chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He erroneously administered 2 doses of M-M-R II; He erroneously administered 2 doses of M-M-R II; No adverse symptoms reported; This spontaneous report was received from an other health professional via company representative referring to an adult patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, unit, route, anatomical location, lot # and expiration date were not reported). The reporter stated that he erroneously administered two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) to the patient with an unknown vaccination history, because he thought that the dose listed in the prescribing information was the dose for pediatric patients and he also mentioned that he thought two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) needed to be administered, based on other unspecified vaccines having a pediatric and adult formulation (incorrect dose administered and extra dose administered). No adverse symptoms were reported. No product quality complaint (PQC) was involved.
Patient was administered 2.0ml of Pfizer COVID-19 Vaccine, noted after the patient left the clinic, unable to reach patient at this time, unknown signs or symptoms, was in good health on leaving the clinic. Patient did report breastfeeding her 9 month old daughter.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2), on 17Jun2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Jul2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 14Jan2022 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 20May2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (13Jun2022) Positive; (15Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid (lot number: GA8851) from 07Jun2022 to 12Jun2022. Clinical course: Patient did not received any other medication in 2weeks. Patient still had mild symptoms and still tested positive (both PCR test on Monday at government site on 13Jun2022 and in-home antigen test on15Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever/chills, headache, muscle aches and joint pain - went away after 24 hours  Significant rash and swelling at injection site two days after shot
Shoulder soreness; Felt yucky; Nausea; Rash at injection site the size of an orange; Hard at the injection site; Itchy at the injection site; Feeling kind of bad; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder soreness), FEELING ABNORMAL (Felt yucky), NAUSEA (Nausea), VACCINATION SITE RASH (Rash at injection site the size of an orange) and VACCINATION SITE INDURATION (Hard at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced NAUSEA (Nausea), VACCINATION SITE RASH (Rash at injection site the size of an orange), VACCINATION SITE INDURATION (Hard at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and MOOD ALTERED (Feeling kind of bad). On an unknown date, the patient experienced ARTHRALGIA (Shoulder soreness) and FEELING ABNORMAL (Felt yucky). The patient was treated with CORTISONE at a dose of cortisone10 cream. At the time of the report, ARTHRALGIA (Shoulder soreness) and FEELING ABNORMAL (Felt yucky) had resolved and NAUSEA (Nausea), VACCINATION SITE RASH (Rash at injection site the size of an orange), VACCINATION SITE INDURATION (Hard at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and MOOD ALTERED (Feeling kind of bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included cortisone10 cream. Concomitant medication details were not provided.
This spontaneous report was received from a nurse regarding an unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 30-OCT-2017 and on 21-FEB-2018, the patient received a dose of VAQTA intramuscular route for prophylaxis (strength, frequency, lot# and expiration date were not reported). No known adverse effects reported. No product quality complain was present.
Very large and harden lump that was the size of my hand. Took a month for it to go down. Still has a small lump. He also had this reaction to prior shot but not as severe. My son has become very ill after ever shot he has had. He now has active airways disease and has had many ear infections which started after his first shot. He has tubes but still has had two ear infections. He did have to be hospitalized after getting sick right after one of his earlier vaccines.
Hives appeared first on face (mouth, ears, scalp) and then moved to trunk, both front and back.
BUD exp 04/13/23 Manf expiration 06/13/23
appendicitis/diagnosis was acute appendicitis with prerenal azotemia; appendicitis/diagnosis was acute appendicitis with prerenal azotemia; This is a spontaneous report from a contactable consumer. A 22-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 11May2021 12:45 (Batch/Lot Number: EW0176) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 on 20Apr2021 for covid-19 immunization (lot_number=ER8735,lot_unknown=False, administration_date=20Apr2021,administration_time=12:30 PM, dose_number=1,vaccine_location=Left arm]. He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced appendicitis/diagnosis was acute appendicitis with prerenal azotemia on 14May2021 10:00 with outcome of recovering, lower abdominal pain on 14May2021 10:00 with outcome of recovering. The patient was hospitalized for appendicitis/diagnosis was acute appendicitis with prerenal azotemia for 2 days.The patient was hospitalized for lower abdominal pain for 2 days.  The patient underwent lab tests and procedures which included computerised tomogram: acute appendicitis   on 14May2021, sars-cov-1 test negative: negative on 14May2021 Nasal Swab. Three days after receiving his second dose, he noticed lower abdominal pain, which resulted in visit to his primary care physician, who suspected appendicitis. He was immediately sent to the hospital for a CT scan that Friday night, and had surgery to remove my appendix Saturday morning. Official diagnosis was acute appendicitis with prerenal azotemia. He was discharged Sunday afternoon. Therapeutic measures were taken as a result of all events. The all events were reported as seriousness criteria of life-threatening.  Information on lot/batch number was available. Additional information has been requested.
On February 2nd woke around 07:50 that morning wasn't feeling well but her eye was foggy and she thought something was in her eye but when she looked out her left eye everything went blank. Went to the hospital the same day went to the Eye Center at the hospital and then got admitted into the hospital. Did a full stroke work up and examination of the heart. Was on a heart monitor for a month only thing they found was that her high blood pressure was really high. Patient is now blind in her left eye.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 12-MAR-2021 for prophylactic vaccination into left arm. The product was stored in appropriate temperature conditions and was properly stored from receipt to administration. It was unknown for how many times, and for how long (cumulative), the vaccine was removed from storage. No concomitant medications were reported.  On 20-SEP-2021, the patient got Covid and was really sick with Covid. It was reported that, the patient had Real-time reverse transcriptase-polymerase chain reaction (RTPCR) test done on vacation while she was there. She contacted her doctor. Laboratory data included: COVID-19 PCR test (NR: not provided), the swab was taken and she was contacted back on 21-SEP-2021 with a positive test result (confirmed covid-19 infection and confirmed clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20211022587-COVID-19 VACCINE AD26.COV2.S-Confirmed Clinical Vaccination Failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Headache; fever; This is a spontaneous report from a contactable nurse. A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:00 in left arm at single dose for COVID-19 immunization. Medical history included Crohn's disease from an unknown date. The previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Dec2020 14:30 in right arm at single dose for COVID-19 immunization. The patient's concomitant medications were not reported. The patient experienced headache and fever on 05Jan2021 01:00. The facility where the most recent COVID-19 vaccine was administered was in the hospital. 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 not been tested for COVID-19. The outcome of events was recovered in Jan2021. The patient was given over the counter medication as treatment for the events. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
This spontaneous report received from a health care worker refers to a patient of unknown demographics. No medical history was reported. On 01-SEP-2015 the patient was inadvertently vaccinated with VARIVAX (lot # K016127, route, dose and frequency: unknown) instead of PROQUAD due to a human error. No adverse event reported. No Product Quality Complaints (PQCs) was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Dizziness,  weakness,  burning hot to freezing cold, extreme fatigue,  nausea,  chronic pain in neck, red blotchy skin arms, back and chest. Today I'm starting 3rd day of symptoms.
Swollen / painful underarm area of left arm Started this afternoon.  No lessening in pain or swelling with ibuprofen.
covid 19 booster given pink cap 0.2 ml ( 10mcg) and the recommendation is blue cap 0.25 ml (25mcg)
PT received adult dose of Havrix (1 ml) instead of Havrix (0.5 ml). No symptoms or signs have developed or been reported by patients guardian.
fine rash on trunk w/fever of 101-102;tx w/APAP & DPH;bitten by neighbor's dog 28MAY95;seen in ER 4JUN95 w/cellulitis of facial bites that was treated w/Augmentin;dog died most likely from heat stroke;fine red rash on trunk;
Information has been received from a physician concerning a 31 year old white female, with no past medical history, no known allergies and no known illness at the time of vaccination, who on 25-JUL-2001 was vaccinated with a first dose of Meruvax II, administered SC, in the left deltoid. There was no known concomitant medication. It was reported that the vaccination was given "pre-pregnancy attempt". On 04-AUG-2001, in the evening, the pt developed a sore throat, rash on the back of her throat, rash on her face and arms and blister on her external nose and ears. On 07-AUG-2001 the pt was seen by a physician and treated with prednisone for 4 days. It was reported that she "feels febrile" but had not monitored her temperature. It was also reported that no laboratory tests were ordered by the primary care physician. Follow up information received 28-SEP-2001, from a RN, indicated that the PCP did not believe that the symptoms were related to vaccination nor to poison ivy. Subsequently the pt recovered. No further information is available.
pt recv vax 24JAN97 & had a  sz @ home & was adm to hosp 8 hr post vax;pt was afeb upon admission;A CT scan revealed a massive brain hemorrhage behind the eye;@ this date of this report pt remained hosp & required mechanical ventilation;
Positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive for Covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 (Positive for Covid). At the time of the report, COVID-19 (Positive for Covid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported by reporter. Patient received Moderna. Patient was positive of COVID. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment-This spontaneous case concerns a female patient of unspecified age with no medical history reported, who experienced the unexpected non serious AESI event of COVID-19 (reported as Positive for Covid) in the context of mRNA-1273 vaccination.  Latency cannot be assessed since vaccination date nor event onset date was not disclosed. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement; Sender's Comments: This spontaneous case concerns a female patient of unspecified age with no medical history reported, who experienced the unexpected non serious AESI event of COVID-19 (reported as Positive for Covid) in the context of mRNA-1273 vaccination.  Latency cannot be assessed since vaccination date nor event onset date was not disclosed. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement
Extreme headache within 30 minutes of injection. Rash/skin redness- didn?t notice until 7 hours later; chest and entire face going into part of neck. Fatigue.  I took some Tylenol and fell asleep. When I woke up, only my chest was slightly red and the headache had dulled some.
This is a spontaneous report from a contactable other healthcare professional, the patient. A 46-year-old non-pregnant female patient received the third dose (booster) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028) via intramuscular route of administration in the left arm on 24Nov2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via intramuscular route of administration in the left arm on 05Jan2021 at 12:00 (at the age of 45-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via intramuscular route of administration in the left arm on 26Jan2021 at 12:00 (at the age of 45-years-old); both as a single dose for COVID-19 immunisation. On 24Nov2021 at 12:15, the patient experienced left arm pit pain and swelling. The patient could not raise arm without pain and could not sleep on it. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm pit pain and swelling and can't raise arm without pain. can't sleep on it was not resolved at the time of this report.
I had typical side effects the day after the shot...nausea, achy, tired, etc. Two days after the shot (Tuesday late afternoon)...all of a sudden I have loud ringing in my right ear and pressure. I do have ringing issues regularly, but not like this. I normally hear a very faint ring and can only hear when it is really quiet in the room. This current ringing is loud and I hear it constantly. By Wednesday morning it was gone. It is now Thursday afternoon and it just came back.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In March 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by healthcare provider for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Not feeling well; Cough; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well) and COUGH (Cough) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MALAISE (Not feeling well) and COUGH (Cough). At the time of the report, MALAISE (Not feeling well) and COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.
At 8:30am, 2/26/21, He was asleep on chair in dining room. Very hard to wake him up! I got him to a recliner, but then he had to throw up. He said he was "foggy" and went to sleep when he got back to the recliner. At 11:45am, his blood pressure was 66/47, then 71/48 in his left arm. In his right arm, 74/51. He did have some top ramen soup and was feeling better. I took his temperature earlier and it was 96.1.
Pt. developed rash (blotchy) at injection site (4 x 2 inches). Rash was warm, swollen. MD states pt had cellulitis. Worsened psoriasis. Low grade fever 99.9. Hives on face also.
Sore arm; severe chills, fever (100.6 F), fatigue, nausea, moderately severe headache.
17 year old female vaccinated with Moderna COVID-19 vaccine in error as she was not 18.
received a vial that was punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vial that was punctured more than 12 hours ago) in a 3-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vial that was punctured more than 12 hours ago). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received a vial that was punctured more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was provided.  The vial was initially stored in the refrigerator and was first punctured on 15-Oct-2021 around 9-10 o'clock. the vial was stored at room temperature post puncture. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): Around 2 days.
This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 30 year-old male patient. On 09-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL for the prevention of influenza. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.