chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a social media through company representative concerned a patient of unspecified age, sex, race and ethnic origin. 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 were not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered at the end of NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient felt pretty sick and on 14-JAN-2022, the patient was tested positive for corona virus disease (Covid-19) which was confirmed clinical vaccination failure and had confirmed covid-19 infection. It was also reported that the patient was fully vaccinated for 6 weeks and 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000211987. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Version created to amend previously reported information on 25-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V2:Upon review the following information was amended: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. This updated information does not alter the causality of previously reported event  20220128576-COVID-19 VACCINE AD26.COV2.S: Confirmed Clinical Vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Extremely tired, headache, short of breath,  runny nose, sore throat, ear ache, stuffy nose from time of start and has continued.  Headache, extreme tiredness, SOB and runny nose have been consistent.
Had seizure at 12:00 noon. Temperature immediately following seizure was 97 degrees F. Patient had been eating/drinking/acting normal prior to seizure. We were immedietly brought by ambulance to Medical Center where he had bloodwork & 24 hour EEG performed - all which came back within normal limits.
Nothing that I feel was related to my two vaccinations and booster shot.  I had more angina and underwent catherization in a hospital and received my 5th stent in the coronary artery
I got sick with the flu for 2 weeks; Initial information received on 17-Feb-2022 regarding an unsolicited valid Social Media non-serious case from a Patient.  This case involves an adult patient of unknown demographics who got sick with the flu for 2 weeks while receiving vaccine Influenza vaccine.  The patient's medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing COVID-19.   On an unknown date, the patient received a dose of suspect Influenza vaccine (dose, form, route, strength, batch number and expiry dates: unknown) in an unknown administration site for immunization. Information on batch number has been requested.  On an unknown date the patient got sick with the flu for 2 weeks (influenza) (unknown latency) following the administration of Influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (influenza).  At time of reporting, the outcome was Unknown for the event influenza.
slight difficulty swallowing; feeling of something stuck in my throat; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration, administered in the left arm on 12Mar2021 11:45 (at the age of 57-years-old), as first dose, single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced slight difficulty swallowing and feeling of something stuck in my throat on 13Mar2021 00:30. Patient did not seek consult to physician or urgent care. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt developed clinical varicella with less than 12 lesions. Pt was afebrile. At the time of reporting, the pt's condition persisted. Additional information has been requested.
I woke up, and could not get out of bed  because I was sick. Aches and pain on entire body, tired, malaise, and  sick.  Then I got the chills, accompanied with a fever. My everyday temperature is 96.7 and I had a 99.7 fever.  My eyes were glassy and grey.   I was like this until the next day.  I had COVID19 on 11/18/2020 - I did not have the above symptoms of aches and pains or a fever or the chills.  My breathing and coughing finally was 99% better by February 2, 2021. My taste and smell is not back yet. Are there studies on how people react to vaccination if they had the COVID19? Is there research comparing prior COVID19 symptoms with adverseReactions symptoms?
No additional AE; PROQUAD was administered on 8/3/2020 but expired on 8/2/2020; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.   On 03-AUG-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliters as prophylaxis (ml) (formulation, strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number S003326, expiration date reported 02-AUG-2020, which were verified to be valid). There was no previous temperature excursion. No additional events were reported.
I received the Pfizer Bivalent booster on 11/17/2022. On 11/28/2022, I had a severe headache and a little bit of nausea. I took some hydrocodone and promethazine. They didn't get rid of the headache, but the promethazine did take away the nausea. After I took the medicines, I just slept, because there was nothing else to do. During the week of 11/28/2022 to 12/2/2022, the symptoms got progressively worse. On 11/30/2022, I had persistent chest pains. On that day, I had a telehealth visit with a PA who works with my pulmonologist. She agreed to ask my pulmonologist to prescribe me some prednisone. At this point, I had taken a home antigen test every day between 11/27/2022 and 11/30/2022 and had gotten a negative result each time. However, my wife had tested positive, so the PA felt pretty confident that I also had it, despite the results of the tests. On 12/1/2022, I took another home antigen test and got a positive result. The symptoms I was dealing with during this time included difficulty breathing, body aches, severe cough, chest pains, nasal congestion, and nausea. I had to use my rescue inhaler when I had difficulty breathing; the inhaler helped somewhat, but not completely. On 12/1/2022, I finally got a prescription for prednisone, Z-PAK, and promethazine, and I began taking the prednisone and the Z-PAK on 12/2/2022. On the night of 12/2/2022, the chest pains had diminished somewhat, so I had less discomfort. At the time of this writing, I continue to have chest pains, which are now somewhat intermittent and are much milder than they were at the beginning of my illness. I also continue to have a persistent (but milder) headache, a mild cough, and intermittent nausea. Of all those, I would say that nausea is the worst symptom, but it now seems to be diminishing. On 12/13/2022, I took another home antigen test and got a positive result. When I took another antigen test on 12/15/2022, I finally got a negative result for the first time since the beginning of my illness.
Information has been received from a health professional concerning a 4 year old male with an infected toe and a OMNICEF /allergy who on 07-MAY-2007was vaccinated SC with a 0.5 ml dose of ProQuad (lot # 657183/0299U). Concomitant therapy included an unspecified antibiotic for a toe infection. On 08-MAY-2007 the patient experienced swelling, redness and warmth at the injection site. Unspecified medical attention was sought in the emergency room on an unspecified date. There were no lab tests performed. The patient was then seen in the office on 10-MAY-2007 and it was noted that the swelling, redness and warmth was getting less. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was provided. The reporter considered the patient's events to be other important medical events because the patient was taken to the emergency room. Additional information has been requested.
Patient Received second dose of COVID-19 vaccine Pediatric Pfizer (LOT#: FK5618) exp: 2/21/22 on 12/26/21 and first dose COVID-19 Pediatric Pfizer was given on 12/07/21. Patient came in with siblings and mother. Mother brought children two days early from second dose due date., RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID second dose Pediatric Pfizer. Per Dr. approval to proceed with COVID second dose Pediatric Pfizer vaccine was obtained from medical consult team via text message from, RN, Vaccine Operations Lead. Client received COVID vaccine Pediatric Pfizer 2 days before due date. The patient did not report any symptoms during the 15 minute observation period. RN educated client on possible adverse reactions and when to seek medical care. Patient left vaccination site with her mom and siblings at 1545 unassisted and with a steady gait.
Narrative: Headache, Myalgia, Fever, Diarrhea, left sore arm.
None at the time.  Approximately three weeks after I develop headache behind my ear.  I developed a fever on 12/22/21 which lasted 2 days. And now I have left side paralysis with started on 12/27/2021.
Partial Complex Seizure with low grade fever. Lasted 40 mins. Ativan administered in ER. Overnight stay at hospital.
Two weeks after receiving my booster shot on 11/21/21, both my hips started hurting.  The pain has remained since then with no lessening.  On January 15, 2022 I got shingles.  On April 1, 2022 I got cellulitis.  On about May 20, 2022 I got a serious reaction to my reflux medicine (Omeprazole).  Reaction was painful and swollen tongue and throat.  Around May 15, 2022 I got severe fungus on my left big toe (not athlete's foot).  As of this date, severe pain in hips remains as well as toe fungus.  Changed reflux medication.
Patient with history of cerebral palsy, seizure disorder, and CKD. He was brought to the ED by EMS on 1/26/23. Per EMS, the patient was having trouble walking and talking at his group home. This is different from his baseline, so his group home staff called EMS. Upon EMS arrival, patient was hypoxic with sats in the 80s. He was initially placed on supplemental oxygen with improvement. In the ED, chest x-ray confirmed pneumonia, and a COVID PCR test performed resulted positive. Patient was admitted 1/26/23 with septic (possibly mild hypovolemic) shock, hypoxic respiratory failure from suspected COVID-19 pneumonia, and possibly emesis aspiration. He was discharged 2/1/23.
Tremendous pain in ALL of the left arm (where vaccine was administered) from shoulder blade on my back to upper arm and to forearm.   Pain began 5 days after getting the vaccine, and as of now, I am on my 10th day of significant pain. Taking FULL doses of Advil and Tylenol as advised by my physician. Helps a bit, but the pain is still significant.
Fever 103 @ 11AM on 30MAR91 until 31MAR91-highest 104-took APAPq3h- ER MD gave antiobiotic; Rechecked on 3APR91 OK
Per patient's representative, after receiving the vaccine around 0230pm,  the patients arm began to swell and she was taken to an emergency room at 0800pm. While in the ER, the patient was given a steroid shot and an NSAID. The swelling in the patient's arm resolved.
It started with three days of mild fever and then on day four 02/08/2021. I lost function of my muscles, I couldn't walk, I couldn't lift my arms, I couldn't chew and my  kidneys shut down and quit working. My blood pressure was 80/50 at the hospital. There is a heart enzyme troponin its supposed to be 4 if it reaches 40 you're having an active heart attack and mine was 37. I was in the hospital for four days. In a weird series of events during this time they found some heart conditions that I had. Had I not been hospitalized they would have never found these heart conditions.  The condition I had was similar to the reaction I have had to steroids before hence why I don't take steroids.
sore throat; chills; headache; fatigue; bruise and bump at injection site; bruise and bump at injection site; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration, administered in the left arm on 10Feb2021, at 12:15 (at the age of 70 years old) as dose 1, single for COVID-19 immunisation. Medical history included known allergies: sulfa drugs, contrast dye, and bee venom. She was not pregnant at the time of report. The patient's concomitant medications were not reported. The patient did not receive any other vaccines prior to the COVID vaccine. On 21Feb2021, 12 days after injection (as reported), the patient got sore throat, chills, headache, fatigue, and bruise and bump at injection site. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. At the time of report, the patient has not recovered form the events.  No follow-up attempts are possible. No further information is expected.
pt received immunization around 9:15 am 9/9 got home around 11 am. said eyes started to itch, throat scratchy, and lips swelling. called pharmacy at 2:15 pm. advised pt to take benadryl, call dr or go to dr or er, pt was home with husband. pt wanted took benadryl 50 mg. called back to pharmacy at 3:55 pm and swelling and other symptoms had improved. advised pt to continue benadryl and go to er if worsened. pt states has dr personal number and will call dr if needed. will call pt to check on them in the am 9/10
Rash on the left arm, developed rashes, on Left thoracic spine and under my L breast; Pain, extremely painful; Unable to sleep at night; Unable to work, workout, do housework; Additional fatigue; Numb; Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ankylosing spondylitis (took Humira for a very mild case of AS (Ankylosing Spondylitis) which was diagnosed when patient was 64 year old). Previously administered products included HUMIRA (took Humira for a very mild case of AS (Ankylosing Spondylitis) which was diagnosed when patient was 64 year old).   On 14th October 2022, the patient received the 1st dose of Shingrix. In October 2022, 3 days after receiving Shingrix, the patient experienced shingles, pain, difficulty sleeping, activities of daily living impaired, fatigue and numbness. On 17th October 2022, the patient experienced rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir Hydrochloride), lidocaine, non-drug therapy (Cryotherapy) and triamcinolone diacetate (Triamcinolone Acetate Cream). On an unknown date, the outcome of the shingles, pain, difficulty sleeping, activities of daily living impaired, fatigue and numbness were unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash, pain, difficulty sleeping, activities of daily living impaired, fatigue and numbness to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's comment: The case was self reported by the patient. The patient received first dose of Shingrix into left arm and now experiencing a rash on the left arm that she stated was diagnosed as shingles by her dermatologist. Three days later, after vaccination the patient developed rashes on left thoracic spine and under left breast. Her doctor found it strange and had no explanation for that. The patient had no discharge, no pus, but extremely painful entire thoracic/lumbar area, painful both quads to the patella area, and unable to sleep at night and obviously unable to work, workout, or even do housework due to additional fatigue. At present the patient was taking Valacyclovir HCL 1 gram tablet 3x/day for 7 days, spreading Lidocaine and applying cryotherapy to numb pain, and Triamcinolone acetate cream to help with healing. The patient stated that her entire health status could be obtained from her primary care physician, if that helps with her case. The reporter did not wish to provide health care professional information. The reporter did not consent to follow up. Additional Supportive Information: Conservatively numbness event coded.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022GSK126305:Literature case previously created for the article mentioned at narrative
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in an 80-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 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that vials had not undergone any temperature excursion.   Total of 102 doses/vials were given for LOT  026C21A.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up document received contain non significant information.
Swelling, redness, pain and fever. Fevers up to 105F with spreading redness and pain over the arm in the following days. Pt seen 12/7/2015 for follow up, started on Keflex for possible cellulitis.
Hives completely covered his body; Face ears lips eyes swelled shut; ears lips eyes swelled shut; lips eyes swelled shut; eyes swelled shut; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and an unknown time after starting Cortison, the patient experienced hives, facial swelling, ear swelling, lip swelling and eye swelling. The patient was treated with cortisone acetate (Cortison) and steroid shot (nos). On an unknown date, the outcome of the hives, facial swelling, ear swelling, lip swelling and eye swelling were unknown.   It was unknown if the reporter considered the hives, facial swelling, ear swelling, lip swelling and eye swelling to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The case was reported by patient's parent. The reporter mention the the patient had a severe reaction to the Flu shot. The patient experienced face, ear, lips and eyes swelled shut and had hives completely covered the body. The patient god shot or cortisone and steroids. The reporter said that the vaccines should not be pushed on people like the Flu vaccine was pushed on me. The reporter said no but they insisted and was persistent. The reporter said that see what happens when you did not listen to yourself and trust in god. No other information was provided. The reporter did not consent to follow up.
Systemic: Seizure-Medium, Additional Details: pt was given moderna vaccine, as per technician onsite, patient tripped and fell to the ground and started having a seizure. pt has history of epilepsy as per husband who was with her at the time. i was in the pharmacy for a minute and got called to the immunization area. i asked technicia to call 911 immediately and had on her side on the floor as per 911 instruction. paramedic arrived shortly after and pt left in stretcher