chrisvoncsefalvay/vaers-outcomes huggingface dataset:
immediately had a "syncopal episode"; This initial spontaneous report was received from a nurse referring to a 17 years old female patient. The patient had no concomitant medications, pertinent medical history or drug reactions/allergies.  On 28-FEB-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1621931, expiration date 26-JAN-2022; strength and dose details were not reported) intramuscularly for prophylaxis (reported as routine vaccination).    On the same day, the patient immediately had a "syncopal episode". The nurse placed the patient in a supine position, elevated her feet and observed her for 20 minutes. After the 20 minutes, the patient's syncope was resolved. There was no treatment given for the event. The patient did not seek medical attention, as the event occurred at the office and was handled immediately. There were no lab diagnostics/studies performed. The causality assessment was not reported.  Upon internal review, syncopal episode was determined to be medically significant. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Information has been received from a 16 year old female with no medical history and no known allergies, who in January 2008, was vaccinated with a dose of GARDASIL. Concomitant therapy included PAMELOR 25 mg. She reported she was experiencing headaches after receiving her first and second dose of GARDASIL. The headache occurred above both eyes. Laboratory/diagnostic tests performed: CAT scan: Results not provided. At the time of reporting the patient had not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.  10/10/08 Reviewed PCP medical records of 12/29/06-8/14/08. FINAL DX: Records reveal patient experienced usual state of good health on day of HPV vaccines, HPV #1 on 2/11/08 & HPV #2 on 4/19/08.  RTC 5/6/08 w/intermittent HA, dizziness & blurred vision since 3/08 & worsening after HPV #2.  Exam revealed nasal congestion & boggy turbinates, tx w/allergy meds w/ no improvement in s/s.  Tx w/antibiotics unsuccesful & referred to neuro.  Neuro consult included.  Tx w/meds.  No further records available.
Rash started approximately 6 hours post vax, by next AM rash extensive included soles and palms, no drainage (MP type rash) Treatment with Prelone, now take Benadryl as needed and Pediapred.
After leaving office appox 1 hour - c/o dizziness, lightheaded, "seeing spots", top lip swollen. No resp distress.
After second vaccine, very tired, joint pain everywhere knees to wrists, slept entire next day. What I am reporting now is herpes simplex outbreak on my lower lip. I have had in the past, many years ago, however never this bad. I have three large lesions on lower lip, leak and drip water when drinking, feels like after being numbed at dentist. Using abreva topical on it. Started Zovirax pills last night.,
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: loss of appetite-Severe, Systemic: Unable to Sleep-Severe, Additional Details: patient upset about side effect stated her employer required her to receive covid vaccine
HIVES; FEVER; NAUSEA; COLD; BODY PARTS FELT BAD; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced cold. On 09-APR-2021, the subject experienced body parts felt bad. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced hives. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, and nausea, had not recovered from hives, and the outcome of fever and body parts felt bad was not reported. This report was non-serious.
Subsequent to receiving one dose of varicella virus vaccine live ont 02/05/98, the pt experienced between 40-50 spots on her legs, vagina, buttocks and belly on 08/20/99. The pt was very itchy and had a fever of 102F. The pt sought unspecified medical treatment and was treated with Tylenol. Her fever went down to 101F. Additional information has been requested.
Injection site soreness  approx 5 hrs later  Extreme shaking/chills approx 6-7 hrs later  Fever of 102-104 approx 8 hrs later  Severe joint/muscle/body pain approx 8 hrs later  Cont severe pain, inability to move, elevated HR 140-150, shortness of breath, severe migraine,  fever 103-104 the entire next day with the use of 650mg Tylenol q4hrs  (02/06/2021).  Joint/muscle pain, generalized fatigue, migraine, elevated HR 110-140, fever 102 the entire day (02/07/2021).  Irregular HR dropping to 43-51 from 110, shortness of breath, dizzy, generalized weakness, shaking, went to ER for observation (02/08/2021).  Symptoms nearly resolve 02/09/2021 with the exception of occasional shortness of breath and mildly irregular HR.
In December 2022, I got very sleepy and slept a lot. I had a lot of headaches and a fever. I took a home antigen test and got a positive result. I was sick for about ten days. I called my doctor, who offered medication, but I refused it. I also did not take any OTC medicines or herbal remedies. I just basically slept a lot, and that was how I managed my illness. I eventually took another test and got a negative result. Altogether, I was out of work for ten days. I felt better after the ten days were up. A few months after this happened, I underwent a mammogram, and it was discovered that I had lumps in the left breast. I was told that the lumps were benign and probably the result of the vaccine. This was not this first time this had happened, because after I got my first dose of COVID-19 vaccine, I developed lumps in my right breast and in my neck. The lump in the neck lasted for about three months. I underwent a mammogram and a biopsy of the lump in the breast. They weren't cancerous, but they were enlarged nodules, and the doctors believed they may have been caused by the COVID-19 vaccine. The lump in the neck eventually went away, but I think I still have the lumps in the right breast, because when I underwent another mammogram, they were detected. However, the doctors did not think it was necessary to conduct another biopsy. After I got my second dose of COVID-19 vaccine, I had lumps in the left breast. The lumps hurt a little. I believe the lumps in the left breast are also still present, since they were detected in my last mammogram. My doctors have told me that I need to undergo a mammogram every six months to make sure that the enlarged nodules have not turned cancerous.
Tingling; Spasm -legs; body fever; This is a spontaneous report from a contactable Nurse. This 52-year-old (age at the time of vaccination) female Nurse reported in response to HCP follow-up letter sent in cross reference case that included who received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 2 (Lot number and expiry date was not reported) via an unspecified route of administration on 14Jan2021, as a dose 2, single for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE dose 1 (Lot number EJ1685 expiry date was not reported) via intramuscular route of administration on 20Dec2020 10:00 in left arm as a single dose for covid-19 immunisation. The patient provided information to you regarding the reported adverse event(s) with the use of the product and considered the Pfizer product had a causal effect to the adverse event. Patient's height was reported as 5foot 3inch and weight as 134 lb. Patient experienced tingling, spasm-legs, body fever o 17Jan2021. After 3 days of 2nd dose - still experiencing until now- 2nd vaccination date 14Jan2021. Vaccination Facility Type was reported as workplace clinic. Vaccine was not administered at Facility. Patient was not deceased. Treatment as muscle relaxant was required for the events. The events required visit to physician's office (urgent care). The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a noncontactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# EW0167), at the age of 70, via an unspecified route of administration, left arm, on May 18, 2021, single dose, for COVID-19 immunisation. The patient did not have any medical history. Concomitant medications included antibiotics (unspecified) for unknown indication from unknown start date and unknown if ongoing. The patient has no known allergies. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Jun 23, 2021, patient's breast started hurting. She also experienced hurting under arm pit and overall feeling bad (still present at the time of this report). No therapeutic measures taken as a result of the events. The events did not result in doctor or other health care professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. The outcome of patient's breast started hurting, hurting under arm pit, overall feeling bad not recovered at the time of this report. No follow-up attempts possible. No further information expected.
Swollen L armpit, medial, at same side of vaccine.  Resolved in 2 days with ibuprofen
Soreness and swelling at injection site for 1 day after both injections. Lasted only for the day following injection.   After dose 2, massive headache, fatigue, muscles cramps beginning the morning after vaccination. Most concerning is my heart has been aching and possibly beating out of rhythm. Report submitted night of 2nd day after vaccination. Side effects not subsiding.
Patient states she has had swollen arm, redness, some difficulty breathing.  States that she has an "invasion of her body"
Heart pain / chest pain; muscle pain; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Heart pain / chest pain), MYALGIA (muscle pain) and FATIGUE (tiredness) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, the patient experienced CHEST PAIN (Heart pain / chest pain), MYALGIA (muscle pain) and FATIGUE (tiredness). On 12-Jun-2021, CHEST PAIN (Heart pain / chest pain) had resolved. On 13-Jun-2021, MYALGIA (muscle pain) and FATIGUE (tiredness) had resolved. Not Provided          No concomitant medications were reported by the reporter.  No treatment medications were reported by the reporter.  Does not have any information regarding the first dose   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Non-significant follow up appended - New Reporter (Consumer) added
Started having a severe reaction after I received the vaccine, my symptoms started at around 6:30 PM I started to get very red and my face was swollen then I started to have a difficultly in breathing then I felt dizzy and I had a high fever and I started vomiting. and my blood pressure was very high. Then I called 911 and I was transferred to the Emergency hospital.
c/o COVID symptoms after 2nd Moderna vaccine on 2/9 Pt reports of scratchy throat, nausea, diarrhea x2 since yesterday (unknown if bloody), occipital and temporal HA, chills, fever Tmax 105F, body/joint aches, fatigue, difficulty concentrationing, and feeling easily after x1 flight of stairs. Ibuprofen and tylenol helps, and reduced his temp to ~98F at work.  Pt admis to previous symptoms after his 1st Moderna vaccine on 1/21. At that time he had current symtpoms, and also noted intermittent numbness at left side corner of mouth. Pt reported his symptoms resovled after approx 3 days.  Pt previously test +COVID (6/25/20) with PNA, untilmately pt had residual intermittent tolerable dyspnea. That was managed with albuterol.
Pt received 2nd dose of Moderna 1 week and 2 days early.  1st dose was received at Pharmacy on 8/30/21. Vaccine card return date for 2nd dose was dated 9/14/21. Patient had no symptoms and sat whole monitoring time. Pt was stable when leaving. Patient was called to be informed of incident  4 times but did not pick up, a voice message was left. Awaiting patient call back.
mom called 7APR95; on 6APR95 pt devel fever @ 1PM T101, 4PM 102.5, 8PM 103-104 & remained elevated all noc; 9AM on 7APR95 T101; pt recv APAP q 3-4hr; MD had been notified;
Bruising at Injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising at Injection site) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.    Co-suspect product included non-company product ABALOPARATIDE (TYMLOS) injection for Osteoporosis.    Concurrent medical conditions included Osteoporosis. Concomitant products included IBUPROFEN and OXYCODONE HYDROCHLORIDE (OXYCONTIN) for an unknown indication.   On 18-Jun-2021, the patient started ABALOPARATIDE (TYMLOS) (Subcutaneous) 80 microgram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, the patient experienced VACCINATION SITE BRUISING (Bruising at Injection site) and HEADACHE (Headache). At the time of the report, VACCINATION SITE BRUISING (Bruising at Injection site) had resolved and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Expiry date of Tymlos was Jun-2021 and reaction attributed by it were reported as forgot to push green button on Tymlos pen (Wrong technique in product usage process) on 13-Jul-2021 and administered 2 doses of Tymlos on same day (Overdose) on 14-Jul-2021.  Concomitant medication included unspecified steroid injection on back.  No treatment medication was reported by reporter.  No further information was expected.
i have been diagnosed with the diabetes and it is really weird because I haven't had it before. Now I am on a diabetes medicine and it was after the second dose. I was really sleepy after the second dose. After the second dose my chest where my port was placed decreased.
This spontaneous report was received from a health care worker (office manager) refers to 3 unspecified patients of unknown demographics. No medical history was reported. The reporter stated that the 3 unspecified patients were administered RECOMBIVAX HB (dose, route and frequency unspecified) that was stored improperly. No concomitant medications were reported. Nurse was then placed on the line to answer additional questions regarding event. No adverse effects were reported. No further information was provided. This is one of the two reports received from the same reporter and linked to case. All Telephone attempts to obtain follow up information have been unsuccessful. Follow up has been received from the office manager. The office manager stated this temperature excursion was supported and the vaccines were out of range for approximately 3 hours. The office manager was unable to provide patient identifiers and dates of administration at this time, but was able to provide lot numbers and expiration dates for RECOMBIVAX HB: lot# reported as J011235, expire date 16-DEC-2015. Additional information has been requested.
She developed the fluttering heart 2 weeks later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received bnt162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: 301US8A) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (Lot number: EK4176), administration date: 15Jan2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "Allergic reaction of numbness and swelling of her lips", "Allergic reaction of numbness and swelling of her lips", "Allergic reaction of numbness and swelling of her lips"; bnt162b2 (Lot number: E, not sure if it's a K or a C, not sure its like they wrote something on the top of the something but the number is 8982), administration date: 10Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "no reaction". The following information was reported: CARDIAC FLUTTER (medically significant) with onset Oct2021, 2 weeks after the suspect product(s) administration, outcome "unknown", described as "She developed the fluttering heart 2 weeks later". Clinical course: Patient had her shot last year and had a fluttering heart 2 weeks after getting the vaccine. She would like to know what to do if she got the same with the latest vaccine. All of her COVID-19 vaccines have been Pfizer products. She has had a total of 5 doses. When she had the first dose, she started to get the allergic reaction of numbness and swelling of her lips. She was at the hospital, so they gave her an antihistamine and observed her for an hour. The second dose she had no reaction. On her last three shots she took an antihistamine prior to getting them and did not have an allergic reaction, however she developed the fluttering heart 2 weeks later after each of the doses. She was concerned about what she should do if she is alone and develops the fluttering heart again. Therapeutic measures were not taken as a result of cardiac flutter. She was calling to ask what to do when she feels that flutter. The report was considered as non-serious by the patient.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300320687 same patient/vaccine, different dose number/event;
Patient was administered the bivalent vaccine two days after the beyond use date was. Pfizer was contacted and said viability of vaccine could be up to 72 days in the refrigerator in accepted temperatures. The day of vaccination would have been the 72nd day in the accepted temperature range.
Patients arm swole and ended up having an abscess. She didn't go to Drs office for this. She has a scab on her elbow. She called her Drs office and they told her to go to urgent care.
Severe aphthous ulcers formed on the labia.  First noticed at 4am on April 24 (2 days after the vaccine on April 22 and on April 23 I had felt achy and fatigued which had passed by the time the ulcers started to appear).  The ulcers rapidly grew and were in full "bloom" about 36 hours from first noticing them.  There were 4 areas of ulcers: 2 of them on the interior of the vaginal wall near the opening that were about an inch in diameter/length and 2 other smaller patches on the exterior labia minora.  For the first several days there was also extreme swelling of the entire area.  During this time and in particular the first couple of days pain from the ulcers was extreme - the evening of April 25 I was completely unable to sleep.  On April 26 I went to see a gynecologist who diagnosed them as aphthous ulcers based on my history of having these before and tests I have had in the past to rule out other possible diagnoses (A biopsy to check for cancer, STD tests including swabbing the ulcer to test for herpes). She prescribed medication for pain management  (lidocaine jelly, a small amount of narcotic to help me get through the worst of it) and a Medrol pack in hopes it may help accelerate the healing time.  For the first 2.5 weeks urinating was extremely painful.  After 3 weeks I could urinate relatively comfortably and I started being able to ride my Peloton bike 1-2 times a week for 30 minutes (formerly 6 days a week for at least 30 minutes).  The large ulcers are still healing almost 4 weeks later.  I'm not sure when my husband and I will be able to have sex again.
Blurred vision in right eye; muscle aches; chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision in right eye), MYALGIA (muscle aches), CHILLS (chills) and HEADACHE (headaches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040821A and 002821A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 12-Apr-2021, the patient experienced MYALGIA (muscle aches), CHILLS (chills) and HEADACHE (headaches). On an unknown date, the patient experienced VISION BLURRED (Blurred vision in right eye). At the time of the report, VISION BLURRED (Blurred vision in right eye), MYALGIA (muscle aches), CHILLS (chills) and HEADACHE (headaches) outcome was unknown.            Concomitant medicines include Blood pressure medication Treatment medicine include Tylenol