chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got the shot after me 2nd round & they came back about 4 months later / suspect 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.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 months 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got the shot after 2nd round and they came back about 4 months later. The patient had them 3 times now. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule and laboratory test confirmation were unknown at the time of reporting. The follow up was not required.
CHILLS; BODY ACHES; DISTURBED SLEEP; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 29-JUN-2023) once a total dose, start therapy date were not reported, vaccinated on arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced chills, body aches, disturbed sleep, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, body aches, and headache, and the outcome of disturbed sleep was not reported. This report was non-serious.
Persistent moderate to severe headache that was daily from December 16, 2021 to December 28, 2021.  This required multiple doses of Acetaminophen or Ibuprofen daily,   The headache then became intermittent (not daily) until January 7, 2022.
Patient received  a dose of 0.5ml bivalent vaccine on 4/19/23 that has a lot exp of 6/13/23 and was pulled from the freezer on 3/18/23 with  a beyond use date of 4/17/23
Approximately 1 hour after the injection, pt developed redness at injection site that was 6 to 7 inches across. Then later that afternoon, she developed lumps in the arm from the shoulder to the elbow, and the arm was sore to the touch.  Most of the lumps have subsided as of 10am this morning, but she still has a red spot on the bicep.
Several symptoms over a period of weeks to a month - loss of early speech, withdrawal, diaper rash, loss of immunity (always sick with runny nose). Resulted in & continues to result in several developmental & speech delays.
Noticed heart palpitations approximately 24-36 hours after first Moderna vaccine.  Symptoms have been persistent since 4/1.  I decided to let it play out to see if they would subside in a few days/weeks.  The palpitations did not, so I went to see my PCP, who noticed the abnormality.  We did an electrocardiogram and I was referred to a cardiologist.   Had an initial consultation with cardiologist,  Echocardiogram, and a follow up here in the next few days.
Achy arm; This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the vaccination left her with little more than an achy arm. The reporter consented to follow up. For tolerance to 2nd dose, refer case US2020AMR004482.
Severe headache/body aches/cough, fever, OTC Tylenol Migraine.
No adverse reaction to MMR given in error on 10/20/2015. Initial MMR given on 7/13/2014.
Have feelings of tingling like needles in my hands and knees; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 32030BD) via an unspecified route of administration in the right arm on 30Oct2021 at 22:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and COVID-19. It was unknown whether the patient had any allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient received the first dose of influenza vaccine (FLU VACCINE) in the left arm on 21Oct2021 for immunization. The patient received unspecified concomitant medications for unknown indication from an unknown date and unknown if ongoing. On 30Oct2021 at 23:30, the patient had feelings of tingling like needles in his hands and knees. It was not constant but it did happen a lot throughout the days (at the time of this report). The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event had feelings of tingling like needles in his hands and knees was not resolved at the time of this report.
Headache, chills, body aches and pains, nausea onset 11 hours after vaccination.
Left supraclavicular lymph node 3 cm in size, noticed day 5 post first dose, persisted > 20 days later. Hard, mobile, tender for 2 days but now non tender.
a low grade fever of 99.7; developed total body aches; This is a spontaneous report from a non-contactable nurse (Patient). A 31-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL0142, Expiration date: Unknown) via an unspecified route of administration in Arm Right on 18Jan2021 16:00 as single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis. Allergies to medications, food, or other products: Bactrim. The patient received levothyroxine, daily multivitamin, collagen within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL0140) via an unspecified route of administration in left arm on 28Dec2020 03:45 pm as a single dose for COVID-19 immunization. On 19Jan2021 10:30, the patient experienced a low-grade fever of 99.7 and developed total body aches. As a therapeutic measure, ibuprofen was taken. On 25Jan2021, nasal swab was taken and the result was negative. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
When the shot went in, it burned greatly and within minutes I returned ask the gentleman who gave me my shot, if it was normal for me to have a tremendous hot flash after receiving the flu shot.  He said he did not know and that he had never heard of it.  I went on back to my office and finished a busy week.  On Saturday, 09/29/12, I awoke experiencing muscle spasms in my right shoulder blade and by Sunday, 09/30/12, I had numbness in my right ring finger and my pinky finger on my right hand.
covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in a 12-month-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos.) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2023, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In March 2023, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2023, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. reporter's1 yr and 3 yrs old child patient received 2 doses of the Moderna COVID-19 vaccines and then contracted COVID-19. and reporter had questions  regarding booster doses, if recently diagnosed with COVID-19 then how long need to wait before receiving another booster. Infant received 2 doses of the Moderna COVID-19 vaccines in FEB2023 and MAR2023. He was diagnosed with COVID-19 on 20JUL2023. He had a fever for a day. He has taken all other disease control recommended vaccines. Toddler received 2 doses of the Moderna COVID-19 vaccines in NOV2022 and DEC2022 who also contracted Covid-19 in July-23 Asymptomatic. No medication or treatment.   This case was linked to US-MODERNATX, INC.-MOD-2023-738004 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Aug-2023: Follow up received which contains significant information like patients details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738004:3 Year old Child case
Initial misuse report received from a healthcare professional on 03 February 2014. A 64-year-old female patient had received a dose of FLUZONE HD on an unspecified date. No adverse event was reported. List of documents held by sender: none.
This spontaneous report was received from a consumer refers to unspecified female patients of unknown age. Information on patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with  GARDASIL injection (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis. The reporter enquired where in the public literature, was the percentage of girls/young women who had ended up with an autoimmune disease disclosed. The outcome and causality of autoimmune disorder were not reported. Upon internal review, autoimmune disorder was determined to be medically significant.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 67-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "BPH" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti viral details includes on 22Jun2022, the patient received COVID 19 treatment with Paxlovid via oral route of administration till 27Jun2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Felt fine except for dehydrated for several days after shot. On the 4th day started to feel feverish and head stuffed up. 5th day still feeling much of the same.
This spontaneous report was received from a pharmacist regarding to a unspecified number of patients of unknown age. Pertinent medical history and concurrent conditions were unspecified. On an unknown date the patients were vaccinated with PNEUMOVAX 23, vial (SDV, MDV OR ADDITIVE) (EA) 25, subcutaneous for prophylaxis (dose not reported). Concomitant therapies were unspecified. On an unknown date the patients experienced unspecified injection site reaction. Treatment for the adverse event and lab diagnostic tests were unspecified. There was no intervention required to prevent the seriousness criteria. There was no significant disability, no hospitalization and event was not life threatening. The outcome of injection site reaction was recovered. The causality was unspecified. No PQC reported. The case has been linked with the cases (same reporter link) # 1407USA004448 and 1407USA004450. Additional information has been requested.
elevated heart rate at rest. It's usually 80-90 at rest and now it's 130 and it's been like this for 2 to 3 hours.; received other vaccine at first dose in right arm on the same date; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in right arm on 15Jan2021 at 12:00 PM at a single dose for COVID-19 immunization.  Medical history reported as none.  The patient has no known allergies. The patient also received other vaccine at first dose in right arm on the same date. On 16Jan2021 at 05:00 PM (17:00), the patient experienced elevated heart rate at rest. It's usually 80-90 at rest and now it's 130 and it's been like this for 2 to 3 hours. The patient did not receive treatment for the event. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination.  The patient had not yet recovered from the event elevated heart rate at rest.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient is a 66 year old male with a history of cardiovascular conditions (including AFib) which is being treated through the VA system. This issue was first brought to my attention on 1/10/22 by the patient's wife. I was able to speak with the patient on 1/11/22. Patient received a booster dose of the Moderna vaccine on 12/6/21. He reported that approximately 1-2 hours after receiving the shot, he felt a dull pain which started at the site of injection, then radiates toward the back left shoulder blade. Over the course of the last month, it has become progressively worse to the point where it's making it difficult to sleep. I verified site of injection with patient (left arm, center of deltoid) and ruled out any administration error. Records show patient received 0.25ml dose which is appropriate for Moderna Booster Dose. Patient reports that he first went to urgent care (date not specified). Per patient, Urgent care performed an X-Ray and "found no clots or damage." He was instructed to take naproxen and/or acetaminophen for the pain. On Jan 1, 2022, he went to the ER due to elevated heart rate due to pain. He was admitted to the hospital. The hospitalist suggested that he see his PCP at the VA to get a Neuro referral. Confirmed patient has a PCP appointment scheduled for 1/20/22.
Patient developed right sided weakness, right facial droop, and slurred speech day after second COVID vaccination. Patient received TPA followed by thrombectomy. Mental status changed again about 20hours after initial thrombectomy and patient return to IR for second thrombectomy.
Mild depression; joint leg and arm pain; Mild muscle pain; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 23Feb2021 at 10:30 (at the age of 79-year-old) as a single dose for COVID-19 immunisation. Medical history includes thyroid disease, high cholesterol, sleep disorder and anxiety. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included temazepam (MANUFACTURER UNKNOWN), alprazolam (MANUFACTURER UNKNOWN), mirtazapine (MANUFACTURER UNKNOWN) and famotidine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in left arm on 26Jan2021 at 10:30 (at the age of 79-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 02Mar2021 at 06:00, a week after the second shot, the patient experienced mild muscle and joint, leg and arm pain. On an unknown date in April2021, two months after the second shot the pain became severe in both legs and arms and developed mild depression. The events resulted in doctor or other healthcare professional office/clinic visit.  No therapeutic measures were 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 mild muscle and joint, leg and arm pain, pain became severe in both legs and arms and mild depression was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
BREAKTHROUGH INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report was received from literature. This report concerned multiple patients (3 patients) of unspecified sex, age, race and ethnicity. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, primary dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The patients additionally received non-company suspect vaccine included: MRNA 1273 (elasomeran) (dose number in series 2) (form of admin, route of admin not reported, batch number: Unknown and expiry: Unknown), dose, start therapy date were not reported for prophylactic vaccination. On an unspecified date, the patients had confirmed clinical vaccination failure (dose number in series 1). It was reported that the patient had breakthrough infection after 60 days of booster shot, MRNA 1273 (elasomeran). The days between symptom onset and blood draw was 16 days. The second patient was administered the booster dose of MRNA 1273 (elasomeran), and 50 days after the booster shot patient had breakthrough infection. The days between symptom onset and blood draw was 7 days. It was also reported that the third patient also had breakthrough infection in 34 days after received booster dose of MRNA 1273 (elasomeran). The days between symptom onset and blood draw was 10 days. (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breakthrough infection and confirmed clinical vaccination failure was not reported. It was concluded the data suggest that breakthrough infection with the Omicron variant can occur despite robust immune responses to the vaccine strain spike protein. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint and reference number requested.; Sender's Comments: V0: 20220430845- covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related. 20220430845- covid-19 vaccine ad26.cov2.s - breakthrough  infection. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
had rebound of covid symptoms and re-tested positive; had rebound of covid symptoms and re-tested positive; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left 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 and concomitant medications were not reported. No known allergy noted. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "had rebound of covid symptoms and re-tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: re-tested positive (after testing negative; Negative, notes: re-tested positive (after testing negative; Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19 with antiviral treatment drug Paxlovid, starting from 10May2022 till 14May2022. Clinical course: Patient had rebound of covid symptoms and re-tested positive (after testing negative and being asymptomatic at the completion of his paxlovid 5 day course).  The information on the batch/lot number for BNT162b2 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 events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
This may not be related at all, but it was a first time, life-threatening event for me. I developed hematuria during the morning of July 7, 2021, which was a symptom of a pending excruciatingly painful kidney stone attack that was followed by left ureteral calcium oxalate calculus obstruction of my distal left ureter, just proximal to my ureterocystic junction. At the time of surgery to relieve the obstruction on 7/9/2021, it was discovered that I had bilateral microureters.
LVL site reaction measured 3 ¼ x 4 ½ inches. The next morning the mother calls me and the redness and swelling then measures 4 ½ x 6 inches. No hives, rash, or difficulty breathing. Recommended that mother contact allergist to inform him of reaction as well.