chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Vaccine was thawed on 13-JAN-2023 and dose was administered on 17-FEB-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was thawed on 13-JAN-2023 and dose was administered on 17-FEB-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 17-Feb-2023, 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 17-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was thawed on 13-JAN-2023 and dose was administered on 17-FEB-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was thawed on 13-JAN-2023 and dose was administered on 17-FEB-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was thawed on 13-JAN-2023 and dose was administered on 17-FEB-2023).    Concomitant drugs were not reported. It was reported that the vaccines were thawed on 13-Jan-2023.  It was also reported that no symptoms were reported at that time. Treatment medications were not provided. This case was reported for patient 3 of 4.   This case was linked to US-MODERNATX, INC.-MOD-2023-712038, US-MODERNATX, INC.-MOD-2023-712309, US-MODERNATX, INC.-MOD-2023-712275 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712038:Master case US-MODERNATX, INC.-MOD-2023-712275:Patient 2of 4 US-MODERNATX, INC.-MOD-2023-712309:
Chills, nausea, fatigue, body aches, "itchy" sensation. Symptoms resolved after 4 days w/out intersection except symptomatic treatment (Motrin, anti-emetic)
Patient started having pain prior to her injection on 3/11/21.  On 3/12/21, she started bleeding, and on 3/14/21 she miscarried at 13 weeks.
Mild redness and swelling without pain noticed at the injection site in right deltoid, the day after MENVEO vaccine given.  The second day, increased redness and swelling with warmth noticed with complaint of discomfort and tightness in arm when moving shoulder joint.  No fever.
On 7/3/21 in early morning, case was hospitalized due to Covid symptoms including Shortness of Breath, Fever, Cough, Nausea, Vomiting, Diarrhea, Headache, Fatigue.
get so sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media  on 24-Nov-2020.  This case involves a patient of unknown age who reported that the patient got so sick after the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient stated that the patient got so sick (sickness) after the patient got the shot.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
Pt w/ knot and pain to right arm approx 2-3 inches round, which progressed to swelling around rt arm and down rt forearm with redness; cellulitis diagnosed by ultrasound with cephalic vein thrombophlebitis; pt febrile w/ temp of 103 F; iv antibiotics initiated 3/10/10; iv fluids required for hypotension to 90/55.
not feel right; Nauseous; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple sclerosis.   On 5th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced feeling unwell, nausea and influenza-like symptoms. On an unknown date, the outcome of the feeling unwell, nausea and influenza-like symptoms were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, nausea and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient had 2nd shot and the patient did not feel right. The patient also had nauseous, flu-like symptoms. The patient asked how long side effects would stay.
seen 26AUG96 w/mom stating pt has had elevated temp since recv vax on 22AUG96;mom also states dec fluid intake & dec appetite;afeb @ ER visit;
feeling tired; achy; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 2nd of two reports. A patient of unspecified age and gender received bnt162b2 (Covid-19 vaccine) , via an unspecified route of administration on 16Dec2020 at single dose for immunization.  The patient's medical history and concomitant medications were not reported. The consumer had two friends who are health care professionals who received the Covid-19 vaccine on 16Dec2020. They just reported feeling tired and achy in Dec2020 to the consumer. The outcome of the events was unknown.   Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020501278 same reporter/drug/event, different patient
No additional adverse events; administered improperly stored; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 29-SEP-2021, the patient was vaccinated with incorrectly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 ml, lot # T027115 with expiration date on 07-FEB-2021 (route of administration was not reported) for prophylaxis. No adverse event was reported. The vaccine experienced excursion of 8.5 degrees Fahrenheit for 18 minutes and 11.9 degrees Fahrenheit for 1 hour.
This spontaneous report was received from a pharmacist, referring to a 24 year old patient. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On 22-SEP-2018 the patient was vaccinated with M-M-R II (strength, dose and dose number were not reported) lot number N019126 (recombinant human albumin (rHA)), expiration date on 22-JUN-2019, for prophylaxis, intramuscularly rather than the recommended subcutaneous route. Concomitant therapies included sterile diluent (MERCK) (lot number N028090, expiration date on 13-FEB-2020). No adverse effects were reported.
3" x 2" area of redness to the right and below the actual injection site. The area is feverish and painful (pt states she cannot sleep on her arm, too painful). Contacted Dr at the patient's request. They stated this was an expected side effect and pt didn't need a followup appointment or further care.
18 minutes post vaccine dose 1, Pfizer COVID vaccine, development of globus sensation without airway compromise or stridor.  Frequent throat clearing and swallowing.  Followed by diaphoresis, loss of vision, extreme neuropathic tingling over entire head non painful.  Bradycardic event to heart rate 35 recorded by Apple watch.  Loss of consciousness with pupil dilation.  Weak pulses but no loss of pulse.  Heart rate recovered quickly.  Blood pressure after initiation of iv fluids was normal in upright position once loss of consciousness subsided.  Continued globus sensation.  30 minutes after initial event, again developed clammy hands, head tingling and worsening globus sensation but again no stridor or airway compromise.  Given PO Benadryl 25 mg which did resolve globus sensation in next 30 minutes.  Monitored for one hour post event with no subsequent symptoms other than fatigue.
Red inflamed 5" x 2" hot reaction at injection site. No pain itching or swelling. Temperature of ~100 F
scheduled to take their second dose on 26th Jan2021 but could not; tested positive few weeks after receiving first dose of Moderna Covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive few weeks after receiving first dose of Moderna Covid-19 Vaccine) and PRODUCT DOSE OMISSION ISSUE (scheduled to take their second dose on 26th Jan2021 but could not) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Heart disease, unspecified and Cholesterol.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced COVID-19 (tested positive few weeks after receiving first dose of Moderna Covid-19 Vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (scheduled to take their second dose on 26th Jan2021 but could not). At the time of the report, COVID-19 (tested positive few weeks after receiving first dose of Moderna Covid-19 Vaccine) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (scheduled to take their second dose on 26th Jan2021 but could not) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Diabetes pills, Heart pills, water pill, Cholesterol medication, not otherwise specified.  No treatment details were provided.   This case was linked to MOD-2021-213385 (E2B Linked Report).; Sender's Comments:  MOD-2021-213385:MOD-2021-213385 (WifeCase)
Itching by her wrist; Red bumps on legs, torso and up to hip; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching by her wrist) and RASH MACULAR (Red bumps on legs, torso and up to hip) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 042120A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Temperature extremes makes her react with bumps on back.). Concomitant products included VITAMINS NOS for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PRURITUS (Itching by her wrist) and RASH MACULAR (Red bumps on legs, torso and up to hip). At the time of the report, PRURITUS (Itching by her wrist) and RASH MACULAR (Red bumps on legs, torso and up to hip) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitants - bariatric medicine, osteoporosis medicine, for bladder sensitivity. Treatment information as not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.   This case was linked to MOD-2021-021562 (Patient Link).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Received vaccines on 08/12/2005 Friday.  Developed big red rash and swollen leg around injection site.  Mom gave Benadryl and rash went away - rash came back Sunday - gave Benadryl again and rash resolved.  No fever, eating and drinking okay.
Backache, ache all over upper body, lethargic, chills, headache.  Took Acetaminophen, bed rest.  Almost all symptoms gone next afternoon.
Pain to left shoulder and swelling, no cellulitis. Predinsone 40 mg x2 days, tylenol.
Initial report received from a nurse on 16 Feb 2011: This patient was vaccinated with MENVEO (batch number A100028) 0.5 ml dose, intramuscularly on 09 Feb 2011. The patient received MENVEO lyophilized powder reconstituted with saline instead of liquid conjugate component 09 Feb2011. No other information reported.
PT HAS SHINGLE BROKE OUT AFTER RECEIVED THE VACCINE AND NEEDED TREATMENT FOR.
No adverse reaction reported. To whom it may concern: In November 2022 our state immunization program did our every-other-year audits in both our offices. It was discovered at that time, that some covid vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received from the state.) The state program directed us to fill out VAERS forms and send them to you. The state also counseled us that it was our providers and parents joint decision as to whether to re-vaccinate pts or not. We only use Pfizer vaccines for covid-and the list lot #s given outside the expiration date are listed below.  FM0698 (orange top)      FM0698 (purple) FM0698 (purple top)       FP4554 (purple) FL8095 (orange top)      FL8094 (orange) FL8094 (orange top)      FL8095 (orange) FM7553 (purple)            FT1551 (orange) Please see the attached VAERS forms, and feel free to contact the office for further questions or concerns.
Facial redness/swelling/fussy. Pt went to ED; given TYLENOL and discharged.
Pt vaccinated with MMR on 30AUG90  developed macular erythema some papules on trunk arms, thighs, pruritic fadingly 22JUL90.
Although I had no allergies, I broke out in painful Hives and bumps. I went to a Dermatologist and was given, Dermagran, Prednisone, Benadryl and Claritin. It seemed to help it clear up a little, but the condition is still there mildly.
Woke up in the night with chills, shakes, and feverish symptoms; Woke up in the night with chills, shakes, and feverish symptoms; Woke up in the night with chills, shakes, and feverish symptoms; Soreness of the body; Headache; Slight soreness of the arm; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 20Apr2021 at 11:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 30Mar2021 at 11:15 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021, the patient experienced slight soreness of the arm later in that day. On 21Apr2021 at 03:00, the patient woke up in the night with chills, shakes, feverish symptoms, soreness of the body and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 event slight soreness of the arm was resolved on an unknown date in Apr2021 and of the events woke up in the night with chills, shakes, feverish symptoms, soreness of the body and headache was resolved on 21Apr2021.  No follow-up attempts are needed. No further information is expected.
Pain occurred w/in 12 hours of injection. 3 days later red rash to left arm (upper) and edema noted from shoulder to mid forearm.
Redness spreading around the arm and in armpit, itching, numbness, tingling sensation in arm, extreme pain. lasted for weeks.
I was 6 weeks pregnant and I started cramping and bleeding within two days of receiving the vaccine. I went to my obgyn on Wednesday and on Thursday I was in Urgent Care and having a complete miscarriage. 11/19/09 Medical records received for date 10/30/09. DX: probable complete abortion.  F/u for SAB. pt began to bleed on 10/26 and increased bleeding on 10/29. Decreased beta HCG. 12/7/2009 Ed records for 10/29/2009, RLQ abd pain, heavy vaginal bleeding with clots
Client (Vams-118951653) moved before receiving the injection and the needle came out. with Dad's help in securing the client, she successfully received the vaccine in the other arm (Left).
tachycardic event, Heart rate 106, febrile - temperature 99.9, inflammation at injection site
RASH COVERING BUTTOCKS AND BACKS OF THIGHS, BEGINNING 24 HOUR POST VACCINATION
Extreme chills, tachycardia at rest (130s), fever 101.5, shortness of breath at rest, tachypnea, headache, extreme weakness, sore throat, swollen throat, numbness in extremities.  Treatment- rest, benadryl, excedrin migraine
When I woke up, I could barely get out of bed; extreme fatigue; chills; body aches all over; nausea; temperature; weakness; pain at the injection site that continued through the night; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weakness), VACCINATION SITE PAIN (pain at the injection site that continued through the night), MOBILITY DECREASED (When I woke up, I could barely get out of bed), FATIGUE (extreme fatigue) and CHILLS (chills) in a patient of an unknown age and gender 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 29-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site that continued through the night). On an unknown date, the patient experienced ASTHENIA (weakness), MOBILITY DECREASED (When I woke up, I could barely get out of bed), FATIGUE (extreme fatigue), CHILLS (chills), MYALGIA (body aches all over), NAUSEA (nausea) and PYREXIA (temperature). At the time of the report, ASTHENIA (weakness), VACCINATION SITE PAIN (pain at the injection site that continued through the night), MOBILITY DECREASED (When I woke up, I could barely get out of bed), FATIGUE (extreme fatigue), CHILLS (chills), MYALGIA (body aches all over), NAUSEA (nausea) and PYREXIA (temperature) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information was not provided.
Watery diarrhea; has not had a regular bowel movement; lost about 35-40 pounds; does not have appetite to eat; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Watery diarrhea), BOWEL MOVEMENT IRREGULARITY (has not had a regular bowel movement), WEIGHT DECREASED (lost about 35-40 pounds) and DECREASED APPETITE (does not have appetite to eat) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 007M20A) 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 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced DIARRHOEA (Watery diarrhea), BOWEL MOVEMENT IRREGULARITY (has not had a regular bowel movement), WEIGHT DECREASED (lost about 35-40 pounds) and DECREASED APPETITE (does not have appetite to eat). At the time of the report, DIARRHOEA (Watery diarrhea), BOWEL MOVEMENT IRREGULARITY (has not had a regular bowel movement), WEIGHT DECREASED (lost about 35-40 pounds) and DECREASED APPETITE (does not have appetite to eat) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Colonoscopy: Negative. In 2021, Computerised tomogram abdomen: (Negative) no inflammation or diverticulitis. In 2021, Endoscopy: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included Omeprazole and Pepcid.
Adacel given to a patient over 64 years of age, no AE; Initial information received on 14-Sep-2020 regarding an unsolicited valid non-serious case received from a physician via phone.  This case is linked to case 2020SA25090 (same reporter).  This case involves male patient (age over 64-year-old) who was vaccinated with a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number and other dosing details were not reported) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration (latency was same day).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Patient developed Bell's palsy approximately 2 weeks after receiving ZOSTAVAX. Symptoms have gradually improved over the course of several months. Still says she has some twitching in her left eye on occasion. Patient was treated with Prednisone (60mg daily x5 days), VALTREX (1 G TIDx7 days), and physical therapy (8 sessions).
Large, raised rash around injection site, which consists of two round areas, like it has spread throughout the day. Slightly itchy, feels a bit like a bad, big mosquito bite. Red and splotchy around the edges. Not tender to the touch.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history reported. On an unspecified date since 01-APR-2016, the patient was vaccinated with improperly stored doses of PROQUAD (Merck) lot number L040412, expiration date 13-APR-2017 and lot number L030587, expiration date 10-FEB-2017. Albumin status for lot number L040412 and L030587 was determined to be recombinant human albumin (rHA). The nurse could not specify the lot of PROQUAD (Merck) that the patient received and stated that it had to have been one of the other for this patient. The temperature excursion for PROQUAD (Merck) was 33.8 F for a timeframe of 6 hours and 45 minutes. After excursion, the temperature went back to range. Digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.