chrisvoncsefalvay/vaers-outcomes huggingface dataset:
coughing terribly; stuffy nose; sore throat; painful ears; sneezing; loss of voice; This is a spontaneous report from a Pfizer-sponsored program regulatory authority Sup-port via a contactable consumer (patient).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZ-ER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 12Feb2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she started coughing terribly on 24Feb2021. She was asking if this was okay. The patient also had stuffy nose, sore throat, painful ears, sneezing and loss of voice 12 days after the first dose (12Feb2021). Suspects that it was caused by the vaccine. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number can-not been obtained.
Information has been received from a pharmacist referring to a 19 year old female patient. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 11-NOV-2016, a dose of ZOSTAVAX 19400 PFU (dose was unknown; lot number was M035147 with expiration date 25-OCT-2017) was administered subcutaneously to the patient in error today for prophylaxis. The patient was indicated to receive a dose of yellow fever vaccine, manufactured by Sanofi Pasteur. She states that the error was made because she reached in the freezer to get the vaccine, rather than the refrigerator. The patient did receive the dose of yellow fever vaccine in the other arm. No adverse effects were reported. Additional information has been requested.
A spontaneous report was received from a consumer concerning a 80 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore /pain, itched really bad /pruritus, bothered her more at night /anxiety. The patient's medical history was not provided. No relevant concomitant medications were reported. On 21 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 041L2OA) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 18 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 016M2OA) via unknown route in the left arm for prophylaxis of COVID-19 infection. On Feb 2021, the patient experienced the event(s) sore, itched really bad, bothered her more at night. Treatment details included used vinegar in the bath water, acetaminophen and aspirin. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The outcome of event(s), sore, itched really bad, bothered her more at night was unknown.
PATIENT GOT THE COVID19 VACCINE. 1 MIN ONTO MONITORING, PATIENT COMPLAINED OF SWELLING OF THE THROAT. ONE OF THE CLINICIAN FROM THE MONITORING AREA CHECKED THE PATIENT THROAT BUT IT SEEMS NORMAL. WE GAVE DIPHENHYDRAMIN 25MG BY MOUTH AND MONITORED VITAL SIGNS. VITAL SIGNS ARE NORMAL WITH O2 SAT 97% ON ROOM AIR. WE MONITORED THE PATIENT FOR 30MINS AND WALK-OUT ON A STABLE CONDITION.
Vaccination Site Erythema; Vaccination Site Rash; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE ERYTHEMA (Vaccination Site Erythema) and VACCINATION SITE RASH (Vaccination Site Rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included VALACYCLOVIR [VALACICLOVIR], ROSUVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination Site Erythema) and VACCINATION SITE RASH (Vaccination Site Rash). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE ERYTHEMA (Vaccination Site Erythema) and VACCINATION SITE RASH (Vaccination Site Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Within a week of 1st shot, I began to have joint pain... shoulders/neck, hips/top of legs, & knees. Called Dr. after 2 weeks. He said common complaint. Wait Took 2nd dose of Moderna. 2/3/21.  Pain continued. By March 1st Dr. setup lab work.  Diagnosis: PMR - polymialgia rheumatica My symptoms were fatigue-physical & mental, loss of appetite & weight, aching muscles, and stiffness. Rx: 15mg prednisone which will be reduced gradually.  Also worked with physical therapist for 4 sessions to gain strength & flexibility. Still tired, but gradually becoming more active.   In
This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 56-year-old female patient who received SHINGRIX) (batch number 32GR4, expiry date 4th July 2020) and (batch number D3L5G, expiry date 29th November 2020) for prophylaxis. Concomitant products included ADACEL. On 26th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 26th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site warmth, appetite lost and feeling unwell. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site warmth, appetite lost, feeling unwell and pharmaceutical product complaint were unknown. The reporter considered the injection site warmth, appetite lost and feeling unwell to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on the right arm. The lot number of the adjuvant/liquid was D3L5G with an expiry of 11/29/2020. On the same day, the patient received the 1st dose of ADACEL on the left arm concomitantly. The patient experienced hot at injection site to touch, feeling sick, and loss of appetite after SHINGRIX vaccination. The pharmacist reported that he had been giving SHINGRIX injections since January 2018 and said that this last batch of SHINGRIX might be suspect. He reported that the patient experienced Adverse drug reactions (ADE's) unlike previous injections. The reporter did not have any product to return and was not seeking reimbursement. When asked, the pharmacist reported there was nothing unusual about the vials or the box. The side effect profile and percentages of ADEs experienced were reviewed. The pharmacist also reported via VAERS. This case is 1 of the 7 linked cases reported by the same reporter.
Pt. had rash on body and stated he was feeling really itchy and it is getting worse.
initially patient had fever, mild headache, fatigure x1 day and on day 2 he had flat rash on entire torso, lower back, bilateral arms
Most painful vaccine I have ever received/experienced; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Most painful vaccine I have ever received/experienced) in a female 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) at an unspecified dose. On an unknown date, the patient experienced PAIN (Most painful vaccine I have ever received/experienced). At the time of the report, PAIN (Most painful vaccine I have ever received/experienced) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
I must have been pregnant at the time of vaccine but I did not know, my baby did not live, they had to do a DNC. So it all started when I skipped my period. I took a pregnancy test on 02-15-2021 and it was positive. On 02-17-2021 I had some discharge with calcifications and so I went to see my doctor and she could not find a heart beat. They did a DNC on 02-25-2021. My baby would have been 6 weeks when I had the DNC.
Vaccine administered was expired.  Nurse noted after administration.  Patient made aware and will readminister when new vaccine arrives to clinic.  No adverse reaction noted or reported post vaccine.
On day of vaccination (8/22/2018) pt reported minimal pain, swelling. 8/25/2018, pt reported size up to mosquito bite. Today area was swollen, red, inflamed, painful, warm to touch & about 6 inches by 4 inches in a rough oval shape. Could be ADR (25-35% of recipients) or infection, such as cellulitis. Advised to consult physician if does not resolve on own by tomorrow.
Patient was given the COVID 19 Bivalent Booster past the Beyond Use Date. The BUD date was 01/13/2023.  The patient received the vaccine on 01/25/2023.
Started noticing slobbering while brushing teeth then three days later during drinking from soda bottle and noticed loss of sweet taste.
patient caregiver reported he experienced severe headache, nausea, body ache ,chills chest tightness and went to emergecy room in hospital and by the time patient was seen by dr he started feeling better so he was discharged from hospital after monitoring for some time
An online magazine reported that a consumer said that on an unspecified date her daughter was vaccinated with all 3 injections of GARDASIL and after each one she got sicker and sicker. At the time, the patient's mother had no idea that it was the shots doing it to her. After the first shot, she had flu like symptoms, would pass out and had seizures. The second shot left her with vision problems and a lot of pain. She was so sick to that she was hospitalized, but it was not possible to find what was wrong. The physician declared: "you have one sick daughter, but we don't know why". At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Upon internal review, seizure was considered to be an other important medical event. No further information is available.
Shingles on face and eye. I did get a vaccination/ Suspected vaccination failure; Have shingles on my eye; Have shingles on my face; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received a dose of Shingles vaccine several years ago and now had shingles on his/her face and eye. The patient did get a vaccination several years ago therefore his/her case was not severe because of that.  The patient's PCP told him/her that the vaccinations would not guarantee prevention of the disease but would much lessen the severity.  The patient planned to take this newer vaccine as soon as he/she could. The patient could not imagine and  dealing with anything worse than what he/she had already experienced. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Patient is a 26-year-old with kidney failure. He has had left-sided renal transplant. He presented with left flank pain as well as left lower abdominal pain. He had a CT scan that showed no evidence of significant complication. It was felt he might have had acute pyelonephritis. He was admitted to the hospital and started on IV antibiotics. Cultures were obtained, both with blood and urine, which did not grow anything. After his culture returned he will be discharged on his prehospital medications. ED visits and hospital admission within 6 weeks of receiving the COVID vaccine.
Pregnant; This spontaneous pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Dec-2020 and the estimated date of delivery was 21-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) 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.   patient uses unspecified prenatal vitamins as concomitant medications.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Concentrated dose of Pfizer vaccine was administered after diluting vial with only 0.8 mL  of 0.9% sodium chloride solution (should have been diluted with 1.8mL). Patient was contacted and was notified of the error 2 hours after vaccine was administered & advised of potential for increased localized reaction; she reported feeling well at that time. Pt was contacted again at 24 & 48 hours post-vaccine & reported feeling well during both calls with no redness/swelling at vaccine site or other systemic reactions. She was instructed to call out office if any new/concerning symptoms developed.
No adverse event, I will call the mother explain the situation and have her bring the baby back to redo vaccine. When i was preparing the vaccine there was Diluent that came with it and not knowing that  I used sterile diluent instead.
This spontaneous report was received from a nurse referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On an unspecified date in 2014 (reported as 24 months since from the last year), the patient was vaccinated with the first dose VAQTA injection for prophylaxis (strength, route, dose, lot number and expiration date were not provided) .On an unspecified date in 2016 (reported as "sometime last year) about 24 months after the first dose, the patient received the second dose of VAQTA Injection for prophylaxis (strength, route, dose, lot number and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
6:00 PM 06/05/2013 Arthralgia, weakness. 9:00 AM 06/06/2013 Weakness, paleness, tachycardia & palpitations. These advanced to hallucinations, fever, severe weakness (unable to walk) & hypoxia.
Patient's entire left leg swelled up, was warm and had red blotches on it. It was tender and sensitive, he was unable to walk on it for a day. He was in pain when he applied pressure or if I touched it. He developed a fever and was vomiting throughout the night.
Stiffness and pain in arm - difficulty w/ movement especially in morning. Pain all day. Limited mobility with left arm where shot was administered.
When patient came in on 4/10/2021 for second dose of Moderna COVID-19 vaccine he reported that after first dose he experiences swelling from shoulder to hand, so much he could barely take watch off.  Swelling occurred 1 day after the first vaccine, which was administered on 3/6/2021.  Patient took Benadryl at home and did not notify Health Center facility or his physician at the time of occurrence.  Swelling resolved by next day.
Lower dose 0.2 of the ages 5-11 yr vial given to patient of age 14 yrs.  No adverse reaction or symptoms occurred.
On 12/7/99, pt complained of pain & swelling in lt arm. Arm appeared red & edematous from top of arm to elbow & warm to touch. Tx w/ moist heat. On 12/8/99, arm somewhat better but face & nose was red.On 12/10/99, entire arm swollen.
Patient with a h/o syncope to vaccines, felt light headed and laid down on floor roughly 3-5 minutes after vaccination in the observation area.  Patient pale, pulse regular in mid-60's, A&O x3, conversant.  Medical assistance team called, bp 94/60, lightheaded after attempt at standing for 90 seconds.  Transported to ED for observation.
When vaccines were given pt had inconsolable crying for 4 hrs. She had no fever. She was screaming like she was hurting as reported by mother. Calm at 13:49 when called to check back, pt asleep and no fever.
Upon receiving vaccination patient began feeling light headed and dizzy.  Symptoms later included palpatations.
couldn't straighten his leg; flu-like symptoms; soreness; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (couldn't straighten his leg), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (soreness), HEADACHE (headache) and CHILLS (chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced LIMB DISCOMFORT (couldn't straighten his leg), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (soreness), HEADACHE (headache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ALKA-SELTZER) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (couldn't straighten his leg), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (soreness), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.   .
Neck pain was much worse than the normal arthritis pain, hips were achy for a few days, I have deep cramping in my muscles in arms, right thigh, left side of  my abdomen, and feet that is still going on today.
No additional AE reported; During administration when they pulled the needle out, some of the vaccine leaked out of the patient; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 02-SEP-2021, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (route of administration not provided) lot number T041503 expiration date 09-DEC-2022 as prophylaxis.  During administration when they pulled the needle out, some of the vaccine leaked out of the patient (vaccine underdose). It's unknown how much the patient received since the product leaked out. The reporter confirmed that there was no product quality complaints.  No adverse symptoms were reported.
Severe body aches, fatigued, chills and low grade fever 99.2 and mild headache, woke up on 2/11 feeling all of the above. Lasted until I went to bed. Today  2/12 no further chills, but slight headache, body aches and fatigued still.  Hopefully I will be better soon. Thanks. Treatment was Tylenol and lots of  water, and rest.
Swollen lymph nodes under left arm and near left breast. Vaccine was received in left arm.
16 hrs after vaccines, pt. developed fever and inability to open mouth "lock jaw" (lasted 45-60 mins). Hot compressed released jaw after 15 mins. This happen at 2am, went back to sleep, woke up 3am with locked jaw (3-4) would lock up about 2-3x every hour -> woke up OK 7am, no fever.
Inflammation of middle ear, pulsatile tinnitus since first shot worsened after second shot.
Three weeks after the second vaccine, I had a snotty nose and low voice, I was Itchy all over, the next morning I had red spots ALL over  head, torso that really itched.  The next day the spots had joined into blobs and continue to be really itchy.  I have been taking Benadryl every four hours since the break out.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 12-APR-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # H012351, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
2nd dose of the Moderna Covid 19 vaccine injected subcutaneously; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (2nd dose of the Moderna Covid 19 vaccine injected subcutaneously) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 05-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (2nd dose of the Moderna Covid 19 vaccine injected subcutaneously). On 05-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (2nd dose of the Moderna Covid 19 vaccine injected subcutaneously) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
swelling under both eyes and pain; swelling under both eyes and pain; This is spontaneous report based on the information received by. Reference Number: GL-012221-1879. A contactable Physician reported for a 27-year-old female patient that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration from 18Jan2021 to 18Jan2021 at single dose for covid-19 immunization. Patient's medical history included recently testing positive for COVID-19 (date unknown). Past drug included Restylane from Jun2020 to an unspecified date for tear troughs. Concomitant medications were not reported. Patient injected with Restylane to tear troughs in Jun2020. The patient received the first dose of the COVID (Pfizer) Vaccine on 18Jan2021. Reported swelling under both eyes and pain on 20Jan2021. Swelling resolved without treatment by 21Jan2021. The outcome of events was recovered.
Pt c/o back pain, nausea around 1am day after injection then around 5am c/o trouble breathing, wheezing. Pt called office at 8:30am, told pt to go to ED due to not having a physician in office.