chrisvoncsefalvay/vaers-outcomes huggingface dataset:
coughing; Fever; Chills; This is a spontaneous report from a contactable consumer (daughter). A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced coughing, fever, and chills on an unspecified date. Therapeutic measures were taken as a result of the events, which included paracetamol (TYLENOL) and unspecified steroids. The clinical outcome of coughing, fever, and chills was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is  32 years old,Unfortunately i had a worst experience with my first dose of Moderna, I got my first dose of Moderna on March 29 2021, My dizziness started 5 hours after getting the vaccine, and then i was feeling nausea, a day after on March 30 i felt a lot of pain under my belly, I did Urine pregnancy test at home and it was Positive, On April 1 My blood test pregnancy result was Positive too and showed i am 4 weeks pregnant, Everything was ok until April 10 that i  realized I?m bleeding so much, It was Saturday i went to ER , They did blood test and Ultrasound and said you had a Miscarriage ????????? without any medical problem, Your blood test is completely normal and Ultrasound doesn?t show any problem like cyst or anything, I told them that the only reason is could be my vaccine and they said i should reported to CDC. I am vvery very healthy person, No alcohol, No drug, don?t tell pregnant people this vaccine is safe please please.
Flu-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) as dose 2,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 04Apr2021, outcome "recovered" (07Apr2021), described as "Flu-like symptoms". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Health care professional (HCP) mentioned that there was incident because of miscommunication as a coworker told that There were some lot number whose expirations dates had been extended. Patients received expired doses from the lot numbers: 013f21a, 031h21a, 059h21a. HCP did not have more information at the time of the call. The patient received 2nd booster dose. Treatment medications were not reported.
Eye is red/half eye is red/Eye is blood shot red; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Eye is red/half eye is red/Eye is blood shot red) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 020B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OCULAR HYPERAEMIA (Eye is red/half eye is red/Eye is blood shot red). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, OCULAR HYPERAEMIA (Eye is red/half eye is red/Eye is blood shot red) outcome was unknown.            Concomitant product use was not provided by the reporter. Off branded Zyrtec by pharmacy took last night as treatment along with Flonase.
2nd dose of Moderna vaccine was given at 3 weeks instead of four weeks .  Patient denied any adverse reactions
On Thursday I present a rash at the level of the trunk and back similar to measles, no fever or any type of symptoms, only the rash, sensitivity in the area of ??the rash and a little itching ... even today 04 / 26/2021 I continue with the same rash despite having taken medications such as steroids, anti-allergies, even ivermectin prescribed by my primary doctor.
Patient mentioned that she felt short-ness of breathe.  Patient had vitals taken and asked to sit to relax as she kept standing during her time in the office. Patient was able to speak and communicate with MA.  Her vitals came back a little high and was asked if she had any chronic issues like Diabetes or BP which she replied, "No."  Staff informed patient that she would have to wait 15 additional minutes before being cleared.  Patient asked for water and it was provided. Patient was checked once more after 30 minutes and re took vitals.  Patient said she felt better and was cleared to leave.  Patient was called at approx. 5:30pm and she said she was doing a lot better.
pt recv 2 doses of vax & became violently ill & lab values indicated a lack of seroconversion;
" COVID-19 Vaccine EUA" Day 3 following injection 1-11-21--Difficult breating, chest pressure all day and night. Extreme fatique and weakness. Day 4 following---continued difficulty breathing and chest pressure continuous. Moderate fatique and weakness.  Day 5 following--- breathing difficulty improved significantly. Right arm muscle spasms and severe pain radiating to neck and chest and back (right side only), and stiffening of right hand and fingers. Tingling in are and pale color along with it feeling very cold. Small rash also at injection site. Moderate fatique and weakness. Day 6 following---breathing back to normal. Arm stiffening better.  Still severe pain in right arm, neck, chest and back muscles. Less fatique and weakness.  Day 7 following---Pain in right side of body continued. Chest tightness and cough started. 100 Temperature at 7pm. Fatique and weakness worsened.  Day 8 following--- Pain in right side of body continued w a little less severity. Chest tightness and cough w 99.8 temperature.  Day 9 -10following--- Pain in right side continues now with injection site (R arm) red, itcy and warm at site.  Days 11-18----symptoms at there least. Overall felt well. Day 19 following--- sore throat, heavy chest tightness and cough w slight breathing difficulty.  Day 20 following ---Severe body aches, cough, lowgrade fever of 99, Extreme fatigue. Sore throat. Difficulty breathing, moderately. Unable to work. Day 21 (today 1-29-21)---chest tightness, cough, lowgrade fever 99.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reproted. On 13-NOV-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J006831 and expiry date: 14-SEP-2014) which was improperly stored. Primary reproter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
itchy rash on right arm near injection site; itchy rash on right arm near injection site; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE PRURITUS (itchy rash on right arm near injection site) and VACCINATION SITE RASH (itchy rash on right arm near injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa drugs), Adhesive tape allergy, Ulcerative colitis since 1984, Hashimoto's disease since 1995, Blood pressure high since 2010, Osteoporosis since 2019 and Type 1 diabetes mellitus since 12-Feb-1978. Concomitant products included LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]) for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease, ALENDRONATE SODIUM, COLECALCIFEROL (FOSAMAX D) for Osteoporosis, INSULIN LISPRO (HUMALOG) for Type 1 diabetes mellitus, MESALAZINE (ASACOL HD) for Ulcerative colitis.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy rash on right arm near injection site) and VACCINATION SITE RASH (itchy rash on right arm near injection site). At the time of the report, VACCINATION SITE PRURITUS (itchy rash on right arm near injection site) and VACCINATION SITE RASH (itchy rash on right arm near injection site) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No treatment information was reported.   This case was linked to MOD-2021-027704, MOD-2021-027704 (Patient Link).
Rumuitoid Arthritis and ITP. Ra started in match ITP started in June.
Bell's palsy; Information has been received from a lawyer referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On 05-JUL-2013, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for routine health maintenance and the prevention of shingles (herpes zoster).   On 04-FEB-2014, the patient suffered debilitating injuries including an outbreak of painful shingles, facial paralysis, eye injuries, and was diagnosed with Bell's palsy. Since these initial injuries manifested, the patient still experienced facial paralysis, pain and other limitations. The patient did not recover from the event. As per the reporter, the patient sustained severe and disfiguring personal injuries, suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event was determined to be medically significant.
20FEB95 mom called MMR given 08FEB95 wk later 13FEB95 rash, fever 103, very fussy, fretful, sores in mouth daily; visit to local MD then referred to hosp 18FEB95 or 17FEB95 was told rxn to vax; adm to hosp IV fluids;
A non-serious spontaneous report of administration by mistake to child 1 yr and 7 months old was received from a health professional concerning a 19-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 08-Nov-2011, the patient received 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.
Difficulty breathing which lasted about 30 minutes. Unusal nose bleed. Migraine headache that lasted about 24 hours. By Saturday morning (12/04/2010) she was feeling better.
Patient received first dose Moderna vaccine on 1/13/21. Pt reported feeling itching to left hand approx 45 minutes after dose. Patient was instructed to ED if symptoms worsened. No further reaction was reported from patient. Patient had stated she had previous allergic reaction with Flu vaccine this year that resulted in ER visit.  Pt did take a dose of benadryl when hand itching started
15:45 PM: PATIENT RECEIVED VACCINATIONS AFTER COMPLETING HER HEALTH ASSESSMENTS: TDAP, HEP-B, COVID-19 & FLU 15:55 PM: PATIENT WAS D/C HOME AND DENIED FEELING ANY S/S OF NAUSEA, VOMITING LIGHTHEADNESS. 16:00 PM: PATIENT REPORTED FEELING LIGHTHEAD AND DIZZY AND NEEDED TO SIT DOWN. PATIENT WAS FOUND BY AN EMPLOYEE IN THE ELEVATOR SITTING ON THE FLOOR OF THE ELEVATOR. PATIENT WAS AWAKE AND ALERT. 16:02PM: PATIENT WAS ABLE TO WALK WITH ASSISTANCE TO A CHAIR NEAR THE ELEVATOR. 16:03 PM: STAT VITAL SIGNS TAKEN: B/P: 86/55, P: 62, SAT: 100% & T: 97.7F. LUNGS SOUNDS CLEAR AND NO ECTOPIC HEART TONES NOTED. 16:06 PM: PATIENT STARTED TO REPORT NUMBNESS TO HER THROAT AND SLIGHT DIFFICULTY SWALLOWING. PALLOR NOTED AND DIAPHORESIS NOTED. 16:09 PM: PATIENT GIVEN DIPHENHYDRAMINE 25MG IM X 1 TO L DELTOID. 16:15 PM: REPEAT SET OF VS: B/P: 109/80, P;82 & 100%, BLOOD SUGAR: 110. LUNGS CLEAR-BILATERAL. 16:20 PM PATIENT STATES SHE WAS FEELING BETTER AND NO LONGER FELT HER THROAT NUMBNESS OR DIFFICULTY SWALLOWING. 16:30PM: PATIENT WAS STABLE AND LEFT SITTING IN THE CHAIR WITH ROUTINE V/S TAKEN. 16:50 PM: ATTEMPTED TO HAVE PATIENT STAND UP WITH ASSISTANCE AND PATIENT EXPERIENCED ORTHOSTATIC HYPOTENSION. B/P DROPPED TO 75/55, P: 100. 16:51 PM: PATIENT WAS ASSISTED TO FLOOR AND PLACE IN TRENDELENBURG POSITION. B/P RECHECKED: 92/70, P: 84 O2 SAT: 100%. 16:52 PM: EMS ACTIVATED 16:53 PM: VS REASSESSED: 79/60, P: 72 & O2 SAT: 82% 16:54 PM: VS: REASSESSED: 90/62, P: 76 & O2 SAT: 100%. PATIENT WAS DENYING FEELING SICK OR SHORT OF BREATH. DENIED CHEST PAIN. 17:03 PM: EMS ARRIVED 17: 10PM: EMS COMPLETED ASSESSMENT AND OFFERED TO TRANSPORT TO MEDICAL FACILITY FOR FURTHER MEDICAL EVALUATION AND TREATMENT. PATIENT AND SPOUSE REFUSED. PATIENT STATED SHE FELT MUCH BETTER AND WANTED TO GO HOME. 17:1PM:  EMS ESCORTED PATIENT AND SPOUSE TO PERSONNEL VEHICLE. 17:20 PM: NO FURTHER INCIDENT NOTED.
pain at injection site, Lethargic stiff neck ringing in ears slight numbness left side of cheek chin area
Patient admitted due to SOB from receny COVID viral infection. CXR showed RLL airspace opacity, She was treated with nasal oxygen, IV remdesvir and decadron. Pt discharged home
Left arm redness 1/2" width and 2" length and warm to touch. Right arm redness 2" width and length and warm to touch. Tylenol administered.
No adverse event; 3 patients administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna bivalent; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (3 patients administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna bivalent) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (3 patients administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (3 patients administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (3 patients administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna bivalent).    No concomitant medication information provided. No treatment information provided.
(L) arm red, raised, warm to touch at injection site. Given methylprednisone, CLARITIN OTC.
Rigor chills. Body aches. Low grade fever. Head ache. Fatigue. All resolved 2 days later except headache which is persisting 4 days later without resolving
This spontaneous report as received from a nurse refers to a 17 year old male patient. On an unspecified date in MAY 2013, the patient was vaccinated with his first dose of GARDASIL intramuscularly, 0.5 ml (lot# unspecified). The patient fainted immediately and went into clonic movements for an unspecified amount of time after receiving GARDASIL. The patient sat in the physician's office for an hour after experiencing those symptoms. It was also reported that the patient's mom called the physician's office when they returned home from the physician's office and she reported that the patient was "okay". The patient did not seek medical attention and no treatment was given for the patient. The outcome of patient was reported as recovered/resolved. Additional information has been requested.
Patient experience lip numbness/tingling after 30 min of evaluation. Vitals stable, no swelling, no dyspnea. Patient took Benadryl and was continuously monitored. After 45 min, patient reported no longer having numbness/tingling to lips.
Tip and edge of tongue feels on fire, white scabs and very painful. No swelling occurred. I have not seen a Dr about this. I called the location of where I got the vaccine to see if I could speak to a Dr and they gave me a email to send questions.
Baby had temp of about 102 degrees F 24 hours after immun and (L) leg (HIB) swelled significantly at injection site. Reacted to 2 mo shots also.
Patient received Janssen COVID vaccine on 4/20/21. Patient was diagnosed with COVID 1/3/22. On 1/12/22, patient admitted to our inpatient med/surg unit with possible NSTEMI versus pericarditis versus myocarditis in the setting of COVID-19 pneumonia/infection and left adrenal mass/hemorrhage found incidentally in CT scan. Patient discharged home on 1/15/22.
Menstrual spotting outside of period; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955) via an unspecified route of administration in the right arm on 23March2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, obesity, anxiety, depression, mitral valve prolapses and allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccine within four weeks prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. On 25March2021, at 07:00 the patient experienced menstrual spotting outside of periods. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event menstrual spotting outside of periods was not recovered at the time of reporting.   No follow up attempts are needed. No further information is expected.
a little bit difficulty on breathing; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was unknown), via an unspecified route of administration on 25Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and had no reaction. On Jun2021, patient experienced a little bit difficulty on breathing. Patient asked should he/she go to the hospital right now. The outcome of the event was unknown.  Information about batch/lot number has been requested.
really tired; stomach issue; really bad cramps; diarrhea; alot of body ache; low grade fever; chills; Freezing; hardly work; cold; This spontaneous case was reported by a consumer and describes the occurrence of FREEZING PHENOMENON (Freezing), GAIT DISTURBANCE (hardly work), FEELING COLD (cold), ABDOMINAL PAIN UPPER (stomach issue) and MUSCLE SPASMS (really bad cramps) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product MELATONIN for an unknown indication.    Concomitant products included ENALAPRILAT (VASOTEC [ENALAPRILAT]), HYDROCHLOROTHIAZIDE, FAMOTIDINE, APIXABAN (ELIQUIS) and METOPROLOL for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started MELATONIN (unknown route) at an unspecified dose. On 26-Jan-2021, the patient experienced FREEZING PHENOMENON (Freezing), GAIT DISTURBANCE (hardly work), FEELING COLD (cold), MYALGIA (alot of body ache), PYREXIA (low grade fever) and CHILLS (chills). On 31-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach issue), MUSCLE SPASMS (really bad cramps) and DIARRHOEA (diarrhea). On an unknown date, the patient experienced FATIGUE (really tired). At the time of the report, FREEZING PHENOMENON (Freezing), GAIT DISTURBANCE (hardly work), FEELING COLD (cold), ABDOMINAL PAIN UPPER (stomach issue), MUSCLE SPASMS (really bad cramps), DIARRHOEA (diarrhea), MYALGIA (alot of body ache), PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include Vitamin C and Vitamin D. Treatment medications were not provided.
Dose 1: 29 minutes after vaccine adm. Pt complained of feeling light-headed and said she hadn't ate. Provided protien bar and juice but Pt continued to feel worse and developed a headache. 37 minutes after vaccine transported to ER for evaluation.  Narrative: Dose 1: Observation extented due to shellfish allergy. 29 minutes after vaccine adm. Pt complained of feeling light-headed and said she hadn't ate. Provided protien bar and juice but Pt continued to feel worse and developed a headache. 37 minutes after vaccine transported to ER for evaluation. No respiratory issues during this event.
PT had aa mild reaction with hives and itchy skin on her upper chest and face. No airway or breathing involvement. Pt given 25mg Benadryl, symptoms  began to resolve after 30-40 min.