chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized 12/22/2021; COVID-19 positive 12/22/2021; fully vaccinated  BRIEF OVERVIEW: Admission Date: 12/22/2021 Discharge Date:  12/28/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Aspiration pneumonitis (HCC) [J69.0] Hypoxia [R09.02] Severe sepsis (HCC) [A41.9, R65.20]   HOSPITAL COURSE: Patient with advanced dementia presents to the hospital with pneumonia, elements of sepsis/severe sepsis met for the purpose of diagnosis, also acute on chronic kidney disease, chronic kidney disease stage 3. Managed with antibiotics, fluids, close monitoring.  Improved, back to baseline, will be released back to the nursing home.   * Severe sepsis (HCC) Assessment & Plan Patient was given 1 L IV fluid resuscitation in the emergency department.  Will give additional 1100 mL to meet 30 mL/kilogram target. Will order 2 hour and 4 hour lactic acid. Will perform Procalcitonin. Will order urinalysis.   04/23/2021 sepsis criteria still positive with leukocytosis, tachypnea, elevated procalcitonin.  Continue present care.  Confirmed do not resuscitate status   12/24/2021 will continue present care and monitor MRSA screen is positive.  COVID PCR positive however we  believe that the PCR is positive from the last known hospitalization for COVID back in November   12/27/2021 the doxycycline will be started now, the patient lost the IV access, medications will be switched to oral since he is dischargeable   12/28/2021 antibiotics will be continued by mouth for 5 additional days, the patient will be discharged back to the nursing home, sepsis has resolved
headache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 37 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional Information: Caller reports that both of her adult sons received the Pfizer covid 19 vaccine. Caller said both sons had to "stay home all day from work". One son had a headache and fatigue, the other son felt hot and cold, and body aches. Caller said her sons felt this way after the second dose of the vaccines.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed symptoms around 4/25, presented to ED with complaints of chest pain and something being stuck in his throat. Subsequently died on 4/27.
The patient experienced Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (The patient experienced Sick) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 4782590) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient experienced ILLNESS (The patient experienced Sick). At the time of the report, ILLNESS (The patient experienced Sick) outcome was unknown.            No concomitant drug information was provided.  It was reported that the patient had received dose 1 and dose 2 of Moderna vaccine through intramuscular route of administration. The reporter causality of the event reported with respect to Humira was not provided. No treatment drug information was provided.
On 11/20 @ 3:30pm, having had no symptoms except slight injection site pain. All of a sudden, I started having chils, temp was 99.9 at worst. My arms and legs, neck and shoulders became quite painful. My joints all ached. By 9pm, I was extremely nauseated and knew, as an RN, that I had to pick up my 6 pound dog, go upstairs and get into bed. Didn?t know if I could make it. Once in bed, I could not even turn on my sides. I laid on my back with lots of charlie horses in my feet, couldn?t get up to go to bathroom. Stayed that way until 9am, when my legs were not as sore. Then I pretty much new I?d be ok. Should have gone to hosp, but not as an RN lying there. I had thought I was becoming paralyzed. I was not completely better, as I was totally exhausted with no stamina, until Sunday, 11/24/19. I notified my lung specialist after it was over. I hope this can help somebody. I will never get another pneumonis vaccine.
Multiple erythematous papules and pustules randomly distributed over both upper arms and trunk (ventral and dorsal surfaces); positive associated Pruritus.
Booster; Woke up with like a red like bump where I got the shot; Woke up with like a red like bump where I got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: FG3527) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; VACCINATION SITE MASS (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "Woke up with like a red like bump where I got the shot".  Additional information: patient got Pfizer booster on Friday and did not had any reaction and then Saturday, woke up with like a red like bump where patient got the shot and still have it today.  No follow-up attempts are possible. No further information is expected.
rashes; uncomfortable bumps on his groin and back that come and go; muscle aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rashes), MASS (uncomfortable bumps on his groin and back that come and go), MYALGIA (muscle aches) and PYREXIA (fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-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 RASH (rashes), MASS (uncomfortable bumps on his groin and back that come and go), MYALGIA (muscle aches) and PYREXIA (fever). At the time of the report, RASH (rashes), MASS (uncomfortable bumps on his groin and back that come and go), MYALGIA (muscle aches) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was provided as IBUPROFEN.
4/21/21: starting 5 mins after shot - chills in spine, headache, lightheadedness; rest of day - arm pain, fatigue, headache 4/22/21: unbearable arm pain, fever, fatigue, headache, chills, loss of breath 4/23/21: headache, fatigue, arm pain, chills 4/24/21: weakness, headache, fatigue, arm pain, swollen lymph nodes under left arm, chills 4/25/21: weakness, headache, fatigue, muscle twitches, swollen lymph nodes under left arm 4/26/21: fatigue, weakness, muscle aches, muscle twitches, chills, join pain, swollen lymph nodes under left arm 4/27/21: fatigue, weakness, muscle aches, muscle twitches, chills, join pain, swollen lymph nodes under left arm 4/28/21: fatigue, weakness, muscle aches, muscle twitches, chills, join pain, swollen lymph nodes under left arm 4/29/21: fatigue, weakness, muscle aches, muscle twitches, chills, join pain, swollen lymph nodes under left arm 4/30/21: fatigue, arm pain, all over muscle pain, warmth in dorsal surface of feet  (feeling like they are on fire) 5/1/21: arm pain, all over muscle pain, ankle/joint pain, lymph nodes under both arms swollen, warmth/tingling on hands and feet (both plantar and dorsal surfaces), fingertips pain 5/2/21: arm pain (both), all over muscle pain, ankle/joint pain, lymph nodes under both arms swollen, warmth/tingling on hands and feet (both plantar and dorsal surfaces), fingertips pain, bottom of toes pain, upper back/neck tingling and warmth  5/3/21: arm pain (both), all over muscle pain, ankle/joint pain, lymph nodes under both arms swollen, warmth/tingling on hands and feet (both plantar and dorsal surfaces), fingertips pain, bottom of toes pain, upper back/neck tingling and warmth, pain/spasms in thighs and biceps 5/4/21: warmth/tingling/slight pain on hands and feet, muscle spasms/aches in thighs arms, quads, shoulders, upper back; lymph nodes underarm swollen, ankle/joint pain
About a week after patient received a Moderna booster shot (second dose was given February 8, 2021), he developed generalized hives and angioedema. The urticaria still ongoing.
Information has been received from a physician concerning a 82-year-old patient who was vaccinated with a dose of Varivax instead of Zostavax. No additional information to report. There was no product quality complaint involved. It was noted that the reason for the medication error was her office's "check out sheet" and an inexperienced nurse. The office has now implemented changes to reduce errors, has reeducated the administering nurse, and the check-out sheet has been amended (now grouped by pediatric and adult vaccines). The physician stated there was no confusion due to the vaccine's packaging. Additional information has been requested.
Arexvy administered to 34 week old pregnant women; increased blood pressure; Arexvy administered to 33 year old pregnant women; Arexvy administered instead of RSV pfizer vaccine; This non-serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of increased blood pressure in a 33-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included pregnancy.   On 01-NOV-2023, the patient received the 1st dose of Arexvy (right deltoid). On 01-NOV-2023, less than a day after receiving Arexvy, the patient experienced increased blood pressure (Verbatim: increased blood pressure), inappropriate age at vaccine administration (Verbatim: Arexvy administered to 33 year old pregnant women) and wrong vaccine administered (Verbatim: Arexvy administered instead of RSV pfizer vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy administered to 34 week old pregnant women). The outcome of the increased blood pressure was not resolved and the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy were unknown.   It was unknown if the reporter considered the increased blood pressure to be related to Arexvy.     It was unknown if the company considered the increased blood pressure to be related to Arexvy.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 34 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter was the husband of a 33 year old woman who was pregnant at 34 weeks gestation.  The reporter stated that pharmacist gave the wrong vaccine to his wife.  The wife went to the pharmacy and requested the Pfizer RSV vaccine and was given Arexvy which led to inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy. Arexvy is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older.  The reporter stated that his wife had increased blood pressure since getting the vaccine yesterday that had not resolved.  (Increased Blood Pressure / Symptomatic). The reporter stated that pharmacist did not give any paperwork to his wife.  The reporter consented to follow up.
cherry color pin point papules v.s. every 4 hr x 24 hr O2 sats
pt recv vax 24MAY95 & 29APR97 pt devel a severe case of chickenpox;It was reported that the pt had pox on every eyelid & mucous membrane;
Tingling in R hand, feels fine other that tingling. Nurse gave patient an ice pack for the site and advised to visit his MD if it persist. Patient departed at 7:08pm.
Day prior to vaccination, INR therapeutic. 2 days after vaccination, INR Supra therapeutic, and I required emergency surgery and ICU stay for hemoperitoneum and hemorrhagic shock.
My mensural cycle came on the very next day. It came on earlier then it was suppose to.
PT EXPERIENCED SWALLOWEN FEET AND TONGUE THE NEXT MORNING. UNCONTROLLABLE ITCHING ALL OVER THE BODY.
20 min after shot, upper nasal passage, lips and tongue began swelling. I was driving from vaccine clinic, stopped at pharmacy to get Benadryl (took it ~60min after shot).  Called doctors office, and had appt ~90 min after shot. Benadryl relieved symptoms, doctor recommended another dose of Benadryl and switching to non-drowsy 24 hr allergy medicine for 48 hours. I followed those directions. No other anaphylactic reaction. Post shot, dairy intolerance discovered and still unable to eat dairy after almost 2 months.
Uncomfortable; injection site is hard; Injection site Itchy; Injection site red; Soreness around injection site; Little swelling around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Uncomfortable), VACCINATION SITE INDURATION (injection site is hard), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE PAIN (Soreness around injection site) and VACCINATION SITE SWELLING (Little swelling around the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided by the reporter.  Concomitant products included LITHIUM, LAMOTRIGINE (LAMICTAL), QUETIAPINE FUMARATE (SEROQUEL) and OMEPRAZOLE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness around injection site) and VACCINATION SITE SWELLING (Little swelling around the injection site). On 11-Mar-2021, the patient experienced FEELING ABNORMAL (Uncomfortable), VACCINATION SITE INDURATION (injection site is hard), VACCINATION SITE PRURITUS (Injection site Itchy) and VACCINATION SITE ERYTHEMA (Injection site red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, FEELING ABNORMAL (Uncomfortable), VACCINATION SITE INDURATION (injection site is hard), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE PAIN (Soreness around injection site), VACCINATION SITE SWELLING (Little swelling around the injection site) and VACCINATION SITE ERYTHEMA (Injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient noticed that the injection area was 4 inches top to bottom and side to side.
information has been received from a health professional concerning a female patient who was vaccinated with a first dose of HPV Vaccine. Subsequently as the patient was leaving the examination room, the patient fainted. Unspecified medical attention was sought. The patient recovered shortly after fainting. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a 42 year old patient. Patient medical history and current condition was not reported. On 19-MAY-2015 the patient was inadvertently vaccinated with ZOSTAVAX of dose 0.65 ml, once via subcutaneous route (Inappropriate schedule of vaccine administered). No adverse effects reported. The outcome of the event was unknown. Additional information has been requested.
arm is red and a little hot and itchy; arm is red and a little hot and itchy; arm is red and a little hot and itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm is red and a little hot and itchy), VACCINATION SITE PRURITUS (arm is red and a little hot and itchy) and VACCINATION SITE ERYTHEMA (arm is red and a little hot and itchy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included VITAMIN B5 [PANTOTHENIC ACID] and VITAMIN B9 for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE WARMTH (arm is red and a little hot and itchy), VACCINATION SITE PRURITUS (arm is red and a little hot and itchy) and VACCINATION SITE ERYTHEMA (arm is red and a little hot and itchy). At the time of the report, VACCINATION SITE WARMTH (arm is red and a little hot and itchy), VACCINATION SITE PRURITUS (arm is red and a little hot and itchy) and VACCINATION SITE ERYTHEMA (arm is red and a little hot and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information were reported.
sick; Initial information received on 08-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced sick (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown for illness.  There will be no information on the batch number to be requested for this case.
erythema, edema and warmth. 3 7/8 x 3 7/8" surrounding injection site. LLT. TX with Benadryl.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 69 year old male of unknown ethnicity. The patient's weight was 179 pounds and height was 74 inches. The patient's past medical history included heart attack and removal of gall bladder and concurrent conditions included non alcoholic, non smoker, has a pace maker and stents, hernia in the stomach and parkinson's disease. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: unknown) dose was not reported,1 total administered on 03-MAY-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  The patients cardiologist requested an antibody test on On 27-JUL-2021, which came back negative and the patient experienced confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210762991-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Pt developed chicken pox lesions (20-30) diffusely over entire body approx 10 days after VARIVAX. No fever, no vomiting. Well appearing child.
fever 102.2R;lesions on trunk, neck & cheek non on arms & legs; 14 days p/shot, very irritable;
She received the 2nd Dose on 3/9/2021.  On 3/10/2021 She complained of a headache.  On the morning of 3/11/2021 she complained of abdominal pain and had no appetite.  We then found her unresponsive, called 911 and the medics pronounced her at around 1300.
Pt recv vax on 9/30/98; 4-10 min post vax pt fainted, exp hypotension, dizzy, diaphoretic, dec pulse x 10 min
No adverse event; 20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, 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 25-May-2023, the patient experienced ACCIDENTAL UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml 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 (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml 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 (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml).    Concomitant products were not reported.  It was reported that patient received the Moderna bivalent to 20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml. All of these patients had their monovalent and a previous booster dose of bivalent vaccine.   Treatment medications were not reported.  Case corresponds to patient number 5 of elderlypatient.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:(Elderly Patient no 1)
irritability, low grade fever approx 2 1/2-3 wk p/DTP/OPV #1 followed by gen hypotonia-followed by neurology;electromyography consistent w/anterior poliomyelitis;
pt recvd MMR/HIB/PPD vax on 9MAY91 & immed following vax devel redness, swelling & inc temp @ inject site; pt was kept for observation & released upon recovery; subsequent visits showed no further adverse reaction due to vax;  '