chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site reactions like itching; Tenderness in the right arm; Redness in the right arm; Swelling in the right arm; Injection site reactions like pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site reactions like itching), VACCINATION SITE PAIN (Injection site reactions like pain), VACCINATION SITE PAIN (Tenderness in the right arm), VACCINATION SITE ERYTHEMA (Redness in the right arm) and VACCINATION SITE SWELLING (Swelling in the right arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE PAIN (Injection site reactions like pain). On 06-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness in the right arm) and VACCINATION SITE SWELLING (Swelling in the right arm). On 13-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site reactions like itching) and VACCINATION SITE PAIN (Tenderness in the right arm). On 05-Apr-2021, VACCINATION SITE PAIN (Injection site reactions like pain) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Injection site reactions like itching), VACCINATION SITE ERYTHEMA (Redness in the right arm) and VACCINATION SITE SWELLING (Swelling in the right arm) had not resolved and VACCINATION SITE PAIN (Tenderness in the right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Fever 100.5 feeling weak, sick (+) body aches (+) headache.
shingles; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3247), via an unspecified route of administration on 01Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On Thursday, 11Feb2021, he developed shingles. He is scheduled for his second shot on 26Feb2021. He planned to discuss further with his doctor. The outcome of the event was unknown.
MEDI-0004973 is a Not Serious Spontaneous case from a Consumer involving VACCINE EXPOSURE DURING PREGNANCY: (Unlabelled). The reporter causality is Possible to FluMist. A 39-year-old female who is 14-weeks pregnant (obtained via ultrasound) received FluMist on 28-Sep-2006 from her child's pediatrician. A few hours after receiving the vaccine, the patient developed mild sore throat, mild headache and mild fatigue. There were no changes in symptom intensity and the symptoms dissipated on their own without any medical interventions. Sore throat was fully resolved on 30 Sep-2006. Headache and fatigue completed dissipated on 02-Oct-2006. After receiving the vaccine, the patient was told by her obstetrician that a "pregnant woman should not be receiving FluMist* vaccine. After hearing this statement and "reading up on FluMist," patient became "quite concerned and became very anxious." Patient attributed developing anxiety to "worrying about the possible effect FluMist may have on my (unborn) baby." This patient was G4P2 with a history of one elective abortion in April, 2006 for Down Syndrome. Her last menstrual period was 21-Jun-2006 and her estimated date of delivery was 30-Mar-2007. The patient denied having any history of medical problems. She denied taking any medications (prescribed and over the counter) during her pregnancy. The patient stated her anxiety persisted throughout her pregnancy. Her anxiety resolved after she delivered a healthy baby boy via scheduled caesarian-section on 21-Mar-2007. She stated that there were no complications during her pregnancy or during the birth of her baby. The baby "is doing well." The reporter causality is possible to FluMist. 27-Jun-2007: Follow up information obtained and incorporated in above narrative: information regarding clinical outcome.
Patient called complaining of pain in her arm since her injection 2 wks ago. The pain has been getting worse and is affecting her sleep and hurts when she gets dressed. She said she was going to call her doctor about it. No redness or inflammation present.
pt recv vax 9APR96 & that day pt exp SOB, inc BP & anxiousness;pt was treated w/DPh;pt recovered;
Redness, pain and swelling to Right arm...swelling approx. 20cm x 20cm per physician office...
This spontaneous report as received from a Licensed Practical Nurse refers to 16 year old female patient. The patient previously received one dose of varicella virus vaccine live (unspecified). On 29-JUN-2018 the patient was vaccinated with improperly stored VARIVAX from lot R002051 expiry date 22-JAN-2020, subcutaneous in the left arm for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019,lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The reporter was not sure which sterile diluent (manufacturer unknown) lot numbers were used.  The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1807USA007589.
Swollen face especially eyes, fever 101.1, swollen glands in face. Neck, ears, throat, swollen tonsils, joint pain, sporadic pain in right arm and right leg, fast heart beat when in motion. Can't sleep from all the pain.
This case was reported by a consumer via call center representative and described the occurrence of sickness in a 91-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included squamous blepharitis. On 7th September 2018, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced sickness, injection site erythema, injection site itching, decreased immune responsiveness, topical adhesive allergy, red face and cold. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the injection site erythema, injection site itching and decreased immune responsiveness were not recovered/not resolved and the outcome of the topical adhesive allergy, red face and cold were unknown. It was unknown if the reporter considered the sickness, injection site erythema, injection site itching, decreased immune responsiveness, topical adhesive allergy, red face and cold to be related to Shingrix. Additional details were provided as follows: The patient had removal of squamous cells from face before receiving Shingrix. After receiving second dose of Shingrix on the 7th of September, she had a tremendous reaction to it. She could not remember the exact symptoms but she was very sick and it took a long time to recovered. At the time of report, she still had the redness and itching at the injection site which came from time to time. She also feels like Shingrix changed her immune system. She is very susceptible to colds normally and recently she felt like coming down with the cold, she took some cold medicine and it went away and this was not normal for her. She also mentioned having some squamous cells removed from her face recently and it was fine but she experienced a terrible allergy reaction to the telfa pads on the side of her temple and she has never had that before. She experienced some redness on her face: on her eyelid, eye, upper part of cheeks and around eye socket. Her physician said that all those symptoms were a result of allergy to telfa pads. The patient consented to follow up with her physician.
Information regarding Prevnar was received from a healthcare professional regarding a 30-month-old female patient who experienced streptococcal pneumoniae bacteremia and pneumococcal pneumonia with pleural effusion. The patient received the fourth dose on an unspecified date. The patient's concurrent illness includes cough (05-Feb-2008-treated with oral Keflex). Concomitant therapy included Keflex (cefalexin monohydrate). On 07-Feb-2008, the patient was hospitalized with streptococcal pneumoniae bacteremia and pneumococcal pneumonia with pleural effusion after a two-day history of cough. The child was not able to walk and was not drinking. A blood culture was performed which identified Streptococal pneumoniae, serotype unknown. The child was treated with intravenous antibiotics cefixime and Vancomycin and discharged to home on intravenous antibiotic Levofloxacin. The physician noted that the child's parents had reported that the child had been fully immunized, however, no medical records had been forwarded. As of 05-Mar-2008, the patient had recovered. Blood culture was done on 07-Feb-2008. No additional information was available at the time of this report.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received bnt162b2 (BNT162B2), on 19Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "sulfa drugs." (unspecified if ongoing), notes: Sulfites and sulfa drugs. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Aug2023) Positive, notes: Tested positive for Covid on 28Aug2023; (03Sep2023) Negative, notes: Tested negative on Sunday, 03Sep2023; (07Sep2023) Positive, notes: Tested again on 7Sep2023 and was positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was tested positive for Covid on 28Aug2023. Patient  started Paxlovid next day, 29Aug2023. Tested negative on Sunday, 03Sep2023. Started feeling sicker again approx 06Sep2023. Tested again on 07Sep2023 and was positive again. Symptoms of rebound Covid are as bad (if not worse) than first time.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
a rapid heart rate for 6months/Fast heart rate after second shot; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (a rapid heart rate for 6months/Fast heart rate after second shot) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart murmur.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-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 PALPITATIONS (a rapid heart rate for 6months/Fast heart rate after second shot). At the time of the report, PALPITATIONS (a rapid heart rate for 6months/Fast heart rate after second shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) Normal.         No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-416123 (Patient Link).
On 6/23/21 patient suffered from a STEMI. Cath did not show any major occlusions so thought to be plaque rupture vs vasospasm.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Additional Details: Pt was given the Shingrix vaccine and states she begin to "see stars" and feel dizzy/lightheaded. Pt was monitored while resting in upright position in chair. Patient never lost consciousness and did not get rash, shortness of breath, clammy skin, etc. Pt took blood pressure several times and was moderately elevated at ~160/95. Pt was seated in pharmacy area for 2 hours and never got any other symptoms, but BP remained slightly elevated. Pt took BP monitor home. Husband with her to monitor.
Swollen lymph node in my left armpit which has been causing pain all day if arm is at side; Fever 100.6 one day after vaccine; Extreme fatigue resulting in having difficulty caring for my children; Sore arm; Headache; Back pain; Neck pain; Nausea roughly an hour after vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 14Jun2021 at 17:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received clarithromycin (MANUFACTURER UNKNOWN) on unknown dates for an unknown indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 24May2021 at 17:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 14Jun2021 at 18:30, roughly an hour after vaccination, the patient experienced nausea. On 15Jun2021, one day after vaccination, the patient experienced fever of 100.6, extreme fatigue which resulted in having difficulty caring for her children, sore arm, headache, back and neck pain that required ibuprofen to be able to move without pain. These effects only lasted about 24 hours. On 16Jun2021, the next day, the patient awoke with a swollen lymph node in her left armpit which had been causing pain all day, if her arm was at her side. It required ibuprofen and cold compresses to treat. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea was resolved on 15Jun2021 at 18:30 while fever 100.6, extreme fatigue, sore arm, headache, back and neck pain were resolved on 16Jun2021. The clinical outcome of the swollen lymph node in her left armpit which had been causing pain all day was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
After vaccine vaccination, patient has vasovagal syncope. Patient states swelling of tongue, blurry vision, nauseous hands tingling, dizzy and lightheaded. Called code green, paramedics arrived. Laid patient down flat down on cot. Patient is stable.  BP 106/67  98% o2sat  HR 65  RR 16
arm is sore; Initial information received on 13-Sep-2023 regarding an unsolicited valid social media non-serious case received from consumer/non-hcp.  This case involves Adult and unknown gender patient who had arm is sore after receiving influenza vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  Concomitant medications included RSV vaccine for Immunisation.  On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, batch number, expiry date unknown) via unknown route in unknown administration site for Prophylactic Vaccination (immunization).  On an unknown date the patient had arm is sore (pain in extremity) (unknown latency) following the administration of influenza vaccine.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (arm is sore).  At time of reporting, the outcome was Unknown for the event arm is sore.
1) blood clots in left thigh, sore muscles, blurry vision, dizzy when sitting up after laying down, blood clots in left forearm, headache. Some of these symptoms are still present.
Patient stated she "got shingles" from the vaccine and had the signs and symptoms of shingles. Diagnosis was not confirmed or treated by a healthcare professional.
Service member reports having an episode of right sided chest pain (4/10), described as aching pain just to the right of my breastbone that resolved without medication in about hour. He awoke the next morning with the pain that persisted for approximately 1 hour then resolved. Later that evening the pain returned a larger area higher up in my right chest under my collar bone described as a dull constant pressure (6/10). He denies any radiation of pain or accompanying symptoms (SOB, HA, Nausea, diaphoresis). He self medicated with Ibuprofen 1 tablet Q 3-4 hrs I took about 3 and consider going to the ER between 12 MN and 1 AM. Instead he was able to fall asleep. The next morning he awoke pain free, but within 1 hour the pain returned (l/7-10) dull, constant, pressure and he sought evaluation at ER where he had an abnormal EKG, and elevated Troponin levels and was admitted. pain  2/17/06 medical records received with initial report revealed patient experienced chest pain, abnormal labs, abnormal EKG, dilated left ventricle, decreased ejection fraction, hypokinesis, mitral regurgitation, tricuspid regurgitation, pericardial effusion, Tietze's disease, rhinitis, dermatitis.  Family hx: MI & Hepatitis C/ss. 60 Day Follow-up Information 04-MAY-2006: Pt. reports he is completely pain free today. He does describe periodic "twinges of chest pains" no specific location, 1-2/10 on the pain scale lasting "maybe 5 seconds, in no specific pattern - not like the pains I had when I went to the hospital". Follow up received 04/09/2007. Last spoke with service member 19 Oct 06. He said that he was "feeling great" with occasional chest pains he characterizes as "twinges". He was cleared for full duty and scheduled to deploy 20-21, Oct 06.
Her husband came in 10/12/23 around 9:30 am and stated that she has had hives since her vaccination with Arexvy on 9/16/23.  He stated that the hives started about a day later all over her body and have continued since then.  She went to urgent care and was given a course of prednisone that did not resolve the hives.  They then went to the ER around 10/1/23 (he does not remember the exact date) where she was given more prednisone.  She has an appointment on 10/16 with either a dermatologist or an allergist (he is not sure).
Strep throat (10 days post 1st dose) Fungal/yeast infection (1 month post 2nd dose)
resident received the 2nd dose after 14 days instead of the recommended 28 day interval
pt c/o itchy throat and pain at injection site(left arm) PS 4/10 with throbbing pain noted. Advised pt. to keep moving arm.  5:32 pt. given benadryl 25mg 1 tab for itchy throat and sips of water given  v/s monitored 5:20pm vitals 134/70 bp 18 RR P-70 99% o2 SAT pt. verbalized feeling anxious.Advised to do breathing relaxation.  5:35pm vitals 126/70 P-68 RR-18 o2 99%RA pt reported with no relief from symptoms still noted with itchy throat , no SOB pt alert and verbally responsive. patient was advised to go to urgetnt care/hospital for further eval.  6:10pm pt guardian mother will accompany the patient to hospital /urgent care
Patient was scheduled to receive her first primary dose of the Pfizer vaccine. She was given the Bivalent booster instead at 1407.  She called back to the clinic about 45 minutes after leaving (after the 15 minute waiting period) to report "Patient reports upon returning home, felt "dizzy" then tingling sensation to limbs, face, may have droop to face as well."  I called her again at 1600 and she reported that her symptoms had subsided and the urgent care felt her symptoms were anxiety induced.
No additional Adverse event; Caller stated the vaccine was admnistered after a temperature excursion; This spontaneous report has been from a nurse concerning to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug or allergy history. No concomitant therapies were reported.  On 21-JAN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter,(lot #U020239 and expiration date since it makes match with the autopopulated expiration date 28-JUN-2023), (strength, route of administration, and indication were not provided), which where stored at temperature excursion. The temperature excursion was - 14 degree Celsius for a time frame of 12 minutes. There was not previous temperature excursion. No additional adverse event was reported.  This is one of several case reported for the same reporter.; Sender's Comments:  US-009507513-2201USA007199:
swollen lymph node on neck on the opposite side of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (swollen lymph node on neck on the opposite side of the injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (swollen lymph node on neck on the opposite side of the injection). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (swollen lymph node on neck on the opposite side of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported  No treatment information was provided   Reporter did not allow further contact