chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Almost immediately I could feel the vaccine moving down my arm into my hand first affecting my elbow and then affecting my 4th and 5th fingers. Next, my throat became irritated and I started coughing if I tried to speak. After the irritation subsided I realized that I was breathing more easily too, so I do think my breathing was somewhat affected. Next I felt fatigued, very tired. This was followed by my forehead feeling warm to the touch. My temperature was normal and my heart rate also checked out fine. Then my face turned very red and the skin on my face was puffy. I stopped at a clinic but they had a long line so I went home and took 10 mg of loratadine. The redness on my face and the puffy appearance resolved soon after taking the allergy medicine. All of those symptoms resolved within about an hour and maybe 15 or 20 minutes from getting the shot. The red, puffy skin on my face is what concerned me the most. Nothing in particular was swollen, just the skin looked a bit puffy.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was vaccinated with a ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2012, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 12-DEC-2012 and 09-JAN-2017, the patient was treated for shingles and neuralgia along with post-herpetic neuralgia. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Severe headaches - 4 months - gotten better over time Light headed, weak, tired, light fevers, confusion in thoughts, forgetful, short term memory loss, blurry vision, red painful eyes, high blood pressure, heart pains, brain feels swollen or some sort of pressure, all around unwell feeling, irritable - ongoing
2 Hours after admin. developed a large ulceration at the pneumococal injection site. This leision measured larger than 3 in diameter. By 4 hrs post injection he developed a fever of 101 degrees F.  That evening his temperature reached 103 degrees F for 3 hours. In the following 2 days his temperature never dipped below 100 degrees F. This child has NEVER had a fever or been sick.  I can't believe I subjected him to this.  If his temp had elevated further I would have taken him to the ER. How can this be what we choose to do to our children?
This spontaneous report as received from a medical assistant refers to multiple patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot # L027431, expiry date: 22-JUL-2017). No adverse effects were reported. Excursion information: Time: 30 Minutes, Temperature 9C and Time: 30 Minutes, Temperature: 11C. The call was because of a data logger. The improperly stored doses were administered. There were no previous excursions. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt states that 11 hours after taking the 2nd dose she collapsed falling to the floor and was paralyzed and  had urinary incontinence for 20 hours.  EMT came to put pt back in bed.  EMT came once again and put pt in wheelchair to get her to  a car so she can be taken to Hospital ER.  They did blood work which potassium was low, urinalysis test showed bladder infection, and CT was normal.  Pt released after 4 hours and told to FU w/ her neurologist.  Pt saw Neuro Dr. on 3/17/2021 said she must have had some sort of reaction to the vaccine.
States she is not feeling good about 5-10 minutes after shot. States she has burning in chest(points to esophageal area up and down mid chest). Also pale and diaphoretic. Nausea. Cool wet rag and cool air provided.  Felt bad for about 10 minutes: BP at this time 240/80.  20 minutes later, systolic BP had returned to normal. She acknowledged that she did not like shots but had not ever responded like this. Released home after 30 minute observation ad symptoms totally resolved.
Sore arms in days after injection (not bad); Sept. 30- Oct. 4 drive 4 .5 hrs for son's wedding celebration. Some incindents of blood with bowell movements over several days. Oct. 7- 15 long drive over two days; significant blood in toilet in morning (Oct. *) after eating greasy fish sandwhich for dinner; blood in stool over several days during the trip. Returned home on Oct. 15.; Oct. 18 : used Viagra Oct. 19: Blood in stool in the AM; during afternoon bike ride, discharge while riding, significant blood (photo available),Later  more blood in toilet.  Oct. 20: small black feces with gas, no normal bowel movement, blood seeping into underwear Oct.21: larger evacuation of black feces in AM
This spontaneous report as received from a physician via a doctor of pharmacy refers to a 15 month old female patient. On an unknown date in several months ago the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, expiration date and route not reported). On 01-AUG-2013 the patient presented to the physician's office with a rash that the physician suspected was chickenpox and rash had an unusual presentation in that the blisters were not open or crusted over but were still spreading. Treatment was not rendered for the events. It was unspecified whether lab diagnostic studies were performed for the event. The outcome of the reported events were not recovered/not resolved. Causality was not reported. Additional information has been requested.
Shot was given too high on arm and caused severe shoulder pain when lifting or rotating arm.  Diagnosis was tendonitis/bursitis.  One steroid shot and dose pack was given over a week (10/19 - 10/25).
No adverse effects reported.; missed the administration of the next dose and was administered the second dose of GARDASIL 9 (lot number R023607, expiration date 5/6/2021) late, on 7/9/2019; Information has been received from a nurse referring to a currently 18 years old patient of unknown gender. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided.  The reporter reported that the patient was administered one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date was unknown by reporter) for prophylaxis when the patient was 11 years old, on an unspecified date in August 2011. The reporter reported that the patient missed the administration of the next dose and was administered the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (intramuscular, lot# R023607, expiration date was 06-MAY-2021; strength and dose were not reported) for prophylaxis, on 09-JUL-2019 (Inappropriate schedule of product administration). No adverse effects were reported.
Lip swelling on left side of face, also described numbness and tingling.  "Felt like I went to the dentist".  Given 50 mg Benadryl.  Numbness continued to spread through that side of face, EMS called, transported to ER.
soreness; swelling; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain and swelling. On an unknown date, the outcome of the pain and swelling were recovered/resolved.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. Pharmacist stated that she had patients complained of soreness or swelling for about a week following Shinhgrix administration.  She stated they seen a lot of older patients. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212977:same reporter
This case was reported by a pharmacist and described the occurrence of pain in arm on lifting in a 65-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 October 2010 the subject received unspecified dose of FLULAVAL (.5 ml, unknown). On 21 October 2010, 48 hours after vaccination with FLULAVAL, the subject experienced pain in arm on lifting and shoulder pain. The pharmacist reported that the subject received FLULAVAL vaccination on 19 October 2010 and approximately 48 hours later the subject was experiencing pain when lifting the arm and shoulder pain also described as radiating pain into her shoulder. At the time of reporting the pain in arm on lifting and shoulder pain were unresolved.
strokes; has an amputated arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (strokes) and ARM AMPUTATION (has an amputated arm) in a 56-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (strokes) (seriousness criterion medically significant) and ARM AMPUTATION (has an amputated arm) (seriousness criterion disability). At the time of the report, CEREBROVASCULAR ACCIDENT (strokes) and ARM AMPUTATION (has an amputated arm) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.  Company comment.  This spontaneous case concerns a 56  year  old male patient, with no medical history reported, who received a dose with mRNA  1273.222 (Original/Omicron BA.4/5) and experienced the unexpected, serious (medically significant) AESI Cerebrovascular accident, and the unexpected disabling event of arm amputation. Latency cannot be properly assessed since exact onset dates and vaccination date were not provided. The report stated that the patient "has been taking the Moderna vaccine. He has had a couple of strokes and he has an amputated arm". No further clinical details were provided for medical reviewing. Patient´s vaccination schedule was not disclosed. The benefit-risk relationship of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   Reporter did not allow further contact
pt reported sudden onset of rapid heart rate, 130s-140s. asymptomatic otherwise. approx 1 hour later HR was in the 120s
Pt recv vax on 11/19/98; 7 hr post vax pt exp unconsolable crying
tired; aching/soreness; shivering; flu-like symptoms; stomach cramps; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on unknown date).   On 28th February 2020, the patient received the 2nd dose of Shingrix. On 2nd March 2020, 3 days after receiving Shingrix, the patient experienced tiredness, pain, shivering, influenza-like symptoms and stomach cramps. On an unknown date, the outcome of the tiredness, pain, shivering, influenza-like symptoms and stomach cramps were unknown.   It was unknown if the reporter considered the tiredness, pain, shivering, influenza-like symptoms and stomach cramps to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself. The patient's side effects were much more severe than he was led to believed they would be according to his pharmacist
side effects that she might be having; Bloating; Excessive gases; A spontaneous report was received from a consumer concerning herself, female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced side effects/vaccination complications, bloating/abdominal distension, excessive gas/flatulence.  The patient's medical history was not included. Concomitant products use was not provided.  On 30 Jan 2021, prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch N0:unknown) intramuscularly for prophylaxis of covid 19 infection.  On an unknown date, the patient experienced vaccination side effects, on 12 Feb 2021 patient experienced bloating and excessive gases.  Treatment information was not included.  Action taken with mRNA-1273 in response to the events was unknown.   A follow up was received on 12 Feb 2021, and information about events bloating and flatulence were provided.  The outcome of the events, side effects/vaccination complications, bloating/abdominal distension, excessive gas/flatulence were unknown.
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 65-year-old male patient who received SHINGRIX (batch number ZN22Z, expiry date 2nd February 2021) for prophylaxis. On 16th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the outcome of the extensive swelling of vaccinated limb was unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb to be related to SHINGRIX. Additional details were provided as follows: This case was not reported to anyone previously. At 15: 30 PM, the patient received SHINGRIX on right deltoid. The patient began to experience swelling from their right elbow down to their right hand within two days after receiving the vaccination, which led to extensive swelling of vaccinated limb. The swollen area was not warm to the touch. No issues at the injection site were noted.
Lost 50 pounds between mid January and March with no explanation; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0142) via an unspecified route of administration in the right arm on 10Jan2021 at 12:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration in the right arm on 18Dec2020 at 12:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. On 15Jan2021 at 12:00, the patient lost 50 pounds between mid Jan2021 and Mar2021 with no explanation. The patient went to the doctor and they did blood work and told him everything was normal. The patient had always been healthy and had never lost weight like that until he got the vaccine series. The event resulted in doctor or other healthcare professional office/clinic visit. On an unknown date, the patient underwent blood test and the result was normal. Since the vaccination, the patient had not been tested for COVID-19.  Therapeutic measures were not taken as a result of the event. The clinical outcome of the event lost 50 pounds between mid Jan2021 and Mar2021 with no explanation was not resolved at the time of the report.
Pt reported pain in arm with bright red streaks from the vaccine administration site extending down 1-2 inches. She took ibuprofen.
patient had a near syncope event after administration of vaccines. Gardasil administered last in left arm. Patient seemed weak and was moved from exam table to chair,felt dizzy and became quiet and pale, difficulty answering questions. Legs were elevated on a chair, pt was given water to drink but only took a few sips, eyes were closing and could not hold cup of water. Weak  radial pulse noted, systolic BP ~ 80 (was initially 100 at start of visit). Patient was monitored for approx 5 more minutes, after which time she said she felt better, pulses returned to normal, BP back up to 80. entire episode lasted ~ 10 minutes.
Headache, stomach ache immediate & continuous daily to regular now. Fatigue & weakness. Localized weakness as well to injection sites. Out of sorts.
Vaccination given at 1:00 PM, Patient called pharmacy at 5:30 PM to report itching and redness (may have been from scratching) on lower and upper back. Advised patient to take BENADRYL, watch for worsening and call doctor or immediate care if worsens. Called patient at 7:40 PM to check on her. She was doing much better, the BENADRYL was working.
Within hours, post vax, I had sore throat. During the next day, I came down with severe bronchial infection. Excessive coughing for 1-2 weeks, wheezing, lots of mucus, fever and questionable flu.
shingles; other zoster related injuries; Information has been received from a lawyer regarding a case in litigation reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was administered zoster vaccine live (ZOSTAVAX) by a healthcare provider in a pharmacy for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, lot number and expiration date were not reported).  On an unknown date, the patient was treated by a healthcare provider the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of the events was not provided.
I woke up this morning extremely dizzy. I continue to be somewhat dizzy 9 hours later. I also have a headache.
Staff member came to be vaccinated during  vaccine clinic.  Vaccinator didn't notice she was only 17 yo and gave her the vaccine.  It wasn't until It was being entered into system that it was discovered.
Patient tested positive for COVID-19 on 01/26/2022. One day I had chills, fever and body ache. And five days later I was having flu like symptoms. Then after that on 02/05/2022 I started having heart palpitations. I saw my PCP and he sent me to see a Cardiologist. I am now under their care. The doctor said that since I had COVID 19 10 days earlier, it is maybe from that.
Narrative: Patient reported lethargy and weakness to HBPC team following 3rd Pfizer covid vaccine on 10/20/2021 administered to patient at nursing home. He was later noted to have sustained a fall. Of note, patient had previously completed vaccine series (and tolerated) in Jan 2021 and had been covid positive in 4/2020. Patient was taken to an ED in the community and admitted to Hospital on October 22,2021 for chief complaint of weakness. Patient is a 90 yr old with complex med history to include CAD, s/p CVA, Afib, OSA, MDS, anemia, Parkinson's disease w/dementia and with vertebrobasilar insufficiency with hx of frequent falls. Of note, patient with significant progression of dementia and decline in functioning in the past year and a half following covid diagnosis. At time of covid dx, patient had significant change in baseline functioning. Unknown what treatment was received by patient at Hospital or when he was discharged. Patient was seen again at the facility in Audiology Clinic on November 12, 2021.
Vaccine expired 4/22/2022 and was administered on 5/11/2022, with no reported adverse event; Initial information received on 12-May-2022 regarding an unsolicited valid  non-serious courtesy case received from a consumer/non-hcp.    This case involves an unknown demographic patient whose vaccine expired 4/22/2022 and was administered on 5/11/2022, with no reported adverse event while receiving vaccine diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-May-2022, the patient received a  dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine suspension for injection unknown strength lot C5732AA expiration date 22-Apr-2022 via unknown route in unknown administration site for prophylactic vaccination.  Vaccine expired 4/22/2022 and was administered on 5/11/2022, with no reported adverse event (expired product administered) (same day).  Action taken: Not applicable  Outcome: Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Hair loss post vax, subsided 4-6 wks after each dose. Alopecia post vax lasting 4-6 wks-50% occurred. Regrowth currenty seen. R/O fungal infection on scalp, hormone imbalance, TSH, vitamin dificiency, stress, anemia, immunocompromised.
started having chest pain 10 days after vaccine by June 28 I couldn't take pain anymore so I went to hospital and they did blood work, xray, EKG, liver function test and they all came back normal. they gave me medicine to help with chest pain and sent me home.