chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE information; temperature excursion; Information has been received from an administrator referring to a 12 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 19-APR-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 1.32 degree Celsius. The time frame was 0.77 hours on 02-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA004751:
didn't bite her tongue but her blood vessels burst/didn't bite her lip, but a blood vessel burst in her lip; the blood was gushing and gushing; A blood vessel burst in her lip. It kept bleeding; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 63-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12May2021 (yesterday) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included dimeticone (CHAPSTICK) taken for an unspecified indication, start and stop date were not reported. The patient reported that she got the 2nd shot of the Pfizer Covid Vaccine yesterday. On 13May2021, she did not bite her tongue, but her blood vessels burst this morning, the blood was gushing and gushing. She never had this before not even nosebleeds. This morning, she didn't bite her lip or anything, but a blood vessel burst in her lip; It kept bleeding. It stopped a few hours, but later started again. There was a lot of blood she wanted to go to Medical Information, was asking what information they have on that and was her blood vessels inside our gonna burst. She questioned will she die? and stated that that she does not have any bleeding disorders. She took treatment with Tylenol, she did apply Chapstick and was asking if this was okay. Outcome of events was not recovered/not resolved.  No follow-up attempts are needed. No further information is expected.
Patient felt dizzy almost 5 minutes after receiving Moderna Vaccine. Patient felt better after drinking some water. Patient mentioned that she skipped her lunch and didn't drink enough water today. Patient was stable in 20 minutes. Patient was under pharmacist's observation for 30 minutes.
Tired and sore arm the following day Very sore muscles and chest pain (already have chronic pain but worsened as a result)
it spread out on her upper arm; she feels her arm a little warm; a red spot around the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (it spread out on her upper arm), VACCINATION SITE WARMTH (she feels her arm a little warm) and VACCINATION SITE ERYTHEMA (a red spot around the vaccination site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Down's syndrome.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced ERYTHEMA (it spread out on her upper arm), VACCINATION SITE WARMTH (she feels her arm a little warm) and VACCINATION SITE ERYTHEMA (a red spot around the vaccination site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (it spread out on her upper arm), VACCINATION SITE WARMTH (she feels her arm a little warm) and VACCINATION SITE ERYTHEMA (a red spot around the vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
This case was reported by a physician via sales rep and described the occurrence of nausea in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nausea, vomiting, fever, swelling arm, pain in arm and activities of daily living impaired. On an unknown date, the outcome of the nausea, vomiting, swelling arm, pain in arm and activities of daily living impaired were unknown and the outcome of the fever was recovered/resolved. The reporter considered the nausea, vomiting, fever, swelling arm, pain in arm and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had nausea, vomiting, fever (103 degree F), arm swelling and pain. The patient missed 3 days of work. The fever lasted for 3 days. The reporter agreed to be followed up. Lab Comments: Lab test was done on an unknown date.
pt recv vax 26JAN98 & 12FEB98 pt devel 6 bumps;@ the time of the report pt had just got over cold;
10Jul2021 sudden development of tinnitus left ear. Has continued without interruption (no cessation). No history previously.; Pregnancy at time of Vaccination: Yes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 65-year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jul2021 11:15 (Lot number: EW0181) at the age of 65 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Acute CHF" (unspecified if ongoing); "AFib/flutter" (unspecified if ongoing); "pericarditis" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS; METOPROLOL; LASIX + K; LIPITOR; SPIRONOLACTONE. Past drug history included: Demerol, reaction(s): "Allergy: Demerol"; Codeine, reaction(s): "Allergy: codeine". The following information was reported: TINNITUS (non-serious) with onset 10Jul2021 13:00, outcome "not recovered", described as "10Jul2021 sudden development of tinnitus left ear. Has continued without interruption (no cessation). No history previously."; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 07Jul2021 11:15, outcome "unknown", described as "Pregnancy at time of Vaccination: Yes". Therapeutic measures were not taken as a result of tinnitus, maternal exposure during pregnancy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was neither diagnosed with COVID-19 Prior to vaccination, nor been tested for COVID-19 Since the vaccination. The patient received within 2 weeks of vaccination: Eliquis, Metoprolol, Lasix, Lipitor, Spironolactone.  No follow-up attempts are possible. No further information is expected.
bloated stomach with stomach pain and pain in the ribs, gastro-intestinal upset/pain including alternating diarrhea/constipation and shooting pain in my rectum
Little bit of shingles; 1st dose 2020, pandemic came and never could get 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, not applicable after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced shingles and social problem. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received first dose of Shingles vaccine in 2020 and then pandemic came and he/she never could get the second one and now the patient had a little bit of shingles. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Pt was in the waiting room in his motorized wheelchair when he complained that he feels like he's going to pass out. He also c/o being dizzy. His skin was cold and clammy.  This happened about 5 minutes after the vaccine. We assisted him to a room where he laid down flat and I applied ice pack to his head and chest. Pt felt better after about 30 minutes.  Pt stated he had never had this reaction before.  Pt was discharged from the clinic with his father, in stable condition.
Consistent chest pains on left side of chest. Frequently (3/7 days per week) sharp heart palpitations that still continue to this day that require me to stop what I?m doing. It sometimes feels like my chest/heart is going to explode.
One of the patients was 5-year-old received a GARDASIL vaccine and meningococcal conjugate vaccine along with a DTAP; This spontaneous report has been received from unspecified reporter via company representative concerning a 5-year-old male patient. The patient's medical history and concurrent conditions were not provided. Concomitant therapies included meningococcal vaccine conj and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP).   On an unknown date, the patient was incorrectly vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. The reporter stated that they did not realize that the patient had received the wrong vaccine until the patient's mother had already left (product administered to patient of inappropriate age).
pt recv vax 19JUL95 & 26MAR96 40 2/7 wk gestation labor was induced & pt vaginally delivered a 9lb 10oz baby boy;Apgar scores were good @ 1 & 5min;shortly p/birth pt required blood transfusions d/t low hgb levels;
This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the second booster dose of The Moderna Covid 19 Vaccine from an expired vial.) and PRODUCT STORAGE ERROR (Received vaccine from a vial that had expired on 16Apr2022) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A, 091D21, 016M20A and 032L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the second booster dose of The Moderna Covid-19 Vaccine from an expired vial). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine from a vial that had expired on 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the second booster dose of The Moderna Covid-19 Vaccine from an expired vial) and PRODUCT STORAGE ERROR (Received vaccine from a vial that had expired on 16Apr2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications stated that patient was on concomitant medication, but did not specify on what type of medication. The patient had not reported any side effects yet. No treatment details were reported.
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
11cm x 7cm, red, hot, swollen, tender to touch at immunization site.
12-27-04-1st Hep B shot; 2-24-2005 2nd Hep B shot-nausea, muscle aches, abdominal cramps, diarrhea, loss of appetite, headaches, sinus problems. 7-8-05 3rd shot.  Within 1.5 days approximate started itching.  By 7-11-05 had a itching and knot between mild eyebrow area and eyelid like a cyst.  Given hydrocortisone cream-told ___ to vaccine knot is gone itching persists. Dermatologist says internal allergy.  Since mid Sept-right elbow extremely painful for no reason (except vaccine). Patient flew to California Kaiser clinic for blood work.  Tests negative  doc says could be vaccine related.  1st few doctors said would  be rare.
8 days post vax pt developed a rash that started on face and back and spread to the rest of the body.
Sore arm, sore neck, extreme lethargy, fatigue (different than fibromyalgia pain. Body aches
Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A 17 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Jun2021 13:10 (Lot number: EWD171, Expiration Date: 08Jun2021) at the age of 17 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Headache" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for headache; HEPA [HEPATITIS A VACCINE] taken for immunisation. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache.  Additional information: It was reported that her daughter got the first dose yesterday and she was experiencing headache so she would like to know if she could take Ibuprofen so she was reporting an adverse event. Dosage (Metformin): Reporter stated, she always get headache, the headache was not from the shot she just get headache all time, wanted to know and want to make sure (unclear). No, she had not taken anything treatment yet. Urgent Care Pediatric, vaccine facility type. Patient did receive HepA122908 and 8910 vaccine within 4 weeks prior to the COVID vaccine on 04May2021 and MCV 71615 on 05Apr2021 (Further clarification was unknown and not confirmed). This was just towards a health certificate of immunization.  No follow-up attempts are possible. No further information is expected.
Feeling achy all over body (flu-like) about 8 hours after shot and continued for about 3 days, even soles of feet. Difficulty sleeping that night. Could not sleep on left side for about 3 days. Knees ached,  difficulty walking.
Fever occurred within 12 hours of first dose. Fever reached 101 degrees. Last dose was 11/8/2017.   Stomach ache, vomiting and nausea started 11/10/2017 and are consistent through present (11/29/2017).
during administration the syringe came loose from the barrel, where and unknown amount of vaccine was injected into patient.   some went into patients arm and some ran out
Breakthrough covid case. Pt presented to ER on 6/21/22 with c/o cough, fatigue, headache, fever, congestion and covid exposure by wife. Paxlovid prescribed. DC home
From patient notes: 2/4/2021 shot at 0700 - arm sore right away 1000 slight headache 1300 chills, increased arm pain, headache a little worse, loss of appetite PM  - muscle soreness throughout whole body, hard to sleep 2/5  muscle soreness continues, tired, slight chills 2/6 1300 lips and lower part of face slightly numb and continued throughout day 2/7 numbness not as bad but more on right side and now experiencing sensation of swelling on right side of face 2/8 numbness better but still slight.  Slight swelling as well.
Information has been received from a physician concerning a male who on 26-FEB-2007 was vaccinated with the first dose of Rotateq. On approximately 11-JUN-2007 (16 weeks after the first dose of Rotateq)) the patient was vaccinated with the second dose. No problems reported. Additional information has been requested.
Slight redness at injection site with red blotch appeared approximately 20 hours after shot (daughter complained of pain in leg). - Few hours later (approximately 5pm), daughter slept (uncharacteristic of her) and soon after woke up, vomiting (x1) - Leg pain reported as more intense (screaming and wanting ice applied) - Teledoc contacted (w/ picture of area emailed) for appointment (suspected cellulitis) - Fever of 100º (101 via underarm and also head scan) - MD on telephone advised to circle red area and if spread, then indeed cellulitis (abx ordered to treat) - Throughout night, symptoms of pain reported more extreme, fever peaked up to 103.5º - During early morning hours of 4/17 pediatrician exchange contacted - NP on call did not believe at time could be cellulitis, advised to closely monitor (circled red area) - within few hours, redness had spread (Pediatrician also contacted by NP), confirmed cellulitis, another abx ordered
I started getting muscle aches around noon the day after the vaccine. It slowly got worse and worse and I was miserable. I had muscle aches, back ache, temperature of 101 and chills. My body hurt so bad that I needed help walking across the room. My fever broke at about 4 am and I was sweating. 3 days later, my heart started racing up to 265 BPM. I had diagnosed A-Fib for 6 years before up until this point that has always been able to be controlled with my Diltiazem. I had to go to the ER. I was admitted into the hospital for a day and 1/2.
swelling was increased and spread; very minor pain in the axial area under the arm of the injection site; some minor swelling in that area; fatigue; Minor pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269 and Expiration Date not reported) via an unspecified route of administration, administered in left arm on 05Feb2021 09:30 (at the age of 36 years old) as dose 2, single for COVID-19 immunisation at workplace clinic. The patient medical history included asthma and patient had no known allergies. The patient concomitant medication in two weeks included fluticasone; salmeterol 113/14 inhaler. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL0142 and Expiration Date not reported) via an unspecified route of administration, administered in right arm on 15Jan2021 13:00 (at the age of 36 years old) as dose 1, single for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. The patient did not had covid prior to vaccination. The patient was not tested for COVID post vaccination. Reportedly, after receiving the second vaccine at 9:30 am on 05Feb2021, the patient experienced some fatigue in the evening and minor pain at the injection site. Around 05:00 the morning of the 06Feb2021, the patient noted some very minor pain in the axial area under the arm of the injection site that seemed to stem from some minor swelling in that area. On 08Feb2021, the swelling was increased and spread. The patient did not receive treatment for events. The outcome of events was not resolved.  Follow-up attempts completed. No further information expected.
Slight swelling , tenderness and redness at site. Fever of 102.9, severe chills, severe aching from top of legs down, headache but not quite as severe as when hospitalized  last year. All symptoms resolved within approx. 20 hours except for the arm site.
HEADACHE & EXHAUSTION. EXHAUSTION HAS CONTINUED FOR 3 WEEKS
02/17 received vax. 02/19 medical care sought for increased tenderness, redness at injection site. 02/20 care sought again for progression of symptoms locally with paresthesia. Diameter - 300 cm induration, redness. 03/02 only painful nodule remains. Plan to pre-treat before next dose.
Sore arm for first 24 hours. But, at about 48 hours I broke out in what appears to be a nickel allergy rash on both of my index fingers and my right middle finger despite the fact that I have not touched anything metal or did anything out of the usual. This has never ever happened before. It is incredibly itchy and small bumps.
Initial soreness around injection spread to inner arm, starting about 1/2 way between shoulder and elbow, and going up toward shoulder. Stayed sore for a couple of days and then became very painful. Had about 3 days without being able to lift arm above head. Ice and ibuprofen seemed to address the worst of the pain. Seeing physical therapist to try to address the rest.
Pt recvd 2nd dose of vax 08FEB91 & devel h/a x 2 days, shoulder pain, generalized aching, nausea, abd cramping, malaise & a sore arm; Pt seen in ER however not hospitalized;
Client given immunization on 9/8/06.  Parents called nurse on call 9/9/06.  Child complain of sore arm.  RN called doctor (doctor was on call). He had me tell parents to give child BENADRYL and TYLENOL. 9/11 Telephone conference to parents today-child has no redness or swelling.
S and S = severe spinal/joint pain. Tx = chiropractor therapy. Tx = cortisone injection. Received injection in AM. In pain by PM x 1 1/2 wks with low grade fever.
Omicron; Omicron; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Omicron".  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-202200371280 same reporter/product/event, different patient