chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Vaccine administered beyond use date 07Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date 07Jul2022) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date 07Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date 07Jul2022) 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 (Vaccine administered beyond use date 07Jul2022).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Vaccine received on 07-Jun-2022.
I had blood clots in my left leg; Ultimately resulted in a below the knee left leg amputation; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (I had blood clots in my left leg) and LEG AMPUTATION (Ultimately resulted in a below the knee left leg amputation) 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 THROMBOSIS (I had blood clots in my left leg) (seriousness criteria disability and medically significant) and LEG AMPUTATION (Ultimately resulted in a below the knee left leg amputation) (seriousness criterion disability). At the time of the report, THROMBOSIS (I had blood clots in my left leg) and LEG AMPUTATION (Ultimately resulted in a below the knee left leg amputation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Within two hours of the vaccine my arm became very sore. After just over 2 hours I had decreased mobility,  about 45 degree rotation. At about 12 hour I was unable to life my arm more than 10 degrees despite tylenol,  muscle relaxant, heat and ice
patient came in expecting to get the updated booster dose (bivalent) and they ended up receiving the monovalent
Patient felt dizzy and sat on floor.  May have lost consciousness.  Pulse oximeter on finger showed 90%+ oxygen and pulse of 69-72.  Called ambulance and patient was transported to hospital.  Phone call to patient on 8/19/21 - "stressed from chiropractic appointment migraine and fear of needles/shot" reported by patient. He was feeling well.
Felt light headed  by the time I got home. About an hour or so later my arm started feeling sore with itching and aching. Took a hot shower, tylenol and relaxed for a while.
Pt states that his eyes begin itching and a few hours later his body was itching. He did not notice any rash or hives. He took a Claritin at 6pm and then Benadryl at 10pm. The next morning (12/15/15) he stated it took 50mg of Benadryl at 11am, 2pm and 6pm and took a Claritin sometime that morning. He felt like he was getting better. On 12/16/15 he did not take any medication. He did state his eyes were dry and he had to throw a contact away.
4 inch area at injection site hard, red, hot. Extreme fatigue. Slight fever. Muscle and bone ache. Rash and itch on abdomen. Itch at injection site.  Symptoms slowly decreasing over time, but not yet gone.
Pt got PNEUMOVAX due to new dx of rheumatoid arthritis. 1 day after vaccine got temp 101, redness at site resolved  - for several days had severe (L) wrist pain resolved with ALEVE.
2 days post vax inj site w/surrounding 5cm of site became red, hot & very swollen given antibiotics-local inflammation rxn went away-10 days p/inj site broke out in small itchy papules, high temp systemic rash;
Pt was seen 2-16-16 for strep throat, returned 2-19-16 because she was feeling it worse. HPV was given 2-16-16, with no fever.
temperature excursion was caused by the door to the refrigerator being left open with no adverse event; Three patients were administered DAPTACEL after not being suitable to use post temperature excursion with no adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 3 patients of unknown gender who had received Diphtheria-15/Tetanus/5 AC Pertussis vaccine [Daptacel] after not being suitable to use post temperature excursion which was caused by the door to the refrigerator being left open.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patients received an unknown dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis vaccine Suspension for injection (lot: C5893AA, expiry date: 21-JUN-2023) with unknown strength, frequency, route, anatomical location for Immunization and three patients were administered daptacel after not being suitable to use post temperature excursion (poor quality product administered) and temperature excursion was caused by the door to the refrigerator being left open (product storage error)  Action taken: not applicable.  Outcome: Unknown.  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.
pt recvd vax 29MAR95; 31MAR noted fatigue, h/a, joint aches; 30MAY rash on chest, back, neck, face, legs; all sx resolving by 4APR95;
Started with mild joint pain 3/20, on 3/22 began with red spots all over body, on 3/24 reported joint pain, swelling of neck, red bumps over entire body. Took Motrin 800 q 8 hours, Benadryl at night and Claritin during the day.
Flu vaccine administered at pharmacy high on left arm  -  patient had intense pain for a few days then became chronic with moderate to severe pain worsened with motion, better with rest, aching, burning. Seen by dr in orthopedics: likely inflammation from injection into joint capsule. MRI done, MEDROL DOSEPAK prescribed; patient continues to have discomfort in her shoulder 1/25/17.
Rash, fever, suboccipital, post auricular and cervical lymphadenopathy, joint pain, lethargy, headache.  Antibiotics, pain medications, bed rest for 1 week. About six weeks for full recovery.
Substernal chest tightness that worsened with exertion and gradually improved over the week prior to presenting. On evaluation, Troponins were marginally elevated (0.06; laboratory threshold-0.012) but ECG, CXR and CBC were unremarkable. Repeat Troponin the same day trended down.  The patient was discharged home from the urgent care center. The patient was started on Colchicine 0.65mg one tab by mouth twice a day for 90 days and Motrin taper (800mg by mouth three times a day for one week, two times a day for the next week and once a day for the final week). Echocardiogram is pending.
Approximately 39 hours after receiving the shot, I experienced severe diarrhea.  It continued for four hours.  Upon waking in the morning the symptoms had ceased and I felt well.  While I have Ulcerative Colitis, I do not believe this event was related to it.  It was not food related.  Also, as I have had a C.diff problem in the past and am taking Vancomycin daily, it did not appear to be related to that.
Presyncope, temporary dizziness and vertiginous sensation lasting 5 seconds.
This spontaneous report was received from an office manager and refers to a 4 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 14-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
on and off dizziness, brainfog and  nausea, continuous weakness and fatigue, sometimes incapacitating, varying in duration and severity, continuing to present, 3/29/21
3/10/21 -3/11/21 sore arm 4/7/21-4/9/21 sore arm, fatigue, fever, 7/27/21 Positive Covid Rapid Test, Positive Covid PCR test
After 2nd dose of Pfizer vaccine. On arrival, VSS HR 80s BP 119/82 O2 sat 99% on room air denies difficulty breathing or chest pain. Per patient 1st dose of vaccine had some numbness of lips this time left side of lips numb and spread to tongue, "tongue feels swollen." On assessment no facial droop present. Patient also c/o feeling more drowsy and slower to talk. Transported to ED via wheelchair for monitoring. Care assumed by ED RN.
Information was received 31-MAY-2017 from a medical assistant (see original case 1705USA005086) and refers to a 32 year old female patient. On 13-APR-2017, she was vaccinated with VARIVAX lot # M041513, expiration date 11-OCT-2018, which had undergone a temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected because follow-up information was received.; Sender's Comments: US-009507513-1705USA005093: US-009507513-1705USA005094: US-009507513-1705USA005086: US-009507513-1706USA008915: US-009507513-1706USA008916: US-009507513-1706USA008917: US-009507513-1706USA008918: US-009507513-1706USA008919: US-009507513-1706USA008920: US-009507513-1706USA008921:
This spontaneous report as received from a pharmacist refers to a 18 years old female patient. The patient was vaccinated with dose 1, .5 ml GARDASIL on 16-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 19-NOV-2012 the patient experienced fever of 102F, 4 days after onset of therapy and severe headache. No treatment information was reported. The outcome of fever of 102F and severe headache was reported as not recovered/not resolved. The relatedness for fever of 102F and severe headache is unknown for GARDASIL. Additional information has been requested.
Localized edema and erythema 5/26 rash onset approx. 6/15. Pt states around 13 vesicles all of which are dried at present. Denies any drainage at time of vesicles, positive lethargy during outbreak.
64-year-old female who reports she received zoster vaccine 7 days ago (lot number L006382) and developed a dermatitis to her injection site periphery, elbow, neck, back, and waistband area. The patient reported pruritis, and the dermatitis was characterized by popular lesions, no erythema, pustules or vesicles. She states she also had a large induration at her elbow. She states they first appeared on Monday, 16 November 2015, which was 3 days after vaccine receipt (13 Nov). The lesions did improved overall as of 20 Nov 2015. Also the patient noted the induration decreased in size and there was a decrease in severity of discomfort. The patient took TYLENOL per her usual medication routine. She denied immediate reaction, urticarial, oral facial tongue or throat swelling, shortness of breath, wheezing, conjunctivitis, rhinorrhea. She denied systemic reaction for fever chills, malaise, cough or arthralgias or myalgias. She sated she had headaches intermittently and general aches and pains consistent with her baseline arthritis.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no concurrent condition or medical history reported. On 16-MAR-2016 the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # L006383, expiration date 23-FEB-2017)(dosage, strength and route unknown) (temperature 25.3 degree F, time frame: 3 hours and 30 minutes). No adverse effect was reported. Additional information has been requested.
Pt began screaming immediately p/inject & continued for 4 hrs; high pitched scream inconsolable; Mom felt pt almost having trouble breathing was crying so hard; Refused bottle; t101; no soreness;
Red rashes if scratch lightly; scratching causes white bumps. First began tops and bottoms of feet; chest and back. Itching more out of the ordinary. Tried Eucerin lotion; skin repair body lotion - body lotion.  Not seen yet, but will make an appt. May try otc anti-histamines
Employee received .2 cc of Pfizer instead of .3 cc inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   Our Vaccine Task Force, after speaking with CDC and DOH, decided to offer the employee an additional COVID-19 vaccine dose. Thanks.
Headache, Myalgia, fatigue, sore throat, cough, nasal congestion Narrative:
Expired Havrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 36-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16-DEC-2022) for prophylaxis.   Concurrent medical conditions included hypothyroidism, autism and depression.   On 06-APR-2023, the patient received Havrix. On 06-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). 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 Information: GSK receipt date: 06-APR-2023 The nurse reported that an expired dose of Havrix was administered to a patient. The reporter consented to follow up via email. The patient was administered an expired dose of Havrix, which led to expired vaccine used.
She got her vaccine, drove home and had pain at the site, redness for a couple of days, and a fever.  She had difficulty raising her arm, stiffness, but was ok, some tiredness.  She drank a lot of water, rested and then a couple of days later she had noise in her head like crickets, but her daughter didn't have any crickets in her house and they didn't hear it.  She noticed it more when she's in a room and it's quiet at night and early in the morning, and it still continues still as of 7/7/21.  She doesn't hear them when she's active and busy but she can hear it now as she's talking to me on the phone.  It has not gotten any better or worse, but did not have this problem before having the vaccine.   She has not seen anybody for the ringing in her ears, but is presently in another area and when she goes back she is going to see her doctor regarding the ringing.   She has had no problems with imbalance, no mobility problems, and has had no change in her medications, has been on the same medications for many years.
I have developed sometimes severe pains in my legs after shot #2; This is a spontaneous report from a contactable consumer (patient) or other non hcp via Medical Information Team.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included COVID-19 (I'm a post-Covid 19 patient). The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date the patient developed sometimes severe pains in his legs after shot 2. The event outcome was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received second dose as Moderna, should have been Pfizer. Patient notified. No adverse reaction noted.
Headache, Fever, HA, FEVER, CHILLS, DIARRHEA, FATIGUE, MUSCLE PAIN, JOINT PAIN RESOLVED IN 48 HOURS  Narrative:
Patient ID: Patient 93 y.o.    Admit Date:  7/21/2022   Discharge Date:   7/28/2022   Discharge Diagnosis:  Principal Problem:   Acute metabolic encephalopathy Active Problems:   Dementia   Sepsis   Pneumonia due to COVID-19 virus   H/O: CVA (cerebrovascular accident)   Acute UTI Elevated troponin   Hospital Course:  93 year old female with advanced dementia from NH was admitted for worsening encephalopathy. She tested (+) for Covid-19 infection on admission. She was given Remdesivir and steroids for 5 days. Cardiology saw her for elevated troponins and was determined to be from sepsis and hypoxia. TTE was done and showed LVEF 55-60%. She had sepsis symptoms from UTI and treated initially with IV antibiotics. Urine culture grew E coli with resistance to Quinolones. Blood cultures were (-). She has been on Augmentin since 7/25. She has been tolerating PEG feeding. She was initially hypoxic but has been on RA for the past few days. She will be transferred back to the NH today in stable condition. Follow up with Primary Care Doctor in 5-7 days. Total discharge time >30 minutes.   Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 97.6 °F (36.4 °C) Heart Rate (Monitor): 78 Pulse: 73 BP: 123/56 Respirations: 18 SpO2: 92 % O2 Flow Rate (l/min): 0 l/min General Appearance: no distress  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: no edema Neuro: awake but confused   Consults:  IP CONSULT TO SEPSIS NURSE NAVIGATOR IP CONSULT TO SEPSIS NURSE NAVIGATOR IP CONSULT TO CARDIOLOGY IP CONSULT TO SOCIAL WORK IP CONSULT TO INFECTIOUS DISEASES IP CONSULT TO DIETARY   Significant Diagnostic Studies:   TTE, CT head   Operations: none   Disposition:  SNF   Discharge Condition:  Fair
large red itchy hot circle at the injection site; large red itchy hot circle at the injection site; large red itchy hot circle at the injection site; This case was reported by and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 4th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site itching and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient received 2nd injection of Shingrix on Friday morning, 2.5 days before the date of reporting. The patient was experiencing a large red itchy hot circle at the injection site. The patient asked if it was normal.
Fever of 101.5 F for 2.5 days so far. Chills, vomiting, aches and pains.  Dizziness when standing.
Patient received PNEUMOVAX 23 on 8/16/17. He returned 8/17/17 to pharmacy complaining of redness, soreness, and inflammation on deltoid muscle. I referred him to the local urgent care clinic which confirmed he had a reaction to the PNEUMOVAX vaccination.
1st five days i was fine then wed morning felt like i was hot by a truck. I have dizziness, cant walk straight,  headache, muscles pain and joint pains
Bells Palsy. Seen in urgent care and sent to ER on Oct 4, 2023. Given steroid and antiviral for 7 days. Symptoms still persisting. Symptoms started on Sept 28, 2023 with ear pain, then headaches, and on the 4th woke up with eye issues and right side of her face not working. Speech impaired and eye not closing/blinking.
Per pt. she waited her 15 minutes at clinic, after vaccine given, and she left the vaccine facility and started to feel diaphoretic, itchy, and noticed hives on her chest and arms. Observation nurse noted no airway compromise . HVA personnel took pt.'s vital. BP 144/90 (hx of HTN per pt.), HR 114, RR 20, and O2 97%. Observation nurse notified charge RN. Emergency management protocol followed, and observation gave patient 50mg of Benadryl, IM. PAtient drove self to appointment today, but son in law is coming to pick up patient. HVA personnel assessed VItal signs again, Vital Signs within normal limits. Patient stated symptoms have improved and observation nurse observed patient has returned to baseline. Observation nurse walked patient down to lobby and patient left clinic with son-in-law.