chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with 2018SA296383, 2018SA297469, 2018SA297473, 2018SA297471, 2018SA297472 (same reporter). Medical history and concomitant medications were not reported. This case involves a seven years old patient (gender not reported) who received 0.25 ml once of vaccine FLUZONE QUADRIVALENT (lot UT6259JA and expiration date 30-Jun-2019) instead of the 0.5 ml via unknown route in the left thigh on an unknown date (also reported as 25-Sep - 12-Oct). It was a case of actual medication error due to vaccine underdose. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Dry mouth..bad stomach pains...severe body aches...very sore back of neck...left arm so sore cant move it...flu or covid like symptoms ...all joints very sore...very nauseated...no appetite
Patient c/o being hot 15 min post vaccination patient vomited x 1 - small amt clear  A/P #1 vomited x 1 post vaccine gave H20 and crackers. Pt left clinic @ 4:45 - stable.
t105 ax since 12MN 2MAR93; vomited around 12MN; mom attempted to give APAP but unable to tolerate;  pt taken to clinic; told pt had flu & temp was reaction from immun;
I had no reactions. I received a swollen lymph node a few weeks after receiving the vaccine. I went to Dr., to check my lymph nodes.
17 year old patient got vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient got vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient got vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient got vaccine) had resolved. Not Provided      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 relevant concomitant medications were  reported.  No treatment information was provided.   This case was linked to MOD-2021-068440 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28-jun-2021 - Contact details and patient race were updated; Sender's Comments:  MOD-2021-068440:Same Reporter,Different patient identifier
Ongoing cold and flu symptoms from 2 days after vaccine. Chills, migraine type headache, nausea, intense fatigue. Date of reported adverse event I woke up in the middle of the night 3 am) with severe lower abdominal/pubic area pain. Severe UTI /kidney infection symptoms without prior mild symptoms. Pain was so severe it was difficult to walk for 4 days. Prescribed Macrobid for 5 days of antibiotics, symptoms reduced on day 5, but are continuing (mild to moderate abdominal/pubic area pain, urgency, frequency, occasional mild flank pain).
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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 Information: GSK receipt date: 05-Aug-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. The patient received Shingles vaccine and caught shingles. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GSK-US2022AMR117006:Same reporter
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital 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, 1 month 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 case was reported by the patient's wife. The age at vaccination was not reported. A month after receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
Information has been received from a health professional concerning a male who may have been vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On 27-APR-2006 it was reported that the patient developed symptoms of mumps. It was unknown whether the patient has been previously vaccinated. "Currently" tests are being run to confirm whether the patient has mumps. Unspecified medical attention was sought. No further information is available. There was no product quality complaint involved. Additional information has been requested.
Initially I had flu-like symptoms which included severe dizziness. i called the facility which administered the vaccine to report the dizziness as I was barely able to go up and down the few stairs in the home where I was staying. Within a day, the flu symptoms ceased, but the dizziness has continued although not to the level as on the first day. The dizziness will occur without warning and only for a brief period of time (one to two seconds) and will catch me off balance.
PATIENT WAS GIVEN A BOOSTER DOSE OF 0.5MLS INSTEAD OF 0.25MLS FOLLOWING THE JANSSEN VACCINE. PATIENT HAS NOT RESPONDED TO PHONE CALLS OR VOICEMAILS LEFT.
Pt states approximately 2 hours after receiving the vaccine she developed right facial numbness without drooping. She was taken by Ambulance to a hospital. All tests were normal, per patient.
RIGHT ARM INFLAMMATION. RASH ON BACK, RIGHT EYE SWOLLEN. RIGHT ARM PAINFUL TO MOVE. TREATMENT PRESCRIBED BY PCP: CEPHALEXIN, IBUPROFEN, PREDNISONE FOR 6 DAYS, STARTING 9/10/17. OUTCOME UNKNOWN.
pt was exposed to a child who recv vax 10JUL97 & 30JUL97 pt felt that through household contact may have measles;devel swollen glands;
Died from the Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died from the Covid vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: As per the reporter, the vaccine has killed a lot of people and destroyed a lot of peoples lives, including reporter's family. He has family members that had taken 4 shots of the Pfizer Covid vaccine and got cancer. The cancer was getting worse and they continue to got vaccines because of it. Two of his grandparents died from the Covid vaccine. Family members now had auto immune disorders and have had heart attacks and the doctor had said it was due to the vaccine. Caller references a "Pfizer" Pregnancy and Lactation Cumulative Review from Apr2023 by the FDA that documents deaths of pregnant women and their children from the vaccine. He reported that members of his family who have miscarried from the vaccine and are now can no longer have children. He stated there was a list of over 8,000 side effects but he could not find it.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300259502 Same reporter/ AE, different patient;; Reported Cause(s) of Death: Died from the Covid vaccine
I currently have COVID-19 and I've had COVID-19 a total of 6 times. I currently am dealing with seizures, horrible anxiety, back pain, tiredness, hair loss, and muscle weakness. I am taking muscle relaxers, anxiety medication, Tylenol, Tramadol, Zinc, Vitamin D3 & C.
Tinnitus (Left Ear).  Still continues with no sign of being transient. Seen by Dr. on March 22, 2021.  Placed on Prednisone oral tablet, started 3/23/2021, no improvement to date.
Pt recvd 1st & 2nd dose of Hep B vax on 28MAY91 & 28JUN91; 29JUN91 pt was seen in ER for a red, raised, generalized pruritic rash; pt exp diaphoresis, chills & some tremor; petit roseola;
This spontaneous report as received from a Certified Medical Assistant refers to a currently 67 year old female patient with osteoarthritis and psoriatic arthritis and a history of unspecified reaction to SULFA. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, dose, route and site of administration not reported). Concomitant therapies included ENBREL 50 mg, calcium, PRILOSEC, SYNTHROID, WELLBUTRIN and etodolac. It was reported that the patient received ZOSTAVAX developed an unspecified reaction (dates not provided). It was unknown if the patient sought medical attention. The outcome of unspecified reaction is unknown. Causality was not provided. Additional information has been requested.
A report has been received from a physician concerning, patient of unknown age and gender. The patient's medical history concurrent diseases and concomitant medications were not reported. On 13-JAN-2014 the patient was received nasal FLUMIST but the vaccine was expired on 13-JAN-2014. At the time of reporting, the outcome of the event of expired FLUMIST was unknown. The report was considered to be non-serious by the reporter.
Stroke, M1 left, speech impaired, hospitalized, prescribed blood thinners.
After receiving first dose, patient began feeling itching symptoms while being monitored in the waiting area. Patient was given Benadryl and sat in the waiting area for 45 minutes. Patient later reported that she was feeling ok. Patient was instructed to take Benadryl again at night. Followed up with her the next morning and patient said she was feeling fine. Her physician's office was also contacted and was informed that we gave Benadryl.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 15-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. In 2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Pfizer product on 01/06/2021 and 01/27/2021. They tested positive for COVID-19 on 09/13/2021 at the behavioral health facility at which they were a resident.  They were described as asymptomatic at the time of the test, and were released without incident on 09/24/2021. They were seen in a clinic on 10/07/2021 for purposes of assessing diabetes status and checking in on how blood sugar regulation was going. These clinic notes do not make any mention of COVID-19 or respiratory symptoms or complications related to them. The individual died on 10/09/2021. I see no evidence that they were hospitalized at the time of their death. COVID-19 is listed in Part I of the death certificate.
This case was reported by a physician and a sales representative and described the occurrence of Bell's palsy in a 32-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous vaccination included 1st dose of TWINRIX (GlaxoSmithKline) given on 10 December 2008. There were no concurrent medications. On 17 December 2008 the subject received 2nd dose of TWINRIX (TWINRIX was being administered according to the accelerated dosing schedule) at 1.0 ml in the left arm. On 6 January 2009 days after vaccination with TWINRIX, the subject experienced BELL's palsy and swelling of face. The physician considered the events were disabling. The subject was treated with high dose steroid pack of prednisone. At the time of reporting the events were unresolved. The physician considered the events were possibly related to vaccination with TWINRIX.
High fevers; This is a spontaneous report from a contactable unspecified HCP via Pfizer sales representative who reported similar events for 3 patients. This is the 3rd of 3 reports. A patient of unknown age and gender received a single dose of meningococcal group b rlp2086 (TRUMENBA) for immunization on an unknown date in Jul2019. Medical history and concomitant medications were not reported. After vaccination, in Jul2019 the patient had high fevers. It was mentioned that last 3 patients they vaccinated with meningococcal group b rlp2086 from their private stock, each reported high fevers to the office. These 3 doses came from a box of 5 received in Jul2019, the week before this report. Outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019303935 same reporter/drug/event, different patient;US-PFIZER INC-2019303925 same reporter/drug/event, different patient
Patient developed significant joint pain throughout her body about 24 hours after her second Moderna vaccine on 1/26. 5 days later she developed migraine which required several rounds of imitrex, one headache waking her from sleep which is unusual. She sought care on 2/23 through an office visit with me. At that point she continued to have significant polyarthralgia but no joint swelling. She works as a nurse and her joint pain was worse on days she worked but she was having difficulty doing normal activities on her days off due to the joint pain. I ordered labs and recommended naproxen for pain which has been helping but she still needs this to make her symptoms tolerable.
Patient developed red splotches on back that she claims is very itchy when she scratches it.  She is unsure that this is related to the vaccine as she has had this condition before for which she applies clobetasol cream.
Feeling on and off fatigue and tiredness after a month after the second dose - starting March 8th 2021. Jaundice noticed March 19,2021. Extremely elevated Bilirubin (16), AST (2100) and ALT(2100) liver enzymes and was admitted in the ER following the PCP's suggestion on March 23rd 2021.
April 1, 2021 a rash occurred on both legs from above her knees down to her toes. Legs began swelling, experiencing nerve pain. Received one shot of prednisone in the shoulder. June 28, 2021 legs are still swollen.
Information has been received from a nurse practitioner concerning a patient who was vaccinated with a dose of HPV vaccine. Concomitant therapy included birth control pills. Subsequently, the patient experienced a full body rash. At the time of this report, the patient's outcome was unknown. The reporter felt that full body rash was not related to therapy with HPV vaccine. Additional information has been requested.
(R) arm pain and weakness immediately post IM injection of flu vaccine on 10/15/13. Seen at onsite clinic 16 days post vaccine 0n 10/31/13.
Pain, swelling and redness immediately upon injection which persists two days later; swelling has decreased some. Had zero adverse reactions with dose 1 given in same left arm on 10/01/2018.
One side facial muscle weakness, drooling, unclear speech, eye lid drooping, diagnosed Bell's Palsy.
Hotness in chest area and stomach,  nausea, and headache, and anxiety feeling. Which lasted about 2 hours but headache lasted until next day.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: other medical history: asthma; "heart palpitations" (unspecified if ongoing), notes: other medical history: heart palpitations; "anxiety" (unspecified if ongoing), notes: other medical history: anxiety. Concomitant medication(s) included: WELLBUTRIN, start date: Jan2020, stop date: Apr2023.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: VERY very positive; slightly positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in 2 weeks. The patient received anti viral COVID-19 Treatment Paxlovid from 17Apr2023 to 21Apr2023. The patient had no known allergies.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report as received from a pharmacist via gabby form the patient assistant program on 10-NOV-2014 refers to a 51 year old male patient. The primary reporter was pharmacist. The pharmacist stated patient spoke with her colleague and reported an adverse event. On 29-OCT-2014 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX vial 9lot # K008881, expiration date: 20-SEP-2015), subcutaneous in the left arm. On 30-OCT-2014, the patient had itchy, swelling, warmth, redness down the left arm, post vaccination with ZOSTAVAX. The patient was treated with over the counter BENADRYL. The patient also contacted his primary health care provider, but no other treatment listed. Pharmacist stated the patient's reaction lasted about 5 days. The outcome of events was reported as recovered/resolved on approximately 03-NOV-2014. Additional information has been requested.
Erythema and warmth in right arm consistent with a vaccine reaction. Treated with acetaminophen.
swollen lymph nodes under arm/The lymph nodes are still swollen; inflammation in shot area; feels pain from time to time where shot was/presses against it, it hurt; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes under arm/The lymph nodes are still swollen), VACCINATION SITE INFLAMMATION (inflammation in shot area) and VACCINATION SITE PAIN (feels pain from time to time where shot was/presses against it, it hurt) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE BESILATE (NORVASC) for Blood pressure high, ACETYLSALICYLIC ACID (BABY ASPIRIN) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes under arm/The lymph nodes are still swollen), VACCINATION SITE INFLAMMATION (inflammation in shot area) and VACCINATION SITE PAIN (feels pain from time to time where shot was/presses against it, it hurt). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes under arm/The lymph nodes are still swollen) and VACCINATION SITE INFLAMMATION (inflammation in shot area) had not resolved and VACCINATION SITE PAIN (feels pain from time to time where shot was/presses against it, it hurt) outcome was unknown.            Treatment medications were included hot and cold compresses. She also had a mammogram and ultrasound shortly after, which threw off everything. She mentioned she goes to the gym, does weight training, walks 5-6 miles, was active.   This case was linked to MOD-2021-407328, MOD-2021-407326 (Patient Link).
called man down (emergency) for dyspnea on thursday morning. VS- o2-88%, heartrate- 142, 156/98. o2 dropped to 73%- 3L O2 started then O2 sat at 87%. Per provider, sent to ER.
Child developed a pimp-like, itching,rash @ site of HIB conj inject which spread down to her rt knee & buttocks w/in 24 hrs of inject; 8MAR91 still has pale, itching rash on rt thigh from buttocks to rt knee;
Pain at inject site immediately Fatigue setting in at 9PM Aches, chills, low fever (99.0) at 11PM
I had a heart attack, I had a n indicated heart attack due to the rise in troponin levels,