chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ON OCTOBER 9, 2022, The day after the covid Moderna I got a severe headache, felt nauseous, felt the glands on my neck were swollen and sore. Couldn't keep anything down.   Improved greatly in the later afternoon. On Wednesday, October 19, I experienced both my ears being blocked. That night I called ask a nurse, who said it was a familiar complaint. She said since this was sudden onset, I should be seen in clinic by Friday October21 if not improved. But I couldn't get scheduled in the clinic until Monday October 24 at 9:00 AM. So, I used Mucinex, and the left ear slightly improved. The right ear is still blocked. The right ear does not have any feeling when touched. Has no hearing.  I really tried on Sat. to get the wax out with a dewaxing kit.  No Luck. But then Sat night October 21 about 9:00 PM, I became very dizzy and threw up, many times throwing up. My husband would take away a vomit bucket only to have me vomit again. Very Dizzy, hard to stand and walk.  Then about 11:30 improved and I could sleep for a few hours. Very Dizzy, hard to stand and walk. but found I could not keep anything down in the Sunday morning October 23 morning. I tried to take my blood pressure pill. But up chucked. Continued to throw up, got to only yellow bile. Then put on a patch for Nausea. No dizzier and no longer throw up. But my right ear is still ringing. full, uncomfortable. painful. Very sensitive to sound and more and more ringing whooshing at more sound, dizziness with vomiting last week.   had some episodes of diarrhea.   GI symptoms resolved. continues to have the dizziness.  It feels like lightheaded.  No unilateral weakness or tingling.  no head trauma.  Reviewed HPI.   blood pressures been fluctuating but never low.   had a scopolamine patch that she used at the advice of the emergency room nurse when I called in to see if she needed to come in.  I was instructed to try it and stay home. I was seen on October 24. by the clinic. I was given medications, but after completing the meds in 7 days I still have the painful ringing plugged right ear with no feeling to touch. My provider is recommending a referral to an audiologist or ENT.  Which As of this date of November 2, a PA is to contact me with the referral to the specialist. I will be reaching out for further care for the damage to my ear from the Moderna Covid vaccination given to me on October 8, 2022.
Patient woke up this morning complaining of hot, itchy pain at injection site.  There is also a red spot which is 4 inches in diameter at injection site.
pt recvd vax;about 8 hrs later had generalized aching which lasted 24 hrs;had pains & weakness in arm & hand;after 4 1/2 wks still aching;sometimes pains & general weakness of arm & hands; has had flu vax previously w/ no problems;
flu like symptoms after receiving her Shingrix vaccine; stated having a headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: flu like symptoms after receiving her Shingrix vaccine) and headache (Verbatim: stated having a headache). The outcome of the influenza-like symptoms and headache were resolved.   It was unknown if the reporter considered the influenza-like symptoms and headache to be related to Shingrix.   It was unknown if the company considered the influenza-like symptoms and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-MAY-2023 The patient had having a headache and flu like symptoms after receiving her Shingrix vaccine. The reporter did not consent to follow-up due to limited information.
I24.8 DEMAND ISCHEMIA 4/7/2023 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 4/7/2023 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY
HEADACHE, SWEILLING ON LEFT AXILLA AND DECREASE IN ENERGY. VISITED EMERGENCY ROOM, NO TREATMENT, PATIENT WAS ORIENTED TO MONITOR GANGLIAL SWELLING AND TO REPORT TO ER IF SIGNIFICANT CHANGES WERE NOTED LIKE INCREASE IN SIZE, INCREASE IN PAIN OR REDNESS.
Her skin was a little puffy around the area for about a day; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SKIN SWELLING (Her skin was a little puffy around the area for about a day) and HEADACHE (Headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 23-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced HEADACHE (Headache). On 23-Feb-2021, the patient experienced SKIN SWELLING (Her skin was a little puffy around the area for about a day). On 24-Feb-2021, SKIN SWELLING (Her skin was a little puffy around the area for about a day) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.            This case was linked to MOD-2021-032157 (Patient Link).
Patient was given Pfizer vaccine as second dose instead of Moderna, 28 days after first Moderna vaccine.  Pt reported no adverse events.
Patient felt like she was shaking 5 minutes after getting vaccinated, but did not have trouble breathing and was talking normally. She only had a protein shake for breakfast so we gave her orange juice in case it was low blood sugar. I sat with the patient and she began to lose focus and seemed to have labored breath. We offered benadryl at 10:45 in case it was a reaction. Patient declined us calling medics still at this time and wanted to sit with husband and wait it out. Patient's breathing continued to decline so I chose to call the paramedics and administered epinephrine at 11:06. Paramedics arrived and patient was transported.
RHEUMATOID ARTHRITIS CAME BACK WITH A VENGEANCE; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS CAME BACK WITH A VENGEANCE) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS CAME BACK WITH A VENGEANCE) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS CAME BACK WITH A VENGEANCE) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient received Humira as Solution for injection in pre-filled pen.  The reporter's causality for the event(s) of Rheumatoid arthritis flare up was not provided.  No treatment information was 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.  Company comment: This spontaneous case concerns an adult female patient of unknown age with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after a dose of mRNA-1273. The event is described as a flare up. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns an adult female patient of unknown age with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after a dose of mRNA-1273. The event is described as a flare up. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Site red and swollen, temperature of 102. Given Augmentin 875mg PO BID x10 days.
2 days later, I started having swelling, redness, and itching at vaccination site. I went to the same pharmacy, but not the same location where I got the shot; and they told me I was having an allergic reaction and suggested me to take Zyrtec. I am almost recovered; I do not see much swelling now but it still itches.
Pt recvd vax approx 1988 & 20 mins following vax exp bronchospasm & was treated w/Tolubatine & an inhaler; pt also elected to discontinue the remaining vax;
Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion). On 02-Apr-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion) had resolved.        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.   It was reported that there was a power outage on 02-Apr-2021 and vials were in freezer and refrigerator where temperature dropped to -13.79 C  in freezer for 47 minutes and to 12 C in refrigerator for 59 minutes.  No concomitant products were reported.  No treatment information was provided.
The same day I got the vaccine at 9 P. m I woke up from a nap with uncontrollable shivering and nausea. I decided to take a bath since I could not get warm no matter what I did. When I went to get out of the bath I was extremely dizzy. I took my temperature and it was 102.5. I woke up the next day covered in sweat and my temperature the next morning was 100.1. I felt better until I went to go shower and almost passed out in the shower. The vaccine for some reason really interfered with my POTS and I typically don't have reactions to vaccines at all. The whole morning my temperature was 99 then it finally normalized later in the day. I also had a headache both days and still do into the third day.
Patients have been administered from vaccines that experienced a T excursion/she reported an excursion about a month ago; Patients have been administered from vaccines that experienced a T excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion/she reported an excursion about a month ago) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion/she reported an excursion about a month ago). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion/she reported an excursion about a month ago) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The trans date was given as 18-Mar-2022. HCP was calling because she reported an excursion about a month ago, at the time she did not ask for a stability report but now she had been asked to send the stability report, HCP also mentioned that the excursion duration was 7 hours instead 5 min (previously stated). Storage condition at the time of the excursion: Refrigerator. Maximum or minimum temperatures reached, as applicable (specify temp is in C or F): Max Temperature reached 64°F. Excursion duration: Approximately 7 hours. They were returned to the refrigerator. Visual inspection noting any vaccine state change: (e.g. were frozen vials thawed, were thawed vials re-frozen, were they visualized at all): No changes. Pertinent details: whether the vial(s) were punctured, any previous excursions with the impacted vial(s): At the time they were unpunctured. The patient did not have any adverse events post injection. No treatment information was reported.
mom reports pt was lethargic in PM;medicated w/APAP;temp reported 104 @ 10PM;pt had a gen sz-squad evaluated but did not transport;
ARM PAIN; This case was reported by a consumer and described the occurrence of pain in extremity in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in extremity. On an unknown date, the outcome of the pain in extremity was not recovered/not resolved.   It was unknown if the reporter considered the pain in extremity to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient asked if it was ok to take aspirin to help with arm pain from the Shingrix vaccine.
punctured IPOL administered post excursion with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health care professional.  This case is linked to cases 2022SA422378 and 2022SA424157.  This case involves a 17 years old female patient and reporter reported punctured ipol administered post excursion with no reported adverse event (IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination; varicella zoster vaccine (varicella vaccine) for prophylactic vaccination; and hepatitis B vaccine (hepatitis B vaccine) for Prophylactic vaccination.  On 03-Oct-2022, the patient received a dose of suspect IPV (VERO) standard at a dose of 0.5 ml (milliliter) Once (lot V1A024M, expiry date 17-Feb-2024)(form : unknown) via intramuscular route in right deltoid for Immunization.  On 03-Oct-2022 the patient was administered punctured ipol post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 guidelines. 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.
3/26/2021   Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  Numbness to left fingers,left  arm aches, .   Assessment : Time of assessment 1040am Alert and oriented. No redness or swelling, able to move fingers, reports pain 3?10.   Actions taken: VS @1040am BP- 149/100, P- 81, O2- 99%, recheck at 1049 BP- 152/87, recheck @ 1131- 147/79, P- 77, O2-100%.         Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/26/2021 10:46 AM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc
No adverse event has been reported. This form is being completed because a Jansen vaccine was given to a young man about 1 month away from being 18.
1st experience Approx time was late April 2021. Fast onset severe HA, severe joint pain in the neck, hips and knees. Low grade fever and muscle pain. All symptoms for 24 hours.  2nd episode June 6th 2021. Same exact symptoms and time duration.  I am normally a very well person. I seldom get sick.
Facial swelling, sneezing, generalized urticaria within 5 minutes of Varivax #2. Resolved by 24 hours later.
I had a skin reaction that started on my torso   It felt prickly and itchy over the past week has moved to include my extremities.  I have taken Benadryl a couple of times because of the itching. I also have a constant tinnitus in my life ears. I have had tinnitus before but not for going on a week.
pt recv vax & exp an inj site rxn consisting of redness & swelling extending down arm to elbow regions w/in 2 days of vax;it was reported that pt has an allergy to PCN;sx resolved w/in 3 days;pt reported sx 24hr post vax w/duration of 72hr;
Pt recvd vax & indicated that pain in hands & knees devel in the day immed following inject, pain is arhtritis-like & still persists;
This spontaneous report as received from a Office Manager via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, route not reported, dose reported as 1 injection). Concomitant medications were unspecified. On an unknown date the patient had "a bad adverse experience" (details unspecified) after receiving PNEUMOVAX 23. The patient did not seek medical attention. The outcome of the event was unknown. Additional information has been requested.
First right inner forearm very sensitive, singles rash appeared above waist line on right side, 10/18/2014 night did not sleep good, 10/19 & 10/20 did not feel like eating just rested as best I could. 10/21/2014 to my primary doctor who said it looked like singles and gave me 7 days of Valacyclovir HCL 1. The shingles are not painful. I am starting to feel better.
Starting feeling a little queasy went to bed and by 4:00am woke up with very very bad stomach cramping and started vomiting by 5:00am through the following day.  Had a hard time catching breath felt like I had been running.  Also light headed and could not keep water down.
Information has been received from an office manager concerning a 12 year old female patient who was vaccinated with a first dose of GARDASIL (lot# 662229/1497X, expiration 15-APR-2011, site and route not reported) on 16-JUN-2008, the second dose (lot# 662229/1497X, expiration 15-APR-2011) on 18-MAY-2009 and the third dose (lot# 662229/1497X, expiration 15-APR-2011) on 13-JUL-2009. After receiving the second dose of GARDASIL, the patient had injection site lump and tenderness that lasted for 7 weeks. It was unknown if the patient sought medical attention. Additional information has been requested.
very rapid heartrate on car ride home approximately 33 minutes after shot,  (i was a passenger in the car) had to sit very still and look down because any movement made symptom worse.     about an hour after the reaction symptoms were tolerable but still uncomfortable.  took the remainder of the day off from work and rested. heart rate was still not a normal resting rate and any movement made it go up at a fast pace for a few days.      Thinking back, i mentioned to the vaccination center that i was allergic to wheat, but i did not mention that i do not take antihistamines
Dizziness Left leg tingling intermittingly, BP163/107 HR 75, BP110/119 HR79 O2 98%
Received dose #1 on 4/8/21 and dose #2 on 4/30/21. On 5/1 evening developed chest pain and tightness. He told his family about the chest pain the following day, on 5/2,  which prompted his Mom to take him to an ED.  In ED on 5/2 and found to have ST elevation, elevated troponins and elevated inflammatory markers. ECHO with mildly decreased systolic function. Picture consistent with perimyocarditis. Admitted to Hospital 5/3 AM.  Currently clinically stable but admitted for close monitoring.
PATIENT HAD NO ADVERSE EVENTS REPORTED. PATIENT RECEIVED MODERNA COVID-19  FOR 1ST DOSE , BUT RECEIVED PFIZER AS SECOND DOSE.
Central retinal vein occlusion of left eye with macular edema--symptoms began 5/23/2021
July 28 - nausea, headache. 3 days. August 28 - nausea, headache. 3 days.  Sept 6 - Shingles.
Generalized itching, flare ups of redness on arms. back and legs, and hives.
The guest reported the incident to me on Saturday, November 20, 2010 in the afternooon. Per the guest the itchy and redness on her right arm started Tuesday evening of the next day. I requested her to come into the pharmacy and advised her to take some Benadryl. When she came into the pharmacy Saturday afternoon, I observed the injection site to be red and the size of 1.5mm in diameter. The immediate area was clear but the two areas where the adhesive of the band-aid was applied were very red and slightly raised. The red areas made an outline of the two adhesive areas of the band-aid. She complined of it being itchy since Tuesday night but waited to Saturday to call but she did apply some old steroid cream on it. She mentioned that this was the first time in receiving a flu shot where she had this type of reaction. The denied having received the H1N1 last year. The vaccine administered contained the H1N1 with the Flu vaccine. I gave her some Benadryl topical gel and hydrocortisone cream since her old cream had expired over 3 years ago.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Pfizer product on 01/05/2021 and 01/26/2021. They tested positive via both antigen and PCR testing on 10/29/2021 at the assisted living facility at which they were a resident. I see no evidence the individual was hospitalized related to this illness. The assisted living facility may have more information. The individual died on 11/04/2021.
12/26/02 (02:00) numbness on right side of face and about midnight went to ER. Face paralyzed on right side speech and eyes. Prescribed Prednisone (30 of them) 10mg for 12 days. Dx: Bell's Palsy. No recovery yet. Would not have taken the Flu shot if I had known there was mercury preservative in it because my nephew has autism after childhood vaccinations.
Patient stated she had "normal" stiffness in left deltoid muscle day after vaccine, but on 12/31 (3 full weeks after the vaccine), stated still having tightness in arm and throbbing when she lays down, intermittently.
23 weeks pregnant, due 07/30/2021, broke out in hives 6 days after vaccine