chrisvoncsefalvay/vaers-outcomes huggingface dataset:
wheelchair; it is a square rash that is mottled red and purple; rash below injection site; bruise; sore arm; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534), via an unspecified route of administration, administered in Left arm on 19Mar2021 13:15 (at the age of 79 year old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported as none. After vaccine dose, on an unspecified date in Mar2021, patient experienced sore arm and on 25Mar2021, she developed a rash about 2.25 inches below injection site, stated that at first she thought it was a bruise, and she googled, could see photos of rashes that looks like of hers, those were mottled red and purple. It was reported that she was confined to a wheelchair, has to get transportation through the county. Patient wanted to know if she should get the second dose of the vaccine. The outcome of the event vaccination site rash was not recovered and of other events was unknown.  No follow-up attempts are possible. No further information is expected.
1/13 at 3 am started experiencing severe nausea/vomiting, severe diarrhea, severe body chills and aches, severe migraine and fever of 101.2F. Continued through 1/14 and missed work. Returned to work on 1/15 still having fatigue, nausea and severe headache.
A patient received a expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00701286) and transmitted to Sanofi on 28-Jul-2021.  This case involves a 16-month-old male patient who received an expired HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 28-Jul-2021, the patient received 0.5 mL dose of expired suspect HIB (PRP/T) VACCINE (lot UJ358AAB and expiry date: 27-Jul-2021) via an intramuscular route in the right thigh for prophylactic vaccination (expired product administered).  This was a case of actual medication error due to Expired vaccine used (latency same day).  At time of reporting, no adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
had little sore arm; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 26Jan2021 09:00 (Batch/Lot Number: EK4176) as single dose for covid-19 immunisation. Medical history included High Blood pressure, arthritis and heart problems (Both of her parents had heart problems) from an unknown date and unknown if ongoing. The patient received unknown concomitant medications. The patient experienced had little sore arm on an unspecified date and used ice on it. The patient underwent lab tests and procedures which included weight: 46 lbs on it was intentional. The outcome of the event was unknown.
After receiving , approx. next day, patient noted shortness of breath which worsened over the course of a few weeks. Right leg began to swell with some chest pain approx. 2 days before admission. He presented to ER, CT Chest Protocol showed multiple pulmonary thromboemboli, distal left and right main pulmonary arteries and several segmental branches. and had right heart strain. Venous Doppler of right leg revealed complete occlusion of multiple veins. He was admitted to hospital for anti-coagulation.
At 10PM area with redness, lump and pain.  Patient with complaint of fever.  Treated with ice and motrin by mouth.  Had fever blister on lip.  No seen but triaged by outside facility.
Patient's mother reported ther her daughter (the patient) is still sore on the injection site as of 7/6/18. Patient can rotate her shoulder with no difficulty and also taken OTC Ibuprofen.
four patients had been administered a dose that was extracted after 20 doses were taken from a vaccine vial.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (four patients had been administered a dose that was extracted after 20 doses were taken from a vaccine vial.) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (four patients had been administered a dose that was extracted after 20 doses were taken from a vaccine vial.). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (four patients had been administered a dose that was extracted after 20 doses were taken from a vaccine vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported
Dose administered after 30-day Use By Date; no adverse event; administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (no adverse event) in a 79-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023 at 2:52 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 23-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (no adverse event). On 23-Feb-2023, EXPIRED PRODUCT ADMINISTERED (administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) 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)) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.) to be related and NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date).    Concomitant medication was not provided. Treatment medication information was not provided by the reporter. It was unknown whether patient ever been diagnosed with or tested positive for COVID-19. It was unknown whether patient have acute illnesses at the time of vaccination or not. It was unknown whether patient taking any prescription, over the counter medication, dietary supplement or herbal remedies at the time of vaccination or at the time of adverse event. There are no any other potential causes reported. Patient did not experienced a similar event in the past. Event did not cause the patient to seek medical care. Lot assessment conducted and determined as follows, Analysis of the vials associated with storage excursion was completed. Patient notified at time of initial discovery of event as well as notified when the lot assessment was completed.   This case was linked to US-MODERNATX, INC.-MOD-2023-712565 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712565:Same reporter
High dose flu vaccine adm. 12-08-11, c/o itching tenderness in (rt) arm, sm. hard spot approx. dime size, in last 1-2 wks "red pin pain rash." Now c/o muscle ache in (rt). arm.
On 11/23/22 - Patient told RN that she always gets some "type of reaction" when she get her COVID vaccine and that her doctor told her to make sure she goes to a facility that is close to a hospital.  Nurse gave the patient the vaccine on the gurney at 12:08.  She stated that she had an Immediate flush reaction.  She said she states she gets this when she has an anxiety attack. She states that she has over a 100 allergies to medication.  Also allergic to lobster and eggs?  No other illness at time of vaccination. Medications include:  Aldactone 50mg and Chlorthalidone 25mg for Hypertension She stated that she took a Benadryl 25 mg prior to coming to covid center.  Patient drove herself to COVID center. 12:12 173/98 Pulse 92 and Sat 97% "Immediate flush" 12:20  142/106 P 89 Sat 98%- nose feels itchy and tongue feels itchy.  Encouraged her to drink her Gatorade that she brought. 12:30  148/88 Pulse 85 Sat 93% "tongue itchy".  " I feel much better than I have in the past once given the vaccine. 12:40  Up to wheel chair with minimal assistance/  VS in w/c 167/97 p 86 Sat 99%.  Still states tongue is a bit itchy.  Very talkative and appears in no distress.  States again how much better she feels than last time.  Instructed to call 911 if symptoms increase (SOB, tongue swelling, difficulty breathing or swallowing.  Nurse escorted patient from facility - no difficulty walking, no dizziness, no SOB or issues when leaving.
Patient fell at home on 11/21/21 and was brought to the hospital. He was tested for COVID and was positive. The patient is asymptomatic.
Information has been receiverd from a physician's office concerning a 3 year old male who in 1998 was vaccinated with varicella virus vaccine live (site unknown). On approximately 05/04/01, the pt developed "full-fledged chicken pox". the pt sought medical attention. Additional information has been requested.
GOT COVID; DEAD; BLOOD CLOTS SO BAD; This spontaneous report received from a consumer via a company representative via media concerned a 55-year-old male with unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and Expiry date were not reported) administered 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. the company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, as per reporter "Had a buddy that got the J and J two weeks later he got Covid 3 days later in the hospital and a month later he was dead. Said he had blood clots so bad that if he had made it he would". On an unspecified date, the patient got Covid and was hospitalized (date unspecified) and had and blood clots so bad. On an unspecified date, the patient died due to unknown cause. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid and blood clots so bad was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20220217605-COVID-19 VACCINE AD26.COV2.S-Death, blood clots, got Covid. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
My daughter received the AFLURIA QUADRIVALENT, conservative free, one dose flu vaccine made by Seqirus in the morning of August 19 at a pharmacy. Early that same evening, she developed itchy red skin rash and began to develop itchy pustules on her skin. She went back to college last weekend and has been seen by a nurse practitioner in the student health center referred her to a dermatologist who did a biopsy of a pustule. The biopsy was currently undergoing DNA analyses. The skin problem is still ongoing and new pustules appear each day. Patient has had a flu vaccine every year since she was 2 years old and has never experience an adverse effect. My husband and I, each received a flu vaccine from the same pharmacy as patient this year, but we received the double dose FLUZONE vaccine from Sanofi because we are older than 65. We have not experienced an adverse effect.
I was in the yard and stumbled and fell. I didn't really notice anything but then on Wednesday it started bothering me and couldn't walk by Thursday night so I went to ER.
Mom stated child had a tem up to 102 degrees within 24 hrs (off and on). Soreness, redness, and slight swelling to area where shot was given (L) Vastus lateralis (2 cm X 2 cm of redness)
Client experienced vasovagal syncope immediately following the administration of influenza (administered 1st) and Tdap (administered 2nd). Client described feeling a drop in his blood pressure. Client was seated while being vaccinated and supported from falling by, RN while experiencing syncope. Client remained seated and drinking water for twenty minutes after syncope. Client shared that he had experienced syncope before. RN advised client to share that he has had vasovagal syncope with any immunization provider he sees in the future because he is at risk for falls after immunizations. Client was experiencing no symptoms twenty minutes after vasovagal response.
Booster; can't sit straight; extreme nausea; he is very dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Covid-19 vaccine (Unknown dose), for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021, outcome "unknown", described as "Booster"; NAUSEA (non-serious) with onset 21Dec2021, outcome "unknown", described as "extreme nausea"; DIZZINESS (non-serious) with onset 21Dec2021, outcome "unknown", described as "he is very dizzy"; SITTING DISABILITY (non-serious) with onset 21Dec2021, outcome "unknown", described as "can't sit straight".  Additional information: Reporter was calling on behalf of her husband who received the Pfizer covid-19 vaccine booster shot this morning, about 6 hours ago and now he was experiencing side effects. Reporter mentioned, "extreme nausea, failing up (sounds like) he is very dizzy and can't sit straight." Reporter added, "looks like he had IBUPROFEN he had been taking prescriptions of IBUPROFEN." Reporter wanted to know if IBUPROFEN had an interaction with the vaccine. Upon checking the official PI I did not find any potential interaction or interaction study for the administration of IBUPROFEN to patients who experienced side effects after getting the vaccine, this may not have been studied.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Covid arm on the arm of the injection; Little nauseous; Tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm on the arm of the injection), NAUSEA (Little nauseous) and FATIGUE (Tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU (for 3 days) in 2020. Past adverse reactions to the above products included Arm discomfort with FLU. Concomitant products included LISINOPRIL, PANTOPRAZOLE, FAMOTIDINE, FISH OIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced NAUSEA (Little nauseous). In February 2021, the patient experienced FATIGUE (Tired). On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm on the arm of the injection). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 10-Feb-2021, NAUSEA (Little nauseous) had resolved. In February 2021, FATIGUE (Tired) had resolved. At the time of the report, VACCINATION SITE REACTION (Covid arm on the arm of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-372356 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Followup was received and included no new information.
NOT FEELING WELL; HEADACHE; BLOOD CLOT IN LEFT THIGH; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 77 year old male. The patient's weight was 170 pounds, and height was 71 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 093A2112, and expiry: UNKNOWN) dose was not reported, 1 total administered to left deltoid on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient experienced flu-like symptoms, chills, the night of the vaccination for about 3 days. The patient was not feeling well after the vaccination. On 04-AUG-2021, the patient noticed a lump on his left thigh. On 05-AUG-2021, patient experienced headache which still present. On 17-AUG-2021, the patient went to the emergency room, did an ultrasound, waited there for 6 hours and was told that he had a blood clot in left thigh. He was seen by his primary health care professional on reporting date and instructed to report his symptoms. The patient was started on Eliquis (apixaban) for 3 months till further assessed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 09-APR-2021, and had not recovered from blood clot in left thigh, headache, and not feeling well. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210851502-COVID-19 VACCINE AD26.COV2.S-Blood clot in left thigh. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient has a large rash on her right arm. The rash is very hot to the touch. Patient also complained of fever, severe pain, and limitations in movement. Patient went to the emergency room and received cephalexin. Upon the ER visit, patient was told that the rash is infected.
7.5cm x 6cm area of redness, warmth and tenderness to palpation on the left upper outer arm. I am treating for cellulitis with BACTRIM BID for 7 days.
Patient experienced generalized itching. I specifically observed scratching at back and inside of both arms. Patient described as "ants crawling all over me."  Patient stated she has had this reaction at least 4 other times to injections, described Rituxan infusion and contrast dye, and to both previous doses of Pfizer Covid vaccine.  She took 2 diphenhydramine 25mg capsules by mouth and felt better within 20 minutes. She declined additional care at our Emergency Dept.
I was diagnosed with Cellulitis on October 13th .    Extreme left foot pain, swelling, hot to touch.   An additional sore spot on lower right leg
Severe joint pain (like arthritis) in all joints. It is not going away after12 days. Also, severe nerve pain in left side of body. This has never happened to me before.
Got the vaccine, and the evening of the vaccine had a very bad headache.  During the night he had chills, nausea, vomiting, dizziness.  The arm hurt until yesterday.  All of his symptoms are gone now.  He did have the COVID virus back in December.  He suffers from vertigo so he followed those instructions and drank a lot of fluids and took Tylenol for his symptoms.
55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-418964 (Patient Link).
3/20 vaccination  That evening of vaccination, I had really bad chills and a fever of 102.7. I took some Tylenol.  3/21 fever broke. No chills. Felt almost good as new.  3/22 I started having trouble breathing, almost like I couldn't fully breath in and that lasted pretty much until 4/23/2021. It felt like my chest was clogged, like your nose is clogged. Very uncomfortable. I started with a 'cough', almost like I wanted to cough but I kept it all in.  3/23, or 3/25 Urgent Care telemedicine due to being respiratory. Was prescribed an inhaler with albuterol with steroids. Neither seemed to have an affect. The following week, I took a COVID test; Neg. I went back to urgent care, said my lungs were all clear. Prescribed me 'oral medication' and expectorant with codeine. Didn't have affect until I took the expectorant with the codeine.
Pt had no pain at time of shot or for two days after shot then arm began to hurt and still hurts and is having trouble lifting it.