chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No energy / Lack of energy; Hasn't been able to get out of bed; Spots on back near butt.  Like a rash and has itching associated with it; Tired; This case was reported by a consumer via call center representative and described the occurrence of loss of energy in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number M9P52, expiry date 18th December 2021) for prophylaxis.   On 7th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced loss of energy, bedridden, itchy rash and fatigue. On an unknown date, the outcome of the loss of energy, bedridden, itchy rash and fatigue were unknown.   It was unknown if the reporter considered the loss of energy, bedridden, itchy rash and fatigue to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported but could be between 70 or 71 years. The reporter stated that patient had no energy, but on the day of reporting has been the worst thus far.  The patient was not been able to get out of bed. had an appointment that he cancelled on the day of reporting. The reporter stated that had spots on his back near his butt like a rash and has itching associated with it. The patient was seen at his physician last Friday for an appointment that was already planned. The patient also felt tired but the spots were not evaluated as they were not present. The reporter stated that there were plans to test for viruses that may be causing the lack of energy, but they are waiting for paperwork of where to go for the testing. The reporter was encouraged to have patient discuss the rash with his doctor and the continued lack of energy and itching. The reporter did not consent to follow up.
received vaccines after a temperature excursion; 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 61-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 01-FEB-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023AMR055743:same reporter
Increasing SOB for two weeks. Saw pulmonologist and was told to come to the ED for PE bilateral lungs. Came to the ED and got therapeutic Lovenox. Currently in observation at the hospital.
Patient reports intermittent left arm pain since getting the vaccine that began the same day after getting the vaccine. Pain radiates down to fingertips.
patient received only the adjuvant portion of the vaccine/She initially stated that they had a lyophilized component vial that was left over but didn't have the adjuvant portion; patient received only the adjuvant portion of the vaccine/She initially stated that they had a lyophilized component vial that was left over but didn't have the adjuvant portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 13-Jul-2022 Reporter's comment: The pharmacist reported that she was not implying that the patient received only the adjuvant portion of the vaccine.  The reporter initially stated that they had a lyophilized component vial that was left over but did not had the adjuvant portion, and she believed it was either misplaced or wasted.  The reporter was not concerned that one of the adjuvant portions was administered to a patient. The reporter stated that she will tell the patient to come back for their dose and upon probing, she stated that she thought the patient might be late on their 2nd dose.  The reporter was unable to confirm this as the health care professional placed him/her on hold and then disconnected the call before confirming that the dose was indeed late. As the health care professional disconnected the call abruptly and the reporter was also unable to obtain patient information.  The reporter was also unable to confirm a mailing address or email or permission for follow up. Additional supportive information: The patient received one of the adjuvant portions, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case was kept valid for the 1st dose with medication error considered that one of the adjuvant portions was administered to a patient and as it was not confirm whether the patient was indeed late for 2nd dose or not therefore 2nd dose was not considered as suspect.
Dizziness, Fainting, Loss of Consciousness, Low blood pressure -- duration several minutes followed by fatigue resting in bed.
Complaint of dizziness, headache, flushed cheeks and feeling warm thru body.  Vital signs BP 110/80;  HR: 100; Pulse Ox: 99%. Given cool pack to neck and removed flannel overshirt.   All symptoms resolved by 1:34.  Patient was able to drink water and discharged home with parents at 1:40 pm.  D/C vitals BP: 100/80; HR: 100;  RR: 22;  temp: 98.4;  02 sats 98%.
7JAN94 pt recvd vax & exp redness, swelling, development of welts 4"x4", c/o extreme soreness; cold packs did not dec swelling; seen @ hosp ER 9JAN94 w/DPH & Advil rx'd;
Mother reports 8 hrs. following immunizations that pt. was sleepy with rolling eyes and sticking her tongue out, along with fever. The next night pt. had leg up in the air and mother had difficult time pulling it down. (Mother did give Acetaminophen the first night).
shaky and it made him nervous; shaky; flu like symptoms; muscle pain; joint pain; chills; nausea; headaches; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (shaky and it made him nervous), TREMOR (shaky), INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced NERVOUSNESS (shaky and it made him nervous), TREMOR (shaky), INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headaches). At the time of the report, NERVOUSNESS (shaky and it made him nervous), TREMOR (shaky), INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided  Treatment medication was not provided
cranky, irritable 29NOV93 red rash around mouth; rash to body AM of 30NOV93; body felt warm; no temp; dx bacterial pharyngitis; also said rash was probably due to MMR;
patient was inadvertently given the 5-11 dose of the covid Pfizer bivalent booster. no pain, redness, or symptoms experienced. family was contacted immediately. she was then given a 2nd dose within 30 min of the 5-11 dose of the bivalent booster to complete the full age appropriate dose.
Mother very vague states her daughter has had hives and swelling off and on for the past year for hives and 2 yrs for swelling.  States she doesn't know if it is the vaccine or not causing it.  Refuses HPV vaccine #3 for daughter.
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP. The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: It was reported that all of the patient's shots including the 3 boosters were all Pfizer. The patient had absolutely no complications and only a sore arm after each shot. That made the patient want to always use the same pharma company going forward.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300015071 same patient/event, different vaccine dose;US-PFIZER INC-202300035212 same patient/event, different vaccine dose;US-PFIZER INC-202300035213 same patient/event, different vaccine dose;US-PFIZER INC-202300035215 same patient/event, different vaccine dose;
Vaccine was expired on 13-Jun-2023, vaccine was initially stored in refrigerator on 24-Jul-2023 and vaccine was administered on 25-Jul-2023.; No adverse event; Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vaccine was expired on 13-Jun-2023, vaccine was initially stored in refrigerator on 24-Jul-2023 and vaccine was administered on 25-Jul-2023.) and NO ADVERSE EVENT (No adverse event) in an 82-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     It was unknown whether patient had any relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 25-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 25-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 13-Jun-2023, vaccine was initially stored in refrigerator on 24-Jul-2023 and vaccine was administered on 25-Jul-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vaccine was expired on 13-Jun-2023, vaccine was initially stored in refrigerator on 24-Jul-2023 and vaccine was administered on 25-Jul-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and PRODUCT STORAGE ERROR (Vaccine was expired on 13-Jun-2023, vaccine was initially stored in refrigerator on 24-Jul-2023 and vaccine was administered on 25-Jul-2023.).    Information regarding previous vaccination was unknown. It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. The expiry date was reported as 13-Jun-2023. Individual vial size was unknown. Suspect vaccine dosage text was reported as unknown. Vial did not undergo any temperature excursions.  Treatment information was not provided.  This case contains information about patient 3rd out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-736471 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736471:Same reporter, Patient 1
Joint pain that progressed over the next couple of weeks to anemia, purpuric rash, vasculitis, pulmonary hemorrhage, respiratory failure.
A few days following my first Covid shot, I experienced several symptoms, which lasted for about 4-5 weeks.  I had shortness of breath, where I felt like I couldn?t finish sentences, sing to my kids, and felt like I couldn?t get enough air to breathe. This happened about every day for 4-5 weeks, sometimes several times a day, sometimes missing a day. I experienced chest pressure. I visualized a metal sheet pressing down on my chest from the inside. It wasn?t pain but pressure, like I wanted my chest to be able to expand up more.  This also happened often, at least several times/week for 4-5 weeks.  I also had a racing heart. I would lie down in bed at night and not understand why my heart was racing. This happened daily to several times a week for 4-5 weeks.  At the time, myocarditis was not a known possible side effect from the vaccine. I had no idea these sxs could be related to each other or to the vaccine.
Rash - Information has been received from a registered pharmacist concerning a 10 year old male patient, who was vaccinated with a booster dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Within 3 days of vaccination, the patient developed a rash on the torso described as sandpaper.  the patient sought unspecified medical attention.  Addition information has been requested.
pt recv vax & 4-6 days post vax pt exp synovitis;this adverse event was untreated;pt was referred to an orthopedist;sx spontaneously resolved;
Approximately 5 hrs after vaccination, child woke up screaming. He screamed for about 6 hours, maybe longer. He seemed to have pain in his abdm so a KUB was done which was read as ? obstruction. He was sent to hospital, but no other test was done. He went home & slept the next 36 hrs except for brief moments when mom fed him.
Information has been received from a medical assistant referring to a 4 month old male patient. No relevant medical history or concurrent conditions were reported. On 22-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Awoke 10/6 w/headache, body aches, dizziness, low grade fever & experienced painful swelling of glands/neck, difficulty swallowing, flushing of face;given PM Benadryl w/help. Continued to have pain/difficulty swallowing 1-2 days after vax.
Soreness at injection site, swollen lymph node under armpit near injection site, fever of 100.2, headache, fatigue, loss of appetite, muscle soreness.
Pfizer-BioNTech COVID-19 Vaccine EUA  Patient stated that 2 1/2 to 3 hours after receiving vaccine she had 2 "red dots" on the arm she received the vaccine in. States one dot was where vaccine was administered and second dot was next to area where she received vaccine. The next day patient stated "the two dots became red, raised, and sore to touch". States they were not warm or hot to touch. 2 days following vaccination, the 2 "dot areas" were still present. Patient stated "running through the dot I got the shot in, I developed a red line that ran through the place I got the shot and was about 2 inches long down my arm. " Patient described red line as "It looks like a cat scratch".  3 days following vaccination, states "Bumps are still there but faint" also states "red line is still there". States line is not raised, tender, or hot to touch. States no other reactions. States no fever or fatigue.
Approx 2 hours after vaccine was received, he complained of fever of 100.3 and chills.  Resolved after taking 2 Tylenol.  No further issues since that time.
Aching arm at time of vaccination, then 6 days later arm became very red, tender, hot, and extremely itchy at injection site and surrounding area. Fatigue, inappetence, and lethargy noted in patient.
Around 11:00PM, I went to urinate, but I had a blockage and couldn't urinate. I tried several times with no success. It became somewhat painful. I called 911, and they sent an ambulance. The ambulance took me to the emergency room. They put in a catheter and sent me home. Three days later, I went to my Urologist. He removed the catheter and performed a Cystoscopy. He found a polyp in my bladder. I had outpatient surgery to remove the polyp. At that point, I received a pathology report that diagnosed a bladder tumor. They put in another catheter after the surgery. I had some discomfort and chills. The doctor sent me to get at CT scan of the abdomen and pelvis.
Pt received AFLURIA PF 2011-2012 on 9/6/11 about 11 am. After about 1/2-1 hr pt was experiencing stiff neck. She thought maybe she slept on wrong side. Then she had fever that night. She woke up her face was feeling warm, red, swollen. She said swelling/induration lasted for approximately 2 weeks.
8/5/9 Hep A/Varicella. 9/23/9 HSPE joint pain. BMP, CBC, Multiple UA, 3 office visits.
Pt had hives, rash, itching. He was treated with Benadryl and Prelone.
Symptoms: Red, Pain, Swelling, Spreading (continues to spread today) after ER visit yesterday. Course in ER: TORADOL for pain IV; Ultrasound and lab work; Diagnosis: Cellulitis Left upper arm; Traced arm with marker; Antibiotic and TYLENOL ordered.
This spontaneous report was received from an office manager and refers to multiple unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions, allergies and concomitant therapies was provided. On an unknown dates, the patients might have been vaccinated with improperly stored doses of GARDASIL 9 injection, lot # M031557, expiration date: 07-APR-2019 (dose and site of injection were not reported). All doses were administered before labeled expiration dates. The GARDASIL 9 was exposed to 34.7 degrees Fahrenheit for 40 minutes. The temperatures were logged with digital data logger and there were no previous temperature excursions. No adverse effects were reported. Product quality compliant was not involved. This one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA006441.
Erythematous raised skin, blanchy 4x7cm around injection site of left thigh. Benadryl 1/2tsp-1tsp every 6-8hrs. Cool compresses.
Pt inadvertently received pediatric Pfizer instead of Pfizer 6 months-4 years of age for first dose as a communication error.
Woke up in middle night with very bad headache; extreme weakness; pain in left arm at injection site; dizziness; nausea; elevated blood pressure from pain/headache - several reaction. Called Nurse line for help. Remained in bed from 3 AM to 4 PM; with TYLENOL headache, nausea have subsided; feeling better but reaction so bad that I probably will not take the recommended second dose. I have never had an adverse reaction to other injections, e.g., flu, which I take every year. I felt extremely weak, shallow breathing, sick to my stomach. Symptom at 4:46 PM now are much better and I have been able to eat and drink coffee/tea.
Itchy rash at back of left arm; itching; rash; itchy rash at the back of the right arm; Odd rash on back of both hands after the first dose; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021. The most recent information was received on 24-May-2021 and was forwarded to Moderna on 24-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash at the back of the right arm), PRURITUS (itching), RASH PRURITIC (Itchy rash at back of left arm), RASH (Odd rash on back of both hands after the first dose) and RASH (rash) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included SOTALOL, RIVAROXABAN (XARELTO), TIMOLOL and KETOROLAC for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced RASH (Odd rash on back of both hands after the first dose). On 26-Apr-2021, the patient experienced RASH PRURITIC (itchy rash at the back of the right arm). On 06-May-2021, the patient experienced PRURITUS (itching) and RASH (rash). On an unknown date, the patient experienced RASH PRURITIC (Itchy rash at back of left arm). At the time of the report, RASH PRURITIC (itchy rash at the back of the right arm), PRURITUS (itching), RASH PRURITIC (Itchy rash at back of left arm), RASH (Odd rash on back of both hands after the first dose) and RASH (rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Patient states she had a reaction of a rash on her hands she has never seen before after the first shot and also with the second shot that has not cleared but is fading. Patient has stopped using latex gloves.   This case was linked to MOD21-080705 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow-up doc attached on 24 May2021 in which concomitant medication is updated. On 23-Jun-2021: Additional information received on 23-JUNE-2021; Sender's Comments:  MOD21-080705:CrossLinked case
Gianotti Crosti, infantile papular acrodermatitis.  Extreme pruritus.