chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT WAS NERVOUS ABOUT VACCINE, HE INQUIRED ABOUT USING A NUMBING AGENT BUT WE DIDNT HAVE ANY THAT WE PROVIDED SO HE PROCEEDED WITH GETTING THE VACCINE. AFTER THE VACCINATION HE WAS OK, WAS TALKING AND WALKING FINE. I INFORMED HIS MOM AND HIM ABOUT WAITING AROUND FOR 15 MINUTES AND THEY WENT TO THE FRONT OF THE STORE WHERE HE SUBSEQUENTLY FAINTED. 911 WAS CALLED, PHARMACIST WENT TO PROVIDE SUPPORT BUT PATIENT WAS NOW CONSCIOUS, REACTIVE, AND SPEAKING. HE BEGAN TO TREMBLE AS THE PARAMEDICS SHOWED UP AND WAS CHECKED OUT BY THE PARAMEDICS. THE MOM LATER CAME BACK TO THE PHARMACY TO BUY TYLENOL AND LET US KNOW HE WAS FINE.
Acute onset chest pain occurred July 24 AM,  hospital released July 27, echocardiogram and coronary angiogram were normal. Dx. pericarditis possibly 2nd to smallpox vaccine. CP resolved in 2 hrs. 11/18/05 D/C summary states final diagnosis as acute myopericarditis. Symptoms as per VAERS form were confirmed with addition of cold sweats. 11/18/05 Medical records both pre-and post-hospital were reviewed. Admission diagnosis was confirmed as pericarditis.
Patient received second dose of Pfizer vaccine 4/30/21 at 1410. Pt reported history of asthma and a previous reaction with the last dose of the vaccine consisting of an asthma attack with cough. EMS was called and pt was transported to ER after reaction and stabilized.  As a result, pt was to wait for a 30 min. observation after this dose per pharmacy guidance on-site. Pt had also pre-medicated with maintenance inhaler, nebulizer treatment, Benadryl, and Zyrtec prior to appointment.   Pt reported mild itching of the extremities and cough to RN in observation room at 1430. RN immediately administered 25mg PO Benadryl using emergency kit. RN notified pharmacist in vaccination room who came to assess pt as well. RN obtained vitals, all stable. BP 123/69, HR 76, RR 16, O2 97% on room air. Pt denied chest pain, shortness of breath. Pt able to talk, A&Ox3 with mild cough. Lungs ausculated, clear & equal bilaterally in upper and lower lobes. VS obtained and stable once more.   Pt self-administered albuterol inhaler x 2 puffs with relief. However, cough continued to worsen in frequency. RN advised to pt that discharge would not be safe at this time given her symptoms and that RN would like pt to report to ER via EMS. Pt and husband expressed concern over cost of transportation via ambulance and decided to refuse ambulance transport to ER. Pt and husband ambulatory to exit at 1500 to drive to ER (less than 3 min. away from clinic). At time of discharge, pt remained A&Ox3 with no outward signs of respiratory distress apart from asthma-related cough symptoms.
This spontaneous report as received from a Medical Assistant, refers to multiple unknown patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were administered improperly stored doses of RECOMBIVAX HB lot # M001578, expiration date 21-NOV-2018 and lot#M010212, expiration date 21-JAN-2019 for prophylaxis. The vaccines were exposed to temperatures ranging from 33F to 35F for cumulative total time frame of 72 hours out of recommended storage range. There were no previous excursions reported. The temperature excursion was recorded by a data logger. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Follow up information was received on 09-DEC-2016. As of 09-DEC-2016, All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1611USA000221: US-009507513-1610USA001301: US-009507513-1611USA000223: MERCK 1611USA000222: Mfr number.
no additional AE; dose of VAQTA with a labeled expiry of 7/11/2021 was inadvertently administered to a patient on 7/15/2021; This spontaneous report was received from a certified medical assistant and refers to a 26-year-old patient. of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 15-JUL-2021, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) injection, lot # T018670 (lot # has ben verified to be valid for vial), expiration date 11-JUL-2021, 1 milliliter (route of administration and injection site were not provided) for prophylaxis. No known temperature excursions have occurred. No additional adverse event was reported.
Started to feel cramping in extremities, like light charlie horses; Slight pains in forearms; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 27Aug2021 at 11:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included gluten sensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included cranberry vitamin (MANUFACTURER UNKNOWN), elderberry with zinc (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and multi (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 28Aug2021, the patient started to feel cramping in her extremities, like light charlie horses and then felt in the tops of her feet, hands at times, calves and some slight pains in forearms. The events resulted in emergency room/department visit or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events started to feel cramping in extremities, like light charlie horses and slight pains in forearms was not resolved at the time of this report.
Sudden unexplained rash covering stomach, back and breasts. Rash did not itch and lasted approximately 2 weeks. Appeared somewhat hive-like. I've never experienced anything similar.
Patient received the flu shot and within 4 hrs she got a hive on the back of her neck. The next day she had several more raised red welts. By 1700 10/10/2018 she noticed she had multiple raised red welts in between her thighs and on her arm. These welts were also itchy. She contacted her PMD who recommended hydrocortisone cream and BENADRYL. She took 50 mg of BENADRYL PO and applied the hydrocortisone cream to the affected areas per MD order. The next day she had even more welts and went to her PMD office. She was given 20 mg PO prednisone and 80 mg methylprednisolone IM. Even with all these interventions the welt persisted. She is free of hives on approx. 90% of her body today.
This spontaneous report was received from a healthcare worker and refers to a unspecified number of patients of  unknown age and gender. IN approximately 2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, frequency and route of administration were not reported, lot # L029631 with expiration date: 14-AUG-2017 and lot # L040458 with expiration date: 04-FEB-2018). No adverse effects were reported. Administered vaccine experienced the temperature excursion of 31.5 degrees Fahrenheit for 2 minutes on 10-MAY-2016. Data logger was involved. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had second dose and this morning took 1.5 hours to get dressed and has AMS.
Patient received an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) 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 EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) had resolved.        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.   No concomitant medications were reported.  Treatment information was not provided.
Pt recvd 1st MMR vax & felt like wanted to throw up-vomited; pt rested on cot BP 126/80, p100 reg, color pale; stomach felt funny;
doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.    On 04 NOV 2021, vial was initially stored in the refrigerator. No temperature excursions was noted and patient did not experience any adverse event.   Treatment medications were not reported.   This case was linked to MOD-2022-491837 (Patient Link).
Severe back pain-subside after  3 days but still ongoing -Frontal lobe Headache - lasted for 3days.  -Joint pain - lasted for 24 hrs. Chills- lasted for 2 days. Treated with Ibuprofen, Tylenol and rest
did have mycarditis og the heart; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (did have mycarditis og the heart) 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 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced MYOCARDITIS (did have mycarditis og the heart) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (did have mycarditis og the heart) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided.  Action taken was not applicable.  This case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced serious expected event of myocarditis. The events occurred approximately 4 days after the second dose of Spikevax with first symptom reported as dyspnoea. Rechallenge was not applicable. The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced serious expected event of myocarditis. The events occurred approximately 4 days after the second dose of Spikevax with first symptom reported as dyspnoea. Rechallenge was not applicable. The benefit-risk relationship of drug is not affected by this report
Itchy Rash that appeared on the upper arm 1 week later (3/29). Spot was WARM to the touch and started around 2 inches in diameter and peaked at 6 inches about 3 days later (4/1). Treatment: OTC cortisone started on day 3 (4/1)(when the rash hit the largest size). Applied about 3 times a day to reduce itching. Rash disappeared on 4/7,; never shrunk, just faded.
Hives. A healthcare professional reported that a 4 month old male received Prevnar, IPV, Tripedia, and Pedvax HIB, on 2/27/01. The infant was also received Amoxicillin concomitantly for a respiratory infection. One day following vaccination the infant developed an erythematous nodule about the size of a dime at the site of injection, hives on his right and left thigh, and left wrist redness. It was noted that the wrist redness may have been caused by the child sucking on his wrist. Treatment with Atarax syrup was prescribed.
Pt developed lightheadedness then had fainting spell suspected cabal reaction based on normal ekg and clinical exam on 4/25/18, 2 days after immunization.
Broken/Cracked Vials; Slushy/Delayed Thawing Product; discoloration; unusual appearance i.e. cloudy/Shattered vial that wouldn't thaw and cloudy vials.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT PHYSICAL ISSUE (Broken/Cracked Vials), PRODUCT STORAGE ERROR (Slushy/Delayed Thawing Product) and PRODUCT COLOUR ISSUE (discoloration; unusual appearance i.e. cloudy/Shattered vial that wouldn't thaw and cloudy vials.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) 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 11-Nov-2021, the patient experienced PRODUCT PHYSICAL ISSUE (Broken/Cracked Vials), PRODUCT STORAGE ERROR (Slushy/Delayed Thawing Product) and PRODUCT COLOUR ISSUE (discoloration; unusual appearance i.e. cloudy/Shattered vial that wouldn't thaw and cloudy vials.). On 11-Nov-2021, PRODUCT PHYSICAL ISSUE (Broken/Cracked Vials), PRODUCT STORAGE ERROR (Slushy/Delayed Thawing Product) and PRODUCT COLOUR ISSUE (discoloration; unusual appearance i.e. cloudy/Shattered vial that wouldn't thaw and cloudy vials.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication was reported.  The package was received on 08Nov2021, approximately.  After 5 hours in the fridge, the contents of the vial were rock solid. Also, the rest of the vials looked extremely cloudy.  No vaccines were administered from these vials.  This case concerns a Product quality issue, Product storage error, and Product color issue in mRNA-1273  vaccine with batch/lot no. 067F21A, administered to a patient of an unknown age and gender with no relevant medical history, who had no reported adverse event. The incident  occurred on the day the patient received the dose of mRNA-1273 Vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a Product quality issue, Product storage error, and Product color issue in mRNA-1273  vaccine with batch/lot no. 067F21A, administered to a patient of an unknown age and gender with no relevant medical history, who had no reported adverse event. The incident  occurred on the day the patient received the dose of mRNA-1273 Vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Developed a circular rash at injection site.  Approximately 3 inches in diameter. Seemed to peak at 7 days after and was quite red and inflamed with a ring around the border. Discoloration of different shades preceded as well as followed for another week or so.
This spontaneous report was received from an administrator via a company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 14-AUG-2018, the patient was vaccinated with a dose of VARIVAX subcutaneously (lot # R002508, expiration date: 25-JAN-2020), reconstituted with an expired lot of sterile diluent (lot # L025372, expiration date: 20-MAR-2018) for prophylaxis. No adverse effect was reported.
Hives within one hour of administration. Improved with BENADRYL at home and PEPCID AC.
No adverse event; Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster) 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 related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster).    No relevant concomitant medications were reported. HCP stated that they had a situation at the pharmacy where Moderna monovalent vaccine was administered to approximately 20 patients from 11-Jan-2023 to 21-Jan-2023, instead of the Moderna bivalent booster. No treatment medication reported.   This case was for 3rd patient out of 20 reported.   This case was linked to MODERNATX, INC.-MOD-2023-704234 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-704234:Master
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 30-APR-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021936, expiration date: 10-NOV-2016, subcutaneous, dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The pt was hospitalized with suspected pneumococcal infection one month post vax. Follow-up information received on 2/26/01 from the child's physician indicated that the male child was immunized on 11/28/00. On 1/19/01, the child was hospitalized for a pneumococcal infection. A blood culture revealed the presence of Streptococcus pneumonia with resistance to PCN and cefotaxime. The child was hospitalized for 13 days and has since recovered.
Injection site seems too high near shoulder.  Child is complaining of radiating pain from shoulder ti finger tips.  Can?t sleep due to pain.   Following up with pediatrician  at the earliest available appointment in 2 days
This spontaneous report as received from a nurse refers to unspecified number of patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored GARDASIL (dose, route and lot were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected, because is not possible contact the physician.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Hypertension-Mild, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild
Expiration date for lot # had been extended and vaccine had remained frozen until date of administration.  Vaccine was given 2 days past expiration date.  Moderna consulted and deemed the vaccine viable so  revaccination is not necessary.  No adverse side effects were reported by patient.
Received flu vaccine Monday about 1 PM. Hives came Tuesday eve. about 6:30 - itchy around neck and then whole body covered. Called PMB. He ordered Allegra 1 qd 180 mg and famotidine with no results.
Information has been received from a certified medical assistant concerning an 11-year-old female with no allergies and a history of eczema who in 1997 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccinations included TriHIBit and poliovirus vaccine live oral (manufacturer unknown). Three years later, in 2000, the patient developed "a mild case of" chickenpox. Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. The outcome was reported as recovered. No product quality complaint was involved. Additional information has been requested.
cough, Chest congestion, Fatigue, Muscle or body aches, and Headaches  Clinical Support  10/25/2021    COVID-19  Dx Medication Infusion   Reason for Visit   Progress Notes  Patient is here for MAB Infusion O2 sats > or = 90%   Signs of potential reaction reviewed with patient.   Tolerated IV start and MAB infusion without complication.   Pt has access to pulse oximeter and thermometer for home monitoring   Discharge instructions reviewed. Patient denies any questions
After first dose, severe flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "After first dose, severe flu like symptoms". It was unknown if therapeutic measures were taken as a result of influenza like illness.  Additional information: The patient's age group included Adult (18-64 years). Facility type vaccine included hospital.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
pt had temp 102-103 had trouble keeping down eve of 11DEC93 & 12DEC93; went into convuls & quit breathing eve of 12DEC93 went to hosp dx as result of elevated temp, ear infection & poss react to immun;
I received vaccine. Noted at the 30 minute post wait vaccine site feeling a very slight like it was hard to take a deep breath 15 minutes after receiving the vaccine. I took my pulse. It was 90. I did not tell the  medical monitor people. My husband drove me home after the 30 minute watch period was up. At 1:15pm I gave myself an albuterol neb to. Post tx home pulse ox was 95% pulse 96. No n/v, no itching. Breathing felt improved . I did a home peak flow reading which was 240. My personal best baseline is 350. I auscultated my anterior chest. Diminished, clear, no wheezing. I sat calmly. My husband noticed the left side of my face was mildly swollen. Amazing! For him to notice! it was very slight around cheek bone to jawline. I sent him to get otc Benadryl. I took 25 mg po . At 2:20 pm Pam was 300 p02 sat 98% pulse 96. Lips felt tingling, no swelling. Speech clear. Swallowing intact Drank water, low sodium soup. 3:30 pm did another albuterol next. Sat 95% after neb . Pulse 89. 20 minutes post neb peak flow reading 320. Started feeling chills. Temp outside a nice seventy degree day. Wrapped self 6 blankets,winter hoody fleece, heating pad and finally fell asleep. Family watched me sleep. Woke up 7pm. Still felt cold. Had fluids, urinated, breathing ok. Went back to sleep. 11 pm woke up, peak flow 300, did neb, took Benadryl wore my cpap machine and went to bed till today.