chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From the second shot I was throwing up, I vomited; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2022 as dose  2, single (Batch/Lot number: unknown) at the age of 57 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "major depression" (ongoing), notes: I am currently being treated in mental health department for major depression.; "PTSD" (unspecified if ongoing), notes: PTSD, prior to the shot I do.; "increased Blood pressure" (unspecified if ongoing), notes: As far as I know normal, increased Blood pressure, High cholesterol and Triglyceride.; "High cholesterol" (unspecified if ongoing), notes: As far as I know normal, increased Blood pressure, High cholesterol and Triglyceride.; "Triglyceride" (unspecified if ongoing), notes: As far as I know normal, increased Blood pressure, High cholesterol and Triglyceride. Concomitant medication(s) included: GEMFIBROZIL oral. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical site: left arm , Route of administration: Intramuscular), for Covid-19 immunization, reaction(s): "COVID-19", "Drug ineffective". The following information was reported: VOMITING (non-serious), outcome "unknown", described as "From the second shot I was throwing up, I vomited". Therapeutic measures were taken as a result of vomiting.  Additional information: It was reported that after second shot, the mental health department provided him the shot, he did not know what it was but it helped him go to sleep.  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-202300099674 same product/patient, different dose/events.;US-PFIZER INC-202300100041 same patient, different product/event;
Received Pfizer coronavirus booster shot 2/10/2022.  Upon swallowing felt some pain / swelling around esophagus (lymph node?). Later in the evening sudden onset of tinnitus occurred. This buzzing / hissing sound I have never had in my life. Friday, 2/11/2022, I did not notice the tinnitus. However, Friday evening it came back much worse and has not stopped. I called my Doctor who prescribed a course of prednisone and hydrochlorathiazide diuretic. I am on the 3 rd day of these meds and nothing has changed. I still have tinnitus at this time.
During observation period complained of itching on hands, neck, and face.  Treated with 25 mg benadryl PO.  Sent home in stable condition.
New information was received regarding use of Ethyl Chloride. Information regarding PREVNAR was received from a physician regarding a patient who experienced very painful injection. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant therapy included Ethyl Chloride. The patient experienced very painful injection on an unknown date. Outcome is unknown. Ethyl chloride is used as skin refrigerant or anesthesia to prevent pain at injection site. No additional information was available at the time of this report.
Itchy Hives starting under clothes area then spread to extremities and face within hours. Given Benadryl for 2 days then added prednisolone.
Injection was given via Intramuscular route and not SQ route as intended. No adverse event was reported
Information has been received from a pharmacist concerning a 17 year old female with unspecified drug reactions/allergies and medical history, who was vaccinated with a third dose of GARDASIL in July-2009 ("6 weeks" since vaccination) (route and lot number not reported). The pharmacist mentioned the patient experienced ringing in the ear, 50% hearing loss in the unspecified one ear and genital warts. At the time of the report the outcome of the patient was not recovered. The patient sought medical attention by visit physician's office. Ringing in the ear, 50% hearing loss in the unspecified one ear and genital warts were considered to be disabling. Additional information has been requested.
Experience side effects 6 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Experience side effects 6 days after first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ADVERSE EVENT (Experience side effects 6 days after first dose). At the time of the report, ADVERSE EVENT (Experience side effects 6 days after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
After vaccine: It lasted for 24 hours. I was running a fever of about 100 degrees. I was achy and very tired. Headache. Tylenol for the fever. I stayed home and wore a mask around the house. I had a similar reaction to my shingles shot back before this.
About 3 weeks after vaccination on 6-6-2022, I started having shortness of breath with exertion and pounding heartbeat. I would rest if it started bothering me. On 6-10, I noticed the shortness of breath increased in intensity so I called my EP cardiologist and I spoke to the nurse practitioner who felt that something medically may be going on and suggested going to the ER. Within 90 minutes of talking to the nurse practitioner I was continuing to huff and puff with walking so I went to the local hospital ER. They ran labwork, 2 chest xrays and 2 ekgs. They said everything was fine but that I may have had an AFIB event that resolved before the ER visit. I was still short of breath when walking out of ER to go home. I have improved as far as shortness of breath but I am seeing a cardiologist for follow up. I did start taking my valium for muscle spasms that may have been instrumental in reducing the shortness of breath.
First, was the very tender tailbone. I felt like I had the flu but mainly in my tailbone. Within 6-8 hours it got very tender. I was with my daughter and I told her I had to go home because my tailbone hurt. then I started getting headaches. So, I consciously thought about what I was doing and I did whatever would relax me. I slowed down and quieted myself and the headaches went away. That went on for about 4 weeks. The only other thing was my toe. That happened in August. The other things happened within weeks of the shot. Around August, my left big toe nail turned purple. It didn't hurt. it was just purple. Between Thanksgiving and Christmas, I snagged it and my toenail caught the hem of my jeans. Right before I put on my sock, it lifted. I bought dog bandage so I wouldn't snag it again. I did that until if came off. It never hurt.
J96.00 ACUTE RESPIRATORY FAILURE 8/22/2022 NEPHROSTOMY CATHETER MALFUNCTION, INIT J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/30/2022 NEPHROSTOMY CATHETER MALFUNCTION, INIT R09.02 HYPOXIA 8/21/2022 NEPHROSTOMY CATHETER MALFUNCTION, INIT J96.00 ACUTE RESPIRATORY FAILURE 8/22/2022 ATHEROSCLEROSIS OF AORTA J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/30/2022 ATHEROSCLEROSIS OF AORTA R09.02 HYPOXIA 8/21/2022 ATHEROSCLEROSIS OF AORTA J96.00 ACUTE RESPIRATORY FAILURE 8/22/2022 ATHEROSCLEROSIS OF AORTA J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/30/2022 ATHEROSCLEROSIS OF AORTA R09.02 HYPOXIA 8/21/2022 ATHEROSCLEROSIS OF AORTA J96.00 ACUTE RESPIRATORY FAILURE 8/22/2022 CANCER METASTATIC TO INTRAPELVIC LN J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/30/2022 CANCER METASTATIC TO INTRAPELVIC LN R09.02 HYPOXIA 8/21/2022 CANCER METASTATIC TO INTRAPELVIC LN J96.00 ACUTE RESPIRATORY FAILURE 8/22/2022 SHORTNESS OF BREATH J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/30/2022 SHORTNESS OF BREATH R09.02 HYPOXIA 8/21/2022 SHORTNESS OF BREATH
Within 4 hours post vax, the pt developed swelling and redness. The next day she developed hardness and tenderness. The symptoms continued to worsen for about 36 hours then slowly subsided.
Patient is currently pregnant. She received dose 1 of her Moderna dose on 09/26/21, and she incorrectly received dose two 21 days after on 10/17/2021. She does not report any adverse effects besides headaches, which she claims she was also experiencing before the vaccine, so she is unsure if they are worsened by the vaccine. She will follow up with her OBGYN to discuss her pregnancy and the vaccine event as well.
Mother of patient called the office the day after receiving the vaccine stating that the patient had severe pain in her arm at the site of injection and was worried that she had developed SIRVA. It was her second dose of the vaccine and mom said she didn't have pain like that with her first dose. We asked mom to send us a picture of her arm so we could try to identify if the vaccine was injected too high in the upper arm and she has yet to send us anything.
Information has been received from a physician concerning an 11 year old female patient with no known allergies or pertinent medical history who on 12-AUG-2009 was vaccinated IM with a 0.5 ml first dose of GARDASIL (Lot number 662300/0100Y). There was no concomitant medication. The physician reported that the patient received the first dose of GARDASIL and later experienced swelling and redness with a raised scaly border at the injection site. On 25-AUG-2009 the patient's mother called the office to report that she thought the child had ringworm and had been applying hydrocortisone cream (manufacturer unknown) to the affected area. On 13-OCT-2009, the patient was seen in the office with a hypopigmented 2 cm around the injection site. The area had a small induration that remained. At the time of the report that patient was recovering. On 13-OCT-2009, the female patient with hyperhidrosis and chronic foot dermatitis was scheduled to be vaccinated with the second dose of GARDASIL (Lot number not reported). (It was not reported if the patient actually received the second dose). The patient reported that she had a rash on the area where she received her last dose of GARDASIL that had been there since the vaccine, it is not going away. The patient reported that it had loss of pigment circumferentially around site. On 12-AUG-2009, the patient was treated with HYTONE and DRYSOL, on 13-OCT-2009, treated with triamcinolone acetonide 0.5%. No further information is available.
12 hours after my 2nd dose of Moderna, I began to experience chills, headache, general body aches, and fatigue. I took Tylenol 1000 mg at 12 hours, Ibuprofen 600 mg at 18 hours, Tylenol 1000 mg and Benadryl 50 mg at 21 hours. I then slept for 10 hours. Once I woke up I was only experiencing fatigue and right arm soreness at the injection site.
I had a scratchy sore throat, headache, fever, fatigue, and chills. Friday my sore throat got worse to where I could barely swallow. I tested positive for COVID-19. I went back to work for a couple of days in January. I started to get shortness of breath and a cough well after I started feeling. Then I went to the urgent, and she prescribed me an inhaler.
8/9/21: pt presents to ED with about 1 week of increased SOB and cough positive COVID 19 test pt put on Bipap then returned to baseline of 2L  steroids gave significant improvement remdesivir for 5 days planned
Fully vaccinated (Pfizer, 1/18/2021, 2/8/2021) Exposed on 7/22/2021. Asymptomatic.
a rash on her arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: RASH (non-serious), outcome "unknown", described as "a rash on her arm".  Additional information: An unknown consumer wanted to know why is there a reaction and a rash on her arm after she took the new COVID-19 vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed symmetrical bilateral wrist tenderness and swollen hands progressing over the next 5 days to majority of her joints -- finally resolved with Ibuprofen.  On 3/16/16 she developed a racing heart rate and some chest discomfort -- went to Urgent Care and was advised she has PSVT and placed on a Holter monitor.  Currently as of today 3/18/16, continuing to have intermittent rapid heart rate.
This spontaneous report has been received from a registered nurse referring to an unspecified number of patients (gender and sex were nor specified). No concurrent or medical history was reported. On unspecified dates were administered unspecified number of improperly stored doses of Oral, ROTATEQ (lot number K006455 - expiration date 10-FEB-2016 and lot number K004468 - expiration date 08-DEC-2016), (dose, route, frequency and anatomical location were unknown). No adverse event was reported. No further information was provided. No product quality complaint was reported. This is one of several cases received from the same source (MARRS numbers 1507USA010114, 1507USA010881, 1507USA010882, 1507USA010884). Additional information has been requested.
Patient had schedule to receive a procedure on the 13th April 2022; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Patient had schedule to receive a procedure on the 13th April 2022) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (NOS) in 2010 and Immunocompromised.   On 04-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient had schedule to receive a procedure on the 13th April 2022). At the time of the report, VACCINATION COMPLICATION (Patient had schedule to receive a procedure on the 13th April 2022) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: Follow-up document received includes no new information.
Her arm was now swollen; Bright red; Warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Her arm was now swollen), VACCINATION SITE ERYTHEMA (Bright red) and VACCINATION SITE WARMTH (Warm to touch) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, FLUOXETINE HYDROCHLORIDE (PROZAC), ALPRAZOLAM (XANAX), OMEPRAZOLE, PHENYLAMINE, TRAZODONE and CETIRIZINE HYDROCHLORIDE (ZYRTEK) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Her arm was now swollen), VACCINATION SITE ERYTHEMA (Bright red) and VACCINATION SITE WARMTH (Warm to touch). At the time of the report, VACCINATION SITE SWELLING (Her arm was now swollen), VACCINATION SITE ERYTHEMA (Bright red) and VACCINATION SITE WARMTH (Warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She wanted to know what she should do?
patient was given moderna vaccine as booster dose for immunocompromised instead of Pfizer. Pharmacy was not able to catch correct history of prior immunization and only got to know correct history after dose was given
Patient felt no symptoms/pain. Right arm began to swell at injection site. Instructed Patient's wife to take patient to the urgent care center across the street.
FELT FAINT, DIFFICULTY BREATHING, CHEST TIGHTNESS. PARAMEDICS CAME, VSS, HX OF FAINTING WITH BLOOD DRAWN. DID NOT EAT OR DRINK PRIOR TO VACCINATION. PROVIDED HYDRATION, SX RESOLVED. NO TRANSPORT.
On Thursday July 22, 2021 I started experiencing muscular pain on the bottom of my left calf. the pain continued through the weekend and on Monday July 26,2021 my left leg from the knee down got swollen.  I went to Emergency room and found out I had a blood clot on me left leg and lungs.
MENQUADFI was in a previous excursion and was administered after the excursion with no reported adverse event; MENQUADFI was in a previous excursion and was administered after the excursion with no reported adverse event; Initial information received on 10-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to case 2023SA082363(CLUSTER).  This case involves an 18-year-old male patient, to whom MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] was in a previous excursion and was administered after the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Dec-2022, the patient received 0.5ml total dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength: standard) (lot number: U7449AB, expiry date: 23-Sep-2024) via intramuscular route in unknown administration site for Immunization on the same day menquadfi was in a previous excursion and was administered after the excursion with no reported adverse event (poor quality product administered), (product storage error).  It was reported, caller originally stated that it was not administered post excursion. Caller is requesting revaccination information. No additional information available. This situation is reported as a medication error due to administration of MENQUADFI post excursion.   Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  At time of reporting, the outcome was Unknown for both events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
soreness in his arm; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in his arm), MYALGIA (body aches) and HEADACHE (headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0021321A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 18-Feb-2021. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN CALCIUM (LIPITOR), WARFARIN and TRAZODONE for an unknown indication.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in his arm), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (soreness in his arm), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Other concomitant medication included nitrates and nebulizer.
Patient was found deceased at  Nursing Home in his room 01/12/2021 at 5:25 AM.
after the vaccine, he basically had fever since then so, since Friday and up to 103.7; his temperature it is up and down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 07Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "periodic fever syndrome" (unspecified if ongoing), notes: usually he get fever once a month on a cycle. no more than one day, . The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First Dose, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "after the vaccine, he basically had fever since then so, since Friday and up to 103.7; his temperature it is up and down". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information Reporter stated, "So, my son got the second dose of the vaccine (COVID-19 vaccine) on this 07Dec2021 (further not clarified) and he also have something called periodic fever syndrome (intent medical history). I do not know, if it is something you are familiar with but usually he get fever once a month on a cycle. So, he is actually and usually he gets it for not more than one day, well and he is actually, he had not had once for over a month (further clarification unknown) and then now after the vaccine he does, he basically had fever since then so, since Friday and up to 103.7 (further clarification unknown) and the Tylenol does not seems to bring it down. So, I keep, basically right now I have one and he is 'under' (further clarification unknown) with an ice pack over his head and I like, constantly taking his temperature it is up and down, crazy."  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient missed her second dose, it has been more than 42 days since first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient missed her second dose, it has been more than 42 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient missed her second dose, it has been more than 42 days since first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Raised, red, tender spot on upper right arm 8 days after vaccine (rash like). Mild and no current need to see doctor unless it spreads or doesn?t resolve itself