chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm is hot to the touch; Red mark of 2 by 3 inches at the site of the injection; Armpit was swollen; Arm was very sore; Arm was swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm was very sore), PERIPHERAL SWELLING (Arm was swollen), AXILLARY MASS (Armpit was swollen), FEELING HOT (Arm is hot to the touch) and VACCINATION SITE ERYTHEMA (Red mark of 2 by 3 inches at the site of the injection) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's medical history was not provided.  Concomitant products included GABAPENTIN for Restless leg syndrome.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was very sore) and PERIPHERAL SWELLING (Arm was swollen). On 01-Feb-2021, the patient experienced AXILLARY MASS (Armpit was swollen). On 02-Feb-2021, the patient experienced FEELING HOT (Arm is hot to the touch) and VACCINATION SITE ERYTHEMA (Red mark of 2 by 3 inches at the site of the injection). The patient was treated with Manual therapy (Ice, drank lots of fluid and warm compress) for Peripheral swelling. On 26-Jan-2021, PAIN IN EXTREMITY (Arm was very sore) and PERIPHERAL SWELLING (Arm was swollen) had resolved. At the time of the report, AXILLARY MASS (Armpit was swollen), FEELING HOT (Arm is hot to the touch) and VACCINATION SITE ERYTHEMA (Red mark of 2 by 3 inches at the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's arm got very sore and swollen. She put some ice on it and drunk a lot of fluids and the symptoms went away after 24 hours. Last night (01-FEB-2021) she noticed her armpit was swollen, so she put a warm compress on it. Today (02-FEB-2021), the arm is swollen again, and it is hot to the touch and has a red mark of 2 by 3 inches at the site of the injection.
Tongue felt funny tingling, generalized hives,  throat tingling.  50 mg Benadryl given, hives continued to spread, taken to ER.
Delayed localized rash. Onset occurred about 8 days after vaccination. Symptoms included redness and mild itching. Rash was about 2 inches in diameter.  Resolved within 4 days.
Information has been received from a health professional concerning a 32 month old male who on 04/17/00 was vaccinated with one dose of Varivax. Concomitant therapy that same day included the first dose of MMR SC in the thigh and the first dose of Tuberculin PPD IM. In 01/02 (exact date not reported), the patient developed breakthrough varicella with approximately 10-15 lesions. Scattered over the body including the scalp. The patient was slightly itchy. It was also reported as a minor case of chicken pox. Subsequently, the patient recovered. No further information is available.
Shingles on 2/12/2021, first occurrence. Received Famvir. Reported on 3/6/2021 still having some neuralgia pain at site of flair.
Information has been received from a registered nurse concerning a 15 month old female with a history of eczema that is "not a problem of late" and no known drug allergies who on 07/31/2002 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 642695/0490M).  Subsequently the patient developed a generalized rash over the body.  It is unknown if medical attention was sought.  It was also reported that two other patients developed rashes after vaccination from the same lot (WAES # 0208USA01578 and WAES # 0208USA01577).  Additional information has been requested.
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 17-month-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 07-JAN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date was not provided, but upon internal validation process it was established as 03-DEC-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.01 Fahrenheit (F) for 1 minute 30 secundes. Data logger was involved. There were no previous excursions reported. No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
At 2 yo CPE on 5/4/2009 pt received a Hepatitis A vaccine. This was a 3rd Hep A (thought to be 2nd due to incomplete vaccine records). Pt came to office 5/19/09 after 3 days vomiting/diarrhea. Mother and MGM adamant this was due to Hep A vaccine. Continued with loose stool x 1 month while consuming large amounts of juice. Has not been back to office since 6/8/09.
Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SA092508, 2015SA092509, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092723, 2015SA092725 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of TDAP (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. As Tdap vaccine was exposure in utero, out of total 2,093 number of neonate patients out of which 206 (3 percentage) patients birth weight was observed less than the third percentile, 364 (5 percentage) patients birth weight was observed less than the fifth percentile, 714 (10 percentage) patients birth weight was observed less than tenth percentile and 809 (11 percentage) patients birth weight was observed greater than the ninetieth percentile. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
A few hours after my second shot I got a mild headache, tired, and a bit blurry vision. The next day things got worse with high fever, bad headache, and very tired. The bad side effects went away after 4 days but since then I often feel tired with a mild headache and a little chest pain now and then. Before my vaccination, I played tennis 3 times a week, each time I played  about 2 to 3 hours continuously without feeling tired. But after the vaccination, it takes only 15 to 30 minutes for me to run out of breath so I have to slow down to catch my breaths. My stamina is adversely effected after my vaccination . I'm afraid that I have a case of Myocarditis, a condition similar to Pericarditis, which is an inflammation of tissue surrounding the heart, that caused by the vaccine.
Approximately 30 seconds after administering the Hep A and Influenza vaccine the patient started to experience shortness of breath, facial flushing, hives, and chest pain. Epinephrine administered immediately at 1515. EMS also activated at that time. Patient felt almost full relief of symptoms after administration of epi pen. Patient still however reported slight chest pain. Vital signs stable. EMS arrived at 1520 and transported patient to Hospital. Patient ambulated to ambulance.
skin feels sensitive on his forearm on both sides, it does not appear to be a rash but is sensitive to the touch.; feeling of nauseous; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (skin feels sensitive on his forearm on both sides, it does not appear to be a rash but is sensitive to the touch.) and NAUSEA (feeling of nauseous) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 017A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SENSITIVE SKIN (skin feels sensitive on his forearm on both sides, it does not appear to be a rash but is sensitive to the touch.) and NAUSEA (feeling of nauseous). At the time of the report, SENSITIVE SKIN (skin feels sensitive on his forearm on both sides, it does not appear to be a rash but is sensitive to the touch.) and NAUSEA (feeling of nauseous) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided.  The patient stated that feeling of nauseous was not a major concern as the sensitive skin. Patient stated, it was unfolding and changes every day and stated that he meant it was folding in front of eyes every day.  No treatment medication information provided.
Whimpering after vaccination (10 minutes); Fainted (non-responsive): 5 minutes; Disoriented when woke up; Lethargic for a few hours after vaccination;
She got her vaccine, her arm was hurting but that was normal with every vaccine.  DIdn't have any symptoms other than that until this morning.  She has body aches, and temperature of 100.9 and a headache.  He has taken Ibuprofen for her symptoms, and she ordered a COVID test online and is waiting for that one to come.
allerg rxn manifested by rash all over body,mostly in joints areas,some hives some redness p/3rd dose in post exposure series;bitten by a stray dog that was not captured;
The day she received the vaccine in January 12, 2016, she was very sleepy immediately after. Once she awoke about 4 hours after, she was very low energy. Not herself. The next day she had the same low energy & started to show signs of an allergic reaction by eczema on her face & then developing on her arms & legs. We took her into the doctors office on Jan 14, 2016 & explained to them that she was having an allergic reaction to the vaccines that were administered a few days prior. We received confirmation that it in fact was a vaccine reaction.
Employee administered the incorrect flu vaccine.  She was supposed to administer the  Flublok but accidentally administered the Fluzone Quadrivalent instead. Patient stated that her arm is swollen, burning and painful. She notified me as her manager and also spoke with Doctor who prescribed her a steroid for the pain and swelling.  I notified Occupational Medicine and was told to submit a Safety and a VAERS report.
140PM pt recvd vax fainted for approx 5 mins; head lowered p/regaining consciousness; alert & talking; pale; 155PM BP 124/86; 205PM BP 110/80;
Vaccine was mixed with smaller dose of saline than 1.8 ml , no reaction to report as of today
pt recv vax 215PM 1APR96 red area to lt of spine;2-3APR96 red hive-like rash today-total body;saw MD-tx DPH
High fever and uncontrollable crying for first 4 days, continued Seizure like activity until present.
This spontaneous report was received from a physician via a company representative refers to a male child patient of unknown age. On 17-MAR-2014, the patient was vaccinated with M-M-R II, route-injection, (dose, strength and lot number not reported). No concomitant medication reported. It was reported that the company representative was in a group setting and was told a story by the reporting physician about a recent unspecified male patient that he administered a vaccine of with M-M-R II to. The child left the office after the injection, but on 17-MAR-2014, the patient came back with hives (Hospitalization) (medically significant). The physician administered epinephrine and sent the child to the hospital. Patient sought medical attention. There was no product quality complaint (PQC) involved. The outcome of hives was reported as improving after epinephrine administration. Causality between M-M-R II and the event hives was not reported. Upon internal review the event of hives was also considered as medically significant. Additional information has been requested.
Following administration of the first dose of COVID-19 vaccine (Pfizer), pt reported feeling tired and having a "metallic taste" in her mouth. Pt reported very little fluid or food intake prior to the vaccine. Given Gatorade and crackers; monitored for 30 min.  Symptoms resolved.   Patient received 2nd dose of vaccine on 1/6/2021 and no  adverse reactions were reported during the 30 minute monitoring period.
Hives, itching,  started with lip on 9/21 by 9/24 hives covered large area in body
Dose administered after more than 1 temperature excursion; Dose administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 4:21 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 4:21 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient's age was reported as 61.71 years.  Batch number 007C21A administered on 19-Apr-2021 underwent temperature excursion with temperature range of 33 degrees Fahrenheit at 10:00 am. This vial was moved to fridge on 19-Apr-2021. Product moved to clinic on 19-Apr-2021. Beyond use date for the vial was reported as 19-May-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
09/7/2021    Patient began feeling unwell 01/09/2021 discover the lymnodes  swelling   had 01/21/2021  , 01/22/2021 had a in person visit with ultra sound to 01/26/2021  neck specialist for the location of the lynode swelling in neck, then 01/27/2021 neck CT,  02/05/2021 byopsis of the lymnodes, 02/18/2021 follow-up with normal diagnoisis of no cancer and likely reactive from vaccination.  swallen lymnodes with the second and had a bioysis, third vaccination 09/13-17, 2021 extrem fatigue, 10-14 hours ache/s and pains rumatologist is coming to prolong reaction to the vaccination  self stimulation of caffine and base line heart rate 90-130 at a resting position not typical normal is 60-70 at rest. Our of break heart rate and short of breath .
This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 74-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 1st August 2018, the patient received the 2nd dose of SHINGRIX. On 1st August 2018, several hours after receiving SHINGRIX, the patient experienced malaise, pain, influenza-like symptoms and fear of death. On an unknown date, the outcome of the malaise, pain, influenza-like symptoms and fear of death were not recovered/not resolved. It was unknown if the reporter considered the malaise, pain, influenza-like symptoms and fear of death to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received BENADRYL as concomitant medication. The health care professional stated that by the evening, the patient felt like she was going to die. The patient experienced aching, malaise and flu-like symptoms, but no fever. The symptoms were not resolved at the time of reporting. The patient had not sought out medical attention as of the date of reporting.
pt recvd flu shot 4OCT93 c/o fever, achiness, productive cough late that noc; seen 11OCT93 rales; URI;
Two  weeks after given the vaccine  the injection site became raised, warm to touch, itched,  and burned
dark yellow urine on 18-Oct-2020; received / first dose / one year before this report / second dose on 13-Oct-2020; This case was reported by a physician via call center representative and described the occurrence of urine coloring yellow in a 91-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included metal poisoning (cobalt metallosis after a joint replacement failure) and myopathy (myopathy after a treatment with statins). Previously administered products included Shingrix with an associated reaction of myalgia (1st dose received approximately 1 year before this report, refer case- US2020211174). Concomitant products included rosuvastatin calcium (Crestor).   On 13th October 2020, the patient received the 2nd dose of Shingrix. On 13th October 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 18th October 2020, the patient experienced urine coloring yellow. On an unknown date, the outcome of the urine coloring yellow was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the urine coloring yellow to be related to Shingrix.  Additional information was provided as follows: The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient experienced dark yellow urine and c- reactive protien increased to 37 after receiving the 2nd dose of Shingrix. On 16th October 2020, the patient had a bloodtest and all the values were within normal range except for c-protien which was increased to 37. The patient was expecting to undergo further laboratory investigations including more specific muscle damage markers. The reporter consented to follow up.; Sender's Comments:  US2020211174:same reporter
Per family, pt reported fatigue and elevated glucose, nausea and diarrhea 3-4 days after immunization. She was seen by her PCP following week and again was experiencing elevated blood glucose.
Patient was waiting in 15 minute waiting area after recieving vaccine. Patient called for nurse. Patient informed RN that she felt like her throat was closing up. Patient had her own personal pulse oximeter with a reading of 84%. Patient had redness at site of injection Epinephrine 1mg administered IM in (L) ventrogluteal Diphenhydramine 50mg administered IM in (L) ventrogluteal, O2 started on patient by paramedics on site. IV attempted in (L) ac without success. IV started in (R) ac with NS 0.9% Ambulance arrived at approximately 1450
Patient developed swelling at site of Prevnar on lt thigh approx 2 to 3" later after receiving shots.  Still swollen next day when we saw him.