chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates starting on or after 11-JAN-2017, the patients were vaccinated with improperly stored doses of VAQTA injection, lot number N003194, expiration date: 28-OCT-2018, (dose, dose number, route of administration and injection site were not provided) for prophylaxis. The reporter stated that in February 2017, the patients were also administered improperly stored doses of VAQTA injection, lot number M038572, expiration date: 11-MAR-2018 and in March 2017, the unspecified patients received improperly stored doses of VAQTA injection, lot number M047658, expiration date: 28-OCT-2017, (dose, dose number, route of administration and injection site were not provided) for prophylaxis. According to the reporting office manager, the first vaccine underwent a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 839 hours, while the second vaccine was exposed to the excursion conditions of 52.3 degrees Fahrenheit for 168 hours (from 20-JAN-2017 to 26-JAN-2017), 46.9 degrees Fahrenheit for 336 hours (from 26-JAN-2017 to 07-FEB-2017) and 46.4 degrees Fahrenheit for 8 hours (from 27-FEB-2017 to 28-FEB-2017). The last VAQTA with lot number M047658 was exposed to the excursion conditions of 49.5 degrees Fahrenheit for 144 hours (from 16-FEB-2017 to 21-FEB-2017), 46.4 degrees Fahrenheit for 8 hours (from 27-FEB-2017 to 28-FEB-2017), 46.6 degrees Fahrenheit for 120 hours (from 10-MAR-2017 to 12-MAR-2017), 53.4 degrees Fahrenheit for 48 hours (from 14-MAR-2017 to 15-MAR-2017) and 53.4 degrees Fahrenheit for 48 hours (from 20-MAR-2017 to 21-MAR-2017). There was no previous temperature excursion reported. No adverse events were reported. No digital data logger was involved. Follow up information has been received from the reporting office manager via telephone call on 18-MAY-2017. The reporter stated that she would run a report and fax the patient identifiers and dates of vaccination. This is one of several reports received from the same reporter (linked with MARRS# 1704USA005744, 1706USA007377 and 1706USA007378). Additional information has been requested.; Sender's Comments: US-009507513-1704USA005744: US-009507513-1706USA007377:  US-009507513-1706USA007378:
Covid vaccine x 3.  Positive covid on 8/10/2022. Admitted to the Medical Center on 08/18/22. DC'd home on 8/21/22. Readmitted on 8/21/2022 and expired on 8/24/22.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (Lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and route unknown). No concomitant medications were reported. No adverse effects were reported. Lot number L003775 with expiry date 04-FEB-2017 has been verified to be a valid lot number for VARIVAX (Merck). Follow-up information has been received on 03-AUG-2015. Telephone call was made to the medical assistant. A voicemail message was left requesting she return the phone call. Additionally, a request was made for patient identifiers, lot number and expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow-up information has been received on 05-AUG-2015, a call was received from the certified medical assistant who reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. The company fax number was reviewed with the reporter, if information becomes available. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 12-month-old patient of unknown gender. On 17-JUL-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) lot number was confirmed as L001325 with an expiry date of 04-FEB-2017. This is one of several reports received from the same source. Additional information has been requested. Patient's details, suspect details, event information and narrative were updated.
Deep vein thrombosis left calf; Difficulty breathing; Pulmonary Embolism; Felt doggy, sluggish, punky; Arm hurt; A spontaneous report was received from a nurse concerning a 54-year-old, male patient who experienced pulmonary embolism, deep vein thrombosis, vaccination site pain, sluggishness and dyspnoea.   The patient's medical history was not provided.    Concomitant product use was not provided by the reporter.   On 12-Feb-2021, approximately 2 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    The patient received his vaccine on 12-Feb-2021 and reported that his arm hurt a little for a few days. On 14-Feb2021, he reported that he started feeling sluggish and on 20-Feb-2021 he began to have difficulty breathing and pain in the right lower base of rib cage. He went to urgent care where he was diagnosed with a pulmonary embolism for which he received treatment. On the evening of the same day, he again started having difficulty breathing with pain upon inhalation. He returned to urgent care and was subsequently admitted at 12:30 AM on 21-Feb-2021. That  Monday, 22-Feb-2021, a doppler ultrasound revealed a deep vein thrombosis in the left calf. Patient was treated with heparin intravenously (IV). He was discharged 22-Feb-2021.    Treatment for the event included Xarelto 20mg twice per day for two weeks and Heparin IV.    Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events, pulmonary embolism, deep vein thrombosis and dyspnea, was considered recovering/resolving as of discharge on 22-Feb-2021.  The outcome of the events, vaccination site pain and sluggishness, were considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Itching at the injection site; Itchy rash under skin near elbow; Warm to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than 2 weeks after receiving Shingrix, the patient experienced itchy rash and skin warm. On an unknown date, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was recovered/resolved and the outcome of the itchy rash and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, itchy rash and skin warm to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comment: The reporter was a patient. The patient stated that she received her first shingles vaccine dose 3 weeks ago in her left arm.  The patient stated that after received Shingrix vaccine she experienced little itching at the injection site that was went away.  The patient stated that now she has a itchy rash under her skin and near her elbow that appeared a week ago that was a little warm to the touch but not hot and it was can be felt but not seen.  No other information was provided. The patient did not know the lot number and expiration date of the shingrix vaccine she received. The patient was unable to give her phone number. The reporter did not consent to follow up
Information has been received from a registered nurse concerning a female patient who, on an unspecified date, was vaccinated with a 0.5 mL dose of Gardasil and fainted.  It was also reported that the patient's blood pressure dropped to 20/70 and she had to be taken to the hospital.  No further information was provided.  Outcome was not reported.  Additional information has been requested.
Severe shaking chills after 2nd dose of SHINGRIX which lasted several hours.
vaccination failure; SARS-CoV-2 infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2021 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21May2021 at 17:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 26Aug2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28May2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing); "Multiple Sclerosis" (unspecified if ongoing). Concomitant medication(s) included: CEFDINIR, start date: 07Jul2022, stop date: 13Jul2022; EZETIMIBE; PRAVASTATIN; RITUXIMAB, start date: 06Jul2022, stop date: 06Jul2022. The following information was reported: COVID-19 (medically significant) with onset 19Jul2022, outcome "not recovered", described as "SARS-CoV-2 infection"; VACCINATION FAILURE (medically significant) with onset 19Jul2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I was still testing negative at this time; (19Jul2022) positive, notes: tested today 19Jul2022 and I am positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Post vax, the pt states she started to black out and broke into a cold sweat and felt nauseated. Afterwards a headache came. Pt also states that she feels tired and achy ever since vax.
None Covid 19 vaccine expired 11/22/2022 Covid 19 vaccine given 12/09/2022
Vial administered was stored outside recommended temperature. Punctured and past 12hrs at room temperature Vial punctured @ 256p 6/23/21 therefore expired 12hrs later 6/23/21 @ 256am
This 19 year old female started to take the 4 dose regimen Vivtotif (oral typhoid vaccine) on  01/16/2004. After ingesting the second dose on 01/18/2004 she experienced nausea and vomitting, abdominal cramps and rash. She subsequently discontinued to take further capsules. The patient recovered without sequelae. Pharmacovigilance Comments: Nausea, vomiting, abdominal cramps and rash are known to occur after intake of the oral typhoid vaccine. These ADR's are labeled and therefore expected. The causality is assessed as possible.
Severe stabbing pains and aches throughout body, nausea, extreme fatigue, sensation of skin crawling, pain at injection site, redness 2 days after, now (after 3 days) redness almost all gone and rest of symptoms gone except skin crawling sensation (mild)
On approximately 10/27/2000, the patient "broke out" with a rash all over her body. The rash was described as "not necessarily itchy but uncomfortable". The patient's husband did not think it was chickenpox. Additional information has been requested.
Information has been received from the reporter who stated that she was told by a doctor. An 80 year old female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 665402/1339Y). On 16-MAR-2010 the patient's arm she was given the dose in was extremely swollen and very red. The doctor prescribed an antihistamine and told the patient to use ice packs. The adverse event lasted for about a week and it was finished (on approximately 23-MAR-2010). The doctor told the reporter that he had 3 patients who all had the same reaction to injections given from the same 5 dose vial. Follow-up information was received which reported that the adult patient was vaccinated and had severe local reaction which appeared to be an allergic. The patient was treated with ice packs and CLARITIN and the patient did well. The final outcome of the patient was not reported. Follow-up information received from a physician concerning the 60 year old (previously reported as 80 year old) female patient who on 16-MAR-2010 had a reaction to PNEUMOVAX 23. The injection site on the patient's arm became extremely swollen and very red. The physician described the look of reaction as "awful". The physician stated "never saw reactions so severe in all the time he has been administering this product". The physician prescribed an antihistamine and had the patient put cold packs on the arm. The swelling and redness lasted about a week and the patient was fine as of 30-APR-2010. This is one of several reports from the same source. Additional information is not expected.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: PATIENT FELT DIZZY AND WENT TO SIT DOWN AND FAINTED FOR APPROX. 10 SECONDS BEFORE WAKING UP. PATIENT WAS VERY PALE AND HAD LOW BLOOD PRESSURE. MANAGER GAVE THE PATIENT SOME ORANGE AND SAT DOWN UNTIL COLOR RETURNED TO HER FACE AND BLOOD PRESSURE WAS AT 96/78 AND PATIENT REPORTED FEELING BETTER BEFORE SHE WAS SENT HOME.
Pt seen at Primary Health 6/24/17. 7cm area of erythema, tenderness, maculopapular rash spreading from red and irritated injection site. Assessment cellulitis. Treated with Clindamycin and F/U with PCP.
I started feeling ill on 1/8/23. I didn't go to the doctor right away, but when I went, they believed that I had the Flu. I had a cough, runny nose, and a fever. Then I got diarrhea. The fever only lasted for about three days. I was prescribed benzonatate for my cough. I also took FLONASE, CLARITIN D, and ROBITUSSIN. I am still not 100 percent.
This is a spontaneous report from Pfizer Medical Information from a contactable reporter. This mother reported about her 2 months old female daughter that received a dose of PREVNAR 13 on 15May2012 as per pediatricians recommendation (as per Nurse and Pediatrics Association). Infants relevant medical history was unknown. The relevant concomitant medication included DTaP vaccine, rotavirus vaccine and HIB, all administered on 15May2012. On unknown date in June 2012, the infant had blood in stools. On unknown date in July 2012, she also experienced fussiness which was elaborated as yelling. The mother further reported that on an unknown date in 2012, the infant was diagnosed with milk soy protein intolerance (MSPI) due to PREVNAR 13 culture in soy. Therapeutic measures taken in response to the reported events, if any, were unknown. At the time of this report, clinical outcome of the events were was unknown.
I was weak, tired, and achy all over that lasted the whole day. As if I had the flu. I may have had a low grade temp. and I stayed in bed all day. I took Tylenol. I felt better by the next morning. My arm hurt intermittently off and on for about a month. When I moved it would hurt.
Patient hospitalized with COVID-19;  Still hospitalized (ICU);  Fully vaccinated.   Admission Note H&P:  HISTORY OF PRESENT ILLNESS: Patient is a 73-year-old female with past medical history of diastolic CHF, hypertension, hyperlipidemia, seizure disorder s/p VNS, coronary artery disease status post CABG, sick sinus syndrome status post permanent pacemaker, CKD 3, diabetes type 2, GERD. Patient was recently hospitalized from 06/11/2021 to 6/20 3/21 for acute congestive heart failure found to have chronic diastolic CHF.  Patient during this visit was suicidal and was EN route to facility when she developed chest pain and taken to Hospital.  During hospitalization patient was noted to have chronic abdominal pain, a possible seizure that was followed up with an EEG and neuro evaluation all unremarkable.  Patient denies suicidal ideations once admitted therefore no further psych placement needed and she was discharged to subacute rehab. Today patient is coming from facility with complaints of altered mental status from baseline, increased fatigue, fevers, and hypoxia.  On 08/23 patient was diagnosed with COVID-19. Patient complains of some shortness of breath, cough, severe headache, abdominal pain but this appears chronic, numbness testing into her left lower leg.  States having reduced appetite but no loss of taste or smell. ASSESSMENT/PLAN: Severe COVID-19 infection with acute hypoxic respiratory failure - First onset of symptoms: unknown, roughly week - Tested Positive: 8/23 - Decadron: 6mg PO daily, day #1 - continue home PPI - Give Remdesivir      *Daily renal and liver function monitoring for kidney and liver toxicity due to Remdesvir is required. - Oxygen Requirements: 2L, wean as tolerated - COVID lab panel:              - D-Dimer = ordered              - CRP = ordered              - alkaline phosphatase = 244 - DVT Prophylaxis: Heparin - treat CHF keeping euvolemic, encourage proning, IS - PRN albuterol, tessalon, tylenol   Superimposed Bacterial CAP - procal mildly elevated at 0.29 - ER started Rocephin day 1/5 and Azithromycin day 1/3 - sputum culture, legionella, strep pneumoniae, blood cultures ordered    Acute exacerbation of chronic diastolic CHF  -last echo 6/12/21 EF 57%, diastolic dysfunction grade 2, right ventricle mildly to moderately decreased, mild MR, moderate TR right ventricular systolic pressure 43.1 mmHg -chest x-ray shows findings of mild congestion; BNP 17,476 -start Lasix 40 mg IV push 2 times a day    *The patient is on IV Lasix which requires daily monitoring of electrolyte and renal function to monitor for the following toxicities:  renal failure, hyper/hyponatremia, hypokalemia, metabolic alkalosis. -2 L fluid restriction, strict I&Os, daily weights   Indeterminate high sensitivity troponins -trope 61 with a 2 hour delta of +3 -demand ischemia from CHF exacerbation and in the presence of CKD
SOB, Wheezing, headache that started hours before arrival to ED. She has never had COPD or asthma exacerbation before
Upset stomach; Concussion; Hit back of head; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of upset stomach in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced upset stomach (Verbatim: Upset stomach), concussion (Verbatim: Concussion) and head injury (Verbatim: Hit back of head). The outcome of the upset stomach, concussion and head injury were not reported.   It was unknown if the reporter considered the upset stomach, concussion and head injury to be related to Shingles vaccine.     It was unknown if the company considered the upset stomach, concussion and head injury to be related to Shingles vaccine.   Additional Information: GSK receipt date: 01-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that did get the two shots vaccine, but a word of warning mentioned that did not use the bathroom if get an upset stomach like patient did.  The patient was ended up on the bathroom floor with a concussion and hit the back of his/her head on the way down on the tiled bath surround. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR034746:Same reporter
PT REPORTS PAIN, SWELLING AND REDNESS OF INJECTION SITE(LEFT ARM). SSX STARTED RIGHT AFTER AND STILL ONGOING.
Mother states child began leaning to the left a few hours, post vax. This lasted for 4 days. No other symptoms. No fever or pain with movement.
Received AVA 12/7/2009 c/o fever, ha, nasal/chest congestion, malaise resolving with MUCINEX and TYLENOL 2 days later. In Jan 2010 c/o 4 days mid sternal chest pain worse w/cough, breathing and supine. Unsure if before or after H1N1 IM vaccine. Self treated with NSAID x4day before resolving. Med Records show treated for pharyngitis on PCNVK sometime in Jan 2010. Pt traveled Jan-Mar 2010 c/o URI, fatigue, subjective fevers prn. On prophylactic doxycycline. Tx 3/30/10 for strep throat (GAS +) and c/o SOB, fever, cold sweats, pain left arm w/numbness x 12 hr easing with MOTRIN. No medical care for chest pain, only ST. Approximately 5/21/2010 he was awakened again about 3 am with another episode of chest pain (similar to above). However this pain caused him to "pass out" (pain made him drop to knees, blurry vision, weak). He advised positional changes did not affect his pain. He was taken by ambulance to a nearby ER being treated with IV TORADOL, DILAUDID, NTG SL and INDOCIN. His physical exam was normal with cardiology noting a possible faint pericardial rub. He was admitted for 5 days with diffuse ST elevation on EKG in peripheral leads, a negative echo for effusion/wall motion abnormalities and EF60%, and a negative CTA for dissection. Cardiac lab studies, including Troponin levels, were normal. ESR was elevated at 41. His diagnosis was pericarditis and HTN. He was readmitted 8/28/10, 9/22/10 with cyclic fevers, headaches, chest pain, fatigue, etc. Rheumatology eval neg. As of 12/7/2010, he continued to experience sharp anterior chest pains about every 2 weeks lasting 2 days with fevers of 103 degree F. He treats with VICODIN for pain/sleep and takes colchicine 0.6 mg BID regularly and MOTRIN TID only with flares. Cardiology instructed him to take MOTRIN 800 mg 4 times a day with current medications and then to go to ER with next flare for echo and evaluation for pericardial fluid (consider pericardiocentesis or biopsy).
PATIENT BECAME LIGHT HEADED AND DIZZY ABOUT 20 MINUTES AFTER FLU SHOT. WENT INTO THE BATHROOM AND SAT DOWN. PATIENT DOES NOT REMEMBER HOW LONG HE WAS IN THERE BUT YELLED FOR HELP AND WAS CONFRONTED BY PHARMACY STAFF. CALLED EMS. UNABLE TO TAKE BLOOD PRESSURE. PATIENT WAS IN A COLD SWEAT AND WAS HAVING PROBLEMS WITH BALANCE. PATIENT WAS NOT ABLE TO RECALL LAST MEAL/FOOD OR DRINK OF WATER. PATIENT WAS TAKEN TO LOCAL HEALTHCARE FACALITY FOR FURTHUR EVALUATION.
Pt recvd measles vax & following vax lab eval revealed that the pt did not seroconvert; No further details were provided;
Could not eat; NAUSEA; DIZZINESS; CHILLS/ shaking; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2019, the patient received the 1st dose of Shingrix. On 13th September 2019, less than a day after receiving Shingrix, the patient experienced nausea, dizziness, chills and unable to eat. On an unknown date, the outcome of the nausea, dizziness and chills were resolved with sequelae and the outcome of the unable to eat was unknown.   It was unknown if the reporter considered the nausea, dizziness, chills and unable to eat to be related to Shingrix.  Additional details were provided as follows: The patient's husband reported the case. The patient received Shingrix in her left arm. In the same afternoon, the patient presented several adverse reactions like nausea, dizziness and shaking. The patient could not eat due to the nausea. The patient was bed ridden with the symptoms for 2 days and events were lasted for 2 to 3 days. The reporter consented to follow up. This case was found to be duplicate of US2020000432. The case US2020000432 will be voided and all the future correspondence will be added in the present case which stands as a case of record for this patient.