chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 23-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sudden sensorial hearing loss/Decreased Hearing; started to feel right ear fullness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS NEUROSENSORY (Sudden sensorial hearing loss/Decreased Hearing) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced DEAFNESS NEUROSENSORY (Sudden sensorial hearing loss/Decreased Hearing) (seriousness criterion medically significant) and EAR DISCOMFORT (started to feel right ear fullness). At the time of the report, DEAFNESS NEUROSENSORY (Sudden sensorial hearing loss/Decreased Hearing) and EAR DISCOMFORT (started to feel right ear fullness) had not resolved.            Information about concomitant medication was not information provided. Treatment details included  steroid with Antihistamine.  Action taken with mRNA-1273 in response to the events was not applicable.  Company Comment: Based on current available information and the temporal association between product date and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product date and the start date of the events a causal relationship cannot be excluded.
many itchy red bumps type rash on left leg, 2in by 2in at first, treated with Cortizone-10, more single red bumps show up every week,  mostly on legs and feet never completely go away, red color and itch go away, small bump remains
Immediately after injection, the patient felt very dizzy and hot. Her face was very flushed and she felt the need to take off her cardigan sweater.  She reached across the chair to me because I was going to take her blood pressure on her left arm, however, she wanted her blood pressure taken on her other arm.  She immediately felt a sharp pain under her shoulder blades in her middle back that traveled down her spine to her lower back. She was arching her back in pain.  She continued to feel dizzy. Her blood pressure was 108/59 with her RIGHT arm.  She stood for a little while while a technician and myself stood on either side of her and holding her arms to make sure she didn't fall. We discussed when she had eaten last.  She said she had not eaten since the night before (19 hours prior to her vaccine).  She was feeling better and sat down on the end of the chair. She ate some almonds and had a glass of water. She left the pharmacy about 25 minutes after her vaccine. She was speaking clearly and refused for us to call someone to pick her up. Patient left our parking lot at 1:05pm.  She went to an auction for about an hour and started to feel very tired. She then went home to take a nap.  Her daughter came to visit and noticed patient was shaking uncontrollably and she had a low grade fever. They decided to take her to Dr.'s office. They sent her to the hospital to have lab tests and a chest XRay.  She was not admitted to the hospital. Patient's labs and chest XRay were normal.  She was feeling better and was instructed to take Ibuprofen 800mg when she got home at 9:00pm and then Ibuprofen 200mg every 4 hours while at home for her back pain and fever. She said her back pain and low grade fever continued through the next day.  By 48 hours later, she was just tired and fatigue. Her fever was gone within 48 hours and her back pain has subsided.
Report with Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2); Report with Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2); This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 at 20:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT, start date: 10Aug2021, stop date: 07May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Report with Pfizer BioNTech Vaccine administered (patient also took paxlovid for covid-19 treatment after received BNT162b2)". Therapeutic measures were taken as a result of drug ineffective, covid-19. The treatment start date was reported as 27Apr2022 and stop date was reported as 01May2022. The patient took Zoloft as the other medication in 2weeks. The start date for Zoloft was reported as 10Aug2021 and stop date was reported as 07May2022. The adverse event Rebound of symptoms was 4 days following cessation of medication. Device Date was 07May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Drug ineffective", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
BODY ACHES; FEELING HOT; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 10:30 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 08-APR-2021 18:00, the subject experienced body aches. On 08-APR-2021 18:00, the subject experienced feeling hot. On 08-APR-2021 18:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, feeling hot, and headache on 10-APR-2021. This report was non-serious.
Throbbing headache.  Uncontrollable shaking of entire body.  Pale face, blue finger tips, goose bumps all over body.  4:00 PM temperature:  100.0. 10:00PM temperature:  104.7.
3 days p/vax mom found pt in crib not breathing greyish in color; mom picked up pt & shook him; responded but was limp; pt unresponsive; t95.7 ax was taken to ER ambulance ? sz stayed in hosp overnoc; dx ? SIDS or viral infect;
According to the patient, she had multiple temporal lobe seizures that rendered her unable to speak or communicate. These were more extreme and for longer duration than she has had before. Prior to this her seizures were controlled with her topiramate and the patient states she has not had a seizure in a "long time".  Seizures are still occurring intermittently.
Patient came to clinic one hour after receiving HPV vaccine, stating throat felt itchy with hives on face and arms. Patient was given SOLU-MEDROL 125mg im, BENADRYL 50mg IM, and 150mg ZANTAC oral. Patient watched for1 hour with full recovery of symptoms. Orders at discharge: continue ZANTAC PO 150mg twice a day 7 days, start ZYRTEC PO 10mg daily for 7 days, prednisone po 40mg once a day for 5 days.
Information has been received from a physician concerning a 13 month old female who was vaccinated with her first dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3).  One month later, the patient developed a rash and was hospitalized.  Laboratory diagnostic studies performed included a titer drawn at the hospital which was positive for measles.  It was unknown when the child went into the hospital, may have been last week, and it was unknown if the child was discharged from the hospital.  The outcome was unknown.  There was no product quality complaint.  No other information.  Additional information has been requested.
Body ache, fatigue, fever, chill, swollen lymph node (left), headache, snotty nose
Lymph nodes swelled after first shot; This is a spontaneous report was received from a contactable consumer. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications of the patient were not reported. It was unknown if, patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19 or since the vaccination, has the patient been tested for COVID-19 or not. On an unspecified date, patient experienced lymph nodes were swollen and patient was hospitalized for the same. Patient received unspecified treatment for the event. Outcome of the event was unknown.
Within 22 hours of vaccination, developed fever to 102.7 with subsequent diarrhea and nausea. Resolved by Saturday, 5/17.
Pain on the back of his legs; Burning Sensation on the back of his legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on the back of his legs) and BURNING SENSATION (Burning Sensation on the back of his legs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain on the back of his legs) and BURNING SENSATION (Burning Sensation on the back of his legs). At the time of the report, PAIN IN EXTREMITY (Pain on the back of his legs) and BURNING SENSATION (Burning Sensation on the back of his legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
sz w/fever Sunday 9JUN;no sign of fever seen;by Monday had herpetic like lesions in mouth; rx herpangina
This spontaneous report was received from a physician via field representative refers to a patient of unknown gender and age. Patients concurrent condition included shingles on an unspecified location of their body. Information regarding their medical history and concomitant medications were unspecified. On an unknown date, the patient was vaccinated with ZOSTAVAX 9dosing details were unspecified). Physician reported that an unspecified time after receiving the ZOSTAVAX, the patient's shingles got worse and spread all the way down their unspecified arm and across their back. On an unknown date, the patient required medical attention and was seen by their physician. Outcome of the event was unknown. Reporting physician did not assessed the causality of the event with respect to therapy with ZOSTAVAX. Additional information has been requested.
Rash on right thorax returned after 2nd Hep. B vaccine - came to clinic on 5/7/09 - 'Shingles'. Treated with ACYCLOVIR X 3 weeks- 5/22/09 still symptomatic - Also given BACTRIM DS to follow up next week.
This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (bloody nose) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced EPISTAXIS (bloody nose). At the time of the report, EPISTAXIS (bloody nose) outcome was unknown.            Concomitant product use was not provided. No treatment was reported.
rash/She stated that her sister in law and also a third person had the same reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "rash/She stated that her sister in law and also a third person had the same reaction".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200153268 Different patient, same drug/event.
No adverse event; Inappropriate schedule of vaccine administered; This spontaneous report was received from a physician referring to a 1-day-old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant vaccines were not provided.   On 11-AUG-2011, 17-OCT-2011 and 15-MAY-2012, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (strength, route of administration, exact dose, lot number and expiration date were not provided) for prophylaxis, respectively (inappropriate schedule of product administration for the second and third doses).   This is one of several reports from the same reporter. This is one of two reports for the same patient.
It started in the middle of night - dry, scratchy throat between the 30th and 31st of December. I wasn't scheduled to work again until the 5th of January. I called my employer about getting a COVID test. I never ran a fever. I was congested. I wasn't really coughing (from chest anyway) - just from what was happening from drainage in my throat. I had my test on Tuesday, the 5th, to get my test. It was positive and so I had to quarantine 14 days from start of symptoms. I did a virtual appt with my doctor before going to work and she cleared me to return to work. I waited a week until I re-tested. I took another COVID test and it came back negative. They pushed back my second vaccine until later to give body time to recuperate.
Quarter of vaccine ran down patients arm during administration; A report was received from a nurse concerning a 44-year-old, female patient was participating in the mRNA-1273 Emergency Use Program and experienced a quarter of the vaccine ran down patients arm during administration.   The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their planned dose of mRNA-1273 (011J20A) on 23 Dec 2020 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On Dec 23 2020, the nurse was providing the vaccine to the patient and a quarter of the 0.5 mL vaccine ran down the arm of the patient. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was unknown.    The reporter did not provide causality assessment for the event, quarter of the vaccine ran down patients arm during administration.; Reporter's Comments: This case concerns a 44-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Accidental underdose without any associated adverse events.
Chest pain; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 15Jun2021 at 04:00 PM (age at vaccination: 35 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient did not have any known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 25May2021 at 05:00 PM (age at vaccination: 35 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 17Jun2021 at 08:00 AM, the patient experienced chest pain and difficulty breathing. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. The patient was not received treatment for the events. Outcome of the events was not recovered.  The lot number for [BNT162B2], was not provided and will be requested during follow-up.
Intense Itch started about a week after my 1st dose on my upper left chest area.  Lesions appeared in the same area as the itch around April 4th which was 3 days after my 2nd dose (4/1/21).  I was diagnosed with Shingles by my Dermatologist on Thursday April 8th.  I was prescribed Zovirax tablets but by that time the medicine was not effective and I discontinued it after 2 days instead of taking it for the full 10 days as prescribed.
This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients of unknown age and gender. On an unknown date in 2015 (reported as since 29-JUN-2015), the unspecified number of patients were vaccination with ROTATEQ, orally (dose, lot# and expiration date not reported). ROTATEQ was improperly stored. There was no adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unspecified date in 2012, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis. Then, on an unknown date in 2017, another dose of ZOSTAVAX 19400 Plaque-forming unit (PFU) with lot number M036297 and expiration date of 14-NOV-2017 (dose, route of administration and anatomical location were unknown) was given to the patient for the same indication. There were no adverse effects reported. No product quality complaint was involved. Additional information has been requested.
First Night - vision was distorted Sleeping - pain of the entire left arm Next Morning - unable to stand, unable to "walk" straight, feeling nauseous, hurt all over, strong body shaking chills Thursday/Friday - short of breath for seven days with left side chest pain, continued chills Had EKG, Cat-scan, follow-up bloodwork  Currently prescribed High Doses of Steriods for approx. 10 days
Patient was administered Pfizer Bivalent 5-11 instead of Monovalent  vaccine as a first dose.
8 hours post vax, the pt vomited 4 or more times. Now feeling shaky, no headache or chest tightness. She feels different than when she had food poisoning-very little nausea or warning of vomiting.
He was ok right after administering vaccination. 10 minutes later he stood up and said he was feeling hot and collapsed on the floor. Seemed like he was having difficulty in breathing.  Called 911 and administered chest compressions. He was partially alert during chest compressions and after 2 minutes of administering chest compressions he gained full consciousness and requested me to stop chest compressions and requested an ice pack to place on his forehead and also requested some electrolyte drink  and they were provided. He sat up on the floor after a few minutes. He also said this fainting happens to him all the time when he gets any shot (injection). He  was responsive and sat on a chair until paramedics arrived. on arrival they asked his couple of questions and checked his blood pressure and monitored his heat for a few minutes. He left with paramedics about 30 minutes from the time of vaccination.
Suspected Vaccination Failure; Shingles; Pain, hurts; Rash is from my stomach around to my spine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), pain (Verbatim: Pain, hurts) and rash (Verbatim: Rash is from my stomach around to my spine). The outcome of the vaccination failure and rash were not reported and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 The case was received from the patient via interactive digital media. The patient had shingles now (at the time of reporting) and horrible pain for a week now and he/she had Shingles vaccines.  The patient had rash from stomach around to spine.  The patient stated that it hurt and it was no joke, everyone should get vaccinated for shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.