chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection given in right arm. Mom reports swelling and pain 24hrs following injection. Blotchy red patches appear around area of injection.
About 10 to 15 minutes after the injection, I had a slight pressure on the right side of my neck that went up to  my right jaw, and up in front of my right ear and up to my cheekbone.   That pressure lasted the rest of that day.  When I went to bed around 10:30 pm, I took one 325mg tylenol.  In the morning, the pressure was still there but lessened.  It continued on and off the second day but by nighttime was mostly gone.
Fever 100.5, chills, body aches, headache, tiredness.  Lasted from 4 am until 9 pm and then suddenly resolved.  Also had metallic taste for 2 hours afyer vaccination.
Flu shot given too high up on arm. Pt went to 2 doctors about soreness & can't lift up arm - hurts. She is going for a MRI. Day of shot - swelling/black & blue.
Developed redness, swelling of arm, & low grade fever 48 hrs p/immun. Admitted to hosp for 3 full day of IV antibiotics (Nafcillin) which resulted in resolution of sx of cellulitis.
she had fatigue and was not feeling well the day of taking the Vax.  Pt had pain that started in the lower back, moved to the groin, down to thighs and then switched and moved down to the right ankle.  She then developed a swollen right foot.  On 3/22/21 she went to her doctors office and saw an alternate physician at Medical Group.  She was prescribed a 10mg pain killer along w/Tylenol.  On 3/25/21 she went to Emergency Center.  She had x-rays.  She was diagnosed w/ chronic right sided lumbar radiculopathy, poly articular arthritis and spondylolisthesis of the lumbar region.  She was told to FU w/ a pain specialist and PCP.  She saw Dr. on 4/9/2021 and was told it maybe gout so ordered lab test and prescribed steroids.   Around 4/12/21 she saw another Dr. at a Spine and Pain specialist.   She was just told to come back if she had another flare up.  On 5/13/2021 she had lower back pain flare up so went back to PCP Dr. .  She upped her gabapentin medication to 300 mg and referred her back to Pain Specialist.  On 5/26/2021 she went back and was given steroid injections.  She will FU Dr. on 6/14/21.
Erythema; Pain in extremity; Skin warm; Edema peripheral Information has been received from a health care professional and a 54 year old female white consumer with hypertension, hyperlipidemia, allergic rhinitis and no allergies who on 17-NOV-2005 at 1)30 PM was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot #650329/0747P). Concomitant therapy included HCTZ/triamterene and simvastatin (MSD). Subsequently on 17-NOV-2005 the patient's right arm was swollen ("size of baseball"), hot, red, and also created a great deal of pain. There were no relevant diagnostic tests or laboratory data. Unspecified medical attention was sought. The patient recovered after several days over 2 days. Additional information is not expected.
Diarrhea, diffuse abdominal cramping/pain throughout all 4 quadrants
patient with pain and swelling of whole upper thigh with limp for 3 days  splotching to upper thigh as well  seen in clinic next day and than 24 hrs later of treatment of Motrin, ice, and benadryl went to urgent care due to continued swelling and given steroids which resolved symptoms over next 24-48 hrs
Localized muscle soreness at the injection site occurred within an hour following the vaccination on 7/29/2021. Upon waking on 7/30/2021, I experienced severe widespread muscle soreness, headache, and extreme fatigue. As the day progressed, I developed a dry cough, had chills and body aches, difficulty breathing, and lethargy. By evening, I was having labored breathing (with and without exertion), chest pain and tightness, localized pain in my right neck and shoulder, and pain in lower back. At approximately 10:00 PM on 7/30/2021 I went to the Emergency Room due to my breathing. At the emergency room they examined me for a pulmonary embolism taking an EKG, chest x-ray, and a chest CT scan as well as running a d-dimer, CBC with differential, and platelet lab test. The scans were ordered after my tests revealed a positive result with the d-dimer lab test but revealed no sign of blood clots at the present time. The diagnosis was an adverse reaction to the vaccine and I was told to keep monitoring for signs of blood clots while taking Motrin.
0100- fever 0200- fatigue, muscle aches, headache 0400- rapid heart rate 130 bpm, extreme fatigue, feeling of surroundings being 'cloudy'
This spontaneous report as received from a nurse refers to numerous patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL. The nurse reported that numerous unspecified patients complain of pain during administration of the GARDASIL. The nurse reported that the pain was reported when the GARDASIL was being injected into the patient's arm. It was also reported that the patients recovered from pain. Additional information has been requested.
On 1/11/2019 Patient reports that shortly after receiving the injection of GARDASIL on 1/10/2019 that her left upper arm became red and hot to the touch. Patient also states that the site was raised. Patient received vaccine in the deltoid muscle on Thursday 1/10/2019. On 1/14/2019 Patient states that it has been painful, warm to touch at the site of vaccination. Patient says the pain is decreasing but there is a bump that looks like a mosquito bite. I asked the patient to come in today so that we can assess the site. Patient refused. Patient said she will call us tomorrow with a follow up. On 1/15/2019 Patient states that the area is improving. Patient made an appointment for 1/17/2019 so that APN, CNP can assess the site. On 1/17/2019 The Left Deltoid Muscle is still healing from receiving the GARDASIL vaccine.  No induration, no rash, no warm to touch at the site. Take Tylenol 500mg po , or Ibuprofen 600mg TID for discomfort. Avoid manipulating the site. May use a cold compress to the site. On 2/15/2019 The patient is calling today to report that she has a thickened area the size of a nickle on her left deltoid. She states there is no rash no itching. She is able to sleep on her side. I advised that she should avoid sleeping on her arm. Patient states that she is going to be seen by her new PCP.
Patient states her whole body starting swelling up. She states that she was confused and her whole body was shaking up and down. She refused medical treatment.
shortness of breath insomnia, high blood pressure, feeling of something logged in my throat,low-grade fever and  chills, digestive issues weight loss body aches.
Admitted 04/30/2021 for increasing slurred speech and confusion; previously admitted to outside facility 04/15/2021 through 04/19/2021 for similar symptoms
Severe localized rxn to DTP; reddness & swelling began shortly p/administration; area became painful to the touch w/erythema to below elbow area; Seen @ MD's on 6MAR92 & DPH begun;
Experienced small and dense red rash all over right and left arms 5 days after vaccine; Rash at the bottom of face both right and left; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 15Apr2021 at 14:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer (post radiation treatment) and latex allergy. 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 concomitant medications included gabapentin (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), pentoxifylline (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN) and tocopherol (VITAMIN E); all from unknown dates and for unknow indications and unknown if ongoing. The patient previously received ampicillin (MANUFACTURER UNKNOWN) and experienced allergy. On 19Apr2021, the patient experienced rash at the bottom of the face both right and left. On 20Apr2021, five days after vaccine, the patient experienced small and dense red rash all over right and left arms. It was reported that both rashes were persistent. The patient had no changes in anything for what she was taking orally and had no other injections except a computerized tomography (CT) scan with iodine injection and not allergic to Iodine. The patient wanted to know that whether she should take the second vaccine on 06May2021 or not. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events small and dense red rash all over right and left arms and rash at the bottom of the face both right and left were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fever 101.7, fever off and on for 24 hours beginning 14 hours after dose. Headache, muscle aches, extreme fatigue and weakness, same duration.
Information has been received from a nurse practitioner concerning a 9 year old female patient who on 12-SEP-2008 was vaccinated with a first dose of GARDASIL (lot # 659184/0843X). Concomitant therapy also given on 12-SEP-2008 included varricella virus vaccine live (MSD). On 15-SEP-2008, the patient's hands and feet began to peel 2-3 days after she was given the first dose of GARDASIL. The patient contacted the office. On an unspecified date, the patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2009. Follow up information reported that the Nurse Practioner reported that she "was sorry that the event was a long time ago. She did not have a copy of the event was a long time ago. She did not have a copy of the paperwork". Additional information is not expected.
Vaccine expired on 1/2/2022 but was administer on 1/3/2022. Vaccine was stored in freezer since arrival to our site. No adverse reaction following administration.
Second dose has not been administered more than 2 months away from the first dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose has not been administered more than 2 months away from the first dose) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose has not been administered more than 2 months away from the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose has not been administered more than 2 months away from the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment information was reported.
shortness of breath; asthma reaction; This is a spontaneous report from a contactable consumer or other non-health care professional. A 57-years-old non-pregnant female patient received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6200), via an unspecified route of administration (at the age of 57-years), administered in arm left on 19Feb2021 at 16:00 as dose number unknown, single for COVID-19 immunization. Medical history included asthma and known allergies to fish, seafood, iodine from an unknown date and unknown if ongoing. Concomitant medications included lisinopril (LISINOPRIL), esomeprazole magnesium (NEXIUM 24HR), esomeprazole (ESOMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient took other vaccine in four weeks. Patient did not have covid prior vaccination and had not been tested for covid post vaccination. On 19Feb2021 at 16:15, the patient experienced shortness of breath and asthma reaction. The treatment was not received for all the events. The clinical outcome of the events was reported as recovering.  Follow-up attempts completed. No further information expected.
the patient was administered improperly stored VARIVAX; This spontaneous report was received from a Medical assistant and refers to a 15 year old male patient.   Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 27-AUG-2020,  the patient was vaccinated with an improperly stored  varicella virus vaccine live (oka/merck)(VARIVAX) lot # S024364, expiration date 06-AUG-2021  for prophylaxis (strength, dose, frequency, and route of administration were not reported).    The improperly stored suspect vaccine experienced a temperature of -14 degree Celsius (°C) to - 10 °C with an average of -13.04 °C  for 45 minutes. There was no previous temperature excursion.  The suspect vaccine was reconstituted with a properly stored merck sterile diluent.  The call was made due to a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA000716: US-009507513-2009USA002063:
Sx: left arm warm/tender/erythema. Dx: cellutitis left arm. Tx: PCN
had shingles 3 times/Suspected vaccination failure; had shingles 3 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 82-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shingles 3 times/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles 3 times). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-MAR-2023 This case was reported by a patient's friend via interactive digital media. The patient had shingles 3 times since getting the shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Stroke; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included stroke (had stroke 1 time approximately 1 month prior to Shingrix vaccine). Concomitant products included COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA COVID 19 VACCINE (DOSE 1)) and COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA COVID 19 VACCINE (DOSE 1)).   On 26th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 2nd April 2021, 7 days after receiving Shingrix, the patient experienced stroke (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the stroke was unknown.   It was unknown if the reporter considered the stroke to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient for herself. Teh patient received 2 doses of MODERNA COVID 19 VACCINE on 7th January 2021 and 4th February 2021.  The patient received Shingrix in left arm intramuscularly. The patient had a stroke approximately 1 week after the Shingrix vaccine. The patient inquired about the efficacy of Shingrix after 1 dose. The reporter consented to follow up.
Mom states she found her son around 9 PM in the bathroom vomiting. She stated she moved him to the couch and he  continued to vomit. She stated he fell off the couch and  he was seizing. She called 911, when they arrived he was no longer seizing. When her arrived at the hospital, it was documented he was postictal and would not respond to painful stimuli. The hospital kept him overnight and are discharging him home today. He has fully recovered.
2 female adult patients received Shingrix first dose after being exposed to freezing temperatures; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Herpes zoster (Shingrix) (batch number 5954H, expiry date 15-AUG-2025) for prophylaxis.   On 28-AUG-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: 2 female adult patients received Shingrix first dose after being exposed to freezing temperatures).  The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2023 On 28 August 2023 a medical assistant reported that patient received Shingrix dose after being exposed to freezing temperatures, which led to incorrect storage of drug. The reporter consented to follow up. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023118048:Same reporter, different patient
Extreme swelling shoulder to elbow, excruciating pain from shoulder down to hands excessive amount of aspirin taken of 3 days now swelling has receded, discomfort is tolerable.
Patient called 7-17-2019 and said when she woke up, she notice swelling under the arm where the boostrix was administered. The patient said she had been fine prior to 7-17-19. The package insert states that a patient may experience a possible reaction up to 14 days of administration. There are reports stating swelling >20mm 3.9% and >50mm 1.4%, This documentation is on package 9 of package insert. Patient said she is going to contact doctor and I recommended ibuprofen to reduce the swelling .
At approximately 2030 hrs after having received the vaccine, my left elbow started to hurt. The pain level increased from a throbbing pain to an extremely high pain level to the point that I was unable to straighten out my arm. The pain has not subsided through the course of the day, in fact it has radiated up my arm and into my shoulder. I do have metal in my left elbow, but I  would not think that would cause an adverse reaction.  All I know is the pain that I am having is affecting my quality of life.
started having difficulty breathing and tightness in chest around 2 AM after the shot was given the previous day; member went to Urgent Care and they didn't do anything when he was there, said it was nothing to worry about as it was just a reaction to the vaccine; so he then went to the ER at  and was treated at the ER there for about 5 hours
Started with itchy scalp, then became hives / bumps like bug bites in multiple spots on body, from neck shoulders arms and legs.
pt recvd vax 16OCT95 11:00 in early PM devel severe h/a cont until 11:00 17OCT95; 1wk later devel laryngitis w/moderate hearing impairment cont 14 days; also had severe arm pain, feelings of flu-like sxs;
Per mother - 7/25/09 A.M. had fever 101 with jerky movements in sleep, breathing labored. Clenched teeth when trying to give TYLENOL, crying, eyes rolling, wouldn't make eye contact. Difficult to get in car seat due to stiff body. Seen at hosp. ED with temp 103. Dx with simple febrile seizure. Hospital reported to PCP.
Pt to clinic with c/o redness, warmth, swelling to site and increased irritability.
1 day after - tiredness, aches. 2 days after: fever 101.3, aches, very tired. Fever continued for 4 more days, night sweats. After fever left, began congested coughing. Went to doctor on Nov 12 and diagnosed w/ bronchitis. Have never had a lower resp. illness before in my life. Just wondered if there could be a connection.
11-year-old patient received a 0.5 ml of the vaccine 6 month to 5 years; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (11-year-old patient received a 0.5 ml of the vaccine 6 month to 5 years) in an 11-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     Patient had no allergies to medications, food and other products.     On 20-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jul-2022, the patient experienced INCORRECT DOSE ADMINISTERED (11-year-old patient received a 0.5 ml of the vaccine 6 month to 5 years). At the time of the report, INCORRECT DOSE ADMINISTERED (11-year-old patient received a 0.5 ml of the vaccine 6 month to 5 years) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient height was reported as 53.5 inches. No concomitant medications were provided by the reporter. The vaccine was stored in the fridge and the beyond use date was 22-Sep-2022. It was reported that patient is not immunocompromise. Patient was not taking other medications. Patient do not had side effect. No treatment information was provided.
Flu like symptoms, soreness, redness, swelling at injection site for the last 4 days.
pt recvd vax 250PM, seen in ER @ 12M devel fever & irritability; APAP given; later felt hot & was trying to cool down & had a sz; all activated; crying frantically x 1 hr p/;
COVID-19 breakthrough. I have a cough fever fatigue and congestion. It started on Sunday and its improving as of today.
pt recv vax 29SEP97 3PM;mom notice swelling @ site by 5PM & cont to present;pt unable to move lt arm very well yesterday d/t swelling but today able to move lt arm;
Information has been received from a physician concerning a 13 year old male, with no prior history of chicken pox nor been vaccinated. A titer was done on 28-January-2007 which showed no immunity. On 05-February-2007 the child was vaccinated subcutaneously at 16:30; with a first dose of varicella virus vaccine live (Oka/Merck) (Lot#654750/1256F). The child had no prior medical history or allergies and no illness at the time of vaccination. The patient developed what was considered to be a mild case of breakthrough ( less than 50 lesions), varicella type rash on 20-FEB-2007 at 17:00. On 21-Februaury-2007 child was seen by the physician, and was said to have new lesions appearing and some crusted over. Unspecified medical attention was sought. There was no product quality complaint. The patient recovered on 01- MAR-2007. No further information is expected.
Patient under age 18 was vaccinated with Moderna, which is a vaccine error, on 4/02/2021. Second vaccine provided 4/30/2021 - Moderna 017C21A. Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn away on a Moderna-only day. For the second error,  but second vaccine could have been given per standing orders. Unreported as error, found in data mining. Age restriction/confirmation rules were put into effect after the date of the first vaccine to prevent underage vaccines.
Developed  hives day after receiving vaccine.  Had swollen lymph nodes.  Resolved on 12/21.
Papular erythematous confluent rash bilateral ankles with sparse erythematous rash ascending both legs. Vaccine site looks good.
high fever, high pitched cry-began 6 hrs p/shot cont until next AM; was seen in office & eval; pt had strep pneumonia sepsis;