland hurt to the touch.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 022M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced the event(s) gland swollen under injection arm, gland hard under injection arm, gland hurt to the touch.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), gland swollen under injection arm, gland hard under injection arm, gland hurt to the touch was unknown.
Information has been received from a pharmacist referring to a 19 years old patient. The patient's concurrent condition, medical history and concomitant therapies were not provided. On an unknown date, the patient received a booster dose RECOMBIVAX HB (strength reported as 10/1.0 microgram/ml, lot #, expiration date and route were unknown) 10 microgram instead of the 5 microgram. No adverse event was reported. No product quality complaint was involved. Additional information has been requested.
pregnant woman received the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (pregnant woman received the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 15-Apr-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (pregnant woman received the Moderna vaccine). On 15-Apr-2021, MATERNAL EXPOSURE BEFORE PREGNANCY (pregnant woman received the Moderna vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant was provided. Patient treatment information was not provided.
Pt experienced three raised coin shaped lesions on both arms and erythema. Symptoms resolved one month post vax.
I experienced irregular heart beat, shortness of breathe, chest pains. In result, have to have a cardiac abrasion done.
pt recvd Engerix-B on 28NOV90, 28DEC90, 28MAY92 & reported as being a nonresponder;
Dizziness, felt like was to pass out,  rapid heart rate all within a few seconds after injuction.
Mother described a rash 2 days post receiving the vaccine. She stated she thought it was contact dermatitis and applied cream. She did not take patient to PCP. The mother treated symptoms at home with Benadryl cream.
swollen lymphnode and pain under left arm pit. Tired, overall feeling bad. Lymphnode very painful.
High cholesterol, Flu like symptoms, headaches, incontinence, urinary, memory loss, numbness and tingling fingers, Sleep problems and feel not refreshed upon waking up, urinary frequency.
The patients said that she had chills and shaking all night long and with jerking of her left arm.
Patient given vaccine from punctured vial that was on the counter since 16Jul21 and administered on 30Jul2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given vaccine from punctured vial that was on the counter since 16Jul21 and administered on 30Jul2021) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given vaccine from punctured vial that was on the counter since 16Jul21 and administered on 30Jul2021). On 30-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient given vaccine from punctured vial that was on the counter since 16Jul21 and administered on 30Jul2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Immediate headache, fatigue, decreased appetite, body ache, dizziness, diarrhea, cough, sore throat
A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a 28-month-old female. Neither relevant medical history nor concomitant medication have been reported for this patient. The product expired on 19-Jan-2011. On 09-Mar-2011, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information received on 22-Apr-2011 and incorporated into case: no late occurring adverse events.
did not feel well; Aches; fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (173415). The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "did not feel well"; PAIN (non-serious), outcome "unknown", described as "Aches"; PYREXIA (non-serious), outcome "unknown", described as "fever". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
body aches; pain in left arm; Initial information regarding an unsolicited valid non-serious case was received from other health professional via consumer/non-health care professional via Medical Information (Reference number- 00762056) and transmitted to Sanofi on 09-Sep-2021.  This case is linked to case 2021SA300941 (same reporter).  This case involves a 48-year-old female patient who had body aches (pain) and pain in left arm (pain in extremity) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history, past vaccination, medical treatment(s), and family history were not provided.  The patient had no other concomitant vaccines.  On 08-Sep-2021, the patient received a 0.5 ml first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7319LA, expiry: 30-Jun-2022 and form: prefilled syringe) via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date the patient developed a non-serious body aches (pain) and pain in left arm (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The intensity of events was moderate to severe   It was reported "Caller asked for information regarding the product composition of FLUZONE QIV NP Prefilled syringes. Caller states that representatives from pharmacy administered FLUZONE QIV NP vaccines at her facility on 08SEP2021 and that 3 coworkers had adverse reactions to the vaccine. Caller asked if patients were having more site reactions this year and asked if anything was added to the vaccine. Caller states that switching from the prefilled syringe to the multi dose vial (MDV) containing preservative (FLUZONE QIV T) had relieved site reactions in the past. Caller provided information on 2 of 3 coworkers that experienced adverse reactions and stated that she would contact Medical Information when she obtained information on the third coworker. Caller states that she can be contacted by Sanofi Safety if further information is needed and asked for the direct phone number for Medical Information. This information is regarding the second of two reported patients that experienced an adverse reaction to FLUZONE QIV NP on 08SEP2021. Caller states that there was a third patient who experienced adverse reactions but that she does not have the information at this time and would call back. Caller states that a representative from pharmacy came to her facility on 08SEP2021 to administer FLUZONE QIV NP vaccines and that this patient experienced moderate to severe pain in left arm as well as moderate to severe body aches compared to past reactions. This patient was sent home to rest"  Caller also states that the representatives did not have a cooler for the vaccines and that they appeared out at room temperature when she saw them  No laboratory data was reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome of the events was unknown.
on 4/4/2021 around 2 PM I started to become very tired and my right upper arm started to develop a red mark which is itchy and swollen.  I also got very cold, chills and started to sweat.  by 5pm that same day I was running a fever of 101 degrees which lasted on and off until Tuesday 4/6 when the fever stopped.  As of 4/8/2021 at 1pm EST, the fever, cold sweats and chills are gone.  The arm is less swollen however it is till very itchy and red.  The redness is starting to not be as noticeable.
This case was reported by a nurse via call center representative and described the occurrence of fever in a 41-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date January 2020). The patient's past medical history included shingles. On 9th February 2018 10:45, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th February 2018, 8 hrs after receiving SHINGRIX, the patient experienced fever, muscle pain, fatigue and lethargy. The patient was treated with TYLENOL. On 12th February 2018, the outcome of the fever, muscle pain, fatigue and lethargy were recovered/resolved. The reporter considered the fever, muscle pain and fatigue to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the lethargy to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. Approximately 8 hours of administration of the SHINGRIX, the patient experienced a fever, muscle aches, lethargy and fatigue. On 9th February 2018, the patient's body temperature was recorded at 100.4 degrees Fahrenheit. The patient contacted the office by phone and TYLENOL was recommended. The symptoms were resolved by the third day after vaccine administration. The baby number of SHINGRIX (CZ4KL) did not exist and was updated to 3Z4KL, as per sales database.
Information has been received from a physician concerning a 62 year old female with a codeine allergy and a history of breast cancer 8 years ago, who on 10/12/06 was vaccinated SC in the arm with a 0.65ml dose of Varicella Zoster vaccine (lot 652966/0722F). Concomitant therapy included Vagifem. Concomitant vaccination included a dose of Influenza vaccine (unspec) given in the other arm on the same day. On 10/28/2006 the pt experienced fever blisters or cold sores on her lips. The pt was seen by a physician on 10/30/06, no lab or diagnostic test were performed. At the time of this report the pt had not recovered. no product quality complaint was involved. Additional information has been requested.
pt recv vax 3OCT96 & c/o dryness of mouth, throat felt different;seen in ER, dx systemic allergic rxn to vax;rx meds also felt chilly & nauseated, facial blotching;
Admitted with: mental status changes (confusion), urinary retention (recent TURP).  In the last couple of days he started having increased confusion.  He did not recognize family members.  This is very unusual for him. Generalized weakness. Lower back pain with pain radiating to left leg. DX: COVID, urinary retention. Actue metabolic encephalopathy, intractable lower back pain. Treatment: Foley catheter, pain management. Discharged to skilled nursing facility.
This spontaneous report was received from a pharmacist and refers to a 75-year-old female patient. The patient's pertinent medical history included unspecified pain. On 06-OCT-2016 (also reported as future date 16-OCT-2016), the patient was vaccinated with PNEUMOVAX 23 lot # L038522, expiry date 11-AUG-2017, in unspecified arm (dose and route were not reported) and unspecified influenza virus vaccine in the opposite arm. Concomitant therapies included unspecified prescription pain medication. Later, on the same day (also reported as future date 16-OCT-2016), she developed myalgia in the PNEUMOVAX 23 injection arm. The patient sought medical attention by pharmacist visit. The patient came back to the pharmacy on 07-OCT-2016, and stated that could not move her arm. The pharmacist inspected the arm and there was no redness, bumps or swelling at the injection site. The patient received unspecified treatment for the events. The outcome of the events was reported as not recovered at the time of the report. The relatedness between the events and PNEUMOVAX 23 was not provided. The pharmacist considered the event of 'could not move her arm' as disability. This is one of two reports received from the same source. Additional information has been requested.
Vasculitis; Anti-Body level was extremely high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient in his 40's received bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VASCULITIS (non-serious), outcome "unknown"; ANTIBODY TEST ABNORMAL (non-serious), outcome "unknown", described as "Anti-Body level was extremely high". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter stated that "A good friend of mine, roughly in his 40's, suffered similar side-effects from the Pfizer vaccine and his doctor diagnosed it as, I believe the term is, vasculitis. His recovery was swifter than mine because of his age". The reporter also stated that "My friend's doctor presented an important theory. By testing my friend's Anti-Body level (Body's immune response), he discovered that his Anti-Body level was extremely high, which meant, receiving the vaccine created more unnecessary Anti-Bodies and his immune system saw this more as an attack, and the response, was major inflammation".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
NO ADVERSE EVENTS REPORTED BY PATIENT, MONOVALENT WAS ADMINISTERED AS BOOSTER
Consistent chest pressure beginning day 3 after vaccine.  In good health with no previous heart issues.  Scheduled appointment with cardiologist.
pt recv vax 1OCT97 & 12DEC97 pt exp shingles @ T5-T6 anterior & posterior on the lt side & pruritus;lesions were dry & vesicular;
4 days after Booster Shot I had pain in calf.  Foot went numb and turned white.  Called my cardiologist office.  Had Doppler done, and went to hospital for emergency DX PV RT lower ext Angioplasty
Pt exp 1st dose of Hep B vax on 30MAY91; On 12JUN91 pt phoned MD office stating that for the past 2 wks pt had been exp flu-like sx characterized by weakness, sweats, rt upper quad pain, diarrhea, nausea & body aches; sx subsided;
TINGLING SENSATION; PAIN IN ONE LEG; HEADACHE ON AND OFF; BRUISING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On 04-MAY-2021, the subject experienced bruising. On an unspecified date, the subject experienced tingling sensation, pain in one leg, and headache on and off. The action taken with covid-19 vaccine  was not applicable. The outcome of the headache on and off, pain in one leg, tingling sensation and bruising was not reported. This report was non-serious.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: bruise-like (blueish-green) rash on right forearm-Medium
Pt stated her arm was sore and she felt fatigued after getting her booster shot so she went to bed.  When she got up the next day she was trying to eat breakfast when she noticed the left side of her jaw was cracking.   She said it felt like it was going to fall apart and it was very loud.  She rubbed the muscle under her ear which seem to help it.  This lasted about three days before subsiding.  She advised her PA of this.