chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt call hospital call center  5/14/2021. Pt c/o difficulty breathing, swelling throat, palpitation, itching whole body, tiredness, body aches whole body since pt got 2nd covid vaccine 5/12/2021. Pt recommended pt to call 911 or go to nearest ED d/t emergency covid vaccine side effects shown. Pt refused to call 911. The writer offered to call 911 on behalf of pt. Pt agreed the writer to call 911 on behalf of pt. Called 911 and connected with pt in conference phone connection.
The patient did not experience any adverse event. Scheduling the patients for the COVID clinic was not aware that the patient had already received her second dose (Doses given before on 03/05 and 04/09).  The patient received a third dose on 06/03 that was discovered upon entering the information in the vaccination reporting platform.    The patient did not experience any adverse events due to this third dose
Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional via phone. This case involves a 68 years old male patient who was vaccinated with a 0.5 ml expired dose of INFLUENZA FLUZONE HIGH DOSE (Batch number: UI977AC and expiry date: 09-Mar-2019, dose in series and route of administration were not reported) in left deltoid on 28-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Pt c/o dizziness and chills 10 mins post vaccination. Denied cp, chest tightness, angioedema and wheezing. Pt was evaluated by Dr., she started c/o of difficulty swallowing and nausea, BP was 134/88, HR 87, o2 98, blood glucose 95 and temp 106.2, EMS was contacted by RN. Repeat temp was 105.7, epipen was administered by a paramedic. Pt was brought to ED. RN gave verbal report to ED nurse over the phone. physician reached waiting room patient was shaking hands are shaking denied any chest pain shortness of breath swelling of throat, she does not like needles,  her husband was with her stating that she was not complaining of any of the above as he is translating for her from Spanish.  Blood pressure taken in lobby was stable 130s over 80s satting oxygen was 95 to 99% was put in a wheelchair brought back to the room also and was concerned about use of ambulance thought patient would likely be okay PCP was wondering if this was panic attack.  Once in the room laying down started to have more chills stated that her bones were hurting temperature was taken it was 105, 106 EMS was called EMS asked for EpiPen EpiPen was provided patient was transported.
patient received their second dose of Twinrix a year ago and wished to know if the third dose could be administered; patient received first dose on 02-JUL-2022 and second dose on 10-AUG-2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose of Twinrix on 02 July 2023).   On 10-AUG-2022, the patient received the 2nd dose of Twinrix. On an unknown date, the patient did not receive the 3rd dose of Twinrix. On 10-AUG-2022, an unknown time after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient received first dose on 02-JUL-2022 and second dose on 10-AUG-2022). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: patient received their second dose of Twinrix a year ago and wished to know if the third dose could be administered). The outcome of the drug dose administration interval too long and incomplete course of vaccination 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: 10-AUG-2023 The [pharmacist stated that patient received 2 doses of Twinrix a year ago in 2022. Patient wished to know that if she can receive her 3rd dose or the series needed to be restarted. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Twinrix , later than the recommended interval, which led to lengthening of vaccination schedule. Till the time of reporting, the patient did not receive 3rd  dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Patient experienced dizziness and fell the day after receiving vaccine. The patient's wife said that she took him to the ER and that the patient had a sprain.
Flu like symptoms; Achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Oct2021 10:30 (Lot number: FF8841) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "on oxygen all the time at home" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 20Oct2021, outcome "recovering", described as "Flu like symptoms"; PAIN (non-serious) with onset 20Oct2021, outcome "recovering", described as "Achy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  Additional information: It was reported that patient took COVID vaccine yesterday. Today she has some achiness and flu like symptoms since she woke up this AM but noted that they are starting to subside. The caller would like to know if her symptoms are okay and normal.  After guidance provided the caller states that the one side effect listed that she likes the most is the decreased appetite. She said she was given so many papers to read about the vaccination and after today's guidance she does think everything is fine. She notes that she has taken Tylenol but sometimes when the pain is more than what Tylenol will take care of, she takes a BC powder which is quicker and faster. Provider is next door to where the patient lives. She understands that the vaccination is new and testy. Adverse reactions following the Pfizer-BioNTech COVID-19 Vaccine that have been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, malaise, lymphadenopathy, and decreased appetite.   No follow-up attempts are possible. No further information is expected.
I95.9 HYPOTENSION 11/20/2021 SEPTIC SHOCK I95.9 HYPOTENSION 11/20/2021 HX OF INVASIVE BREAST CANCER
Second COVID vaccine at 11.13 am. Sat to wait 15 minutes. After 7 minutes felt very light headed. Was asked to sit in recliner. Heart palpitation. BP 166/92. Started having red blotches on both arms. Waited 10 minutes. BP 148/84. Sat 15 minutes. BP 132/80. Tried to stand up. Starting feeling dizzy right away. Nauseated. Heart palpitation. BP 152/85. Was given 25 mg Benadryl and orange juice. Doctor came . stood up again. Light headed. Was transferred to an exam room. Was given zofran for nausea. Lay down for half and hour. Felt much better. Left to go home. Slept. Better. Still slightly light headed
This spontaneous report as received from a healthcare worker via a company representative, refers to a 4 year old female patient. On 24-APR-2013, the patient was vaccinated with VARIVAX (Merck). Other suspect therapies included MMR II. VARIVAX (Merck) was given only 48 hours after the administration of MMR II. On 24-APR-2013, 3 days after onset of therapy the patient experienced blisters and swelling at the injection site and blisters and swelling at the injection site. The outcome of blisters and swelling at the injection site was reported as recovering/resolving. The action taken with VARIVAX (Merck) was not provided. The reporter did not assess the relationship between the events and VARIVAX (Merck). Additional information has been requested.
1) Severe and continuous headache  lasting 36 hours (not a migraine type) 2) Nausea lasting 3 hours 3) Fever lasting 36 hours.  101.1 °F.  My highest fever in >35 years
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 11-FEB-2016, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. Later in February "2015" (considered an error and supposed to be 2016), the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This spontaneous report was received from a nurse and  refers to an unknown number of patients (gender and age unknown). On an unknown date the patient or patients were vaccinated with improperly stored  GARDASIL 9  (dose, route, application site, frequency,  and lot # were not reported) for prophylaxis. There were no adverse effects. The nurse reproted that the GARDASIL 9 was exposed to 0 to 2 °C for 67 hours. The call was due to a data logger. The patient or patients' outcome was unknown. This is one three reports from the same reporting nurse. MARRS 1611USA000874 and 1702USA005000. Additional information has been requested.; Sender's Comments: US-009507513-1611USA000874: US-009507513-1702USA005000:
Seizure  11/9/2009 ED records from 11/4/2009. Patient presented with grand mal, tonic-clonic seizure episode. Neuro exam normal, no prior hx. Tx: IV Ativan. To f/up with Neurologist. DC DX: Grand Mal seizure
Patient is experiencing severe light-headedness, nausea/vomiting, dizziness upon standing.
62y.o. female with a history of CAD, COPD/asthma, and cardiac arrest 3/2022 c/b anoxic brain injury (nonverbal at baseline) and chronic respiratory failure s/p tracheostomy (3L trach collar at home) who presented from ECF 3/14 with hypoxia. She was found to be COVID positive. She was admitted to the medical floor on trach collar but than had increased oxygen requirements requiring transfer to higher level of care. A CXR was obtained that demonstrated concern for left bronchial mucus plug. The patient is known to have a #6 uncuffed Shiley. Overall long term prognosis is poor. Have been seen by palliative care and hospice in the past, however, family had desired in the past to continue with full code.
Started with periodic sharps pain in back under left clavical.  Then became constant sharp pain, soreness in left arm, could not sit down- constantly trying to "rub" pain away thing it was a muscle spsam . i was in a remote location fishing with my son.  became so painful we went back to cabin and called Advice nurse.  they put ER doctor on the phone and he asked lots of questions and suggested i go to emergency room to get checked out for possible heart attack. While driving out of the isolated area, pain became very bad and we call 911.  emergency people arranged meeting at location and i was transported to hospital by ambulance. i was now having difficulty breathing, they had me on oxygen and monitoring vitals.  at Emergency room- rushed into facility and immediately checked for heart problems.  they took multiple blood samples, chest X-rays and two Chest MRI's.. did not find any issues with my heart and could not explain severe pain.  2nd MRI was to specifically look at Aorta- they found 4cm aneurism in ascending Aorta.  They said this was probably not the source of the pain.  after 3 hours , with new pain meds and muscle relaxers- they released me to my wife and we drove back.  pain really didn't go away and again became more accute, Called Advice nurse again on May 21, no help.   Went back to ER at Hospital on May 24th. same routine as first ER visit, chest Xray and 2 MRI's - again no specific diagnosis  but later in the day spoke to my Primary Physician who suspected Miyrocarditis.
The day after my second shot I woke up ver fatigued with a severe, throbbing, persistent headache to the left side of my head behind my left ear.  I had the headache for 2 days and it intensified.  On 08/06/2021 at approximately 6:00 PM the left side of my face dropped and it was paralyzed.  On 08/08/2021 A Doctor at an Urgent Care diagnosed me with Bells Palsy.  He prescribe Prednisone, Valtrex and antibiotic eye drops.  My PCP, then took over my care.  He recommended physical therapy and placed me off from work until 10/04/2021.  I have been to approximately 4 physical therapy appointments and my symptoms have slowly improved.  I still have pain, swelling, and numbness to the left rear of my head and the left side of my face.  Treatment will continue and an MRI was ordered.
Shivering; his arm was hurting after the SECOND dose of Moderna COVID-19 vaccine; Shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), CHILLS (Shivering) and VACCINATION SITE PAIN (his arm was hurting after the SECOND dose of Moderna COVID-19 vaccine) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. In 2021, the patient experienced TREMOR (Shaking). On an unknown date, the patient experienced CHILLS (Shivering) and VACCINATION SITE PAIN (his arm was hurting after the SECOND dose of Moderna COVID-19 vaccine). In 2021, TREMOR (Shaking) outcome was unknown. At the time of the report, CHILLS (Shivering) and VACCINATION SITE PAIN (his arm was hurting after the SECOND dose of Moderna COVID-19 vaccine) outcome was unknown.            Concomitant medication information not provided.  Treatment information not provided.     Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received: contains NNI
Day 1 site pain, around 24 hour mark was nauseous.  But the event that is not listed in known side effects that I've now experienced multiple times, with the first dose I received 1/28 then had symptoms 1/29 and 1/30 and now with the second dose on the 2/24 I've experienced today,  is from researching it I'd call Raynaud's syndrome.  I had several fingers turn white, numb and cold to the touch.  I've never had this happen previously and now had it happen 4 times each within days of the Covid vaccine.  After the first vaccine, once I was a week out, symptoms disappeared.  Running my hands under warm water, symptoms disappear.  Right now I just picked up a glass of ice water and even typing my fingers are slightly numb.  Once I see how long these symptoms last I'll submit a separate event for the second dose.
death; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (death) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Death occurred on 2022 The patient died in 2022. The cause of death was not reported. It is unknown if an autopsy was performed.            It was unknow if the patient receives any other vaccine in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that patient got moderna vaccine and she died last year.  Treatment information was not provided. Company comment  This spontaneous case reported by a patient family member or friend concerns a female patient of an unknown age with no medical history reported, who experienced the unexpected, serious (medically significant and fatal), event of Death, that occurred on an unknown date in the context of a dose of SPIKEVAX NOS (SPIKEVAX NOS). The vaccination date and event onset date were not provided, thus, exact latency between vaccination and onset of the event could not be assessed. The patient died in the same year that the vaccine was given. The cause of death was not reported. It is unknown if an autopsy was performed. It was unknow if the patient receives any other vaccine in the 4 weeks prior to COVID-19 vaccine. No further clinical information was provided for review. The benefit-risk relationship of SPIKEVAX NOS (SPIKEVAX NOS) vaccine is not affected by this report.   Reporter did not allow further contact; Reported Cause(s) of Death: unknown if autopsy was done
Information has been received from a registered nurse concerning a female (less than 2 years old), the nurse's niece, who, on an unspecified date, was vaccinated with a dose of MMR. Concomitant vaccination at the same time included a dose of varicella virus vaccine live (lot # unknown). Subsequently, the patient developed a fever of 104 F that persisted for 1 week. Subsequently, the patient recovered from fever on an unspecified date. The patient sought unspecified medical attention. Follow up information from a pediatric practice manager (also reported as registered nurse) and physician indicated that the physician was not aware of any problems with administering MMR vaccine to any of his patient's. There was no product quality complaint. Additional information is not expected.
Left side of face and left forehead were numb. Lasted approximately one hour. Went away on it's own.
A 44 year old female pt experienced severe lymphadenitis of the left axilla and a swollen left arm after receiving her second dose of RabAvert for prophylactic vaccination. The pt received her first dose on 24Feb04 with no reported problems. She received her second dose on 03Mar04 and within twenty four hours the pt experienced the lymphatic problems along with a runny nose. The symptoms resolved within three to four days with no further complaints. No further details were currently available at the time of the report. Follow Up received 30Apr04: The physician reported the pt experienced pain and swelling of injection site that extended to the axilla. He provided the injection route (IM) and dates. Three doses given two weeks and three weeks apart, starting 24Feb04, 03Mar04 and 23Mar04. The pt had a complete recovery.
Patient is a 12 years old and 39 days and received in error the Pfizer 5-11 vaccine 10mcg instead of the over 12 year old dose of 30 mcg.
This spontaneous report as received from a healthcare worker refers to 13 years old male patient. In 2011 the patient was vaccinated with first dose of GARDASIL (dose, route, injection site, lot# and indication not provided). On 17-MAY-2013 (reported as now) the patient was vaccinated with the second dose of GARDASIL (dose, route, injection site, lot# and indication not provided). The reporter stated that the patient was late for his second dose of GARDASIL. No adverse effects reported. The outcome of events was unknown. Additional information is not expected.
This case was reported by a other health professional via call center representative and described the occurrence of injection site cellulitis in a 19-year-old female patient who received BEXSERO (batch number 151301C, expiry date 31st December 2016). On 28th April 2016, the patient received BEXSERO. In May 2016, less than a week after receiving BEXSERO, the patient experienced injection site cellulitis. On an unknown date, the outcome of the injection site cellulitis was unknown. It was unknown if the reporter considered the injection site cellulitis to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on the right deltoid. On 4th May 2016, the patient was seen by her physician for cellulitis at the injection site, which developed one to two days prior to the visit.
Shortness of breath. Hx of CVA and COPD. Covid + 3 days prior to arrial. SOB x 2 hays , cough for 5 days
PATIENT HAD AN ALLERGIC REACTION :SWOLLEN FACE,LIPS,CHEEKS, AND AROUND MOUTH. ALSO SWOLLEN FEET. PATIENT WOKE UP WITH SYMPTOMS THE DAY AFTER 1RST DOSE
I am experiencing achy pain from head to toe and feel like I'm running a slight fever. Taking TYLENOL every 4 hrs. No redness or swelling. No shivering.
Swollen lymph node in armpit for4 days, 99.8 temp for one day, chills, fatigue, headache, injection site pain and swelling, lymphadenopathy, malaise, new or worsened joint pain
This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shivering and fatigue. On an unknown date, the outcome of the shivering and fatigue were unknown. It was unknown if the reporter considered the shivering and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient got SHINGRIX by itself and reported shivering and fatigue. This case has been linked to the US2018GSK177718 and US2018GSK177719 (the 2nd patient who received SHINGRIX and FLUAD both) and US2018172531 (the 1st patient who received SHINGRIX and FLUAD both), reported by the same reporter.
Left arm was red and swollen from shoulder to elbow. Entire area was so swollen due to fluid accumulation.
Medical facility gave #2 Pfizer apr 30.  today I see on video R arm from shoulder to wrist not quite twice normal size, symmetric swelling, I do not see the  site. There is NO pain and ROM is normal shoulder.