chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 at 09:00 as dose 1, single (Lot number: EN6201), on 05Mar2021 at 12:30 as dose 2, single (Lot number: EN6198), in left arm, on 23Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 25Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "interstitial lung disease" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "familial hyperlipidemia" (unspecified if ongoing); "kidney stones" (unspecified if ongoing); "gout" (unspecified if ongoing); "preDM" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. Concomitant medication(s) included: TENORMIN oral; NORVASC oral; CLONIDINE oral; SYNTHROID oral; LOSARTAN oral; POTASSIUM CITRATE oral; VITAMIN D3 oral. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Pyrexia: 100 Fahrenheit; SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2 weeks product: Tenormin Norvasc clonidine synthroid Losartan potassium citrate Vitamin D3. Other medication in 2 weeks administrator route: oral, chronic meds. Adverse event: extreme prostration, loss of appetite, new onset clay-colored stools, and fever to 100F. Other medical history: Interstitial lung disease, hypertension, familial hyperlipidemia, kidney stones, gout, prediabetic (preDM).; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events Vaccination failure and Covid-19 cannot be excluded for the suspect drug. The case will be reassessed once new information is available.
Initial misuse report received from a healthcare professional on 02 October 2013. The patient had received only DTaP/IPV/HIB vaccine. No adverse event was reported. List of documents held by sender: none.
Infanrix on 12Apr2022, then Boostrix on 27Apr2022; Infanrix instead of boostrix; 11 year old given Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th April 2022, the patient received Boostrix. On 12th April 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 12th April 2022, not applicable after receiving Boostrix and unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On 27th April 2022, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short, wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-APR-2022 Reporter's Comments: The medical assistant reported that a patient inadvertently received dose of Infanrix vaccine instead of Boostrix. The reporter consented to follow up. Additional Supportive Information: The health care professional reported that a patient received Infanrix vaccine instead of Boostrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration. The patient received the Boostrix dose earlier than the recommended interval, which led to shortening of vaccination schedule. This case is linked with case US2022073866 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022073866:Same reporter
Mom states p/pt recvd vax arm became sore & sl swollen x 2 days; On 5JUL92 pt awoke w/swelling from vax site up through the lt shoulder & neck;
My child started scratching and showed my some rashes on both sides of her temple and stomach Saturday evening (December 4, 2021).  I just monitored her during the night. By Sunday morning they disappeared. But by late Sunday evening (December 5,2021) I noticed her scratching her right arm, right leg, and stomach. When I looked she had red rashes on those locations that she was scratching. I took her to the ER around 11:00-12:00 am. She was seen by ER Dr., MD he observed the rashes and asked if she came into contact or had any new things to eat. I told him that she had taken the first shot of the pzfier covid vaccine on 11/30/2021. He said he could not state that it cause her mild allergy but he also said that he couldn't rule it out either since it was within less than a week since she took it. He said it was a mild reaction. He gave her benadryl and prelone. I asked if I should proceed with the second dose. He said I should and suggested that I follow up with our primary care doctor. I followed up with Dr. on Tuesday December 7, 2021. The rashes did not return and Dr. also advised that we continue with the second dose and that I report the incident. I reported it on the vaccine checkin via text message and received a call from the cdc (who suggested that I make a formal report online).
Headache, CoughWheeze, NauseaVomiting, Chest tightness Narrative:
Information has been received from a nurse and an office manager concerning an 18 year old female patient, with no known medical history, who on 13-JUN-2008 at 11:30 am was vaccinated intramuscularly with a third dose of GARDASIL vaccine (yeast) (Lot # 659435/1265U), which had been improperly stored. The nurse reported that the vaccine was stored in a refrigerator that had gone below an acceptable range. No adverse events were reported. It is unknown if the patient sought medical attention. No product quality complaint was involved. This is one  of several reports from the same source. Additional information has been requested.
Pt woke up morning of 1/10, 2 days post vaccination with redness (about 1" diameter) and a knotty feeling in the muscle.  Slightly itchy and warm to the touch.  Advised her to take Benadryl when she can.
Patient given 2 dose of original series Moderna after 21 days and not 28.
Vaccines given 5/8/01 afternoon. Pt slept all afternoon and night. On 5/9/01 AM, pt had several jerking movements of head, hands and feet for a few seconds duration with 10-15 minute intervals. Pt febrile.
ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE DVT OF RIGHT PERONEAL VEIN
OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: bipolar disorder, attention deficit hyperactivity disorder, insomnia, and pain, and other pre-existing medical conditions included: Patient had no past medical history (PMHx) of headaches prior to vaccine, however he mentioned his father had a history of headaches and ultimately died of a brain tumor. Patient was veteran. The patient was previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 20-DEC-2021) dose was not reported, 1 total, administered on 18-MAY-2021 for prophylactic vaccination.  On 18-MAY-2021, the patient experienced flu like symptoms/bad cold type symptoms/feverish (dose number in series 1). On an unspecified date, the patient experienced severe headache (intensity like migraines) following administration of covid-19 vaccine ad26.cov2.s vaccine (dose number in series 1). The headache frequency was every other day or random. He had not yet gotten any official diagnosis, testing, or treatment for his headaches. The patient recovered from flu like symptoms/bad cold type symptoms/headache/feverish on 19-MAY-2021, and had not recovered from severe headaches (intensity like migraines).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 15-AUG-2021 for prophylactic vaccination which was off label use and inappropriate schedule of vaccine administered (dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included oxcarbazepine for bipolar disorder, and attention deficit hyperactivity disorder, quetiapine fumarate for insomnia, and gabapentin for pain. Treatment medications (dates unspecified) included: naproxen sodium for severe headaches (intensity like migraines). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220327423 (dose number in series 1 case).
9:40 pt came to nurse office c/o swelling & redness in both arm; 9:44 vs Bp 120/70, 02;feeling dizzy & sick;BP 125/70, P74, R18, red splotches on arm;BP 140/100;BP 140/90, P84, R20 pt c/o little hard to swallow spit;
Left arm, shoulder, and upper body severe pain. I couldn't lift my left arm. It felt as if I had the flu. Body aches, disorientation, difficulty breathing, severe body weakness, nose running. I used 8hr Tylenol for the pain. I was restless and couldn't sleep Friday and Saturday night. On Sunday, the symptoms began to subside, but the general weakness and disorientation remained.
Pt recvd vax & exp eye irritation, fatigue, & arthralgia 2 days p/3rd dose; 1 month later 5OCT92 exp general malaise, migraine h/a & worsening fatigue;
Day 3 level 10 joint pain everywhere, fever, chills, muscle aches and sever pain not resolved by 2-3 daily norco 5-325 and 2400 mg of ibuprofen. Also developed a rash at injection site
11 y.o. in with grandma for Tdap and had severe Syncopal episode minutes later. Unresponsive briefly and clammy T994 P72 R20 BP 94/64- EMS called and pt. taken to Hospital- Discharged with eval and returned to school following day.
Information has been received from a medical assistant referring to a female patient of unknown age. Information about concurrent condition, medical history, drug reactions/allergies and concomitant therapy were not provided. On 06-FEB-2009, the patient was vaccinated with her first dose of GARDASIL (strength, dose, route, lot # and expiration date were unknown) for prophylaxis, then the second dose on 02-SEP-2009 and the third dose on 15-AUG-2016, which was outside of the recommendations in the GARDASIL prescribing information. No adverse effect was reported. Additional information has been requested.
Was fine Friday and Saturday after shot.  Sunday and Monday had chills, sore in mouth, headache and body aches. Tuesday had chest tightening for a little while.
On first day 9/11 I woke up with a sore throat and fever. The condition progressed over the next few days to uncotrollable, painful coughing with a screaming sound and other time a whooping sound that caused shortness of breath.  After the first five days the coughing lead to vomiting. Throughout the process there was head and chest congestion with large amounts of phlegm and mucus. Exhaustion. Trouble breathing.
This is a serious spontaneous case involving Bells Palsy. The reporter causality is possible to FluMist. A 35 year old nurse with previous history of Bell's palsy secondary to head trauma when she was 8 years old, experienced slurred speech, watery eyes, drooling at night while asleep, inability to close right side of mouth completely and swelling of right side of face 2 days after receiving FluMist vaccine on Nov 12 2005. She was seen by her primary physician who referred her to a neurologist. She was diagnosed with Bell's Palsy. She was treated with oral prednisone for 6 days and Valtrex (Valacyclovir) for one week. No diagnostic procedures or laboratory test were done. By Nov 18 2005, her symptoms had improved and as of Nov 28 2005, she had completely recovered. However, she stated that she is beginning to have an ear infection. She will see her primary physician regarding treatment. No signs and symptoms of other central nervous system disorder was reported. The reported assessed the events as possibly related to FluMist.
30 YEAR OLD MALE COMPLAINED OF ANXIETY AFTER VACCINE. ON SITE EMS RESPONDED.  VITALS LISTED BELOW. HE RECOVERED AND WAS RELEASED TO HOME
Pt recvd vax & exp a maculopapular rash; in addition p/2 doses exp raised welts; treatment DPH;
Fever of 102.5 since this morning. Will not break with Tylenol. Hallucinating. Heart rate reaching 120 resting.
Daughter nursed at about 50% of her normal feeding, slept almost entire 72 hours, very hard to keep awake, limp baby with little flection, took a full 72 hours to recover. After 5 hours of the injection, she started to scream in inconsolable pain at the injection site that would only be soothed with infant tylenol.
I am writing this on behalf of my mother. She received the first round of the vaccine (Pfizer/EL9269) on 2/18/21. That evening she reported not feeling "right".  Over the next two days after receiving the vaccine on Thursday she reported to family that she didnt feel well. She had no fever but muscle aches, an earache and sore throat (this was on Friday and Saturday). On Sunday her breathing became a bit labored. She still had previous symptoms reported and labored breathing -- she stated she thought she would have to go to the Dr the next day (Monday, Feb 22, 201) if she did not feel better.   Sometime in the night of Feb 21st and Feb 22nd my mom passed away.   My mom had many health problems. Heart disease, diabetic, she was on dialysis and had sleep apnea. However, she definitely seemed to be having some difficulty with the affects of the first vaccine.   Please let her life be counted.
High fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (High fever). At the time of the report, PYREXIA (High fever) outcome was unknown. Not Provided          Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No relevant concomitant medications reported.  No treatment information was provided.   Reporter did not allow further contact
Had my shingles shot, but still had suffered it/Suspected vaccination failure; Still had suffered it for 3 months; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-AUG-2022.  Reporter's Comments: This case was reported by patient via interactive digital media. The patient had shingles shot, but still had suffered shingles it for 3 months.  The doctor said if patient hadn't vaccinated for shingles he/her would have it worse. Additional Supportive Information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for herpes zoster were unknown. The follow up would not be possible as contact details not provided.
Patient reported significant fever, felt like "crap", stayed in bed all day after receiving vaccine, vaccine site was swollen and red over the weekend.
Death Non-STEMI (non-ST elevated myocardial infarction) (CMS/HCC) Chronic renal failure
The patient's husband informed the pharmacy that the patient passed away the day following vaccination.  He stated he was unaware of the cause of death at this time.
Vertigo. Pt states he has not had anything to eat since yesterday around 10:00pm
Breakthrough case of COVID - 05/17/2022. Sx on 05/15/2022 I had a very sore throat once I got back home. Sx on 05/17/2022, home swab on 05/18/2022. Sx began extreme fatigue and weird stuffy nose, chest congestion and cough. Increasing chest congestion and fatigue, over the next 24 hours it got worse and after speaking to my doctor,  I started Paxlovid 05/19/2022. It started to elevated sx quickly with in 24 hours and now at the end of the medication. I still have a cough and way less mucus and still tired. I'm very sure this was from the variant and traveling.
30 minutes after the vaccine I had diarrhea that continued off and on all day. I felt nauseous and barely made it to the toilet in time. In total, about 4-5 episodes of sudden onset diarrhea. I felt dehydrated and a little weak. There were lots of strange gurgling sounds in my abdomen as well.
Information has been received from a physician concerning a 60 year old female smoker with severe chronic obstructive pulmonary disease (COPD), chronic pancreatitis who on 30-JUL-2009 was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently, on an unspecified date the patient experienced septic shock and cardiac disease. The patient was admitted to the intensive care unit (ICU). On 04-AUG-2009 the patient died eight hours after admission. The physician did not think death was related to ZOSTAVAX (Merck). The physician felt the patient died of cardiac reasons, but her documents said that the cause of death was septic shock and pancreatitis. Additional information has been requested. reported the following additional information:  No other vaccines were administered at the time of the ZOSTAVAX   Hospital records not received by the office, but a copy of a cardiac consult done on admission on 02-AUG-2009 showed renal insufficiency and DIC (consumptive coagulopathy); patient was intubated due to decreased mental status changes; consult also shows that patient went into cardiac arrest on 03-AUG-2009; onset of AEs was within 48 hours of death  Death certificate showed the immediate cause of death as septic shock with the underlining cause of death as pancreatitis; no autopsy was performed.
feeling weak; headache; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the arm left on 30Mar2021 at 13:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included single functional kidney. The patient had known allergies to epinephrine and lobster. The patient did not receive any other medications within two weeks of the COVD-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 09Mar2021 at 13:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 30Mar2021, Tuesday, at 22:00, the patient experienced pain in his arm. On 31Mar2021, Wednesday ,the patient experienced feeling weak, which got worse as the day progressed. The patient developed headache. The patient felt weak and had headache all day, and started feeling better at night. The patient felt a bit weak the next day but everything else seemed to be fine. Therapeutic measures for headache included treatment with Tylenol which was ineffective. The clinical outcome of the events pain in arm, feeling weak and headache was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
No adverse event; patient received a second dose of PROQUAD approximately 8 weeks after the first dose.; The child was 5 years old at the time of the first administration; This spontaneous report has been received from a nurse, concerning a 5-year-old male patient. The patient's medical history, drug reactions or allergies, concurrent conditions, and concomitant therapies were not provided.   On 17-JUL-2018, at the age of 5-year-old, the patient was vaccinated (Inappropriate age at vaccine administration) with first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot #, and expiration date were not reported) as prophylaxis. On 12-SEP-2018 (approximately 8 weeks after the first dose), the patient received the second dose (Inappropriate schedule of product administration) of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number R011217, which has been verified to be valid, expiration date reported and validated as 15-OCT-2019) as prophylaxis. No additional adverse events were reported.
Outer aspect of left arm at Varicella vaccination site has several clear filled vesicles. Arm warm, red and swollen from shoulder to elbow. 5 inch by 5 inch area. Tender to touch. Student referred to MD on 3/26/09. Saw Dr.
This spontaneous report was received from a pharmacist concerning a 56 year old male patient.  There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 18-DEC-2017, the patient was vaccinated with ZOSTAVAX lot # N023002 with expiration date of 20-NOV-2018, subcutaneously for shingles (dose and anatomical location were not reported). On 19-DEC-2017, the patient experienced pain approximately four inches below injection site. The outcome of pain was reported as not recovered. The causal relationship between the pain and therapy with ZOSTAVAX was not reported.
Unexpected Dizzyness Unexpected Tinitus (regular/expected muscle/joint aches) (regular/expected tiredness/exhaustion)
Patient came back to Pharmacy on December 12, 2019 and stated since her first Shingrix vaccine on 9/16/19, that she has been having significant arm pain and can not lift her shoulder without pain.  She said she has been seeing a physical therapist and he said if angle was not correct that it could cause more pain.  I was the vaccinating pharmacist.  I asked pt to point to the area she received the injection, and she pointed to the upper deltoid region.