chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via a company representative refers to a 62 year old female patient. Medical history and drug allergies were not reported. On 05-NOV-2013, the patient was vaccinated with ZOSTAVAX, lot number J005849, expiration date 17-AUG-2014, subcutaneous in the right arm, dose reported as "standard". Concomitant therapies included an unspecified tetanus toxoid vaccine and influenza virus vaccine (manufacturer unknown) administered on 30-OCT-2013 (reported as "6 days before ZOSTAVAX). On 05-NOV-2013, the patient stayed in the pharmacy after vaccination with ZOSTAVAX for 10 minutes and left without a reaction. After leaving the pharmacy the patient became warm, and had developed a headache that worsened and became very intense, the patient also developed diarrhea. On 06-NOV-2013 (reported as "the next day"), the patient experienced that her whole body felt "on fire" and "every joint ached". Patient did not seek medical attention and did not receive any treatment for the events. At the time of the report the patient was asked if she felt better and she stated that she felt "110% better but was not 100% yet". Additional information has been requested.
severe burning pain in her arms; blurred vision; tingling; burning sensations throughout her body; cold legs which then feel very hot; muscle aches; joint pain; insomnia; anxiety; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 01Oct2021 as single dose for covid-19 immunisation. The patient was pregnant and/or nursing for over 7 consecutive years. She has medical history of Lyme disease & Fibromyalgia, both of which resolved over 10 years ago from unknown start and stop dates and DVT during pregnancy 5 years ago from unknown start date and unknown if ongoing. She gave birth to her 5th child on 25Aug2021. She received her first Pfizer COVID vaccine 3 days later, on 28Aug2021. The patient's concomitant medications include gabapentin and lorazepam for unspecified indication, start dates and stop dates were not reported. On 09Oct2021, she presented to the ER with severe burning pain in her arms. The following other symptoms have since developed: blurred vision, tingling, burning sensations throughout her body, cold legs which then feel very hot, muscle aches, and joint pain. She began feeling anxious about the symptoms and developed insomnia. She presented to the ER again on 16Oct2021 with anxiety. Concomitant medication started once the baby was weaned. Symptoms remain, although concomitant medications have helped reduce the severity. Patient underwent lab tests and procedures which include MRI, EMG, EKG, Lyme test and the findings were negative on unspecified date in 2021. She stated all blood work has come back with normal findings on unspecified date in 2021. She stated that her neurologist and obstetrician both felt these symptoms are related to the COVID vaccine. She has asked to be informed if there is a treatment that will help with her adverse events. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101639288 mother/baby
fever 99.1 degree F.; Fatigue; felt sleepy; Chills; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored Program COVAX US Support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on 11Mar2021 (last Thursday) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced fever 99.1degree F, fatigue, felt sleepy, chills and wanted guidance on what to do, specifically asked about if he can take Tylenol or Ibuprofen. The events were assessed as non-serious. On unspecified date in 2021, patient underwent lab tests and procedures which included fever: 99.1 Fahrenheit. The clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt seen on 23JAN & 24JAN by RN rash on face spread to limbs & neck;fine parotic rash-swollen nose-throat fine;pt c/o low grade fever by MD on 26JAN; neg rash interested in hx w/food;poss rxn given DPH
As I was going to administer the vaccine, I inserted the needle into patient's right thigh.  The patient then tried to grab at the syringe so I immediately withdrew the needle without injecting any of the vaccine.  The needle was slightly bent so I discarded the damaged syringe and needle into the container.  I then drew up another dose of vaccine with a new syringe and needle.  With the guardian properly securing patient's arms and legs, I was able to successfully administer the vaccine in patient's left thigh.  There was a small amount of bleeding from the initial injection site that was easily controlled with pressure.  Bandages were placed on both injection sites.  Patient was monitored for 15 minutes after his vaccine was given and he did not have any adverse reactions during that time.
Swelling, redness, and itchiness on arm around vaccination site. Swelling has gone down on day 3, but is still red and hot.
This spontaneous report as receive from a physician refers to a multiple patients of unknown age and gender. On an unknown dates in 2015 multiple patients were vaccinated with a doses of GARDASIL (doses, routes and lot numbers were not reported). The doses of GARDASIL were exposed to a temperature excursion of 24F for 720 continuous hours from unspecified consecutive days in January to February 2015. The physician noted that those vaccines were not exposed to temperatures below 24F. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Fever (102.5) + severe pain at injection site.  Not able to move arm.  Very lethargic and tired.  Needed to rest after standing for a few minutes.
Discharge Provider:  DO Primary Care Provider:  MD Admission Date: 11/22/2022 Discharge Date: 11/24/2022 COVID positive Date 11/22/2022 PRESENTING PROBLEM: Hypoxia  Acute hypoxemic respiratory failure (HCC) COVID-19   HOSPITAL COURSE: Patient w/ pmhx of bicuspid aortic valve with streptococcus mitis aortic valve endocarditis and aortic root abscess s/p aortic valve replacement and ICD in place, heart failure with reduced EF due to NICM and VF arrest, pAfib s/p LAA excision, HTN, DM who came in with decreased o2 saturation in outpatient setting with recent cough and dyspnea on exertion that was worsening who was found to be in Acute Hypoxemic Respiratory Failure. She was found to be COVID positive with pleural effusions.  She has complex recent medical history including infective endocarditis, aortic root abscess, severe aortic insufficiency s/p valve replacement, afib s/p LAAE and MAZE on warfarin, cardiac arrest 09/2022. Recently completed antibiotics last week prior to admission.  She was treated with remdesivir and decadron for COVID-19 pneumonia, diuresis was started with IV lasix due to HF and pleural effusions.  Pt had good response to 2 days of IV lasix and reached euvolemia.  Pt also achieved symptomatic response and endorsed significant improvement  Repeat CXRs showed improvement in bilateral pleural effusions.  During stay, pt was transitioned to Eliquis from Coumadin.  Pt was also started on empagliflozin 10 mg.  On 11/24, plan was made to discharge pt with these meds, along with furosemide 20 mg a day oral to maintain euvolemia.  Pt was discharged on 11/24 in stable condition with instructions to continue her home meds besides warfarin, start eliquis and empagliflozin, and present in 2 days for repeat basic labs, with possible initiation of spironolactone and discontinuation of furosemide.  Follow up also established with cardiology and pt has instructions to present to primary care physician as well.       CONSULTS / RECOMMENDATION: Cardiology: recommended starting eliquis and discontinuing warfarin.  Recommended empagliflozin as well as continuing the rest of home meds.  Also recommended a short course of 20mg oral furosemide along with follow up for possible initiation of spironolactone
Patient feels dizzy  and light headed. She was given water and laid down for 15 minutes. Patient felt immediate relief. She said she has a history of feeling light headed when receiving vaccines.
Patient reports tingling down the left arm which began a few hours after immunization. Patient was seen by PCP and prescribed MEDROL Dosepak as treatment.
mom noted softball size swelling 2 1/2" diameter on arm w/6M 3MAR97;when child picked up @ daycare area red & warm to touch;fever of 104;mom had prev given 3 doses of APAP;arm con to be swollen & warm to touch x a wk;bruising noted;
Information has been received from a physician concerning a female who was vaccinated intramuscularly with a dose of the Gardasil. Subsequently, the patient experienced "diffused joint pain". Unspecified medical attention was sought. The patient outcome was unknown. The reporting physician was concerned that this could be related to the Gardasil and was worried it could have caused a "problem with the patient's immune response." Additional information has been requested.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. the patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (strength, dose and route were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The temperature was between >-9C - <8C,  for a time frame of 2 hours, 45 minutes.  There were no previous temperature excursions. The call was because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004386: US-009507513-1701USA004701: US-009507513-1701USA004702: US-009507513-1701USA004703.
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. On 10-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 in the arm (lot number and expiration date were not provided). The patient's concomitant medications were not reported. On an unspecified date of 2016, the patient developed redness and swelling that occurred on the opposite side of arm where PNEUMOVAX 23 was administered. The patient sought for medical attention and was seen by a physician who diagnosed her as having cellulitis. No product quality issue was involved. At the time of the report, the outcome of cellulitis was unknown. The relatedness between the adverse event and vaccination with PNEUMOVAX 23 was not provided. Additional information has been requested.
This spontaneous report was received from a pharmacist reporting for a patient of her husband's. This report refers to a female patient of unknown age. On 02-DEC-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous. On 02-DEC-2014, a few hours after administration of ZOSTAVAX, the patient experienced irritation and bruising of her eyelids. The outcome of irritation and bruising of her eyelids was reported as not recovered/not resolved. The patient sought medical attention via an office visit. No further information was provided. Additional information has been requested.
Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 27-NOV-2015, the female patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date [reported as "shortly after" receiving the ZOSTAVAX vaccine], the patient suffered shingles and Bell's palsy. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the patient's condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the ZOSTAVAX, the patients have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. As a direct and proximate consequence of the ZOSTAVAX, the patient sustained serious personal injuries and related losses including but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, Bell's palsy was determined to be medically significant. Bell's palsy and shingles were considered to be disabling. Additional information has been requested.
approx 5 mins p/vax mom & pt left clinic mom returned & states pt leg is red; pt leg was red @ site & @ foot, ankle & calf; knee was nl color; there was no resp distress; pt cry was consoled w/bottle feeding; pt referred to MD;
Following vaccination, pt developed severe swelling of his entire thigh and was hospitalized for 1 to 2 days.  The patient recovered.  This is 1 of 2 pts from this facility who experienced an injection site reaction following vaccination.
feeling extremely tired; severe headache; large palpable knot on her left upper lateral deltoid; weak; her middle finger and index finger feel tight; her left shoulder feel really tight but has full sensation; unable to lift her left arm more than 30 degrees; pain in her arm; unable to sleep very well last night; This is a spontaneous report from a contactable nurse (patient) reported that a 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 08Jan2021(yesterday morning, Deltoid Left) at single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications was not reported. Historical Vaccine was included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. Patient received her second dose and within an hour she started feeling extremely tired, had a severe headache. When she woke up she noticed a large palpable knot on her left upper lateral deltoid in Jan2021. She stated that the injection went well and noticed no problems when she received the shot. At this time she was still very weak, her headache was still severe and she has noticed that her middle finger and index finger feel tight and her left shoulder feel really tight but had full sensation. She stated that she was unable to lift her left arm more than 30 degrees. She does not have a primary care physician at this time as she just relocated to her current residence. She stated that she was so uncomfortable due to the pain in her arm she was unable to sleep very well last night. She was going to seek medical attention at a local urgent care to be safe. The outcome of events, fatigue, knot on her left upper lateral deltoid, finger feel tight, shoulder feel really tight, unable to lift her left arm more than 30 degrees, pain in her arm, unable to sleep very well was unknown.  The outcome of events of severe headache, weak was not recovered.  Information about lot/batch number has been requested.; Reporter's Comments: her symptoms online per the Fact Sheet instructions.   Potential
This is a spontaneous report received from a contactable other HCP (nurse). A child patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient experienced ineffective drug/child was affected (medically significant) and COVID-19 (medically significant), with outcome of unknown. The lot number for BNT162B2 not provided and will be requested during follow-up. Sender's comments: Based on the limited information provided, the causal association between the reported events and the suspect drug, cannot be excluded.
Six days after second injection my toes turned purple/red and swollen. The skin peeled off and I have had numbness and pain since.  Three weeks on, they are still painful and red
Severe body aches started approximately 8 hours after receiving vaccine. Took recommended dose of Naproxin, which only reduced pain slightly. Approximately 16 to 18 hours after receiving vaccine I had severe body aches, fever, chills, headache and nausea. Vomitting started 20 hours after vaccine and continued for 12 hours, approximately every hour. Could not keep water food, fluids or medicine down. Unable to eat food for 24 hours. Headache turned into migraine and had very uncomfortable stomach and abdominal cramping. Also developed severe rash on neck and both sides of chest and abdomen. Migraine and abdominal issues lasted another 12 hours approximately. At about 48 hours after migraine subsided, abdominal issues continued with nausea (no vomitting). Nausea and rash lasted an additional 24 hours.
pT. MOTHER STATES THAT THE BABY WAS RUNNIG A FEVER
Pain , swelling very achy in ankles and knees for a few days.  Later serious pain in hands and fingers, numb feeling, tingling for about a week.  Still have.
This case was reported by a physician and described the occurrence of not responding to therapy in an unknown number of subjects of unspecified age and gender who was vaccinated with Hepatitis A vaccine, manufacturer unspecified. On an unspecified date the subjects received unspecified dose of Hepatitis A vaccine (unknown), and experienced not responding to therapy. The physician stated that he knew of other physicians who had done antibody testing on subjects after Hepatitis A vaccinations series where the antibody tests did not show antibodies. This is one of two cases by this physician; see case A0813885A for not responding to therapy, vaccination error and laboratory error in a female subject.
Numbness in neck and arms. Temperature of 101 at home, 99.7 at ER.
Reconstituted with unapproved diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number KK3JM, expiry date 25th September 2023) for prophylaxis.   On 11th November 2022, the patient received the 1st dose of Shingrix. On 11th November 2022, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 16-nov-2022 Reporter's comments:  Registered nurse reported on 16th November 2022 that, the patient was vaccinated with shingrix 1st dose on 11th November 2022 but they used an unapproved diluent. The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. Additional supportive information: unproved diluent used to prepare shingrix vaccine and administered to patient, which led to wrong solution used in drug reconstitution.
Patient was seen for well visit 3/30/11 - normal exam. On day 4/2/11 presented to the office with vomiting diagnosed with tonsillitis. That afternoon developed shock, hypothermia, sepsis like syndrome, sz. Transported to ICU - admitted 4/2/11.
I developed a fever, muscle aches, and chills beginning in the evening of 10/09/2017 and continuing until the morning of 10/11/2017.
Potential AE due to delay in receiving 2nd dose of Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Potential AE due to delay in receiving 2nd dose of Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Potential AE due to delay in receiving 2nd dose of Moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Potential AE due to delay in receiving 2nd dose of Moderna vaccine) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-080243 (Patient Link).
Per mom received flu vaccine at 15:40, nothing during evening-not sure what time-hives developed.  Gave Benadryl per mouth, no distress.
Initial misuse report received from a healthcare professional on 06 February 2014. It was reported that a 2-month-old patient received PENTACEL and ACTHIB on the same day on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Received moderna vaccine in Jan 2021, followed by second dose march 2021.  April 2021 I had to go back on Advair disk after having been on PRN albuterol only for the past 10 years.  I have had worsening breathing every since I had the second vaccine.  I have had to see a pulmonologist, cardiologist, and PCP for continued follow up.  The timing of the issues correlates with the completion of the original series.  My symptoms can't be attributed to any medications or other factors.   Drs have run all tests and diagnostic labs possible to try and find another cause to no avail  I continued to have upper respiratory infections throughout the summer and was hospitalized with sepsis a few days before late November holiday 2021.   Also, in August of 2021, I was admitted to the hospital with aseptic / viral meningitis with pneumonia.     I received the J&J vaccine in December 2021 as a booster.   Jan 1, 2022 I tested positive for covid.   I had covid a second time Sept 2022.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.