chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician. This physician reported for a 50-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Not reported) via intramuscular route of administration on 26Mar2021 12:30 in Left arm as dose 2, single (at the age of 50 years) for covid-19 immunisation. Medical history included DM (Diabetes mellitus), HTN (Hypertension) (Newly diagnosed) and covid-19 and concomitant medication was not reported. The patient had no known past drug allergies. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration on 23Feb2021 as dose1, single for covid-19 immunisation. The patient was diagnosed with COVID-19 prior to vaccination. It is unknown whether the patient was tested for COVID-19 post vaccination. On 26Mar2021 at 02:00 am the patient experienced developed dizziness, left arm pain, left chest pain and difficulty breathing as a treatment the patient took 3 Advils. These symptoms lasted for 1 day. On 13Apr2021 Dizziness recurred with Nausea/Vomiting, disequilibrium, feeling like walking sideway and about to fall. Headache and gurgling stomach. The AE resulted in physician office visit. The patient received Meclizine and Advil as a treatment drug for events. Outcome of events left arm pain and difficulty breathing resolved in 2021, for event dizziness it was Not recovered/not resolved and for rest of the events the Outcome was unknown.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
had the shot then had the shingles / suspected vaccination failure; shingles; 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had the shot then had the shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Fever, aching, nausea, loss of appetite, and fatigue. Used 2 Tylenol ES. Nothing really changed. This morning fever was 100.6 F. That has now dropped to normal w/Tylenol. Appetite is coming back.
Information has been received from an RN concerning a 45 year old female pt who was vaccinated with a 1st dose of Hep-B vaccine and subsequently, the pt developed "two very large blisters at the injection site. A heat pack was applied and the blisters grew to approx. half an inch high. One blister has broken". The pt sought unspecified medical attention. Follow-up information from a hospital, indicated that the reaction is now not considered a vaccine reaction. "The inquiry may have been a burn from using a hot pack on the injection site following pt complaint of site soreness." No additional information is expected.
Parents describe him as being "Drunk" after vaccines. Not holding his head up. Just not himself.
suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles (it was very painful).   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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles again. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
-@12:04pm, Client fainted while he's getting up from sitting position from a chair. Fell on the floor, felt unconscious for less than a minute. Assisted back to chair, offered gatorade and water, Doctor and EMS onsite assisted with further assessment monitoring. -Client had his Pfizer vaccine booster dose @ 11:47 am and Influenza Vaccine 2-3 minutes before he fainted. -Client stated that he only had a light breakfast and cup of coffee, and normally does high stress activities. He claims that he has history of vasovagal with blood draws, and anxiety of needles. He stated that having low heart rate is normal for him.
Systemic: Nausea-Medium, Systemic: light headed, high blood pressure, shortness of breath-Medium; symptoms lasted 1 day
Loss of feeling in feet, can't walk without support, drops everything, can't move fingers, hands, arms, loss bladder and bowel control, high/low blood pressure, can't move body, takes 3 hours to shower and get dressed, can't get in/out of bed, can't drive, can't stand from sitting position, can't bend over, has trouble swallowing, eating, chokes and coughs.
Employee reported numbness and tingling to left arm, fingertips and both feet. Left hand is shaky. Employee was transported to ED for evaluation.
Injection given on 11/18/16 late afternoon.  Mom called in saying that the evening on 11/18 pt had redness around the injection site.  On 11/19/16 he felt dizzy on and off, felt like he had to sit down, felt sleepy. Temp 99.5.  On 11/20/16, pt felt blah.  Resolved by 11/21 and patient returned to school without symptoms.
Unable to chew on right side of jaw/hinge. Right jaw paralyzed. Patient took ADVIL and was feeling okay in few hours.
temperature excursion; This spontaneous report as received from a nurse refers to a 15-month-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 02-NOV-2020, the patient was vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: T000344, expiration date: 05-JAN-2022; route of administration was not provided) 0.5 ml. The vaccine was stored in temperatures between -13.9 and -14.7 degrees Celsius (-14 to -10 degrees Celsius (-13.9 degrees Celsius) for 0 hours 30 minutes and 0 seconds; -14 to -10 degrees Celsius (-14.2 degrees Celsius) for 0 hours 15 minutes and 0 seconds; -14 to -10 degrees Celsius (-14.7 degrees Celsius) for 0 hours 20 minutes and 0 seconds; -14 to -10 degrees Celsius (-14.6 degrees Celsius) for 0 hours 5 minutes and 0 seconds). There was no previous temperature excursion. Digital data lodger was involved.; Sender's Comments:  US-009507513-2011USA001488: US-009507513-2011USA001736: US-009507513-2011USA001846: US-009507513-2011USA001953: US-009507513-2011USA001966: US-009507513-2011USA001975: US-009507513-2011USA002208: US-009507513-2011USA002225: US-009507513-2011USA002242: US-009507513-2011USA002568: US-009507513-2011USA002572: US-009507513-2011USA002578: US-009507513-2011USA002615: US-009507513-2011USA002620: US-009507513-2011USA002622:
My arm was swollen, in pain and red for three days. On Thursday, April 8th I started feeling very sick, headache, nauseous, weak, chills, back and legs pain. I am still feeling head pressure, fatigue, tired. The shot area still swollen and red.
A few hours after the injection, Pt started complaining of pain under her arm.  Not at the injection site.  The next evening, we noticed a large bruise under her arm.  It spread from under her arm down to her breast.
Received vaccines on 6/5/08 for travel.  C/O redness, swelling to upper arm x2 days.  Seen in clinic on 6/12/08 no fever, chills.  Tx for cellulitis (KEFLEX) vs delayed hypo-sensitivity to vaccine.
Rash that extended down the arm the vaccine was administered in. Rash not seen anywhere else on the body.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age 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 COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter.  No treatment medications were provided by the reporter.  The reported stated that a family got a COVID-19 vaccine possibly Moderna, but uncertain and had COVID-19, 4 months after. The reporter had very limited information.  This case concerns a male patient adult patient with no medical history, who experienced the unexpected event of COVID 19. The event occurred on an unknown date.  Administration date of a dose of mRNA-1273 was not provided however it was stated that the event occurred 4 months after a dose of COVID 19 vaccine. The rechallenge was not applicable. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a male patient adult patient with no medical history, who experienced the unexpected event of COVID 19. The event occurred on an unknown date.  Administration date of a dose of mRNA-1273 was not provided however it was stated that the event occurred 4 months after a dose of COVID 19 vaccine. The rechallenge was not applicable. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 17-10-2012 09:17, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Approximately 5 minutes after vaccines, patient began to feel head and face get warm and "just didn't feel right denied dyspnea, dizziness, nausea. Face and chest blotchy BP elevated; pulse 130 patient given 50mg PO Benadryl. Symptoms began to resolve. BP down and pulse decrease 90's. Skin warm and dry.
Pt arrived for first vaccination.  Approximately 15 minutes after administration, pt stated that her throat felt irritated and that it was closing up.
Patient reported feeling dizzy and lightheaded while sitting in the chair. Patient was noticeably sweating and was lowered to the ground by staff. Ice packs were applied to the patient's body. Vital sign were taken. BP-118/84, HR-72, Sp02-97%. Blood Sugar 90. Ekg- showed normal sinus rhytm. Patient remained alert and oriented. Patient was assessed by ems, nurses,  and MD. Ems administered bolus IV fluids. Patient reported feeling better and was transferred to chair by staff. MD suggested that patient be transferred to ER for evaluation, but patiet declined. Patient left facility in wheelchair accompanied by daughter. Patient was A&O x3, no distress noted upon departure.
Patient has been incoherent and showed increased delirium all day and has had difficulty staying awake that has persisted into the evening
Swelling over left arm over elbow to upper portion of left forearm. Very superficial redness. No warmth. Non tender. Small axillary lymph node. Non tender. No antibiotics necessary. Treated with Benadryl and compresses.
Arm swollen and very sore. Bruise started went down arm to elbow - approx 3" wide.
contact dermatitis; rash on both forearms and knees-looks like poison ivy that itches like crazy/rash has lasted a week; a little soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (contact dermatitis), RASH (rash on both forearms and knees-looks like poison ivy that itches like crazy/rash has lasted a week) and INJECTION SITE PAIN (a little soreness at the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced INJECTION SITE PAIN (a little soreness at the injection site). On 05-Apr-2021, the patient experienced DERMATITIS CONTACT (contact dermatitis) and RASH (rash on both forearms and knees-looks like poison ivy that itches like crazy/rash has lasted a week). On 02-Apr-2021, INJECTION SITE PAIN (a little soreness at the injection site) had resolved. At the time of the report, DERMATITIS CONTACT (contact dermatitis) outcome was unknown and RASH (rash on both forearms and knees-looks like poison ivy that itches like crazy/rash has lasted a week) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included triamcinolone acetonide cream.
delayed (beginning 7 days after injection) reaction of redness, mild itching, and mild pain at the injection site plus arm/shoulder pain on same side as injection
This spontaneous report was received from a physician via a company representative concerning to a patient (encounter key# 246587) of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 07-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The sum of hours in excursion was 16 hours and the lowest recorded temperature reported was 33 Fahrenheit (F) (0.555555556 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product quality complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
One day after 2nd injection I got fever, bad arm soreness and pain and fatigue   I also had reported all my side effects from the first injection and forgot to add that it also impacted my menstrual cycle significantly. I was 10 days late which I?m never late. Just got my period today 9/24/2021, was due 10 days ago and I know this is attributed to the first vaccine dose. Which I got on 8/21/21
intentionally missed dose; Arm itches; Very swollen; Arm is still red and hot; Very hot; Shaking uncontrollably; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (Shaking uncontrollably), VACCINATION SITE WARMTH (Very hot), INTENTIONAL DOSE OMISSION (intentionally missed dose), VACCINATION SITE PRURITUS (Arm itches) and VACCINATION SITE SWELLING (Very swollen) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Nausea since 06-Jan-2020, Diarrhea since 06-Jan-2020, Vomiting since 06-Jan-2020 and Upset stomach since 06-Jan-2020. Concomitant products included BIFIDOBACTERIUM INFANTIS (ALIGN) from 11-Mar-2021 to an unknown date for Stomach pain, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) from 11-Mar-2021 to an unknown date for Vitamin D deficiency.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced TREMOR (Shaking uncontrollably). On 14-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Very hot), VACCINATION SITE PRURITUS (Arm itches), VACCINATION SITE SWELLING (Very swollen) and VACCINATION SITE ERYTHEMA (Arm is still red and hot). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (intentionally missed dose). The patient was treated with LORAZEPAM (ATIVAN) for Adverse event, at a dose of .25 milligram. At the time of the report, TREMOR (Shaking uncontrollably), VACCINATION SITE WARMTH (Very hot), INTENTIONAL DOSE OMISSION (intentionally missed dose), VACCINATION SITE PRURITUS (Arm itches), VACCINATION SITE SWELLING (Very swollen) and VACCINATION SITE ERYTHEMA (Arm is still red and hot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Five vaccines were administered and within 3-5 minutes pt broke out in whelps. Whelps started on face and then covered whole body. Feet were itching and whelps also. Pt complained with tongue itching and lips were swollen. No respiratory distress. Benadryl given I.M. Five minutes after onset of reaction, pt remained for 1 hour in office.
Hands were pink, no blisters, no pain; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included herpetic whitlow (got this on her hands from a manicure 25 years before date of reporting.), blister and erythema. Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX) and acyclovir.   In November 2022, the patient received the 2nd dose of Shingrix. In December 2022, unknown after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   Linked case(s) involving the same patient:  US2022AMR183513   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comments: Patient said she got herpes whitlow on her hands from a manicure 25 years ago.  Patient was taking acyclovir for the herpes whitlow for the past 25 years and she had not changed the amount of acyclovir she takes.  The patient said, about 3 times a year, her hands breaks out in blisters from the herpes whitlow infection and turns dark red with blisters and was painful for several weeks.  She said the blister cycle from the herpes whitlow was caused from great stress.  She said the blisters usually takes about a month to go away.  Patient reports getting the first shingrix shot in September 2022 and getting the second shingrix shot two weeks ago in November 2022.  Patient said that in the last 48 hours, she felt a change in her blisters on her hands.  On 5th December 2022, her hands were a light pink color instead of the dark blisters.  On 6th December 2022, that her hands were pink and had no blisters with no pain.  Patient did not know the lot number or the expiration date of the shingrix shots she received. No further information was reported to the agent by the patient.  Consented to follow up. No further information was reported to the agent by the patient.  Patient declined to provide consent for hcp follow-up.; Sender's Comments:  US-GSK-US2022AMR183513:same patient
Information has been received from the authors in a published literature article regarding 8 children of unknown age and gender. On an unknown date, the patients received 3 doses of ROTATEQ. Concomitant medications were not provided. In this article was reported Group A rotaviruses (33 complete RVA) genomes collected in multiple cities in the country during 2006-2009. Out of the 33 strains, 8 were from children known to have received 3 doses of ROTATEQ, who developed acute gastroenteritis which was demonstrated in the fecal specimens. Additionally, these strains were referred to as vaccine failure (VF) strains. Finally, all the vaccine failure strains also shared one substitution in VP7 gene and 10 substitutions in VP4 gene, which may lead to potential evasion of vaccine induced immunity. The outcome of vaccination failure and gastroenteritis rotavirus was unknown. Upon internal review the gastroenteritis rotavirus was considered as a medically significant event. The reporter considered vaccination failure and gastroenteritis rotavirus to be related to ROTATEQ. Additional information has been requested.
Patient is supposed to have a diptheria, tetanus and polio vaccine. She administered Vaxelis and a polio injectable.; Nurse called stating 13-year old male came in today. She administered Vaxelis and a polio injectable. Polio vaccine has been duplicated.; Nurse called stating 13-year old male came in today. She administered Vaxelis and a polio injectable. Polio vaccine has been duplicated.; This non-serious spontaneous safety report with reference number # 2023SA134066 (Inquiry #01594542) was received by a partner on 27-APR-2023 and forwarded to agency on 01-MAY2023 from a health care professional.  The case was considered as off-label due to product being administered in unapproved population.  Due to the nature of the events, the causality between the events "Nurse called stating 13-year old male came in today. She administered Vaxelis and a polio injectable. Polio vaccine has been duplicated. and " and Vaxelis was not applicable.  Further information is expected.
This case was reported by a nurse via sales rep and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The batch number for SHINGRIX was not provided. The patient went to the office a week later and tested positive for shingles. The name and address of Pharmacy that administered the product were not provided. Lab Comments: on an unknown date serology test was performed.