chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/14/22 at approximately 10:30am. When error discovered facility contacted CDC for course of action. At direction of the CDC, patient contacted regarding occurrence to offer re-vaccination of dose. Patient accepted revaccination on 1/24/2022. No adverse side effects or event as result of dose.
Patient was admitted to Hospital  on 1/29/22 for COVID pneumonia. This is considered a breakthrough case.
on Jan 13th, patient began experiencing a skin rash "all over face, bumpy, red", patient went to health center, and obtained a prescription for betamethasone cream for use on the face, after starting the cream, resolved for 1 week, then the rash recurred and continued until August 25th, when she saw an allergist and tested positive for additional food allergies which were not previously identified. Eggs, egg whites (severe), egg yolk, oats, baker's yeast, chicken, lamb, tuna, salmon, string beans, blueberries, apples, carrots, corn, grapes, coffee, and onions. After seeing the allergist, she minimized her expposure to the above foods, and the rash resolved 100%.
Reported redness & swelling at injection site.  Advised to contact physician, apply ice and take Benadryl if not contraindicated.
Extreme crying to the point of being inconsolable for over 4 hours, spitting up thick chunky liquid repeatedly, excessive gas and very tender injection sites that are bright red only on 1 thigh. Injections occurred in both thighs. 2.5 ml of infant TYLENOL helped to fall asleep and lessen crying, thighs still appear to be tender.
Swelling in (L) upper extremity. Red swollen - vaccine given 3/25/11.
Extreme fatigue Pain at injection site A lot of swelling at injection site Redness that spread throughout the upper arm Hot to the touch at injection site Feeling under the weather
lost his sense of taste and smell; lost his sense of taste and smell; This is a spontaneous report from a contactable consumer, the patient via a Pfizer Sponsored Program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on 17Jan2021 as a single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced lost his sense of taste and smell . The clinical outcome of lost his sense of taste and smell was unknown.  Information regarding lot number has been requested.
Severe migraine for 3 days, migraine made me nauseous and stomach hurt. Day #2 severe lower back pain as well. Migraine so bad I had nights I couldn?t even sleep.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299808, 2018SA299815, 2018SA299810, 2018SA299811, 2018SA299812, 2018SA299813, 2018SA299814, 2018SA299805, 2018SA299794 and 2018SA299809 (cluster). This case involves 94 years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and 1816022 expiry: UNKNOWN) dose was not reported, administered on NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced out of specification product use. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and out of specification product use was not reported. This report was non-serious.
FEVER, HEADACHE, NAUSEA, DIARRHEA, CONGESTION, BODY ACHES.
After 8 minutes, I got a warm feeling and felt tight and short of breath in my chest area.  My heart felt like it was was skipping and flipping.  It lasted  about 10 seconds but then of course it created anxiety and my heart started racing.  I waited another 20 minutes before I left.  I also had swollen lymph nodes the next morning and sporadic pain in the armpit which gradually got better over the next 3 to 4 weeks.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Mar2021 as dose 1, single (Lot number: 010A21A), in left arm and on 08Apr2021 as dose 2, single (Lot number: 036B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Positive, notes: I developed symptoms again and tested positive for Covid two weeks later. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication in 2weeks. She developed symptoms again and tested positive for Covid two weeks later. Patient had no known allergy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Received ProQuad (varivax + MMR) on 9/14/06. Developed chicken pox on 2/7/2005. So vaccine for Varicella did not work.
Next day patient experienced localized red inflamed area at site of injection with pain, developing into lack of mobility in left upper extremity. Non responsive to ice or heat treatment. Patient seen by orthopedic surgeon 2 days later. Bursitis confirmed by xray below deltoid. Treatment includes sling for 1 week and physical therapy for 1 month (still ongoing).
77-year-old male, with a history of multiple medical problems including renal transplant, states he was exposed to a patient with COVID-19 5 days ago.  The day after he was exposed he began to feel somewhat ill with generalized malaise, runny nose, mild cough.  He has some mild associated shortness of breath.  He attributes some of this to exposure to smoke.  States he has no change in taste or smell.  He has had a few episodes of diarrhea over the weekend.  Denies nausea or vomiting.  No chest pain.  Temperature has been around 99 intermittently.  Has been taking Mucinex and Tylenol.  Denies abdominal pain or back pain.  Review of Systems  Constitutional: Positive for fatigue and fever. Negative for chills.  HENT: Positive for rhinorrhea.   Respiratory: Positive for cough and shortness of breath.   Cardiovascular: Negative for chest pain.  Gastrointestinal: Positive for diarrhea. Negative for abdominal pain, nausea and vomiting.  Genitourinary: Negative for difficulty urinating.  Musculoskeletal: Negative for back pain and neck pain.  Neurological: Negative for dizziness.  Psychiatric/Behavioral: Negative for confusion.  All other systems reviewed and are negative.    MDM Number of Diagnoses or Management Options Close exposure to COVID-19 virus: new and requires workup Lower respiratory tract infection: new and requires workup Diagnosis management comments: 77 yo male, with symptoms of acute upper respiratory tract infection.  Overall description is viral in nature.  Was also exposed to Covid but is vaccinated and he has no change in taste or smell making this less likely.  Overall his exam is reassuring.  Will perform a chest x-ray to further evaluate, treat with Tylenol.   CXR shows questionable RLL infiltrate, by my interpretation, will treat with azithromycin.  Rapid COVID was invalid.  Will wait for PCR instead of re-swabbing.  Encouraged to follow-up with his primary care physician if symptoms or not gradually resolving.  Certainly return here if new or worsening symptoms develop.   1. Lower respiratory tract infection   2. Close exposure to COVID-19 virus   Disposition: Discharge to home
pt rcv vax; approx 1wk later, dx w/ cervical lymphadenopathy. child observed tugging on her ears on date of vax; ears were clear on examination
This spontaneous report was received from a nurse and refers to a female patient (the patient's mother) of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-APR-2018, the patient inadvertently got (reconstituted with sterile diluent) M-M-R II (lot# and expiry date were not reported) in her eye. No adverse effects were reported.
An expired dose that had been left in the fridge the previous evening was erroneously administered to the patient the following morning
DIZZINESS; MUSCLE ACHES; SWELLING IN THE NECK AND SHOULDER AREA; UNUSUAL TASTE IN THE MOUTH; UPSET STOMACH; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-MAR-2021, the subject experienced swelling in the neck and shoulder area. On 22-MAR-2021, the subject experienced unusual taste in the mouth. On 22-MAR-2021, the subject experienced upset stomach. On 22-MAR-2021, the subject experienced muscle aches. On 24-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in the neck and shoulder area, muscle aches, unusual taste in the mouth, upset stomach, and dizziness. This report was non-serious.
seizures x 2 the day after immunizations.  11/05/2007 MR received for DOS 9/25-26/2007 with DX: probable provoked seizures 2' to immunizations.  Child presented to ER after an episode of irritability follwed by  becoming rigid, back arching, extension of extremities, eyes rollling back and subsequent limpness. Event was preceded by low grade fever. Child had shallow respirations and was poorly responsive for 5-10 minutes. Upon arrival to ER pt was fine but had a 2nd episode in the ER with apnea, unresponsive limpness x1 minute.  Admitted for observation with no further episodes.
A nurse, the mother of the subject, reported the occurrence of lethargy in her approximately 3 month old son who was vaccinated with DTAP (Infanrix) for prophylaxis.  The subject had no relevant medical history or concurrent conditions.  He received no concurrent medications.  On 12/17/2002, the subject received his first injection of Infanrix.  On that same date, he received injections of inactivated poliomyelitis virus vaccine (IPV, AP), and HIB (Hib, Manufacturer unknown).  At an unspecified time post-vaccination, on 12/17/2002, the subject began to experience inconsolable crying which was intermittent and recurrent and lethargy.  The reporting nurse considered the events to be probably related to Infanrix administration.  The events resolved on 12/26/2002.
Chills, arm pain, on 07/25/2018 left hand and fingers started to swell. Between 07/26/2018 -> 07/29/18 swelling and pain in hand.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient has since received her second dose on 04/09/2021.
Swelling of face. No involvement of tongue, mouth or nares.  Rash at injection site. Symptoms present for 48 hours, then gone.
Vaccine expired on 1Apr2022, stored in refrigerator on 4Apr2022 and administered on 8Apr2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 1Apr2022, stored in refrigerator on 4Apr2022 and administered on 8Apr2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 1Apr2022, stored in refrigetator on 4Apr2022 and administered on 8Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 1Apr2022, stored in refrigetator on 4Apr2022 and administered on 8Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant drug information was provided. It was reported that the pharmacist thought that the expiry date of the vaccine was JUNE 2022, however the vaccine expired on 01-Apr-2022. Vial was initially stored in refrigerator on 04-Apr-2022. It was confirmed that the vial had not undergone any temperature excursion issue.  No treatment drug information was provided.
On 5/30/01, the child went into a coma. He was unresponsive, had low breathing ability and seizures. To date, he is on 4 drugs and still has seizures. Approx. 5 days prior to hospitalization, he had a fever of 104F for 2 days. He was lethargic and slightly delirious. The annual follow up states seizures. Despite trying all seizure medications and brain surgery this July 2nd, my son still has recurrent seizures and n ow learning disabilities.
I woke up and felt bad, achy all over, tired and extremely dehydrated. This lasted for 3 weeks of more. I had no appetite.
Per patient 3-4 days after he received his vaccine he developed a rash on the arm of the vaccine further down from injection site, the rash was red and itchy and dissolved after a few days. He states he got this rash each time with his previous doses of Moderna, previous doses were administered at different facility. According to research and his doctor this is called "Covid arm" and is not a contraindication to get the vaccine.  He didn't have any further symptoms develop and didn't need to seek medical attention.
She had an upset stomach and was feeling really tired. Then the  next morning, she had a rash - itchy and bumpy -   torso, back arms and face. Went to the Doctor and she said it looked like an allergic rash. She told us that based on my daughter's genetics and her asthma -  (I (her mother) had an anaphylaxis with my second Moderna shot  - my entire body was giant hives.)- That he did not recommend her to have the 2nd shot. My daughter still has some of the rash - a little on her left cheek, stomach and back still. The itching is gone. She did take Benadryl for it.
mom states pt broke out w/whelps on neck, chin & thighs p/about 4PM day of vax; pt turned red all over; face began to swell; exp some itching;
Immediatly after the vaccine, both od my hands became very hot and red. Over the next few days, I experienced pain and numbness in my hands. They felt as if they were on fire. Sometimes my fingers would go numb and feel tingley. Other times, they were just hot and very red. As the month progressed, my hands did not get better. I began to feel the pain go up my arms so I thought maybe I had sprained my wrist. I began to take pictures of my hands everyday and bought splints. I suddenly began to notice that my feet were swollen and that they hurt. I recieved the second COVID shot on May 1 and immediatly after my hands swelled like balloons. They switched from being hot and red to numb and painful. The pain was growing worse and shooting up my arms. The pain and swelling became so bad that I could not sleeo at night. I would wake up and cry out in pain. On May 22, 2021, I finally went to Medical Center to the Emergency Room. I explained that my pain was due to the COVID shot. I tried to show the ER doctors my pictures of how my hands were getting worse right after recieving the COVID shot. When asked how bad my pain was, I said it was a 10 on a scale of 1-10. They laughed at me and ridiculed me for blaming my red hot hands and sudden pain on the COVID shot. One doctor blamed my poor posture for my swollen, red hot hands. I was sent home with paperwork for Carpal Tunnel Syndrome and was told to sit straight. As the weeks went by, I lost the ability to use my hands. I could not even hold a cup of coffee in the morning. Soon, I was unable to dress myself or use my hands or walk. On August 24, 2022, a rheumatologist finally agreed with me that my illness was related to the COVID vaccine.  On that day, after blood work and numerous tests and xrays, my rheumatologist diagnosed me with an inflammatory arthritis. I take prednisone daily, as well as methotrexate and sulfasalizine for all the inflamation. All of a sudden, at the age of 50, I have joint pain, swollen feet, rheumatoid arthitis, anemia, vitamin D deficiency, a positive ANCA, and vasculitis, all of which are due to the two COVID vaccines. They have ruined my life! I have pictures documenting and chronicling this mystery from the first day I recieved the vaccine.
Patient is experiencing  shoulder pain described as someone knuckle-punching her shoulder with any usage of her left arm. She states is affects her job and everyday tasks.
Shortness of breath, irregular heart rate, vomiting for 48 hours couldn?t keep anything down, bladder incontinence, unable to stand or walk, total loss of muscle movement, severe body aches no medication would help, severe  stomach cramps, arm swelling hot to the touch, bad arm pain, nausea, fatigue, dizzy, loss of motor skills, irritable, uncontrollable crying, severe headache , felt like I was going to die. Worst Ive ever felt in my life
Information has been received from a literature article concerning a 13 year old female patient developed uveitis, following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17. The median time from vaccination to onset of ADRs was 30 days; time to onset was unknown in 1 case; the time to onset in this case was of 476 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports form the same literature source. Additional information has been requested.
A syringe leaked while being used to give a dose of the Moderna COVID-19 vaccine; patient received approximately half to little more than half of the 0.5mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (A syringe leaked while being used to give a dose of the Moderna COVID-19 vaccine) and ACCIDENTAL OVERDOSE (patient received approximately half to little more than half of the 0.5mL dose) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included NAFTIFINE HYDROCHLORIDE (NAFTIN) and AZATHIOPRINE (AZATHIOPRIN) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced DEVICE CONNECTION ISSUE (A syringe leaked while being used to give a dose of the Moderna COVID-19 vaccine) and ACCIDENTAL OVERDOSE (patient received approximately half to little more than half of the 0.5mL dose). On 22-Oct-2021, DEVICE CONNECTION ISSUE (A syringe leaked while being used to give a dose of the Moderna COVID-19 vaccine) and ACCIDENTAL OVERDOSE (patient received approximately half to little more than half of the 0.5mL dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided. It was reported that patient was administered approximately half to little more than half of the 0.5mL dose. The patient is not experiencing any side effects or symptoms.
This spontaneous report was received from a nurse and refers to an unknown number of unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies, and concomitant therapy were not reported. The nurse reported that between 08-MAY-2017 and 24-MAY-2017, the patients were vaccinated with a single improperly stored dose of GARDASIL 9, intramuscularly (lot # M034195, expiration date 14-APR-2019, lot # M031557, expiration date 07-APR-2019, dose was not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature of 49 Fahrenheit degrees, for 2 hours (supported). There were no previous temperature excursions. Data logger was not involved. No adverse effects were reported. This is one of 3 reports from the same reporter. Additional information is not expected, as there was no consent to follow up. Sender's Comments: US-009507513-1705USA013741: US-009507513-1706USA004263.