chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shaking; chills; extreme fatigue; Fever; loss appetite; Discomfort at ulceration; Had excruciating pain; resetless; patient reports developing a lipschutz ulcer/ Developed a lipschutz ulcer, (internal vulvar ulcer) one large one and one small one/ Dark red ulcer at beginning, like a scab/ Ulcer worsened, larger and deeper; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (loss appetite), DISCOMFORT (Discomfort at ulceration), PAIN (Had excruciating pain), RESTLESSNESS (resetless) and VULVAL ULCERATION (patient reports developing a lipschutz ulcer/ Developed a lipschutz ulcer, (internal vulvar ulcer) one large one and one small one/ Dark red ulcer at beginning, like a scab/ Ulcer worsened, larger and deeper) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and METOPROLOL for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (loss appetite), DISCOMFORT (Discomfort at ulceration), PAIN (Had excruciating pain), RESTLESSNESS (resetless), VULVAL ULCERATION (patient reports developing a lipschutz ulcer/ Developed a lipschutz ulcer, (internal vulvar ulcer) one large one and one small one/ Dark red ulcer at beginning, like a scab/ Ulcer worsened, larger and deeper), TREMOR (Shaking), CHILLS (chills), FATIGUE (extreme fatigue) and PYREXIA (Fever). The patient was treated with LIDOCAINE for Adverse event, at an unspecified dose and frequency and TRIAMCINOLONE for Adverse event, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (loss appetite), DISCOMFORT (Discomfort at ulceration), PAIN (Had excruciating pain), RESTLESSNESS (resetless), VULVAL ULCERATION (patient reports developing a lipschutz ulcer/ Developed a lipschutz ulcer, (internal vulvar ulcer) one large one and one small one/ Dark red ulcer at beginning, like a scab/ Ulcer worsened, larger and deeper), TREMOR (Shaking), CHILLS (chills), FATIGUE (extreme fatigue) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Sexually transmitted disease test: negative (Negative) STD tests negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also included iron supplement.
PT HAD ARM PAIN THROUGHOUT THE ENTIRE ARM 3 HOURS POST VACCINE.  AT AROUND 5 HOURS POST VACCINE PT STATES SHE ALMOST FAINTED AND WAS NAUSEOUS.  HER ARM WAS SLIGHTLY SWOLLEN AND RED.
Raised red patch on arm, hot to touch and itchy. 2 days after injection--sore arm and small bruise, red patch was present but not hot to touch or itchy
Sleepy; COVID-19 BOOSTER DOSE KNOCKED DOWN; FELT LIKE HAD HANGOVER; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), DEPRESSED MOOD (COVID-19 BOOSTER DOSE KNOCKED DOWN) and HANGOVER (FELT LIKE HAD HANGOVER) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for Plaque psoriasis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) (Subcutaneous) at an unspecified dose and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepy), DEPRESSED MOOD (COVID-19 BOOSTER DOSE KNOCKED DOWN) and HANGOVER (FELT LIKE HAD HANGOVER). At the time of the report, SOMNOLENCE (Sleepy) had resolved, DEPRESSED MOOD (COVID-19 BOOSTER DOSE KNOCKED DOWN) was resolving and HANGOVER (FELT LIKE HAD HANGOVER) outcome was unknown.            No concomitant medications were reported. Patient stated after he took second COVID vaccine he was sleepy the next day, but when he did the booster dose, it knocked him down and he felt like he had a hangover all of the next day. After the third shot of the Skyrizi, he cleared up significantly and since it has been a year, it was almost like he did not had psoriasis anymore. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Swelling in the face, particularly on the right side cheek close to the nose Painful to touch 10 day course of antibiotics Swelling disappeared after 6 days on the antibiotics
received Engerix after a cold temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 1-day-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric (intramuscular) and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 20-JAN-2023 Reporter's Comment: The reporter was calling to report that patient received Engerix B after a temperature excursion of too cold.  The reporter consented to follow up. Additional Supportive Information: The reporter was calling to report that patient received Engerix B after a temperature excursion of too cold, which led to incorrect storage of drug. This was 1 of 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023008733:same reporter - female case US-GSK-US2023AMR009450:same reporter - female case US-GSK-US2023008735:same reporter - male patient US-GSK-US2023AMR009387:same reporter - male patient
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 02/05/2021, 02/26/2021, and 10/18/2021. The lot numbers and injection sites were not reported to the state immunization system for the first 2 doses. The individual also received a FLUAD Quad dose on 10/18/2021. The lot number was not reported for this dose.   The individual tested positive for COVID-19 on 08/08/2022, when they presented to emergency department via EMS for evaluation regarding shortness of breath, hypoxia, and frequent falls.  They were found to be dehydrated and have a urinary tract infection. However, the individual had an advanced directive in place that refused IV fluids or nutrition, so they were given antibiotics and discharged back to the assisted living facility at which they were a resident. They were re-admitted to hospital on 08/23/2022 after they stopped eating and drinking. They were admitted to hospital at request of wife and primary care provider, in order to obtain comfort/hospice/end of life care. They were diagnosed with respiratory failure and remained hospitalized until their death on 08/25/2022.
Irregular, painful, and heavy menstrual cycle. No treatment as of yet. Ultrasound indicated thickened uterine lining, uterine fibroid and uterine polyp.
2 days after the vaccine developed sore throat, lump in throat, hoarseness, voice diminished and rash on back. These reactions are still happening currently.
5-6 raised quarter-sized areas on back of neck only.  Areas were itchy.  1st noted Sat 11th. No other symtoms noted.  Only tx was topical benadry.  Areas were gone Sun 12th.
Information has been received from a company representative concerning her 4 year old son who was vaccinated with only one dose of VARIVAX (Merck) (lot#, route and site of administration not reported). On 07-JUL-2009 the patient had an outbreak of chickenpox with 4 lesions. At the time of reporting the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Severe cold and sinus infection.  Sore throat, congestion, coughing, headache, tiredness.
Had migraine for the 1st 3 days following the vaccine. Over the next couple of weeks became "mentally foggy and fatigued".  Patient attributed that to the recent stress of 2 deaths of close family/friend. When he came to me for a first aid/vital sign check at the occupational clinic, I observed that both of his hands were trembling and did not appear to feel well. I asked that he leave and follow up with his PCP and obtain a full medical release to return to work. He has returned back to work this week and informed me of the events /reaction that he attributes to the vaccine. Although his neurologist and PCP has not clinically diagnosed him with Guillen Barre, I highly suspect that this is what he experienced. He reports resolved left sided paralysis. He reports a tough recovery and is back to work but stills has some tingling sensations and mental fogginess.
On 03/24/2008, baby for 2nd set immunization. Mom said baby recieved Rotateq vaccination on 01/18/2008 and became ill with severe diarrhea and projectile vomiting on 01/19/2008.  Baby also had fever 101 - 102. Seen in physician office on 01/22/2008 with continued diarrhea and was able to keep Pedialyte down, no fever at that time. No lab work drawn.  Mom said physician verbally told her baby probaby got rotavirus from vaccine but progress notes document acute gastroentritis. Baby returned to physician office on 01/28/2008 and was diag with UTI.
Reason for Admission: 31 YO female with history of Rett's syndrome, seizure disorder, GERD, vitamin d deficiency, neurogenic bladder, chronic constipation, who was brought in due to symptoms of labored breathing with cough and fever since yesterday.   Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) treated for bacterial left-sided pneumonia, what appears to be an incidental COVID 19 infection   weaned of oxygen, is being discharged on room     COVID-19 virus infection with hypoxia   - confirmed by rapid test   - symptomatic with cough, fever, hypoxia   - no known sick contacts   - prednisone po initiated in ED   -  antibiotics initiated in ED given result of CT chest suggestive of consolidation in left lung   - symptoms likely Covid-19 related, no leukocytosis  Given CT findings of complete whiteout of the left lung, this could be consolidation or aspiration causing collapse, would treat with IV Rocephin and IV doxycycline for now   - PCT is normal at 0.05, streptococcal and Legionella you urine antigens are also negative   - met parameters for Covid-19 treatment ( hypoxia requiring supplemental O2) > change prednisone to decadron po, remdesevir    - breathing treatments with albuterol nebulizer    - droplet precautions    - cough relief    - O2 per protocol 4/8 suggestion of pleural fluid, was reviewed with interventional radiologist Dr., not sufficient to need thoracentesis 4/9 chest x-ray does mention of moderate pleural effusion, will attempt to do thoracentesis tomorrow   4/10 3rd day of the discharge repeat chest x-ray shows significant improvement and bruit small amount of pleural effusion Active Problems:   With consideration of aspiration high on the list, speech therapy consult was made the modified the diet further patient to have follow-up VFSS as outpatient after being followed by about patient's speech therapy   Rett's syndrome   - neurology following out pt    - wheelchair-bound   - up to chair or wheelchair with 2 assists        Seizure disorder (HCC)   - stable, no recent seizure episode   - on phenobarb, continue   - last phenobarb level therapeutic on 3/23/23   - seizure precautions     Chronic constipation   - increased fibers and fluids   - prn laxative     Asthma   - stable, continue with albuterol neb tx while inpateint     GERD (gastroesophageal reflux disease)   - stable, on PPI, continue   Issues Requiring Follow Up: (Who, what, when, and how communicated?)   diet initiation of NDD Level 1 (purees) with nectar-thick liquids via single sips Follow-up with speech pathologist
OBSTRUCTIVE SLEEP APNEA HYPOTENSION 2/18/2023  &  2/16/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Strange cough, throat seemed to be closing, nausea, extreme fatigue.  Patient went to urgent care at 9:00 PM and was deemed not be in danger, but took Benadryl per urgent care's recommendation.  Nausea and throat constriction remitted soon, but extreme fatigue has persisted as of now, 11 AM.
Local swelling about 2 inches in diameter mildly tender. No redness, no fever or streaking.
Vaccine stored improperly and administered; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine stored improperly and administered) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021 at 2:35 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine stored improperly and administered). On 13-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine stored improperly and administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. Concomitant medications were not provided by the reporter.  Treatment information was not provided.
Information was received on 02-MAR-2018 from a 39 year old male patient referring to himself. He had no pertinent medical history, no allergies, and was taking no concomitant medications. In September 2017, the patient was vaccinated with ZOSTAVAX for "shingles" (lot # not provided).  He stated "1 shot administered in my arm". The patient reported that ZOSTAVAX "really messed me up and did no good." He also mentioned that ZOSTAVAX made his health situation "real bad." He reported that the adverse events occurred on 05-DEC-2017. He felt depressed and was currently experiencing a shingles breakout. The patient visited the Emergency Room (ER) three times (unable to confirm whether he was admitted). While at the ER, the patient was prescribed an unknown medication to treat the shingles outbreak. The patient felt the events were related to ZOSTAVAX. The events were not resolved at the time of the report. The patient stated he wants "settlement" for the adverse reactions he experienced and was planning to launch a lawsuit against Merck because of ZOSTAVAX. The patient did not provide consent to follow up.
Pt recvd DT/OPV/MMR on 2JUN92 in afternoon & woke up in AM 3JUN92 w/vomiting, stared off into space w/occ twitchs w/fever;
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for two patients. This is the second of two reports. A 21-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration at single dose in the left arm on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced big red bumpy spot at injection site, pain and trouble lifting arm on an unspecified date with outcome of recovered. Follow-up (15Aug2016): This is a follow-up spontaneous report from a contactable Nurse. This nurse reported for the same patient that: Suspect products: TRUMENBA. Adverse events: Skin reaction which was red hot. Patient details. Is the patient also the reporter? No. What happened: Skin reaction which was red hot. Products: Suspect products: TRUMENBA. Is this a Pfizer product? Yes. In your medical opinion, is there a reasonable possibility this event is related to this suspect product? Skin reaction which was red hot: Yes (Related). Additional Context: This is the 2nd case among two cross linked cases. The nurse mentioned that their sales rep had reported the event and she was reporting it again. The nurse mentioned that two of their employees received the first vaccine and had quite a skin reaction and it lasted for several days. She added it was red hot. The nurse mentioned that the patients had come for their second shot, so she wanted to know was that a bad enough reaction not to give it. The nurse further stated that the sales rep did report it but when she came the other day she said she did not what to do about it. The nurse stated that she was not gong to stay on for that long for probing, because this event was already reported to Pfizer by their sales rep (Name). She did not have the reference number of the previous call. The nurse stated that all the information was taken from the two girls by their sales rep, including their names when it was reported earlier and they had spent quite a bit of time in finding out what happened but nobody know whether to give them the second shot or forget it. Causality: The nurse said that in her medical opinion the skin reaction was definitely because of TRUMENBA. The nurse was informed that regarding this concern her call could be transferred to Pfizer Medical Information to which she agreed. QR Comment: The medical inquiry is captured in the parent case.
Vaccine was stored in the fridge since 11Oct2022 and administered on 15Nov2022; No adverse event; We had a vaccine that was given past the due date/received expired 2nd primary dose (Monovalent) 4 days beyond the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had a vaccine that was given past the due date/received expired 2nd primary dose (Monovalent) 4 days beyond the 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was stored in the fridge since 11Oct2022 and administered on 15Nov2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 063B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had a vaccine that was given past the due date/received expired 2nd primary dose (Monovalent) 4 days beyond the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the fridge since 11Oct2022 and administered on 15Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had a vaccine that was given past the due date/received expired 2nd primary dose (Monovalent) 4 days beyond the 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was stored in the fridge since 11Oct2022 and administered on 15Nov2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (We had a vaccine that was given past the due date/received expired 2nd primary dose (Monovalent) 4 days beyond the 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine was stored in the fridge since 11Oct2022 and administered on 15Nov2022).    No concomitant medications were reported.  The cartons were unbroken. The vial size was 5.5 ml. The vial did not undergo any temperature excursions.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Nov-2022: Live-significant Follow-up appended: Suspect vaccine, event, narrative and primary reporter details were updated
A non-serious spontaneous report of two patients were given expired FLUMIST was received from a health professional concerning a five-year-old female. Neither past medical history nor concomitant medications were reported for this patient. The product expired on 29-Dec-2010. On 05-Jan-2011, the patient received the expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
March 2nd a few hours after receiving the shot I had a headache that lasted two days. I became and still are very tired and become nauseous off and on during the day since I received the shot. I also had a severe vertigo attack which lasted over an hour a week after my 1st shot.  I am currently under the care of my ENT for further evaluation.
Fever, red circle around site of injection, hot, sore. Patient came on 9/8/2018 at 12pm to show me signs. Fever and chills are gone. They lasted for 1 day.
Following 1st vax experienced pain @ inject site; Following 2nd dose vax experienced prolonged pain & tenderness @ inject site;