chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving 2nd dose, he had night sweats.; strong reaction to both doses; chills (lasted a couple of days); fever (lasted a couple of days); 1st dose on 28Jan2021 and 2nd dose on 05Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (After receiving 2nd dose, he had night sweats.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 28Jan2021 and 2nd dose on 05Mar2021), VACCINATION COMPLICATION (strong reaction to both doses), CHILLS (chills (lasted a couple of days)) and PYREXIA (fever (lasted a couple of days)) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 28Jan2021 and 2nd dose on 05Mar2021). 05-Mar-2021, the patient experienced CHILLS (chills (lasted a couple of days)) and PYREXIA (fever (lasted a couple of days)). On an unknown date, the patient experienced NIGHT SWEATS (After receiving 2nd dose, he had night sweats.) and VACCINATION COMPLICATION (strong reaction to both doses). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 07-Mar-2021, CHILLS (chills (lasted a couple of days)) and PYREXIA (fever (lasted a couple of days)) had resolved. At the time of the report, NIGHT SWEATS (After receiving 2nd dose, he had night sweats.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 28Jan2021 and 2nd dose on 05Mar2021) had resolved and VACCINATION COMPLICATION (strong reaction to both doses) outcome was unknown.      Concomitant medications included BP medicine. Treatment medications included Anti-histamines along with above mentioned medications.  The caller reported he had a strong reaction to both Moderna COVID-19 injections. The caller stated the first Moderna COVID-19 dose (28Jan2021) "knocked me out" and "bothered me".   This case was linked to MOD-2021-324078 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Significant follow up due to event has been updated
Patient had no side effects from HPV #3 intially. Two weeks after vaccine was administered patient complained of a bruised feeling at site. No discoloration of skin noted and no swelling or lump noted at site.
DIFFICULTY BREATHING, FAST HEART BEAT, DIZZINESS, MUSCULAR (ELECTRIC SHOCKS), WEAKNESS.
1 of 2 pts vaxed from same lot exp an adverse event;pt w/ h/o COPD was in hosp being treated for pneumonia;pt recvd vax in 1194 & had a bad rxn; sxs unspecified;no further clinical details available
On 8/30, patient received two vaccines, TDaP on left arm, and flu vaccine on the right arm. She received the vaccine and after 30 minutes patient came and said her right arm felt swollen and sore. It didn't look swollen, but counseled pt. on using pain killer and told her to let me know how she feels, on 8/31 patient said right arm swollen and left eye swollen.
had a splenectomy for an unspecified reason; This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.   On unknown dates, in 1997 and in 2007, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot#, expiration date, dosage information, route of administration and anatomical locations were unknown) for prophylaxis. The vaccine was reconstituted with a sterile diluent (lot#, expiration date, dosage information, route of administration, indication and anatomical locations were unknown). On an unknown date, the patient had splenectomy for an unspecified reason. The reporter could not clarify if the patient had the splenectomy before or after the vaccination. The outcome of splenectomy was unknown.   The reporter's causality assessment was not reported.  This is a non-valid case due to lack of patient identifier.  Follow-up information was received from a pharmacist on 16-AUG-2019. It was reported that the patient is a female and the age of patient was 18 or 19 years old. She was going into collage. The information was received through a phone call from "upstairs" floor nurse.  Upon internal review, the event of splenectomy was considered to be medically significant.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Jun2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results; (unspecified date) negative, notes: Viral rebound after completion of Paxlovid, documented with negative test; (07Jun2022) Positive, notes: new + test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: other medication was received in 2 week, product: COVID 19 Treatment, brand: Paxlovid  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
On 5/30/06 the infany received Pediarix, HiB and Prevnar veccines at her regular health screening exam.  At the time of the vaccinations the infant was in good health with no problems noted on her physical examination.  About 2 hours after the vaccines were given the infant began screaming and developed a red indurated area on both thighs where the injections were done.  The mother applied warm compresses to the areas with resolution of both the redness and the crying.  The following day (5/31/06) the infant became more irritable and was noted to be "jittery" and breastfeeding less than normal.  No fevers were noted.  The jitteriness continued for the next 48 hours.  By the time the infant returned to my clinic for evaluation on 6/2/06 most of the jitteriness had resolved and she was breastfeeding "almost normally."
C/o stomach pain due to flu. Chest CT A  - HR 80 - resp easy. C/o increase symptoms and  child mother - does not want to do assessment.
UrticariaPruritus inj site itchy/red/painful/swelling 3-4 cm x10 days Narrative:
This medically confirmed spontaneous report (initial receipt 17-OCT-2014) was received via a sales representative and involves an infant. On an unspecified date, the patient received a flu vaccine (manufacturer and batch number not reported), MMR II (batch number J014875) via the subcutaneous route, VARIVAX (batch number not reported), PREVNAR (batch number not reported) and HIB (batch number not reported). ON an unspecified date, the patient developed an MMR-like rash over the back and truck area. It was not specified whether the rash looked like measles, mumps or rubella specifically. The patient also developed a node at the injection site. Outcome was not recovered.
Patient reports insomnia and palpitations approximately 12 hours after vaccination lasting around 6 to 8 hours.
Patient was administered vaccine following improper storage (vaccine was left in freezer too long and was considered expired per manufacturer due to lack of stability study data). Patient acknowledged recommendation but will likely not seek revaccination.
Patient felt nauseated and felt her heart was racing. Blood pressured was checked and was slightly elevated based on what the patient reported was normal. Chills/felt flushed/ weak.
Sore throat; Right eye is red; Headache; Achy body/ achy muscles; Achy joints; Tired; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), OCULAR HYPERAEMIA (Right eye is red), HEADACHE (Headache), MYALGIA (Achy body/ achy muscles) and ARTHRALGIA (Achy joints) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced OCULAR HYPERAEMIA (Right eye is red), HEADACHE (Headache), MYALGIA (Achy body/ achy muscles), ARTHRALGIA (Achy joints) and FATIGUE (Tired). On 10-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), OCULAR HYPERAEMIA (Right eye is red), HEADACHE (Headache), MYALGIA (Achy body/ achy muscles), ARTHRALGIA (Achy joints) and FATIGUE (Tired) outcome was unknown.            Concomitant medications were not provided by the reporter. The patient did not receive any treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Reporter contact information updated
Multiple episodes of dizziness, coming and going. Arm hurt upon movement starting shortly after midnight after received and still hurting, joint pain and headache began early AM 01/09/21. All have ended except pain at injection site and joints still achy.
Patient was a breakthrough case diagnosed on 8/14/2021 and died of COVID-related conditions on 8/21/2021.
outbreaks of Shingles on her right arm/Shingles; sensitivity from breastbone through spine; weird shooting pain; 3 spots of rash on arm; pain in right armpit; This case was reported by a consumer via call center representative and described the occurrence of axillary pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2019, the patient received the 1st dose of Shingrix. On 2nd February 2019, 3 days after receiving Shingrix, the patient experienced axillary pain. On 3rd April 2019, the patient experienced shooting pain and rash. On 8th April 2019, the patient experienced shingles and hypersensitivity. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the axillary pain, shooting pain, rash and shingles were unknown and the outcome of the hypersensitivity was not recovered/not resolved.   It was unknown if the reporter considered the axillary pain, shooting pain, rash, shingles and hypersensitivity to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on an unknown arm. The patient received Shingrix shot, soon after that she had pain in her right armpit. 3 months later, the patient experienced weird shooting pains, she saw her doctor who identified 3 different outbreaks of Shingles on her right arm. The patient then developed a full blown case of Shingles. The patient experienced sensitivity from breastbone through back to her spine. She was in constant pain. The patient completed a course of valacyclovir. The patient did not have her second dose of Shingrix. The reporter gave consent to follow up.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEADACHE (Mild headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (Mild headache). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (Mild headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
In the past few weeks, starting at the end of June, when I bend over, viscous fluid pours out of my nose. It's persistent post-nasal drip that lacks the consistency of familiar snot. It isn't minuscule enough to ignore. It's like I am climbing out of a chlorinated pool. It only happens when I bend down to pick something up and whatever comes out keeps coming until it decides it is done.
This dose was a booster after an initial Janssen dose.  The dose should have been 0.25ml, however, a 0.5ml dose was given.
Patient's lips turned blue/grey and she lost all coloring to her skin. He whole body was a pale grey/white i had never seem before. She had thrown up. She said she felt like passing out. She could hear ringing in her ears. She was freezing cold. Her temperature was 94.8. She also said her whole arm hurt really bad. We wrapped her in a heat pad for a back. In blankets to get her temperature up. It took along time to get her warm. In the morning 7 am she now has a fever of 100 and seems to be doing ok.
6:00 PM and 8:30 PM - stomach pain with severe crying (unusual for my daughter). Lasted about 20 minutes each time.
After a couple of hours pain at injection site for 4-5 days. 1 to 10 scale a 7. Very slight pain if you touch the area after 5 days for a few more days. Redness at injection site for 3 days. Size approx 3-4 inches dia. Believe there was slight swelling but masked by pain. Heat (Warm to touch) generated at injection site for 2-3 days. Had slight fatigue but that may have nothing to do with injection.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported  Treatment information was not reported   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received -No new information
Redness, warmth, swelling and itching in his left upper arm. Hydrocortisone cream
Information has been received from a registered nurse concerning a 10 year old patient who was vaccinated SC with 0.5 ml dose of Zostavax (Lot # 657675/0618U) instead of varicella virus vaccine live. It was reported that the office was expecting an order of varicella virus vaccine live and an order of Zostavax and the Zostavax vaccine arrived first. According to the nurse, vaccine boxes looked similar and thus the Zostavax was put into children freezer instead of adult freezer. The nurse also reported that the names of both vaccines sound similar. The patient did not experience any known symptoms. Unspecified medical attention was sought. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
left sided facial numbness in cheek, lip and tongue; left sided facial numbness in cheek, lip and tongue; This is a spontaneous report from a contactable other health care professional (Patient). A 45-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201, Expiration date not reported) via intramuscular route of administration in left arm on 17Feb2021 at 10:00 (at the age of 45-year-old) as single dose for COVID-19 immunization at School or Student Health Clinic. The patient medical history was reported as none. The concomitant medications were not reported. The patient previously took erythromycin and experienced allergies on an unspecified date. The patient has not received any other vaccine in four weeks. No other medications in two weeks were reported. No COVID prior vaccination was reported. The patient has not been tested for COVID, post vaccination. On 17Feb2021 at 10:45, the patient experienced left sided facial numbness in cheek, lip and tongue; started 45 minutes after vaccine. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The clinical outcome of both events was not resolved.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Took vaccine 8:30am-s/s started 10:00am with sore arm. By 10:00pm, arm was aching, chills, then sweating. By next morning, was ok.
Rash around neck, upper back, chest, lower stomach/abdomen areas. Also low-grade fever of 100.2F.
She received her first COVID vaccine 1/15.  She tested positive for COVID 1/17 in outpatient clinic. Presented to ED 1/18 with a chief complaint of fatigue. admitted to Hospital Medicine for treatment of COVID-19 viral infection and was treated with supportive care. She was enrolled in the COVID-19 Home Symptom Monitoring program & discharged home 1/20/21
Flu-like-fever, chills aching joints, congestion, severe headaches, weakness. Bedridden for 24 hours
After receiving the vaccine, I had extreme fatigue. Then I got muscle aches, soreness at the injection site, and I was really exhausted. When I took Advil that relieved the aches. The symptoms lasted for about a day.
Explosive diarrhea without any warning 24 hours after booster shot.  It happened in two seconds and was down my jeans pant leg and on the floor before I could do anything.  This is very embarrassing, but nothing like that has happened to me before.  I had really bad muscle pain and headache, but took Tylenol and felt better.  I went to work and then this happened.
Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021; vaccine administered past its 30-days expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered past its 30-days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.  On 28-Mar-2022 at 12:57 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Mar-2022 at 12:57 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered past its 30-days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered past its 30-days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that, vaccine was administered on 02-Apr-2022 at 12:57:27. Vaccine dose reported was booster.  No treatment details were reported.
1 dose administered from dose, "unsure of expired or not"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose administered from dose, "unsure of expired or not") in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose administered from dose, "unsure of expired or not"). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (1 dose administered from dose, "unsure of expired or not") had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Dose administered after 30-day Use By Date or after manufacturer date of expiry,Nurse utilizes the lot  does not state this lot number is expired and shows as expiration of "21Dec2069". Number of doses/vials: 1 dose from 1 vial. The vial was initially stored in the refrigerator and  was pulled out of freezer and utilized. The vial   doesn't undergo any temperature excursions. Concomitant medication use was unknown Treatment information was unknown.
sore injection site arm after first Moderna Covid-19 dose; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm after first Moderna Covid-19 dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm after first Moderna Covid-19 dose). At the time of the report, VACCINATION SITE PAIN (sore injection site arm after first Moderna Covid-19 dose) outcome was unknown.        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 medication were reported by the reporter, No treatment medication were reported by the reporter.   This case was linked to MOD-2021-354302, MOD-2021-354332 (Patient Link).
Bumpy rash at injection site that progressed to red area. Also have rash on left arm.( unsure if related)
immed "wheat & flare" @ inj site w/itching;subsided w/in hrs
Sx began within one hour of injection. Patient complained of fatigue, fever, chills, vomiting, headaches, muscle aches, arm discomfort on side of injection. The following day developed a rash at and below injection site. Had some diarrhea. Six days later, less tired, rash improved.