chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt began experiencing nausea, weakness, fatigue, and myalgias 4 days after the vaccination.
Found him dead while he was sleeping; Heart attack; This is a spontaneous report from a contactable consumer. This consumer (patients brother) reported for a 66-year-old male patient (reporters brother). A 66-year-old male had received BNT162B2 (Pfizer-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and expiration date: not reported) via an unspecified route of administration on 08jun2021 as DOSE 2, SINGLE for covid-19 immunization (At the age of 66 years).The patient medical history had included High blood pressure, Diabetes, and Continuous positive airway pressure. It was reported that, patients brother son had brain cancer. He was on high blood pressure medication and was diabetic but, does not know what medication he was on. He is not sure of the name and can't say.The patient concomitant medication He was on high blood pressure medication. It was reported that there was no idea that patient took any vaccination within 4 weeks of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: PHURCR8735) on 18May2021 as DOSE 1, SINGLE for COVID-19 Immunization. On 25Aug2021 the patient found while he was sleeping. It was reported that, received Comirnaty second dose and died in his sleep 6 weeks later and was found dead last Wednesday when he was sleeping. He reports he was cremated so an autopsy was unable to be performed so they are unable to determine if there is a connection between the vaccine and his death. He wants to know if deaths after the vaccine have been reported. As cause of death was unknown, Caller figured he just had a heart attack. He still had his CPAP machine on and had copabilities. They figured he would outlast all of them. The patient was on a CPAP machine, had diabetes that wasn't too bad, and was overweight, probably about 250 pounds, and had been taking blood pressure medications for years. The patient had not visited any emergency room and physician office. The clinical outcome of the event Found him dead while he was sleeping and heart attack was fatal.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Found him dead while he was sleeping
No actual adverse event occurred. Patient was ineligible to receive second bivalent booster due to age and lack of being immunocompromised.
Moderna vaccine was given to a 16 year old male when it has not been approved to be administered to this age group.
2 inch or slightly greater area of redness with some bumps that looked like hives to the mother around the injection site on the left thigh that was noted the morning after the immunizations were given/also had swelling of the left thigh from injection site down to his knee/child c/o itching at the site/child taken to ED for evaluation and was prescribed an oral antibiotic/area looks less red today per mom.
Extremely painful injection followed by shoulder pain, weakness, lack of mobility. Been taking Advil or Tylenol everyday. Have tried ice and heat. Still in a lot of pain. I?m so frustrated I don?t know what kind of doc to go to. Please get back to me
doctor told to get shingles shot once a year; doctor told to get shingles shot once a year; Circumstance or information capable of leading to medication error; This case was reported by a consumer via interactive digital media and described the occurrence of drug use for unapproved indication 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 drug use for unapproved indication, off label use and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the drug use for unapproved indication, off label use and circumstance or information capable of leading to medication error were unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, his or her physician told to get shingles vaccine once a year, which led to drug use for unapproved indication, off label use and circumstance or information capable of leading to medication error.
muscle pain back in both legs, muscle pain down to her knees and muscle pain in both upper arm from her shoulder to elbow; pain worsened; soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), MYALGIA (muscle pain back in both legs, muscle pain down to her knees and muscle pain in both upper arm from her shoulder to elbow) and PAIN (pain worsened) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm). On an unknown date, the patient experienced MYALGIA (muscle pain back in both legs, muscle pain down to her knees and muscle pain in both upper arm from her shoulder to elbow) and PAIN (pain worsened). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (soreness in the arm), MYALGIA (muscle pain back in both legs, muscle pain down to her knees and muscle pain in both upper arm from her shoulder to elbow) and PAIN (pain worsened) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported by the reporter.
Right arm very sore starting that evening. Soreness into the nest day. Heart pain.  Today is only the second day abs his symptoms are bad enough to go to the doctor.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received SHINGRIX (batch number S45FC ?, expiry date 30th January 2020). On 15th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, 3 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site induration and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site induration and injection site warmth were unknown. The reporter considered the injection site erythema, injection site induration and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the right arm. The patient reported to the pharmacist that after the initial dose, there was a large red area at the injection site. It was hard and hot to the touch. The reporter said it did not itch and it seems to be getting better but she was concerned about proceeding with the 2nd dose. The reporter's call was transferred to medical information for further assistance. The batch number of SHINGRIX (S45FC) did not exist as per sales database and was updated to S45FC ? Clarification has been requested for the same.
Onset of arm redness, swelling, pain 1 hour after the vaccine. Worsening swelling and redness for 3 days.
Guillain-Barre Syndrome; This spontaneous case was reported by a nurse and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre Syndrome) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre Syndrome) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre Syndrome) outcome was unknown.        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.   No concomitant medications were provided. No treatment information was mentioned.  Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced unexpected event of Guillain-Barre Syndrome. It is not possible to establish a temporal relationship as vaccination date and start date of the event were not provided. Clinical course and treatment details were not disclosed. Very limited information regarding this event has been provided at this time. Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced unexpected event of Guillain-Barre Syndrome. It is not possible to establish a temporal relationship as vaccination date and start date of the event were not provided. Clinical course and treatment details were not disclosed. Very limited information regarding this event has been provided at this time. Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Got a large possible lump on left side of my neck and started small and then got bigger size underneath left ear; Flushed; Chills; Weird side effect; not feeling well; Got a large possible lump on left side of my neck and started small and then got bigger size underneath left ear; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3248 and expiry date unknown), via an unspecified route of administration on 13Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient stated, "I got Covid vaccine yesterday (13Jan2021) at an Institute and I stayed for 15 minutes Since that but just about an hour ago I got a large possible lump on the left side of my neck and I was concerned because you know it started small and then it got bigger and bigger it's like the size of a "quarter" underneath my left ear (on an unspecified date) and I am just flushed and having chills and I don't know I mean it did say if have any weird side effect to call so I just wanted to make sure that it is nothing serious." The consumer stated "I am not feeling really well." The outcome of the events was unknown.
PATIENT RECEIVED THE VACCINE AT 9:00AM, SAT IN STORE FOR 15 MINUTES AND LEFT THE BUILDING. AT ABOUT 9:20 SHE CAME BACK TO THE PHARMACY SAYING SHE IS NOT FEELING WELL AND FELT WEIRD. PHARMACIST ASKED HER TO DESCRIBED THE FEELING, PATIENT SAID SHE JUST FEEL WEIRD LIKE NAUSEA AND NUMBNESS AROUND HER LEGS AND HER CHEST FELT TIGHT. PHARMACIST OFFERED HER TO SIT DOWN AGAIN AND ASKED HER IF SHE HAS ANY HISTORY OF ALLERGIES OR REACTIONS TO OTHER VACCINES BEFORE. PATIENT SAID NO REACTION TO HER YEARLY FLU SHOTS AND NEVER FELT LIKE THIS BEFORE AND STATED SHE'S ALLERGIC TO AMOXICILLIN ONLY. PHARMACIST OFFERED TO CALL THE AMBULANCE FOR HER AND GAVE HER SOME WATER.  AMBULANCE CAME IN AROUND 9:40AM AND ASKED PATIENT SOME QUESTIONS AND TOOK HER TO THE ER.
zoster-related hearing loss; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was diagnosed with zoster-related hearing loss by a healthcare physician. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event hearing loss was not recovered.  Upon internal review, hearing loss was determined to be medically significant.
Injection site soreness and itchiness - almost gone now, took about 96hrs Fever with dry cough - lasted 48hrs treated with Tylenol  Body aches (back and neck uncomfortable)- lasted 48 hrs treated with Tylenol  Headache - lasted 72hrs (off and on) treated with Tylenol  Nausea - off and on 72hrs Fatigue - getting better each day but still feeling this last symptom now  Sunmary, 16 to 18 hrs after injection to 48 hrs was the peak. The next 24 hrs was on the recovery side but didn't take long to become physically winded and exhausted. In the current 24 hrs just dealing with the fatigue.
pt recv vax & knee feeling weak almost fell;later did fall twice as came downstairs;lost muscle control in knees;pt strained sciatic nerve;leg & veins & muscles in thigh very sore;lost 20lb;MD did not feel was allerg react;arthritis;
Patient was administrated a varicella  vaccine on 12/09/2019, When Medical assistant logged the route for this  vaccine M.A  used the drop box and indicated by mistake that the vaccine was given intramuscular when this vaccine was given subcutaneous. This  patient was given the varicella Subcutaneous.
pt recvd vax & w/in 24hrs post vax exp a fever of 101,nausea,chills,weakness,& shakiness;pt dx as having bronchitis;these sx were not treated;sx persist;attending MD stated that the presenting sx were not caused by Engerix-B inj
caller was hurt at work; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENT AT WORK (caller was hurt at work) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Injury at work: Tetanus Vaccine (Patient was hurt at work and received a tetanus shot). Past adverse reactions to the above products included No adverse event with Tetanus Vaccine.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACCIDENT AT WORK (caller was hurt at work). At the time of the report, ACCIDENT AT WORK (caller was hurt at work) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not provided by reporter.
Case number PHEH2013US012628, is an initial spontaneous report received from a nurse on 07 Jun 2013 with a follow-up received on 02 Jul 2013: This case refers to an 11-year-old male patient. He received only Men A lyophilized conjugate component of MENVEO (batch number: M12094) reconstituted with sterile water, intramuscularly on 05 Jun 2013. He did not receive Men C, Y, W-135 liquid conjugate component of MENVEO vaccine. No adverse reaction was reported following this administration error. The nurse commented that there was no problem caused due to the medication error and the patient would be vaccinated with the correctly constituted MENVEO. Follow-up received from the nurse on 02 Jul 2013: Updated nurse's comment.
pt recv vax & devel a varicella-like rash @ inj site 10 days later; 3 to 4 wk following vax pt was exposed to natural varicella; No further details provided;
I was working in the yard.  I started to feel faint.  And then I had chest pain and had pain down my left arm.  I felt nauseous.  I came back in the house and had a glass of water and sat down.  It did not help.  So my husband took me to the ER.  They did blood work and admitted me.  They did a chest x-ray, with a normal result.  I had a Antigram and MRI of my heart, abnormal results. They wanted me to see a Cardiologist, which I did last week.  The Cardiologist thinks that it will go away.  I will see her in 3 weeks.
Patient with 2 COVID Moderna vaccinations who admitted with positive COVID test.  Provider discharge summary below:  "Brief Summary of Hospital Stay:  Patient is a 67 YO female who presented due to non massive hemoptysis after being diagnosed with COVID 19 pneumonia She was found to be tachycardic and in atrial flutter vs atrial fibrillation w/ RVR in ER and subsequently admitted.    During her hospitalization stay, she was started on decadron therapy for mild hypoxia likely due to COVID 19 infection that then led to severe hyperglycemic episodes.  Insulin was slowly up titrated throughout her stay. Home Amiodarone dosage was increased to control her heart rate.    On day of discharge, she was noted to be saturating well on room air and without complaints. Blood glucose control was improved and back to her usual baseline (per patient, ranges from 140 to mid 200s). She will be discharged with instructions to take her home PO diabetic medications with increased dosage of her long acting and meal time insulin. "
I am nursing my son, I started getting feverish and had a lump on the breast that was red. I called and had a phone appointment with my OB. They diagnosed me with Mastitis and I was given antibiotics.
From initial information received on 18/May/2005 from a health care professional regarding an adverse event occurring in the USA. It was reported that a four year old female patient received a dose of DAPTACEL, lot number C2103AA, administered intra-muscularly in the left arm, a dose of IPOL, lot number Y0218-2, administered subcutaneously in the right arm and a dose of MMR/Measles, Mumps and Rubella vaccine, lot number 0777P, administered subcutaneously in the left arm on 16/May/2005. The following day, on 17/May/2005, the patient developed redness and swelling of her entire left arm. She was diagnosed with cellulitis. The patient was seen by a physician and was treated with Omnicef orally for seven days and Atarax orally twice a day. At the time of this report, the patient had not recovered from these events. Follow-up information received on 03-November-2005. No additional information was provided.
Patient had no symptoms, but realized that the vaccine was given off label as the patient is actually only 17 years of age.
patient was given adult Pfizer on 1/8/2022. Was contacted by corporate and confirm. Mom was contacted and stated she is fine with no side effects.
The day that I got the Vaccine, my arm was sore, and I was very tired, I had a mild headache.  I had a slight fever of 99.7. I was very very fatigue, I was tired, my arm hurt and I had a slight fever.
Vaccine in left arm. Still having major pain and at injection site. Unable to lift arm above head or very far out to my side. Have been to ortho, therapy, regular dr. Had a MRI and am now seeing a neurologist.   I am unable to sleep I?m my bed longer than an hour before the pain gets so bad I have to get up. I sit up in recliner the rest of the night alternating heat and ice so I can continue to work.
24 year old female. Patient recently found out she was pregnant. Her last period was 21 Feb 2016 and she has a due date of 27 Nov 2016. She received vaccines on 17 Mar 2016 in preparation for travel. She received (Typhoid) (Smallpox) (Anthrax) (Japanese Encephalitis). Patient was approximately 6 weeks gestation at time she reported inadvertent vaccination to her primary care provider. Primary Care provider referred patient to Immunization Healthcare Office to evaluate her following the inadvertent live virus vaccination while pregnant.
small, red, non-itchy blister below injection site; red, below injection site; This case was reported by a consumer via call center representative and described the occurrence of blister in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had shingles more than 40 years ago). Previously administered products included Shingles vaccine (Patient also received shingles vaccine approximately 10-15 years ago).   In September 2022, the patient received the 2nd dose of Shingrix. In September 2022, less than 2 weeks after receiving Shingrix, the patient experienced blister and erythema. On an unknown date, the outcome of the blister and erythema were not recovered/not resolved.   It was unknown if the reporter considered the blister and erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comments: The case was reported by patient's wife. The reporter reported that patient received second dose of Shingrix approximately two weeks ago, in the left arm. Reporter reported patient noticed a small, red, non-itchy blister just below the injection site.  Reporter reported patient had Shingles more than 40 years ago, but thought the blister had the same appearance of those that accompanied their previous Shingles outbreak.  Reporter did not consent to follow up.
Patient fussy and crying. Mom noticed 4pm 08/08/2005 right thigh redness and swelling. Give Tylenol, do cool packs to site.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included diabetes mellitus and rheumatoid arthritis. On 1st October 2018, the patient received the 1st dose of SHINGRIX. On 2nd October 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms and weakness. On an unknown date, the outcome of the influenza-like symptoms and weakness were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and weakness to be related to SHINGRIX. Additional details were provided as follows: The reporter reported the case for his wife, who caller reported his wife experienced flu like symptoms and weakness the day after receiving her first dose of SHINGRIX. The symptoms resolved after 3 days. She did not report it to her physician. The reporter asked Health care professional was asked but declined at the time of reporting.
At 1720 the patient reported palpitations and having upset stomach (she had her scarf, hat, and coat all on). We had her remove her hat, coat, scarf and provided an icepack to her.  At 1726 she stated her throat felt a little "itchy" to which she informed us of a recent reaction of the same nature she had with fish (haddock then cod). We administered 25 mg of benadryl. At 1736 we put the patient's feet up as she stated she was getting a bit dizzy if she sat upright for too long.  At 1755 she stated her throat was totally gone but still felt a bit shaky and felt like her heart was racing a bit. She called to get her parents to bring her home. At 1825 her parents arrived, and she stated she felt much better and was ready to leave.
On 8/22/01, pt developed fever (temperature was not taken). On 8/24/01, she developed a red, blotchy rash. She saw a doctor while visiting in Seattle and was given Tylenol. On 8/27/01, pt had nausea and vomiting and a headache. On 8/28/01, she saw another doctor and had a spinal tap and was dx'd with viral meningitis. On 8/29/01, a follow-up telephone call, she states she is much better.