chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received 2 doses of Pfizer's Covid vaccine.  I tested positive for Covid on August 28th, 2021.; I received 2 doses of Pfizer's Covid vaccine.  I tested positive for Covid on August 28th, 2021.; Other vaccine same date vaccine date=12Mar2021, Other vaccine same date dose number=2; This is a spontaneous report from a contactable consumer or other non hcp.   A 41-years-old non pregnant female patient received (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6204), via an unspecified route of administration, administered in Arm Left on 12Mar2021 12:00 as dose 1, single and dose 2 via an unspecified route of administration, administered in Arm Left on 12Mar2021 (Batch/Lot Number: EW0150) as dose 2 single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine 75 mcg tablet (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Aug2021 13:00, the patient stated I received 2 doses of Pfizer's Covid vaccine. Other vaccine same date vaccine date=12Mar2021, Other vaccine same date dose number=2. On 27Aug2021, the patient had laboratory investigation on nasal Swab which results in positive. I tested positive for Covid on August 28th, 2021.  This is a breakthrough case.  I'm fully vaccinated and still got Covid. No treatment was received in response to the adverse events. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the outcome of the events were recovering and the event other vaccine same date vaccine date=12Mar2021, other vaccine same date dose number=2 was unknown.
did not get Adacel at 9 years old and in January 2019 she was given a dose of TD at 14 years old; Initial information received on 25-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 14 years old female patient who she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and reported that the patient did not get Adacel at 9 years old and in January 2019 she was given a dose of td at 14 years old.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  In January 2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate schedule of vaccine administered.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
CELLULITIS AT INJECTION SITE, FEVER, ARM PAIN TX: KEFLEX X10 DAYS, ICE, TYLENOL/MOTRIN
pt recvd vax;woke up in am w/ fever,chills,ha,n,d & upper resp infect;called MD; was placed on cipro;
experienced side effects like chills; fever; headache; body aches; This is a spontaneous report received from a contactable male consumer (patient) via Pfizer-sponsored program.  A male patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced side effects like chills, fever, headache and body aches but they're gone already. He's feeling good. Reporter was querying for if he can resume his normal activities/life now. Outcome of events was recovered on unspecified date.  Follow-up attempts completed. No further information expected.
My brother had his second vaccine shot on 4/30.  When I talked to him on 5/5 he told me he'd had a lot of joint pain and fatigue but thought he would go into work the next day.   Thursday he left work feeling sick with a lot of 'rib pain'.   At some point that night he passed away.   We still do not have an autopsy report, but the timing seems odd.
72 hr after vaccine awake with S.O.B and Dysphagia. Seen in emergency dept- No cardiac disorder. Treated with Pepcid & Benadryl with partial relief
This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Circumscribed rash at injection site which looked like a cellulitis infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (Circumscribed rash at injection site which looked like a cellulitis infection). At the time of the report, VACCINATION SITE CELLULITIS (Circumscribed rash at injection site which looked like a cellulitis infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Body temperature increased: 99° to 100° f (High) High. On 11-Jan-2021, SARS-CoV-2 test negative: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Reporter's Comments: 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.
Presented w/ body ache, weakness, cough, congestion. Dx Covid+ by PCP. Tx for pneumonia w/ abx, admitted d/t elevated troponin, EKG changes. Dexamethasone
A pharmacist reported that a pt received an injection of Flu Shield '00-'01 on 12/2/00 and 2 days later, the pt developed an injection site reaction characterized by a "knot at the injection site".
Pt received HPV vaccine in (R) deltoid. Approximately 5 minutes later slipped from chair to floor after freely conversing with nurse and mother. Pt came to rest on (L) side with eyes closed and no response to calling of name. Aroused shortly with touch to face and asked, "What happened?" Slowly assisted to sitting position. Back slightly damp to touch. Assisted to recliner and feet elevated. Once talking freely, given water and peanut butter crackers (pt had not eaten). Skin warm and dry. BP 104-64. Pt discharged home in care of mother. Walking without difficulty. Gait stable and straight. Conversing freely with mother.
Patient received vaccine on 2/5.  We were told on 2/9 that the patient visited another emergency department on 2/6 but no information was given as to what prompted that visit.  She was sent home.  Daughter found her on 2/6 or 2/ 7 unresponsive and she died.
Pt received shot and after shot pt complain of feeling flushed and "nervous".  Pt was given water with gatorade packet.  No acute distress noted.  Pt given extra 15 minutes for wait time.  A/Ox3.  Pt tolerated well.
Presented to EHS c/o lip swelling and rash/redness around lips a week after TDap was administered on 11/01/2018. Reports same reaction with Influenza vaccine in 2015. Denies fever, SOB, Chest pain, nausea, vomiting, stomach ache, and diarrhea. Intermittent pricking/burning pain around lips 5/10 pain scale. No open wound/cuts around mouth, no drooling and swallowing problem. Pt has been applying Neosporin and lip balm since 11/7/2018. History of same symptoms and reactions from Influenza vaccine in 2015 and 2016 but no adverse reactions from Influenza vaccine in 2010 to 1014. Prescribed with Neosporin, carmex lip balm in 2015 and anti-fungal (unknown name) in 2016. Symptoms in 2016 resolved and healed in 1 month after prescribed with Azithromycin. Stated unable to tolerate Influenza and Tdap since Right kidney excision in Jan 2014.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a stored improperly dose of VARIVAX (Merck) (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Case number PHHY2015US159838, is an initial literature report received on 24 Nov 2015. The author assessed the adverse events after FLUCELVAX reported to the Vaccine Adverse Events Reporting System (VAERS). This report refers to a 49-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX (batch number: not reported) on an unknown date. Six days after vaccination, the patient had onset of neurological symptoms described as Guillain-Barre syndrome (GBS). Final outcome of the event was not reported. The author considered the report to be serious and met Brighton level criteria 1. The author stated that during the first two influenza seasons (2013/2014 and 2014/2015) following licensure of FLUCELVAX, approximately 5.6 million doses of vaccine were distributed in a specific country and the crude reporting rate for GBS cases was 0.7 per million doses distributed. Moreover, there was no disproportionate reporting for GBS was observed in the present study using Empirical Bayesian (EB) data mining. The author concluded the article stating that the review of VAERS reports did not identify any concerning pattern of adverse events after FLUCELVAX. Injection site and systemic reactions were the most commonly reported adverse events. Reports following FLUCELVAX in persons less than 18 years highlight the need for education of healthcare providers regarding approved FLUCELVAX use.
States she has patches of hives and rashes at areas lymph nodes especially behind ears it is hot and itchy; States she has patches of hives and rashes at areas lymph nodes especially behind ears it is hot and itchy; has patches of hives and rashes at areas lymph nodes; Reports 9 days after booster dose this past Sunday afternoon/ night she was aching all over body; states she broke out in itchy hives on Saturday/ has patches of hives and rashes at areas lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (States she has patches of hives and rashes at areas lymph nodes especially behind ears it is hot and itchy), PRURITUS (States she has patches of hives and rashes at areas lymph nodes especially behind ears it is hot and itchy), URTICARIA (states she broke out in itchy hives on Saturday/ has patches of hives and rashes at areas lymph nodes), RASH (has patches of hives and rashes at areas lymph nodes) and MYALGIA (Reports 9 days after booster dose this past Sunday afternoon/ night she was aching all over body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06BF21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Dec-2021, the patient experienced URTICARIA (states she broke out in itchy hives on Saturday/ has patches of hives and rashes at areas lymph nodes). On 05-Dec-2021, the patient experienced MYALGIA (Reports 9 days after booster dose this past Sunday afternoon/ night she was aching all over body). On an unknown date, the patient experienced SKIN WARM (States she has patches of hives and rashes at areas lymph nodes especially behind ears it is hot and itchy), PRURITUS (States she has patches of hives and rashes at areas lymph nodes especially behind ears it is hot and itchy) and RASH (has patches of hives and rashes at areas lymph nodes). At the time of the report, SKIN WARM (States she has patches of hives and rashes at areas lymph nodes especially behind ears it is hot and itchy), PRURITUS (States she has patches of hives and rashes at areas lymph nodes especially behind ears it is hot and itchy), URTICARIA (states she broke out in itchy hives on Saturday/ has patches of hives and rashes at areas lymph nodes), RASH (has patches of hives and rashes at areas lymph nodes) and MYALGIA (Reports 9 days after booster dose this past Sunday afternoon/ night she was aching all over body) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.
Nausea Vomiting Local symptoms: Pain- discomfort, itching. General  symptoms: fatigue, nausea, swollen glands.
After each anthrax vaccine (1-6) patient reports the following reaction: 1. The night of vaccine receipt, he noted a small knot at the injection site that lasted approximately 3-4 days before resolving. 2. About 24-48 hours after receiving his anthrax vaccine, he noted that the upper arm (from the shoulder to his elbow) on the arm where he received the vaccine would nearly double in circumference and the area that was swollen was tender. This edema and tenderness lasted about 3-4 days before resolving. 3. About 24-48 hours following vaccine receipt, he noted red streaking under his vaccinated arm, that axilla, and across the affected side of his chest. He describes the streaking "like someone took a dark red magic marker and drew lines." Denies generalized erythema surrounding the site or uppper arm. He noted axillary tenderness, but no swollen nodes. In 5 of the 6 instances where he had a reaction, the anthrax vaccine was the only vaccine received within 2 or more weeks of other vaccines. He denies systemic symptoms like fever, chills, headaches, fatigue, myalgias, or arthralgias. He sought medical evaluation on at least 3 occasions and was told by military providers that this was a normal reaction. He saw a civilan provider 1 time and was told that it was not normal and that he should not continue the anthrax vaccine series. He denies any hives/urticaria, angioedema, throat or chest tightness or difficulty breathing.
injection site arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site arm hurt) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced VACCINATION SITE PAIN (injection site arm hurt). At the time of the report, VACCINATION SITE PAIN (injection site arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter. No treatment medications were provided by the reporter.   This case was linked to MOD-2021-228407, MOD-2021-228505 (E2B Linked Report).; Sender's Comments:  MOD-2021-228407:Patient-Brother link case MOD-2021-228505:Patient Case
Subject, a 33 year old male with no medical conditions, received the 3rd dose of Anthrax vaccine on 02Jan02. No other vaccines were given on this date. The pt was taking no concomitant medications at the time of the event and had no illness at the time of the vaccination. He experienced itching and rash with the 2nd dose of Anthrax vaccine that was administered on 11Dec01. The itching and rash resolved after approximately one week. On 02Jan02 approximately 12 hours after the immunization, the pt noted whole body itching that was especially intense under the left eye. On observation of the skin, he noted patches of faint, red, raised rash. The itching has gradually lessened, but continues to be present as of 08Jan02. Areas of rash continue to be present as well. The pt also noted intermittent left elbow achiness and stiffness since 02Jan02 that also continues. Additional information received 03/26/02: Left elbow stiffness and achiness resolved approximately 01/16/2002. Whole body itching and rash improved but remains on legs. Additional information received 05/14/2002: rash completely resolved.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. In March 2017, the patient was vaccinated with the improperly stored dose of VARIVAX (dose, route and anatomical location were not reported) (lot # M038225 and expiration date 07-SEP-2018) for prophylaxis.  Additionally, a propped stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported) was used to reconstitute the vaccine. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 480 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004456: US-009507513-1703USA013275: US-009507513-1704USA004455: US-009507513-1704USA004452: US-009507513-1704USA004453:
After a routine ACL reconstruction surgery I had searing pain to my operative leg calf. Upon standing I had 10/10 pain and my entire leg would cramp. I went for an emergent ultrasound at local Hospital where it was discovered that I had two large deep vein thrombosis' in my calf of the surgical leg. I was then sent to alternate Hospital and treated in the ER. I took a therapeutic dose of Eliquis and was then put on a daily dosage. I then had to have two other surgery due to post op complications of arthrofibrosis, which I also believe to be due to the vaccination. I have had 8 other previous surgeries with no complications. After my third surgery I again ended up in ER for suspected pulmonary embolism. I was already on the recommended treatment of Eliquis so I was to just continue this therapy.  Since surgery, I have still had issues with calf pain, cramping, and suspicions of more blood clots. It continues to be an ongoing issue.
Bad headache arm to fingers - hardly able to move & pain nausea - temp. 1 hr. 101 1 1/2 days.
Information has been received from a physician concerning a 20 week old female with a history of being the second of birth twins born vaginally at 37 weeks gestation who on 07-AUG-2008 and on 01-OCT-2008 was vaccinated PO with the first and second 2.0 ml doses respectively of ROTATEQ (lot #'s for both doses was 660550/0616X). Concomitant therapy included DTAP-IPV-HIB (mfr. unknown) and PREVNAR. On 12-OCT-2008 (late evening), the patient began vomiting. On 13-OCT-2008 (in the morning), the patient was taken to the ER, blood tests (unspecified) were done (results not reported). The patient was diagnosed with a stomach virus and sent home. On 13-OCT-2008 (in the evening) the patient vomited coffee ground blood "matter" and was taken to the ER. The patient was dehydrated and intussusception was diagnosed. The patient had a urine test and an x-ray performed (date and results not reported). The patient was transferred to another health care facility where an air reduction enema ultrasound was performed and was curative. The patient was not hospitalized. The patient was reported as recovered on 14-OCT-2008 and doing fine. The reporter considered the intussusception to be both an other important medical event and life-threatening. A product quality complaint was not involved. A lot check has been requested. Additional information has been requested.  11/11/08 Reviewed ER medical records of 10/13 & 10/14/2008. FINAL DX: viral illness w/fever, vomiting Records reveal patient seen in ER on 10/13 for fever & vomiting, sent to ER by PCP w/concern for possible jaundice. Did well in ER w/o further vomiting.  D/C to home.  Returned to ER 10/14,  FINAL DX: Intussusception, enema reduced At home had continued vomiting, now bilious & coffee grounds; abdominal tenderness, dehydration.  Surgery consult done.  D/C to home same day & to f/u next day w/PCP.
At the time of vaccination, patient is only 17 years old. Patient is a essential worker in food industry. Patient denies any sign and symptoms of adverse events at the time of vaccination or 15 minutes post vaccination (monitoring period).  Report is made as vaccine was given outside of EUA accepted age range at the time of vaccination.
Heat on left arm Injection Site after second vaccine; Swelling on left arm Injection Site after second vaccine/Knot on left arm Injection Site after second vaccine; Redness on left arm Injection Site after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat on left arm Injection Site after second vaccine), VACCINATION SITE SWELLING (Swelling on left arm Injection Site after second vaccine/Knot on left arm Injection Site after second vaccine) and VACCINATION SITE ERYTHEMA (Redness on left arm Injection Site after second vaccine) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039C21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Heat on left arm Injection Site after second vaccine), VACCINATION SITE SWELLING (Swelling on left arm Injection Site after second vaccine/Knot on left arm Injection Site after second vaccine) and VACCINATION SITE ERYTHEMA (Redness on left arm Injection Site after second vaccine). At the time of the report, VACCINATION SITE WARMTH (Heat on left arm Injection Site after second vaccine), VACCINATION SITE SWELLING (Swelling on left arm Injection Site after second vaccine/Knot on left arm Injection Site after second vaccine) and VACCINATION SITE ERYTHEMA (Redness on left arm Injection Site after second vaccine) outcome was unknown.            Concomitant medication were not reported. Treatment medication were not reported.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 09-OCT-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 232 hours, with the recorded temperature of -1.66 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.