chrisvoncsefalvay/vaers-outcomes huggingface dataset:
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        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 (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medication was reported.  190 patients (9 different lot numbers) received a vaccine past the beyond used by date.  It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No treatment medication was reported.  This case contains information for the 75th of 190 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
sick for a whole two years after the COVID shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFCTURER UNKNOWN, Lot number and expiration date not provided.), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick for a whole two years after the COVID shot".  Additional Information: The reporter's son got his second COVID shot and got sick and had reported adverse side effects. Reporter had turned in all the paperwork, and needed to know what can be done for reimbursement to the son for being sick for a whole two years after the COVID shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient began having swelling of the lips the night she received the vaccine. She reportedly took a dose of diphenhydramine at that time, but the swelling later returned. As of this time (2/19) she has not sought medical attention for this adverse event.
rash with hives. Started on right arm 12 hours post 1st vaccination and rash and hives spread to back and legs. Duration = 5 days Rash and hives resolved 5 days.
felt weak; dizzy; had a high temperature; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had side effects from the 1st dose so won't be able to take the 2nd dose on the 22Apr2021. It was reported 3 days after the 1st dose patient felt weak and dizzy, he had a high temperature. He's not sure if he had a virus prior to the 1st dose. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient moved during vaccination attempt and over half of COVID 19 vaccine was not injected intramuscularly. Patient returned on 6/23/22 to another mobile vaccine clinic to receive full dose appropriate for her age.
Local reaction at left deltoid where DTAP and IPV were given 24 hours ago. Mild uniform erythema extended from shoulder to elbow. Indurated about 6cm central deltoid.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 03-JUN-2016, the patient was vaccinated with improperly stored M-M-R II (lot # L003855 and expiration date 05-FEB-2017; lot L026553 and expiration date 16-JUL-2017, albumin status therapy type, dose and route of administration were not reported) and VARIVAX (lot # L039092 and expiration date 06-OCT-2017; lot # L043622 and expiration date 03-NOV-2017; lot # M004326 and expiration date 25-JAN-2018, dose and route of administration were not reported). On 06-JUN-2016, the patient was vaccinated with improperly stored VAQTA (lot # M011116 and expiration date 17-JUN-2017; lot # K008333 and expiration date 10-MAR-2017, dose and route of administration were not reported) and GARDASIL 9 (lot # L045711 and expiration date 08-MAY-2017; lot number M004116 and expiration date 12-OCT-2017; lot number L011846 and expiration date 16-JUN-2017, dose and route of administration were not reported). On 27-JUN-2016, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # M006708 and expiration date 02-JUN-2018; lot # L033343 and expiration date 13-SEP-2017, dose and route of administration were not reported). The maximum temperature of excursion of M-M-R II, VAQTA, GARDASIL 9, RECOMBIVAX HB (lot # L033343 and expiration date 13-SEP-2017) was 22.7 Celsius degrees with the frame of 3 hours and 48 minutes and the minimum temperature of excursion was 0.2 Celsius degrees with the time frame of 31 hours and 1 minute. The maximum temperature of excursion of VARIVAX was minus 5.2 Celsius degrees with the time frame of 50 hours and 17 minutes. The maximum temperature of excursion of RECOMBIVAX HB (lot # M006708 and expiration date 02-JUN-2018) was 22.7 Celsius degrees with the time frame of 3 hours and 48 minutes and minimum temperature of excursion was 0.2 Celsius degrees with the time frame of 7 hours and 36 minutes. There were no known adverse effects. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Hot red rashes on neck, chest and top of breasts  March 2021 to July  severe headaches shooting up left and right side on back of head March 2021 to July exhaustion March 2021 to present Patchy rashes and bumps August 2021 to present
Information has been received from a health professional concerning a patient who was vaccinated with a dose of GARDASIL. Concomitant therapy included a dose of VARIVAX (MSD). Subsequently, the patient experienced a "10 x 8 centimeter of left arm redness, warmth and tender," No medical attention was sought. At the time of this report, the patient's outcome was unknown. Additional information has been requested. This is in folow-up to report (s) previously submitted on 7/16/2007. Information has been received from a health professional concerning a patient who was vaccinated with a dose of VARIVAX vaccine (Merck). additional information has been requested. This report was previously sent to FDA V501.
Per parent phone call: anaphylaxis reaction after receiving travel shots en route home when he had trouble breathing. Stopped at emergency room - released to home after 2 hrs with tagament and steroid
I experienced heart palpitations, fever of 105, tachycardia around 03:00AM on 02/17/2021 and called my doctor who wanted me to come in so an EKG could be performed; however, I decided to play it by ear and the symptoms subsided so I did not go to see my doctor. I assessed myself since I'm a Physician.
Red circular swelling at injection site; forearm and wrist swollen, wrist itchy.
she had Myalgic Encephalomyelitis syndrome for many many years and was mostly wheelchair bound. Shortly after the covid vaccine she is remarkably better.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. Relevant medical history included: "Myalgic Encephalomyelitis syndrome" (unspecified if ongoing); "mostly wheelchair bound" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "she had Myalgic Encephalomyelitis syndrome for many many years and was mostly wheelchair bound. Shortly after the covid vaccine she is remarkably better.".  Additional information: Reporter reported of an amazing effect someone reporter know had with the Pfizer vaccine. She has had Myalgic Encephalomyelitis syndrome for many years and was mostly wheelchair bound. Shortly after the COVID vaccine she is remarkably better. Amazingly better. Reporter trying to have someone in Pfizer involved with the COVID vaccine to talk to her or her doctor in regard to this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
9/26/2022: 7:30pm began experiencing mild nausea, fatigue, chills and hot flashes intermittently, lasting until 9/29. 9/28/2022: 11am began experiencing nausea, fatigue, lightheadedness, slight numbness in both hands (could still feel and move them, but dulled senses). Heart rate sat at 77 bmp, temperature was recorded at 97.7 by non touch thermometer. Symptoms lasted until 4:40pm. Nausea and fatigue continued until 9/29.
Sever body aches and fever complicated by shortness of breath episode.  SOB started at 2:00 AM almost 12 hours after the vaccine administration and lasted 20-30 min. Fever and body aches started at 10:00 PM 05.04.21 and continued through 05.05.21
This spontaneous report was received from a physician and refers to a 13-month-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 10-SEP-2018, the patient was vaccinated with PROQUAD, lot# R012416 with expiration date on 28-OCT-2018 (dose, route and site of administration were not reported) for prevention of measles, mumps, rubella and varicella. On 11-SEP-2018, the patient came to the physician's office with chicken pox-like rash over the lower body. No treatment was given for the event. At the time of the report the patient was recovering from the rash. Causality assessment between the event and vaccination with PROQUAD was not reported.
Vivid dreams multiple times every night; He wakes up many times and is Not being able to sleep right ,he's still waking three or four times a night.; His left sinus keeps getting infected; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (Vivid dreams multiple times every night), INSOMNIA (He wakes up many times and is Not being able to sleep right ,he's still waking three or four times a night.) and SINUSITIS (His left sinus keeps getting infected) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042C20A and 022M20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE for Blood pressure high, LITHIUM for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABNORMAL DREAMS (Vivid dreams multiple times every night), INSOMNIA (He wakes up many times and is Not being able to sleep right ,he's still waking three or four times a night.) and SINUSITIS (His left sinus keeps getting infected). The patient was treated with MELATONIN for Insomnia, at an unspecified dose and frequency. At the time of the report, ABNORMAL DREAMS (Vivid dreams multiple times every night) and SINUSITIS (His left sinus keeps getting infected) outcome was unknown and INSOMNIA (He wakes up many times and is Not being able to sleep right ,he's still waking three or four times a night.) had not resolved.            Reporter did not allow further contact
Not able to sleep; Trouble breathing; Throat closed up; Tired all day; Coughing; Feeling achy; This is a spontaneous case, initially received from other non-health professional via Communications (reference number: SEQ19-02681) on 13-Sep-2019, concerning a 65-year-old, female patient.   The patient's medical history included Augmentin (amoxicillin, clavulanic acid) for unknown indication.   On 12-Sep-2019, the patient was administered Fluad [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose, route of administration, anatomical location, batch number and expiration date: not reported] as protection against seasonal influenza.  On the same day, 12 hours after vaccination, the patient's throat closed up and she had trouble breathing. The patient was not able to sleep, had been tired all day, along with coughing and feeling achy. As reported, the patient had a reaction similar to this after taking Augmentin years ago, but at that time, she also had a rash, which she did not have now.   The patient did not seek medical treatment, but it was unknown if she received any treatment.  At the time of initial reporting, the outcome of the events was not resolved (reported as ongoing).  The reporter assessed the case as serious and did not provide causality assessment.  The reporter did not give consent to be contacted for further information.  Company comment: A 65-year-old, female patient experienced insomnia, dyspnoea, throat tightness, fatigue, cough and pain after vaccination with the suspect product Fluad (TIV). Chronology is plausible. Reportedly, the patient had a reaction similar to this after taking Augmentin years ago. Patient medical history of reported Augmentin reaction with similar events suggest presence of allergic predisposition which was not reported. Presence of adjuvants in vaccine (egg-derivates) may have triggered some sort of allergic reaction in the patient. Medical data of the patient is necessary for the assessment of causality. For now, considering provided information, causality is assessed as related to the product for the events of dyspnoea, throat tightness, fatigue, cough and pain, however not related to insomnia due to physiological inconsistency.; Reporter's Comments: A 65-year-old, female patient experienced insomnia, dyspnoea, throat tightness, fatigue, cough and pain after vaccination with the suspect product Fluad (TIV). Chronology is plausible. Reportedly, the patient had a reaction similar to this after taking Augmentin years ago. Patient medical history of reported Augmentin reaction with similar events suggest presence of allergic predisposition which was not reported. Presence of adjuvants in vaccine (egg-derivates) may have triggered some sort of allergic reaction in the patient. Medical data of the patient is necessary for the assessment of causality. For now, considering provided information, causality is assessed as related to the product for the events of dyspnoea, throat tightness, fatigue, cough and pain, however not related to insomnia due to physiological inconsistency.
This spontaneous report as received from a medical assistant refers to a 18 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 15-JUL-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # J013324, expiry date: 12-FEB-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Tested positive for Covid-19 on June 14, 2022. I tested at an urgent care clinic and due to very mild symptoms was told to take Tylenol for the temperature and rest and fluids.
Pt was in exam room with mom and 2 other siblings.  Room was warm and humid.  Gave immunization after confirming no previous reactions or allergies. Pt. tolerated well and allowed to walk out of exam room a few moments later.  Before exiting to sit in waiting room patient slowly helped himself to the floor and was unconscious x 20 seconds.  Pt. states he had not eaten yet that day and felt very hot.  Patient was able to sit up in chair with limited assistance.  Provider notified and vitals obtained. Provider states it was a Vasovagal response.  Pt was very pail and sweaty.  Answers questions appropriately and states he felt "everything go black and I just needed to lay down" Pt remained in clinic and vitals checked every 15 minutes x 1 hour.  BP came up to normal and pt. was smiling and feeling much better at time of discharge from clinic.  Mother called over next 2 days and no further complaints or symptoms noted.
I got the vaccine and got the Shingles right after / I'm leary of the Coronavirus vaccine / suspected vaccination failure; got the Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter. The age at vaccination was not reported. The patient received Shingles vaccine and experienced shingles right after and because of that patient was leary of the coronavirus vaccine. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      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 ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients).    No concomitants product information reported.  Health care professional stated she had called for an administration error in which they administered patient the Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL to adult patient.  No treatment product information reported.  This case was for patient 6 of 9 patients reported.
Other severe and personal injuries which are permanent and lasting in nature; shingles including any and all of its sequelae; This initial spontaneous report was received from a lawyer and a 61 year old female patient regarding a case in litigation on 24-MAR-2020. Her medical history, concurrent conditions, concomitant medication, drug reactions or allergies were not provided. On 17-MAR-2016, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, lot number, expiration date, route of administration, and anatomical location not provided) as prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), in 2016, the patient suffered shingles, including any and all of its sequelae. As a result, patient had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. Also, the patient was caused to suffer other severe and personal injuries (unspecified), which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The patient required and/or would require more health care and services and did incur medical, health, incidental and related expenses. The patient was informed and believed and further alleged that would in the future be required to obtain further medical and/or hospice care, attention, and services. At the reporting time, the outcome of shingles and the other unspecified permanent injuries was considered as not recovered. The reporters considered the events to be related to zoster vaccine live (ZOSTAVAX).   The reporters considered the other severe and permanent injuries (unspecified) to be a disabling event.