chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PROVIDER PROGRESS NOTE 2/8/2022 ASSESSMENT/PLAN:  Patient. is a 57 y.o. male with past medical history of GERD, hypertension, depression, chronic pain syndrome and migraine presented to ED for evaluation of coffee-ground emesis/melena. S/P EGD which showed visible non-bleeding vessel but likely source of bleed (injected and cauterized). Remains on full barrier precautions due to asymptomatic COVID infection seen on screening. Medically ready for discharge, awaiting TCU.    Coffee-ground emesis/melena Severe symptomatic, acute blodd loss anemia Presented with epigastric pain x 1 week, coffee-ground emesis and dark stools. Hemoglobin 6.8 MCV 66. BP 90s/60s, heart rate low 100s. Received 2 unit of PRBC. S/P EGD on 2/2 showed 3 ulcerations, non-bleeding (1. gastric ulcer with a nonbleeding visible vessel (Forrest Class IIa), which is likely source of GI bleeding. Injected. Treated with bipolar cautery; 2. non-bleeding gastric ulcer with a clean ulcer base (Forrest Class III); and 3. one non-bleeding duodenal ulcer with a clean ulcer base (Forrest Class III). - Hgb qAM - follow up gastric biopsies for H. Pylori. - avoid NSAIDs - continue PPI  - repeat EGD in 2 months to check ulcer healing   Hypokalemia  - replace prn   Depression/insomnia Hypertension/hyperlipidemia Chronic pain syndrome GERD - resume PTA meds   Anemia due to acute blood loss  - Transfuse prn. On iron supplement   Asymptomatic COVID-19 Infection -  Full barrier protection.  The patient is vaccinated but not received 3rd dose.
12NOV91 visual disurbances driving home from work; chills, anorexia, exhausted; numbness half body; half throat sore; no movement problems;
Around 2 PM, baby began vomiting continuously for one hour (including bile). Vomiting slowed and then ceased after about 6 PM. No fever or other symptoms.
1/3/2023 Patient received prevnar 20 in his left deltoid during his yearly physical. 1/11/23 and 1/13/23 patient presented to the ER with complaints of left deltoid pain. He had told the ER 3 days after he received the pneumonia vaccine he developed achiness and pain in the left deltoid that continued to worsen. He also reported a sense of fullness in the armpit. After work up in the ER, he was noted to have a DVT in the left subclavian vain extending down the axilla into the basilic vein.  On 1/13/23 patient started on Eliquis 10mg twice daily for 7 days then 5mg twice daily. 1/18/2023 Follow up with doctor. Holding testosterone injections. Upper arm pain improving. Referral to hematology placed for further evaluation.  1/23/23 Patient saw Hematology. Advised to have thrombotic reflex panel drawn to evaluate for any underlying gene mutation that may be predisposed to a clotting event. If negative he will require 6-9 months of anticoagulation. If gene mutation found, he will require lifetime anticoagulation.  2/3/23 waiting lab result interpretation from Oncology
Chest pain behind sternum. Continuous for two weeks, beginning approximately a week after the vaccine, then intermittent for the next month (still ongoing intermittent pain). No shortness of breath or heart palpitation, but pain felt like it was coming from my heart and the whole area felt enflamed. Ibuprofen reduced the pain but did not eliminate.
Mild flu-like symptoms; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose on an unknown date. For the tolerance of 1st dose, refer linked case US2020AMR157702).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experianced mild flu-like symptoms for a day or two. The reporter did not consent to follow up. This case was linked with case US2020AMR157702, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR157702:same patient, 1st dose
(had the initial extremely sore arm for about a day and a half after the vaccine..making it painful to lift my arm above my head.  my neck also felt sore and was a little fatigued...again very short lived.)  The itchy rash that i am reporting started with a little itchiness at the injection site almost two weeks later...  it began last evening and it felt firm to the touch-like here was a knot at the injection site.  Today, I noticed the large red rash.
Became lethargic approximately eight hours after vaccination. Fever presented shortly after. Fever up to 101 through the night. Headache, chills, body aches, joint aches, stomach discomfort, diarrhea. Fever lessened by 9 a.m. the following day. Mild arm pain developed at sight of injection. Lethargic through the day following the vaccination. Fever broke appx 36 hours after vaccination. Raspy voice, similar to what happens after chest cold or congestion, continued for several weeks after other symptoms let up.
When outside in cold weather, hands become red and itchy.  Hands also become slightly swollen.  Buttocks also red and itchy with hives.  Once I go inside, the symptoms go away in about and hour, warm shower has helped speed the situation .
Fainted, passed out hit his head on the floor about 5 minutes after receiving the vaccine.  Started seeing spots and feeling funny afterwards he has never passed out before or had a reaction to any vaccines so didn't know he was about to pass out.
Breakthrough case admission after three vaccines: Pfizer 3/9/2021 batch/lot# EN6199; Pfizer 3/30/2021 batch/lot# EW8733; Pfizer 12/24/2021 batch/lot# 33025BD.
Chills; Fever; Intense muscle paid the next day/ ongoing muscle aches and pains; felt terrible/ difficulty focusing and foggy; tiredness/ fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), MYALGIA (Intense muscle paid the next day/ ongoing muscle aches and pains), FEELING ABNORMAL (felt terrible/ difficulty focusing and foggy) and FATIGUE (tiredness/ fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-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 CHILLS (Chills), PYREXIA (Fever), MYALGIA (Intense muscle paid the next day/ ongoing muscle aches and pains), FEELING ABNORMAL (felt terrible/ difficulty focusing and foggy) and FATIGUE (tiredness/ fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, CHILLS (Chills), PYREXIA (Fever), MYALGIA (Intense muscle paid the next day/ ongoing muscle aches and pains), FEELING ABNORMAL (felt terrible/ difficulty focusing and foggy) and FATIGUE (tiredness/ fatigue) outcome was unknown.            The action taken with mRNA-1273 with the events was considered as not applicable. No concomitant medication reported by reporter.
This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 17-year-old female patient who received BEXSERO (batch number 151401A, expiry date unknown). On an unknown date, the patient received the 2nd dose of BEXSERO 1 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site patient was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced pain in the injection area for 3 months following vaccination. The patient required several office visits, blood work and x rays. The workup resulted negative for osteomyelitis. The sales representative did not have the expiration date of the vaccine or the patient's date of birth.
pt tested positive on 3/22/2021 , mild symptoms started on 3/18/2021.
Received injection 12/12/16 at 9:49AM Rt Deltoid. On 12/14/16 at 5AM pt noted that body aches, weak, painful legs, swelling and pain to Rt armpit radiating to Right breast, nausea, feverish, chills, headaches. Denied vomiting, diarrhea, no redness at injection site. 12/15/16 9AM pt states armpit and Rt breast slightly less swollen and painful.
Rash at injection site after 2 days after vaccine and then 5 wks later, apx 11/21/15 started with thigh weakness, neuro dx'ed as variant Guillain-Barre, resolved March 2016.
Information has been received from a physician concerning a 16 year old female patient who is a tampon user and who on an unknown date was vaccinated with the first dose of GARDASIL. Three days later, the patient experienced toxic shock syndrome and was admitted to the hospital. It was reported that the patient was menstruating and was using a tampon at that time. The physician stated that the patient survived but she spent one week in the hospital. The patient's final outcome was not reported. Additional information has been requested.
sweat; Pregnancy; Chills; Soreness at injection site; little bit of a headache; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of HYPERHIDROSIS (sweat), EXPOSURE DURING PREGNANCY (Pregnancy), CHILLS (Chills), VACCINATION SITE PAIN (Soreness at injection site) and HEADACHE (little bit of a headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included BECLOMETASONE DIPROPIONATE (QNASL) for Nasal allergy, LEVOTHYROXINE SODIUM (SYNTHROID), ACETYLSALICYLIC ACID (ASPIRIN 81), COLECALCIFEROL (VITAMINS D3), SELENIUM, ZINC, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), MONTELUKAST, OLOPATADINE HYDROCHLORIDE (PATADAY) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Jan-2021, the patient experienced HYPERHIDROSIS (sweat), EXPOSURE DURING PREGNANCY (Pregnancy), CHILLS (Chills), VACCINATION SITE PAIN (Soreness at injection site) and HEADACHE (little bit of a headache). On 04-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. On 07-Jan-2021, HEADACHE (little bit of a headache) had resolved. At the time of the report, HYPERHIDROSIS (sweat), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The pharmacist believed that the headache was in correlation with the soreness in the arm for which the patient  just iced her arm . The patient never had fever. The patient received 2nd dose of vaccine on 01-FEB-2021.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Delayed due to systems/technical; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs for this 39-year-old female. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
I had frequent PACs.  I am an ER physician.  I felt these and also witnessed on my Fitness Watch.  These escalated through 9/30 then resolved by10/2.  I had no chest pain or shortness of breath.  Just palpitations, up to 15 per minute.
Rash appeared on torso and underside of arm 2 days after receiving vaccine. Pt took Benadryl pt improving as of 10/6/09.
Started having random breakout of hives (urticaria) approximately 11 days after receiving Moderna COVID booster shot. I had received Moderna for first and second shots.  Hives appear randomly on different areas of the body, are intensely itchy, and then go away after 30 minutes or so. Then reappear later at some other spot.  Initially started on back of neck, inner thighs, wrists and top of hands. Palms and feet also now get breakouts as does my trunk (stomach and back).  Approximately 12 hours after the shot I started feeling ill, with a fever, sore arm at injection site, chills and lethargy. This lasted 24 hours. I then had a ringing sensation in my left ear for approximately 5 days. Then the hives outbreak started on approximately day 11 post vaccination and still continue.
Approximately 24 hours after receiving dose 1 of the Pfizer vaccine, I began having chills and vomited. My fatigue became more severe as well. Later that evening my fatigue persisted and I noticed a rapid heart rate via my Watch. My resting heart rate which usually is about 80 BPM was at 100 while laying down and not engaged in any physical activity. When I stood I was dizzy and had poor balance. While my entire arm no longer hurt, the injection site showed a bump as well. When I awoke the next day my heart rate appeared normal again, and I wasn't especially fatigued compared to before I got the vaccine. I did experience another minor gastro-intestinal episode later that afternoon, but otherwise my symptoms appeared to have passed aside from the fatigue. By the end of my work day I was very tired again, although it is uncertain if this is due to the vaccine or from my continued recovery from Covid and adjusting to the physical demands of going back to my job in-person. Because I received my vaccine on the same day as my first day back to work, I have no experience working post-covid before having the vaccine to compare my current state of fatigue to. On the evening of 01/07 I noted that fatigue was slightly less pronounced. I do not currently have a primary care doctor but will be calling to try to gain an appointment so that my second dose can be monitored.
Looked like a sunburn all over my body except my face; Very itchy; Felt like shards of glass on my skin; Very painful; Skin rash all over; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Looked like a sunburn all over my body except my face), PRURITUS (Very itchy), PAIN (Felt like shards of glass on my skin), PAIN (Very painful) and RASH (Skin rash all over) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Looked like a sunburn all over my body except my face), PRURITUS (Very itchy), PAIN (Felt like shards of glass on my skin), PAIN (Very painful) and RASH (Skin rash all over). At the time of the report, RASH ERYTHEMATOUS (Looked like a sunburn all over my body except my face), PRURITUS (Very itchy), PAIN (Felt like shards of glass on my skin), PAIN (Very painful) and RASH (Skin rash all over) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information included kena given to the patient.
BODY SORENESS; LOSS OF APPETITE; FEELING COLD; WEAKNESS; FEVER-LIKE; HEADACHE; DIZZY; NAUSEATED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, 8782021 expiry: UNKNOWN) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced dizzy. On JUN-2021, the subject experienced nauseated. On 26-JUN-2021, the subject experienced headache. On 27-JUN-2021, the subject experienced body soreness. On 27-JUN-2021, the subject experienced loss of appetite. On 27-JUN-2021, the subject experienced feeling cold. On 27-JUN-2021, the subject experienced weakness. On 27-JUN-2021, the subject experienced fever-like. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, weakness, body soreness, feeling cold, loss of appetite, fever-like, dizzy and nauseated was not reported. This report was non-serious.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 30-NOV-2015, the patient was vaccinated with an insufficient dose of VARIVAX (Merck), because the vaccine leaked out of the needle during the administration. Administration route, lot number and expiration date were not provided. No concomitant therapies were reported. No adverse symptoms were reported. It was unknown if the patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Information has been received from a physician concerning a male who, on an unspecified date, was vaccinated with a single dose of Zostavax (Oka/Merck). Vaccinations received on the same day included tetanus toxoid (manufacturer unknown) and influenza virus vaccine (unspecified) (manufacturer unknown). The physician reported that after receiving the vaccinations the patient's hemoglobin levels dropped. The patient was sent to the hospital and admitted. There was no product quality complaint. Hemoglobin levels dropped was considered to be disabling. Additional information has been requested.
soreness and pain on injection site; fatigue; muscle aches; unable to focus; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EB6202), via an unspecified route of administration in the right arm on 17Mar2021 at 11:30 (at the age of 24-years-old), as single dose for COVID-19 immunisation. Medical history included decreased blood sugar, vitamin D deficiency, ovarian cyst and was diagnosed with COVID-19 virus prior to vaccination. The patient was allergic to bananas (fruit allergy). Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 17Mar2021, the patient experienced soreness and pain on injection site, fatigue, muscle aches and was unable to focus. No therapeutic measures were taken for the reported events. The clinical outcome of the soreness and pain on injection site, fatigue, muscle aches and unable to focus were not recovered/ongoing.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX subcutaneous (dose, lot number and expiration date were not reported) for prophylaxis instead of ZOSTAVAX. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Received call from Dr. that this patient had seen in his office on 01-31-19 for a physical and complained of abscess and inflammation on right arm. Dr. called our office and left a voice message on 01-31-19 to notify our office. Our office was closed for a training 01-31-19 & 02-01-19. Contact was made by phone to Dr. on 02-04-19. He stated that he had seen patient and lanced and drained affected area. Patient was prescribed an antibiotic. Made contact with husband of patient to follow up 02-04-19. Husband stated that wife's affected area is healing well and she is taking antibiotic as prescribed, applying hydrogen peroxide, and applying pressure around area to cleanse wound as doctor instructed him to do. Husband self reported that patient had previously received vaccines given August 2018 but no paperwork or record available for verification of vaccines. It is unknown to spouse as to type of vaccines received in past by patient.
Patient returned w/palpable masses tender to palpate site of injection. No erythema, swelling, fluctuance. Positive induration. No fevers, chills, N/V or other systemic signs of infection. Resp stable. Rx given for Ibuprofen and KEFLEX.  Return in 3 days for follow-up. Addendum: Injection site on left thigh.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 08-APR-2021 for covid-19 prophylaxis. The patient received non-company suspect vaccine Moderna (elasomeran) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 005C21A expiry: UNKNOWN) dose was not reported, administered on 22-NOV-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with non-company suspect vaccine Moderna (elasomeran) (Dose number in series 2). The patient received non-company suspect vaccine Moderna (elasomeran) (Dose number in series 3) (form of admin, route of admin were not reported, batch number: 014B22A expiry: UNKNOWN) dose was not reported, administered on 14-JUL-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). No concomitant medications were reported. On an unspecified date in 2023, the patient experienced covid-19 infection (confirmed covid-19 infection) (Dose number in series 3) which led to confirmed clinical vaccination failure (Dose number in series 1) and received non-company treatment drug Paxlovid (nirmatrelvir/ritonavir) from 26-MAY-2023 to 31-MAY-2023 for covid-19 treatment. Original positive test on 26-MAY-2023 with negative testing (2023) following completion of Paxlovid. Patient experienced worsening of symptoms (had improved but never fully resolved) with new positive covid test on 09-JUN-2023.  The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and elasomeran was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230629512-confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.