chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Date of Admission: 7/11/2023 Discharge Date: 7/12/2023   DETAILS OF HOSPITAL STAY:   PRESENTING PROBLEM: Tachyarrhythmia [R00.0] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 71 year old female with past medical history of PAF on Xarelto, OSA with CPAP, obesity who presented to the Emergency Department with fatigue and shortness of breath.  Patient stated her symptoms began earlier the day of arrival.  In the emergency department she was found to be positive for COVID, additionally 8 sodium 133, creatinine 1.14, BNP was elevated 2418. EKG demonstrated AFib with RVR.  She was noted to have a heart rate into the 170s while in the emergency department.  They did give her 1 L bolus.  They also did speak with Cardiology who recommended initiating Lopressor, they gave her a dose of 25 mg.  Hospitalist team was consulted for admission.  Patient did have an echocardiogram which demonstrated ejection fraction of 60%, no significant valvular heart disease or anatomical concerns.  Heart rate was much improved after initiation of Lopressor, but it was noted that her heart rate was into the 50s.  She was initially asymptomatic from a COVID standpoint, she has developed dry cough during admission.  At this time her heart rate is much controlled, she will be continued on metoprolol tartrate 25 mg 2 times a day, she will continue to be monitored with a ZIO patch to be sent to her cardiologist office.  She has been instructed follow-up with the cardiologist within 2 weeks.  She has also been instructed to continue quarantine for total of 5 days, continue masking for 5 days after that.  She does have a history noncompliance with Xarelto, she has been educated, and also seems motivated to continue Xarelto as prescribed.   Electrolytes were monitored and repleted PRN throughout the admission. Patient clinically improved and hemodynamically stable for discharge.  Discussed plan of care discharge with patient including outpatient follow-up PCP within 7 days. Patient voiced understanding was agreeable with plan of care discharge.
Information has been received from a lawyer concerning a male who was vaccinated with RECOMBIVAX HB (manufacturer unknown). The patient suffered a vaccine injury Guillain Barre syndrome as a result of RECOMBIVAX HB. In 2005 the patient died from hypertension. No further information was available at the time of this report. No further information is available.
body aches, hot/chills starting 8 hours after vaccine and lasting for 24-36 hours; headache starting 20 hours after vaccine and lasting for   2.5 days
Patient seen in ER at Hospital on January 3rd.  Patient felt his throat was swelling shut and had a sore throat. Hospital diagnosed patient with uvulitis.  Patient last ate around 7PM the night before.  No URI, no fever, no headache, no cough.  They did a CXR which was negative and rapid strep that was negative.  Patient was given a shot of steroids, Benadryl and told to follow up at IHS.
No adverse event noted and none expected at this time. Pediarix was accidentally administered instead of Infanrix, thus causing the child to receive 2 doses of IPV, also causing the third dose of Hepatitis B vaccine to be given 5 days before the child would be 6 months of age. The  State Department of Health and immunization representative was contacted along with the CDC (ID number 12727413). He told her that receiving the second polio would not hurt the child. He did say that we should submit a VAERS report. The mother of the child was contacted and told about the error. She was also informed that CDC had been contacted and had stated that this incident should not cause any problem for the child. The child's doctor was also informed in case any problems do occur. The county health officer has also been notified of this incident.
No additional AE; HCP calling to report that a patient was administered a improperly stored vaccine.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 28-JUN-2023, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (strength, vaccination scheme, anatomical site of vaccination, route of administration, lot number W035460, expiration date reported and validated as 06-MAY-2024) as prophylaxis (product storage error). No additional adverse events reported.
This case was reported by a nurse via sales rep and described the occurrence of injection site lump in a 4-year-old male patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT (subcutaneous). On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site lump and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site lump and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site lump to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient received FLULAVAL QUADRIVALENT on an unknown thigh. The healthcare professional stated that the patient's mother reported there was a knot on thigh at the injection site and a knot right next to the injection site. The nurse thought that the injection might had been administered subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. No additional information was provided.
This spontaneous report has been received from a medical assistant and refers to a 4-year-old patient of unknown gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 17-APR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M041083, expiration date 04-APR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint was involved. The reporter also stated that she had a printed report of the patients who received vaccines that had undergone the temperature excursion. The report included vaccine name, date given lot number and the name, gender and birth date of patient. This is one of several reports received from the same reporter. Additional information is not expected as all relevant correspondence has already been received. This report was previously submitted with the incorrect Worldwide unique case identification number US-009507513-1705USA005093', and this new follow-up submission is to provide the correct identification number US-009507513-1706USA003937'. US-009507513-1705USA005093' is an existing case, therefore this safety report is not being nullified, just updated to reflect correct Worldwide Unique identification number. This is an amended report, as corrected. Company Number was updated to US-009507513-1706USA003937. Sender's Comments: US-009507513-1705USA005086: US-009507513-1705USA005094: US-009507513-1706USA003934: US-009507513-1706USA003935: US-009507513-1706USA003936: US-009507513-1705USA005093: US-009507513-1705USA005086: US-009507513-1705USA005094.
The lot number I believe is ASD 44B- it was handwritten and the D could be something else. The lot number is definitely AS-something-44B, given 9/23/22 at Pharmacy on 9/23/22  About one week after vaccination, I started having an itchy rash. Increasingly over the next few weeks I have been extremely itchy all over my body, in completely random areas that are so itchy they needed to be scratched or I would scratch without thinking. Within 5 minutes after itching I would develop a deep red rashy discoloration on the area that was warm to the touch and depending on the instance would develop hives, small bumps, raised lines etc. Over the course of the next hour these would fade and the skin would return to normal. I went to a dermatologist on 10/17/22 and while we can not say definitively, we both think it is vaccine induced as there have been no other changes in my day to day life.  The dermatologist gave me a steroid injection of Kenalog which after two days gave a lot of relief. I am no longer itchy, when I do scratch there is still a red splotchy area that develops but it was 80% resolved with the steroid shot. It remains to be seen if it comes back after the steroids wear off.
Mom gave APAP when arrived @ home 30OCT91; pt had t105 7PM; given APAP & sponge bath, pt had febrile sz, stopped breathing; mom started mouth to mouth resuscitation & called 911; Pt resumed breathing, transported to ER;
rash w/itching onset day p/MMR; skin w/hive-like areas all over; severe itching;
Provider hospital summary "Patient is a 85 y/o male w/ history of prostate cancer on Xtandi, Hypertension, CKD III, hyperlipidemia presented 11/24 with weakness, syncope, hypotension, hypoxia and known history of COVID 19 infection. He is admitted for acute hypoxic respiratory insufficiency and debility.    During his hospitalization stay, he received IV Regeneron and was monitored closely. His oxygen requirement has been minimal and did not need O2 supplementation at discharge. Orthostatic hypotension test was negative and no evidence of arrhythmia on telemetry were revealed. No further presyncope or syncopal episode noted while inpatient after holding all anti-hypertensive medications. He was able to ambulate in the room and work with therapy without difficulties. All his anti hypertensive except his diuretic was restarted on discharge. He is advised to discuss re initiation of his diuretic with is PRIMARY CARE PHYSICIAN."
patient was administered undiluted childrens pfizer in error 0.3ml. Instead of pfizer bivalent 0.3ml.
Within a couple of hour 05:00PM felt like had water in her ears in both ears like it was stopped up like when you fly and ear need to pop and it could not pop. This continued for close to 5-6 days she notice that the TV the was louder and louder to hear and notice the volume level on tv was up. Hearing tested as soon as possible at. Visited with audiologist and hearing test and advised that she see and ENT specialist. She made an appointment earliers she was able to get in was a Friday, ENT another test was given and it showed hearing was going in different direction and  there was progress at the second test  showed improvement. Prescription was given but was not needed with the directives given to wait a couple of days.
Hospitalization 1/24/22-1/28/22 cough, tachycardia, nasal congestion, respiratory failure, dyspnea, body aches, PNA
Day after receiving shot, patient felt flu like symptoms (joint pain, extremely achy, severe chills, lethargic, headache), pain to body over simple touch, bodily inflammation, muscle weakness. Symptoms were gone by next day
We paid a great price for me to get the shingles shot in 2010. It is supposed to prevent or lighten the case if you do get it. I started with pain in the upper back, progressed to a very painful rash, and now after 6 weeks of misery I am finally recovering. And I did visit my doctor to confirm that I had shingles. I feel that the shot does not work that well. If they allow it to continue to be used at least the price should not be so exorbitant.
Phizer shot 1 of 2 in the left arm on Thursday 5/6.  I arrived home 45 minutes after the shot was administered and went to the bedroom as my heart rate continued increasing until it was racing non-stop. As my rate increased, so did my breathing until it became rapid and shallow.  It is difficult to describe how fast my heart was beating.  The rapid heart rate and shallow breathing reminded me of how my breathing changed when I summited a 5800-meter volcano and there was insufficient oxygen near the peak.  As my pulse increased I became weak and fell asleep, or fell unconscious.  I awoke at 11:00 PM and my breathing was normal however my heart continued racing for an additional hour until midnight.  I have experienced no other side effects except heart rate and breathing.
Day 1 (within 30 minutes of vaccine): Tingling and prickling on left fingers and left toes; general malaise; fatigue; difficulty concentrating;  Day 2: General malaise, fatigue; difficulty concentrating; headache; lower back pain Day 3: Fatigue; runny nose, sneezing, cough, aches all over the body; headache; a red, itchy blotch on the right index finger; lower and upper back pain Day 4: Same as above, but vision problems right before bedtime;  Day 5: Severe headache, lightheadedness,  difficulty talking, numb left side of thCT e face, left hand, left arm, left food. Went to ER and still in the hospital in observation  (Day 6)
10NOV95 pt father stated over phone that school nurse phoned parents stating they needed to take pt to MD because pt was paralyzed on lt side of body involving arm & face;father advised to take pt to MD for eval;dx Bells Palsy
Rash developed all over back 10-12 hours after receiving shot. Some spread to chest 1-2 days later; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jul2022 at 12:00 as dose 4 (booster), single (Lot number: FO7139) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: ESTROGEN; LEVOTHYROXINE; PROGESTERONE. Vaccination history included: Covid-19 vaccine (Dose: 03, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 02, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 01, manufacturer unknown), for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 16Jul2022 at 23:45, outcome "not recovered", described as "Rash developed all over back 10-12 hours after receiving shot. Some spread to chest 1-2 days later". The event "rash developed all over back 10-12 hours after receiving shot. some spread to chest 1-2 days later" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash.  Additional information: Consumer reported rash developed all over back 10 to 12 hours after receiving shot. Some spread to chest 1-2 days later. Adverse event treatment was Claritin, Benadryl. Patient had covid prior vaccination. Patient had not tested covid post vaccination. Known allergies was unknown. Patient visited Doctor or other healthcare professional office or clinic.  No follow-up attempts are possible. No further information is expected.
7 hours after vaccination, patient was hypotonic and hyporesponsive for several seconds, remained pale and less active for 2-3 hours afterwards. Subsequently was back to normal activity without recurrence.  Parents did not seek medical attention until 4 weeks later.
Pt had a syncopal episode 5 minutes after receiving the vaccine. He stood up to notify a staff member when he passed out and fell, hitting his head and sustaining abrasions to his right hand. Pt recalls what happened prior to the syncopal event. He experienced a similar event in the past after receiving the flu shot. Pt also did not eat or drink anything prior to coming here.  EMS was notified and pt was brought to a ER.
approx. ten or eleven days after receiving the Moderna  vaccine, my mother experienced fatigue, nausea, body aches and a fever. Within hours, her body was inflamed with rashes from head to toe, with hives in certain spots, and she looks sunburned all over her body.  She is extremely itchy and in pain and generally very uncomfortable.
Pt experienced lymphadenopathy, developed 15 - 20 erythematous papules on trunk. The next day, 2 vesicles appeared, then all began to resolve.
I attempted to give him his vaccination. I stuck him with the needle, but as soon as I did the vaccine expelled from the syringe all over my hands and his arm. None of the vaccine got into his arm. Therefore, I drew him another another 0.5mL of vaccine and injected him. He had no adverse events at the time I filled out the paperwork.
RECEIVED A HALF DOSE FOR THEIR BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 35 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 in total, (dose number in series 1) for prophylactic vaccination and it was unknown whether patient had any adverse events (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) (lot number also reported at 211A21A) 0.25 ml (milliliter), frequency 1 total, administered on 27-NOV-2021 for prophylactic vaccination (Dose series number 2, Booster dose). No concomitant medications were reported.  On 27-NOV-2021, the patient received half dose of their Booster dose vaccine (captured as: Vaccine underdose) and off Label use (dose number in series 2). The reporter stated that something was printed and was disseminated which said to administer 0.25ml. It was reported that HCP (from public health dept) stated that there were 33 patients who received half doses (0.25mL) for their booster or 3rd dose a few days ago. Most of them were patients from (town). HCP stated that something was printed and disseminated that said to administered .25ml. HCP is not sure where that information came from. Stated it was over the holidays so people could have thought that info changed and staff was just not made aware. At the time of conversation with HCP, they did not think it has been reported through VAERS. HCP thought that vendor will file the report with VAERS, not the public health department. HCP stated that they figured it out after the event because they could not figure out how so many doses were given. They were looking for a discrepancy in the number of vials perhaps, but then realized that half doses were given. HCP consented to being contacted but preferred contact be on alternative contact. Specific report was in regards to male patient aged 35 received half dose of the Janssen COVID-19 vaccine for their BOOSTER dose. They were given at a pop up clinic at a renaissance festival by Medical clinic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received a half dose for their booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211201046, 20211202193, 20211201228, 20211201168, 20211200752, 20211201351, 20211200994, 20211201450, 20211201286, 20211204104, 20211201179, 20211201443, 20211220152, 20211220146, 20211220262, 20211220250, 20211220145, 20211219871, 20211219926 and 20211202250.
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media (suspected) and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received all doses of shingles but got shingles, though not severe. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 24-FEB-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (strength, dose number, route and lot# were not specified) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered to patient.
4 months old received kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 9th February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was 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: 7-Dec-2022 Reporter's comment: The reporter consented to follow-up. The case was for 1 of 5 linked patients reported by same reporter. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2022183609:Same reporter US-GSK-US2022183611:Same reporter US-GSK-US2022183612:Same reporter US-GSK-US2022183615:Same reporter
ITCHING AT STIE OF INJECTION WHICH LASTED FOR A FEW DAYS.
This spontaneous report as received from a registered nurse referred to a patient of unknown age. Nurse reported that an unspecified patient received the first dose of GARDASIL (lot #, dose/frequency, route were unspecified) in January 2011, "2 years ago" and was now (22-JAN-2013) in office to receive the second dose (lot #, dose/frequency, route were unspecified). The outcome was unknown. Additional information has been requested.
She developed painful swelling in left knee the day after vaccination. The swelling resolved after 2 weeks and then returned several hours after 2nd Pfizer dose.