chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (diarrhea) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medication reported.
9 days after the vaccination, I had fever 102-103 F with chill, malaise, paresthesia and body ache requiring taking Tylenol alternate with Advil every three hours.  I tested for COVID-19 (PCR) and it was negative. Fever continued. On day 6,  I went to urgent care center and was tested again  with PCR for SAR-CoV-2 virus. The result was again negative.  On day 7, I started coughing so I went to Hospital ER and was admitted. Chest X-ray and CT scan of chests showed pneumonia. The COVID-19 PCR test was again done and was negative. Respiratory panel PCR was negative. Mycoplasma titer was negative. I was given steroid and fever improved. I continued to cough until now (1/30/2021)
Did not feel much discomfort; It hurts to raise the arm/its hurts more; Shoulder is more sore muscularly speaking; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Did not feel much discomfort), PAIN IN EXTREMITY (It hurts to raise the arm/its hurts more) and ARTHRALGIA (Shoulder is more sore muscularly speaking) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), FLUOXETINE and PRAVASTATIN for an unknown indication.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (Did not feel much discomfort), PAIN IN EXTREMITY (It hurts to raise the arm/its hurts more) and ARTHRALGIA (Shoulder is more sore muscularly speaking). At the time of the report, DISCOMFORT (Did not feel much discomfort), PAIN IN EXTREMITY (It hurts to raise the arm/its hurts more) and ARTHRALGIA (Shoulder is more sore muscularly speaking) outcome was unknown.            No treatment medications were provided.   This case was linked to MOD-2021-396351, MOD-2021-396244 (Patient Link).
Pt states that when she first received the vaccine, injection site became swollen. Throughout the day, she massaged the area and swelling went down. Around 8 pm started noticing cold symptoms. Pt complains of chest pain that started today.
Difficulty breathing, tightness in lungs - weakness: treated with 50 mg BENADRYL symptoms resolved.
It was discovered after the patient left that the patient received a full vial of undiluted vaccine (6 doses). Our organization contacted Pfizer, poison control and the hospital for recommendations on next steps. The patient was notified of the dosage error the same day and had not had any unusual side effects at that time.
Had four hives/welts lined vertically along her spine.  About 1/4 to 3/4 inches in size.  Length of all four welts were about 1 foot in length.  One welt was blistered and oozing. Looked liked potential chicken pox or shingles?
Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: unknown) during 2007/2008 season. It was unknown if the patient was vaccinated completely as per schedule. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.
got the worst respiratory infection/  deathly sick; Initial information received on 23-Nov-2020 regarding an unsolicited valid serious case received from a physician and consumer or non-healthcare professional.  This case involves female patient (age not reported) who experienced got the worst respiratory infection/ deathly sick (respiratory tract infection), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious got the worst respiratory infection due to which she was deathly sick for 12 long weeks (respiratory tract infection) within a week following the administration of INFLUENZA VACCINE (patient took the influenza vaccine once in his life).   This event was assessed as medically significant.  It was the sickest he had ever been. She will never take another flu shot. She said they are poison and that is not debatable. Then she made it a mission after that to get educated about these things like vaccines and what she found was astonishing. They have crippled and killed many caused autism, polio, nervous system disorders just to name a few by the thousands but they will always tell you they are safe. She just have one simple question that everyone should think about how in the world does it make any sense at all to inject poisons and toxins into your natural immune system as a means to stay healthy. Staying truly healthy is to not do that  Laboratory details were not reported.   Patient had to make three trips to the Doctor and they had to put her on three different strong antibiotics that didn't work. Finally had to be put on complete bed rest to recover.  On an unknown date, the patient recovered from respiratory tract infection (patient haven't been sick again once recovered).  Batch number has been requested for suspect product for this case.; Sender's Comments: A female patient (age not reported) who presented with respiratory tract infection within a week following the vaccination with INFLUENZA VACCINE (unknown manufacturer). Time to onset is compatible. Medical history, concomitant medication, precise final diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
PATIENT CALLED ON 02/04/2022 SAYING EVER SINCE SHE GOT THE VACCINE, HER ARM HURTS AND CANNOT LIFT UP ALL THE WAY. SHE SAID WHEN SHE TAKES IBUPROFEN IT HELPS BUT COMES BACK AFTER FEW HOURS.
Gave above vaccine past 75 days of storage in frig to 25 days past the BUD. Calling all patients to inform them of their options.
Temp 104 degrees. Left thigh slightly warm and layer (swollen) then right thigh treated.  Pharynx infected. (Rapid strep/ throat cultrue done).
vaccine was kept in freezer for 3 weeks instead of 2 weeks, patient had no adverse reactions and does not want to receive another vaccine at this time
Nasal drip; Cough; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Nasal drip) and COUGH (Cough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sinus infection since March 2021.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Nasal drip) and COUGH (Cough). At the time of the report, RHINORRHOEA (Nasal drip) and COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was concern about drug interaction about using Doxycycline for a sinus infection. Concomitant product information was not provided. On 7 May 2021 patient was prescribed with Doxycycline by ENT physician.
Between 1st & 2nd shot of Gardasil patient developed severe stomach pain, cramping, and burning that lasted weeks. Muscle aches and overall feeling of not being well. In August 2009 patient had flu like symptoms, anxiety, depression, fatigue, ulcers, acne, overall feeling of illness or impending death.
Information has been received from a registered nurse concerning an adult female patient with a penicillin allergy who in 1995 or 1996 was vaccinated with a third dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  The reporter indicated that the patient received a first and second dose at 15 months and 11 years of age respectively.  A titer was drawn and was negative at 0.85.  Unspecified medical attention was sought.  No further information is available.
Approximately a month after the vaccine, I experienced an A-Fib episode everyday of 110/120. Sometimes it would do this for one hour and sometimes two hours. In January I noticed this happening more frequently and all the time. I went to my cardiologist and was referred to an electrocardiologist. I had an EKG and showed an A-fib flutter. I was prescribed a medication Flecainide. I went back a week later and it indicated again the A-Fib flutter. I then went to get an Cardiac ablation 04/20/2022 . I also took  Pantoprazole for 30 days then stopped.
Information has been received from a licensed practical nurse referring to an unspecified number of unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with doses of improperly stored M-M-R II (lot # L032044 with expiration date 24-AUG-2017, therapy type rHA; Lot # L036853 with expiration date 24-SEP-2017, therapy type rHA; dose and route were not reported). No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
I woke up the following morning with a swollen, hot, red rash below the vaccination site. This has continued to grow, is uncomfortable and looks identical to images of ?Covid arm?.
severe brain fog; I was very drunk,slurring my words or had been hitting the bottle; My memory of the previous day was mostly temporarily lost; I developed Pulsatile tinnitus hearing wooshing loudly in my head from blood; This is a spontaneous report from a contactable consumer (patient). This 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left, on 22Feb2021 15:45 (at the age of 30-year-old) (Lot Number: EN6198) as single dose for COVID-19 immunisation. Medical history included lupus and allergy to sulfa. Concomitant medications included hydroxychloroquine taken for an unspecified indication, start and stop date were not reported; iron taken for an unspecified indication, start and stop date were not reported; biotin taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 16:45 (Lot number EL3249). On 24Feb2021 21:30, the patient experienced "severe brain fog within the first 60 hours beginning the morning after the 2nd shot starting around hour 15". People around her commented it sounded like she was very drunk slurring her words or had been hitting the bottle. Her memory of the previous day was mostly temporarily lost. The patient also experienced "pulsatile tinnitus hearing wooshing loudly in her head from blood" on 24Feb2021 21:30. The events resulted in doctor or other healthcare professional office or clinic visit. It was unknown if the patient received corrective treatments. The patient had not had COVID prior to vaccination and she was not tested for COVID post vaccination. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Immediate to lasting pain, soreness and redness at injection site. Fever within 2 hrs.,  exceeding 101.0 - lasting longer than single course over-the-counter remedy (acetaminophen 8 hr. relief),  abdominal cramps & discomfort, acute neuralgia/sharp muscular aches and pains, headache, nausea.
Received my second shot of Shingrix. In the night I had chills that caused my body to jerk. In the morning, I woke to find the bottom half of my face swollen. I could breath normally and had no other symptoms. I just took a Tylenol. By mid-afternoon the swelling was gone.
This child had varicella form lesions on her body, and febrile 2 days prior.
That night after vaccine, nasal congestion. Now, following day 9/10/2020 11pm, mild fever with nasal congestion.
Injection given at 0917 and at 0925 she was coughing and felt someone wrong with her breathing and had increasing mucous. Pt stated this is how she feels when she has an anaphylactic reaction. HR was 122 and B/P 155/93. Benadryl 50 mg  given at 0930, and epi given at 1001. Solumedrol at 1032 O2 99% at 1034. ACLS transfer to ER.
During the first dose I only experienced pain in the arm from the pinch, in the second dose at dawn the next day fever, severe pain throughout the body, vomiting and daily for 4 days and from then on there is a lot of inflammation of the body and pain in the bones and in the 3rd dose fever, body aches and vomiting. An inflammatory picture was presented again, especially abdominal. I had a chronic inflammation of my organs that required surgery and removal of my gallbladder. I am still recovering and that 3rd dose was on October 7, 2021.
Patient started feeling off on Sunday (October 21, 2018) and more yesterday with chills and diarrhea and still today. His shot was last Tues. (October 16, 2018).
low grade fever. Highest temperature was 100 and fell to 99.3 after hours. I had a headache and muscle aches. My skin was sore to touch and body ached to the point t I could barely walk or raise my arms over my head. The symptoms subsided after day 4.
Severe arm pain. Severe swelling, redness, and hardness of shoulder to elbow.
Patient and Mom came into our clinic today. Patient's left arm is warm to touch and minimally swollen.  Gave patient an ice pack to apply at home and instructed Mom to follow up with Clinic if further reactions occur.  Also gave Mom my contact information if any further questions.
Breakthrough case admission after 2 vaccines Moderna 1/13/21 Lot# 039K20A;  Moderna 3/10/21 Lot# 023M20A
Fatigue and malaise at 6pm, low-grade fever overnight, headache and scratchy throat at 6:30 am. Soreness at injection site from injection onward.
It began with a slight headache and post-nasal drainage. Within the next day, I developed a cough, very tired, and I did take Paxlovid twice a day for five days. I took a home test December 15, 2022 and tested positive for COVID-19. On Friday, December 23rd, I began to feel back to my normal self. I retested at home on December 28th and the result came back negative.
Temperature excursion at 31.3 degrees Fahrenheit / Below 0 degrees Celsius to 46.4 degrees Fahrenheit/ 8 degrees Celsius for 1 hour and 30 minutes with no reported adverse event; vaccine administered post excursion with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to cases 2022SA377654(CLUSTER), 2022SA378232(CLUSTER) and 2022SA377972(CLUSTER).  This case involves an unknown age and unknown gender patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] post temperature excursion at 31.3 degrees Fahrenheit / below 0 degrees Celsius to 46.4 degrees Fahrenheit/ 8 degrees Celsius for 1 hour and 30 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE was exposed to a temperature excursion at 31.3 degrees Fahrenheit / below 0 degrees Celsius to 46.4 degrees Fahrenheit/ 8 degrees Celsius for 1 hour and 30 minutes with no reported adverse event (product storage error).  On 07-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ882AE and expiry date: 30-Jun-2023; strength, formulation, dose, route and administration site not reported) for prophylactic vaccination.  On 07-Sep-2022, (latency: same day) the patient was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE post excursion with no reported adverse event (poor quality product administered).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 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.; Sender's Comments:  01268516: 01270405: 01270731: 01270733: 01270734: 01270737: 01270744:
Pruritic, indurated, erythematous plaque, measuring 1.5" x 2" present 2" below the injection site.
Headache, Arthralgia, Fever, FATIGUE, CHILLS, SLIGHT INJECTION SITE PAIN AND SWELLING Narrative:
Redness and knot around site, approx. the size of a dime, no fever and no irritibility.  Follow up: Problem at right thigh at DTaP site.  Treatement: warm compresses/Tylenol
Tongue swelling, lip tingling, total body hives (itching with welts). Treated with multiple doses of BENADRYL. At 12 hrs tongue and lip sensations were gone. At 36 hrs still have welts, but itching is gone (still using BENADRYL).
Approximately 3 minute after vaccination, pt was not alert for approximately 30 seconds. Arms became very rigid. Eyes were open at all times, but she but she became alert after 30 seconds but was under anxiety/distress - 20-25 minutes to recover.
hurt when given; swelled; red; hot; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced injection site pain, swelling, erythema and feeling hot. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site pain and swelling were unknown and the outcome of the erythema and feeling hot were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, swelling, erythema and feeling hot to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got first one Shingle shot it swelled so bad, it hurt when given felt like person who gave it hit a mussel. The patient had to keep icing it down, 4 days later still red and hot.  The patient asked how long in between to get second Shingle shot. The follow-up would not possible as no contact details were available.
developd a little bit of a rash on her chest which spread down to her arms, and shoulders; This is a spontaneous report from a non-contactable consumer reported that. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. After the administration of vaccine on Friday the patient experienced a little bit of a rash on her chest which spread down to her arms and shoulders on an unspecified date in Feb2021. She wants to know if this is a normal reaction to the vaccine. The patient should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of this vaccine and had a severe allergic reaction to any ingredient of this vaccine. She referred the consumer to her HCP for more guidance on whether it is still safe for her to receive the 2nd dose. The event outcome was Unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Moderna COVID?19 Vaccine EUA : Severe tenderness, swelling, redness, itching in site of injection and area around it started ~6 days after injection. It seems that it is progressively worsening.
This  patient was admitted to Hospital on 1/2/2022 for COVID related symptoms. This is considered a breakthrough case.
Lip tingling 4:00 next day felt like a cold sore By 6:00 lower lip was swollen and painful  By the next morning upper lip was grossly swollen
Dyspnea, mental slowing & anxiety are reported in pt who recvd flu vax; pt also taking meds; pt exp events 20 min p/recvd flu vax; Pt immediately seen @ clinic;
8 hours after vaccine lasting approx 24 hours-- body aches, chills, sweating, nausea
(L) thigh swelling and redness, oral shaped erythematic 3 cm induration with 5 cm erythema.
Bruising; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising) in a 30-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (Bruising). At the time of the report, VACCINATION SITE BRUISING (Bruising) outcome was unknown. Not Provided      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.   No concomitant and treatment information was reported.   This case was linked to MOD-2021-097880 (Patient Link).
Had temp of 101-102 X 24 hours - se & eating otherwise Review of sy-neg.