chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administrated with an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number bc75g, expiry date 29th August 2021) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 3rd September 2021, the patient received Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 3rd September 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Medical assistance reported that a patient was administrated with an expired dose of Rotarix which led to expired vaccine used.  No adverse event was reported . The reporter consented to follow up.
18APR red dots appeared on arms & face;each day devel more red dots until 22APR when became large, blotchy & raised blister areas to 1/4-3/4 inches in diameter; seen by MD;t103;feet swelled & were black & blue above ankles;face swelled;
At approximately 3:50 pm on 06/16/2021 patient during 15 minute observation had dizziness, lightheadedness, nausea, and chest pain.  Vital signs at 3:50 pm HR 74, BP 142/100, RR 14, SaO2 98%, pain 8/10. Patient was complaining that she feel more nauseas  and has pain in the middle of her chest. Suggested tranportation to ED. At 4:00 pm HR 63, BP 148/100, RR 18, SaO2 98, pain 6/10. 4.05 pm paramedics tranfered patient to hospital.
Swollen, red, sore injection site. Rash -mild. Pt. reports jitteriness often associated with high blood pressure. Advised to go to primary care to check blood pressure.
Patient became dizzy, passed out briefly, came to with blank appearance, diaphoretic, gray color.
Subjective fever/chills, headache, generalized body aches, soreness in L deltoid (injection site) for ~4-6 hours overnight, with only mild headache and arm soreness the following morning. Resolved by the following mid-day,  approx. 24 hrs post-injection.
significant pain last over 2 months, moderate size palpable but not visible nodule (about a quarter size) recommended observation and f/u in 3 mo.
the patient did not report experiencing symptoms after the improperly stored ROTATEQ; temperature excursion / temperature 8.6 C; This spontaneous report was received from a clinical coordinator and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 18-MAY-2021, a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # T026932, expiration date 28-DEC-2021 (exact dose was not provided) was stored improperly in a temperature of 8.6 degree Celsius (C) for 16 minutes. There was previous temperature excursion reported: 9.3 C for 45 minutes. Digital data logger was involved.  On 04-JUN-2021, the improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to the patient for prophylaxis. They did not report experiencing symptoms after the vaccination.
Left arm redness, swelling of nearly whole arm, tenderness, ?cellulitis, running nose, diaphoresis. Treated with Allegra and Levaquin but pt wants to wait before taking Levaquin.
Within a period of an hour or so after receiving the immunization, the vaccinee developed itching, flushing, chest discomfort, and breathing difficulty.  She was at work as an RN in a hospital so, as she collapsed and began to seize, a code was called.  She was intubated and taken to the ICU where she remains at this time.  She has been extubated. Nurse follow up on 06/28/04 states: "ADD: Anaphylactic reaction, respiratory failure, pseudo seizure, gastritis, left sided weakness."
Persistent moderate to severe headache. Fuzzy head and thinking. Akey muscles and joints. Diarria. Tiredness
itchy; rash on the tattoo,one is about 6 inches, one 7 inches; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and RASH (rash on the tattoo,one is about 6 inches, one 7 inches) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) and SPIRONOLACTONE for an unknown indication.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced RASH (rash on the tattoo,one is about 6 inches, one 7 inches). On an unknown date, the patient experienced PRURITUS (itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE for Rash, at a dose of 1 dosage form. At the time of the report, PRURITUS and RASH (rash on the tattoo,one is about 6 inches, one 7 inches) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient took Primary series of J&J vaccine on 24-Mar-2021.Patient said there is blue ink for her tattoo, and the rash is only in the blue ink. Her doctor said he's never seen it before, gave her Benadryl.
immed felt itching @ site;area hot to touch;19OCT98 swelling down to elbow;+ swelling & warmth rt arm;mild erythema medial arm;
Pt developed a slight progressive non productive cough 5 days ago with a rash that started 3 days ago and was characterized as papular and flesh colored lesions on the bilateral anterior and lateral legs.  The rash rapidly progressed to larger firm nodules on the legs and subsequently included the back, trunk and proximal upper extremities. There was weeping from one lesion on the foot, a clear serous d/c.  No pus, no crusting.  Pt had one episode of NBNB emesis but no diarrhea or alteration in PO intake.  There was some puffiness around the eyes which progressed to lateral canthal injection with clear discharge, and some nasal discharge.
I experienced headaches, aches and pain whole body, feels pulsation to my hands, like carpal tunnel syndrome, My whole body feels icky, I had shortness of breath, my doctor thinks I have inflammation and I am now on prednisone medication. Pain in my back and all over and difficulty sleeping. These aches and pain come and go and move to different parts of my bodies and also resting heart rate that comes and goes.  To this day I continue to have aches and pain on my body and also still on steroid prednisone medication.
Pt received Influenza vaccine for the first time. About five minutes later, the pt c/o dizziness and feeling lightheaded. He remained seated while I checked his vital signs and offered him a cool towel and a glass of water. The supervisor was notified and another staff person and I assisted the pt to an exam table in the room next door. The pt drank more water and juice and rested in a semi-recumbent position with his legs elevated until he said he felt better and his color returned. The pt was escorted from the office about 30 minutes later, with his mother and siblings.
Fevers; Headaches; Chest pressure; Rash on palms and soles; Myopericarditis; Possible atypical Kawasaki disease; Sore throat; This is a spontaneous report from a contactable physician. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 07May2021 (at the age of 18 years), as first dose, single dose, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. On the day of the first dose of vaccine (07May2021), the patient developed sore throat. The next day (08May2021), the patient had fevers and sore throat, developed headaches and chest pressure. Fevers persisted for 5 days so presented to emergency department with rash on palms and soles, diagnosed with myopericarditis, possible atypical Kawasaki disease; all started on 08May2021. The events were considered serious per hospitalization in May2021 for 8 days. Treatment received for the adverse events included vancomycin, ceftriaxone, intravenous immunoglobulins (IVIG), ibuprofen, aspirin, and dobutamine. Since the vaccination, the patient has been tested for COVID-19 (nasal swab) that was negative on 12May2021. The patient was recovering from the events.  Information about lot or batch number cannot be obtained. No further information expected.; Sender's Comments: Based on current information available, the event myopericarditis, Kawasaki disease, sore throat, pyrexia, headache, chest pressure and rash mostly represented intercurrent condition in this patient, unrelated to Bnt162b2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate
Fever, body pain, diarrhea, loss of appetite, headache, injection site swelling with heat ant pain
patient experienced sharp, stabbing, intermittent pain around the injection site; This spontaneous report has been received from a registered nurse concerning a 12-year-old female patient. The patient was allergic to amoxicillin and bacitracin. Pertinent medical history and concomitant medications were reported as none.  On 05-NOV-2019 the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, intramuscular, (lot number 1621931, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 26-JAN-2022) (concentration, dosage, vaccination scheme frequency and anatomical location were not provided) as prophylaxis (reported as routine physical).   On approximately 12-NOV-2019 (also reported as one week after), the patient's father sought medical attention as he called the office to report the patient experienced sharp, stabbing, intermittent pain around the injection site. The nurse recommended ibuprofen (MOTRIN), heat, and gentle massage as treatment. On 05-DEC-2019, the pain was worsening and seemed to be in the joint, not the muscle, the pain lasted for 10 minutes, and it was intermittent (injection site joint pain). No laboratory diagnostics or studies were performed. At the time of reporting, the patient had not recovered from the event.  The causality assessment between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the event injection site joint pain was not reported.
p/vax pt exp less than 50 lesions on stomach & legs;pt sought unspecified medical attention;
Patient was approaching 18 years of age but had not passed his birthday and received the Moderna CoVID vaccination.  He did not experience any immediate hypersensitivity reactions.
This case was reported by a healthcare professional and described the occurrence of hypotonia in an infant male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included ear infection.  Concurrent medications included antibiotics.  In 2001 the subject received 3rd dose of Engerix B (lot numbers received: 5187A2 and 519082).  An unspecified amount of time after administration of the 3rd dose of Engerix B, the subject became floppy.  He was unable to raise his head.  This was further described as, he became hypotonic.  The physician felt that the hypotonia might be due to the thimerosal in the Engerix B.  The child required physical therapy and occupational therapy.  The subject had many ear infections that required antibiotics.  It was reported that it is thought that taking an antibiotic close to the vaccine delays the elimination of thimerosal from the body and may have contributed to the events.  The timing of the onset of the ear infections was not clarified.  The subject has undergone a detoxification process to remove the thimerosal from his system.  At the time of reporting, the subject was 6 years old.  At the time of reporting hypotonia was unresolved and the outcome of the other events was unspecified.
I am dealing with a systemic dermatitis. Since receiving the vaccine, I have not changed my diet or daily activities but I am experiencing a dermatological reaction over my abdomen, arms, and legs. I am taking steroids prescribed to attempt to control the reaction, but as of yet nothing has worked fully.
Pt vaccinated with DTP/OPV developed prolonged high pitched cry for several hrs. Acetaminophen
On 2/1/2023, I woke up with fever and nasal congestion. I took a home antigen test and got a positive result. Later that day, I had a telehealth visit with a doctor, who prescribed Paxlovid, which I began taking that day. I felt better on 2/2/2023; my fever was gone, and I was less congested. However, I still tested positive at this point. Although I felt better, I felt fatigued. I don't really remember how long the fatigue lasted, but I think it was a few days. I tested negative on 2/6/2023. I felt fine and was able to return to work on 2/7/2023. On 2/11/2023, however, I decided to take a home antigen test to make sure I was COVID-19-negative in anticipation of meeting a relative for lunch; I felt fine, but there was a faint pink line that indicated a positive result, so I decided not to meet up with my relative. On 2/12/2023, I went on a road trip. I began to get nasal congestion, which progressively got worse. When I woke up on the morning of 2/13/2023, I felt terrible, as I had a fever and nasal congestion. I took another home antigen test and got a positive result. I called the doctor's office, and the nurse I spoke to just told me that I was experiencing the rebound effect of Paxlovid.  I stayed in bed for three or four days and treated my symptoms with ibuprofen. I had a fever that lasted for two or three days, and I was very fatigued. I tested every other day and finally got a negative result on 2/19/2023. At that point, I was still fatigued, but I felt better, since I had less congestion and less coughing. I took another test on 2/20/2023 and got another negative result. After 2/20/2023 or 2/21/2023, I felt fine again. I didn't really feel especially fatigued or congested at that point.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-APR-2016, the patient vaccinated with an improperly stored dose of ROTATEQ, lot # L027076, expiration date 25-MAY-2017 (dose was not reported) and PEDVAXHIB lot # L035880, expiration date 11-AUG-2018 (dose and route of administration were not reported). There was no adverse effect reported. No product quality issue was involved. Administered dose of vaccine experienced the temperature excursion of low - 28 degrees Fahrenheit for 5 hours on 22-APR-2016. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
No symptoms reported.; patient who was administered improperly stored VARIVAX.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 19-SEP-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml/dose, lot #W031813, expiration date: 05-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). Administrated varicella virus vaccine live (oka/merck) (VARIVAX) was stored at -14 Celsius degrees (C) up to -10 C for 4 hours and 15 minutes, -8.33 C / -10 C up to 8 C for 7 hours and 45 minutes, total duration: 12 Hours.  No symptoms reported (no adverse event).
Patient had swelling and redness, but also had a fever. This could potentially be due to the Lupus, but patient was advised to be seen at urgent care.
Nurse administered a dose of monovalent vaccine to patient instead of Bivalent Booster
tested positive had mild symptoms; tested positive had mild symptoms; received the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (about 8 weeks ago) (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (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: IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", described as "received the booster"; COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jan2022 (last week), outcome "unknown" and all described as "tested positive had mild symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive. The consumer wanted to know "what level of protection am I going to need next. Another vaccine or booster? "  The lot number for bnt162b2 was not provided and will be requested during follow up.
No adverse event; Expired doses administered/ administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered/ administered with expired vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered/ administered with expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered/ administered with expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired doses administered/ administered with expired vaccine).    No concomitant medications information was reported.  Number of doses/vials- 35 doses, 4 vials Date the vial was initially stored in the refrigerator- 07-Jun-2022 Expiration date: 01-Apr-2022  Date(s) of administration of the vaccine: 01-Apr-2022, 05-Apr-2022, 06-Apr-2022, 08-Apr-2022, 11-Apr-2022, 12-Apr-2022, 14-Apr-2022, 22-Apr-2022, 09-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022.  The vial did not undergo any temperature excursions.  Pharmacy operations manager requested for any guidance to patients who had been administered with expired Moderna vaccine and queried if they should be revaccinated or not.  No treatment medications were provided.
red hot area of about 70mm circular from point of injection started in approx. 3-4 hrs after injection and was painful and hot and red all weekend and today (4 days after) remains somewhat red and continues to be slightly warm to touch but appears to be resolving.
FEVER; MUSCLE ACHES; BLOOD CLOTS IN URINE; BLOODY URINE; This spontaneous report received from a pharmacist concerned a 23 year old male with unspecified ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergy, The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: 11-APR-2022) dose was not reported, 1 total administered on 11-NOV-2021 17:00 to the left arm for prophylactic vaccination. No concomitant medications were reported.  On 11-NOV-2021, between 22.00 to 23.00 the patient experienced blood clots in urine and bloody urine. The patient visited physician for the same. On 12-NOV-2021, the patient experienced fever and muscle aches. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clots in urine, and bloody urine on 12-NOV-2021, and had not recovered from fever, and muscle aches.  This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210414709.; Sender's Comments: V0: 20211130285-COVID-19 VACCINE AD26.COV2.S- blood clots in urine. 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).
After receiving the 2nd dose I experienced mild symptoms compared to the first dose of the Moderna vaccine. I experienced a fever of 101 and had slight chills throughout my body. Also I have experienced soreness at the sight of vaccination.
Information has been received from a physician concerning an under 2 year old male who on 10-AUG-2007 was vaccinated with a dose of hepatitis A virus vaccine inactivated. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 10-AUG-2007, the patient developed hives which lasted for a week. Medical attention was sought and the patient was put on steroid. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Patient reported swelling, red tenderness that moved down her arm for about 4 days following the administration of the shot.
Flu symptoms 14 hours after injection. Respiratory failure within 22 hours after injection leading to dealth
Patient complained that 3 hours post vaccination began to have  sweats and feeling like he was running a fever.  He checked his temp on 3 different occasions during a 3 hour period and it did go up to 99.2 from 97.6.  The patient denies any other symtoms. He received his vaccine around 4pm 12-22.  He reported his concerns at 9am on 12-23.  There was soreness at the injection site.  No redness.  And he felt fine today. And indicated by the time he went to bed last night was feeling fine again.   Advised patient to contact me if any further concerns on work cell #.
After 15 min I got the shot I didn?t feel anything but after two hours or so my arm started to hurt. Next day still hurts and I can?t move it as usual but I haven?t took any pills. I?m drinking green tea as usual in the morning and I?m still feeling good and not having any other symptom.
Patient experienced vasovagal response and momentary loss of consciousness. recovered within 15 minutes with ice pack, elevation of legs and rest