chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Prolonged cough that has lasted 3 days; loss of voice; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Nov2021 (Lot number: Unknown) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date 08Oct2021.  The following information was reported: COUGH (non-serious) with onset 13Nov2021 05:00, outcome "recovering", described as "Prolonged cough that has lasted 3 days"; APHONIA (non-serious) with onset 13Nov2021 05:00, outcome "recovering", described as "loss of voice"; FATIGUE (non-serious) with onset 13Nov2021 05:00, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of cough, aphonia, fatigue.  Additional information: The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, patient not been tested for COVID-19. The patient had no known allergies. Device timestamp:15Nov2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Erythema palm site at the YF inj. site (L) lat. arm.
Event: Uveitis in left eye Treatment: Durezol, steroid drops to the eye Outcome: currently pains inside the eyeball and has headache
This spontaneous report as received from a nurse refers to an unspecified number of patients. Demographic information was not provided. The nurse reported that an unspecified number of patients were "probably" administered an improperly stored dose of ROTATEQ (lot number not provided). Dose, dose strength and therapy dates were not provided. The minimum temperature the ROTATEQ was exposed to was 31 degrees Fahrenheit for an unspecified number of hours and the maximum temperature the ROTATEQ was exposed to was 55 degrees Fahrenheit for an unspecified number of hours. No adverse effect was reported. This is one of multiple reports from the same source. Other case IDs 1307USA012447 and 1307USA013320. Additional information has been requested.
Influenza vaccine was administered, but type and lot are unknown at this time. Within 6 hours, injection site was red, itchy and painful. Swelling and redness continued to spread throughout night. Awoke with neck and back stiffness, in addition to inflammatory response adjacent to injection site.  Swelling progressed within 36 hours to a severity that produced numbness and tingling along median nerve (into hand and digits 1-3). Was seen at convenient care location, by a nurse practitioner, who prescribed a short dose of prednisone (3x 20mg tablets), ice and ibuprofen.
Fairly severe headache - sharp pain behind right eye managed with Ibuprofen.  Rash above right eyebrow and mild pain when touched in scalp above rash.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional concerned a 58 year old female. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  After receiving the vaccine, the patient underwent antibody test ((SARS COV 2 AB IgG Spike Semi quantitative (SARS-CoV-2 IgG) antibody test )) conducted on 16-JUL-2021 which was negative (the value was less than 1.00). The patient experienced confirmed immunological vaccine failure (therapy non-responder).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). The report was associated with product quality complaint: 90000186856; Sender's Comments: V0-20210745802-Covid-19 vaccine ad26.cov2.s- CONFIRMED IMMUNOLOGICAL VACCINE 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
I had a large floater in my right eye that made my vision blurry. I had it for a week and then went to an optometrist. They discovered that I had a tear in my retina on August 31, 2022, and sent me to a retina specialist the same day. He performed laser eye surgery that same day. He discovered that there were 2 tears and repaired. I have since had a follow up and he indicated that it looked.
vision loss; 30% of left eye is blurry; This is a spontaneous report from a contactable other hcp (Patient). This 28-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Arm Left on 10Nov2021 15:30 at age of 28-year-old as DOSE 1, SINGLE (lot number: FG3527) for COVID-19 immunisation. Medical history included Asthma. No covid prior vaccination. Concomitant durg included budesonide (PULMICORT). No other vaccine in four weeks. She experienced Left eye vision loss. 70% of vision was gone for about an hour. What I could see looked like tv static. Currently approximately 30% of left eye is blurry and almost looks like items are moving forward on 10Nov2021 08:45 PM. No covid tested post vaccination. No treatments received. Outcome of the events were not recovered.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events Blindness ,Vision blurred and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
This consumer report (initial receipt: 18-Oct-2012) concerns a 58-year-old female patient, who had a pertinent medical history of hay fever and an egg allergy. On an unknown date, the patient received a flu vaccine (manufacturer, brand name and batch number were not provided). The patient also received PNEUMOVAX 23 (batch number was not provided) injection on an unknown date. The patient developed an allergic reaction to PNEUMOVAX 23 and was treated with a shot of adrenaline (manufacturer unknown) by a physician. She was held at the physician's office for "about 8 hours" for observation. The patient reported that she had a similar reaction to a flu vaccine. The event outcome was not reported.
Initial case was received on 30 September 2010 from another manufacturer with service request number 1-3708860854. The initial reporter was a consumer. A 2 month old male patient received in 1983 an injection of DTP (lot number and manufacturer not reported) and the next day he was shaking head to toe. The following day he was lethargic, turning blue, possibly seizing. A subsequent CAT scan was negative "for injury." No further information was available. Document's held by sender: None.
exaggerated cellulitis; painful arm; swollen arm; Initial information was received on 12-Nov-2021 regarding an unsolicited valid serious case from other healthcare professional.  This case is linked to 2021SA387396 (same reporter)  This case involves a 50-year-old male patient who experienced exaggerated cellulitis (cellulitis), painful arm (pain in extremity) and swollen arm (peripheral swelling) after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   On an unknown date in between 08-Nov-2021 to 11-Nov-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE produced by Sanofi Pasteur (suspension for injection, lot number: C5882AA and expiry date was not reported) via intramuscular route in the arm not otherwise specified (NOS) for prophylactic vaccination.  On an unknown date in Nov-2021, the patient developed a serious exaggerated cellulitis (cellulitis), painful arm (pain in extremity) and swollen arm (peripheral swelling) within 24 hours following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.   These events were assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the events.  The reporter did not report causality of events with suspect.  At time of reporting, the outcome of the events was unknown; Sender's Comments: This case involves a 50 year old male patient who experienced cellulitis, pain in extremity and peripheral swelling after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The time to onset is compatible. Additional information regarding patient's medical history, condition at the time of vaccination and lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Have tinnitus in LEFT ear.  Constant low roaring. Still present and not lessening at this time.
Red, inflamed, swollen area measuring 50mm in length and 40mm in width.  The site is warm to touch, and c/o minor soreness in the L deltoid area.
Early afternoon on 7/15,, extreme tiredness, headache. By evening chills, nausea, fever. 7/16 was still extremely tired with a slight headache.
Temp to 102 that lasted 2 days 12/24 - developed a rash with red lesions about 1/2 cm, slightly raised over the entire body except feet. He was scratching this. Slept all day after immunizations. Drank milk but would not eat for the 2 days of fever.
on/around 1/26/2022, began cough, SOB, fatigue,  worsened to extreme, transported via ambulance on 2/22 to ED 2/22/22 Real-Time Reverse Transcriptase COVID PCR (+)
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female who on 07-MAY-2009 was vaccinated with the first dose of GARDASIL while pregnant.  After GARDASIL vaccine was given, unspecified pregnancy test was conducted and positive.  The patient's last menstrual period was 17-APR-2009 and estimated date of delivery was 22-JAN-2010.  The patient had gone to office to seek medical attention.  There were no adverse events reported.  Follow-up information has been received from a completed questionnaire, concerning a 17 year old female patient with no concurrent medical conditions and a history of THC use, 0 pregnancies, 0 spontaneous abortions, 0 elective terminations and 0 live births who on 07-MAY-2009 was vaccinated with the first dose of GARDASIL vaccine (lot # 659655/0940X).  It was reported that the patient's last menstrual period was 06-APR-2009 (previously reported as 17-APR-2009) and estimated date of delivery was 08-JAN-2010 (previously reported as 22-JAN-2010).  Three times ultrasounds performed on 08-MAY-2009, 02-AUG-2009 and 27-OCT-2009 respectively showed normal.  MSAFP and amniocentesis were not performed.  On an unknown date, the patient developed urinary tract infection (UTI) and hematuria during pregnancy.  On 23-DEC-2009, at 38 weeks from LMP, the patient delivered a male baby, who was normal and no congenital anomalies, and his weight was 6 lb 4 oz, length 19.5 inches, head circumference 12.75 inches and Apgar score 9/9.  There was no complication during labor/delivery.  Additional information is not expected.
Donor reported lump under his left arm, reported that he found it the day after his second rabies injection.
Patient received the vaccine on 1/8/21. On Saturday 1/9/21, she was feeling tired, headache, body aches and right eye and mouth started drooping.  Patient was able to see Dr on 1/13/21, where she was diagnosed with Bells Palsy. The doctor gave a Toradol shot for the headache and was prescribed Valacyclovir 1 gram and Prednisone 10 MG. Patient was feeling worse went to  Urgent Care on 1/14/21, where they did blood work and checked for Covid and Flu. On Friday 1/15/21. she started vomitng and feeling more weak and went to ER, where they also did blood work and checked for Covid and the Flu.
nausea; vertigo; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 08Feb2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (Patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Feb2021 13:40 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at the age of 69-year-old. Medical history included severe allergic reaction to Dimyristoyl Glycerol. The patient's concomitant medications were not reported. The patient experienced nausea and vertigo on 02Feb2021 around 21:30 with outcome of unknown. The events were reported as non-serious.  Information on the lot/batch number has been requested.
Intense itching began in palms of both hands and both feet, red rash broke out over entire body. Got  Allergy Tablets containing Diphenhydramine HCI 25 mg. Took three tablets and itching stopped 30 minutes later.
Within one hour of flu vaccine left arm painful. Deltoid had bruise and swelling. Pain had lasted and remains tender to touch.
Ten minutes post second vaccine pt. reports feeling of "ants crawling on my head", slight dizziness. EMS contacted and care handed off. Per EMS pt. was hypertensive that did not improve after lying pt. down to rest. EMS made decision to transport and pt. exited in care of EMTs.
Patient presented 11/5/03 after being vaccinated for Td and Varivax 10/27/03. Temperature of 101 and rash with onset 11/3/03. Had cold sore last week, nausea and vomiting and cough 2 days prior to 11/05/03 visit. Numerous papules and vesicles in various stages (50-100 present).
Pt c/o dizziness, lost consciousness and fell, hitting the back of his head on the floor. Loss of consciousness lasted 30-45 seconds. Although he denied s/s of neck/back/head injury (N/V, dizziness, ha, back/neck pain), he complained of chest pain that felt like "pins & needles". No difficulty breathing or respiratory distress noted. This RN did not observe any rash and pt did not c/o pruritis. Approximately 15 minutes after the episode, pt c/o difficultly visually focusing on objects far away. He was sent to the closest emergency room without incident, where he was diagnosed with 1.) vasovagal syncope  2.) single contusion with soft tissue hematoma to the scalp  3.) Probable allergic reaction with skin rash.   Pt was discharged to home with instructions to apply ice intermittently, take Benadryl 25mg PO every 6 hours for itching and to observe HEAD INJURY PRECAUTIONS.  Pt was also advised not to participate in sports the following day and to follow-up with PCP.
This time the shivering, fever and aches were more severe than the first time. Since then he is being treated for hyperthyroid and his monocytes count is not in the normal range. He is taking methimazole for the thyroid and has to have more blood labs next week to check thyroid levels and monocytes again.
Two days after receiving vaccine employee began to experience a discomfort in right chest wall upon inspiration.  Upon physical assessment there was not redness, swelling or limited mobility of extremity, no noted lymph  node inflammation detected.  Thus far discomfort has caused no loss of sleep or other activity.
Within 2 hours of his 2 month shots our baby was crying uncontrollably, fever and would not eat. When he wasn't crying he was very fussy or lethargic. He remained that way for several days. On the night of March 29th I took him for a walk in the stroller to calm him down. As soon as we entered my house after checking on him a few minutes earlier I realized he wasn't responding to anything (sound, movement, touch, pulling on his arm), he was limp and white/ashen color.
11 hours after injection starting having headache, muscle aches, nausea, fatigue. Lasted about 2-3 days.
Within one minute after receiving vaccinations, pt became unresponsive- eyes rolled back- all 4 extremities became very rigid and his body convulsed for approx 45 sec to 1 min. No post-dictal - atox3 within 20-30 sec following end of seizure. Staff MD and EMS responded. BP initially full seizure 70 palpable- Increase 108/50-Mother declined transport to ER. Brought child to pediatrician.
axilla lymph node swell; This is a spontaneous report received from a contactable reporter(s) (Physician). 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization.  The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "axilla lymph node swell".  Additional information: Physician told me he got both shots. The second shot caused his axilla lymph node to swell and the affected node was on the same arm as the injection. The swelling subsided on its own.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
papular rash back of both hands and both elbows since getting small pox 16 Apr 2009.
I have had heavier periods, every two weeks with spotting in between. I have always had periods around the same time for the past 20 years with no spotting
This spontaneous report was received from a healthcare student, concerning a 51 year old male patient with diabetes. In January 2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare student reported that in January 2015 (reported as a month ago), a patient who received ZOSTAVAX experienced a shingle-like rash on his unspecified thigh, buttock and torso region, about 4 days after being vaccinated. In approximately 2015, the patient recovered of the "shingles-like rash". The healthcare student reported that the patient seek medical attention at the physician office and was treated with acyclovir. Additional information is not expected, due the healthcare student do not wish to be contacted regarding this adverse event report and declined to provide physician's information.
Pain in arm, fatigue, nausea, fever , shivering, high  fever, vomiting, rash in arm
Pimple like eruptions/different than normal eruptions; Fatigue with Moderna covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ACNEIFORM (Pimple like eruptions/different than normal eruptions) and FATIGUE (Fatigue with Moderna covid vaccine) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML. On an unknown date, the patient experienced DERMATITIS ACNEIFORM (Pimple like eruptions/different than normal eruptions) and FATIGUE (Fatigue with Moderna covid vaccine). At the time of the report, DERMATITIS ACNEIFORM (Pimple like eruptions/different than normal eruptions) and FATIGUE (Fatigue with Moderna covid vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter.  The reporter's causality for the events of fatigue with Moderna covid vaccine and pimple like eruptions/different than normal eruptions with Adalimumab Solution for Injection was not Provided.  Treatment information was not provided.
The patient was scheduled to receive the 2nd dose of her primary COVID monovalent vaccine series of Pfizer but erroneously received the bivalent booster, 0.3ml. The MD was notified.
Mom states rash developed 2 days after vaccine with fever. But child at this time is also being treated for viral illness, ear infection and is also taking Amoxicillin. Child presents 8/22/06 with macular papular rash to body and face. Stopped amoxicillin dx possible viral illness or reaction to amoxicillin or vaccines.
Dose Number: 03; Soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Dec2021 11:30 (Lot number: FF2589) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 14:00 PM, Route of Administration: Intramuscular), administration date: 22Mar2021, when the patient was 30 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 15:15 PM, Route of Administration: Intramuscular), administration date: 01Mar2021, when the patient was 30 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Dose Number: 03"; PAIN (non-serious) with onset 03Dec2021, outcome "unknown", described as "Soreness".  Additional information: Prior to vaccination, the patient was not diagnosed with covid-19 and post vaccination, the patient had not been tested for covid-19.  No follow-up attempts are possible. No further information is expected.
Soreness at injection site 4 hours after shot given.  Moderate to severe pain in right arm with intermittant numbness and tingling to fingers right hand x 3 wks.  Also complain of pain right leg.  MD to rule out possible Guillain-Barre. Refer to neurologist who suspects pinched nerve. Information from medical records states cervical radiculopathy.msv
following flu vax & pneumonia devel resp failure; lung biopsy-usual interstital pneumonitis; died 18DEC93;
Woke on July 2 with swollen lips. Called pharmacist, was instructed to take BENADRYL and if I couldn't breath or it got worse, go to the ER. Lips got more swollen and eyes became swollen on July 4. All swelling was gone by July 6.