chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious, spontaneous report of inadvertently gave FLUMIST to a 1-year-old was received from a health professional concerning a 12-month-old female. Neither medical history nor concomitant medication was reported for this patient. The patient received FLUMIST on an unknown date. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Moderna Booster (0.25ml) vaccine was drawn up after max 20 drawn doses allowed. Proper aseptic techniques were used during dose extraction and vaccine was inspected prior to administration. Patient was given correct dose (0.25ml) and was monitored for 15 minutes after vaccination. No adverse event/reaction occurred after administration.
Loss of hearing in left ear; Dizziness more than 24 hours after; loud tinnitus; Deep pain in left side upper abdomen/ lower ribcage.; Deep pain in left side upper abdomen/ lower ribcage.; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Apr2021 at 14:15 at single dose in left arm for COVID-19 immunisation at the age of 29-year-old. Medical history and concomitant medications were unknown. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Mar2021 at 13:00 in left arm for COVID-19 immunisation at the age of 29-year-old. On 17Apr2021 at 16:00, the patient experienced loss of hearing in left ear, loud tinnitus, deep pain in left side upper abdomen/ lower ribcage, dizziness (also reported as more than 24 hours after). The patient was no treated due to the events. On 19Apr2021, nasal swab resulted negative. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
7 days after vaccines given patient started having fevers. He may have had a few "spots" on skin per mom. The next day he had a seizure - seen in ER. Dx with his 1st febrile sz. The next day he started having an itchy rash consisting of red papules and few with vesicles. I saw him on day 4 of illness or 10 d post-vaccine. Fever is still ongoing. Rash mostly on trunk but does involve scalp and extremities.
This spontaneous case report was received from a certified medical assistant regarding a 28 unspecified patients of unknown age and unknown gender. No medical history and concurrent conditions were reported. on an unknown date, the patients were vaccinated with improperly stored oral ROTATEQ (lot number # L013192 and expiry date: 19-JAN-2017). No adverse effect was reported. No product quality complaint (PQC) was reported. This is one of the two cases from the same reporter. Additional information has been requested.
Tested positive for covid 19; Tested positive for covid 19; This is a spontaneous report received from a non-contactable consumer (patient) reported for himself   A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 05Aug2021, the patient had tested positive for covid 19 (Covid test post vaccination). The patient underwent lab tests and procedures which included Nasal Swab: positive on 05Aug2021 Tested positive for covid 19 (Covid test post vaccination). Patient did not received treatment for the adverse events. Outcome of the events was resolving.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My right foot also got tendonitis which I have never gotten before; Periodic numbness in leg; Abnormal bruising/entire wrist area bruised; Bump swell up in wrist area and felt a slight burst; Feet just had random pains like muscle pain; I have been having joint pain in my wrists and feet; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to sun flower seeds. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on 24Feb2021 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. On an unknown date in Mar2021, the patient had been having joint pain in wrists, and feet, and periodic numbness in leg, as well as abnormal bruising, a few weeks back (unspecified date), in the middle of the night, the patient felt a bump swell up in his wrist area, and felt a slight burst, and the next day his entire wrist area was bruised. The patient felt that he was more easily bruised than normal. The patient wrist still had a pain in it, and his feet just had random pains like muscle pain. The patient right foot also got tendonitis which he had never gotten before, and sometimes if he step wrong, he could feel pain. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events right foot also got tendonitis, periodic numbness in leg, abnormal bruising/entire wrist area bruised, bump swell up in wrist area and felt a slight burst, feet just had random pains like muscle pain and joint pain in wrists and feet was resolved with sequelae, with lasting effects on an unknown date in 2021.   No follow-up attempts are needed; information about lot number cannot be obtained.
lip swelling and hives occurred approx. 8 hours after vaccination.  Mom gave Benadryl, observed and resolved the following day.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender who on 13-NOV-2012, was vaccinated with dose 1 GARDASIL (dose, route and lot # not provided). On 19-DEC-2012, was vaccinated with dose 2 GARDASIL (dose, route and lot # not provided). On 22-JAN-2013, was vaccinated with dose 2 GARDASIL (dose, route and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The medical assistant stated the patient did not experienced any adverse event. Additional information is not expected.
17JUL92 Hep B vax #1 administered 0800 c/o nausea starting 3 hrs later (accompanied by feeling of shakiness);
Mother called 8/5/16 stated patient has a red sore area warm and hard BENADRYL and TYLENOL advised.
Severe abdominal cramping, vommiting and diarrhea, lasting about 24 hours
Hematoma like hard area at injection site next day with erythema and painful to touch.    Area is approximately 1-2 cm in diameter.   Also couple hours of nausea the next day.    Iced right upper arm next day following injection for several hours.
No additional AE information; a dose of VARIVAX that expired on 12AUG2022 was administered to a patient on 02NOV2022.; This spontaneous report was received from an office manager and referred to a patient of unspecified age or gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 02-NOV-2022, the patient received vaccination with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (ml), lot #T027303, expiration date: 12-AUG-2022, administered for prophylaxis (strength and route of administration were not provided) (expired product administered). Patient did not experience any adverse events outside of the expired dose being administered. No additional AE information (no adverse event).
0.25 ml administered as primary series dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (0.25 ml administered as primary series dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 02-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (0.25 ml administered as primary series dose). On 02-Dec-2021, ACCIDENTAL UNDERDOSE (0.25 ml administered as primary series dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
This spontaneous report was received from a registered nurse and refers to a 68 years old female patient. The patient's medical history and concomitant therapies were not reported. The patient's concurrent conditions included drug reactions/allergies for Sulfa and ENTEX. On 09-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N022703, expiration date: 27-FEB-2019, 0.5 ml, intramuscularly in the right arm for prophylaxis. In the afternoon or evening on 09-OCT-2017, the patient experienced swelling and redness, from her bicep down to her elbow on the right arm. The patient sought for medical attention and was seen in the office on 11-OCT-2017 due to the reaction. On the same date, KEFLEX was prescribed by the doctor as a treatment for cellulitis. The doctor thought that there was some cellulitis going on. The reporter stated that they had another patient with a similar reaction to PNEUMOVAX 23 and requested a lot check for PNEUMOVAX 23 lot # N022703. The outcome of the event was unknown. Relatedness between the event and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant. This is one of two cases from the same reporter (MARRS# 1710USA009576). Sender's Comments: US-009507513-1710USA009576.
Patient had the 2nd Vaccine on 3-25-2021 and Passed away on 3-28-2021. our tech found out.  No clue if it is related to the vaccine or not.
PT started having a fever about 2 hrs p/receiving the immun; late in night mom discovered T of 106; stated gave Tylenol a/PT recvd injection; (event not reported 'til 3SEP91)
Day after getting injection, my right side  (leg, foot, hand, arm) went numb (feeling asleep).  After a week, the symptoms are still the same.  My feet were already numb from type 2 diabetes and MS, now the right side is numb.
Streptococcal bacteremia. A CT scan on 10/9/21 indicated that she has a portal vein thromboses.  She was started on a heparin drip 48 hours post-operatively.  Her case was also discussed with hematology who recommended Xarelto or Eliquis for a duration of 3 months.   She was also found to be bacteremic with streptococcus gordonii and infectious disease was consulted for antibiotic management.  She required a long term dose of IV Ceftriaxone through 10/27/21 and will discharge to home with a PICC and HHC,  ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Heart pain; Rapid heart beat; Arm pain shooting through arm; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 12Mar2021 15:15 (Batch/Lot number was not reported) (at the age of 23 years old) as 1st dose, single dose for COVID-19 immunization. Medical history included allergies to sulfa from an unknown date. The patient's concomitant medications were not reported. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 at 20:45, the patient experienced rapid heart beat, heart pain, arm pain shooting through arm. The outcome of the events was not recovered.  Information on the batch/lot number has been requested.
COVID-19 Vaccine administered to under-age patient. This error may have involved not using two patient identifiers to confirm the patient was of-age to receive the vaccine.   Patient, first dose of moderna was requested by mother. Immunization was given curbside in left deltoid (8/17/2021 around 12:10 pm) by pharmacist. After administering the vaccine, the staff member realized that the moderna vaccine has not yet been approved under EUA to be given to children 17 years or younger. Patient's parent/guardian was then contacted and updated on what happened. Based on all information available, there is no reason to suspect any harm.
red, swollen arm @ inj site; hot, sore to the touch; cool compresses on site;
Woke up with severe vertigo. Could not walk, threw up several times in the course of six hours. Slept most of the afternoon, but was very nauseous could not stand up all day. In the evening started feeling slightly better and could walk to the bathroom unassisted.
she notes that she had severe chills, and sweating after immunization.  She did not have a thermometer to check her temperature.  She also had redness and swelling at the injection site. She said these symptoms subsided over a couple day time frame.  No other infectious symptoms were noted so she truly feels it was related to the immunization as it happened just after the shot was given.
Patient was given shot, and shortly after patients father states he is having a allergic reaction. Patient was unconscious with eyes very dilated and ended up urinated. Patient was warm to touch when felt.
pt reports that he developed paresthesia left side of face approximately 24 hours after receiving the 2nd vaccine;  very mild facial asymmetry; hx of bells palsy in past
24 hrs after the shot, I threw up for 5 hrs straight. There were some 20 min breaks but violently throwing up even after nothing was in my stomach
More than usual pain at site of injection, which was very high in arm, that got worse throughout the day reaching extreme pain and stiffness with any movement.  Pain and weakness with movement has persisted since shot administration.
Patient sweating profusely, diaphoretic, dizziness, states had nothing to eat after midnight, BP 65/58 P98 R22 O2 sat@99% on room air, no respiratory distress noted, was monitored by staff for 20 minutes, Given food -  Blood sugar 111 mg/dl. BP readings 90/60 P88 R20, patient states feeling better, Patient stated feeling well to go home
Highest temp measured 101, rash other than @ inject site, allergic event hives;
Headache, fever starting 3 days after administration. SOB, throat closing up, sore throat, cough, ear discomfort.
"Covid Arm"  Hardness at injection site. Itchy. . Pain in arm pit--lymph node?
I have developed blepharospasm; possible cranial dystonia; This is a spontaneous report received from contactable reporter (Pharmacist). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2021 (Lot number: El3302) at the age of 52 years as dose 1, single for covid-19 immunization. The patient's relevant medical history was not reported. The patient had no known allergies. The patient took concomitant medications (unspecified). The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine.  Prior to vaccination, patient was not diagnosed with COVID-19. After the vaccination patient has not been tested for COVID-19. The following information was reported: BLEPHAROSPASM (disability) with onset 25Jan2021, outcome "not recovered", described as "I have developed blepharospasm"; DYSTONIA (disability) with onset 25Jan2021, outcome "not recovered", described as "possible cranial dystonia". The events "i have developed blepharospasm" and "possible cranial dystonia" were evaluated at the physician office visit. Therapeutic measures were taken as a result of blepharospasm, dystonia included botox injections.; Sender's Comments: Based on the available information in the case provided, the causal association between the events Blepharospasm, Dystonia and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal association. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Patient presented to walk in clinic on 4/4/18 (6 days later) with 104.7 Fever and abscess near injection site. Patient was given TYLENOL and sent to Emergency Room.
Instead of adding 1.8 ml of diluent to the vaccine vial to mix, 1.2 ml were added.  Patient received vaccine with no issues and stated no other symptoms a few hours  after the same day
Morning/day after 101.9 fever. Eating cause stomach pain. Second day nausea and vomiting. Clammy skin but no fever. No appetite.
Information has been received from a registered nurse concerning a 13 year old female patient who on 04-SEP-1998 was vaccinated with a dose of VARIVAX (Merck) (lot number not provided). In September 2010, the patient experienced an outbreak of varicella. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Breakthrough case after two vaccines  Moderna 4/12/21 Lot# 031B21A;  Moderna 5/10/21 Lot# 052B21A
Breast milk production significantly decreased and has not returned to normal, met with lactation consultants and began supplements, pumping and nursing routine and no change or increase.
Note: The confirmation that I received from pharmacy indicates that the injection was given in the 'Left Deltoid' but it was actually in my 'Right Deltoid.' (I am left-handed, so I requested that.) Also, to be noted, this was the second dose. I did not experience any adverse affects with the first dose (other than maybe a slight sore arm after the injection.) (Pharmacy indicates that the dosage was .5 ml.)  Adverse Events: Extreme pain in my right arm immediately when the injection was given which increased over the next six hours or so. I had extreme arm pain for two days and my arm was also hot to the touch. It hurt to move or lift my arm and I could not lay on it. The arm pain started decreasing by Friday, 2/17/23 but I had a red welt at the injection site which finally went away by Tuesday, 2/21/23. By the evening of 2/15/23 (starting approximately 6 pm) and through the entire next day 2/16/23, I experienced a headache, fatigue, body aches, fever (low grade), shivering and chills, slight nausea. I was feeling better by late evening 2/16/23.
Patient was a resident of a health care facility who tested positive for Covid-19 on 08/01/2021.  Patient expired on 09/02/2021 with Acute Stroke listed as cause of death.  Other significant contributing factors listed include dysphagia, failure to thrive, coronary artery disease, and recent Covid-19 infection.
24 hours after receiving vaccines pt. developed temp 102 degrees F. Pt was lethargic, but responded to TYLENOL. 48 hours after vaccines, fever was gone, but pt. had fine rash all over his body. Pt acting normal with usual ADLs.
Patient presented with a rash on neck area.  Following day 10/10/13 patient had rash spread to neck, torso, back, and arms.
This spontaneous report as received from a 69 year old female patient with spinal pain. The patient's pertinent medical history included spinal pain. The patient had no drug reactions or allergies. In 2009 the patient was vaccinated with ZOSTAVAX (1 time vaccination, route, dosage and lot number unknown). Concomitant therapies included gabapentin and TYLENOL. The patient stated that on 26-SEP-2013 she had gotten shingles after getting the ZOSTAVAX vaccine. She stated it was on her right side on her hip to her groin. She stated she is under doctor's care currently. The patient sought medical attention and received treatment with hydro-morphone and gabapentin. No lab diagnostics studies were performed. The outcome of the shingles was unknown. Additional information is not expected.
Developed fever with in 24 hours after receiving vaccines.  Had a 30 second seizure 07/08/2003.