chrisvoncsefalvay/vaers-outcomes huggingface dataset:
done in his left arm, and it was a little sore; slight headache; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiration date were not reported) via an unspecified route of administration on the left arm on 04Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies: dust, pollen, grass, and trees. The patient's concomitant medications were not reported. He received first shot on 04Jan2021, 5 days ago. He has had no bad reactions. He was happy to report. He then stated it was done in his left arm, and it was a little sore. He also had a slight headache that first evening which was unusual for him. So far so good. He was due for his regular allergy shot which he generally gets every 2-3 weeks for dust, pollen, grass, and trees. He lived in (City) and has pretty good allergies. It is said on the allergy shot not to have a flu shot within 72 hours of getting the allergy shot, so he was just wondering if it will be safe for him to have the allergy shot within approximately 120 hours of receiving the Pfizer COVID vaccine. "Is it safe or advisable to have his allergy shot done today when it has only been 5 days since getting the COVID vaccine? Is he putting himself at any kind of risk?" He did not have the name of the allergy shot to provide. He said it is just an injection of a little bit of the allergen. He is not a health provider. He was on the early receiving end of the vaccine because he was a hospital volunteer and works in PACU. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
6/16/21 -1 month after 2nd dose of Moderna i started having intestinal issues with chronic diarrhea  and intestinal cramping.  After 3 weeks of no relief (thought it would clear up on its own) and loss of 5lbs, I contacted my doctor and scheduled a visit on June 2, 2021.  After running blood tests and stool tests to rule out other issues It was determined I was having a flare up of diverticulitis as my last colonoscopy in 2020 showed multiple diverticula in my lower colon.  I have never had this issue before.  My doctor prescribed Augmentin, 875 mg.  As of today 7/24/21 my system is getting back to being somewhat normal.   I decided to file this report because I have heard of other women having similar issues and thought I should report.  I did report my issue via the C-19 symptom tracker app and received a call from the CDC about it - but I lost the call back number.
I had brown menstrual discharge with hints of blood that lasted 5 days. I had no menstrual cramps, but the color of blood/discharge resembled the end of period color, but across the time span of 5 days.
approximately 5.5 hrs after receiving her vaccination, the patient developed chills, headache, bodyaches and weakness, lasting approximately 4 days. She did not seek medical treatment for this
Arm pain, numbness down whole arm for 48 hours, headache, body aches, fatigue for first 24 hours
Sudden swelling and redness around injection site. Initial swelling/redness had subsided significantly, then I woke up to a very painful swelling/redness. The swelling/redness was approximately 4 inches wide & 4 inches tall - expanding from the injection site. This lasted from Jan. 20th-Jan. 24th then subsided suddenly. As of Jan. 25th, the swelling/redness is gone. I did not seek treatment for this.
Continued lightheadedness as if intoxicated.  occurs with every flu shot for the past 5 years, usually persists for 2 - 3 hours.
Severe arm pain at site of injection that limited mobility, vomiting, fever, dizziness, myalgia, headache.
Sunday (day of vaccination) - Inflammatory reaction in the form of TMD/TMJ flare up about 1.5 hours after shot.  Sore arm about 5-6 hours after shot.  I have not had issues with TMD/TMJ for over a year until receiving the shot.  Monday - Worsening TMD/TMJ pain, headache, fatigue, sore arm  Tuesday - Chills, body aches, TMD/TMJ pain, headache, vision issues (from headache?), sore arm  Wednesday - Chills and body aches went away, but still experiencing lower back pain, TMD/TMJ pain, sore arm
Extreme fatigue upon mild exertion. If heart rate goes above 90-100, patient reports feeling faint along with tightness in the shoulders and hamstrings. Recovers quickly upon resting.
Skin rash appeared 1 day after 1st dose and spread further and to more parts of body over the 8 days of treatment.  Very itchy.  Did not go away with prescription CORTICOSTEROID cream.  Suddenly went away 1 day after last dose.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. During 2015 (specific date not provided), the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about May 2016, the patient was treated at an emergency room and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, 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 is unknown. Additional information has been requested.
started with muscle aches and fatigue. Later after going to bed severe chills and uncontrollably shaking for two hours. After that alternating severe sweating and chills all night. Skin sensitivity during this whole time.
Severe rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK receipt date: 8-Jul-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The patient asked that the rash was common after a Shingrix vaccination and severe rash formed after shot. Additional supportive information: The follow-up could not be possible as no contact details were available. In worst approach, the case was kept as valid considering that the patient had severe rash after the shot.
Information has been received from the nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered a dose of GARDASIL on 17-APR-2013 (lot # H011350, Expiration Date: 21-FEB-2015). No adverse event was reported. This is one of the report from the same source, linked reports. Additional information is not expected.
pain at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) 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 reported  No treatment information was provided   This case was linked to MOD-2021-303281 (Patient Link).
Moderate to severe joint pain in entire body ongoing. 19 hours since onset. Insomnia night of first dose. Facial flushing and fatigue ongoing, 19 hours since onset.
Terrible rash on the hands; Very intense itching; Hands red; Hot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Terrible rash on the hands), PRURITUS (Very intense itching), ERYTHEMA (Hands red) and FEELING HOT (Hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Terrible rash on the hands), PRURITUS (Very intense itching), ERYTHEMA (Hands red) and FEELING HOT (Hot). At the time of the report, RASH (Terrible rash on the hands), ERYTHEMA (Hands red) and FEELING HOT (Hot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment.   Reporter did not allow further contact
Covid "arm". Came on quickly, called dr. this AM. No fever or red lines. Bump on arm is raised, hot to touch and about the size of a small egg.
4/22/2021 notice skin rash, 5/1/2021 evening severe pain at a skin rash near stomach, partial O2 at 90%, difficult breathing, 5/2/2021 severe pain near the back where there is a different skin rash
Progressively worsening muscle pain due to muscle weakness.  Started 3 to 4 days after administration.  Pain is to the point where patient has a hard time standing or moving.
Patient reports she took her second SHINGRIX on 1/29/19 and broke out with a rash on right lower face 1/30/19. It was several blisters and very inflamed around it. She took an old CIPRO pill her husband had found and used ZOVIRAX from something else and used it. It has helped some. She felt sick with her vaccine- Muscle aches, headaches, and nausea. She did not have those symptoms with this injection. She is otherwise healthy. She has had shingles in this location in the late 90"s. She feels it is some better than it was. Not feeling sick otherwise. The are felt tingly when it first broke out.Treated with valacyclovir.
Stayed on bed all day /slept all day; tired all day; Bad headache; Nauseous; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (Stayed on bed all day /slept all day), FATIGUE (tired all day), HEADACHE (Bad headache) and NAUSEA (Nauseous) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced SOMNOLENCE (Stayed on bed all day /slept all day), FATIGUE (tired all day), HEADACHE (Bad headache) and NAUSEA (Nauseous). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Nauseous, at an unspecified dose and frequency and IBUPROFEN for Headache and Nauseous, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Stayed on bed all day /slept all day), FATIGUE (tired all day), HEADACHE (Bad headache) and NAUSEA (Nauseous) had resolved.            Action taken with mRNA-1273 was not applicable.  No relevant concomitant medication was reported.   This case was linked to MOD-2021-075368 (Patient Link).
Puffy and red, pox reaction identified with a pharmacy, Next day, 10-14-11, patient went Urgent Care; rxn and infection inside the tissue, (cellulitis) cephalex 500 TID for 7 days, pt stopped all medication except only started back 10-17-11.
Patient called pharmacy stating her arm was red, hard, swollen and painful.. She noticed it almost immediately after vaccination. She has been icing it today and some of the swelling has gone down, but the hardness remains. Pt called at about 745pm. She will continue to ice, possibly try a warm compress to increase circulation, keep moving arm and will try some ibuprofen. Pt will call pharmacy back this evening or morning if any further help is needed or will go to urgent care or ER if needed. Pt is keeping eye on arm.
Stomach craping pain; Low pain in her chest; Feels choked up; Feels terrible/Feels like she got ran over by a diesel truck/Just don't feel good; Freezing; Several chills/Chills was so bad she had to use 4-5 covers to cover herself; Having really high fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach craping pain), CHEST PAIN (Low pain in her chest), FEELING ABNORMAL (Feels choked up), FEELING ABNORMAL (Feels terrible/Feels like she got ran over by a diesel truck/Just don't feel good) and NASOPHARYNGITIS (Freezing) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. CO2C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach craping pain), CHEST PAIN (Low pain in her chest), FEELING ABNORMAL (Feels choked up), FEELING ABNORMAL (Feels terrible/Feels like she got ran over by a diesel truck/Just don't feel good), NASOPHARYNGITIS (Freezing), CHILLS (Several chills/Chills was so bad she had to use 4-5 covers to cover herself) and PYREXIA (Having really high fever). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach craping pain), CHEST PAIN (Low pain in her chest), FEELING ABNORMAL (Feels choked up), FEELING ABNORMAL (Feels terrible/Feels like she got ran over by a diesel truck/Just don't feel good), NASOPHARYNGITIS (Freezing), CHILLS (Several chills/Chills was so bad she had to use 4-5 covers to cover herself) and PYREXIA (Having really high fever) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were provided. Lot number: CO2C21A (Patient said she could not see the writing very well so it could be COZC21A).
The day I received my first dose I had an unexpected bladder issue and urinated on myself. As I had never done this before I found it strange that it was only a couple hours after receiving the vaccine but ignored it. It only happened a couple times again before my 2nd dose which only made the situation worse.  I have for the last 9 months suffered with this and now, at 23 years old, have to sleep with a diaper on.  I thought it would get better with time but it hasn?t.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a female patient of an unknown age (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Feb-2021. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 06-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Dec-2020, Ultrasound Doppler: not provided (Inconclusive) Not provided. On an unknown date, Genetic counselling: normal (normal) Normal. On an unknown date, Glucose tolerance test: normal (normal) Normal.     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.   Company Comment:  This is a case of product exposure during pregnancy with no associated AEs for this female whos age was not reported. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female whos age was not reported. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Baby turned blue localized from navel to knees 4 hours following vaccinations. Massaged baby color returned. While on phone with Doctors office baby turned blue localized from the nipples to toes (20 mins later). Baby screaming, spewing saliva, and mildly gasping. Baby was in father's arms cradled. Massaged. Color turned ghost white. Was awake during both episodes. 3 Days following episode full body.
Friend got the shot continually fights shingles several times/suspected vaccination failure; Fights shingles several times; awful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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 vaccination failure (serious criteria GSK medically significant), shingles and feels awful. On an unknown date, the outcome of the vaccination failure, shingles and feels awful were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.     Additional Information: GSK receipt date: 12-June-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The reporter was patient's friend. The patient got the shot and continually fights shingles several times a year, anyway. It's been awful for her. The shot did nothing for her. Now her doctor was trying to convince her insurance company to let her have the shot for people over 60 because that one was the better shot. The reporter asked why there was a substandard shot for those under 60. The reporter's doctor told him/her it was only 50% effective, so he/she refused. The reporter wanted to know why the better shot was not available to everyone.  Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not provided.
Patient also received: MMR lot S032036 in the right deltoid, IM  She developed redness (mild), swelling and significant pain within  24 hours.  treated as cellulitis.
Swollen itchy rash several days after vaccine around injection spot for 2nd shot. No reaction after 1St shot on ja 21.
Child had fever, headache and rapid heart rate 3-4 hours after immunization was given. S/S lasted 12-24 hrs.
Generalized rash. No itching or pain. Symptoms slightly improved with BENADRYL.
15 minutes after patient received her #1 Pfizer vaccine, she started to feel flushed with some throat irritation.  She states she feels " a bit shaky inside ".  Given juice and crackers.  BP 143/84. heart rate 89. O2 sat 99%.  She was moved into another quieter observation area. She claims she felt better. Given H20 to drink. States she had a bit of  chest discomfort but this was nothing new to her. She has been having chest discomfort for the past 1-2 weeks periodically.  Upon observing patient for 40 minutes, patient states, she felt better. BP 115/78, heart rate 80. Patient was then released.  She states this is the first time this has happened while taking an IM injection.
This case was reported by a consumer via (Shingrix GSK) interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2019) and Shingrix (received 2nd dose in 2019). On an unknown date, the patient received Shingrix and Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced extra dose administered and extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received shingrix vaccine twice. The patient received 2 shots over last several months from the date of reporting, which led to extra dose administered.
I felt a heart palpitations and I held off for a day or two before going to see my PCP. I was able to speak with an advice Nurse ordered an EKG from the suggestion of another doctor. I was placed on a heart monitor for two weeks and my heart beat seemed to be normal. Another test was ran that was not related to the heart symptoms that I experienced and it was not helpful. I will be going to do a blood test to access whether there is something going on in my blood that's related to the palpitations that I am currently experiencing (symptoms went away for two weeks and recently came back).
Pt developed large local reaction measuring 4.5cm x 3cm on upper left thigh after PCV13 4 hrs later. Had a similar reaction with PCV13#2 though not as severe per reported history
constant 'field of crickets' sound,  and ringing in the ears (sometimes loud, sometimes not as loud), I have noticed when I move my jaw sometimes the ringing stops and sometimes it get much louder (happens in both ears but the constant 'field of crickets' is always. steady decrease of hearing.. I think I have lost at least half my hearing now. I fear it is getting worse. My doctors have pushed my appts back and back because of CoVid19. I have now tried to move to (I just called today 6/15/2020) Monday July 13, 2020 for new patient appt. I hope I am not totally deaf by then.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.
Patient has golf ball sized soft swelling with erythema at site of Varicella injection.