chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headaches almost daily; This is a spontaneous report from a contactable other healthcare professional (patient). A non-pregnant 36-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in the right arm on 19Jan2021 at 13:15 (at the age of 35-years-old) at dose 2, single for COVID-19 immunisation. Medical history included endometriosis. The patient had not COVID prior vaccination and no COVID tested post vaccination. Concomitant medications were reported as none. The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient received the first dose of BNT162b2 intramuscularly, in the right arm, in Dec2020 at 13:15, at the age of 35-years-old, for COVID-19 immunization. The patient would very rarely get a headache before taking the COVID vaccine. A few months after taking vaccine, since 18Feb2021, she had headaches almost daily. At times had to miss work due to the severeness of headache which was not like her to do at all. No treatment was received for the event. The patient had not recovered from the event.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the limited information in the case, a possible retalitionship between BNT162B2 and the event headache cannot be completely ruled out. 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.
Started having tingling up and down his left arm; Feels like something is crawling up and down his left arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Started having tingling up and down his left arm) and FORMICATION (Feels like something is crawling up and down his left arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2020, the patient experienced PARAESTHESIA (Started having tingling up and down his left arm) and FORMICATION (Feels like something is crawling up and down his left arm). At the time of the report, PARAESTHESIA (Started having tingling up and down his left arm) and FORMICATION (Feels like something is crawling up and down his left arm) had not resolved.            No concomitant medications were reported.  Treatment information was not provided.  The patient had events after 2 weeks of his second shot of COVID-19 vaccine. Patient had seen his doctor and they don't know what's wrong.
About 9 days after getting my first Covid vaccine I awoke to a red itchy spot at the injection site.  It has grown in size the last 5 days and is hot to the touch.  It feels like a allergic reaction or a big bug bite.  Still here tonight and about the size of a large orange.
Information has been received from a certified medical assistant concerning a female who on 15-AUG-2008 was vaccinated intramuscularly with a dose of GARDASIL (Lot # 660387/1967U) 0.5 mL. It was reported by the certified medical assistant that the patient had a muscle spasm as she was being vaccinated with GARDASIL. Most of the vaccine dose leaked back out of the injection site. An additional dose was then administered. On 15-AUG-2008 the patient recovered from muscle spasm. The patient sought medical attention: In office. There was no product quality complaint. Additional information has been requested.
Sudden severe headache followed by severe joint pain (elbows, knees, neck and back) and axillary and left arm lymphedema and left breast swelling.
patient was administered ADACEL on 1 Oct 2020 and again  on 3 Nov 2020/ no AE.; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Agency and transmitted to Sanofi on 05-Nov-2020.  This case involves a 76 year old male patient who was administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] on 01-Oct-2020 via unknown route in an unknown site (lot number unknown) and again in error on 03-Nov-2020 at a dose of 0.5 ml (lot number C5655AA expiration date: 15-Aug-2021, strength- standard) via intramuscular route in the right deltoid (vaccine presentation unknown) (extra dose administered).  Medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications was reported as none.  It was a actual medication error due to extra dose administered.  The reporter wanted information on any adverse reactions that they need to be aware of  At the time of this report, no adverse event was reported.  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 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. There will be no information on the lot number for this case.
Spent most of the day in bed, not worth anything for 3 days; Wiped out; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Spent most of the day in bed, not worth anything for 3 days) and FATIGUE (Wiped out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Wiped out). On 05-Mar-2021, the patient experienced VACCINATION COMPLICATION (Spent most of the day in bed, not worth anything for 3 days). In March 2021, VACCINATION COMPLICATION (Spent most of the day in bed, not worth anything for 3 days) had resolved. At the time of the report, FATIGUE (Wiped out) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-407483, MOD-2021-407593 .
Patient reported feeling numbness to the left side of her face including her left ear 30 minutes after the vaccination. Patient also reported experiencing tinnitus in both ears 1 week later.
Red patches in the abdominal area and in the back. Small hives in the arms and legs, including feet. Itchiness from head to toe
Client came in 09/07/2022 to receive a Hepatitis B Peds vaccine. Instead, I wrote the clients sibling vaccines on the consent form of the above-mentioned vaccines. He did not need a Pneumococcal vaccine he was already up to date. Once I realized that I made this error I called to speak to the parent on 9-8-2022 but his phone number went straight to a recording stating ?this caller phone is not setup to accept voicemail?. I then reached out to the translator that accompanied the family and she answered the phone. I explained to her that I did give the wrong vaccines and she was familiar with this error because she had an appt slip that had the vaccines written down what the sibling and this client were to receive. But I was looking at the vaccines that I had written down on the consent form, thinking that those were correct. I asked if she knew if the client had a pediatrician so I could notify their physician of my error and get guidance due to the extra vaccines this client received. The translator stated that this client does not have a pediatrician and that this is the reason the client was brought to the health department. I explained that I do need to get an update on how the child is doing. Also, my error was reported to Nurse Manager on 9-8-2022 and that a VAERS will be done. I explained to her the parent should expect to be contacted by VAERS of this however, I will be entering both the parent phone number and hers, just in case the parent is not reachable. She said ok.  The translator called me this morning 9-9-2022 and stated the parents were very upset and I told her I do not blame them and I apologized several times for my error. She stated the client was complaining of soreness, unable to lift his arms (because he received vaccinations in both arms), redness is noted and having bad dreams. The mother gave the child Tylenol due to the reaction from the vaccines administered. She stated as far as the bad dreams and crying is concerned that it could be partly due to the parents are upset and he is reacting off of their emotions. Per translator the parents will be taking the client to a physician to be evaluated and go from there. I did ask that the translator call me back with the physician?s name and she said ok.  I did reach out to the clients translator on 9-14-2022 to discuss the outcome of the md visit and she stated the parents made an appt with physician but the appt is a month out before he client will be seen. I asked to please call me and let me know that information because she had to call the parents to ask about the date and name of md that he will be seen about. She said she would call me back the next day 9-15-2022 but I have not heard back from her as of yet.  She stated it will be better to contact her instead of the parent because the parents do not answer their phone.
Pt had already received a dose of Jensen/J&J COVID vaccine 5/06/2021 and was under the impression that he could also get both doses of either Moderna or Pfizer.   No treatment needed/given.  Pt informed that he does NOT need to get any additional COVID vaccines at this time.
chills; body aches; fatigue; nausea; arm soreness at the injection site; This is a spontaneous report received from a non-contactable consumer, the patient. A 47 year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) in the left arm on 26Mar2021 at 09:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included tuberculosis as a toddler. The patient had no known allergies to food, medications, or other products. The patient did not receive any other medication within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. It was unknown if prior the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021, the patient experienced nausea the day of and the following day of the vaccine, arm soreness at the injection site and on 27Mar2021, the patient had chills, body aches and fatigue the date following the vaccine. Therapeutic measures were not taken as a result of nausea, chills, body ache, arm soreness and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events nausea, chills and body aches, arm soreness at the injection site and fatigue was recovered.   No follow-up attempts are possible; information about lot/ batch number cannot be obtained.
In less than 1 hour after receiving Pro Quad Infanrix, and IPV pt developed red rash and hives. Hive size of half dollar on right arm where ProQuad was given. Periorbital and lip swelling, no heart rate increase no breathing difficulty.
Severe vertigo in lying and standing positions with headache, nausea and vomiting that lasted about 12 hours. Rapid pulse and blood pressure of 178/74. Symptoms resolved with no treatment. Patient felt fine by late morning as if nothing had happened.
General achiness.  Soreness at left deltoid injection site.  Infraorbital puffiness and itchiness without any other apparent cause.  Denies new eye makeup.  Not wearing her contacts.  Denies sinus congestion or drainage and says this is nothing like prior sinus infections.
beginning on the afternoon after the 2nd Gardasil shot, pelvic and stomach pain, joint pain, vaginal discharge with fishy odor, slight bloody discharge 6/9/08-records received for DOS 4/28-5/08/08-received vaccination #2 on 4/28/08-on 5/3/08 C/O middleschmertz pain few days ago. Extremely bad cervical pain, blood tinged fishy odor. 5/5/08 episodic pain since second vaccination. C/O positive urine urgency, polyuria. Pain intermittent. Pelvic exam normal. Impression likely middleschmertz vs. ovarian cyst.
Cough-three Weeks, Fatigue, temperature, arm swelled (have pictures), aches, loss of appetite, breathing problems.
Pfizer shot on 03/24/2021 began cycle/and or bleeding at 9 pm for 5 days Pfizer shot 04/04/2021 began another cycle and/or bleeding at aprox 10 pm for 4 days
2 days after shot arm rash, swelling, painful, hot to the touch (covid arm) swelling/rash/burning is from shoulder down to elbow. Was given topical steroids on 3/2/22 it has helped a little
05/02/2005 had Prevnar in right thigh. Same day leg got red and she was scratching at it. 05/04/05 the thigh was swollen. Rx for Benadryl given 05/05/05.
Sporadically a few days after vaccination I'd occasionally feel a sharp pain. I had continued to work out without event. I did PT including pushups at 0700-0740 on 11APR. Around 1700 my left deltoid around the injection site started to become painful and has become progressively worse; I am unable to move my arm without debilitating pain; naproxen did not help alleviate any of the pain. I will be seeking medical attention ASAP. I have never had any inflammation, redness, or swelling at or around the injection site.
Pericarditis with chest pain, EKG changes, and echocardiogram abnormalities in addition to fevers, rigors and systemic myalgias.
101-degree fever that went down and came back up as the day progressed Body aches Headache Dizziness Fatigue Chills Muscle ache Lethargy
Pt c/o sore arm, left sided m=body malaise 8 hours after vaccine, then diffuse body pain and malaise. took IBU 800mg.  CBC and CMP clinically unremarkable with no elevation of white blood cell count.  HOWEVER, urine with 388 white cells/36 red cells/few bacteria and positive leukocyte esterase/nitrites. Chest x-ray without abnormalities. EKG showed sinus tachycardia at 108.  No acute ST or T abnormalities.  No ectopy. Renal ultrasound showed a non-obstructing stone in the kidney, but no hydronephrosis. COVID and Respiratory Panel were all negative.  ER COURSE: Patient had already be given IV fluids/Tylenol/morphine prior to my evaluation and was feeling slightly better, but was still having generalized body aches and malaise... Blood cultures were drawn, and IV Rocephin was given.  A second dose of morphine and Benadryl was needed to get the patient somewhat comfortable, but was still having severe body aches and malaise  MEDICAL DECISION MAKING: Initial thought was adverse reaction to COVID vaccine,  but patient also with significant UTI, febrile, and severe body pain requiring multiple doses of IV narcotics for control... Question of adverse reaction to vaccine and or UTI/early pyelonephritis or combination of both...  Hospitalist was consulted to evaluate the patient... Will admit for observation status and continued IV medications. Date of hospitalization = 4/24/2021
Information has been received from a physician concerning an 82 year old female who on 17-APR-2007 was vaccinated SC with a dose of Zostavax. On approximately 21-APR-2007 the patient developed an itchy rash that started around her waist. It was reported that the patient had an doctor visit on 23-APR-2007 and was diagnosed with shingles. The physician reported that patient had a "vesicular rash on the left-side of her upper abdomen". The patient was treated with Neurotin 300 mg BID twice daily and "Sanvir" 500 mg, 2 tablets BID for 7 days. The physician had instructed the patient to call the office back if symptoms did not improve. The physician had not heard back from the patient. A product quality complaint was not involved. Additional information has been requested.
This is a spontaneous report from a contactable consumer. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE, dose 2 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. Caller received her 1st Pfizer vaccine dose on 21 and she received her 2nd Vaccine dose on 16Apr2021. Caller states her menstrual cycle started the beginning of March/2021 and "then my cycle started the very next day right after I received the 1st vaccine dose. So, I had 2 menstrual cycles in March and none in April. Caller states she knows she is at the age for "menopause" but did not think it would happen this quickly. The outcome of the event was unknown. Follow-up needed. Information about batch/lot number has been requested.
Immunization given left shoulder on 5/2/06. On 5/3/06 entire area over deltoid is red, very tense, warm, non tender. On 5/4/06 area increased to include entire upper arm, from elbow to top of shoulder.
REPORTS NAUSEA, VOMITING, GENERALIZED MUSCLE PAIN, AND BONES ACHING FROM WHEN HE GOT HOME POST DONATION TO THE DAY.
Left upper deltoid with significant swelling, warm to touch, tender to palpation. Area of induration 4.5cmx6cm. Temp 100.3. Treated with Ibuprofen, icing.
Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had resolved. Not Provided          This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   Humira was citrate free.  No treatment information was provided.  The reporter's causality for the event of rheumatoid arthritis flare up with Humira (Adalimumab) was no reasonable possibility.  Company comment  This spontaneous case reported by a consumer, concerns an adult male patient, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Concurrent medical conditions included Rheumatoid arthritis. On an unknown date, the patient had received ADALIMUMAB for Rheumatoid Arthritis, which could be considered as a confounder. No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The event was reported as resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns an adult male patient, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Concurrent medical conditions included Rheumatoid arthritis. On an unknown date, the patient had received ADALIMUMAB for Rheumatoid Arthritis, which could be considered as a confounder. No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The event was reported as resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
The patient had the first dose  5/27/21 which was reported earlier and this was the second dose.
COVID 19 Vaccination:  Fever (ranged from 99.7 - 103.4)  24-48 hours after vaccination Chills All over body Aches Rash on neck/chest headache
I started with the expected symptoms (chills, body aches, low grade fever) on the same day  (03/06/21) about 12 hours after the injection.   On March 7th at about 10:00 am, I developed a pruritic papular rash to my right arm.  The rash was from my right wrist to my antecubital area.  The next 1-2 days I developed another pruritic papular rash to the left side of my neck and my  left ear.  I developed another rash to my both my eyelids and to the skin area around my eyebrows.  As of today 03/11/21, I continue to have the rashes.  Today I also developed pruritis and a red macular rash to my left palm and continue to have continued pruritis to both arms, my scalp and both eyes.
Patient was given Tdap and MENACTRA after already receiving them at another provider's office.
Pins and Needles Sensation in fingers- Pt suspects it might be due to anxiety that was exacerbated by the stress of getting an injection - Pt also stated cold feeling in localized to left arm similar to tickling - Continued medical elevation by Doctor and EMT.   Pt Parent stated that Pins and Needles Sensation disappeared after the pt arrived at home - As per mom Pt also presented with fever and "pretty bad body aches"
mild body aches; low grade fever; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (mild body aches) and PYREXIA (low grade fever) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN (mild body aches) and PYREXIA (low grade fever). On 31-Mar-2021, PAIN (mild body aches) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   First dose was given on 30Mar2021, Lot# 038A21A, IM injection in the right arm (non-dominant) symptoms started same day he had low grade fever, mild body aches lasted for 24 hours.   This case was linked to MOD-2021-094896 (Patient Link).
Injection site on upper left arm was red and itchy with bumps.  Reddened area was apprx 3-4 inches long and 2 1/2 inches wide.