chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills?30 hours after lasted 4 hours. Headache?30 hours after lasted 12 hours. Ibuprofen. Body aches?30 hours after lasted 40 hours. Ibuprofen. Fatigue?30 hours after lasted 40 hours. Arm tenderness?lasted 40 hours.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old female patient who received HAV (Havrix 1440) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 31st January 2023, the patient received the 1st dose of Havrix 1440. On 31st January 2023, unknown after receiving Havrix 1440, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comments: Nurse reported 47-year-old female patient was administered a dose of Havrix on 31st January 2023, which had an expiration date of 30th January 2023. This was the patient's first dose in the series. At the time of reporting, the patient had not been re-dosed. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The patient received Havrix, which was already expired.
ACHES; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced aches, chills, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, aches and headache was not reported. This report was non-serious.
missing 2nd dose by 1 year; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: missing 2nd dose by 1 year).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 3-Oct-2023 The case was reported by the physician. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
This spontaneous report as received from a healthcare worker refers to 8 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2016, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (lot # L005292, expiration date: 17-AUG-2016) (strength, dose, frequency and route of administration were not reported). The PROQUAD (Merck) was stored at -4 Celsius degree for 145 days since January 2016. There was no adverse effect reported. Additional information has been requested.
LMP 1/24/2022 MODERNA BOOSTER RECEIVED ON 1/14/2022 FIRST TRIMESTER MISCARRIAGE CONFIRMED IN OFFICE VISIT ON 4/4/2022
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; TAMSULOSIN; JARDIANCE; LISINOPRIL; ROSUVASTATIN; LANTUS. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sore arm, large red patch at injection site, felt like sleeping for 1 week after ( so tired), within 2 months,  , walking difficulties, joint pain in both hips, both knees and left hand. Diagnosis: cyst removed left hand and arthritis in left hand. Inflamed left hip bursa, osteoarthritis in right knee.  Treatments all starting from Dec 2021.
pt recv vax 12SEP95 & child had an elevated temp (degree not specified) @ the time of vax;the next day child was hosp w/dx of viral meningitis;
pt devel chickenpox-reporter believes chickenpox from vax;pt feels infanct should not be vaccinated until older-felt child to young to have to deal w/chickenpox;
dry heave; tenderness; soreness; bladder problems; couldn't walk; chest pain & pressure; chest pain & pressure; headache; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heave), TENDERNESS (tenderness), PAIN (soreness), BLADDER DISORDER (bladder problems) and GAIT DISTURBANCE (couldn't walk) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RETCHING (dry heave), TENDERNESS (tenderness), PAIN (soreness), BLADDER DISORDER (bladder problems), GAIT DISTURBANCE (couldn't walk), CHEST PAIN (chest pain & pressure), CHEST DISCOMFORT (chest pain & pressure) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RETCHING (dry heave), TENDERNESS (tenderness), PAIN (soreness), BLADDER DISORDER (bladder problems), GAIT DISTURBANCE (couldn't walk), CHEST PAIN (chest pain & pressure), CHEST DISCOMFORT (chest pain & pressure) and HEADACHE (headache) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications were reported.  Symptoms: Patient reported that she dose not wanted to take second shot of vaccine.
Feel respiratory distress. A lot of wheezing accompanied by a cough as I cannot take in a full breath without coughing.
Child went to bed and mom heard shaking, seizure lasted about 90 seconds, Night nurse called one of our doctors, and he spoke to mom. Child was not seen at our office or any other medical facility after the seizure. Child does have seizure disorder but has been quiet for a while.
Patient started to become tired, disoriented and shaking. 911 called. Paramedics assessed. Patient opted not to go to hospital and left with her cargiver.
Patient came into the pharmacy and wanted group B meningococcal vaccine (TRUMENBA). This was given without incident. An hour or two later when she got home she called the pharmacy indicating she had passed out. I advised her to go to the emergency room. I called a few minutes later and she indicated that she was feeling much better and was getting something to eat.
molar's cracked; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH FRACTURE (molar's cracked) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007CZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Tomatoes and Mangoes).    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced TOOTH FRACTURE (molar's cracked). At the time of the report, TOOTH FRACTURE (molar's cracked) outcome was unknown.        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 reported. Consumer reported that no treatment was taken for the events.; Sender's Comments: Based on the nature of the event and physiologic plausibility, the event is assessed as unlikely related to mRNA-1273.
hives; a rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and RASH (a rash all over the body) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 012L20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced URTICARIA (hives) and RASH (a rash all over the body). At the time of the report, URTICARIA (hives) and RASH (a rash all over the body) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Information has been received from a healthcare worker (medical assistant) referring to unknown number of patients of unknown age and gender. Information about current conditions or medical history was not reported. The healthcare worker reported that on unspecified dates the patients might received doses of M-M-R II (lot#, dose, route not reported), that were exposed to temperatures of 0 degree C for 4 hours and 55 minutes. This is one of several reports from the same reporter. Additional information has been requested.
tested positive for covid-19; very hot; very tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for covid-19), FEELING HOT (very hot) and FATIGUE (very tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for covid-19), FEELING HOT (very hot) and FATIGUE (very tired). At the time of the report, COVID-19 (tested positive for covid-19), FEELING HOT (very hot) and FATIGUE (very tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's friend reported that the patient was  tested positive for covid-19, 7 to 10 days after the injection following an X-ray of lung and a Covid-19 test. Treatment details were not reported. Reportedly, the patient had fully recovered. Concomitant medications were not reported.
Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No concomitant medications were reported. No treatment medications were reported.  Reporter stated on 08-Oct-2022, 09-Oct-2022 and 10-Oct-2022, 26 doses to adult patients were administered from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster.  Reporter was not aware of any AEs after the vaccines were given.  This case is for the 12th adult patient out of 26 adult patients.
dose leaked out from syringe; dose leaked out from syringe; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (dose leaked out from syringe) and SYRINGE ISSUE (dose leaked out from syringe) 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 18-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (dose leaked out from syringe) and SYRINGE ISSUE (dose leaked out from syringe). At the time of the report, UNDERDOSE (dose leaked out from syringe) and SYRINGE ISSUE (dose leaked out from syringe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and no Concomitant medications were provided.
Information has been received from a registered nurse concerning a 55 year old female with hypertension who in 31-MAY-2007 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 655499/0988F).  There was no concomitant medication.  Subsequently the patient experienced "50 cent piece size" injection site reaction, the area was warm and sore.  The patient has not been seen by the physician but the registered nurse anticipated treatment of an unknown type.  At the time of the report, the patient had not recovered.  Additional information has been requested.
Papular rash on 6/6/13, generalized tonic-clonic seizure on 6/11/13.  Admitted to hospital on 6/12/13, started on IV Acyclovir.  DFA of the skin lesion positive for VZV.
Pressure to back of head when injected.  About 5 hours later chills and fever started.  Very tolerable.  An hour after that,  a bad  headache started.  It was unbearable.  IT WAS UNBEARABLE.  It lasted 40 hours. At that point I still had a bad headache but I could walk and talk. As the week went on it slowly got better. If I tried to do normal activities for a few hours, then I would get dizzy and more headachy again and would have to lie down.  So after a week of this  I called my family physician. Over the following week (week 2 after shot) I continued to feel better so I didnt call my doctor back. He instructed me to call in a week if I was not getting better.
Got sore on her arm; This is a spontaneous report from contactable consumer (patient's spouse) received from a Pfizer sponsored program. A female patient of an unspecified age received dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that "About the medication Celebrex being removed from the Patient assistance program. During the call caller stated the following about their experience with The Pfizer-BioNTech COVID-19 vaccine. The caller stated that My wife and I both we took the COVID shot both of them it was through Pfizer. We did not had no side effects my wife it kind of got sore on her arm on unknown date, but it was just like nothing on me I did not feel nothing". The outcome of the event was reported as unknown.   Note: The patient's first and last name and date of birth was not provided during the call.  The following information was not confirmed during the call, but retrieved from the system: Patient DOB.  Information about lot/Batch number has been requested
period arrived 5 days late after taking the vaccine. Patient had an extremely regular cycle and was never late. Now that it had arrived, it was not a normal flow (light). Late menstrual cycle.; This is a spontaneous report from a contactable consumer (the patient, reported for herself). A 36-year-old non-pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number and expiration date were not reported), via unspecified route of administration, in the right arm, on 07Mar2021 08:45 (at the age of 36-year-old), as unknown dose number, single, for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications was not reported. Patient did not receive other vaccine in four weeks and did not receive any other medications in two weeks. No COVID prior vaccination. The patient was not tested for COVID-19 since having the vaccine. On 09Mar2021, patient's period arrived 5 days late after taking the vaccine. Patient had an extremely regular cycle and was never late. Now that it had arrived, it was not a normal flow (light). Late menstrual cycle. Patient did not receive the any treatment for event. Outcome of the event was recovering.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
under left arm swelling , tender , lymphadenopathy  site of injection tender and sore body ache, left shoulder ache
Mild to fairly significant brain fog; Difficulty concentrating and remembering things; Difficulty concentrating and remembering things; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 05May2021 at 13:15 (at the age of-52-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history (no significant conditions). The patient had 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. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), lansoprazole (PREVACID), valaciclovir hydrochloride (VALTREX) and montelukast sodium (SINGULAIR) for unknown indication from an unknown date and unknown if ongoing. On 07May2021 at 14:30, the patient experienced mild to fairly significant brain fog, had difficulty concentrating and remembering things. 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 brain fog, difficulty concentrating and remembering things were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Fever, flu like symptoms, and body aches. Also large knot on the arm at injection site. Warm to touch.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 23-JAN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX, lot number L036823, expiration date 24-DEC-2016, (dose, route and anatomical location were not reported) for prophylaxis. No adverse events were reported. Additional information has been requested.
Temp 102; glands on neck swollen; tonsils had white patches on them; was given Ceclor and was better in 48 hrs;
Received immunization 02/14/05, swelling started 02/15/05 in the a.m. Cellulitis today in office (02/16/05), 8" by 6". Will treat with antibiotic. Area hard, red, swollen, warm to touch.
about 2 weeks after vaccine developed sudden onset of muscle weakness, pain, lack of coordination and progressed to numbness with tingling. Having difficulty with walking and physical exertion as well as sleeping related to the pain
Shortly after receiving the vaccine, he was coughing and said he felt a little tightness, I quickly gave him 2 Benadryl 25mg tablets and water, had him sit down. I checked on him every few minutes and he said the symptoms were improving. After about 25 minutes, he said he felt fine and was ready to go home. He was instructed to follow up at an emergency room.
Developed a red blotch on her arm three inches long by two inches wide; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Developed a red blotch on her arm three inches long by two inches wide) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced RASH MACULAR (Developed a red blotch on her arm three inches long by two inches wide). At the time of the report, RASH MACULAR (Developed a red blotch on her arm three inches long by two inches wide) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment was provided.    Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received on 21-APR-2021 contains telephone contact report.
Staff/patient reported that she woke up in the middle of the night because she was hot and noticed she had a very itchy arm and hives all over her body. Took benadryl at home and symptoms resolved and did not return.
fever av.104 F for 3 days, muscle aches, redness app. 4 ench where shot was given. Treated with Motrin for fever and Benadryl. Per annual report-He has cough very often.  We end up taking antibiotics.  I am very disappointed.
pt. recvd 1st dose of hepatis B vac & exp. nausea,h/a,dizziness,& chills.