chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Aches; injection site swollen; Bright red and hot; fever of 102.3 degrees Fahrenheit; CHILLS; arm was swollen; could not lift her arm; could not sleep; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (could not lift her arm), INSOMNIA (could not sleep), PAIN (Aches), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (Bright red and hot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included ESTRADIOL (ESTROGEN), PROGESTERONE, SPIRONOLACTONE and THYROID (ARMOUR THYROID) for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced LIMB DISCOMFORT (could not lift her arm), INSOMNIA (could not sleep) and PAIN IN EXTREMITY (pain in arm). On 03-Apr-2021, the patient experienced PAIN (Aches), VACCINATION SITE SWELLING (injection site swollen), VACCINATION SITE ERYTHEMA (Bright red and hot), PYREXIA (fever of 102.3 degrees Fahrenheit), CHILLS (CHILLS) and VACCINATION SITE SWELLING (arm was swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (could not lift her arm), INSOMNIA (could not sleep), PAIN (Aches), VACCINATION SITE SWELLING (injection site swollen), VACCINATION SITE ERYTHEMA (Bright red and hot), PYREXIA (fever of 102.3 degrees Fahrenheit), CHILLS (CHILLS), PAIN IN EXTREMITY (pain in arm) and VACCINATION SITE SWELLING (arm was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
30 minutes after the injection my tong started tingling. I spent 1 hour at the facility, and I drank apple juice.  The tingling didn't get any worse so I went home. It last 4 hours
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "breastfeeding" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound of Covid- 11 days post treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 26Sep2022 to 30Sep2022. Additional information: The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The third dose of Pfizer covid vaccine was administered 1 day past the "beyond use date."  The patient has not reported any adverse reactions or has not reported any issues.
Injection site reported to become swollen, tender with red patch on January 1, 2021.
Mild headaches/Stronger headache; Sleepiness; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old non- pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 15Mar2021at 11:00 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included cancer in 2015 and 2016 which was fully recovered. The patient did not have any allergies to medications, food, or other products. Concomitant medications included DEXILANT, LINZESS and PRISTIQ; all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 22Feb2021 at 11:00 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021, the patient experienced mild headaches and sleepiness first four days post vaccination. On the eight-day, the patient still had achiness and stronger headache. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headaches and sleepiness were not recovered at the time of reporting.  Information about lot/batch number cannot be obtained. No further information is expected.
side effects after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after second dose) in an adult male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects after second dose). At the time of the report, VACCINATION COMPLICATION (side effects after second dose) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.   Reporter did not allow further contact
Beginning 4/22/06, 3 day Hx of fever 99.0-102.0, fussy, crying
Nausea, vomiting, headache, body pain... had these same side effects with the first and second vaccines. Both happened the day after the shot. Lasted all day
Approx 48 hours after admiin of FLUZONE vaccine, pt reported to ED with left deltoid redness, edema and blisters.
Increased redness around the vaccination site several days after the injection accompanied by soreness and itching at the injection site. Lasted about 1 week
Developed muscular aches, leg weakness diagnosed as Guillain Barre Syndrome  - monitored and followed by neurologist. Has recovered.
Patient is fully vaccinated. Tested + for COVID at ED visit on 1/2/2022. 44-year-old presented to emergency center for evaluation of syncopal episode.  Patient states that for the past 3 days has been having body aches. Patient states the past 2 days he has been having cough nonproductive in nature. Patient states that for the past 3 days has been having body aches. Patient states the past 2 days he has been having cough nonproductive in nature. CXR: Patchy airspace opacities at the left lung base. Findings may relate to atelectasis or developing consolidation. Patient remains stable, will discharge home.
Pt was given Invalid vaccine which expired 10-02-21. Pt will need to get the HIB  Vaccine again in 4weeks. No adverse reaction noted on date of administration or since.
Initial information regarding an unsolicited valid non-serious case received on 09-Oct-2018 from a Pharmacy student (consumer). This case involves a 13 months old patient who accidentally injected with 0.5 ml of FLUZONE QUADRIVALENT instead of 0.25 ml from the vaccine FLUZONE QUADRIVALENT (Batch number: UT6331LA, route: intramuscular and site of administration was thigh nos, expiration date and was unknown) on 09-Oct-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to Accidental overdose (accidentally injected with 0.5ml of FLUZONE QUADRIVALENT instead of 0.25mL/No AE). No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. List of documents held by sender: none.
The adverse event is Dermatographic urticaria. The symptoms of Dermatographia began on January 23rd, 2022. The symptoms are still on going as of February 21st, 2022.  Antihistamines such as Cetirizine (Zyrtec) relieve the itchiness symptom however they do not prevent the distinct welts that occurs from pressure being applied to the skin. In other words, the antihistamines make the itchiness go away but they don't prevent the welts from occurring.
Pt developed shortness of breath after vaccine, diphenhydramine was administered orally with no improvement, EpiPen 0.3mg given and pt went to hospital.  Pt was seen in ER and given  5 day course of prednisone and advised to continue to take diphenhydramine ever 6 hours
This spontaneous report as received from a registered nurse refers to unknown number of patients with unknown age and gender. On unknown dates the patients were vaccinated with GARDASIL lot # J008423, expiration date: 21-JAN-2016(strength, dosage, frequency and route unknown). There was temperature excursion during vaccine storage. The patient was vaccinated at private doctor's clinic/hospital with public funds. The manufacturer was contacted. Vaccine was stable and no adverse event was observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
Positive COVID-19 test; Sore throat; Swelling on armpits; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive COVID-19 test), OROPHARYNGEAL PAIN (Sore throat), SWELLING (Swelling on armpits) and HEADACHE (Headache) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concomitant products included COLCHICINE for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), SWELLING (Swelling on armpits) and HEADACHE (Headache). On an unknown date, the patient experienced COVID-19 (Positive COVID-19 test). At the time of the report, COVID-19 (Positive COVID-19 test), OROPHARYNGEAL PAIN (Sore throat), SWELLING (Swelling on armpits) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included over-the-counter oral medication containing paracetamol, caffeine and phenylephrine.
Extreme redness of face and neck starting within 30 min of injection.  Some tiredness , then with a few days some headache (mild ) and upset stomach (also mild). About 5 days after I noticed 2 purple spots on my right arm, they have not went away and there are now 2 more.  All symptoms are gone but the spots are getting worse and continue to multiply.
This spontaneous report was received from a male patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX on 31-DEC-2012 (Monday). No other co-suspects were reported. No concomitant medications were reported. The patient reported that he still had some tenderness at the injection site. This is one of several reports received from the patient. Additional information is not expected.
At about 5 PM on March 20th, 2021, I felt so dizzy that it was almost impossible to walk.  I had to hold onto furniture as I made my way across the room.  After this continued for several hours, I did some research on the web and was led to believe that being dizzy was a serious event.  At 7:11 PM, I got a ride to the hospital and checked into the emergency room.  I was there at the hospital for about 30 minutes and noticed that the dizzy feeling was gone.  I walked out of the hospital without every going back to an examination room.  I caught a ride home at 8:08 PM.  Note that the only other adverse event was a sore arm and a vague feeling of not being well.
vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 18-Jun-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. 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 VACCINATION SITE PAIN (vaccination site pain). At the time of the report, VACCINATION SITE PAIN (vaccination site pain) had resolved. after first dose      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 treatment medicine is reported by reporter   This case was linked to MOD-2021-087465 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up document received on 24-MAY-2021 and it does not contain any new information
Dizzy; This is a spontaneous report from a contactable consumer (daughter). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on unspecified date as single dose for COVID-19 immunization. After he got his second vaccine shot of Pfizer the patient started getting dizzy on an unspecified date and has been dizzy for a while now. The outcome of the event was unknown.    The lot number for BNT162B2 was not provided and will be requested during follow up.
Patient's shoulder froze, pain in shoulder cap area down into deltoid (towards bicep) Limited range of motion  Pain from mid arm to front of shoulder/chest/anterior of shoulder Generalized muscle pain
Headache, body aches, 101 temperature, nausea, chills, and tired
Patient began crying 4 am on the morning after immunization. By 8 am, he was screaming nonstop. Tylenol did not help. Patient was taken to the clinic and told it was a reaction to vaccine and to continue taking Tylenol. Patient continued crying all day for two days. On the third day he was fussy, and by the next day, he was all right. He had a low grade fever of 100.6. He had a red, swollen leg at site of DTAP injection.
Received flu shot in employee health services. Soreness noted. 2nd day achiness back of shoulder, mild pain with arm overhead and extending back. (+) point tender. Therapy (physical) ordered.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 5-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. The subject has no known drug allergies. Concurrent conditions were not provided. Concurrent vaccinations administered on the same date as Infanrix, 21 August 2006, included inactivated poliomyelitis virus vaccine (IPOL; Aventis Pasteur; lot and expiration not provided) and live attenuated measles, mumps, rubella vaccine (MMR; Merck; lot number and expiration not provided). On 21 August 2006 the subject received 5th dose of Infanrix (lot AC14B033AA, expiration 02 November 2008)  at 0.5 ml, intramuscularly in the right thigh. On 22 August 2006, after vaccination with Infanrix, the subject experienced injection site redness (2 inches), injection site warmth and hardening at the injection site. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events were was unspecified. the healthcare professional considered the events were probably related to vaccination with Infanrix. Follow-up received on 31 August 2006, indicated that the subject was vaccinated with Infanrix on 17 August 2006. The same day the subject experienced unspecified symptoms that was diagnosed as cellulitis. The subject was treated with keflex. At an unspecified time, the symptoms resolved. The reporter considered that the events were related to the use of Infanrix. Comment: The physician indicated that he is "positive" that there is a quality assurance issue with this lot of Infanrix, due to the number of adverse events he has seen with the lot. The physician did not indicate how many subject had adverse experiences, other than the one described above, and did not specify the nature of any other adverse experiences.
Developed severe case E. Multiforme (she has in the past when develops acute illness)
Pain started within 2 hours of vaccination shot. This 2nd shot was much more painful than 1st shot. Pain worsened through the night and I went to Urgent Care the next day. They had never heard of Sirva so they sent me home with no diagnosis. Have been seeing a physical therapist but pain continues over 2 months later.
Pt developed a rash approximately 48 hours post MMR. Pt was seen in MD office on 11/16/01 with a rash consistent with German measles. The rash had started caudally. Pt was afebrile and looked good.
No adverse reaction. Patient was given and expired vaccine. Rotavirus expired 2/22/22 but was given to patient on 2/23/22
Pain at injection site, few days Chills/ couldn?t sleep, 10/17/23 Fever, 101.9-10/17/23 and 10/18/23 Tired, few days Canker Sores, 10/18/23 to present
HPV vaccine ordered by provider. Confirmed Name, DOB and patient allergies. Discussed and confirmed was not pregnant. Pt denied suspicion of pregnancy. Pregnancy test run after vaccine given. CMA reported positive pregnancy test. Dr notified. Per Dr "it should be fine." Pt phoned to return to clinic to speak with provider regarding urine results. No answer. Left message for patient to call back. RN Team Lead notified.
On Thursday, September 16th, 2022, at Healthcare, we administered the new bivalent Modena Booster Vaccines to the following patients (listed below). Our Nurse Practitioner on duty was used to the ?0.25mg per dose' booster vaccines which yields 20 doses per vial. She was aware of a difference between the previous monovalent and the new bivalent but wasn?t aware of a vast difference. The bivalent vaccines appear to give 5 doses per vial (0.5mg per dose) versus the monovalent which yielded 20 doses per vial. Our provider was under the impression that it yielded 10 doses per vial. Since 10 doses per vial were administered each patient received 0.25mg instead of 0.5mg.   Each patient did not receive the recommended amount. The POC at the facility is aware of this. There were no adverse reactions noted and everyone seemed to be in good health status prior to our departure. ?
Lower abdominal (pelvis/bladder area) intense pain.  This pain prevented me from walking upright.  Had to hold an to countertops and walls and crotch down in order to move from one place to another,  Could not bear weight on feet.  Also intense muscle pain in legs (thighs)  from knees up to lower abdomen.  This started approximately 6 hours after injection.  I thought I had a very bad either UTI or bladder infection.  Went to Hospital Emergency Room and CTScan as well as bloodwork results showed no infection, no kidney stones and bloodwork came back ok.  I had tested positive for Covid  on January 15 then tested negative Feb 2
Random sharp heart pain and heart discomfort since getting the vaccine; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8731) via an unspecified route of administration on 14Apr2021 at 11:00 (at the age of 26-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was reported as none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks of the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8733) via an unspecified route of administration on 24Mar2021 at 11:00 (at the age of 26-years-old) as a single dose in the left arm for COVID-19 immunization. On 14Apr2021 at 17:00, the patient experienced random sharp heart pain and heart discomfort since getting the vaccine. Treatment was not received for the event. The clinical outcome of the event random sharp heart pain and heart discomfort since getting the vaccine was not recovered/not resolved. Since the vaccination, the patient had not been tested for COVID-19.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got the Shingle vaccination for shingles and guess what the patient had shingles on his/her back at the time of reporting. The patient said, yep. It's shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
Very high blood pressure with hospitalization required on April 2, April 17, and again on May 9. Catherization on May 11. Discharged late May 11 with additional blood pressure meds.
I have  been running a 101-102 degree temperature for the past couple days with alternating chills (feeling extremely cold), and pain in my gastro-intestinal tract.  I have take ibuprofen and acetaminophen to sleep.  Last night, I had night sweats.  I think tonight will be more of the same.  I have taken 3 Ducolax to see if a good bowel movement will set things straight.  Except for a couple of very small BM's , I have been constipated for the past 3 days.