chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BRIEF OVERVIEW: Admission Date: 7/25/2023 Discharge Date: Jul 28, 2023 Discharge Disposition:  home health care svc  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxia COVID-19    HOSPITAL COURSE: Patient is a 82 y.o. male with past medical history significant for history of ESRD with renal transplant and now CKD stage 3, hypertension, paroxysmal AFib on Coumadin, Alzheimer's disease, depression, chronic diastolic CHF, type 2 diabetes, hypothyroidism who presented to the emergency department from home with complaints cough and generalized weakness.     Patient was found to be hypoxic and placed on 6 L nasal cannula to maintain oxygenation.  Patient was admitted to General Medicine for acute hypoxic respiratory failure.  Viral testing revealed COVID pneumonia.  Patient was initially started on Rocephin and azithromycin for concerns for community-acquired pneumonia, though quickly taken off this as COVID was determined to be the cause of his respiratory failure.   Given his history of renal transplant nephrology was consulted.  And assisted with care while he was hospitalized.   Patient was started on dexamethasone for COVID pneumonia.  He quickly improved and was able to decrease oxygen back to room air.  Patient was monitored at on room air without additional desaturations.  Given the improvement patient was discharged home in stable condition on 07/28.  Given that he was no longer on dexamethasone he was started on 5 mg of prednisone at the recommendation Nephrology given his history of renal transplant.
She mentioned that she had no issues with her 1st dose other than a sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 35-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 18Jun2021 (at the age of 35 years old) (Batch/Lot Number: EW0167) as single dose for COVID-19 immunisation. Medical history included migraine, anaphylactic reaction due to selfish, 3 months postpartum. Concomitant medications included vitamin d3; ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). On an unspecified date the patient experienced sore arm. She mentioned that she had no issues with her 1st dose other than a sore arm but had problems with her 2nd dose. The patient was asked if her side effects from the vaccine would affect her baby as she was breast feeding. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Monday 3/22 and had real bad migraine left side headache and I can hardly see because my head hurts bad, the whole left side of my head hurts and the vaccine was given on the right side. My previous medical issues was Six nerve palsy where my left eye pointed to my nose, I had Bells Palsy in the past as well.
covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Arthritis (She was on maintenance arthritis medications.).    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-May-2023, the patient experienced COVID-19 (covid 19) (seriousness criterion death). The patient died on 25-May-2023. The reported cause of death was covid disease post booster. It is unknown if an autopsy was performed.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   She was fully boosted. She was on maintenance arthritis medications.   No treatment information was reported. Company comment: This spontaneous case concerns a 69-year-old female patient, with no relevant medical history reported, who experienced the unexpected and serious (death) event of COVID-19 and died. The vaccination date with an unspecified dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine was not reported; hence, latency could not be properly assessed. The reported cause of death was covid disease post booster. It is unknown if an autopsy was performed. Information regarding clinical evaluation, diagnostic tests, autopsy report, and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-748142, US-MODERNATX, INC.-MOD-2023-748144 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2023: Live follow-up received with no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748142:Patient 3 US-MODERNATX, INC.-MOD-2023-748144:Patient 2; Reported Cause(s) of Death: COVID Disease post booster
Information has been received from a physician referring to a patient of unknown age and unknown gender. Pertinent medical history and drug allergy were not reported. In September 2012, the patient received the first dose of GARDASIL (dose, route, lot# and expiration date were not reported). On 20-AUG-2013 and 04-OCT-2013, the patient received the second and third doses of GARDASIL respectively. Concomitant drug was not reported. No adverse effects were reported. It was unknown whether the patient sought medical attention. Additional information has been requested.
A mother reported that her son completed the series of Rota Shield immunizations in November, 1998 and subsequently developed constipation and abdominal pain. He sometimes produced no bowel movement for 4 to 5 days. He also developed decreased appetite, described as a decrease from 4 to 5 ounces of formula to 1 ounce of formula per feeding. The infant was seen by an MD several times. He recovered after 4 months.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-FEB-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (strength: 0.5ml) (lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion for one time. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer) (R/F) were 216, 34 and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
This is one case out of a cumulative total of 237 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 10 November 2014. These 237 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 10 November 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 32-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot numbers not reported on 06 Apr 2012, on 18 June 2012 and on 28 July 2012 (routes and sites not reported). The subject also received one dose of DAPTACEL, lot number C4431AA on 02 October 2013, (route and site not reported). The subject developed cold-like symptoms on 11 October 2014, approximately 12 months after the last dose. On 14 October 2014, the subject developed a cough and paroxysmal cough on 19 October 2014 without a whoop. The subject experienced posttussive vomiting on an unreported date. The subject did not experience sleep disturbance and apnea. Laboratory testing included positive PCR on 20 October 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 21 October 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 29 October 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
11:44am Numbness to upper section of lip.  Patient voiced that she is feeling much better.  156/88, HR 86, O2Sat 96%
pt recvd vax; exp red, swollen & sore arm; to er; tx w/ cefprozil;
Patient c/o face swelling "like allergy" face is red.  1415 patient resting in chair; cheeks red; states face feels "a little hotter." Will continue to moniter. RN administered benadryl 25mg po at 1425. Per supervisor, patient is stable and ok to leave. Patient states going to mom's house which is "6 minutes away." Patient told to follow up with PCP and verbalized understanding.
Fever 3 days/Diarrhea 3 days/Headache 4 days- still taking Tylenol for it and now Friday at 715pm and still with headache/ rash both arm pits starting going away at day 3. /Tired 4 days / 2 days Brain was foggy/ Body joint pains 2 days almost 3
nasal allergies; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program.This male patient of unspecified age received the second dose of BNT162B2 (TRADE NAME UNSPECIFIED; lot number unknown) via an unspecified route of administration on 01Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. On an unspecified date the patient experienced nasal allergies. The patient inquired if he could take fluticasone propionate (FLONASE) allergy nasal spray because he was experiencing nasal allergies. The clinical outcome of nasal allergies was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Small red bumps on flexor surface of forearms and legs, abdomen and back.  Itchy.
Inadvertent administration intra dermal of Td caused erythema, edema, arm pain. Action due to look-alike packaging.
Pt received her GARDASIL (HPV) shot, pt fainted & fell forward off the table, hitting face down & whole body on the floor. Pt had urinary incontinence while transferring back to the table. MD & RN's notified. VS & BS check done by the 2 assessing RN's. Pt also noted to have seizure-like activity.
Arm swelling; Arm very red; This case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-JUL-2022 Reporter's Comments:  The patient had arm swelling and very red from the first dose Shingrix. The reporter did not consent to follow up.
patient received shot in left arm around 9:30 am about 2 hours later started having pain on left side of body, pain and numbness of arm, pain in neck and even jaw.  She was seen by the school nurse.  Patient started taking naproxen for pain.
First of all, the second dose may be FM - it was cut too close for me to tell.  His problem was severe itching across the back and down the back to below his waist.  Itching on shoulders and down below the underarm, some on legs/arms.  It started around the time of the vaccine and was starting to get better, then he got the second shot on Feb 10 and he's still itching today but not as bad.  He did see his heart doctor after the first shot and the nurse also had some itching.  We also went to see a dermatologist and he couldn't figure out what the cause was.  His back/shoulders/arms/legs had red splotches all over where the itching was.  Not exactly a rash but small up to medium sized - about the size of one's fingernail, and raised a little bit.  All this was why he went at least a month only taking his necessary heart medications and then he went back on the regular stuff but the itching is still there, although not as irritating now as before.
Ever since I had this vaccination, I have had extreme chest pain located in the 6th intercostal space left of the sternum. In January of 2022, I experienced sharp pain upon inhalation and had tachycardia up to 160 bpm. These symptoms subsided, but ever since I have had pain upon palpation. I can barely touch the area without wincing. I also experience pain just sitting sometimes.
Patient started complaining of discomfort by bedtime. Saturday L upper arm was red around injection site. Sunday morning Left arm swollen from shoulder to elbow, red & tender. Went to urgent care
Patient feels cold and hot, sick to stomach, very warm and red (6x6 area), swollen, very raised like the size of a tennis ball.
itching; red mark; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and ERYTHEMA (red mark) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 PRURITUS (itching) and ERYTHEMA (red mark). At the time of the report, PRURITUS (itching) and ERYTHEMA (red mark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
The second and third set of vaccinations were given 1 month apart,developed head to toe fine sandpapery rash after approx. 24 hours after each set.  Mom states seen dermotologist and was told could be eczema, or could be vaccines after the first set to continue with vaccines, seen same dermotologist after third set,states was told was most likely the vaccines.  Infant was placed on Cortisone topical cream and placed on antibiotic for the skin infection that developed as a result of the itching child experienced. Mom states Dr. will consult with other doctors and advise her regarding future immuinization.  States was told Dr. especially wanted infant to receive MMR and Varicella due to his existing skin condition.  This nurse advised she have her doctor put into writing what he advised this child should reciece for vaccinations in the future.
Developed large hives About 27 hours after injection on torso. Treated with topical hydrocortisone and oral Benadryl. Hives reoccured daily for 5 days then had asthma exacerbation on 11/24. Tested negative for covid.
Severe back pain; was unable to leave the bed for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Sep2021 01:30 (Lot number: FC3182) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; AMLODIPINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9267, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 25Feb2021, when the patient was 65 years old, for Covid-19 Immunization, reaction(s): "No adverse effect"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9265, Location of injection: Arm Right, Vaccine Administration Time: 02:30 AM), administration date: 29Jan2021, when the patient was 65 years old, for Covid-19 Immunization, reaction(s): "No adverse effect". The following information was reported: BACK PAIN (non-serious) with onset 01Oct2021 15:30, outcome "recovered with sequelae" (Oct2021), described as "Severe back pain"; BEDRIDDEN (non-serious) with onset 01Oct2021 15:30, outcome "recovered with sequelae" (Oct2021), described as "was unable to leave the bed for 2 days". Therapeutic measures were not taken as a result of back pain, bedridden.  Additional information: Pharmacy or drug store was the facility where the most recent COVID-19 vaccine was administered. The patient received Rosuvastin and Amlodipine medications within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. No other medical history reported. Device date: 22Oct2021. The next day after the 3rd shot, he had severe back pain and was unable to leave the bed for 2 days. He still had chronic back pain. He had no problems with the first 2 shots.  No follow-up attempts are possible. No further information is expected.
12 year old patient received a dose of the Moderna COVID-19 vaccine on 2 separate dates as dose 1 and dose 2 in their vaccination series. No adverse events have been documented as a result of the administrations to date.
Information has been received from a registered nurse concerning an approximately 23 year old female (patient 3 of 4) who was vaccinated with Gardasil. The registered nurse reported that she and another nurse had given "numerous" Gardasil vaccinations. Subsequently this patient experienced a "trickle of blood down her arm when the needle withdrawn". The nurse further commented that there was "nothing wrong with the patient, she didn't even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Bleeding resolved ant the patient was sent home. Additional information has been requested.
Within 10 minutes: lightheaded, whole body weak like before fainting; by 15 minutes - lump in throat/indication of throat tightening, sore throat - took first Benadryl; within 20 minutes - noticeable 'lump' in throat when swallowing - took second Benadryl; symptoms reducing until about 45 minutes, then started increasing again; at 50 minutes took third Benadryl; at 1 hr. 5 minutes - improving and left the pharmacy (my husband drove although the  3 Benadryl did not make me drowsy - while one at bedtime would normally put me to sleep.) I am very aware of my body's reaction to things and told the pharmacist up front of my reaction to the 2020 flu shot, as well as my preparedness with the Benadryl and my epipen. I
Chest tightness; Shortness of breath; Diarrhea; Runny nose; Muscle ache; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Shortness of breath), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose) and MYALGIA (Muscle ache) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included NAPROXEN SODIUM (ALEVE), ATORVASTATIN, METFORMIN, WARFARIN, METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ACETYLSALICYLIC ACID (EQUATE [ACETYLSALICYLIC ACID]), BIFIDOBACTERIUM INFANTIS (ALIGN) and LISINOPRIL for an unknown indication.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Shortness of breath), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), MYALGIA (Muscle ache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Shortness of breath), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), MYALGIA (Muscle ache), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Treatment medications were not provided by reporter.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL PAIN, ORAL MUCOSAL BLISTERING, MUSCULOSKELETAL STIFFNESS, DECREASED APPETITE, and MUSCLE SPASMS in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-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 GASTROINTESTINAL PAIN, ORAL MUCOSAL BLISTERING, MUSCULOSKELETAL STIFFNESS, DECREASED APPETITE, MUSCLE SPASMS, ILLNESS, NECK PAIN, NECK PAIN, DIARRHOEA, ARTHRALGIA, PAIN, ARTHRALGIA, CHILLS, and VOMITING. At the time of the report, GASTROINTESTINAL PAIN, ORAL MUCOSAL BLISTERING, MUSCULOSKELETAL STIFFNESS, DECREASED APPETITE, MUSCLE SPASMS, ILLNESS, NECK PAIN, NECK PAIN, DIARRHOEA, ARTHRALGIA, PAIN, CHILLS, and VOMITING outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-427028 (Patient Link).
Patient already had received two doses of Moderna 6 months to 6 years and then on 11/7 received an extra dose of Pfizer 5-11 monovalent.
Describes the adverse(s), treatment, and outcomes(s), if any:(symptoms, signs, times course, etc.) Patient left after administration and started to experience chest pain approximately 10 minutes after which lead to him going to the emergency room. He was seen and discharged
I woke with chest pain and high heart rate around 3 a.m. Rate was around 180 bpm, but irregular and difficult for watch to calculate. It kept giving an error for "poor recording," despite sitting still. Felt very fluttery/irregular. Felt short of breath in addition to pain. I have had continued episodes of chest pain/ shortness of breath/ tachycardia/ palpitations off and on since 11/19/21.  I have not received new treatment- merely sent tracings from my watch application to my doctor via my health portal. His nurse responded that it was "vaccine related, and should subside." I have a follow up appointment in December.
Client experienced widespread hives two days after the pediatric flu #1 was given. Client visited emergency room and was treated with a 5 day corticosteroid regimen. Today, 11-25-15, client's hives are still present but better than yesterday.