chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the area where I got the shot felt a little warm - left arm; the area where I got the shot is itchy - left arm; the area where I got the shot is red- left arm; the area where I got the shot is swollen - left arm a little bit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (the area where I got the shot felt a little warm - left arm), INJECTION SITE PRURITUS (the area where I got the shot is itchy - left arm), INJECTION SITE ERYTHEMA (the area where I got the shot is red- left arm) and INJECTION SITE SWELLING (the area where I got the shot is swollen - left arm a little bit) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced INJECTION SITE WARMTH (the area where I got the shot felt a little warm - left arm), INJECTION SITE PRURITUS (the area where I got the shot is itchy - left arm), INJECTION SITE ERYTHEMA (the area where I got the shot is red- left arm) and INJECTION SITE SWELLING (the area where I got the shot is swollen - left arm a little bit). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, INJECTION SITE WARMTH (the area where I got the shot felt a little warm - left arm), INJECTION SITE PRURITUS (the area where I got the shot is itchy - left arm) and INJECTION SITE SWELLING (the area where I got the shot is swollen - left arm a little bit) had not resolved and INJECTION SITE ERYTHEMA (the area where I got the shot is red- left arm) was resolving.        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.   No Concomitant medications were reported. Treatment included cold compress.
Rash all over body lasting over 30 days. Dizziness at onset after receiving the vaccination.
Shot recieved Wednesday.  By Wednesday night, I had a headache (forehead and back of neck) and fatigue.  Friday I became dizzy, and had 2 near fainting spells (this included dizziness, weak muscles, and slight loss of sight). I became achy (back and shoulders) and my headache continued.  These dizzy spells and headaches have continued for 6 days.  The dizziness is starting to subside, however the headache and fatigue remains.
C/O dizzy; blurred vision about 5 min after injection of flu vaccine see #17 130pm 10/7/2020- PC to participcat and he stated he went to the ER and stayed until 7pm. His BP went down to normal and he was discharged home. Feeling much better today.
After patient observed for 45 min. and left the site, driving away felt she could not swallow.  This lasted about a minute.  Also, felt as if left side of face was going to become numb and felt pain in back of left knee.  Left eye felt dry.  These symptoms lasted about a minute.  She put eye drops in eye when she got home and ate with no difficulty.  She spoke with her doctor today.
No additional AE reported; improperly stored VARIVAX were administered to patients.; \This spontaneous report was received from a registered nurse and referring to a 12 months 22 days old male patient. The patients' medical history and current conditios were not reported. Concomitant medications included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), Hepatitis A Vaccine, Inactivated (VAQTA) and pneumococcal vaccine conj 13v (PREVENAR 13).   On 13-MAR-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number W021740 with expiration date: 10-JUL-2024, administered subcutaneously on right thigh for prophylaxis (strength, and route of administration were not provided).   On 21-MAR-2023, it was found on the look back data logger monitoring that the defrost on the freezer has been getting too warm, out of range temp noted to be out of manufacturer storage recommendations. Temperature and time frame were unknown. There was previous temperature excursion (-9.8 degree celsius for 8 hours and 38 minutes) (product storage error). No complications, no reactions, no complaints. No adverse event.  The outcome of the event was reported as recovering.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2303USA007314:
1st dose on 2020, inquire about the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 20th Oct 2020 with batch number 97C2S and expiry date 14th May 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 28-Oct-2022 Reporter's comment: The pharmacist called to inquired about the administration of the second vaccine in a patient whom received the first dose of Shingrix. The patient was 79 years old at the time of the vaccination. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
1 cm raised, redness, bruised right deltoid, slight pain, WNL ROM. Advised warm/cold compress. Ibuprofen/Tylenol for pain. Return to clinic if worse.
Severely sensitive skin all over body to the point of pain, fever of 99.5. No rash or raised bumps at injection site, no early signs of vaccine reaction
PHN administered 0.5cc (incorrect dosage) of the influenza vaccine to patient who is 20 months old. Patient had primary series of the influenza vaccine last year. No tx. was needed at this time. PHN informed mother that an error had occurred. PHN gave mother a VIS information sheet and s/s were reviewed for observation.
1/10/03: Right deltoid red, swollen, approx. 10cm in size. No drainage - advised supportive measures - cold and warm compresses, Advil and Tylenol. 1/14/03 - spoke with mother via phone, symptoms decreased, child much improved, swelling down.
Caller stated a pharmacy technician mentioned to her that when both the pharmacy technician and the pharmacy technician's daughter received the GARDASIL9 vaccine, they both experienced injection site pain; This spontaneous report was received from a pharmacist technician and refers to herself, a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and historical drugs, was not provided.  On an unknown date, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dosage regimen, lot #, expiry date, and route of administration were not provided).  On an unknown date, the reporter stated that both the pharmacy technician and the pharmacy technician's daughter (reported in MARRS# 2309USA002865), experienced injection site pain (vaccination site pain.)  The causal relationship between vaccination site pain and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.; Sender's Comments:  US-009507513-2309USA002865:
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M005714, expiry date 03-OCT-2017, dose and route of administration not reported). No adverse effects were reported. Additional information has been requested.
Headache; Soreness on her arm side; This is a spontaneous report from a contactable other HCP Pfizer-sponsored program. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache and soreness on her arm side after her first dose of vaccine. The patient was also asking if she could take Ibuprofen and Tylenol. Outcome of the events was unknown.   Information on the Lot/Batch number has been requested.
Information has been received from a registered nurse concerning a 4 year old male with no prior medical history or allergies who was vaccinated subcutaneously in the right deltoid on 07AUG2000 (also reported as vaccinated at 15 months of age) with a first dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). There was no known illness at the time of vaccination. On 01MAY2003 it was reported that the patient "now" tested negative for mumps immunity. Mumps IgG antibody was negative. Unspecified medical attention was sought. Additional information is not expected.
2 days later fever over 103 degrees for 2 days then 100 degrees for a week, throwing up and irritable.  Child said "head pain", coughing.  05/03 ear infection, ear perforated.
Pt stated she was itchy all over, no rash, no shortness of breath, no injection site reaction.
CLIENT REPORTS TINGLING OF B/L LOWER EXTREMITIES, MILD DIAPHORESIS, TOLERATED WATER AND ORANGE JUICE, WITNESSED WALKING 50 FEET,  SYMPTOMS IMPROVED BY 10:35AM. STABLE ENCOURAGE TO FOLLOW UP WITH PCP.
KINRIX was diluted with 1 vial of sterile diluent 0.5 ml and administered to patient. No actual side effects were noted with this patient. Health Nurse, RN, Clinic VP., pharmacy and immunization coordinators notified. Incident report submitted and nurse retrained regarding incident. Attempting to notify patient's parent regarding incident and re-immunize patient.
Urticarial rash noted all over body including face, neck, blanchable with pressure
Rash on hands and back, face; red dots on hand; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (red dots on hand) and RASH (Rash on hands and back, face) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: INFLUENZA VACCINE in December 2020.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced ERYTHEMA (red dots on hand). On 09-Feb-2021, the patient experienced RASH (Rash on hands and back, face). At the time of the report, ERYTHEMA (red dots on hand) was resolving and RASH (Rash on hands and back, face) 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.   The patient reported that rash appeared on his face on 17-Feb-2021. The patient was scheduled for second dose on 21-Feb-2021. The patient visited their health care provider who recommended the patient to see an allergist. The patient had an appointment with his allergist on 08-Mar-2021. Concomitant medications were not provided. Treatment information was not reported.
Extreme fatigue beginning 4 hours post admin of vaccine.  Intense  (8/10) diffuse pain throughout limbs for two days following.  Intermittent S.O.B. for ten days. Diffuse intermittent headache in occipital region for about two weeks.
Patient had syncopal episode in lobby striking her head on floor & had brief LOC. Transferred to ER per EMS due to neck pain/visual disturb. Evaluated & released to home & diagn. with mild concussion. Episode occurred 10 min. after injection.
Pain, swelling initially, then dull achy pain remained and not able to sleep on left side, pain becoming remarkably worse about 5 weeks later.  Since that time, sharp pain, squeezing pain in Arm and shoulder requiring almost constant use of Advil, muscle relaxers and resulting in loss of sleep, constant pain ...
Hours after injection i had a small welp about the size of a nickel now the welp has flattened out and is very hard and the size of a half dollar and bright red and hot to the touch  And tender.
p/vax pt became fussy; inc crying; lasted 4 days; advised to call MD; pt ok now; mom states stools seemed harder the 4th day; lt leg seemed sore
This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 07-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N013279, expiration date 28-APR-2019, for prophylaxis (Strength, dose, route and frequency were not reported). The M-M-R II was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion was of 9°C to 25°C, during 8 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA007574: US-009507513-1802USA007580: US-009507513-1802USA007576: US-009507513-1802USA007577: US-009507513-1802USA007578: US-009507513-1802USA007579: US-009507513-1802USA007573: US-009507513-1802USA007572: US-009507513-1802USA006448:
patient was given Fluzone Quadrivalent this morning instead of Fluzone HD/NO AE; Initial information received on 25-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 74 years old female patient who received vaccinesand INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Sep-2019, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6645MA via intramuscular route in the right deltoid instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported.  It was a case of actual medication error due to wrong vaccine administered.  It was unknown if any adverse event occurred.  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.
Pt went to the ED arriving at 2359 on 12/28/2022 with shortness of breath and wheezing. Patient was given nebulizer treatments and IV steroids. Pt remained in ED for observation about 8 hours and was sent home on a steroid taper. This was her 5th dose of COVID vaccine/ 1st bivalent booster.
Admitted on 6/21 due to progression of renal failure in the setting of borderline acute T-cell medicated rejection undergoing steroid treatment. Covid + and found to have pneumonia. Started on dexamethasone, remdesivir contraindicated due to renal failure. Started on dialysis. In ICU for several days due to respiratory failure then improved some. Remained on Vapotherm at 40% with flow rate of 40 L/Min. Completed a treament course of ceftiaxone for bacterial pnuemonia. Unfortunatley oxygen requirements and inflammatory marks increased with worsening Chest x-ray. Resumed ceftriaxone. Pallative care consulted and family decided on comfort care based on patient's wishes.
Pain in arm/shoulder where vaccination was given for at least 2 weeks after vaccination was administered.  Vibrations felt from top of shoulder down through finger tips very often - and especially during physical activity.
Caller states that she has not had a period in two months.; This is a spontaneous report received rom a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 26Jun2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller states that the caller received the vaccine sometime around 26Jun2021 and has not had her period since, and she wants to know if this was normal. Caller states that she has not had a period in two months. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Routine Celiac screening in newly diagnosed type 1 diabetic noted positive, confirmatory endoscopy completed this week consistent with presence of celiac disease.
A month after the vaccine, 05/20/2021-  my arrhythmia from Micro Valve Prolapse  got significantly worse. I don't know if that is the vaccine or if that is just age, I just don't know. I went to my PCP, and he referred me to Cardiologist..  It was in August, before I saw Dr. They put me through several heart related test. And now have me taking a Beta blocker, Metoprolol 25 mg once a day. The outcome was that my Calcium Score was only 16. My heart was strong. the heart monitor showed 23 PVC's a minute.
ARM PAIN, CHILLS, SEVERE MYALGIA, NAUSEA, ABDOMINAL PAIN
Patient tested positive for COVID-19 on 07/09/2021. Sx onset 07/04/2021 (SOB, cough, loss of taste/smell, fatigue, body aches, subjective fever; afebrile at time of testing). CXR has been ordered, pending.   Lab contacted to request specimen be held, and requested they contact TN DOH to coordinate with CDC to discuss the case further.  Attempting to coordinate monoclonal antibody infusion for this patient.
Headache, Myalgia, Arthralgia, Fever, lynph node swelling under the arm. left arm soreness,  weakness, fatigue, malaise Narrative:  Other Relevant History:
anxious; her oxygen levels have been lower than usual/Oxygen dropping; This is a spontaneous report from a contactable consumer (patient, self-reported). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9263 and expiry date: May2021), via an unspecified route of administration, in Arm Left, on 27Jan2021, as a single dose for COVID-19 immunization. The patient's medical history included ongoing diabetes from 2020 and COPD from 2018. Concomitant medication included prednisone. The patient took COVID vaccine because she believes science was safe; anything was better than how things were now. The patient said she had COPD. She was on oxygen 24/7. 3 Liters in day and 4 Liters at night. She had the first dose of the Pfizer vaccine on 27Jan2021 and was scheduled for the second on 17Feb2021. At first, she had no reaction that she knew of. Then 4 days ago, on 05Feb2021, she was on the exercise bike and she noticed her oxygen dropped lower than usual, which it did, but it dropped quickly and was very slow to recover. She waited a few minutes and it just kept dropping. Now it still drops, even with little exercise- like walking across to another room. It has gotten as low as 90. She was unsure if it was connected with the vaccine or not. She will be seeing her new doctor at the end of the month, and she was getting a CT scan this week. Her new doctor she sees on 22Feb2021. She was wondering if this was something that Pfizer was finding. The patient confirmed that she had COPD and was already on oxygen prior to getting the Pfizer Vaccine. This was still occurring, and she thought so far it has stayed the same. She has not gotten back on the exercise bike yet. She was anxious too. She will be getting a full blood workup. Again, she was unsure if this was related to the vaccine, or if her condition was deteriorating, which she knew at some point it will. The patient said about Prednisone that she will not increase this until discussing with her doctor and investigating this aspect. At one point she had stopped the Prednisone because her blood sugar levels went up. But when she stopped it, it did not make a difference, so she went back on. But she only went back to taking it every other day, instead of everyday like she was. So, she has been taking it every other day for the last 4-5 months she thinks. She has been fine. Maybe she will be diagnosed with Alzheimer's. Outcome of the event anxious was unknown and for another event, it was not recovered.  Follow-up attempts completed. No further information expected.
Although I have a history of Meniere's disease, the previous 18 months prior to the second Pfizer dose I had not had many episodes of lightheadedness and dizziness. A few days after the second shot, I started having regularly lightheadedness and dizziness. It often happens in the afternoon after lunch, but I didn't have this problem previously.
This spontaneous report was received from a nurse, regarding to a 30 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 30-OCT-2017, the patient was accidentally vaccinated with GARDASIL 9 which had a lot # N010497 with expiration date on 15-JAN-2020 (dose, strength and route were not reported) for prophylaxis. However, at the reporting time no adverse events were reported.
Had a fever (about 100) and a rash all over her body.  She received Pneumococcal Conjugate, MMR and Varicella all on the same day.
feel like things were crawling through her body; stiffness in her right arm; This case was reported by a consumer via call center representative and described the occurrence of crawling sensation in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th November 2019, 1 days after receiving Shingrix, the patient experienced crawling sensation and limbs stiffness. On an unknown date, the outcome of the crawling sensation and limbs stiffness were unknown.   It was unknown if the reporter considered the crawling sensation and limbs stiffness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and it caused her to felt like things were crawling through her body.   The patient also reported that she experienced stiffness in her right arm although she got the vaccine in her left arm. The reporter did not consent to follow up. This case linked with US2020031415, reported by same reporter.