chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed an atypical case of shingles. Symptoms of nerve pain in upper/outer right thigh began 9 days after receiving the Moderna bivalent booster and seasonal flu shot. On Day 10, I experienced flu-like symptoms (aches, elevated body temperature, fatigue) and nerve pain continued until I saw a medical professional on Day 14 and was prescribed Valtrex (1 gram, 3 x day, 7 days).
I21.4 - Non-ST elevation (NSTEMI) myocardial infarction E87.1 - Hypo-osmolality and hyponatremia D69.6 - Thrombocytopenia, unspecified
trying to fight off abscessed teeth; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 72-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: TOOTH ABSCESS (medically significant), outcome "unknown", described as "trying to fight off abscessed teeth". Therapeutic measures were taken as a result of tooth abscess. Clinical course: Patient was a nurse and under understands the immune system. For the last week she had been trying to fight off abscessed teeth. She was scheduled an appointment for her sixth booster. It would be her sixth booster. She was trying to support her immune system. Had some teeth pulled (extraction) yesterday and was on antibiotics and immune support supplements. She was thinking she should probably not go ahead with the vaccine while she was still on antibiotics and on immune support supplements. Clarified she was doubting the efficacy of a booster while she was already under treatment for an infection. The way she understands how mRNA works, she was doubting if it would be effective. All her previous COVID-19 Vaccines were by Pfizer. Confirmed she had not gotten the latest COVID-19 Vaccine yet, she was scheduled for it tomorrow, 07Oct2023.  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: As there is limited information in the case provided, the causal association between the reported event Tooth Abscess with the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Pain and swelling continued right after shot was given, extreme pain the morning of the 17th of April. Reported to Dr office told to use heat therapy and aspercream. Today redness swelling and lack of mobility with right arm. Can't stretch out my arm without pain and I can't work with a heat pad on my arm.
first Shingrix vaccine right about a year ago, but have not gotten the second dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2022, right about a year ago on left arm from the reporting date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK Receipt Date: 03-JAN-2023 Reporter's Comments: The reporter was the patient and did not want to give any further demographics. The patient did not get the second dose yet (till the time of reporting). The patient had planned on getting the second vaccine. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Headache, Myalgia, Arthralgia, Fever, Chills Narrative:  2nd vaccine on 5th at 14:45 2245 Nausea, low-grade fever 99, bad headache like a migraine. Used ibuprofen, "living on it" Had headache all night extending down to shoulders. Chills x 2 hours.
LOW grade fever for five days now; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had non known allergies to medications, food or other products. The patient did not receive any concomitant medications. The patient previously received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Apr2021 at 19:00, the patient experienced LOW grade fever for five days now. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event LOW grade fever for five days now was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Extreme Muscle pain, chills, fever, headache, fatigue, weakness, dizziness . Last total of 2 days, better but still weak and shaky as of 3rd day. Took Ibuprofen for fever which reached 102.
This man was in good health until the experimental jabs he received, also a Covid swab in the ER.  His health declined rapid, and even the Nursing Home and Hospice gave him the Johnson and Johnson booster. Then he passed away. Lot number EN6206/EP6955.
Aug 14 had slightly itchy throat. Home Covid iHealth was negative. Aug 15 had sore throat, temperature rising to 99.2 F.. Took iHealth test at approx. 1:00 pm. It was positive. Temperature went to 99.6 overnight. Strong headache. Took generic severe cold pill. Aug 16 went to local Clinic and tested positive for Covid. Prescribed 5-day treatment of Paxlovid. Fever (100.2 to 100.4) headaches, sore throat, sneezing, and coughing phlegm for several days. Fever and headaches controlled with acetaminophen. Afterwards basically sneezing and coughing phlegm with headaches. Aug 30 Home iHealth test was positive with very faint line. Temperature back in my "normal" range of  97.6. Sep 1 Home iHealth test was negative.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patients was administered with expired vaccine. 2 vials were administered from same lot number. 1st vial was administered on 05-Nov-2021 and 2nd vial was administered on 12-Nov-2021. On 04-Nov-2021, the vials was initially stored in the refrigerator. The vial did not undergo any temperature excursions. There was no  adverse event as a result of this misadministration, patients were monitored.  No treatment information was provided.
Sore muscles in upper legs, and changes in swallowing ( throat muscle) Swallow test hospital. Rheumatologist blood test results shows Myopathy Myositis no treatment.
Large spot on arm at injection site. Itchy a little bit mostly a large red spot the size and shape of a small potato.  Noticed it about 8 days after shot.  Flue like symptoms the day after shot - aches, fatigue, headache
I had horrible tinnitus; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, NDC number, UPC number and Expiry date are Unknown), via an unspecified route of administration on 26Jul2021 as dose 1, single for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. It was reported that the patient got vaccinated on 26Jul with first dose and since then the patient has had horrible tinnitus on an unspecified date in Jul2021. The reporter asked, why would the vaccine cause this? The reporter stated, I am sorry. I am getting tinnitus. I need to know why this is happening with your vaccine. When probed for further probing: the reporter stated, No, I really gonna get my answer first like my question answer because this is driving me insane. So, I got to go. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
Tested Positive on 25Aug2023; Tested Positive on 25Aug2023; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2022 as dose 1, single (Batch/Lot number: unknown) and in May2022 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No known allergies. No covid prior vaccination. No other vaccine in four weeks. No other medications in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Aug2023, outcome "unknown" and all described as "Tested Positive on 25Aug2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Aug2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical courses:  the patient received all vaccines according to the recommended schedule. No hx (history)/no concomitant meds. Symptoms: Cough and runny nose. No treatment  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client complained of hives/welts, red, hot, and itchy over upper extremities; trunk. client has been using Benadryl.
Shingrix reconstituted with other diluent.; Shingrix reconstituted with other diluent.; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number 4G94Z, expiry date 3rd February 2023) for prophylaxis.   In October 2021, the patient received Shingrix. In October 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received powder component of Shingrix reconstituted with other diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not want to provide patients demographic data. The reporter consented to follow up. This case was 1 of 8 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232215:Same reporter US-GLAXOSMITHKLINE-US2021AMR232924:Same reporter US-GLAXOSMITHKLINE-US2021AMR232925:Same reporter US-GLAXOSMITHKLINE-US2021AMR232926:Same reporter US-GLAXOSMITHKLINE-US2021AMR232927:Same reporter US-GLAXOSMITHKLINE-US2021AMR232928:Same reporter US-GLAXOSMITHKLINE-US2021AMR232929:Same reporter
Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage; At the time of the shot she was 7 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage) in a 39-year-old female patient (gravida 1) 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 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 07-Jul-2021, the patient experienced EXPOSURE DURING PREGNANCY (At the time of the shot she was 7 weeks pregnant). On 08-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage) (seriousness criteria medically significant, life threatening and congenital anomaly). On 07-Jul-2021, EXPOSURE DURING PREGNANCY (At the time of the shot she was 7 weeks pregnant) had resolved. On 09-Jul-2021, ABORTION SPONTANEOUS (Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage) had resolved.      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.   Concomitant medication use information was not provided by reporter.  The laboratory exams performed to further understand the event included were ultrasound a week prior to the shot to show the babies heart rate. Treatment medication use information was not provided by reporter.; Sender's Comments: This case concerns a 39-year-old female patient gravida 1 who received mRNA-1273 at 7 weeks of pregnancy and experienced spotting one day post vaccination and spontaneous abortion 2 days post vaccination.  Last menstrual period and estimated date of delivery were not provided. Spontaneous abortion show temporal association with product use and a causal relationship cannot be excluded.  The event of exposure during pregnancy is assessed not applicable
inconsolable crying >12hr w/in 72hr of vax (began sat noc-through sun) exaggerated local rxn also
No adverse effects; reconstituted in error with the diluent that is for "Menveo"; This spontaneous report as received from a nurse refers to a 8-year-old male patient. The patient's pertinent medical history, concomitant medications, drug reactions and allergies were not reported.  On 19-AUG-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R035221, expiration date reported as 04-DEC-2020, but upon internal validation established as 04-DEC-2019, dose and route of administration were not reported) and was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) (lot # reported as: S006646, expiration date reported as 05-MAR-2021, dose and route of administration were not reported), that were reconstituted in error with the diluent for meningococcal ACYW conj vaccine (CRM197) (MENVEO) (NDC 58160-959-01 MenCYW-135 liquid conjugate component), both vaccines were administered for prophylaxis. No adverse effects were reported.
Sz short, generalized, tonic clonic sz @ day care; Lasted approx 1min; Has lt OM on exam that might be responsible for fever;
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No information regarding their current condition and medical history was provided by the reporter. On an unknown date since 30-DEC-2015, the patients were vaccinated with improperly stored VAQTA (strength, dose, route and indication not reported) of lot # L018499 and expiry date: 25-FEB-2017. Concomitant medications were not mentioned. The vaccine was stored at 58.5 degree Fahrenheit for a time frame of 24 hours which was outside of the recommended range (incorrect product storage) and administered to patients. There was no previous temperature excursion. No adverse effects have been reported. No additional information was provided. Product Quality Complaint was not filed. Additional information has been requested. This is one of the five reports received from the same reporter.
Moderna Covid-19 Vaccine EUA Complaints of feeling tired/groggy, sore arm nauseated, warm, "feel like Zombie"
Syncope caused patient to lose consciousness and fall out of chair hitting her head. Paramedics were called to the scene but patient did not require additional medical assistance at the time. Follow up with PCP recommended.
Got a reaction, very bad on the, next to the breast, it is getting like a ball in there and red on the, where they put the vaccine on the arm; Got a reaction, very bad on the, next to the breast, it is getting like a ball in there and red on the, where they put the vaccine on the arm; This is a spontaneous report from a non contactable consumer, this consumer reported for a male patient (husband). A male patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Lot number was unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient got the vaccine on the 6th(unspecified) and he got a reaction, very bad on the next to the breast, it is getting like a ball in there and red on the, where they put the vaccine on the arm. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1st dose eight months ago, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose eight months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 12-Jan-2023 Reporter's comment: The patient was not immunocompromised. The reporter declined to provide additional information. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
weak; Breathing is labored; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak) and DYSPNOEA (Breathing is labored) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 09-Mar-2021, the patient experienced ASTHENIA (weak) and DYSPNOEA (Breathing is labored). At the time of the report, ASTHENIA (weak) and DYSPNOEA (Breathing is labored) outcome was unknown.            Treatment information was not provided. Concomitant medication was not provided.
The evening after receiving the injection my head felt pressure and bilateral ears began ringing (tinnitus)  this has been constant since the time of the first vaccine.  No change  after my second dose.
No rash has broken our, but I have the pain, tingling and sensitivity of my skin.; No rash has broken our, but I have the pain, tingling and sensitivity of my skin.; No rash has broken our, but I have the pain, tingling and sensitivity of my skin.; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration on 08Apr2021 as a single dose for COVID-19 immunisation. Medical history included mild achalasia and shingles 2 times. The patient had one episode on left side on an unknown date in Sept2019, second episode on right side on an unknown date in Feb2021 and had completely recovered with no post-herpetic neuralgia both times. Concomitant medications included multi-vitamins (MANUFACTURER UNKNOWN), B- complex (MANUFACTURER UNKNOWN), lysine (L-LYSINE), magnesium (MANUFACTURER UNKNOWN), olea europaea leaf extract (OLIVE LEAVES EXTRACT) for unknown indication from unknown date. The patient previously took metronidazole (FLAGYL) for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, since about one week after receiving the first vaccine the patient felt like she was going to get shingles again on the left side. No rash had broken out, but patient had pain, tingling and sensitivity of the skin. The pain was milder then when she had shingles. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain, tingling and sensitivity of skin was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Day  1 -Muscle spasms, muscle aching the worst across shoulders and up neck. Severe headache (lower back of head).  Severe muscle pain in arm that was injected. Including hyper sensitive to touch. Not the normal pain you experience from intramuscular injections. Upset stomach. Day 2 - previous symptoms plus, joint pain bilateral knees,  joint pain left ankle, shooting pain in left hip (nerve pain?) Felt like a stabbing, shooting pain from outside hip/upper thigh traveling inwards to mid/inner thigh. Fatigue. Day 3 - all of the same symptoms Day 4 - same symptoms but decreasing in intensity. Shooting hip/thigh pain reduced frequency. Extreme fatigue. Day 5 - symptoms continue to decrease. Day 6 - Can resume most normal activities with tolerable arm pain.