chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced severe fatigue, chills, headache, fever (100.8), arm pain; on 2/11/21 began experiencing runny nose, congestion, cough, sinus pain, and return of shortness of breath similar to recent COVID infection; reached out to the  Hospitals and Clinics COVID clinic where I was followed during my COVID infection; they explained that due to the recent COVID infection, the reaction would be more severe; they could not re-test for COVID since the test would come back positive due to recent infection; the duration of symptoms lasted for approximately 1 week; the fever, arm pain, and headache resolved with 48 hours, but the runny nose, congestion, sinus pain, cough, and shortness of breath lasted for another week
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported). The physician stated that the patient developed herpes simplex in her genitalia. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Follow-up information has been received from a physician who reported that he had received that stated, the case and there was no relationship to the vaccine and the incident. No further information is available.
Tingling and numbness of gums and palate after 10 minutes of administration. After 25 minutes she stated that it was diminishing.
Fever; Fatigue; Headache; Body ache; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO179) via an unspecified route of administration in the right arm on 30Apr2021 at 03:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included sickle cell trait. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8729), via an unspecified route of administration in the right arm on 09Apr2021 at 13:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 01May2021 at 10:30, the patient experienced fever, fatigue, headache and body ache. The clinical outcome of the events fever, fatigue, headache and body ache were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
About 2 months post vaccine, I started getting tired, SOB. I'm a big golfer and it began to get difficult for me to just walk on the golf course. That was the beginning symptoms. I finally got in to see my doctor in August. I ended up in the hospital. My heart rate and BP were very high for 6 weeks. They finally got it down. I'm on 3 pills for my heart.  My lungs were collapsed, they had to do a biopsy, My GI system, I got an autoimmune disease. I lost 30 lbs. Now my kidneys are shutting down. I was perfectly healthy. We are at a standstill because of the kidney failure. My lungs, heart and everything is  being affected. There is a risk to do a biopsy because of my kidney. They know my lungs are getting bad, but they cannot confirm why. They cannot put me to sleep to do some of these test because of my kidneys. The test they have done are not giving them an affinitive diagnosis, they call it unresolved.
patient received dose of Moderna vaccine post excursion; patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a child 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 an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This case is for 17th patient out of total 19th patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941, US-MODERNATX, INC.-MOD-2023-706966 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:Patient 1 of 19 US-MODERNATX, INC.-MOD-2023-706966:Patient 17 of 19
pt received regeneron on 12/14, should not have received 1st dose Pfizer until 90 days post mab infusion. Will delay 2nd dose until after 90 days per current CDC guidance.
This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 01-APR-2016 the patient was vaccinated with expired dose of RECOMBIVAX HB injection 2.5/0.5, lot # J007946; expiry: 24-MAR-2016, dose: 0.5 ml, intramuscular. No concomitant medications were reported. No adverse effect was reported. No further information was provided. Additional information has been requested.
CDC Reports: 2 mo infant received DTP/OPV on 14NOV89 and died 17NOV89.
Fever, headache and eye pain, aching head to toe, extreme fatigue for one and half days
Patient given vaccine in left deltoid on 5/8/17. Returned to office on 5/9/17 with a hypersensitivity reaction. Large area of redness and swelling near site of PNEUMOVAX vaccination. Patient advised cool compress, hydrocortisone and BENADRYL.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium
Burned going in and then down to my elbow. A couple hours later my fingers where numb and tingling. Over next 2 weeks the numbness in my right hand would keep me up at night. Went to employee health clinic 10/16, my primary care Dr 10/19 low dose steroid was prescribed. 10/23 emergency room feet felt numb sent home after bloodwork, 10/25 hard to walk went to ER, blood work sent bilateral ultrasound for DVT done negative sent home, later that night went back was getting worse my legs wouldn't go my quadriceps hurt like no pain I ever had. Dr prescribed 40mg prednisone x5 days until my neurology appt. 10/31 Neurologist appt. ordered a cervical MRI and a prednisone taper and see what happens. Called it Post vaccination syndrome/allergic to vaccine. 11/3 hand numb/tingling again 11/5 legs started hurting again. 11/12 second neurologist appt for 2nd opinion.
(On 10/23/17) Patient's arm at injection site was red, fevered, hot to the touch and very inflamed. The Doctor that she visited had made demarcation lines around the site to show if the swelling progressed after treatment with antibiotics was ordered. The doctor diagnosed as "rash" and recommended BENADRYL by mouth, doxycycline 100 mg bid for 10 days, ice for swelling, and to be reseen if no improvement following antibiotic treatment.
mom states onset of fever 10OCT in AM followed by diarrhea, shaking, loss of appetite; reported fever to 104 in spite of APAP; mom advised to see MD in ER;
ADMISSION:   12012021  Patient is a 55-year-old man with a history of diastolic heart failure, moderate/severe pulmonary hypertension, COPD, CAD, and DMII who presented to the ED with subacute worsening of shortness of breath.  He tested positive for COVID-19 upon admission.   Patient was recently admitted to this facility from  10/25 - 11/5.  He was treated for left upper lobe pneumonia and CHF exacerbation during that admission.  His hospital course was complicated by an AKI.  He responded appropriately to diuresis.  Patient underwent a RHC that admission which was notable for moderate/severe pulmonary hypertension that was not responsive to vasodilator therapy.  Since being discharged from hospital, patient reports that his oxygen status has been intermittently worsening.  He reports that he was discharged on 4 L NC.  Patient reports that he has been adhering to low-sodium diet and fluid restriction with good results.  He reports that his dyspnea has fluctuated quite a bit since his discharge and that he has "good days and bad days."  Patient reports having a cough which is largely chronic and does not seem to be much worse than baseline.  Patient denies having any fever or infectious symptoms.  Patient reported acute worsening of his shortness of breath one day prior to admission which prompted him to come to ED for further evaluation.    Upon arrival to ED, patient was noted to be tachycardic to the low 100's.  He was noted to be hypoxic on his home 4 L nasal cannula and had to be increased up to 6 L NC.  Admission lab work was notable for WBC 7, creatinine 1.3 (close to baseline), BNP mildly elevated to 800.  Patient tested positive for COVID-19.  CXR showed cardiomegaly with no acute airspace disease.  CTA chest showed no PEs, but did comment on some ground-glass opacities which could be seen in viral pneumonia.  Hospitalist was then contacted for admission.    Of note, patient reports that he was fully vaccinated with mRNA vaccine (not sure which) around 7/2021.  Patient is unsure about date of finishing his vaccine series, but thinks it was around 7/2021.
Information has been received from a physician concerning a 10 year old female who was vaccinated with a dose of VARIVAX (lot # not reported) when she was 12 months old, approximately in 1999. Last week, on approximately 21-OCT-2008 the patient developed a case of breakthrough (15 lesions). The patient sought medical attention at physician's office. At the time of reporting, she is recovering. Additional information has been requested.
pain, soreness, & redness around inj site p/vax that lasted x 5 days;poss lt arm reporter not certain;pt laid around & was listless x 5 days;pt would get up but acted as if arm was in a lot of pain;t101 for 1st 2 days;
unable to get on with life for 6 months; illness; bedridden; This case was reported by a consumer via interactive digital media and described the occurrence of activities of daily living impaired in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included fibromyalgia. Previously administered products included TUBERCULOSIS VACCINE with an associated reaction of malaise (received vaccine when the patient was child) and Influenza virus vaccine with an associated reaction of malaise (For tolerability of the previous dose of influenza vaccine, refer case US2019GSK077261).   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced activities of daily living impaired, unwell and bedridden. On an unknown date, the outcome of the activities of daily living impaired, unwell and bedridden were unknown.   It was unknown if the reporter considered the activities of daily living impaired, unwell and bedridden to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient for herself. The patient received the flu jab and became ill, bedridden or unable to get on with life for 6 months to be told not one of chosen virus were correct for that year not had again. The patient also reported that her daughter had ASD (Autism spectrum disorder) and they both had fits after the MMR (measles mumps rubella) jabs. The follow up was not required.
Redness, swelling, and rash surrounding injection site. Area was size of baseball. Patient noted itching.
NO ADVERSE EVENT, ONLY DTaP WAS GIVEN BY MISTAKE INSTEAD OF TD, PT DIDN'T REPORT ANY ADVERSE SYMPTOM.
During post vaccination observation pt complaint of weakness and was hypotensive. Transported to ED, blood sugar 39, given IV fluid and food. Other lab work within normal limits, symptoms resolved and discharged to home
small amount of blood in the bandage a little smaller than a dime/there's blood on his arm/with his second dose, there was blood at the injection site; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 40 years of age), dose 2 via an unspecified route of administration, administered in arm left on 14Apr2021 10:20 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. Historical vaccine included BNT162B2 (at 40 years of age), dose 1 in the left arm on 23Mar2021 for COVID-19 immunisation, wherein he experienced sore arm after first vaccine. He had no other vaccines within four weeks before covid vaccine. It was reported that the patient got the second dose of the vaccine today (14Apr2021) and there was blood on his arm, the first time he got the shot for the first dose there was no bleeding. He added that with his first dose he had no blood at the injection site, he only had a sore arm the next day and that was it. He stated that today, with his second dose, there was blood at the injection site. He asked if this was something he had to concerned about. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Shaking, almost spasm type shaking. Weakness in her legs. progressing to abd. pain, cough, headache, nausea
This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 05-AUG-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 16-APR-2016), "TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates,  the RECOMBIVAX HB had six temperature excursions: 80 hours (Lowest recorded temperature was 30 F (-1.111111111 Celsius); 24 hours (Highest temperature was 48 F (8.888888889 Celsius); 168 hours (Highest 49 F (9.444444444 Celsius); 1172 hours (Lowest recorded temperature was -3 (-3 Celsius); 336 hours (Highest recorded temperature was 59 F (15 Celsius); 416 hours (Highest recorded temperature was 47 F (8.333333333 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
stroke; heart attack; neurological problems; This is a spontaneous report from a contactable consumer (patient's neighbor). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after getting the vaccine; the patient experienced stroke, heart attack and neurological problems. The events caused of hospitalization. The clinical outcome of the events was unknown.  Information about lot/Batch number has been requested.
After receiving the first and second vaccine, I did not have a menses for 3 months. Still today, I have not been able to conceive a child after many attempts.
No adverse event; Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) in an 18-month-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 09-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients).    No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 16th of 17 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713254 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Follow-up document received includes patient demographics (initial and DOB) added. On 28-Feb-2023: Follow-up document received includes no new information. On 28-Feb-2023: Follow-up document received includes reporter details were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713254:Patient 1 out 17 patients
Covid Infection; Covid Infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Nov2021, outcome "unknown" and all described as "Covid Infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Nov2021) covid infection. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Any other vaccine in four weeks: Unknown, if covid prior vaccination: No.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Hot/cold flushes; Hot/cold flushes; This is a spontaneous report from a contactable consumer (patient) from a . A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced hot/cold flushes after having the 1st dose. The patient took Tylenol after the first dose. The patient received treatment for events. The outcome of events was unknown.  Information about lot/ batch number has been requested.
Injection site minimally effective; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL3302, Expire date: Unknown) via an unspecified route of administration on 06Feb2021 at 15:00 (at the age of 78 years-old) as dose 2, single for COVID-19 immunization. Patient medical history included ongoing asthma and chronic obstructive pulmonary disease (COPD) from approx. 2000 to an unknown date and underwent thoracostomy 2014 - Dx book, ongoing hypogammaglobulinaemia from 2016 to an unknown date, ongoing sjogren's syndrome from approx.2000 to an unknown date, ongoing Paroxysmal sympathetic hyperactivity (Nonspecific paroxysmal spell) from 2000 to an unknown date controlled with RX, not controlled after vaccine, atrial fibrillation was ongoing from 2016 to an unknown date (ongoing). Patient was never smoked. The concomitant medications included ongoing metoprolol tartrate, ongoing hydroxychloroquine sulfate, Apixaban from 2020 still ongoing, ongoing propafenone, ongoing Topiramate (TOPAMAX), ongoing ciclosporin (RESTASIS), ongoing tiotropium bromide (SPIRIVA), ongoing amlodipine, ongoing fluticasone propionate, salmeterol (WIXELA INHUB), ongoing montelukast, ongoing methenamine, ongoing buspirone hydrochloride (BUSPAR), ongoing omeprazole, ongoing cevimeline all taken for an unspecified indication, start and stop date were not reported. The patient had shortness of breath (SOB) with lidocaine + methylparaben, leg pain with ciprofloxacin (CIPRO) and SOB with Rocephin (ROCEPHIN). Historical vaccine included BNT162b2 (COMIRNATY, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 16Jan2021 (at the age of 78 years-old) as dose 1, single for COVID-19 immunization and experienced nauseous (time of onset: 15:01), lightheaded (time of onset: 15:20, Fine now), unbalanced (time of onset: 15:20), difficulty in walking and talking (Gait and speech disturbances, time of onset: 15:25), Intermittent shortness of breath (time of onset: 15:30), headache (Fine now), Dizziness (Fine now), Tired (Fine now) Brain fog (Fine now). No treatment received and not admitted in hospital for the events. This symptom Lasted the longest 2 weeks. The others were gone within 24 hours of administrating the vaccine. Patient previously taken Prevnar (PREVNAR PNEUMONIA Vaccine, Batch/Lot number: Unknown), via an unspecified route of administration from an unspecified date to an unspecified date (at the age of 70 years-old), for pneumonia vaccine. It was reported that adverse events relating to prior vaccination was none. The patient experienced injection site minimally effective on an unspecified date in 2021. None of these medicines (SOB with Lidocaine + Methylparaben, Cipro-ceg pain, Rocephin- SOB) were taken. No illness ware noted at time of vaccines. No tests or labs performed. The patient was not visited to physician and emergency room. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Pt began experiencing pain at the injection site, a few days after immunization. His whole arm has been throbbing and the pain is not relieved by any medications that he has taken.