chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was not feeling well; I am experiencing mild symptoms of cough; nasal congestion; tired; back pain; lost my taste and smell; lost my taste and smell; took a rapid test yesterday which came out positive for COVID; took a rapid test yesterday which came out positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Iron deficiency anemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "took a rapid test yesterday which came out positive for COVID"; MALAISE (non-serious), outcome "recovering", described as "I was not feeling well"; COUGH (non-serious), outcome "recovering", described as "I am experiencing mild symptoms of cough"; NASAL CONGESTION (non-serious), outcome "recovering", described as "nasal congestion"; FATIGUE (non-serious), outcome "not recovered", described as "tired"; BACK PAIN (non-serious), outcome "recovering", described as "back pain"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "lost my taste and smell". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective, covid 19 cannot be totally excluded.
onset large localized redness, swelling, warmth which spread to lower part of arm (near elbow) 6x6cm around site, 9 x 6.5 cm area 10" below site.
Initial report was received from a consumer, who is also the patient's parent on 20 and 24 January 2011.  A two year-old female patient with no reported past medical history, had received a dose of FLUZONE (unspecified) on 20 November 2010.  The lot number, route and site of administration were unknown.  On 15 January 2011 the patient experienced a febrile seizure and an undetermined amount of "neurological stress" as a result of the seizure.  Treatments were not reported.  The patient has no family history of febrile seizures.  The parent reports the patient had "no other problems, was doing much better and almost back to old self".  Documents held by sender: none.
Patient received expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The healthcare professional (HCP) mentioned that there was incident because of miscommunication as a coworker told that there were some lot number whose expirations dates have been extended.  The frequency was reported as times per.  No treatment medications were reported.
Vaccines administered on 5/22/01. That evening she started running a fever >101F (ax). Mom gave Tylenol q 4 hours, until afternoon of 5/23/01. Afebrile afterwards. Had 1st seizure at 07:30 AM on 5/24/01; was nursing, stopped and "body shook" then went stiff and eyes rolled. Lasted about 1 minute. 2 other similar episodes prior to 09:00AM. Went to ER. I saw pt on 5/29/01 and her exam is entirely normal. Her mother said that on 5/24/01, she was quite sleepy and inactive. By the next day, she was back to normal. Her mother denied extensive crying, irritability or bulging fontanel at the time. ER found her afebrile and no focal signs nor signs of meningeal irritation. (I talked to ER physician on 5/24/01). I don't have lab values from ER visit. Perhaps her family physician will have these.
I had my vaccination on 09/23/2022. I started to experience a sore throat congestions and runny nose on 01/01/2023. On Monday 01/02/2023 I started to have these symptoms to include a dry cough. I tested COVID-19 positive on 01/02/2023. I contacted my doctor office and was prescribed PAXLOVID.
administered YF-VAX to a patient intramuscularly instead of subcutaneously, with no reported adverse event; Initial information received on 16-Mar-2022 regarding an unsolicited valid non-serious case received by a health care professional and physician.  This case involves a 27 years old male patient with incorrect route of product administration (administered yf-vax to a patient intramuscularly instead of subcutaneously, with no reported adverse event) while receiving vaccine Yellow Fever Vaccine - [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 16-Mar-2022, the patient received 0.5 mL dose of Yellow Fever Vaccine -  (form, strength: unknown; lot UJ409AA and expiry date: 22-Oct-2022) via intramuscular route in the left deltoid for Immunization  On 16-MAR-2022 (Latency: same day), they administered YF-VAX to the patient intramuscularly instead of subcutaneously, with no reported adverse event (incorrect route of product administration).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  Event outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Patient developed ileocolic intussusception 4 days after receiving 4 month vaccines (PENTACEL, PCV-13, Rotavirus).
Patient experienced shortness of breath and increased heart way hours after recieving the flu vaccination. She went to the emergency room and was treated appropriately. She was told that these symptoms were an allergic reaction to the flu vaccination that she had received earlier that day.
On 12/31/00, pt developed some muscle aches and pains. By 1/1/01, he had severe myositis/joint pains/weakness and could not walk or even feed himself. Admitted to hospital on 1/1/01 to rule out Guillain-Barre Syndrome and other causes. All tests were normal.
Swelling, shoulder to elbow; Redness, shoulder to elbow; This non-serious case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-APR-2023, the patient received the 1st dose of Shingrix. On 10-APR-2023, 3 days after receiving Shingrix, the patient experienced swelling arm (Verbatim: Swelling, shoulder to elbow) and erythema of extremities (Verbatim: Redness, shoulder to elbow). The outcome of the swelling arm and erythema of extremities were not reported.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.     It was unknown if the company considered the swelling arm and erythema of extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-APR-2023 The other health professional reported that a 56 year old patient in their practice received her first dose of Shingrix immunization on 7 April 2023.  The patient received the vaccine on a Friday and experienced redness and swelling from her shoulder to her elbow through the following Monday. The reporter did not agree to follow up from GlaxoSmithKline.
I had vertigo upon sitting up from bed on Saturday ( a few days after ) then quickly had pain in joints, muscle spasm that bent me over. Dizzy,  headache bad, fever and chills, abdominal bloating, lost appetite, tummy hurt,  foggy headed, deep stretchy yawns many times the first day, then they stopped. Oh! the shaking and trembling. I waited to see if it would get worse but it didn't 4 degrees high, dropped to 2. Most of the symptoms were gone in 24 hours. The fever in two days but lower.  Headache and some muscle aches remained but tylenol helped. Some vertigo remains but not barfing bad.
I started getting symptoms of sore throat and was taking cough drops and TYLENOL. I tested positive for COVID-19 on a home test. I contacted my doctor and prescribed PAXLOVID. I had weakness and fatigue as well as a cough. My symptoms lasted for a total of 4 days. The weakness lasted for longer.
Pain at injection site, down right arm and into right shoulder. Difficulty sleeping that night due to the discomfort. Continued pain on 10/3/2012 though slightly less. IM injection given at one and on-half finger widths below acronium process.
COULD NOT STAND; VERY STIFF; This spontaneous report received from a patient concerned a 7 decade old male. The patient's past medical history included hemorrhaged after surgery, cataract, cataract surgery, and concurrent conditions included legal blindness, crippled in hands, and Parkinson's disease. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included HUMIRA (solution for injection in pre-filled syringe, subcutaneous, batch number: 1151530, 1154832) 40 mg, 1 time every 2 weeks, therapy dates were not reported for rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced could not stand, and very stiff. The action taken with covid-19 vaccine was not applicable, and action taken with HUMIRA was not reported. The outcome of the could not stand and very stiff was not reported. This report was non-serious.
Approximately 2 hours after receiving Hep B vaccine booster, patient reported that he started to experience itching, mainly on both elbow and neck with accompanied reddish spots. Spots had deepened and bulged with worsened itching by night time. Patient applied OTC hydrocortisone cream, 1%. The following day the sports reduced but was still experiencing mild but spontaneous spots with rash and itching that would erupt.
MOTHE CALLLED ON 10/31/2022 REPORTED PATIENT HAD LOW GRADE FEVER ON 10/27/2022, WAS GIVEN TYLENOL. SHE ALSO STATED PATIENT DEVELOPED A RASH TO INJECTION SITE ON 10/30/2022. SHE STATES TODAY RASH LOOKS LIKE IT IS CLEARING UP SOME, NOT AS RED. MOTHER WAS INSTRUCTED IF SYMPTOMS WORSEN, GO TO ER.
p/vax pt devel a rash consistent w/erythema multiforme & bactrim, PCN & Paxil were discontinued;pt devel severe myalgias 6/6/99 & numbness in feet on 6/8/99;hosp w/a clinical dx of GBS & tx w/pred & plasmapheresis;
Got sick every year; Initial information was received on 23-Nov-2021 regarding an unsolicited valid social media non-serious case from a consumer/non-healthcare professional.  This case involves Adult (unknown gender) patient who experienced got sick every year (illness) after receiving INFLUENZA VACCINE.  The patient's medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious got sick every year (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Mother states, post vax, child would not move leg and held hip and knee flexed. On 1/11/01, right knee swollen, warm and with pain on movement. Right hip had normal ROM. No fever. Admitted to rule out septic joint and toxic synovitis. Dx: Toxic Synovitis.
p/vax pt had low grade fever, nausea, achy; sx relieved by 8/30/99.
Vaccines given 9/12/13. Abdominal pain, projectile vomiting, screaming, pulling legs to chest - started 10/4/13. No fever. No diarrhea. Took her to Urgent Care - was told "she has a virus" and sent home. No diagnostics performed. 10/6/13 - took her to hospital. Extremely dehydrated, basically non-responsive. Admitted for bowel obstruction caused by intussusception. Ultrasound, X-ray and barium performed. Had surgery 10/7/13 at 4 AM to remove section of intestine and appendix. Released from hospital 10/12/13.
few days after started to have abdominal pain on-off until 11/17 where I developed appendicitis
Swollen and tender lymph node/ gland in right armpit. Started 3 days after shot, has gotten more swollen and tender to touch. No fever or other reactions
Left eye only crossing over on the evening of the vaccine administration. Mom stated she had a slight temperature by touch. No other symptoms noted.
Pfizer-BioNTech COVID-19 Vaccine EUA Patient received Pfizer-BioNTech COVID Vaccines on 1/20/2021 and 2/12/2021. Presented to ED on 8/9/21 from acute rehab with complaints of unresponsiveness at Rehab. PMH of CVA (2019). 2 weeks prior to admission patient with admitted to hospital and diagnosed with pontine stroke. Patient was scheduled for TEE and underwent routine COVID test and tested positive. Pt caregivers reported patient showed no respiratory symptoms prior to this admission. During this stay patient was treated with empiric antibiotics, Decadron for 10 days and Lovenox for treatment of a DVT and discharged to acute rehab. Upon arrival to ED pt was hypotensive, intubated and found to have a large retroperitoneal hematoma. Pt was also started on Cefepime, Vancomycin, and Doxycycline. Patient diagnosed with acute hemorrhagic shock and, acute blood loss anemia. Patient continued to decline and family decided to withdraw care and initiate comfort care. Patient expired on 8/10/2021.
10 minutes after the administration of vaccines child developed erythema & hives around the site where varicella was administered.
Red/Swelling/hot to touch right anterior leg - size of jar lid & about 2" above knee - child walking & not complaining.
Sixteen hours after vaccine, patient developed shakiness, backache and fever. Before Tylenol she was burning up, and after Tylenol her temperature was 100. She was asymptomatic after 30-35 hours.
This patient had worsening of osteoarthritis, especially in the knees. The right knee swells, and decrease in range of motion.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 11Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 24Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Positive, notes: I have tested positive for COVID again on 25Jul2022 on two at home COVID tests; (21Jul2022) Negative, notes: after two negative at home tests on 21Jul2022; (22Jul2022) Negative, notes: One negative PCR test on 22Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Very red raised rash about 2cm by 4cm. (day 1) Then a secondary rash grew around it (day 2 - 3) (unraised). Total size of rash at treatment was 4cm by 8 cm, hot to the touch. Saw Dr on 7/10, recieved steroid cream. Inner rash still visible on 7/13, not as red, no longer itchy.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 70-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided. No treatment information was provided. The reporter was an internal medicine manager.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.
A month or so after my vaccination, I came down with pneumonia went to the doctor and she prescribed some pills and X-ray. She said I had an infection. After a week, I became weaker and weaker. I went to my oncologist; he ordered a sniff test and a breathing test. And he ordered another X-ray and discovered water in my lungs. My doctor had me on a CPAP, and they added oxygen and concentrator. When the x-ray came back, he made arrangements to have my left lung drained, they removed 260 cc of fluids. They didn't get it all, but they got most of it.  I am due to get another x-ray before the end of the month.   My left lung was smaller than my right lung. At this point I sleep with a CPAP with an oxygen, and I am getting stronger. I still feel a little bit of fluid in my lungs. I will go back next week to get another X-ray in my lungs.
Drug Ineffective; Covid-19; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient (husband). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 29Mar2021, as single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the caller and her husband (patient) had their 1st dose on 29Mar2021 and were supposed to return on 19Apr2021, however, they were tested positive for Covid-19 virus on the same day, so they were not able to receive the 2nd shot. On 19Apr2021, the patient underwent lab tests and procedures which included covid-19 virus test (sars-cov-2 test) which showed positive result. The caller was asking how to set up an appointment for their second dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021455009
developed s/s consistent with brachial neuritis in R arm a few days post vaccination; required medical treatment and 10 day course of oral steroids; imagining and physical therapy ordered as well; as of today (2/16/21) condition has improved with majority of R arm function regained
Per Dad: Patient started breaking out in a rash on Monday 10/16/2017 pm all over her body. He states he cannot think of anything that is different other than the flu vaccine. Dad denies change in patient's diet, laundry detergent, environmental exposure. Patient had received the Flu Vaccine 10/16/2017 am @ School Based Flu Clinic. Dad states on Saturday 10/21/2017 patient started itching. They took her to her pediatrician: for eval and to Dermatology Clinic. Dad states patient is taking Steroids, Benadryl and now Claritin. Dad states the rash is still there, but seems to be getting a little better with the meds.
On 5/27/98 Pt. recv. vax.  On 6/1/98 pt. exp. shingles.  Medical attention was sought
Urticaria, facial swelling w/ in 12 hrs. Lasted 3 days, no h/o egg or other allergy.