chrisvoncsefalvay/vaers-outcomes huggingface dataset:
You got it from the Shot/ Suspected vaccination failure; You got it from the Shot; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the Shingles vaccine and got shingles from it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. This case had been linked with US2021AMR100406 and US2021AMR100411, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR100406:Same reporter. US-GLAXOSMITHKLINE-US2021AMR100411:Same reporter.
pt recv vax 9FEB97 & 13FEB97 pt devel a rash consisting of clumps like little blisters;some blisters were the size of a quarter;devel blisters on legs;dec appetite;devel resp/cold sx;
dizziness, one hive on cheek, fever, muscle aches, joint aches, headache, pain in left arm, increased heart rate
wheezing in her chest; cough waking her up; coughing her head off; runny nose; Chills; coughing cold that went on for a few days; arm hurting a little bit; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing cold that went on for a few days), PAIN IN EXTREMITY (arm hurting a little bit), WHEEZING (wheezing in her chest), ABNORMAL SLEEP-RELATED EVENT (cough waking her up) and COUGH (coughing her head off) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 040A12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.  Concomitant products included AMLODIPINE, METOPROLOL, METFORMIN, LEVOTHYROXINE, GLIMEPIRIDE and ATORVASTATIN for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm hurting a little bit). On 12-Apr-2021, the patient experienced COUGH (coughing cold that went on for a few days), WHEEZING (wheezing in her chest), ABNORMAL SLEEP-RELATED EVENT (cough waking her up), COUGH (coughing her head off), RHINORRHOEA (runny nose) and CHILLS (Chills). On 12-Apr-2021, PAIN IN EXTREMITY (arm hurting a little bit) had resolved. At the time of the report, COUGH (coughing cold that went on for a few days), WHEEZING (wheezing in her chest), ABNORMAL SLEEP-RELATED EVENT (cough waking her up), COUGH (coughing her head off), RHINORRHOEA (runny nose) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  Treatment medication included honey halls cough drops.   This case was linked to MOD21-075530 (E2B Linked Report).; Sender's Comments:  MOD21-075530:
First dose of the vaccine on 13Aug; few days after that I tested positive for the COVID; First dose of the vaccine on 13Aug; few days after that I tested positive for the COVID; This is a spontaneous report from a contactable consumer.   A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0185) via an unspecified route of administration on 13Aug2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, patient had first dose of the vaccine on 13Aug2021 and few days after the patient tested positive for the COVID on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test positive. The outcome of the events was unknown.
Hives all over her body; Shortness of breath; This is a spontaneous report from a contactable nurse reported for patient (coworker). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 30Dec2020 at occupational health department at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had a worse reaction than reporter did. The patient's worse reaction included hives all over her body and shortness of breath. Caller cannot believe the patient was still working like this. The outcome of events was unknown. Caller declined to provide any further information for this report.  Information on the lot/batch number has been requested.
Immediately after giving the injection, patient felt lightheaded, nauseated, had a decrease in her hearing and became pale.  She slumped down in her chair and  became limp and was carried to a reclining chair where her legs were elevated.  Ice packs were placed on her neck.  Her pulse was 70 and a few minutes after this her BP was 100/60.  Dr. and an EMT were onsite and did help to monitor her status.She drank water and ate some food and by 10:25 was feeling well enough to return to her classes.  She was escorted to class by a teachers aide.
Patient felt dizzy 10 minutes after receiving his booster vaccine and experienced tremor, excessive sweating, and pale skin.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 28-DEC-2015 at 09:46, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 7.4 and 6.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 11:08 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 11:08 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 53.95 for dose administered on 22-Jun-2021  No concomitant medications were reported. Batch number 008C21A underwent temperature excursion on 22-Jun-2021 with temperature 35 degrees Fahrenheit from 08:00 AM. This vial was moved to fridge on 22-Jun-2021 and beyond use date for the vial was reported as 26-Jun-2021 . Product moved to clinic on 27-May-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Pt. reports Sat. night developed chills, was dizzy and vision was "bad, like my eyes were tired and had trouble focusing them and just wanted to go to bed", Reports woke up with same symptoms and also had some confusion and had red swollen hard area on L arm were vaccine was given and it is still red and swollen today.
Developed itchy hives and rashes throughout body on January 13, 2022. 10 days after receiving the MODERNA COVID BOOSTER SHOT.  Diagnosed with Dermatographia by health care provider. No other signs or symptoms other than those.  After research, found out more cases of Dermatopgraphia after Moderna COVID booster shot.
The husband reported to me the following:  Soon after the vaccination pt. developed SOB, "bumps" on her skin , swollen lymph nodes and throat tightening.  He called emergency services and she was taken to an emergency room.
Around 10:00-11:00 pm on 03/02/2021, I woke up with extreme soreness on left arm bicep (where injection was received and all over bicep). I kept waking up about every hour will chills and sweats as well as muscle and joint aches. From this time until approximately 7am, I used the restroom and urinated approximately 5 times. On an average night, I may use the restroom/urinate once at the most around 5-6AM.  This is usually only because the dog wakes me up to let her out at that time. At approximately 4am I took 40 mg (two 20mg pills) of DextroAmp-Amphet.  At 7am I attempted to shower for work. During my shower I couldn?t barely lift my arm to wash with out severe soreness. I also became very dizzy and nauseous. I had to get out and sit in front of the toilet because I thought I would vomit. Fortunately I did not. I then proceeded to crawl back into bed and call in to work (notifying them I was too sick to come in). I had extreme chills, muscle aches, and joint pain. I began to cry from hurting so bad. At approximately 7:45 I took 400mg of ibuprofen to help relieve symptoms. My body felt feverish (hot/clammy).  Around 8am I mustered up the strength to get dressed due to extreme chills. I then proceeded to eat a banana, peach yogurt, and a blueberry Benvita breakfast bar package with 4 wafers.  I then took a nap and have been laying in bed ever since until approximately 4:30 PM (with the exception of getup twice to urinate). My body hurt so bad, I barely moved. At approximately 4:30PM I got up to get orange juice and take 600 mg of ibuprofen.
Flu like symptoms; Sick; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and ILLNESS (Sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and ILLNESS (Sick). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and ILLNESS (Sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported.  Patient reported that there were and are still, adverse effects. Patient states that the side effects are not "Flu-like", as stated in the initial report. Patient is undergoing therapy for cognitive decline which occurred(along with a host of other side effects) 30-45 minutes after the 2nd shot of Moderna.   This case was linked to MOD21-065042, MOD21-065091 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: email follow up received on 07-jul-2021: Please note follow also added to MOD-2021-061188, possible NNI; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   MOD21-065042: MOD21-065091:
102-105 fever within 3 hours of shots. Cranky, sleepy, not eating or playing. This has continue for 3 days. Took her to E.R. about 48 hours after shots for 105.1 (Rectal) fever. Did blood and urine tests, negative. Blood and urine culture are pending. DR's do not think the fever is vaccine related, but unable to determine cause.
Rash on anterior neck with linear swelling.  Did not affect airway.  "severe" headache occipital which did not respond to ibuprofen
Rash around injection site with swelling; after rash and swelling went away there was minor occasional itching.
Hospitalized X2 (10.6.21 and 10.12.21);  COVID-19 positive (10.6.21);  Fully Vaccinated  Admission Date: 10/12/2021 Discharge Date: Oct 15, 2021 Diagnosis Pneumonia due to 2019 novel coronavirus  PRESENTING PROBLEM: Hypoxia  COVID-19 virus infection  COVID-19   HOSPITAL COURSE: Patient was admitted 10/6 for acute respiratory failure with hypoxia due to COVID pneumonia, requiring 2L O2 to maintain sats. He did complain on presentation of vague pain in his calves, bilateral duplex were negative for DVT; he was maintained on BID Lovenox. He completed 5 days of remdesivir and 5 days of dexamethasone. He was additionally given 3 days of coverage for CAP given persistent left lower lobe consolidation and slightly positive procalcitonin at 0.33. He was well volume repleted initially and maintained good oral intake the last few days of his hospitalization; as his only symptom was measurable hypoxia with fatigue on exertion, and as he felt comfortable to go home and continue oxygen there, this was arranged for him on 10/10, with advisement to follow up with his PCP in a week. Return instructions given.   READMITTED:  Admission Date: 10/12/2021 Discharge Date: Oct 15, 2021 Diagnosis Pneumonia due to 2019 novel coronavirus  PRESENTING PROBLEM: Hypoxic  Pneumonia due to 2019 novel coronavirus  Pneumonia due to COVID-19 virus  HOSPITAL COURSE: 54 y/o WM married community dwelling patient of Dr. was readmitted to Hospital on 10/12/21 for acute respiratory failure with hypoxia with COVID pneumonia.  The patient was previously admitted from 10/6-10/10 for COVID 19 pneumonia with hypoxia and received Remdesivir and Decadron.  He was discharged home on Decadron.  Unfortunately, the patient became increasingly short of breath and came back of an evaluation.   CTA thorax showed no PE, but extensive pneumonia bilaterally from the COVID 19 infection.  Patient had a procalcitonin of 0.07.  MRSA PCR was negative.  Film arraay was positive only for COVID 19.  We had 2 sputum cultures that were contaminated specimens.   A cardiac etiology was also ruled out.   The patient seemed to improve with ongoing steroids and addition of antibiotics to cover community acquired pneumonia.  He received MDI's including Dulera and Albuterol, as well as the addition of pulmonary toilet.  He improved quickly.  His inflammatory markers were monitored and were slowly decreasing.   He was medically stable and improved for discharge on 10/15/21.  He was sent home on oxygen at 3L nasal cannula.   He will follow up with his PCP in a week after discharge.   Thank you for the privilege of taking care of Patient.
This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (She had contracted Covid-19 despite vaccination and booster with Spikevax) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (She had contracted Covid-19 despite vaccination and booster with Spikevax). At the time of the report, COVID-19 (She had contracted Covid-19 despite vaccination and booster with Spikevax) outcome was unknown. No concomitant medication were reported. No treatment information were provided. Company Comment: This spontaneous case concerns female patient of an unknown age with no medical history reported, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (reported as She had contracted Covid-19 despite vaccination and booster with Spikevax) on an unknown date after receiving booster dose of mRNA-1273 vaccine. Onset latency between vaccine and event cannot be established. SARS-CoV-2 test was not reported. The dates of administration for the current and previous doses of mRNA-1273 vaccines received by the patient were not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns female patient of an unknown age with no medical history reported, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (reported as She had contracted Covid-19 despite vaccination and booster with Spikevax) on an unknown date after receiving booster dose of mRNA-1273 vaccine. Onset latency between vaccine and event cannot be established. SARS-CoV-2 test was not reported. The dates of administration for the current and previous doses of mRNA-1273 vaccines received by the patient were not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Pain; Discomfort; Dizziness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), DISCOMFORT (Discomfort), DIZZINESS (Dizziness) and FATIGUE (Tiredness) in a 68-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (Pain), DISCOMFORT (Discomfort), DIZZINESS (Dizziness) and FATIGUE (Tiredness). At the time of the report, PAIN (Pain), DISCOMFORT (Discomfort), DIZZINESS (Dizziness) and FATIGUE (Tiredness) had resolved.            Concomitant Drugs Not Reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality with Humira for the event(s) of PAIN, DIZZINESS, DISCOMFORT and TIREDNESS was not provided.  Treatment Drugs Not Reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt started having chills after receiving COVID vaccine 11:12 AM BP 120/85, HR 93, RR 18, SO2 99% 11:27 AM BP 122/86, HR 74, RR:16, SO2 98% 11:36 Feeling fine.  Left facility
COVID TOES; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the left arm on 09Mar2021(at the age of 69-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was not provided. Concomitant medications included duloxetine (MANUFACTURER UNKNOWN) 30mg, meloxicam (MANUFACTURER UNKNOWN) 15mg and fluvastatin (MANUFACTURER UNKNOWN) 20m; all from an unknown date for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810), via an unspecified route of administration in the left arm on 16Feb2021 at 13:45 (at the age of 69-years-old), 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 vaccination. On 14Mar2021, the patient experienced COVID toes. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event COVID toes was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.  Follow up (02Aug2021): This follow-up report is being submitted to amend previously reported information: Amended HCP last name and Suffix; Postal Code in patient tab;Age and units for historical Vaccine.
Intermittent fussiness and large non-bilious emesis starting 3 days after rotavirus vaccination. Seen in ED following day and diagnosed with ileocolic intussusception. Succesfully reduced with retrograde contrast enema.
This spontaneous report was received from a healthcare worker (certified medical assistant) and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concomitant medications and drug reactions/allergies was reported. On 11-SEP-2015, the patient was vaccinated with improperly stored dose of VAQTA (lot # L004745, expiration date 28-APR-2017, exact dose and route of administration were not provided). It was reported, that on 10-SEP-2015, the dose of VAQTA was drawn up into a plastic syringe, stored overnight in the refrigerator and used the next day. No adverse experience was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Ringing/pulsating sound began in my right ear about 8 days after second Pfizer vaccine shot. It still persists to today, July 3,2021.  I originally thought it was a condition associated with my Bell?s palsy that began on February 7, 2021 three days after my first Pfizer vaccine shot. But now I?m not sure. Saw my general practice doctor yesterday on July 2nd  and she felt that the tinnitus may be separate from the Bell?s palsy. My usual doctor was out for the day. She prescribed a nasal spray which I have not received as of yet. I also went to see the doctor do to a rib injury. The tinnitus may be lessening the past ten days or so, but still very present all day long.
Patient had already received dose 1 Moderna on February between 25-28th (illegible writing for date, not entered in state Registry). Patient was inadvertently able to sign up and given 1st dose Pfizer on 03/26/2021. Patient denies any s/s from dose of Pfizer. Advised not to revaccinate with either Moderna or Pfizers during this time per CDC recommendations.
Headache, fever, chills, cough, congestion, malaise, patient reports she has been "down" since Saturday and is still experiencing all of these symptoms overall. Patient has been taking TheraFlu