chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 45-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec 2021, Jan 2022, and Feb 2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patients. No treatment medications were reported.
Breakthrough case admission after 4 vaccines Pfizer 2/10/21 Lot# El9267;  Pfizer 3/3/21 Lot# EN6205;  Pfizer 9/28/21 Lot# FF2588;  Pfizer 7/17/22 Lot# FP7139
Diarrhea after blood in stool @ 8pm after vaccines were given at 10:30 am same day on 1-11-10.
FELT VERY THIRSTY; CHILLS; FELT LIKE GOT A HIGH FEVER; HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight was 255 pounds, and height was 69 inches. The patient's concurrent conditions included seasonal bronchitis, heat intolerance, and seasonal asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amoxicillin for chronic bronchitis.  On MAR-2021, treatment medications included: naproxen. On 16-MAR-2021 22:00, the subject experienced felt very thirsty. On 16-MAR-2021 22:00, the subject experienced chills. On 16-MAR-2021 22:00, the subject experienced felt like got a high fever. On 16-MAR-2021 22:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt very thirsty, chills, felt like got a high fever, and headache on 18-MAR-2021. This report was non-serious.
Pt was to received pfizer booster following primary series.  Patient received the lower pfizer dose. PArents consented to vaccinate pt with appropriate dose.
heart rate went really high / fast heart rate; blood preassure shot up; This case was reported by a consumer via other and described the occurrence of heart rate increased in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced heart rate increased and blood pressure high. On an unknown date, the outcome of the heart rate increased and blood pressure high were recovered/resolved.   It was unknown if the reporter considered the heart rate increased and blood pressure high to be related to Shingrix.  Additional details were provided as follows: The patient received Biotech COVID 19 vaccine on an unknown date. After receiving Shingrix, the patient's heart rate went really high, her blood pressure shot up and paramedics came. The reporter stated she was not sure if what was happening what directly related to the vaccine because the reaction was 24 hours later. The reporter stated she was not sure if she should receive the Pfizer COVID vaccine or not. She also would like to know if there might be a connection or common ingredient in the Pfizer COVID vaccine. For the tolerance of 2nd dose, refer linked case US2021AMR027274.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR027274:same patient
Pt experienced diarrhea at 0300 today with vomiting. Pt had body ache and feeling weak, Temperature was 101 at 0930 this morning. Pt has minimal coughing at this time. Current temperature is 99.9  The pt denies any SOA prior or currently at this time. The pt was informed to eat small amount of crackers as tolerated and fluids as tolerated. Get plenty of rest. Should sx's worsen or SOA occur, then call for an ambulance for assistance.
A nurse reported that a 56 year old female received an injection of Flu Shield (2000-2001 Formula). Subsequently, she developed an injection site reaction characterized by redness, soreness and warmth which extended to her elbow. The symptoms resolved in 5 days. A 15-day follow up report received 5/15/2002 adds: Follow-up info received on 02/05/2002 indicated that the pt received an injection of Flu Shield (2000-2001 Formula) on 12/04/2001. That same day, the pt developed the injection site reaction.
SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Pt recv vax on 10/5/98; on 10/6/98 pt exp swollen/red arm at vax site x 2 wk
subcutaneous injection; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (subcutaneous injection) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (subcutaneous injection). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (subcutaneous injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. No treatment medication was reported.
Medical Asst. administered, in error, an "injectable" flu vaccine "intra-nasally". The precipating events are as follows:  1)On 10/23 at 0615a, vaccines were incorrectly dispensed by Pharmacist ; specifically, the correct 500 doses of injectable vaccine was correct but the 60 doses of  "Fluarix" was incorrect (correct vaccine is "FluMist").  2)MA administered the vaccine intranasally althougth she questioned is looked different there was a plastic valve that somewhat mirrored the one on the FluMist.   3)Employee/patient described the feeling of fluid down her throat not that of a mist which caused MA and her concern enough to discuss with writer who was adminstering other vaccines and TB Tests at the time.   4)MA states she examined the insert after and furthered questioned the vaccine administration but did not immediately recognize is was IM administration only. Potential Injury: Pharmacy contacted the manufacturer rep and confirmed there are no adverse reactions due to the injectable form of vaccine being administered/absorped into the nasal mucosa; no mild irration was noted by patient when contacted several hours later; no benefit of immunity is obtained by this method.  Readministration of injectable or intranasally was recommended.  Additional Comments:1) Pharmacy notified of error in dispensing of vaccine in order to determine process defects or procedural concerns. 2) Medical Assistants not considered qualified to make medical/clinical decisions that require judgement. MA did question the unusual container after the employee/patient commented after the the medical was administration, she did review the insert (per patient) and mentioned to writer that it looked different.  3) The RNs responsible for ensuring the vaccine is correct; RNs take some responsibility for not reading carefully the product packaging and/or insert. RN at the time of pick up from Pharmacy and writer after incorrect administration.  4) A 2nd occurrence happened several minutes later 5) VAERS report will be completed
Nasal Congestion for 2 weeks post 1st Hep B vaccine. Then....Fever, Cough, Nasal Congestion, Headache after 2nd injection of Hep B. No redness, irritation or swelling at injection site. Patient told to take Tylenol for fever and call or return if symptoms worsen or does not improve in 2 days.
Pt received flu and pneumonia vaccine. Pt experienced swelling/rash/redness on lower half of arm.
Onset 5/21/2000, local soreness, swelling, fever in area and upper back soreness X 1 week.
Fever for two weeks, nausea without vomit, shortness of breath and difficulty breathing since receiving vaccine, nothing "tasted good" but not complete lose of taste. Stomach is still "weak."
This solicited report was received from a physician, referring to a 16 year old male patient, who was enrolled in a Market Research. The patient's medical history, concomitant therapies and concurrent conditions were not provided. On an unknown date, the patient was accidentally given the 4th dose of GARDASIL (lot#, expiration date, concentration and route were unknown) for prophylaxis.The reporter was not sure if the patient was already gave 3 or 2 doses, and this dose was an extra dose. The reporter considered the adverse event was not serious. Additional information is not expected, because the reporter is not willing to discuss further.
0.2ml dose given without dilution - no immediate effects; 0.2ml dose given without dilution - no immediate effects; fatigue; nausea; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 6-year-old female patient received BNT162b2 (BNT162B2), on 30Jun2022 as dose 3 (booster), single (Lot number: PAA177913) at the age of 6 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "ADHD (attention deficit hyperactivity disorder)" (unspecified if ongoing), notes: ADHD (attention deficit hyperactivity disorder). Concomitant medication(s) included: CETIRIZINE; MELATONIN. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: FK5127; Location of injection: Arm Right; , Administration Time: 10:15 AM; Route of Administration: Intramuscular), administration date: 07Dec2021, when the patient was 6-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: FK5127; Location of injection: Arm Right; Administration Time: 10:45 AM; Route of Administration: Intramuscular), administration date: 03Nov2021, when the patient was 6-year-old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 2022, outcome "recovered" (2022); NAUSEA (non-serious) with onset 2022, outcome "recovered" (2022); OVERDOSE (non-serious), PRODUCT PREPARATION ISSUE (non-serious) all with onset 30Jun2022 at 11:30, outcome "recovering" and all described as "0.2ml dose given without dilution - no immediate effects". Therapeutic measures were taken as a result of fatigue, nausea. Therapeutic measures were not taken as a result of overdose, product preparation issue.  Additional information: Patient had no other vaccine in four weeks. Patient had no COVID prior vaccination and not tested for COVID post vaccination. Patient had no known allergies. Device timestamp: 01Jul2022. The patient did not have relevant test and not specific relevant test for thromboembolic events with thrombocytopenia. The reporter assessed the events as non-serious. The patient received Zofran as a treatment medication for nausea and ibuprofen as a treatment medication for fatigue. Mixing diluent did not happen prior to dose given.   Follow-Up (07Jul2022): Follow-up attempts are completed. No further information is expected.  Follow-up (27Jul2022): This is a spontaneous follow up report from a contactable nurse. This nurse reported for the patient in response to HCP letter (sent to physician) via follow-up letter. Updated information included: At risk classification removed. Reporter details added, suspect details added, new events of nausea and fatigue added and additional information updated.
36 hours duration: Pounding headache, chills and fever, severe nausea, lethargy and sleepiness
Adverse event is  that the vaccine was administered out of the scheduled time. Pt was monitored for 15 min after administration, educated on vaccine side effects and potential adverse effects, no obvious signs of distress noted. Pt didn't report any adverse effects during monitoring.
Shortly after arrival to post vaccination area, patient complained of feeling dizzy with headache. Headache reported 5/10 on 0-10 pain scale VS BP:166/104, p76. 1155 BP 147/100 P76; 1200 Reports dizziness is resolved. 1204 Reports headache still lingering, but is more pressure than pain. 1210 No pain with headache, only slight pressure. Feels good enough to be released.
2 days after shot, patient began having finger and toe tingling, continue to have weakness of hands and feet the following day. Then, started to have weakness of arms and legs and left side of face didn't seem to be working correctly per mom
developed extremely vivid dreams; This spontaneous case was reported by a physician and describes the occurrence of ABNORMAL DREAMS (developed extremely vivid dreams) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 and Vivid dreams (when he was ill with COVID. Those dreams had resolved had comeback with each dose of vaccine.).    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABNORMAL DREAMS (developed extremely vivid dreams). At the time of the report, ABNORMAL DREAMS (developed extremely vivid dreams) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the patient developed extremely vivid dreams where patient was ill with COVID and that the dreams had resolved have comeback briefly with each dose of vaccine. After receiving the bivalent vaccine patient had three or four nights of vivid dreams that awoke from the sleep. They were extremely detailed.  No treatment medications were reported.   This case was linked to MOD-2023-708149 (Patient Link).
fever started 1 day later up to 102.0 up screaming all noc;sx lasted;
Starting 6 days after the vaccination, I began to have itching, burning, discomfort and aching in the muscles of both buttocks symmetrically. It progressed bilaterally down to the soles of both feet over the course of 10 days. I had numbness in a saddle distribution, with multiple patches of cutaneous anesthesia from waist down. I lost feeling in my genitalia. I had urinary frequency, urgency and nocturia. I became constipated with little to no bowel movements for almost 2 weeks. Laxatives did not provide relief. It was very painful to sit at first. 7 days into the progression of symptoms it also hurt to stand. I could not extend my legs at the knee.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 30-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). On 03-JAN-2019, the patient was vaccinated with improperly stored ROTATEQ (lot # R015435, expiration date 17-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
sore arm at injection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at injection site) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M21A and 001B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, LISINOPRIL and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm at injection site) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (sore arm at injection site) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment drugs were reported. She is concerned about why she doesn't have antibodies to the vaccine and wants answers.   This case was linked to US-MODERNATX, INC.-MOD-2021-086192 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086192:Case for dose 2
Injection site swollen and red; injection site started to itch; Injection site swollen and red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site started to itch), VACCINATION SITE ERYTHEMA (Injection site swollen and red) and VACCINATION SITE SWELLING (Injection site swollen and red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site started to itch) and VACCINATION SITE ERYTHEMA (Injection site swollen and red). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Injection site swollen and red). At the time of the report, VACCINATION SITE PRURITUS (injection site started to itch), VACCINATION SITE ERYTHEMA (Injection site swollen and red) and VACCINATION SITE SWELLING (Injection site swollen and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
2nd Covid Vaccine - Within the first 24 hours developed a red oval (approximately 2?)  irritation at injection site. It?s very sore and the whole red oval feels hard. It doesn?t itch and I?ve not contacted anyone about this. I?m expecting this to clear up on its own but if not I will contact my primary doctor.
Patient w/ known glioblastoma multiforme (last temozolomide on 3/25/21), had falls and balance loss x4 days around the same time she received the COVID-19 vaccine so admitted to the hospital and found to have cerebral edema