chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slight irritation in the throat; Discomfort in the throat; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 10:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 07:00, since second day of vaccination, the patient experienced slight irritation and discomfort in the throat. The patient had no other side effects. The patient had doubt whether the events were expected with vaccine. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events slight irritation and discomfort in the throat was unknown at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient stated he experienced "severe chills" that lasted "6 hours straight on and off for about 2 days," before making a full recovery. He also stated that he "felt so tired" that he "could not get out of bed" and that his "hands were shaking so much" that he "could not write." He did not take any medications to alleviate those symptoms during that time. He did NOT experience any redness, rash, or difficulty breathing/wheezing.
Extreme muscular soreness in neck from scapula to head, both sides, perfectly symmetrical, lasting weeks. After 3 physical therapy sessions and continual stretching as directed, symptoms have mostly abated.
Pt returned to clinic approx 5 minutes after vaccine administered complaining of itching all over body, no rash, no hives, no SOB, given 25mg of Benadryl, pt kept in clinic for approx 30 minutes after itching improved. Pt awake, alert, talkative and laughing, stated itching improved prior to leaving the clinic.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient did experience fainting with Janssen, though important to note that patient said he has fainted before in past with vaccinations. He said he is fearful of them and it is more \"mental\" and does not attribute it to the vaccine itself.
A Non - serious spontaneous report of administered two doses of vaccine in two day period has been received from a nurse concerning a 5-year old female patient.  No medical or medication history were reported for this patient.  The patient received FLUMIST intranasally in one office on 27AUG2008 and received another dose at a different office by the same physician on 29Aug2008.  The patient received FLUMIST for flu prevention.  The office were reportedly not computerized and the second office did not have the patient's chart.  The physician's office confirmed that there were no adverse events associated with this medication error; therefore, treatment and reporter/ sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information was obtained on 19Sep2008 and incorporated into the narrative:  confirmation from the physician's office that no adverse events occurred from the medication error.
BRUISE ON FINGER; GENERAL DISCOMFORT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported.  On 06-JUL-2021, the subject experienced general discomfort. On an unspecified date, the subject experienced bruise on finger. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general discomfort on 07-JUL-2021, and the outcome of bruise on finger was not reported. This report was non-serious.
Extremely clingy, fussy and agitated. Pain in left leg (1cm areas of bruising in left thigh skin at site of injection) and warm to touch. Symptoms lasted 3 days, during which time he and his parents, subsequently, developed increased very runny nose.
At 6:15, right on the nose, I felt like I got hit all at once. I had a fever (103.1). I had cold and hot chills. I had body aches. I felt like my body was made out of china. I felt like I would just shatter if I moved. My neuroglia got worse. I have been trying really hard to find something to help with the pain of that. I have been in excruciating pain. I had a facial pain and I had trouble chewing. I have lots of brain fog. I have been getting very confused. I had a virtual appointment with my PCP. I also had that infusion and I feel like that made it worse also. That was after my 2nd dose of my covid vaccine. I saw my neurologist after seeing my PCP. My pain is just increasing. I was always in pain before, but this has been a drastic increase. I am having to have quality of life conversations with my PCP and my pain therapist. I just don't have the strength to even do normal daily activities. I have more triggers than I used to have with the pain. I would have nights where I couldn't wait to fall asleep. My PCP kept telling me to go to the ER, but I never did. Even a shower just wipes me out for the rest of the day. I don't like the "high" feeling you get from pain killers, so I did not want to go to the ER. I feel like every single nerve is exposed everywhere. Everything hurts.
arm pain; injection site warmth; body aches; chills; headache; This spontaneous pregnancy case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (arm pain), INJECTION SITE WARMTH (injection site warmth), MYALGIA (body aches), CHILLS (chills) and HEADACHE (headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm pain), INJECTION SITE WARMTH (injection site warmth), MYALGIA (body aches), CHILLS (chills) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (arm pain), INJECTION SITE WARMTH (injection site warmth), MYALGIA (body aches), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided. Treatment information was not provided.
Patient presented for Covid Vaccination. Nurse used Smiths Medical Hypodermic needle kit 4234 to administer vaccine.  Needle broke off at hub after inserting into arm.  Hub was tight.  Nurse was able to remove needle and patient consented to revaccination.  Patient revaccinated without incident. (Lot #3975524)
Fatigue for a week; Vomiting for 24 hours; Nausea for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea for 24 hours), FATIGUE (Fatigue for a week) and VOMITING (Vomiting for 24 hours) in a male patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea for 24 hours), FATIGUE (Fatigue for a week) and VOMITING (Vomiting for 24 hours). At the time of the report, NAUSEA (Nausea for 24 hours) and VOMITING (Vomiting for 24 hours) had resolved and FATIGUE (Fatigue for a week) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
RIGHT HAND FELT GREASY AND THEN FELT STICKY NEED TO CLEAN HAND  SEVERAL TIMES A DAY; INSECURE FEELING DUE TO MUSCLE WEAKNESS (DIFFICULT TO TAKE A DECISION TO WALK FROM THE DINING TABLE TO THE BATHROOM OR OTHER AREAS); WEAKNESS INVOLVING WHOLE BODY; HAD PROBLEMS WHILE SPEAKING; RIGHT HAND AND LEG NUMBNESS; PARALYSIS RIGHT HALF OF THE BODY; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included back injury, and pain due to back injury, and concurrent conditions included symptoms of covid-19 (runny nose). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: unknown) dose was not reported, 1 total administered on 03-JUN-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 15-JUN-2021, at 21: 30 the patient experienced paralysis right half of the body and paralysis of the right leg. Did not feel any pain of previous back injury once the paralysis happened. On 16-JUN-2021, at 05:30- 06 the patient had problems while speaking, right hand and leg numbness and at unspecified time patient had trouble walking, hesitate difficult to get up from the couch or bed, insecure feeling due to muscle weakness (difficult to take a decision to walk from the dining table to the bathroom or other areas), tongue numbness, right arm weakness and sometimes left arm weakness and weakness that started on the right side and then involving whole body. On 19-JUN-2021, the patient felt right hand greasy and then felt sticky need to clean hand several times a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paralysis right half of the body, and paralysis of the right leg on 15-JUN-2021 lasted about 15 minutes, and had not recovered from had problems while speaking, weakness that started on the right side and then involving whole body, trouble walking, right hand and leg numbness, right hand felt greasy and then felt sticky need to clean hand several times a day, hesitate difficult to get up from the couch or bed, insecure feeling due to muscle weakness (difficult to take a decision to walk from the dining table to the bathroom or other areas), right arm weakness and sometimes left arm weakness, and tongue numbness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210731397-covid-19 vaccine ad26.cov2.s-Hemiplegia. 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).
HEART ISSUE; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced heart issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart issue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210943837.
arm pain localized to injection site starting 2 weeks after injection; initially radiating to neck and head and causing headaches; improved after a few days but still persisting 6 weeks later
discomfort; chest pain; feeling weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-000002784. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 03Jan2022 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: CHEST PAIN (non-serious) with onset 2022, outcome "unknown"; DISCOMFORT (non-serious) with onset 2022, outcome "unknown"; ASTHENIA (non-serious) with onset 2022, outcome "unknown", described as "feeling weak". Additional information: The reporter reported on 28Jul2022. Indication not reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Bell's Palsy; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team.  A male patient received BNT162b2 (BNT162B2), 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: BELL'S PALSY (medically significant), outcome "unknown". Clinical course: Physician reported there was an adverse event with patient that was already reported with the initial version of the vaccine. The physician said it's a well-documented case of Bell's Palsy and in his mind it's related to the vaccine. Physician believed the patient's employer was requiring him to get the current vaccine. Physician didn't want to do it because of the prior adverse event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the event Bell's palsy is related to  BNT162b2 administration cannot be excluded. This case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
Information has been received from the Merck Pregnancy Registry via a physician concerning an 18 year old female with no previous pregnancies and a drug hypersensitivity to codeine who 28-FEB-2007 was vaccinated with a first dose of Gardasil (lot #655617/1447F). On 11-JUN-2007, the patient was vaccinated with a second dose of Gardasil (lot #655617/1447F). On 14-SEP-2007, the patient was vaccinated IM with a third 0.5 ml dose of Gardasil (lot #655617/1447F). There was no concomitant medication. On 14-SEP-2007, the patient had a positive pregnancy test. The patient's last menstrual period was 14-AUG-2007 and the estimated date of delivery was 20-MAY-2008. On 17-SEP-2007 and ultrasound revealed the patient was 4 weeks and 6 days with sac. On 03-OCT-2007, the patient had a spontaneous abortion. Upon internal review, spontaneous abortion was considered to be an other important medical event. Additional information has been requested.
Two days post vax pt developed an injection site reaction characterized by redness, pain, swelling and itching at the site of Pnu-Imune 23 administration. The MD instructed pt to treat with Motrin and applications of ice. That same day she was seen in ER and treated with an unspecified antibiotic. On 11/2/00, pt was seen by MD who noted "some" improvement of her symptoms. The pt had previously recvd an injection of Pnu-Imune 23 in 1993. This is 1 of 4 pts from this facility who experienced an adverse event following receipt of 2 different lots of Pnu-Imune 23. Follow-up info recvd from MD on 3/20/01 indicated the pt recovered.
On 11/03/2022 I woke up at 4AM to begin my daily routine when I noticed my right leg was not working as it should and my right arm was not working as it should either I then experienced a severe headache and took an Ibuprofen.  I crawled up the stairs as I could not walk up to get help from my girlfriend.  When I was able to talk to my girlfriend my speech was slurred and she could not understand me, An ambulance was called I was taken to the hospital under stroke alert.  No immediate clotting was noticed an MRI was done and several blood clots were noted and I am currently on a blood thinner Eliquis 5mg twice daily and Lipitor.
invalid dose (over 42 days period); Arm Soreness; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (invalid dose (over 42 days period)) and PAIN IN EXTREMITY (Arm Soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for an unknown indication.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included METFORMIN, METOPROLOL, LISINOPRIL, DABIGATRAN ETEXILATE MESILATE (PRADAXA) and FLECAINIDE.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (invalid dose (over 42 days period)) and PAIN IN EXTREMITY (Arm Soreness). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (invalid dose (over 42 days period)) and PAIN IN EXTREMITY (Arm Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       In addition, patient shared that she have underlying diseases such as A. Fib, DM, Mini stroke, a mass in the left lower lung and an ablation procedure in the heart.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient seen 4 days post vaccination (r) arm with 3.5" x 4" redness noted surrounding injection site with approximately 1.5" x 1.5" area of soft swelling, no tenderness noted today. Patient states was very tender x 2 days, mild warmth to touch. Patient well appearing. Lump clear, no lip/tongue swelling advised cold compress/Ibuprofen PRN.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021 at 9:22 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:22 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 66.51. Concomitant products were not provided. On 31-Mar-2021, Excursion time was 08 AM, temperature was 32, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 31-Mar-2021. 04 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
- Patient complains of joint pain & in the muscles on both shoulders. Range of motion is limited. He went to the doctor, but no treatment had been noted.
Fever, Fatigue, body aches, hypersensitivity to touch,  Narrative:
higher than normal blood glucose, fever of 103.1 for 12 hours , nausea, diarrhea, muscle and joint pain, extremely cold under multiple blankets, headache , light headed, near syncope, extreme fatigue, long lasting brain fog((until approx June 1), racing heart, shortness of breath, frequent urination, weakness, loss of appetite. Ears rang louder vision blurry, my mild arrhythmia became more frequent/longer symptoms. I had to take 1 week off of work, and when I returned I still could not function normal 7 hour day. I had hard time staying up to normal bed time (11:00 p.m.), fatigue was chronic from waking to bed. Blood sugar dropped far below my normal lows after week  one and have remained lower than normal lows)
Case number PHEH2014US020259 is an initial spontaneous report from the nurse received on 08 Oct 2014. This report refers to a 38-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1411601) intramuscularly on 08 Oct 2014 (at 09:00 am). On the same date, after vaccination she experienced general malaise, nausea, headache, chills and flushed cheeks. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
pt rec'd grey cap pfizer vaccine after being in freezer for 22 days- have not been in for replacement dose
tingling noted shortly p/vax; Hosp ER called & MD recommended APAP-over weekend condition worsened pt devel fever in excess 102, cold became more severe & devel rash, bronchitis, ache or pain in knees; skin flaking, cough;
PT c/o palpitations, lightheadedness, dizziness.  No Chest pain or SOB.  No cardiac hx.   EKG, CK and troponins normal.