chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient ws given GARDASIL injectio and almost immediately turned pale and mentioned she "felt funny". Patient was assisted into a supine position. Approximately 5 minutes after injection, the patient's eyes rolled back, her hands and arms became rigid, her head turned to the side and she lost consciousness. The pt was unresponsive and appeared to be experiencing a tonic seizure for a period of 5-15 seconds.
PATIENT RECEIVED 0.25 ML INJECTION. APPROPRIATE DOSE WOULD HAVE BEEN 0.5 ML INJECTION. THE 0.25 ML INJECTION IS INDICATED FOR PATIENTS BETWEEN 6 AND 12 YEARS OF AGE. PATIENT HAD NOT ADVERSE REACTION TO VACCINE.
Information has been received from a doctor of pharmacy concerning an 81 year old female patient who was vaccinated with a dose of pneumococcal a dose of 23v polysaccharide vaccine. The pharmacist reported that she was informed by the patient that she had cellulitis in the arm following pneumococcal a dose of 23v polysaccharide vaccine. The outcome was unknown. No further information was available at this time. Additional information has been requested.
Multiple verified blood clots. Clots began in mid-August and are continuing. Currently three blood clots in the legs with no family or personal history of blood clots in an active person.
non-serious rheumatoid arthritis flareup in right foot/Usually it was in left foot; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4405472-00.  A 74-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovering", described as "non-serious rheumatoid arthritis flareup in right foot/Usually it was in left foot". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "non-serious rheumatoid arthritis flareup in right foot/usually it was in left foot" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the reported event: "Rheumatoid arthritis" and the suspect drug BNT162B2 cannot be completely excluded.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
feeling feverish; having chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "feeling feverish"; CHILLS (non-serious), outcome "unknown", described as "having chills". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Date of expiry of vaccine 25-march-2022 , the vail stored in referigerator post expiry; Patient received Moderna Covid-19 vaccine that was expired.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that was expired.) and PRODUCT STORAGE ERROR (Date of expiry of vaccine 25-march-2022 , the vail stored in referigerator post expiry) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine (first Covid-19 vaccine). Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine.    On 29-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that was expired.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date of expiry of vaccine 25-march-2022 , the vail stored in referigerator post expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that was expired.) and PRODUCT STORAGE ERROR (Date of expiry of vaccine 25-march-2022 , the vail stored in referigerator post expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication was reported. The vial did not undergo any temperature excursion. The vial was initially stored in the refrigerator 28-MAR-2022 (1 vial).
At 18:00 on day of 12, patient crying, complained of not feeling good, felt very warm.  Left arm swollen and red.  Tylenol alternated with Motrin.  Next day lay in bed most of time.  By 3rd day felt a lot better.  Information obtained by mother.
Systemic: Other- patient said she felt short of breath, administered benadryl immediately precationary. Pt said she thought it might be panic attack afterwards and after breathing deeply & rest went back to work
dental procedure; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH DISORDER (dental procedure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced TOOTH DISORDER (dental procedure). The patient was treated with DOXYCYCLINE for Dental disorder NOS, at a dose of 100 mg once a day. At the time of the report, TOOTH DISORDER (dental procedure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 11-Jan-2021, the patient received the first dose of Moderna vaccine. On 13-Jan-2021, she had dental procedure (unspecified) and her dentist prescribed an antibiotic called doxycycline 100mg a day for 21 days.  No concomitant medications were reported.
Blurry vision in R. eye.  OPthalmologist indicated my reaction likely due to the vaccination, with my corneal transplant performed in 2003.
Soreness of arm (left arm) where vaccine was administered - dull, constant ache from elbow to shoulder. Cannot sleep on affected side. Limited range of motion of affected arm.
polio onset 27NOV56 w/in 10 days of vax came down w/a cold-thanksgiving day went into coma-in iron lung 12wk-paralysis from neck down for 2 yr;wore braces until 13yr of age;dx post polio synd;
Patient developed chest pain on 13 June 2003 when he was recumbent.  Pain returned following night; on 15 June 2003, he contacted on-call physician, who directed patient to Emergency Department.  There, patient was diagnosed as having pericarditis.  Was discharged home on Motrin.  Symptoms have subsided.
Sick for 2 weeks, chill with fever 102.6, body aches, vomitting, nausea, headaches and neck pain.  Hospitalized for testing. 7/5/07-consultation report received for DOS 6/21/07-Reason for consultation:possible viral infection, possible meningitis. Seen while in hospital. PMX: arthritis and migraine. Two to 3 days after vaccine began having headaches, severe body aches, nausea and chills with fever running from 99-101. Generalized weakness. Neck pain. Two days prior to admission fever 103. Some nausea. Impression: Viral syndrome, including west nile virus, epstein barr virus or cytomegalovirus. 8/1/07-records received for DOS 6/21-6/27/07- DC DX: Viral Syndrome. C/O intermittent fever, persistent headaches, severe generalized body aches with weakness for 2 weeks which were gradually getting worse.
felt dizzy and weak. Was diaphoretic. BP at time was 98/32 w P 64. chest clear, no SOB no oral swelling. Rested supine for 30 minutes. Felt much better. BP 118/72, P 68
The pt experienced itching and stinging at the injection site. Then hives and blisters appeared. She stated there are more than a dozen covering her left upper arm. She has had mild reactions to flu shots in the past, but denied this on the consent. Instructed to see MD.
On February 23, 2021, exactly 5 days after my 2nd moderna vaccine, I experienced innapropriate bleeding from my vagina, extreme pain and stiffness in both of my hands and wrists and the heels of both hands became red. The bleeding came every 2 weeks for 3 months. The pain in my hands is still ongoing as are the red palms.
low grade fever; swelling and redness and pain at the site of the vaccine; redness and pain at the site of the vaccine; pain at the site of the vaccine in my arm; random pox-like; itchy pimples; itchy pimples; This case was reported by a consumer and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st January 2020, the patient received the 1st dose of Shingrix. In January 2020, 2 weeks after receiving Shingrix, the patient experienced varicella-like rash, pimples and pruritus. On an unknown date, the patient experienced fever, injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the fever, injection site swelling, injection site erythema, injection site pain, varicella-like rash, pimples and pruritus were unknown.   It was unknown if the reporter considered the fever, injection site swelling, injection site erythema, injection site pain, varicella-like rash, pimples and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had a reaction with low grade fever and swelling and redness and pain at the site of the vaccine on my arm. In addition, a few random pox-like itchy pimples appeared up to two weeks following.  The doctor said should still get the second vaccine but the patient was asking for more advice about that and would like to report the first reaction. The patient six months was up 1st July 2020, but the doctor did not had the vaccine and not giving vaccines due to Co-Vid and the pharmacist told that the patient would wait up to a year for the second dose.
flu; Initial information received on 23-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who experienced flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (formulation, strength, route: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious event "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
On August the 7th 2021 I had a headache, I on the 8th I had a headache and body aches with itchiness in my throat. On the 9th I had fever and chills added to the other symptoms. On the 10th I had a COVID test and the symptoms continued. I went to the Dr again on Tuesday the 17th of August because my throat was so swollen, I ended up having Bronchitis. My Dr gave me a prescription for Z-pack and two inhalers, a steroid and an Albuterol inhaler.
Information has been received from an unspecified healthcare worker via a field representative concerning the healthcare worker's niece of unknown age. The patient's medical history and concurrent condition were not reported. In approximately 2013 (reported as around 2 years ago), the patient was vaccinated with a dose of GARDASIL (lot#, expiration date and dose not reported). Co-suspect therapy and concomitant therapy were not reported. The healthcare worker reported that on an unknown date the patient experienced an unspecified "autoimmune disorder" while on therapy with GARDASIL. The outcome of the event was unknown. Additional information is not expected because the field representative did not have contact information including the reporter, the patient and the physician.
pressure headache in the lower part of her skull; This is a spontaneous report from a non-contactable consumer (patient) via Medical information team. An 82-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as unknown single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient states her family member received the first dose of the vaccine 8 days ago. Patient states immediately after the vaccine her family member did not have an adverse reaction, patient had a pressure headache in the lower part of her skull on an unspecified date. Patient states this has happened every day since and gotten worse since the first day and it is now the eighth day. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PATIENT RECEIVED PEDIATRIC DOSE OF VACCINE WHEN THEY WERE ALREADY 12 YEARS OLD. THERE IS EVIDENCE THAT THIS IS OKAY AS LONG AS PATIENT RECEIVES THE ADULT DOSAGE ON THE ON THEIR SECOND SHOT. WAS CAUGHT WHEN PATIENT CAME IN FOR SECOND SHOT AND PATIENT WILL BE INFORMED
Upon speaking with son on the phone. Son states that for the past week his dad is in complaining that he felt off. He states that Wednesday when he talked to him on the phone his dad said he wasn't feeling that well. Thursday for Thanksgiving his mom and dad decided to stay home. Friday he took him over some food to his parents house, to see how they were feeling. Saturday he called his parents house phone in the morning and he did not answer. He.they might be out for breakfast, he states that his parents go out to breakfast 3 times a week. He said since they weren't answering towards the evening hours he decided to drive over their house, he lives almost an hour away. When he arrived he found both his mom and dad lying on the floor away from each other.    His dad states that he fell down after using the bathroom in the middle of the night, due to him tripping over his own legs. He denied any loss of consciousness. His mother who chronically uses a walker/wheelchair tried to assist his father off the ground. She then fell on the ground as well and was unable to get up. Total downtime was around 15 hours for his father.    Upon talking to the father states that for the past week he's felt more dizzy. He had been more and Wednesday when he bowled he noticed he didn't play as well which made him feel that he must be sick. He endorse a cough for the past few weeks. He said he usually gets his cough seasonally. Patient was vaccinated 2x for COVID and was
Pt received shingles vaccine 3/7/16 and 2 days later developed itch and vesicles L leg and 3/10 developed vesicles L buttock and labia. Pt given Valacyclovir.
PT REPORTED "SHAKING SO BAD THAT THE BED WAS SHAKING", CHILLS, AND FEVERISHNESS THE NIGHT AND NEXT MORNING OF THE VACCINE ADMINISTRATION.
Ulcer and induration at injection site. Treated with antibiotics for presumed cellulitis.
Immediate whole body sensation. Dissasociative feeling at leaving injection booth. Tachycardia started immediately when sitting in observation room. Observer noted rash and flushing on chest and face. Medics called. Blood pressure 182/108, heart rate 152, o2 sat 100. Taken to triage area. Had a hard time responding to questions because tongue felt thick. Airway was clear despite edema. I was taken by ambulance to to Medical Center. The paramedics wanted to administer Epi but I was hesitant since I was still able to breathe and I didn?t want to further increase blood pressure. I have a narrative to paste but the Continuation Page is not letting me input text. Please email me.
No illness or vaccines prior to the COVID-19 shot on February 13, 2021. Monday, February 22, 2021, around 4 p.m. experienced sharp pains that would come & go behind right ear/neck area Tuesday, February 23, pain continue to come & go behind right ear/neck area in late afternoon into evening; trouble sleeping Wednesday, February 24, still having pain behind right ear/neck in early a.m.  Contacted Primary Care Physician in early a.m. and had office visit.  Prescribed Cefdinir 300MG capsules (Antibiotic) and sent for X-ray - Xr C Spine Min+ 4 Vw at Imaging Services.  X-ray showed arthritis and began taking prescription.
Information has been received from a consumer concerning her 12 month old son with pectus excavatum and left kidney enlargement who on 05-SEP-2008 was vaccinated with a 0.5 mL second dose of MMR subcutaneously. Patient received the first dose of MMR II about 7 months apart of the second one. Both times MMR II was given concomitantly with hepatitis A virus vaccine (unspecified) and varicella virus vaccine live (unspecified). The patient had a cold after received the MMR II, and his cold worsened that evening. No laboratories studies performed. The patient sought unspecified medical attention. The patient had not recovered. Additional information has been requested.
This spontaneous case was initially received on 15-Oct-2015. The case report was received from a Health Professional and concerns a 53 year old female patient. The patient received AFLURIA on 15-Oct-2015, Batch no: U54906, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Left arm. No additional drugs suspected. On 15-Oct-2015, 1 day after starting treatment with AFLURIA the patient experienced Discomfort in context of arm, Normally the plunger goes in easily / A lot of resistance on the stopper, Some of the serum came out when the needle was withdrawn from the arm, Revaccinated the patient, Patient was in a lot of pain (injection site)/Pain level from the first injection was 5 out of 10 (injection site) /Throbbing (arm pain at injection site)/Pain at injection site. No swelling was observed by the pharmacist. Resistance in plunger has not been noted from other PFS in the box or other lots. The pharmacist revaccinated the patient in her right arm per CDC recommendation. The second injection was administered without problem and the patient tolerated it fine. The pharmacist recommended the patient take ibuprofen for the discomfort. Reporter's assessment: Non serious. Case correction (31-Mar-2016): AE 4 re-coded.
Complained of lightheadness, weakness, "feeling funny" - approximately 2-4 minutes after receiving IM injection of H1N1 vaccine from new vial.
Swelling and pain of all major joints. Limited mobility, difficulty standing/walking due to swelling in knees.
Late in the night following the vaccination I experienced moderate shortness of breath that lasted for approximately 2 hours accompanied by cough and wheezing on exhale. My airways felt constricted with each exhale which caused me to cough.  The following morning I began experiencing mild to moderate headaches which came and went throughout the upcoming days and lasted 3 weeks in total.
Information has been received concerning a pt with myasthenia gravis, arthritis and has used a wheelchair with a history of influenza symptoms and pneumonia on 01/012000 that resulted in hospitalization. On 11/02/00 the pt experienced soreness and her nose was runny. On11/03/00 the pt reported her eyes feel funny like she was getting a cold, and has a sore throat and a tight feeling in her chest.
golf ball-sized swelling at the posterior base of her right ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (COMIRNATY), on 12Nov2021 as dose 3 (booster), single (Lot number: FO3527, Expiration Date: 31May2022) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot EF3246), administration date: 12Jan2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "golf ball-sized swelling at the posterior base of her right ear"; BNT162b2 (2nd dose-, Lot EL9264, expiration is unknown.), administration date: 02Feb2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "golf ball-sized swelling at the posterior base of her right ear". The following information was reported: EAR SWELLING (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "golf ball-sized swelling at the posterior base of her right ear".  Additional information: Patient also had it with the prior COVID vaccines. It started with one of the first ones and also with last booster in Oct2021. She was nervous of getting another booster. She wants to get another one but is afraid it will swell. She knows it is probably the gland and is active. She wants to make sure there is no risk if she gets another booster.
SHORTNESS OF BREATH WHILE WALKING; PAIN AT INJECTION SITE; BODY ACHES; TIRED; FEVER; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced tired. On MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced pain at injection site.  Laboratory data included: Body temperature (NR: not provided) 104.5 F. On 13-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 14-MAR-2021, the subject experienced shortness of breath while walking. Laboratory data included: Body temperature (NR: not provided) 101.9 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site, and had not recovered from body aches, fever, tired, and shortness of breath while walking. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Muscular/Joint Pain, 3/10, Tylenol, 24 hours 101.7 Fever, Tylenol, 36 hours