chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  Total 42 Dose were administered after 30-day Use By Date. Vaccine was administrated on 26-Jan-2023, 27-Jan-2023, 30-Jan2023, 31-Jan2023, 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. Vial size was reported as 0.4 ml per vial. Vial did not undergone any temperature excursions.  No treatment information was provided.  This case was reported for patient 39 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298: Patient 1 (Master Case)
We gave patient the vaccine at 12:37pm.  At 1:06pm, the mom came back to report that her daughter broke out to rash on back and right thigh along with itchy eyes. We gave patient 2 doses of Benadryl chewable 12.5mg tablets.  Then we monitored her every 5 minutes.  At 1:25pm, patient said she felt much better.  Her eyes felt less itchy and on less itchy on her body as well.  We asked her to sit another 15 minutes and she still said she felt so much better.  We advised the mom to watch patient when she gets home.  We gave 4 extra doses to have it on hand in case of rash.  We also recommended mom to talk to her primary doctor for second dose of covid if necessary.
Tiredness; Diarrhea; Sore throat; not feeling well; arm was sore and tender; Tender/ 2nd day they had very tender arms; sluggish; throat was a little hoarse; Short of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 16Aug2021 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "thyroid issues" (unspecified if ongoing), notes: Verbatim: thyroid issues; "Menopause" (unspecified if ongoing), notes: Verbatim: Menopause; "kidney issues" (unspecified if ongoing), notes: Verbatim: kidney issues; "chronic asthma" (unspecified if ongoing), notes: Verbatim: chronic asthma; "compromised immune system" (unspecified if ongoing), notes: States she has a very compromised immune system and has respiratory system issues; "respiratory system issues" (unspecified if ongoing), notes: States she has a very compromised immune system and has respiratory system issues. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "Tiredness"; DIARRHOEA (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "Diarrhea"; OROPHARYNGEAL PAIN (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "Sore throat"; MALAISE (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "not feeling well"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "arm was sore and tender"; TENDERNESS (non-serious) with onset Aug2021, outcome "unknown", described as "Tender/ 2nd day they had very tender arms"; SLUGGISHNESS (non-serious) with onset Aug2021, outcome "unknown", described as "sluggish"; DYSPHONIA (non-serious) with onset Aug2021, outcome "unknown", described as "throat was a little hoarse"; DYSPNOEA (non-serious) with onset Aug2021, outcome "unknown", described as "Short of breath".  Additional information: Patient states she has side effects on 20Aug2021 (reported as Friday last week), she had tiredness, diarrhea, sore throat and not feeling well and she rested for 2 days and felt fine. Patient states after she got her vaccine she sat for half an hour and was ok, her arms were sore and tender on the 2nd day they had very tender arms. She didn't have swollen lymph nodes and no cough. States she was short of breath but she has that regardless due to her asthma. States she had diarrhea and thought it was from hot chicken she ate but it wasn't. States she's been ok. Patient states they did get documents, information along with their card and is doesn't go into great detail and it's worrisome and it's not approved and doesn't consider how long after the 1st injection, it could be up to 7 days for side effect and it's still in clinical trials.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Intense reaction to the second COVID vaccine received) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Intense reaction to the second COVID vaccine received). At the time of the report, IMMUNISATION REACTION (Intense reaction to the second COVID vaccine received) outcome was unknown. No concomitant medication was reported. It was reported that patient was sensitive to lot many medication. No treatment medication was reported.
This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN620) via an unspecified route of administration in the right arm on 18Mar2021 at 17:30 (at the age 35-years-old) as a single dose for COVID-19 immunization. Medical history was reported as Ehlers Danlos Syndrome (Connective Tissue Disorder). The patient had no known allergies to medications, food, or other products. Concomitant medications were reported as probiotics (MANUFACTURER UNKNOWN), 5-HTP (MANUFACTURER UNKNOWN) and L-tryptophan (MANUFACTURER UNKNOWN). The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 25Mar2021, the patient experienced hive like itching up the right side of neck and at the injection site, it was reported that the injection site was firm to the touch and itchy. After 1 day, that was on 26Mar2021 the injection site was clearly red. and after 2 days, that was on 27Mar2021 the injection site had a red ring around it. After 3 days (10 days post injection), itchiness and redness subsided. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the reported events. The clinical outcome of the events hives like itching up the right side of neck, injection site firm to the touch and injection site had a red ring around it were resolved on an unknown date in Mar 2021 while, the clinical outcome for events itching at the injection site and injection site redness were resolved on 28Mar2021. No follow-up attempts are needed. No further information expected.
Redness, swelling, heat, and hardness about the size of a 50-cent piece at the injection site.
Patient described that during the administration of the flu vaccine, no pain was felt and there were no issues. The pneumonia vaccine was administered an inch from the flu vaccine in the same left arm. During administration of the pneumonia vaccine, pain was felt. The area was a bit red and pain persisted shortly after vaccination. Later the same day, the redness became more larger and the pain worsened to the point where it was difficult to lift the left arm. The patient also noted tingling down her arm towards her fingers as well as up her arm towards her neck the next day.
101 fever, UTI-like symptoms, ringing in ears, body aches, numb/tingling feet moving up legs, swelling near armpits, headache
Pt developed Type I Diabetes, dx'd on 12/31/99. Onset of symptoms was approx. 1 month following 2nd shot (given on 4/3/99). "My son developed Type I Diabetes in the few months following his 1st 2 shots in the Hep-B series. I have talked with several doctors, nurses and others, who believe this is directly related to his vaccinations. He did not have any flu or illness prior to getting his dx. He was healthy and active until his Diabetes started. I hope that you use this information and can prevent other children from having the same reaction. I could not get this form from my own pediatrician. I had to go to a doctor we don't know. (It was very difficult to finally get a form)."
Patient with history of asthma and Crohn's disease. She was brought to the ED by EMS on 12/31/22 with difficulty breathing and suspected COVID-19. She reported a recent COVID exposure, with symptom onset on 12/30 with headache, congestion, sore throat, cough, and shortness of breath. On 12/31 she felt too weak to ambulate on her own and felt too short of breath so called 911. A COVID PCR test performed in the ED returned positive. Patient was admitted 12/31/22 - 1/3/23; discharge diagnoses included acute hypoxemic respiratory failure secondary to asthma exacerbation with COVID-19 infection. During her admission, she was treated with supplemental oxygen and weaned to room air prior to discharge. Patient has received the primary COVID vaccine series and three boosters.
urticarial rash 5 minutes following Prevnar, Rotavirus, Pentacel
Swollen lymph nodes, welps extended from site of vaccine to elbow around arm.  Severe itching, oozing.  No scab formed to date.  Golf ball size knot under arm.
Facial Rash x 1hr pt denied shortness of breath or wheezing. The pt had the H1N1 vaccine 2-3 hrs before rash occurred.
feeling like they were hit with a ton of bricks; This spontaneous report was received from a medical assistant regarding a female patient of an unknown age. The patient's concurrent condition included papilloma viral infection. The medical history, concomitant medication and drug allergies was not reported. On 06-MAY-2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for papilloma viral infection via subcutaneous route (lot number: R027577, expiration date: 23-JUN-2021, dose: not reported). On an unknown date in May 2019 (reported as after receiving HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)), the patient experienced feeling like they were hit with a ton of bricks (feeling abnormal). The patient sought medical attention. The patient was not treated for the adverse event. The outcome of the event was unknown. The causality of the event with respect to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported. No product quality complaint (PQC) was involved.
I got vaccinated, a month later I got shingles/suspected vaccination failure; I got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got vaccinated, a month later I got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-JUN-2023 This case was reported by a patient via interactive digital media. The patient got vaccinated with shingles vaccine and a month later he/she got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
I had all the symptoms when I had COIVD, shortness of breath, severe back problems from neck to pelvic, and confusion.
p/vax 6/14/99 from 6/16 - 6/25 reported sudden onset & persistence of generalized myalgias, fever/chills, bilat earache & diffuse h/a;no visual, nasal or resp sx;c/o resolved x/ for feeling lethargic;no rash;
doses administered past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided
Red bump approx. 15x15mm noted on left lateral thigh after MMR injection. Dr notified. Tylenol and Benadryl given PO as ordered. Ice pack applied, observed patient for 30mins. Discharged in stable condition.
Just after having the shot 20 mins, lips started having tingling, 10 mins later face on the left side started been numb and it lasted for about an hour.
throat tightening, heaviness in chest, dry cough, sore left arm, sore throat
Had Shingles, was vaxxed against it/Suspected Vaccination Failure; Had shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had Shingles, was vaxxed against it/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter stated that shingles was something, people who got vaccinated against shingles and got shingles.  The reporter further stated that every person he/she knew who had shingles was vaccinated against it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
received Shingrix second dose 2 weeks apart form first dose; low grade fever for 24 hrs / following the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2021, the patient received the 1st dose of Shingrix. On 1st April 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever. On 1st April 2021, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix and experienced low grade fever for 24 Hours following the dose on 12th or 14th March 2021. The patient also received the 2nd dose of Shingrix 2 weeks apart from the first dose, which led to shortening of vaccination schedule. The reporter was not at work so did not have further details.  He also mentioned that, from personal experience after administering hundreds of these things (Shingrix) the stats were pretty close to what had been reported in all the literature as far as the frequency at which the side effects happened.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR074216:same reporter
I had a sharp pain going from my left arm into my heart. My jaw stiffened up. All signs indicated it was a heart attack. I went to the hospital and I was there for 2 days. I still have heart palpitations. They ran EKG and I was on a heart monitor. I had a follow up with a cardiologist and he did an echocardiogram and ran all kinds of blood panels. They also did an MRI. All tests came back negative, they said I was having some heart issues but they did not see any heart damage. I also had a PIA. It took me like 6 weeks to recover from that and to recover my strength. I have had terrible headaches ever since.
Initially Itching and rash developed on the ride home.  I took Benadryl. Later muscle aches and chills
This spontaneous report was received from a nurse referring to a currently 78 year old female patient with type 2 diabetes mellitus, hypertension, hyperlipidaemia, and allergy to morphine. On an unknown date, the patient was vaccinated with PNEUMOVAX 23) for prophylaxis (lot # N010109, expiry date: 20-NOV-2018). Concomitant therapies included metformin, Lisinopril, glipizide and aspirin (manufacturer unknown). On an unknown date, the patient sought medical attention by office visit since she experienced redness, swelling, heat, and red blotches. Therapy for the adverse events was administered (details unspecified). The nurse verified the vaccine was stored properly. No laboratory diagnostics were performed. The outcome of swelling, rash macular, feeling hot and erythema was reported as recovering. The causality assessment between suspect therapy and the aforementioned adverse events was unknown. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA010632.
Client noted increased soreness on 10/07/18. She then noted on Monday 10/08/18 that it was more sore with redness noted about 1-2 inches below the site of vaccine administration. She also felt it was slightly more swollen.
Pt called Health Ctr to report that after receiving menomune injection on 10/04/01 she developed fever of 99-402.0. She was tired with dry cough . On 10/08/01 fever was down. She had a non productive cough then fever back up to 101. When saw Dr at the Family Practice who provided RX and told her it was an allergic reaction to Menomune injection.
Beginning around 4/6, an itchy, painful rash developed on my scalp, spreading and intensifying over the next several days and appearing on my neck on 4/9.  Diagnosed as shingles by APN on 4/13.   Antiviral medication prescribed on 4/13.
1 Day following vaccine administration, pt reports itchy, red area around site. 3 days after injection, in clinic with itchy, red area (1 inch diameter), sl warm to touch.
This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a 65-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included PNEUMOVAX with an associated reaction of pain in extremity (received dose on an unknown date). On 17th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm and fever. On an unknown date, the outcome of the pain in arm and fever were unknown. It was unknown if the reporter considered the pain in arm and fever to be related to SHINGRIX. Additional details were reported as follows: Age at vaccination was not reported. The patient received SHINGRIX dose in the left deltoid and his arm really hurts. The patient had slight fever but he had not checked till the reporting time. The reporter declined consent for follow up.
This 65 year old white  male received the Covid shot on 2/27 /21    and went to the ED on  4/1/21     and was admitted  on 4/2/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified