chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient with dementia presented with spouse, who also has dementia. She stated she was here for her first dose.  In observation area, patient called her daughter and then was reminded that this was her second dose.  1st dose was 3/13/21 with Moderna.  On site PA d/w daughter over phone.
This spontaneous report was received from a healthcare worker refer to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, patients were vaccinated with doses of improperly stored (temperature -9.8 C for 15 hours and 42 minutes total cumulative, because of data logger) PROQUAD (Merck), lot # L030592, expiry date 12-FEB-2017; lot # L023111, expiry date 24-DEC-2016, (dose, frequency and route of administration not reported). Previous temperature excursion was reported. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
First Moderna vaccine was administered on 07-Jan-2021 and second on 15-Feb-2021(more than 35 days); This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna vaccine was administered on 07-Jan-2021 and second on 15-Feb-2021(more than 35 days)) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna vaccine was administered on 07-Jan-2021 and second on 15-Feb-2021(more than 35 days)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna vaccine was administered on 07-Jan-2021 and second on 15-Feb-2021(more than 35 days)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The dosage of first and second dose of Moderna vaccine was reported as 0.5. Other vaccines given on the same day of Moderna COVID-19 vaccine included Influenza High Dose (SANOFI PASTE) with lot number of UJ772AA on right deltoid through intramuscular route. Treatment information was not provided.   This case was linked to MOD-2022-503787 (Patient Link).
Started to have joint pains in elbows around 6/14/2021. Patient started to wear elbow braces.  Started to have joint pains in shoulders around 6/21/2021. Patient bought and used shoulder brace. Started to have joint pains in left knee around 7/12/2021. Patient bought and used knee brace. Started to have Joint pains in right knee around 8/18/2021. Patient bought and used knee brace.  September 4, 2021 - Went to his primary care Doctor,  for joint pains September 5, 2021 - Went to Hospital ER for worsening pains and right foot swollen.  September 9, 2021 - Went back to Hospital ER for worsening swelling and left foot swollen - pain got worse.  September 17, 2021 - Rushed Hospital ER. He was having hard time breathing and coughing up blood. Hospital rushed him to another Hospital. They found that he was suffering from ANCA Vasculitis and Good Pasture Vasculitis.  September 18, 2021 - He was put in an induced coma and placed on a ventilator.  October 28, 2021 - He passed away from the damage caused by the Vasculitis.
This case was reported by a physician via sales rep and described the occurrence of shivering in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shivering, pain in arm, shivering and pain in arm. On an unknown date, the outcome of the shivering, pain in arm, shivering and pain in arm were unknown. It was unknown if the reporter considered the shivering and pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the shivering and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced sore arm and severe shivering. The reporter agreed to follow up from GlaxoSmithKline.
Pat w/ hist of Covid 12/5/20(pcr positive). Negative test March at work. Retested 4/9/21 pcr Covid positive(Ct 39.5) when tested for acute appendicitis.
Itchiness at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site). 09-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at injection site) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness at injection site) was resolving.            No relevant concomitant medication was reported. On 10-MAR-2021 patient reported that the redness at the injection site turned to  pinkish color. Treatment details included use of ice on the injection site.
just a little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing), notes: she is diabetic. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "just a little tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (11Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
w/in 7 days of vax exp pain around joints, feet, elbows, shoulders, neck, lower back, thighs & calves, stiffness, fatigue, lower energy level, h/a, fever; exp pain in lt toenail, which became deformed & infected; nail avulsed;see original
Headache Chills Muscle Aches Heartburn All symptoms lasted about 36 hourse
Monday I received the vaccination (1st of the 2). Tuesday I started seeing bruises on my right side (I was vaccinated in my right arm). I can see 5 bruises. 1 on my right arm. 4 on my right thigh. All are various shapes (dime sized to quarter size) but they are all more of a  darker yellowish bruise.   I did test positive for Covid back in November 2020 and didn't need any medical treatment. I was told that 90 days out was okay for receiving the vaccination.
Extreme chills & trembling which caused muscle spasms and body being rigid to the point of being barely able to move; left shoulder pain radiating down left arm; heart palpitations; duration of these symptoms was 8-9 hours
Received shot at 4:15pm got in car after waiting 20 minutes at site.my. left arm was starting to get numb and tingly as i drove home at home my face felt numb and tingly. Called 23 hour nurse told me to call 911 my left leg was numb and tingly and weak my left side of my brain was numb and tingly.
Constant pain in area of injection site; some limited movement and pain with movement; some weakness in left arm; sometimes painful to sleep on left arm; physical therapy has not helped; no prior injury or problems with left arm or shoulder
Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong) 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 09-Jan-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 an unknown date, the patient experienced TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong) and NO ADVERSE EVENT (No adverse event). At the time of the report, TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong) 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 TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong).    No concomitant medication was reported.  On 09-Jan-2023, 26 patients received Bivalent vaccines from 2 different Bivalent lot numbers. 16 Patients Vaccination Cards reflects the wrong lot numbers and pharmacist could not figure out which patient's records were wrong.  All patients received the correct vaccine and bivalent dose. The error only involved documentation.   The Bivalent boosters was administered from Bivalent Lot numbers: 061F22A and AS7170B. Batch number AS7170B was written on all 26 patient's vaccination cards. Can not distinguish which patients received which dose.  The patients did not reported any adverse reactions.  No treatment medication was reported.  This case contains information for 15th of 16 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696236.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696236:Master case
Moderate flu symptoms- nausea, very achy, mild headache, NO FEVER.
Persistent tinnitus in the right ear. Onset was sudden and would fade in and out for the first month before becoming a persistent tone in the right ear. The pitch and tone remains consistent 24/7 and has grown louder since acquiring the booster shot (3rd shot) on December 2nd, 2021.
06Oct2022 began with cold symtoms including head congestion, fatigue and loss of taste and smell/tested positive again for covid on 08Oct2022; tested positive for Covid; tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and on 13Sep2022 at 10:45 as dose 5 (booster), single (Lot number: GH2524) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteopenia" (unspecified if ongoing).Patient had no known allergies. Concomitant medication(s) included: CHLORTHALIDONE, start date: 06Sep2016; FISH OIL, start date: 01Sep2022; TIMOLOL MALEATE (Gel Forming Solution), start date: 08Sep2021.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Sep2022, outcome "recovered" (01Oct2022) and all described as "tested positive for Covid"; DISEASE RECURRENCE (medically significant) with onset 06Oct2022 at 07:00, outcome "unknown", described as "06Oct2022 began with cold symtoms including head congestion, fatigue and loss of taste and smell/tested positive again for covid on 08Oct2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Sep2022) Positive, notes: tested positive for Covid; (01Oct2022) Negative, notes: tested negative; (08Oct2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course included:I have received both vaccines and all three boosters. All Pfizer. I tested positive for Covid on 26Sep2022. I started Paxlovid on 26Sep2022. My symptoms were body aches, headache, fatigue and mild cough. I began to feel much better on 28Sep2022. I tested negative on 01Oct2022. On 06Oct2022 I began with cold symtoms including head congestion, fatigue and loss of taste and smell. I tested positive again for covid on 08Oct2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a consumer via call center representative and described the occurrence of broken blood vessel in eye in a 74-year-old female patient who received BOOSTRIX. On 23rd September 2015, the patient received BOOSTRIX. In September 2015, 2 days after receiving BOOSTRIX, the patient experienced vascular injury, measles-like rash and itchy rash. On an unknown date, the patient experienced broken blood vessel in eye (serious criteria GSK medically significant) and blister. On an unknown date, the outcome of the broken blood vessel in eye, vascular injury, measles-like rash, itchy rash and blister were unknown. It was unknown if the reporter considered the broken blood vessel in eye, measles-like rash, itchy rash and blister to be related to BOOSTRIX. The reporter considered the vascular injury to be related to BOOSTRIX. Additional details were provided as follows: This case was previously reported to a doctor. The patient experienced breaking out of measles-like bumps all over the back of both hands, both arms, neck, and shoulders within approximately two to three days after the initial immunization with BOOSTRIX. The bumps were bright red and itchy. The blood vessels broke under the bumps. The blood got spread on the sheets and pillow case at night because the patient thought that she might be itching them during the night. The patient felt that the sun irritated the bumps and caused them to become large and blister. The patient described the bumps as they looked like boils. In the beginning of the Spring 2016, several months after vaccination, the patient had a broken blood vessel in her left eye. The reporter stated that her pharmacist called regarding this situation, but was unable to find the report and she was referred to her healthcare professional.
This non-serious spontaneous case, was initially received on 14-Aug-2017 from physician, concerning a 08-year-old, child, female patient. Physician reports 10 patients who were vaccinated after multiple temperature excursions. This report was third of 10 reports. On 16-Mar-2017, the patient was administered with FLUCELVAX QIV (batch number: 186686 (reported as 185586), expiry date: (reported as 31-May-2017), dose, route of administration, anatomical location: not reported). Multiple temperature excursions were occurred on 02-Mar-2017, vaccine was stored at 47F for 14.7h (1st excursion), 03-Mar-2017, vaccine was stored at 47F for 16h (2nd excursion) and 04-Mar-2017, vaccine was stored at 47F for 19.75h (3rd excursion) which was considered as incorrect product storage. The patient was administered with vaccine which was stored at 46F to 77F up to 24 hours instead of storing at 36-46F which was considered as drug administration error. The outcome of the events was not reported. Non-significant case correction received with IRD: 14-Aug-2017 Batch number (186686) was captured in the case form and narrative was amended accordingly.
3rd dose of covid vaccine was given 12 days short of the required 5 month interval between 2nd and 3rd dose. No adverse effects were felt following the vaccine.
My daughter is in hospital in (Place). She suffered a stroke.; This is a spontaneous report from a contactable consumer (patient's mother). A 55-year-old female received the second dose of BNT162B2  (PFIZER BIONTECH COVID 19 VACCINE) via an unspecified route of administration on 10Apr2021 (Lot Number: EW0150) at the age of 55-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 20Mar2021 (Batch/lot number: EN6206; Expiration Date: Unknown) at the age of 55-year-old as single dose for COIVD-19 immunization. On 08Jul2021, the patient suffered a stroke and was in hospital. The reporter was very interested and need help. The reporter stated he recently saw the article online with the testing of the article talked about patients was written by people in (Place) pretraining by the Pfizer vaccine side effects and wanted to know what if any studies could being done that can may be help her daughter. The event was resulted in hospitalization. The outcome of event was unknown.
her hand swelled so bad she had to have her ring cut off and her ring finger turned purple; her hand swelled so bad she had to have her ring cut off and her ring finger turned purple; her allergist says take this or that allergy pill; has a hive the size of her hand on the inside of her thigh/the hives are on her entire body: face, ers, throat, nec ,torso, arms and legs, arm pits, buttocks, between her toes , in her hair; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A female patient of 63-Year-old received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown) dose 1 via an unspecified route of administration on 18Jan2021 as single dose, dose 2 via an unspecified route of administration on 8Feb2021 as single dose, for covid-19 immunization.  The patient medical history and concomitant medications were not reported. Patient stated that the hives started five days after the first dose on 23Jan2021 and she had suffered with hives the entire time. She had a hive the size of her hand on the inside of her thigh. Patient reported the hives were on her entire body: face, ears, throat, neck, torso, arms and legs, arm pits, buttocks, between her toes, in her hair. She further told that her hand swelled so bad that she had to have her ring cut off and her ring finger turned purple. Her allergist told take this or that allergy pill. Caller stated her allergist, internist and dermatologist could not do anything. Patient stated that the only thing that made them go away was a solu medrol shot but they would not go away. Patient stated she had two bad days after the second shot that she should have gone to the emergency room, but she did not go. Patient told that the only new thing was the covid 19 shot. Patient wanted to know what people do. Patient wanted to know if Pfizer had done research with these hives. Caller stated she spoke to (Name)and reported on VAER. The outcome of the events was reported as an unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
On January 16, 2022 I had a headache and on January 17, 2022 had extreme body aches and felt miserable and little cough. Then on January 18, 2022 and the remainder of the week had really bad fatigue. It was about a week later started experiencing really bad back pain. I went to go get tested for Covid-19 results positive.
Information has been received from a physician referring to a 15 month old male patient. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On 10-APR-2017, the patient was vaccinated with a dose of M-M-R II (route of administration, lot #, expiration date, dose and anatomical location were not provided) for prophylaxis and a dose of VARIVAX (route of administration, lot #, expiration date, dose and anatomical location were not provided) for prophylaxis. On 15-APR-2017, the physician reported that an additional dose of M-M-R II (route of administration, lot #, expiration date, dose and anatomical location were not provided) for prophylaxis and an additional dose of VARIVAX (route of administration, lot #, expiration date, dose and anatomical location were not provided) for prophylaxis were administered. On 15-APR-2017, the patient experienced a temperature of 101 degrees and cold signs and symptoms. Furthermore, it was reported that the patient did not received treatment for the reported events. At the time of the reporting, the patient had not recovered from temperature of 101 degrees and cold signs and symptoms. Additionally, the reporter did not provided causal relationship between the events and vaccination with M-M-R II and VARIVAX. There was not product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a nurse refers to three patients of unknown age and gender. On unknown dates, the patients were vaccinated with incorrectly stored doses of PROQUAD lot # N010247 for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown).; Sender's Comments: US-009507513-1708USA012367:
injection site pain; weakness; This is a spontaneous report from a non-contactable pharmacist. A male patient of unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine,Formulation: Solution for injection,Lot Number and Expiry date:Unknown), via an unspecified route of administration on Feb2021 as 1ST DOSE, SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Feb2021, post vaccination the patient experienced injection site pain and weakness. The patient was not treated with any medication for the events. The outcome of the events was reported as recovered on an unknown date in 2021.  No follow-up attempts are possible. No information about lot/batch number cannot been obtained.
I was weak and dizzy and I fell.  I was taken to the hospital and monitored for 6 hours.
Pt was fine immediate after vaccination, but 7 hours later, began rubbing her eyes repeated and developed facial redness, splotches and repetitive hand and arm movements. The repetitious movements including turning a spoon over in her hand lasted about 45 min. Pt also started making repetitive 'gasping noises'. Phone triage instructed mom to then give ibuprofen and BENADRYL.  Mom reported some subjective warmth to her skin and questioned fever though we do not have a documented temperature. After meds, she took them but threw up. Repeat movements of her hand continued for at least 2 more hours. She was awake most of the night, not irritable but could not get comfortable. Complete resolution after about 12-14 hours.