chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Urticarial lesions; pruritic reticular nonpalpable, nonblanching lesions over his thighs and ankles; This case was reported by a other health professional via call center representative and described the occurrence of urticaria in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 54H72, expiry date 1st October 2021) for prophylaxis.   On 5th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th July 2019, 1 days after receiving Shingrix, the patient experienced urticaria and itchy rash. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the urticaria and itchy rash were recovering/resolving.   It was unknown if the reporter considered the urticaria and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right deltoid. The reporter was the office manager and provided the initial information. On 6th July 2019, in the morning, the patient experienced urticarial lesions over the upper extremities, neck and arms and at the same time pruritic reticular nonpalpable, nonblanching lesions over his thighs and ankles. The patient went to emergency room and was seen by the physician on the date of reporting. The physician provided little more information
first dose 26Mar2021, has not received dose two.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 26th March 2021).   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: 2-Jun-2022 Reporter's Comments: Pharmacist reported that the patient received the first dose of Shingrix and had not received dose two. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Information has been received from a licensed practical nurse concerning a 17 year old female patient who in November 2008 ("this week") was vaccinated with PNEUMOVAX (lot # not provided).  In November 2008, the next day post vaccination the patient came back to the office with a swollen arm that she could not move.  Additional information has been requested.
No adverse event; Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023) 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Feb-2023, 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 17-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023).    It was unknown patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.    Vaccines were thawed on 13-JAN-2023 and 4 doses were administered on 17-FEB-2023. Bivalent vaccine administered and no symptoms have been reported at that time. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712275, US-MODERNATX, INC.-MOD-2023-712328, US-MODERNATX, INC.-MOD-2023-712309 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712275:Patient 1 of 4 US-MODERNATX, INC.-MOD-2023-712328:Patient 3 of 4 US-MODERNATX, INC.-MOD-2023-712309:Patient 2 of 4
On 11/23/21 Patient experienced a reaction to the J & J covid-19 vaccine.  At approximately 5 to 10 min after receiving vaccine complained of ringing in his ears, dizziness.  Pt appeared diaphoretic and had a thready pulse.  No complaints of inability breathing and when prompted to breath more deeply was able to do so.  Pt was instructed to lie on floor with feet elevated by the seat of the chair.  At 6:06 pm a blood pressure was taken resulting in 145/84 with a pulse of 58.  pt remained on floor until  he felt he could sit up and was instructed to sit up slowly.  He returned to sitting in his chair and BP was taken again with a result of 127/77 with a pulse of 58.  Pt felt he was stable enough to go home and was instructed to seek further medical attention if symptoms worsened.  Pt stated  he would do that.  He was also given the phone number of the medical exchange by NP who assisted with rendering aid. 11/24/21 - A follow up call was made to patient.  pt stated he was doing better than yesterday.  When he returned home on 11/23/21 he ate some food and felt better.  He states he slept a lot and today is experiencing flu like symptoms but feeling overall feeling better than yesterday.
1st dose 8-2-13. 2nd - 4-26-13. 3rd - 8-2-13. Test for Guillain Barre and Bell's Palsy. 8-28-13 - HA, dizzy, nausea, tactile fever, fell to floor shaking, clenched fist, urinary incontinence and drooling - continued well into October. Child went on to homebound in school. Mother has been in contact with Dr. in another state about associated sx's to HPV vaccine.
Rash at site of injection - spreading down leg - hot and itchy. Recommended ice to leg and BENADRYL for itchiness.
4" raise red hot welt below injection site, sore arm & shoulder no treatment, 10/17 bad muscle shoulder/neck pain left side only, muscle relaxant given heat compress no relief, 10/20 pain med given no relief, Ibuprofen & aspirin no relief, found small stinger in neck area removed, started cool compress with Benadryl, skin started burning and felt like small hair cactus thorns stuck in upper left side front below clavicle, intensified, 10/31 raw feel on chest to sternum & neck/shoulder continued pain; Gabapentin given, 2nd Dr and spine clinic diagnosed Shingles.
Swelling on chest above/across collar bone, extended towards right arm. Movement from shoulder to elbow was inhibited. Patient could only move right forearm.
fainting, with loss of conciousness, chills, sweats, fever, vomiting, diarrhea about 12 hours after injection. Lasted several hours. Probably should have gone to the hospital, but every time I stood up I would faint.
A report has been received from a Health Professional concerning a 1 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on 06-Oct-2014. HCP stated that 20 Month Old Patient Inadvertently Received FLUMIST. The outcome of the event of 20 month old patient inadvertently received FLUMIST is unknown. The report was considered to be non-serious.
itching; slight rash; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching) and RASH (slight rash) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067521A, 0461321 and 038AZ1A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Shingles (about 2 months ago) in 2022 and Shingles (about 2 months ago) in 2022. Past adverse reactions to the above products included No adverse event with Shingles and Shingles. Concurrent medical conditions included Sinusitis, Acid reflux (esophageal) and Seasonal allergy.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2022, the patient experienced PRURITUS (itching) and RASH (slight rash). At the time of the report, PRURITUS (itching) and RASH (slight rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Patient experienced itching and a slight rash about 2 months ago. No treatment information was reported.   This case was linked to MOD-2023-706655 (Patient Link).
Pt received Pfizer vaccination series at local pharmacy. Was hospitalized with COVID-19 diagnosis 9-20-21. Passed away 9-24-21.
pulse rate was 114; pulse rate was 118; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (pulse rate was 118) and HEART RATE INCREASED (pulse rate was 114) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thrombocytopenia.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced HEART RATE INCREASED (pulse rate was 118). On 23-Mar-2021, the patient experienced HEART RATE INCREASED (pulse rate was 114). At the time of the report, HEART RATE INCREASED (pulse rate was 118) and HEART RATE INCREASED (pulse rate was 114) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Heart rate: 118 (High) pulse rate was 118. On 23-Mar-2021, Heart rate: 114 (High) pulse rate was 114.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided by the reporter.
Was paralyzed; This serious case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a patient 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 paralysis (Verbatim: Was paralyzed) (serious criteria GSK medically significant). The outcome of the paralysis was not reported.   It was unknown if the reporter considered the paralysis to be related to Shingles vaccine.     It was unknown if the company considered the paralysis to be related to Shingles vaccine.   Additional Information: GSK receipt date:10-April-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she got vaccine and was paralyzed. The follow-up could not be possible as no contact details were available.
Headache mild headache; GI irritability; sore arm Narrative:  took Tylenol 1000mg x1 dose
Episodic lightheadedness, difficulty moving, and brain fog; diagnostic workup overall consistent with new-onset dysautonomia
Nurse misunderstood about the third dose of vaccine and was giving patients that came in the third dose of Moderna. After explaining the guide lines for the third dose of Moderna no more was given. It was explained to her that Pfizer was the only vaccine at this time that was cleared to give a booster dose and that Moderna third dose was only for immunocompromised.
OP Visit 3/10/ Urgent Care Source Organization Encounter Summary      Reason Comments Cough NP cough today. Post nasal drainage causing a sore throat in the AM Encounter Details  Date Type Department Care Team Description 03/10/2021 Hospital Encounter Urgent Care   1 Sinusitis, unspecified chronicity, unspecified location (Primary Dx);  Acute bronchitis, unspecified organism  OP Visit 3/10/20 Source Organization Encounter Summary     75 y.o. Female; Encounter Summary, generated on Mar. 23, 2021March 23, 2021  Encounter Details  Date Type Department Care Team Description 03/10/2021 Hospital Encounter  Urgent Care     Cough (Primary Dx);  Chest congestion;  Wheezing
ED to Hosp-Admission Current  5/8/2021 - present (12 days)   Treatment team Sepsis due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (CMS/HCC) Principal problem    Date: 5/8/2021 PCP:  DC Hospitalist: MD     Assessments     Chief Complaint Patient presents with o Dizziness o Cough     Principal Problem:   Acute respiratory failure (CMS/HCC) Active Problems:   COVID-19       Plan     #Acute hypoxic respiratory failure requiring 50 L of oxygen support to maintain his oxygen saturations, patient came in with a saturations of 58% on room air.  This is secondary to Covid pneumonia             -Patient will be started on convalescent plasma, remdesivir and dexamethasone.             -Reviewed entire plan of care with with him his interpreter at bedside and patient gave consent to receive convalescent plasma.             -We will obtain acute inflammatory markers.             -I will also obtain a CT scan of chest to rule out pulmonary embolism given severe hypoxia.             -Anticipate hospitalization for 5 days given severe acute hypoxic respiratory failure requiring high flow oxygen.   #Acute anion gap metabolic acidosis secondary to lactic acidosis secondary to Covid pneumonia resulting in severe hypoxic respiratory failure.             -Check procalcitonin to see if patient is developing secondary bacterial infection.             -If procalcitonin is elevated will start patient on antibiotics as well.             -Use guaifenesin for mucolytic purposes.             -Recheck lactic acid with the current management.   #Mild hyponatremia:             -Secondary to pulmonary infection with a Covid pneumonia.             -No acute intervention needed, will continue to monitor.   #GERD:             -Continue PPI.   Critical care time today is 38 minutes.     Patient was educated regarding prone positioning and will prescribe a cough medication gave given intractable cough as well.   # VTE Prophylaxis: heparin   Full Code   Diet:  Active Orders No diet order for this patient
sudden onset of spinning vertigo accompanied by nausea; no other sx; vertigo lasted 5 minutes; pt had to sit down p/episode pt returned to nl; pt called MD who had treated labyrinthitis & was given Meclazine for dizziness for labyrinthitis;
6 d after DTaP given, patient recovered 5 am large induration with localized redness @ injection site.
Patient recieved 2nd Moderna Dose on 2/4/20221. No symptoms other than sore arm until 2/10/2021. On 2/10/21, patient developed what was described as "covid toes on both feet." Patient's great toe, 2nd, and 3rd toe is purple, the 4th and 5th toe is red and swollen. Patient is awaiting a call from PCP for evaluation. No other symptoms noted.
shot given on 10/13/21  Next day I had the worst headache ever in my life. Different then Migraine. This type of headache came more often until my Physical in Jan. 2022 I told the Dr that I get theses headaches. Time passed and headaches returned more and more frequent.  Had tooth removed. Still headaches. Had a pacemaker put in to help my slow heart rate 6/22 headaches continue to get worse and more frequent. Saw Neurologist Sept 23/22 Dr. for these headaches.
16 days p/vax pt exp numbness in feet & hands & severe back pain;adm to hosp 25NOV96 & dx w/GBS;discharged to rehab hosp 2DEC96;
Painful rash with fever. Treatment: Cefuroxime, Acyclovir, Benadryl, Motrin, Clindamycin.  9/4/07 Received hospital medical records which reveal patient experienced 10 day history of worsening periorbital cellulitis.  Red raised lesion on left upper eyelid had been scratched, crusted & bleeding.  Then spread to itchy, painful lesions around upper & lower eyelid, below nose & onto left cheek w/fever  3 days.  Admitted 8/23-8/25/07.  Tx w/antibiotics & antivirals.  ID & Opthmol consults. FINAL DX: Periorbital cellulits, probable herpes zoster.
8/30/19 presented with 6x6 reddened, itchy area with 15mm indurated center that is sore. Ice to area and secured with coban, Benadryl 25mg given. Afebrile 98.1.  To return next week to see NP. Employee returned the same day for NP to evaluate site and placed on antibiotics since float employee lives hours away and not sure she will be at work next week.
Patient received Moderna  Covid 19 Vaccine 0.5mg IM on 3/19/2021. But per documentation in  EHRS the patient already  received Covid 19 Pfizer on 1/29/21 as 1st dose and  another Covid 19 Pfizer  on 2/19/21 as 2nd dose.  Patient is stable, asymptomatic and has no complains   from 3/19 up to the present
swelling in her right leg of approximately 1 inch; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (swelling in her right leg of approximately 1 inch) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 012M20A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (sulfa allergy) and Fruit allergy (kiwi allergy). Concomitant products included METFORMIN for Diabetes.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PERIPHERAL SWELLING (swelling in her right leg of approximately 1 inch). The patient was treated with FUROSEMIDE (LASIX [FUROSEMIDE]) at a dose of 3 days and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling in her right leg of approximately 1 inch) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: Everything seemed to be normal.. On an unknown date, Ultrasound Doppler: Everything seemed to be normal..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Two or three weeks after the 1st booster, the patient experienced swelling in right leg of approximately 1 inch, and it was a long term issue that was still ongoing. It did not affected the patient's mobility and there was not pain, it seemed a healthy leg except for swelling. The patient visited an orthopedist and another doctors, and informed had an MRI and a duplex study, and result showed everything to be normal. The physician could not determine a cause for this symptom, but thought it might be due to blood clots, an issue with the patient back or knee. Patient symptoms were ot worse, improve a little but not significantly, but it did not bother.  The patient had treatment with physical therapy and compression sucks for 6 months.  The patient never had tested or diagnosis with COVID. The patient not had medical condition as both acute and chronic illnesses at the time of vaccination. The patient did not had experienced a similar event in the past. The patient had not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.
After receiving varicella vac & hepatitis A vaccine left building & passed out in parking lot hit head on car.
Dizziness at time of shot. Fatigue, Pain at injection site, swelling, fever, chills, headache, mild nausea. No treatment, was told to avoid pain medication. Symptoms worsened the day after the vaccine, but are lessening today, though some symptoms are still present.
Felt dizzy; Increased Heart Rate; Felt dizzy; Increased Heart Rate; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of DIZZINESS (Felt dizzy), the first episode of TACHYCARDIA (Increased Heart Rate), the second episode of DIZZINESS (Felt dizzy) and the second episode of TACHYCARDIA (Increased Heart Rate) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Blood disorder NOS (Blood Thinner).    On 12-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 the first episode of DIZZINESS (Felt dizzy) and the first episode of TACHYCARDIA (Increased Heart Rate). On 16-Feb-2021, the patient experienced the second episode of DIZZINESS (Felt dizzy) and the second episode of TACHYCARDIA (Increased Heart Rate). At the time of the report, last episode of DIZZINESS (Felt dizzy) and the last episode of TACHYCARDIA (Increased Heart Rate) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included unspecified blood pressure medication and blood thinners.  No treatment medications provided by the reporter.
1. First acute left arm pit pain. Started  pretty much the next day of vaccination 2. Pain extended to left under arm/upper arm and part chest. I thought i was having a heart attack. Went to my primary care. He did all test and cleared me for heart. 3. We concluded that it could be a Covid arm or a muscle pull 4. Pain continued and became unbearable. then break into first light rash on 12/10/21 5. The rash spread left chest, left arm/armpit and back. All on left side.  6. Re-visited primary care on 12/13/21 & was diagnosed Shingles. 7. Prescribed Acyclovir ointment, Valacyclovir tabs 1 gm 3 times for 7 days and Tramadol for pain 8. Then continued Zovirax 800mg 5 times a day for a week. 9. The rash subsided by 12/31/21 10. Suffering from acute Postherpetic Neuralgia now.
On the second day after the first dose of the vaccine, red spots appeared on the skin on the back of the breast. Over time increased in size.
This spontaneous report as received from a nurse refers to a 4 month old patient of an unknown gender. On 16-FEB-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Rash, swelling at injection site , swelling in arm pit , swelling in right ear and throat. Tylenol and ice
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Between 16-OCT-2014 and 06-NOV-2014 the patients were vaccinated with an improperly stored VAQTA (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.