chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 17-NOV-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L024264, expiration date: 01-JUL-201). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
pt recv vax & devel sz;pt upper extremities tremor lasting 1sec in duration;advised to go to ER;pt has cold & runny nose;t102-103;irritable 23DEC;
Around 50 booster doses were administered past the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Around 50 booster doses were administered past the expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Around 50 booster doses were administered past the expiration date). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Around 50 booster doses were administered past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 21-OCT-2021 vial was initially stored in the refrigerator. Vial  did not undergone any temperature excursions. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 55-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). Concurrent medical conditions included unknown autoimmune problems and diabetes. Concomitant products included celecoxib, omeprazole, Propranolol, Ropinirole, fluoxetine and TYLENOL. On 30th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 30th March 2018, less than a day after receiving SHINGRIX, the patient experienced fever, stomach pain and pain in arm. On an unknown date, the outcome of the fever and stomach pain were recovered/resolved and the outcome of the pain in arm was recovering/resolving. It was unknown if the reporter considered the fever, stomach pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: On 30th March 2018, the patient body temperature went high till 103.8 degree F.
Facial dermatitis spreading down to the neck. It occurs about 1 month after getting 2nd dose of Pfizer Covid-19 vaccine.  Skin rash, redness and intense itching. Treatments tried and failed: Benadryl capsules and Cream,  Zyrtec tablets,  Lidocaine Cream, Hydrocortisone 1 %  Cr. and 2.5% Oint, Prednisone 20mg 2 tab daily x 5 days, and Metronidazole 1 % cream. Current Rx: Desonide 0.05% Oint. and Pimecrolimus 1% Cream.
Information regarding Prevnar was received from a healthcare professional regarding a 5-month-old male patient who experienced two sterile abscesses at the injection sites. The patient received a dose in 2007. Healthy infant. Concomitant medications were not reported. On 06-May-2007, the patient developed two sterile abscesses on each anterior thigh after receiving "vaccines". Reporters stated that there were surgical intervention but did not know the extent. An allergies saw the patient on 07-May and noted that the "injection sites" are healing. No additional information was available at the time of this report.
This spontaneous report was received from a pharmacist referring to a currently 87 year old male patient with unspecified breathing issues. The patient's concomitant therapies included an unspecified Parkinson medications. No information was provided regarding the patient's medical history. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 lot number N019348 and expiration date of 08-FEB-2019 for prophylaxis (dose and route of administration were not reported). On an unknown date, the patient had a white blood cell count drawn for an unspecified reason after receiving PNEUMOVAX 23 and the result of the laboratory showed an increased white blood count (unspecified amount). There were also performed stool test and blood test and no results were provided. The outcome of white blood cell count increased was reported as resolved. Additionally, the reporter did not provide causality assessment between the event and therapy with PNEUMOVAX 23.
Rash under her right breast; A spontaneous report was received from a consumer concerning her mother, a 94-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  rash under her right breast/rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received their dose of two planned doses of mRNA-1273 (lot/batch: 011M20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced rash under her right breast which was about 4 by 21/2 inches in diameter. The rash was not itchy nor hurting.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event rash under her right breast was unknown.
First dose: some arm soreness and little pain during this time Second dose: did not start off that bad, felt pain when moving arm around (lifting arm) around 3-4pm - felt feverish (about 12 hours after dose), couldn't sleep, felt chills and that lasted until next day - few hours after injection until the next day, felt generalized exhaustion, muscle aches and fatigue - few hours after injection felt nauseous and it went away after waking up from night sleep the next day - took ibuprofen 800mg around the time of injection and then took another ibuprofen 800mg in the evening
This case is a cluster of 2 patients who experienced adverse events following administration of ADACEL; lot number C4023AA. The events for the other patient was captured in case number 2012-00780. Initial report was received from a healthcare professional on 20 January 2012. A female patient (age not reported) had received an injection of ADACEL; sanofi pasteur Ltd. lot number C4023AA. On an unspecified date following vaccination, the patient developed redness, swelling and pain in arm. It is unknown if the patient received any corrective treatment. No further information was available at the time of this report. The patient outcome was not reported.
Sore throat, cold, lethargic, pain in arm. Felt sick. Felt like she had fever.
Patient reports she had fatigue, cough, loss of appetite, and fever lasting 3 weeks after receiving the vaccine.
Patient presented to the ED and was subsequently hospitalized for Acute on chronic diastolic heart failure  within 6 weeks of receiving covid vaccination.
8/12/16 Given #2 VARICELLA. Immediately C/O ears hurting, eyes red and puffy, developed hives on trunk and extremities.
After vaccination, about 10 min patient complained about her heart pumping very fast and severe headache, after 15-20 min the heart rate felt better however she was very dizzy, called 911 ambulance took the patient to hospital
Patient underwent wide resection of a suspected leiomyosarcoma in the deep muscles in the posterior aspect of the left hip on 12/17/2021 and was then admitted to (Medical Center) for post-op care. Hospital admission within 6 weeks of receiving the COVID vaccine.
Wheezing; Swelling of her face; Swelling of her hands and feet; Swelling of her hands and feet; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Wheezing), SWELLING FACE (Swelling of her face), the first episode of PERIPHERAL SWELLING (Swelling of her hands and feet) and the second episode of PERIPHERAL SWELLING (Swelling of her hands and feet) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced WHEEZING (Wheezing) (seriousness criterion life threatening), SWELLING FACE (Swelling of her face) (seriousness criterion life threatening), the first episode of PERIPHERAL SWELLING (Swelling of her hands and feet) (seriousness criterion life threatening) and the second episode of PERIPHERAL SWELLING (Swelling of her hands and feet) (seriousness criterion life threatening). At the time of the report, WHEEZING (Wheezing), SWELLING FACE (Swelling of her face) and the last episode of PERIPHERAL SWELLING (Swelling of her hands and feet) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.  The patient took 2 doses of diphenhydramine hydrochloride, cetirizine, and famotidine. On 28-Apr-2021, the patient was feeling better.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
"Cold sore" shingles outbreak in the lip, relatively large several hours after receiving vaccine second dose; "Cold sore" shingles outbreak in the lip, relatively large several hours after receiving vaccine second dose; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0170, Expiration date: unknown), via unspecified route, administered in left arm on 23Apr2021 09:00 AM (at the age of 48-year-old) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Patient previously received the first dose of BNT162B2 on 31Mar2021at 09:00 am (batch/Lot no: ER8734) at left arm for covid 19 immunization. The patient medical history and concomitant medications were not reported. On 23Apr2021 at 18:00, after the vaccination, the patient experienced Cold sore- shingles outbreak in the lip, relatively large several hours after receiving vaccine second dose. Prior and since vaccination patient has not been tested or diagnosed for covid-19. No other vaccines received within 4 weeks to covid vaccine. No treatment received. The outcome of the events was recovering.  No follow-up attempts possible. No further information expected.
This spontaneous report as received from an administrator and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies, concomitant medications or concurrent conditions were reported. On 20-JUN-2018, the patient was vaccinated with a dose of improperly stored subcutaneously VARIVAX (which had a lot # of N027619 and an expiration date of 04-OCT-2019); however, dosage number were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccines experienced the following temperature excursions: -14 degrees C to -10 degrees C for an unknown time and -9 degrees C to 8 degrees C for 1 hour, on unspecified dates. Reportedly, there had been multiple other unknown previous temperature excursions, and the aforementioned ones were identified due to a data logger.
Patient Recieved HPV vaccine in LA. Walked out of the clinic and building, tripped and fainted. Mom sent younger sister in to get me. We got a wheel chair and brought her back into the clinic, on the way in she fainted again. Got her on to the bed and took BP 106/57. After 5 min sat her up and retook BP 105/54. Got her to the wheel chair and gave her a drink of water and took her to the ER. Gave report to the ER nurse.
Interchange of vaccine products; Transient global amnesia; COVID-19; COVID-19; This is a report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered" (2022) and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; TRANSIENT GLOBAL AMNESIA (non-serious), outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positiive, notes: Contracted Covid. The action taken for adalimumab was unknown.  Clinical course: It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB)-The reporter's causality for the event(s) of COVID-19 was not provided. Causality: Transient global amnesia (Transient global amnesia)-Causality as per reporter (Drug/Vaccine): Not Related. COVID-19 (COVID-19) Causality as per reporter (Drug/Vaccine): Not Related. Transient global amnesia (Transient global amnesia)-Causality as per reporter (Drug/Vaccine): Possible. COVID-19 (COVID-19) Causality as per reporter (Drug/Vaccine): Possible.  The reporter considered "covid-19", "interchange of vaccine products" and "transient global amnesia" related to BNT162b2.  The reporter's assessment of the causal relationship of "interchange of vaccine products" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Drug ineffective, covid-19, transient global amnesia, interchange of vaccine products.
Pt received moderna vaccine when she was suppose to receive pfizer. Patient educated and medical personnel educated/remedial trained.
LIGHT HEADED, MY RIGHT ARM WAS VERY SORE, FELT WEAK, NO APPETITE.
Adverse Event Onset Time is only approximation - fever started early afternoon on day of vaccine continued until 06/04/2014, lethargic, fussiness, loss of appetite, extreme crying in middle of night, trouble sleeping prolonged periods of time, coughing intermittently, 06/01/2014 onset of facial rash, 06/02/2014 back to PCP in am, ran blood tests chest x-rays to discover cause of fever, tests negative, back to PCP in PM they could not perform cath for UTI test was sent to Hospital, misdiagnosed son with ear infections, tried to overdose son with medication for 48.9kb baby instead of for 23lb baby, kept medication from being administered and hospital tried to correct dosage mistake, never fixed prior to discharge from ER. UTI negative. Told that rash on face was from living in a desert and to put lotion on baby. Within 2 hours of being in ER, from 5:01pm to 7pm rash spread down trunk, arms and legs and became redder. Doctor concerned but did nothing further to investigate cause. Fever shot to 104. Administered motrin and gave prescription for inner ear infections, amoxicillin 800mg/10ml twice daily which was changed to 400mg/5ml twice daily when I notified hospital staff of over dosage. Discharged around midnight 06/02/2014. Back to PCP 06/04/2014 for follow up with PCP due to rash spreading from scalp to eyelids, finger tips and palms to soles of feet, all over body. PCP determined cause to be side effect from vaccine Rubella and separate virus causing cough and fever. PCP read notes from ER doctor stating that patients ears were red but no bulging of eardrums thus baby did not have ear infections, was misdiagnosed and to stop antibiotic treatment. Last fever was at 12:30pm 06/04/2014, rash completely gone 06/09/2014. Baby eating and playing and laughing like normal. Still a little fussy and not back to sleeping all night.
This spontaneous report as received from a healthcare worker refers to a 4 month old female patient. On 23-JUN-2014 the patient was vaccinated with the first dose of ROTATEQ (lot#, expiration date, dose were unknown) oral. On 25-AUG-2014, the patient was vaccinated with the second dose of ROTATEQ (lot#J003813, expiration date: 10-AUG-2014, dose was unknown) oral. No adverse effects were reported. Additional information has been requested.
Baby was inadvertently given 2 doses of Hep B while in ICU, one on 10/5/23 and one on 10/14/23.  Baby did not display any signs of reaction to second vaccine.  Doctor counseled parents on event and had them follow up with pediatrician about when to get next vaccine in series now that baby had received a second too early.
Left arm and hand swollen and red.  Lots of pain and cannot lift arm over waist height.
Patient is an 11 years old and had received Pfizer covid-19 vaccine on 9/28/21. Patient did not experienced any wheezing; chest tightness; rashes; swollen lips, tongue, eyes or face. No hospitalization. Patient did experienced arm soreness and slight fever.
8 Days post vaccine (yesterday); Red, warm, hard, itchy area at the injection site. Approximately 2x2 1/2 inches
Itchy eyes, swollen eyelids, itchy skin and wheezing (asthma)
Light numbness on the right side of my face; Tongue started to become numb/Bottom lip went numb; Throat started to become numb; Lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Tongue started to become numb/Bottom lip went numb), PHARYNGEAL HYPOAESTHESIA (Throat started to become numb), DIZZINESS (Lightheaded) and HYPOAESTHESIA (Light numbness on the right side of my face) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (Tongue started to become numb/Bottom lip went numb), PHARYNGEAL HYPOAESTHESIA (Throat started to become numb) and DIZZINESS (Lightheaded). On 21-Jan-2021, the patient experienced HYPOAESTHESIA (Light numbness on the right side of my face). On 20-Jan-2021, HYPOAESTHESIA ORAL (Tongue started to become numb/Bottom lip went numb), PHARYNGEAL HYPOAESTHESIA (Throat started to become numb) and DIZZINESS (Lightheaded) had resolved. On 21-Jan-2021, HYPOAESTHESIA (Light numbness on the right side of my face) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
COVID-19 breakthrough. I am still experiencing symptoms. I started with a fever of 100.6 degrees and I had a very painful throat. It felt like strep throat. I have also had congestion, achiness, and weakness. I was taking Tylenol and drinking fluids. Today I felt a little foggy I the head when I woke up. I feel more fatigued today than yesterday.
Patient had a pre-syncopal event following the event. He felt pale and nauseous; dizzy. Did not pass out. 3-4 days later developed a very dry rash on cheeks of face bilaterally. I do not think the rash is related to the immunization. No hives.
Information has been received from a consumer concerning her 15 year old daughter with a penicillin allergy who on 25-JUL-2007 was vaccinated IM with a first dose of GARDASIL vaccine (yeast). It was reported that when the vaccine was administered, some of it leaked out of the syringe (noted to not be a syringe issue). Another full dose was administered to the patient. There was no concomitant medication. On 27-JUL-2007 "a few days later", the patient experienced a fever of 104F. The physician did not attribute fever to vaccine. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. On 30-JUL-2007 3 days after receiving the vaccine, the patient's temperature returned to normal. No product quality complaint was involved. Additional information has been requested.
Information has been received from a registered nurse concerning a 4 year old female pt with no known allergies who in 1998 was vaccinated with varicella vaccine. On 06/16/2001, the pt broke out with a rash. On 06/18/2001, the pt presented to the physician's office with 15-25 lesions and a low-grade temp. This experience was referred to as chicken pox/rash breakthrough. Follow-up info received indicated that the registered nurse did not have any additional info. No further info is available.
Case number PHEH2013US024297 is an initial spontaneous report from the consumer (patient) received on 13 Nov 2013. This report refers to a 50-year-old female patient. Her medical history included eczema, seborrheic dermatitis, allergic rhinitis and several years ago one episode of shingles. She was vaccinated with FLUVIRIN (batch number: 1308401) at a dose of 0.5 ml intramuscularly on 30 Sep 2013. On 01 Oct 2013, the patient developed red itchy welts all over the front of her torso and over time it spread to her back, neck, buttocks, arms, legs and underarms. She went to a dermatologist and diagnosed with Pityriasis rosea. The patient was treated with a combination LIDEX, loratidine and BENADRYL and variety of creams. The outcome of the events reported as condition improved.
Client is here today for his 2nd Moderna COVID vaccine. He received his first Moderna COVID vaccine on 7/28/21 lot # 037C21A exp. 8/25/2021. With his first dose Moderna COVID vaccine, he reported he had a fever of 106 Fahrenheit and 113 Fahrenheit within 3 hours on  2nd day only. Client reported that he didn?t take any medications for the fever but took a cold shower and drank lots of water then slept it off. Client reported the next morning he felt fine. Client told no shortness of breath with 1st Moderna COVID vaccine. He denied any chronic illnesses. Client stated he didn?t follow-up with his primary care provider or allergist. He is allergic to pork with symptoms of rash only on his body and Tres Leche Cake with symptoms of rash only on his body. Today, he told he ate lunch four hours ago. PHN sent a medical consult to clinical lead RN to get an approval for his 2nd dose. Clinical lead RN sent the medical consult to MD who approved for him to get his 2nd dose Moderna COVID vaccine with 30 minutes observation. Client received his 2nd dose Moderna vaccine today (8.25.21) lot # 021C21A exp. 9/16/2021 at 1757 on his left arm. PHN educated client to seek emergency care if he experienced any adverse reactions or high fever and provided him with Moderna fact sheet. He experienced no symptoms with his 2nd dose at the observation area and left the Public Health Center vaccination site in a steady gait at 1827.