chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 9:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 9:59 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, 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 50.41 for dose administered on 24-MAY-2021.  No concomitant medications were reported.  Batch number 026C21A underwent temperature excursion 24-MAY-2021 with temperature 35 degrees Fahrenheit from 08:00 AM to 09:00 AM. This vial was moved to fridge on 18-MAY-2021 and beyond use date for the vial was reported 17-JUN-2021. Product moved to clinic 24-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 Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Left thigh, reddened, swollen, itching. 2" x 2".
Redness, soreness, swelling, itching and vesicles formed at the site of injection.
History of diabetes on insulin, remote history of panniculitis and now chronic ostomy, short gut syndrome, morbid obesity, hypertension, CKD who has been having frequent watery output from his ostomy for the past 4 to 6 weeks.  He has been in the emergency department multiple times with complaints of dehydration.  Admitted on  with elevated lactate concern for dehydration versus sepsis. ED Visit and hospital admission within 6 weeks of receiving COVID vaccine.
Expired bottle was not discarded or labeled properly. Intern drew up and injected a vial that had expired. Patient didn't have a reaction when waiting the 15 minutes after the dose.
Hospitalized for pulmonary embolism on 4/27/21.  Discharged 4/28/21.  No other notable risk factors besides oral contraceptives (taken since 2017).
Vaccination around 3pm. Mom noticed hives around 7pm. Gave Benadryl, hives were completely gone by next morning.
The injection site soreness is now a large rash (with swelling, itchiness, and redness)? it showed up the morning after the vaccine along with swelling in my lymph nodes in my armpits.   Today, it?s about 3 inches wide and 4 inches tall.  I have had pretty gnarly joint and muscle pain, headaches? but it?s about the same level of intensity as the previous doses? this big rash is new, though!
Started with chest pain middle of the night that woke me up. Positional pain would get better/worse depending on position. Also noticed swelling in right arm pit area. Both symptoms persisted for several days.
Pt stated having body aches, lost of taste and smell, cough, fever, fatigue 1 week after vaccine.  Two weeks after vaccine, pt reports sore throat and weird taste.  Pt later explained having these symptoms after 1 month of receiving vaccine of increased salivation and jaw/tooth pain.
Shortness of breath; hand twitching; left side of my body being tingly and numb; left side of my body being tingly and numb; This is a spontaneous report from a contactable consumer (patient). A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left deltoid (left shoulder/arm) on 25Mar2021 (Lot Number: ER8733) (at the age of 22-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was none. There were no concomitant medications. The patient had a side effect after she had her vaccine shot a day before reporting and it involved with the left side of the body being tingly and numb as well as her hand twitching and shortness of breath. The patient stated that the events were happening until she was sleeping, so it was like 18 hours. When confirmed if she experienced the events after 18 hours, patient stated yes. The patient did not receive any treatment for the events. The patient wanted to know if she needs to go to emergency room to get this check out that because she never had that problem before. The outcome of shortness of breath and twitching was not recovered, and outcome of all other events was unknown.  No follow-up attempts are possible. No further information is expected.
-HA / Nausea / dizziness reported the day of vaccine, followed by chest tightness and shortness breath by second week. Trial of albuterol/xopenex without improvement.  -3rd week - pt developed fatigue, chest pain and joint pains. Referred to Pulm/Rheum - postural tachycardia noted at Rheum visit Pt diagnosed with dysautonomia/AMPS by Rheum 5/6/2021 5/19/2021 ER visit for throat itching/trouble swallowing, abdominal pain + nausea  -Epipen, IVF, antihistamine/steroids given 5/20/2021 - symptoms returned. Epipen given at home. ER treatment - IVF /IV steroids and Atrovent. D/C'd home on PO prednisone, Zyrtec + Pepcid.  6/8/2021 - started on omeprazole by GI for IBS-D 6/3/2021 - seen by Cardiology for chest pain /syncopal symptoms.  - Echo: Sinus bradycardia, LV function @ lower limit of normal, no effusion -ECG: Sinus bradycardia with short PR interval with pre-excitation -Abnormal stress test with EKG changes with exercise (ST segment depression in Leads II, III, aVF and V3-V6, resolves in recovery) 6/3/2021 - starts PT for POTS/AMPS 7/6/2021 Cardiac MRI  - mild enlargement of LV w/normal systolic function - nl RV/function - no sign of MI, myocarditis or cardiomyopathy.  7/13/2021 - palpitations/POTS. Started on metoprolol XL 12.5 mg.  As of 7/29/2021, pt improving. Decrease in palpitations and increase of activity. Still fatigued. Tolerating PT and metoprolol.
Information has been received from a physician concerning a less than 60 year old patient who was vaccinated with a dose of ZOSTERVAX. The patient had remission of genital herpes outbreaks. No medical attention was sought and no laboratory or diagnostics tests where preformed. This is one of several reports from the same source. Additional information has been requested.
I have discomfort in my right arm that travels up to my shoulder.  I have a big red, shot on my arm that is warm to the touch.  I did get COVID-19 on August 24th. I had lost of taste and smell.  I had headache, body ache, chills, fever, and SOB.  I went to the ER on Sept. 3rd.  They did an x-ray.  These symptoms lasted about 14 days. They said that I have a pneumonia from the COVID-19.
On August 1, 2021, I began experiencing shortness of breath, heart palpitations, and dizziness. This persisted for the next few days until I nearly passed out and went to the ER. I was found to have nothing medically wrong, with the exception of high blood pressure. I was prescribed anti-vert, which did not help with the dizziness. I then saw my primary care physician and was prescribed a medication for an ear infection, that did not help. I then saw an ENT who believed I had BPPV, and wrote me a script to a physical therapist. The physical therapist did not see any BPPV, and I began doing vestibular rehabilitation. This has not helped either. I then went to a neurologist and had a MRI and another test done for inner ear issues. I was not found to have anything wrong. I was prescribed medication for stress, and given a medication for panic attacks. The dizziness is still here and greatly effects my every day life.  I found a forum with others describing the condition to a tee with what I have been experiencing, with the common factor we all received the vaccine. With every test I have completed, I am certain the vaccine has done something.
after April 2 22 episodes of dizziness of short duration then April 9 sustained episode of rotational vertigo with vomiting
Experience severe tendon pain in knees shoulders and wrists most pronounced in joints previously  Compromised by sports injuries as a 18 year old.
Stomach ache began in the morning after the vaccine. I awoke the following morning to my throat feeling different and had throat swelling after taking my morning medications, then used the first epinephrine shot (not an auto injector due to severe reaction to preservatives in auto injector). With each swallow of food or water during the day I experienced some throat swelling then used second epinephrine shot at 6:30pm after a meal. The process continued the filling day, Sunday, with two more epinephrine shots, one in the a.m and another in the p.m.  After eating my nightly meal, there was no reaction.
Patient has a rash on upper arm right above the elbow (cellulitis per MD) patient was put on an antibiotic to treat.
This spontaneous report was received from a health care worker (medical assistant) regarding unspecified number of patients of unknown gender and age. The reporter states that on an unknown date the patients were vaccinated with GARDASIL (dose, frequency, lot number, expiry date not reported). Also reported that the patient's were administered doses of GARDASIL that were improperly stored and no adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Began having numerous myoclonic sz w/in 24 hrs of vax administration; These have continued for the past 11 months; pt has since been dx w/ tuberous sclerosis; sz are currently partially controlled by clonopin;
About 7 hours after the vaccine injection I started to feel flu-like symptoms: aches, chills, woozy and slightly nauseous. Within the next few hours the symptoms became increasingly worse, but not different other than the addition of a headache. I took 2 Tylenol to help with the headache and fever. Overnight sleep was difficult due to chills, sweats, fever dreams and aches. The symptoms lessened the next day (24-hours post injection), but still included muscle/body aches, headache, and extreme fatigue. Again took 2 Tylenol to help. Today (48-hours post injection) I'm feeling quite a bit better although still not 100%. Soreness at injection site persists, especially when lifting my arm.
Subsequent to receiving one dose of varicella virus vaccine live the pt presented to a physician with herpes zoster of the ophthalmic division of the trigeminal nerve on left side. He has no reported fever or other signs/symptoms. A viral culture specimen obtained showed negative and direct immunoflourescence was positive for varicella. The pt recovered.
ONE RED SPOT ON ARM; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's past medical history included torn rotator cuff. The patient experienced drug allergy when treated with codeine, and tramadol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021  for prophylactic vaccination. No concomitant medications were reported. On 15-APR-2021, the subject experienced one red spot on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from one red spot on arm. This report was non-serious.
No additional AE details were available; Administered a dose of VARIVAX on 24-SEP-2020, which had expired on 20-AUG-2020; This spontaneous report was received from a licensed practical nurse concerning a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, historical drug and concomitant therapies were not provided.  On 24-SEP-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot # R0123735 expiration date 20-AUG-2020 for prophylaxis (route and anatomical location of administration were not provided). The vaccine was used beyond the expiry date. No additional adverse event details were reported.
Severe  chest pain tightness in chest blood pressure very high.trouble breathing  .started on 08/31/2021  and continues to be a problem.I was told  to there best guess is pluersiey given pain medication .
Patient with episode of altered mental status.  Had been unresponsive and showing seizure-like activity.  Mother brought her to the emergency room where evaluated and hospitalized overnight for observation.  Discharged next day and doing well
This spontaneous report has been received via a company employee from a female consumer concerning her daughter of unknown age. Information about concurrent condition, concomitant medication and medical history was not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 (dose, route, lot number and expiration data were not reported) for prophylaxis. On an unknown date, the patient passed out after vaccination. The company employee described the event as a ''seizure convulsion incident'' and the patient was ''fine'' by the evening (on an unspecified date). The reporter reported the events to the doctor's office (unspecified physician and location). Upon internal review, seizure convulsion incident was determined to be medically significant. This is one of several reports received from the same source. Sender's Comments: US-009507513-1707USA012608.
This is a spontaneous report from a contactable pharmacist. A 72-year-old female patient received the first dose of PREVNAR 13 (lot M88543, exp. date Jul2017, NDC number 00005197105) at single dose for immunization on 17Feb2017 16:30 via intramuscular route in the left arm. Medical history included allergy. The patient had received an influenza vaccine 6 months before the vaccination with PREVNAR 13. On unspecified date in Feb2017 the patient experienced rash and cellulitis. The patient was not hospitalized for the event but she was in urgent care for the cellulitis. The outcome of the events was unknown. The patient received some antibiotics for the events. Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: onset date of the events. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Information has been received from a physician concerning a 9 month old male with no pertinent medical history who in January 2011, was vaccinated with VAQTA (lot number not provided) instead of hepatitis B virus vaccine. No adverse event seen. Additional information has been requested.
Swelling on his left chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (159558).  A 50-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious) with onset 29Aug2021, outcome "unknown", described as "Swelling on his left chest".  Additional information:  The patient had Reaction and event as reported by primary source of Swelling on his left chest. The Characterization of drug role was Suspect and Proprietary medicinal product name: COVID Vaccine. The unknown Batch/Lot number and Action taken with drug. The Narrative case summary and further information about Case Description was Submitted. The report related to a study or programmed and Details: 159558. The patient was not a reporter also with his wife. The Reporter type was Consumer or other non-health professional. The Primary / Prescribing Healthcare Professional Info and HCP postal address: The Dates for Swelling on his left chest was From Unspecified to Unspecified. The patient was administered COVID Vaccine a Pfizer product. The COVID Vaccine manufacturer by Unspecified. The Dates for COVID Vaccine was Start: Unspecified and Stop: Unspecified. The unknown NDC number of COVID Vaccine and UPC number of COVID Vaccine. The Reason for no lot number: of COVID Vaccine: Other: Reporter stated: "He said, he doesn't have it here with him mam." The unknown Expiry Date of COVID Vaccine.  The patient was transferred (159558) Transferring agent stated, "I have a caller here on the line who have the questions about the side effects of the vaccine. So, her family got the vaccine on Friday, but then her husband woke up today with swelling on his left chest. They just wanted to know if that was the part of the side effects of the vaccine. The age was 50 years (Age at the time of adverse event was not clarified, hence not captured in tab)." When paraphrased the above concern reporter confirmed the same. The Reporter was provided with the number of Pfizer Medical Information Department. In response to further probing, reporter stated, "No, I just wanted to say if you have an answer for me, no, that's fine."  The did not reported LOT and Reporter stated, "He said, he doesn't have it here with him." The Reporter was unwilling to share further information, hence, product details (Expiration date, NDC, UPC) and other details were unknown. Limited information was available over the call. The Reporter type was not available over the call as the reporter was unwilling to answer further questions; hence reporter type was captured as consumer or non-healthcare professional by default.  Follow-up (08Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Diagnosed with shingles; I noticed a red rash on the left side of my torso; It followed in a straight lint and itched; Was painful; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Oct2021 10:30 (Lot number: FH8020) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESCITALOPRAM. The following information was reported: HERPES ZOSTER (non-serious) with onset 03Nov2021 12:00, outcome "not recovered", described as "Diagnosed with shingles"; RASH ERYTHEMATOUS (non-serious) with onset 03Nov2021 12:00, outcome "not recovered", described as "I noticed a red rash on the left side of my torso"; RASH PRURITIC (non-serious) with onset 03Nov2021 12:00, outcome "not recovered", described as "It followed in a straight lint and itched"; RASH (non-serious) with onset 03Nov2021 12:00, outcome "not recovered", described as "Was painful". The events "diagnosed with shingles", "i noticed a red rash on the left side of my torso", "it followed in a straight lint and itched" and "was painful" were evaluated at the physician office visit.  Additional information: Dose received -2: Most recent dose details: product=COVID 19, brand=Pfizer, lot number= FG3527, administration date=06Nov2021, administration time-10:45, vaccine location=left arm. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: Escitalopram. Reported Event: After the first dose of the vaccine About a week after patient noticed a red rash on the left side of his torso. It followed in a straight lint and itched and was painful. On 08Nov2021, 5 days after I noticed the rash he saw his primary care physician and was diagnosed with shingles. If covid prior vaccination: no. If covid tested post vaccination: no. Known allergies -no. Other medical history- none. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Device Date: 08Nov2021.  Follow-up attempts are completed. No further information is expected.
pain on the arm where the vaccine is administered, cold-like chills, and body aches (minor), temp 37.5 deg Celcius.