chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a 72 year old female with hypertension and sulfonamide allergy who on 22-JUL-2008 was vaccinated intramuscularly in the arm with a dose of PNEUMOVAX 23 (Lot # 659149/1383U; dose # unspecified). Concomitant therapy included hydrochlorothiazide (unspecified). On 23-JUL-2008 the patient experienced a swollen, reddened arm. The patient sought unspecified medical attention in the office. The patient applied ice and then heat to arm and took TYLENOL for discomfort. On 30-JUL-2008, also reported as "within a week's time (exact date unspecified)", the patient recovered from the swollen, reddened arm and discomfort. No other symptoms and no other treatment were reported. No additional information was provided. Additional information has been requested.
Passedout-  BX/Excision, Lymph NoDes-9-8-21 Stroke System week later-mild stroke Headaces- Shoulder Pain & Stomach Pain on left side Colonscopy-Removal, Lesion Two day after being released from Quarantine, went to dinner, had a couple drinks with friends. All of a sudden getting ready to go home and I had to be carried out of the establishment. Once home got out of the care and fell on the ground. My body was like dead weight and a rubber band. I had no mobility of my extremities. My wife called our son. Once he got there all he could do was put me back in the car. My son couldn't lift me because I was dead weight. I stayed in the car from 10:30pm to 3:15am. I had vomit & peed on myself. I finally made it up the steps and into the house. The next morning my wife is telling me all the events I am writing about. I don't remember anything. I had fewer drinks than I normally have. We weren't out that long (2) hrs, I feel like I was forced to take the vaccine. I explained to the people giving the vaccines my condition & issues I was having and he told me it would be ok and gave me the vaccine anyway. I feel I am still having set back and reactions from this vaccine.
Above reaction reported 3/1/13 with resolving symptoms. Injection site pain/redness.
Patient was given the wrong vaccine at this pharmacy. He was supposed to receive a HIB vaccine which was very clearly written on the script. His pediatrician noticed the mistake today, and he had to get multiple vaccines today.
I have and I had the shot./suspected vaccination failure; I have and I had the shot.; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. As per the patient, you could had shingles more than one time and he/she know because had shingles and also had the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Redness, firmness, and swelling to the L arm at the site of injection.  Patient complaining of itching at the site.
Beginning at 10:40 pm: Chills, fever as high as 101.7 orally, headache, very sore injection site, severe body aches, nausea but no vomiting In bed all day. Can't sleep more than 20-30 minutes. Just got up to sit up and complete this form. Going back to bed. Took 1 Excedrin migraine at 3:00 am. No other medication. I have never had a reaction to another vaccine and I have had many. Scheduled for second injection 3/25/2021 and worried about getting it now!
On 10-16-13 pt was given FLUZONE at approx 9:42 am. Shortly thereafter pt complained of his stomache hurting. He began having seizure like activity including jerking movements, loss of bladder control and eyes rolling to the back of the head that lasted about 15 sec. He then was lethargic but was able to answer questions appropriately. Vitals were monitored.
Patient received influenza vaccination.  Next day complained of pain in arm, severely decreased range of motion, tender @ injection site, no erythema.
bump the size of silver dollar; itching; arm was pink; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (arm was pink), SWELLING (bump the size of silver dollar) and PRURITUS (itching) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and PRAMOXINE for an unknown indication.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced SKIN DISCOLOURATION (arm was pink). On 10-Feb-2021, the patient experienced SWELLING (bump the size of silver dollar) and PRURITUS (itching). At the time of the report, SKIN DISCOLOURATION (arm was pink), SWELLING (bump the size of silver dollar) and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient also took Allergy meds as concomitant medication The Treatment information was unknown.
Vesicles on extremities, chest, back - BENADRYL, CALAMINE Lotion.
accidental overdose in reported in a pt receiving fluogen; pt has hx of alzheimer's disease; this is 1 of 30 cases reported from this site; No adverse effects noted;
Fever, chills, body aches, headache, stiffness, joint pain, fatigue.
Information has been received from a medical assistant referring to a patient of unknown age and gender. On an unknown date of 2015 the patient was vaccinated with a dose of expired PNEUMOVAX 23 (injection, expiration date 17-FEB-2015, lot#, dose, route and strength were not provided). No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information is not expected as the reporter didn't want to be contact.
55 years old was administered Gardasil 4; no adverse effects reported; This spontaneous report as received from a nurse and refers to a 55 year old patient of unknown gender. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.     On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (route of administration, dose, frequency, lot number and expiration date were not reported). However, no adverse effects were reported.
Grandmother (guardian) said at around 3:30am 6/12/21 patient woke up and came to her bedroom, was shaking uncontrollably, felt cold to the touch, this lasted for about 45 minutes. Patient did not have a fever but continued with the shaking, she said it reminded her of a seizure but patient was able to talk and walk around. Patient was able to go back to sleep after that and only had a fever of 101 during the day of 6/12/21.
Patient received Pfizer Covid vaccine on 1/8/2021 and 1/29/2021 and was admitted to the hospital for 12 days for COVID symptoms.
Started off with a really bad headache and sore arm. Then began chills, severe headache and nausea. by around 9pm. Developed a fever that even with meds still climbed to 103.3. Was dizzy, whole body aches, and felt like she could not take full breaths during the night and could not sleep most of the night. Saturday 10am the fever was down to 100.9 with a bad headache, body aches, very tired, and some dizziness off and on. Sunday the fever was gone, but still soreness in arm, headache and felt extremely worn down.
Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse by phone. This case involves a 18 months old male patient who was vaccinated with a fourth dose of ACTHIB (batch number: UI905AA and expiry date: 18-Nov-2019) via intramuscular route in the left thigh on 11-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR 13, ROTATEQ and DTAP on same visit. It was a case of actual medication error due to inappropriate reconstitution technique because the diluent portion of the ACTHIB was given without mixing in the powder. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
No immediate AE. noted to have symptoms suggestive of night terrors. 1 week after administration which were notified of today.
Back pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Apr2021 10:00 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREDNISONE, start date: 09Apr2021 (ongoing); CYCLOBENZAPRINE [CYCLOBENZAPRINE HYDROCHLORIDE], start date: 09Apr2021 (ongoing); TRAMADOL, start date: 09Apr2021 (ongoing). The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "Back pain". Therapeutic measures were taken as a result of back pain.  Additional information : No additional Vaccines administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). The 2nd dose is scheduled for 02May2021. He was currently taking the pain killer, muscle relaxer, and steroid. Vaccination Facility Type: Facility. Reporter clarified that the steroid he was taking was Prednisone 10mg. He started taking it on 09Apr2021. He was still taking it. He was taking it because his back went out. He took three the first day and three the second day. It was that kind of thing. The muscle relaxer was Cyclobenzaprine 10mg. He started it on 09Apr2021 because his back went out and he was still taking it. He takes it once a day before bed. The pain killer was Tramadol 50mg every four hours as needed. He started it on 09Apr2021 because his back went out. He was still taking it. The Prednisone, Cyclobenzaprine, and Tramadol are all in pharmacy bottles, so he doesn't have NDC, lot, and expiry to provide.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BREAKTHROUGH COVID: PT IS FULLY VACCINATED AND BOOSTER WITH A HISTORY OF COVID. PT DOES HAVE AN ALLERGY TO DECADRON. Pt admitted for severe headache and elevated BP. Pt also was found to be COVID positive. Pt denied any Resp symptoms and sating well on RA. Rx for Albuterol PRN and Symbicort was given. No Rx for steroids were given due to side effect of palpitations and anxiety.
Recipient of vaccine reports mild lightheadedness, mild nausea, and fatigue after waking up the morning after receiving the vaccine. Symptoms still present today.
Information has been received from a nurse concerning an unspecified number of patients of unkonwn age and gender. No current or historical conditions were reported. Since unknown dates from 01-APR-2015, the patients were vaccinated with PROQUAD (Merck) (route, dose, Lot# and expiration date not reported), the vaccines were exposed to temperatures outside of the recommended range on 01-APR-2015. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse practitioner via a company representative refers to a 53 year old female patient. On 07-NOV-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, frequency and route were unknown, lot# was reported as K009A76, expiration date was reported as 19-MAR-2016). On 09-NOV-2014, the patient went to the emergency room after experiencing redness at the injection site and feeling 'hot' in the area surrounding the injection site, and the patient was diagnosed with cellulitis. On an unknown date in 2014, the patient was admitted to the hospital for an unspecified amount of time. The patient sought medical attention by visit the emergency room. The outcome of the event was unknown. Additional information has been requested.
Patients if fully vaccinated and boosted on 10/2/2021.  Patient is COVID + on 12/10/2021.  ED visit on 12/20. Diagnosed with COVID three days ago, has been sick for over a week.  Main concern today is fatigue, no appetite, diarrhea for the past several days. Denied shortness of breath, chest pain, abdominal pain, vomiting.  Given IV fluids for hydration with marked improvement. No respiratory distress, pulse ox 95%, breathing comfortably. Stable, discharged with instructions.  Return to ER if symptoms worsen.
Urticaria on abdomen, both legs and both arms with onset approximately 24 hours after vaccine administration. Treated with Benadryl and prednisolone in emergency department.
Both of us received the vaccine in the same appointment. Will fill out another form for him. We experienced extreme fatigue, body aches, feverishness with chills and shaking. We felt like we had a viral infection. On Saturday 12/11/2021 we were barely able to get out of bed. As of Sunday morning 12/12/2021 we are better than yesterday but still questionable for leaving the house.  Not recovered yet.
Consumer answered "Yes" to having side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Consumer answered "Yes" to having side effects) 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 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 VACCINATION COMPLICATION (Consumer answered "Yes" to having side effects). At the time of the report, VACCINATION COMPLICATION (Consumer answered "Yes" to having side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
patient was given pneumonia vaccine 9/21  presented to pharmacy with cellulitis  9/24
Information has been received from a nurse concerning premature 9 month old female twins with numerous medical problems who on 22-JAN-2008 were vaccinated with ROTATEQ. The nurse reported that the twins were born prematurely and have had lots of medical problems. The nurse reported that they put some of the vaccine in a preemie nipple and had the patient suck on it. One of the twins developed pneumonia and one developed bronchiolitis. On 24-JAN-2008 the patient developed pneumonia. Subsequently, the patient recovered from pneumonia. One of the twins was put on antibiotic and developed diarrhea. It was reported that the twins were given their 4th month vaccine and were fine. Additional information has been requested.
The vial which was expired on 28-Feb-2023 was initially stored in refrigerator on 07-Mar-2023 and was administered to patient on 17-Mar-2023; No adverse event; Vaccine expired on 28-Feb-2023 was administered to patient on 17-Mar-2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 28-Feb-2023 was administered to patient on 17-Mar-2023), PRODUCT STORAGE ERROR (The vial which was expired on 28-Feb-2023 was initially stored in refrigerator on 07-Mar-2023 and was administered to patient on 17-Mar-2023) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 28-Feb-2023 was administered to patient on 17-Mar-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial which was expired on 28-Feb-2023 was initially stored in refrigerator on 07-Mar-2023 and was administered to patient on 17-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 28-Feb-2023 was administered to patient on 17-Mar-2023), PRODUCT STORAGE ERROR (The vial which was expired on 28-Feb-2023 was initially stored in refrigerator on 07-Mar-2023 and was administered to patient on 17-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 28-Feb-2023 was administered to patient on 17-Mar-2023) and PRODUCT STORAGE ERROR (The vial which was expired on 28-Feb-2023 was initially stored in refrigerator on 07-Mar-2023 and was administered to patient on 17-Mar-2023).    Concomitant drugs were not reported.  It was reported that monovalent vial of 5.5 ml size was not delivered to pharmacy until 07-Mar-2023. The vial was not exposed to any temperature excursion. No side effects were reported.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-716139, US-MODERNATX, INC.-MOD-2023-716138 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716139:same reporter US-MODERNATX, INC.-MOD-2023-716138:same reporter
Started throwing up at 2 am and continued until 530 pm, body chills, fever, muscle & body aches, head ache, diarrhea that is still present
Maternal Exposure During Pregnancy; After vaccination sequence of body changes happened, which led to preterm delivery; This is a spontaneous report form a contactable consumer (mother). This consumer reported information for both imother and Neonate. This is the Neonate case.   A neonate patient of an unspecified gender received bnt162b2 (BNT162B2), transplacental on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. No known known allergies. The patient's concomitant medications were not reported. Last menstrual date Nov2020. The 32-year-old mother received bnt162b2 at the age of 32-year-old. The patient experienced maternal exposure during pregnancy and after vaccination sequence of body changes happened, which led to preterm delivery with outcome of unknown. Gestational period 30 weeks. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization for 24 days in 2021. The patient had no covid prior vaccination, no covid tested post vaccination.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021805597 mother case
Information has been received from a nurse practitioner referring to a 13 year old male patient. The patient's medical history, concurrent condition and concomitant medication were not unknown. On an unknown date, the patient was vaccinated with PROQUAD (lot # M004893, expiration date 26-JUL-2017, dose unknown) subcutaneously (product use in unapproved population). At the same time, the patient received a purified protein derivative (PPD) tuberculin skin test, which was positive. There was no treatment given for the events. The patient did not seek medical attention. The outcome of the events was unknown. The relatedness between tuberculin skin test positive and PROQUAD was not reported. Additional information has been requested.
Pt complained of a rash that formed on his arm at the injection site. He also complained of itching & being uncomfortable.
TOOK VIVOTIF THAT WAS ABOVE RECOMMENDED TEMPERATURE FOR UNKNOWN DURATION; This spontaneous case report (PVX2019-1721) was received from a pharmacist on 01-Jul-2019. It describes a 16-year-old adolescent female consumer who "took Vivotif that was above recommended temperature for an unknown duration" (PT: Product storage error), while being on Vivotif for an unknown indication.  Case report: The consumer took doses of Vivotif that was stored above recommended temperature for an unknown duration.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vivotif that was above recommended temperature for an unknown duration" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif that was above recommended temperature for an unknown duration" was considered as not applicable.
Folate Deficiency; clinical s/s were pain in upper left thigh muscle, no injury to area, pain 7/10 when actively walking; pain present at rest-aching pain; pain occurs while sleeping and causes sleep interruption, not alleviated by NSAIDS; Duplex U/S was negative for DVT, issue resolved with addition of B-Complex supplement (2 caplets/day with meals; am/pm);  pain returns when supplement isn?t taken daily
her shoulder hurts again (48 hours after the second dose); This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number was not reported), dose 2 via an unspecified route of administration on 06Feb2021, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number was not reported), administered on an unknown date, as single dose for COVID-19 immunisation and experienced shoulder was sore at the injection site. The patient previously took flu shot on an unspecified date for immunization and She had the same reaction to the flu shot. However when she went to sleep the pain was still bothering her so she called (Specialty Pharmacy name) and they told her it was okay to take Advil 24 hours after the vaccine, she took 2 Advil, after a couple of days the pain disappeared. When she received the second dose of the vaccine, the nurse told her that she should not have taken Advil. She would like to know if she should not have taken it because she reduces the effectiveness of the vaccine. After 48 hours of the second dose on 08Feb2021, the patient shoulder hurts again. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.