chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nov 13, pain started in arms then went into legs. Nov 14, weakness with the pain, couldn't get off the toilet without help and later couldn't walk and was admitted to hosp with severe soft tissue pain and weakness of hands, arms and legs- weak grasp, could not lift leg of the bed, later mild inflammation of wrists, Sed rate 98 mm/ hr  Inf A& B and Inf A PCR neg.  Muscle biopsy left thigh pending, rapid improvement in 3 days after diaphoresis and weaknees has resolved and myalgias are greatly improved.   11/20, 11/23. 11/30/09 Medical records and discharge summary received for DOS 11/15-11/19. Final DX: Acute myositis and myalgia with weakness possibly related to H1N1 vaccine. C/O progressive profound weakness, strength 3/5.  4/5 dorsiflexion and plantar flexion bil. Extreme diff lifting arms and legs. Myalgia. Chills. Fever 101. WBC increased. EMG abn.       ICD9 Codes: 367.1, 780.79R, 780.60BW, 729.1, 367.31  12/22/09 operative report received for DOS 11/17/09. DX: Inflammatory myopathy Left deep muscle biopsy of psoas muscle. Muscle visualized as markedly abnormal and surgeon noted muscle strength was markedly abnormal. Patient tolerated procedure well. Specimens taken to pathology.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 61 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 16-SEP-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
This spontaneous report was received from a medical assistant, concerning a 17 year old patient of an unknown age. Medical history and concurrent conditions were not reported. On 05-SEP-2014 the patient was vaccinated with a dose of PROQUAD (Merck) (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. Medical assistant reproted that a 17 year old patient received a dose of PROQUAD (Merck) on 05-SEP-2014. No symptoms reported. Additional information has been requested.
Patient was very anxious before vaccination and stated that the shot would probably cause an asthma attack. Vaccine administration proceeded without complication. Shortly after receiving vaccination, while the patient was in the waiting room during observation she stated that her chest was feeling tight and her heart was racing. Pharmacist brought her back into clinic room so she could breath freely without her mask and take a puff of her proair inhaler. After 5-10 minutes, she stated that her chest was still tight and her back hurt. Family members were called to take her home/to ER. She did not want to wait so a store employee drover her to patient's preferred emergency room for a breathing treatment.
administered doses of the affected lot after the Sept. 30 expiration date but on or before Oct. 19.  manufacturer data to support the stability and efficacy, revaccination is not indicated, and patient notification is not required. Any dose administered on or after Oct. 1 must be reported in SCRT and VAERS.
Severe headache, nausea and fever only marginally relieved with Benadryl, Zofran, Tramadol, Pepcid, Tylenol. Symptom onset evening of 12.29 and increasing over the next several hours, finally beginning to resolve around noon on 1.1.21. Patient was in contact with her Oncologist who is recommending second dose with additional prophylaxis. Not evaluated in person.
Menstrual cycle started nearly two weeks early; Spotting; Extreme pain over pancreas; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the left arm on 17Mar2021 at 09:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included epilepsy. Concomitant medications of the patient were not reported. 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 was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 18Mar2021 at 04:00, the patient reported that her menstrual cycle had started nearly two weeks early along with spotting. On 18Mar2021 at 04:00, the patient also experienced extreme pain over pancreas. The patient stated "I would have written this off as being 43 but I the 5th woman I know that has received the Pfizer vaccine (others Moderna) where this has happened with the hormonal issues and cycle coming too early with spotting and weight gain.It won't prevent me from getting the second shot but I think it's important to report and have Pfizer look into No I've managed but if it doesn't settle down after the second vaccine I'm going in. The events did not result in a doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events early menstrual cycle with spotting and pain over pancreas was unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.  Follow up (02Aug2021) via Amendment: This follow-up report is being submitted to amend previously reported information: Age at Vaccination updated; Narrative added.
Patient reported redness and swelling in upper left arm 1 day after immunization. She applied ice to soothe injection site. Day 2 redness and swelling spread below her elbow. Primary care physician ordered doxycycline, famotidine and diphenhydramine. Day 3 patient reported swelling and redness on entire left arm to the wrist.
Information has been received from a physician's office concerning a 16 year old female who was vaccinated with a dose of HPV. Subsequently, the patient fainted. The patient did not seek medical attention. The patient's outcome was unknown. Additional information is not expected.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or  (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of Merck sterile diluent). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
12:14 Post vaccination reports feeling dizzy, diaphoretic, color flushed and pale; medical monitoring w/vitals assessed: BP 93/53 P55 O2 sat 96%RA, rest w/feet elevated, po hydration provided, answering questions; 12:30 BP 101/71 P77 02 sat 98% RA , status improving, remains coherent; 1240 BP 107/78 P 72 reports "feeling better", stands w/no dizziness or reports of additional symptoms, color returns to normal; Released from facility w/self.
Have not had any reaction to the previous Pfizer/BioNTech vaccinations. Received #4 vaccine at approx. 8:10am 11/12 and stayed for monitoring for 15 minutes following. Normal reaction to vaccination as previously experienced was soreness at injection site, slight fatigue, and slight body temp. rise. At approx. 9:20pm 11/12, felt itching on back. Overnight, itching continued and at 5:30am 11/13, full body rash/hives were present. Redness and swelling of both ears also present. As the day continued, redness and rash continued to progress and spread to arms/hands and legs/feet. Full-body rash and itching still present as of 11:20am 11/14. Treatment sought at urgent care facility and included prescription antihistamines.
Symptoms began on 4/22/21 Headache, nausea, bed spins. symptoms than subsided for a few day and returned on 4/29/21. Meclizine 25 Mg 1 tab 4x a day.
During initial screening, patient did not report history of food allergies and the Screening form specifically asks for any past allergic reactions to vaccines or other injectable medications.  Patient received vaccination without any problems.  Patient came from Immunizations Clinic to post vaccination observation area with her chalk in no distress after 1min of receiving her 1st dose of Pfizer COVID Vaccine.  She stated she felt like she was having difficulty swallowing.  The patient denied allergy to Benadryl and 25 Mg was offered her immediately, which she took.  Physician was at side by this time and EMS was notified.  Co-workers with patent said her face appeared "puffy" Four minutes after initial symptoms her vitals were as follows: BP 118/79  Sao2 99% on room air HR 97 Physician ordered Epipen and  EMS was arrived and placed patient on gurney.  Epipen 0.3.mg IM delivered by paramedic. Six minutes after initial symptoms report wasgiven to EMS and patient was taken to the hospital.
Sore Arm- same side of injection site; This spontaneous case was reported by a physician and describes the occurrence of AXILLARY PAIN (Sore Arm- same side of injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced AXILLARY PAIN (Sore Arm- same side of injection site). At the time of the report, AXILLARY PAIN (Sore Arm- same side of injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMULA INSTEAD OF 0.2ML OF THE 10MCG FORMULA.
headache; muscle aches; weakness; A spontaneous report was received from a type concerning a 60-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  muscle aches/myalgia, weakness/asthenia, headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient experienced muscle aches/myalgia, weakness/asthenia, headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 16 Jan 2021 the outcome of muscle aches/myalgia, weakness/asthenia, headache  was resolved.
83-year-old male with past medical history significant for coronary artery disease with MI, CABG, atrial fibrillation, and COPD, who came to the hospital with shortness of breath.  Upon arrival at the ED on June 12, 2021, the patient was in severe respiratory distress with oxygen saturation in around 70s. The patient was intubated for respiratory distress.  The patient had recent angiogram with 2 stents placement.  The patient was admitted to the ICU with acute hypoxic respiratory failure/ventilator-dependent respiratory failure, pleural effusion, possible pneumonia with sepsis, hypotension, and urinary retention.  Critical Care, Cardiology, and Infectious Disease were consulted.  Urology was consulted for the patient for urinary retention.  The patient went to the OR for urinary retention and urethral stricture.  The patient had transurethral incision of the vesical neck contracture.  Foley catheter was placed. Infectious Disease was consulted for evaluation of the patient for positive COVID-19 infection.  Infectious Disease recommended to continue COVID-19 isolation precautions, anticoagulation and steroids.  The patient was seen and examined on June 15.  At that time, Neurology was consulted for patient's seizure.  Neurology saw the patient and recommended CT of the brain, which showed no acute intracranial process and EEG for further evaluation.  Cardiology was consulted for evaluation of the patient for STEMI type 2. The patient had 2D with ejection fraction of 60%.  The patient was on aspirin and Plavix.  The patient had a recent stent placement. The patient was seen and examined on June 22, 2021.  At that time, the patient was successfully extubated to nasal cannula.  The patient was improving.  The patient had IV antibiotics for suspected pneumococcal bacteremia and hospital-acquired pneumonia.  Infectious Disease was following the patient.  The patient was seen and examined on June 28.  At that time, IR was consulted per Pulmonary request for thoracentesis.  IR requested to hold Plavix for the procedure.  The patient went to the procedure on June 29. The patient had 300 mL blood-tinged right thoracentesis done. The patient was seen and examined on July 3, 2021.  At that time, the patient was lying down in the bed, no acute distress noted.  The patient denied any chest pain or shortness of breath.  The patient was status post thoracentesis.  Infectious Disease was following the patient and IV antibiotics recommended.  The patient was status post pneumococcal pneumonia with septicemia, bronchitis.  At that time, Infectious Disease was okay to discharge the patient on p.o. antibiotics for 5 more days.  The patient was discharged on July 3, 2021, in stable condition to subacute rehab with advice to continue outpatient followup for further medical care. The patient was stable at discharge.
Pt received Pfizer vaccine at 9:15 in left deltoid. At 9:30 pt complained of throat feeling itchy, and tongue feeling larger than usual and numb. Provider informed, provider assessment revealed no rash, no redness, no visible swelling of tongue, and patient reported an itch on right arm. Vitals 9:35 BP 126/70, HR 88, oxygen saturation 99% on RA, and respirations of 20/min. Vitals retaken at 9:40 BP 117/70, HR 75, oxygen saturation 98% on RA, and 20 breaths/min. Vitals retaken at 9:50 BP 115/71, HR 74, oxygen saturation 98% on RA< and 18 breaths/min. At 9:53 patient stated her throat is no longer itchy, and tongue no longer feels large.
Information has been received from a physician, the author of the literature report, concerning a 112 days infant, gender unknown. The infant was preterm baby and had low birth weight of <1000g. This was a progressive observational cohort study in all VLBW infants who were discharged from the NICU from May 1, 2008 to April 22, 2010, when rotavirus vaccination (manufacturer unknown) with RV5 was provided at discharge to all age-eligible infants. The medical records of the infants were reviewed, and pertinent demographic, clinical, and laboratory data were recorded. The number of infants who received the rotavirus vaccine, the number of missed opportunities for vaccination, and the number of infants falling outside the recommended time period for vaccination were recorded and analyzed. There were no complications noted on follow-up. On an unknown date, the infant was vaccinated despite being older than the recommended age limit at the time of discharge.  Rotavirus vaccination (manufacturer unknown) is recommended for use in preterm infants at the time of discharge from the NICU as long as they are clinically stable and have an age range of 42 to 104 days V.10. Our study highlights the limitations of the currently recommended schedule for rotavirus vaccination, because 22% of all VLBW infants were too old at discharge to receive the vaccine, in additional 25% of all ELBW infants discharged from the NICU were older than 104 days and also were not vaccinated. This is one of four reports received from the same source. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Apr-2021 at 1:40 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:40 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient age was reported as 64.37 years. On 03-Apr-2021, Excursion time was 9 AM, temp was 34, total doses given for the day was 210, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vial was moved to clinic. Vaccine BUD date was 29-Apr-2021. Concomitant products were not provided. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Vials only punctured right before administration. Treatment medications were not reported.
diarrhea; can't barely stand / Can stand only for 40 minutes; loss of appetite; sore throat; loss of taste; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support from a contactable female consumer (patient). A female patient of unspecified age received first dose of bnt162b2 (Pfizer COVID-19 Vaccine, Solution for injection, Lot number: Unknown), via an unspecified route on 06Feb2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced diarrhea, loss of appetite/not using the toilet due to loss of appetite, can't barely stand/ can stand only for 40 minutes, sore throat and loss of taste. She can only stand today. Asking what must be done? The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Vial was stored in the refrigerator beyond 30 days; All patients received Expired Moderna COVID-19 vaccine from a vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator beyond 30 days) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vial was stored in the refrigerator beyond 30 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were provided.
gotten the flu vaccine but had still gotten the flu.; gotten the flu vaccine but had still gotten the flu.; Initial information received on 03-Dec-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case is linked to case 2019SA340023 (same reporter).  This case involves a child female patient of unknown age who experienced flu (Influenza), while she received vaccine INFLUENZA VACCINE.  The patient medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was a case of vaccination failure.  Detailed laboratory examination was not provided.  Final diagnosis was influenza.   It was not reported if the patient received a corrective treatment.  The patient's outcome was not reported.  The information on the batch number was requested.; Sender's Comments: This case concerns a Child female patient who presented with influenza despite vaccination with Influenza vaccine (an Influenza containing vaccine). The time to onset is unknown. However, there is no information regarding patient's condition at time of vaccination, immune status, confirmatory laboratory reports,of confirmed vaccination failure cannot be assessed.
Shot given on 11/07/2005 on Wednesday noticed red area and swelling continued, now on Monday 11/14 redness continues to spread, swelling is the same. Redness is 5" wide and almost all the way around the arm. Called ER they said Benadryl and Ice pack.
First dose of Moderna and mistakenly Pfizer was given as second dose; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (First dose of Moderna and mistakenly Pfizer was given as second dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025a21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN GLARGINE (Lantus), METFORMIN, GLIMEPIRIDE, LISINOPRIL and SIMVASTATIN for Diabetes.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (First dose of Moderna and mistakenly Pfizer was given as second dose). On 26-Mar-2021, INTERCHANGE OF VACCINE PRODUCTS (First dose of Moderna and mistakenly Pfizer was given as second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was feeling fine.