chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed visiting nurse concerning a 24 year old female patient with thyroid problems and no drug reactions or allergies who in November 2010, was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot# not reported). Concomitant therapy included iron, ascorbic acid and medication for thyroid. The nurse stated that 3 days ago "on 11-JAN-2011", the patient started with a mild cough and sore throat. There was no lab diagnostics studies performed. The patient sought medical attention. At the time of the report, the patient had not recovered. Information was received from medical records concerning a 24 year old female (59 inches, 169 pounds) who on 14NOV10 received a first dose of GARDASIL. On 14JAN11, the physician reported that the patient presented for her second dose of GARDASIL, and at the time already had symptoms of mild sore throat, mild cough, and no fever (temp 99.0 degrees F). On 14JAN11, the patient received the second dose of GARDASIL (lot #0768Z) in the left deltoid. Additional information has been requested. All available medical records will be provided upon request.
Site of injection on right deltoid down to 2 inches above antecubital space-circumferential swollen, warm and reddened, slightly.
red, swollen, sore bump about 4 inches wide and 2 inches tall. started yesterday and still there.  patient is waiting another day or two before contacting provider.
I had the two Pfizer and the booster of Pfizer so, cause I had covid last year; I had the two Pfizer and the booster of Pfizer so, cause I had covid last year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 63 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "I had the two Pfizer and the booster of Pfizer so, cause I had covid last year". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) unknown results.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200343007 Same reporter/vaccine/event, different patient
Received inj on 10/25/14. Had severe pain and soreness for 3 weeks. MD Rash just extreme soreness in arm and under arm.
Patient experienced swelling in the face. The swelling decreased after patient took BENADRYL.
Received first vaccine on 3/25/21 and had elevation in blood pressure, increased anxiety and had report made out.  After 30 minutes, his blood pressure had decreased but stated that he gets almost like a panic attack.   Shortly after receiving his 2nd Covid 19 shot, he started to feel very anxious but not at the same level as the first one.   VSS at 1:32 pm 150/72 RA sitting; 97% pulse ox-90 HR.  He stated that he was anxious just right after receiving the shot.
Extremely Heavy period, I typically don?t get periods due to PCOS and this is very heavy bleeding. I am struggling to do daily tasks because of the amount of times I need to change my tampon and pad, this has never happened before.
postherpetic neuralgia; shingles/herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications.  On or around 18-NOV-2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot # and expiration date were not provided). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a severe painful, burning rash on the left upper quadrant of his abdomen. The patient was thereafter diagnosed with shingles/herpes zoster and postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the events of shingles/herpes zoster and postherpetic neuralgia was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of shingles/herpes zoster and postherpetic neuralgia were considered to be disabling.
Hospitalized 11/11/2021; COVID-19 positive 11/10/2021; fully vaccinated  DATE OF ADMISSION:  11/11/2021 DATE OF DISCHARGE:  11/14/2021   DISCHARGE DIAGNOSES 1. Severe COVID pneumonia with acute hypoxic respiratory failure. 2. Community-acquired pneumonia. 3. Chronic diastolic congestive heart failure. 4. Persistent atrial fibrillation. 5. History of repair of ruptured thoracoabdominal aneurysm. 6. Gastroesophageal reflux disease.  HOSPITAL COURSE An 84-year-old gentleman presented with 5 days of cough.  See H and P for full details.  He was hypoxic and required 2 L of oxygen.  He was started on Decadron and remdesivir.  Chest x-ray showed bibasilar interstitial thickening and airspace opacities.  Procalcitonin elevated which raised the suspicion for bacterial pneumonia on top of COVID.  The patient had rather rapid resolution of his hypoxia and by the third day of admission, was on room air.  On that day, however, he had increased crackles.  He received 40 mg IV Lasix.  On the fourth hospital day, crackles were essentially resolved.  He remained on room air.  He felt that he was stable for discharge.  He received 4 days remdesivir and 4 days Decadron.  We did not feel that the fifth day of remdesivir was necessary.  He will, however, complete another 6 days of Decadron at discharge.  He received 3 days of Rocephin and doxycycline and will complete another 3 days of both at discharge.
PASSED OUT; LIGHT HEADED; DEHYDRATED; FELT WEAK; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included controlled high blood pressure, controlled high cholesterol, stroke like symptoms in MAR-20219, however he was not diagnosed as having stroke because all tests were negative but he still had the symptoms, and alcohol use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: UNKNOWN) 1 total, dose was not reported, administered on left arm on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-JUN-2021 after vaccination, the patient felt weak but it was not significant. On 05-JUN-2021, the patient felt weak while doing daily activities. The patient had not felt anything and had breakfast. He got in the sun and got dehydrated as not had water for three hours during the day. Later, he got water. The patient had taken one drink of alcohol, sat down and got light headed then passed out for less than a minute. It was reported that, upon contacting emergency services advised patient to visit emergency room to check him as a precaution but the patient denied. It was reported that, the patient's heart, blood pressure, and blood glucose were normal. The patient was fine at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out on 05-JUN-2021, and light headed, dehydrated, and felt weak on JUN-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210613161-covid-19 vaccine ad26.cov2.s-passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Headache; Horizontal red line of swelling at the injection site; Horizontal red line of swelling at the injection site; Nausea; Circular rash on the shoulder; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 20Jan2021 (12:30) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization. Medical history included high blood pressure (HBP); atrial fibrillation (atrial fib.); sleep apnea; heart disease; contrast dye allergy; and mold allergy. Concomitant medications included losartan, carvedilol (COREG) and piroxicam (MAXIDENE). On 22Jan2021 (08:00), the patient had headache; horizonal red line of swelling at the injection site; nausea; and circular rash on the shoulder. The patient did not receive any treatment for all the reported events. The outcome of the events, 'headache', 'horizonal red line of swelling at the injection site', 'nausea' and 'circular rash on the shoulder', was not recovered. The patient was not diagnosed with COVID-19 prior to the vaccination, and was not tested post-vaccination.
Friday afternoon received Typhoid and Japanese Encephalitis vaccines. Saturday night, my legs felt achy while lying down. Sunday, my legs felt achy thru Monday morning. Also, Saturday night, I had chills. Monday morning pain was worse pain at lower extremities. Affected running.
Information has been received from a physician concerning a 16 year old female who on approximately 03-OCT-2008 was vaccinated with the second dose of GARDASIL. On 03-OCT-2008, about 6 hours after the vaccination, the patient complained pain and experienced rash started on face and then rash all over the face. On 05-OCT-2008 the patient experienced injection site hard swollen, red, warmth to touch and injection site knot. However after the first dose of vaccination, the patient was fine, no pain and adverse event occurred. The mother of the patient informed the doctor about the event and wanted to have her daughters examined, then she called MNSC. No further information is available.
Fussy for 24 hours and inconsolable for 6 hours following immunizations on 10/25/2001 (not reported  to us until visit of 12/21/2001).
A couple hours after the vaccine my BS went up to 274 so I called my PCP.   After about 5hrs I went to my PCP but it had gone down to like 130 something and was advised to sign up for the vsafe.  After a few days I did begin to feel a little better.  I was very tired, groggy and sore for a few days and after that all symptoms subsided
Itchy red rash on upper part of both arms, worse on the right arm, large red discolored lump at injection site.
pt exp swollen lips purple on ever of 4APR this AM swelling lips/face & purple color to lips- c/o joint pain both knees; MD stated allergic react related to Diptheria component of DTP;
Patient is currently hospitalized with COVID-19.  Patient was diagnosed with COVID on 11/15/21 and subsequently was admitted to the hospital after an emergency room visit on 11/16/21. Admission note states: presents with complaint of cough, shortness of breath, weakness, fevers.  Occasional nausea.  Cough productive of yellowish sputum.  She has been sick for 5 days.  Reports that today is the 1st day that her temperature has been under 100. COVID-19 positive yesterday.  She is vaccinated for COVID-19, but has not had booster. As of 11/18/21, patient is still hospitalized.
No additional AE reported; expired dose of PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from a pharmacist and concerns a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 05-APR-2022, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23); dose 0,5 ml; lot number: T021485; expiration date: 15-MAR-2022 (formulation, dose number, frequency, route of administration were not reported) for prophylaxis (expired product administered). Suspect drug did not experienced any temperature excursions.   No additional adverse events were reported (no adverse event).
Patient presented to emergency room with complaints of vesicular rash and L periorbital swelling. She was diagnosed with herpes zoster ophthalmicus based on positive VZV DFA of one of the lesions. Swab was sent to Dept of Public Health lab for testing, which confirmed vaccine strain of VZV
Approx 3.5-4 inch redness, swelling, itching and induration at injection site
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 17-NOV-2015, the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # K005402, exp. 07-NOV-2015). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
pt recv vax 22MAR99 10AM;11AM red blotches all over, body w/severe itching;gave DPH 1115AM;took a DPH;1PM all itching stopped;VS 11AM 102/60, P80, R18;
Severe pain in thighs and knee joints which persists and makes walking, getting up and down from sitting very difficult.  what can be done.  ruining my life
When I caught COVID-19 I had a cold, sore throat, coughing, headache, and a little bit of body aches. I felt like I had the flu. I had a slight fever of 100 degrees at the highest, but it didn't last very long. I went to an urgent care clinic. I was put on prednisone and PAXLOVID. I have had a terrible smell of smokiness in my nose, but my sense of taste is fine. I am a little tired.
didn't feel well; couldn't work for several days; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on 04Jun2021 as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 infection prior to getting the COVID vaccine from Jun2021 to an unknown date. The patient's concomitant medications were not reported. The patient mentioned that she was not able to get the second dose on her scheduled date as she had a lot going on and thought that she may have had antibodies enough since she already had COVID-19 infection before aside from the vaccine. On an unspecified date, the patient mentioned that she didn't feel well and couldn't work for several days after the vaccine but nothing out of the ordinary. The patient wanted to know if she can still get the second dose of the Pfizer BioNTech COVID-19 vaccine because she was worried about the Delta variant. She called today to question about getting the second dose of the vaccine and it being past six weeks. She was planning on getting this second dose. The patient wanted a clear answer regarding the effectiveness of the 2nd shot of the vaccine once administered past 6 weeks. It was just they have no information on how effective it would be. Outcome for all the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.  Follow-up activities completed. Batch/lot number not available for [Vaccine BNT162B2], No further information is expected.
lungs collapsed; left arm locked up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: PNEUMOTHORAX (hospitalization, medically significant), outcome "unknown", described as "lungs collapsed"; MUSCULOSKELETAL DISORDER (hospitalization), outcome "unknown", described as "left arm locked up". Therapeutic measures were taken as a result of musculoskeletal disorder. Clinical course: Verbal report: The (withheld) made an outbound call to the patient (name withheld) to do a follow-up call and offer a resource. Upon contacting the patient, the patient reported that recently she changed medicines. She no longer takes Ibrance. Now she is on Xeloda. They took her off of Ibrance because her neutrophils were too low on Ibrance. The patient's lowest score was 300-400. Patient also said that being on Ibrance helped a little with her tumors in her upper chest, but the doctor(s) still want to put her on Xeloda because her neutrofills were consistently too low. Patient also has lymphedema in her left arm. Patient also reports that after taking the Pfizer covid vaccine her left arm locked up and her lungs collapsed. She had to be hospitalized. She also explained that ever since she took the Pfizer covid vaccine, she has had to do physical therapy to improve the movement in her left arm that locked up after taking the Pfizer vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200096606 same patient, different drug and different events.;
Hives - 8 hours after the shot. treated with antihistamine . Went away 8 hours later. Fever, body aches, chills- 10 hours after the shot.  treated with ibuprofen . Went away 48 hours later
This spontaneous report has been received from a licensed practical nurse referring to a 16 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccine of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided). The vaccine were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Woke up early next morning with a blinding headache, stiff and inflamed neck, and pain, burning, numbness and tingling in both arms down to my fingertips.
Information has been received from a physician concerning a female who was under 18 years old who on 20-MAR-2007 was vaccinated IM with her second dose of Gardasil. On 20-MAR-2007, within 12 hours after vaccination the patient experienced joint achiness. On 22-MAR-2007, the patient sought medical attention and the Nurse practitioner reported that the patient experienced "petikia" on her face and a red bump on the white of her one eye. Nurse Practitioner reported that the patient had no reaction to her 1st dose of Gardasil, but they are not planning to vaccinate the patient with the 3rd dose at this time. No further information is available.
30 minutes after receiving vaccine (received at 1030AM), felt slight numbness and tingling in my whole face, but mostly between lower cheeks and upper forehead. Feeling is comparable to when you have local anesthesia for dental work and the anesthesia has almost worn off - area is still slightly numb but tingling and pin pricks are felt along with a slight chill. It is now 3PM on the same day, And while the feeling still seems to be minor, it has gotten worse since this morning. I am also experiencing minor diarrhea and stomach cramps which seem to have been brought on out of the blue. The injection site is not inflamed or red, although it is very sightly sore, and has a small, hard area around where the needle was inserted. Heart rate feels normal and temperature is average - 96.8. I have had no treatment for my symptoms, but if they progress, I will return to the doctors office.
Patient complain of chest pressure  35 minutes after Moderna Vaccination 2 dose. No reaction to first dose
patient presented to ED 2/6/2021 with CC of SOB. Patient reported that she started having a cough and runny nose 14 days prior to presentation. Patient was admitted due to further evaluation of respiratory failure. Patient was started on IV decadron due to symptomatology and worsening hypoxia.  Infectious disease was consulted for this patient and recommended supportive care and dexamethasone. Patient hospitalized for 10 days due to shortness of breath and oxygen requirements.
Information has been received from a pharmacist concerning a 6 month old male patient who on 26-JAN-2007 was vaccinated IM with a first 0.5 ml dose of PEDVAXHIB (OMPC).  Concomitant therapy on 26-JAN-2007 included doses of ROTATEQ (MSD), PREVNAR and PEDIARIX.  On 28-JAN-2007 the patient developed wheezing and eye erythema.  Details regarding treatment were unknown.  The patient fully recovered.  On 27-MAR-2007 the patient received the second IM 0.5 ml dose of PEDVAXHIB (OMPC).  Concomitant therapy on 27-MAR-2007 included doses of ROTATEQ (MSD), PREVNAR and PEDIARIX.  On 29-MAR-2007 the patient developed eye erythema and wheezing.  Subsequently, the patient fully recovered from wheezing, eye erythema but treatment details were unknown.  Additional information has been requested.
C/o muscular ache 2 days p/immun relieved of aches p/5 days; no c/o of other rxn when followed-up on 2DEC91; cardio-pulmonary arrest 18DEC91 @ 120PM; death certificate not available for review, as yet;
I had a huge rash that started on my right ear, and then came down, but later I had the rash on my neck, arms, and knees.  Finally I had a huge red area on my knees since Saturday. Its not painful or anything is just a huge red spot.
Headache.  Chills.  Sweats.  Nausea.  Stomach pain.  Aches
3 - 4 hours post vax pt developed fever of 102F, chills, total body aches like the flu and had to lay down until the next evening. No residual symptoms.
This case was reported by a nurse via call center representative and described the occurrence of injection site reaction in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 6th June 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 6th June 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In June 2018, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that, the patient inadvertently received the SHINGRIX subcutaneously instead of intramuscular route, which led to inappropriate route of vaccination. The healthcare professional also mentioned that, the patient had severe localized reaction at the injection site. No other information was provided. The healthcare professional did not have lot number or expiry date.