chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site big; Injection site hot; Injection site red; Injection site sore; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site big), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PAIN (Injection site sore) and VACCINATION SITE REACTION (COVID arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Injection site big), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PAIN (Injection site sore) and VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE SWELLING (Injection site big), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PAIN (Injection site sore) and VACCINATION SITE REACTION (COVID arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-024106, US-MODERNATX, INC.-MOD-2021-024767 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-024106:MOD21-023085 US-MODERNATX, INC.-MOD-2021-024767:
November 26th with shortness of breath.  Was COVID positive.  Her vital signs were significant for blood pressure 153/96, heart rate of 76, temperature of 36.7°, respiratory rate of 24, oxygen saturation of 74% on room air required 4 L of oxygen to maintain saturation above 90%.
Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbeat, nausea, numbness in lips, sinuses pushing on roof of mouth, difficulty swallowing for about 15 minutes about a half hour after taking vaccine. Then about 6 hours same symptoms but without rapid heartbeat, swallowing issues were worse, took Benadryl, after about an hour symptoms lessened and I fell asleep. Next morning roughly 13 hours later would randomly have tightness in face and under chin. Lasted off and on all day.
12/7/16-Received MMR #1 at 5 year old check up. C/O stomach pain in the car on the way to the office, but normal exam and would not say if stomach still hurt. 1/20/17-Diagnosed with strep throat. Put on amoxicillin. 1/23/17-rash and vomiting for 1-2 days, headache, stomach ache, sore throat, diarrhea. Diagnosed with HSP. - Purpura on legs, buttock, lower back. 1/27/17-changed to KEFLEX to finish strep treatment. 1/20/17-(+) rapid strep test. 1/23/17-UA - 50 ketones, trace protein.
ACUTE RESPIRATORY FAILURE 2/18/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
I have been having terrible dry mouth and cannot fix it, I've tried every over the counter product and even drink triple what I was.
Rash to the top of bilateral thighs, waist and breast bilaterallys, Palms of bilateral hands bright red and tongue felt a little thich
Right arm site of injection with redness, swelling, tenderness. Chest with blotchy, itchy, red rash.
get sick again; Arm was red & bruised; Arm was red & bruised; it's still sore today; left arm swole; This is a spontaneous report from a contactable consumer (patient). A 67-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0172), via an unspecified route of administration, administered in Arm Left on 07May2021 11:00 (at unknown age) as single dose for COVID-19 immunization. Medical history included Breast cancer from Mar2020 and ongoing, COVID-19 Dec2020. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) from 19Apr2021; antibiotics from 19Apr2021, Steroid cream From 19Apr2021 For Pain. The Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0169) at 16Apr2021 11:00 AM at left arm as single dose for COVID-19 immunization and had Fever, Chills, No appetite, Arm was sore. The patient had Left arm swole (Disability, Medically Significant) on 08May2021. Seriousness Criteria: Persistent/significant. Patient called Pfizer because it was time for second shot. Was hesitant because patient just barely got over first shot. Patient's oncologist said it was ok so took second shot. Got sick all over again. Arm was red bruised like before used rest of steroid cream. It's Still sore today but much improvement. The patient underwent lab tests and procedures which included Bone scan 2021: Unknown results, CT scan 2021: Unknown results, X-ray 2021: Unknown results. COVID-19 Dec2020: Positive. Emergency room visit for left arm swole. Treatment received for left arm swole, Arm was red bruised like. The outcome of the event left arm swole was recovered on 22May2021, for other events was unknown.
shingles; This is a spontaneous report from a contactable consumer (patient) Pfizer-sponsored program. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The received her first dose on 01Mar2021 and she is scheduled to get the second dose on 29Mar2021. The patient is concerned because she had shingles in Mar2021 after the first dose and has been taking steroids. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-JUN-2016 the patient was vaccinated with an improperly stored dose M-M-R II 0.5 ml (lot # L003856, expiration date 02-FEB-2017, therapy type recombinant human albumin (rHA), dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion eight times. The total cumulative excursion time of the first time was 204 hours with the lowest recorded temperature of 33 Fahrenheit degree; the second time was 444 hours with the lowest recorded temperature of 34 Fahrenheit degree; the third time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree; the fourth time was 24 hours with the lowest recorded temperature of 21.7 Fahrenheit degree; the fifth time was 1732 hours with the lowest recorded temperature of 29 Fahrenheit degree; the sixth time was 24 hours with the lowest recorded temperature of 31 Fahrenheit degree; the seventh time was 96 hours with the highest recorded temperature of 48 Fahrenheit degree; the eighth time was 304 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine were refrigerator (R)/freezer (F). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Intense pain and cramping in lower abdomen/pelvic area with fever 100.7.  I took Tylenol the first day then switched to ibuprofen (better results).  Never any body aches, nausea , or diarrhea.   Nurse thought a type of colitis.  I have never had colitis.  Today fever is gone but the pelvic area is very tender to touch.  Cramps are very mild and now infrequent.  My stools and urine were normal.  Just weak from fever.
Swollen tongue, which continued to swell. Pt diagnosed with Angio Edema given prednisone, benedryl, and Pepcid. Pt took dose of benedryl prior to going to ER following ap with PCP.
No adverse event; HCP stated patients was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated patients was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     Patient had no known relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 01-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 01-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated patients was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated patients was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.) 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 (HCP stated patients was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.).    Concomitant products were not reported.  The health care professional stated that, the patient was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture. Patient did not reported any adverse event.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706683 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706683:Same reporter
Narrative: COVID infection following COVID vaccine series 05/07 Janssen, dose #1 09/21 COVID swab, result: detected 09/20 pt cc: chills,  cough, fatigue, myalgias, sore throat exposure: unknown
Episode of exertional substernal chest pain radiating to jaw and left arm accompanied by tachycardia to 150s, all resolving with rest and returning with exertion lasting for 20 minutes.
TOOK VAXCHORA FIVE DAYS BEFORE LEAVING TO ENDEMIC AREA; This spontaneous case report (PVX2019-1649) was received from a consumer on 26-Jun-2019. It describes a 41-year-old female consumer who "took Vaxchora five days before leaving to endemic area". She was receiving Vaxchora (lot number: 7000014) for travelling to endemic area.  Case report: The consumer took Vaxchora on 10-Jun-2019 and left for the endemic area on 15-Jun-2019.  Action taken with Vaxchora was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vaxchora five days before leaving to endemic area" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vaxchora five days before leaving to endemic area" was considered as not applicable.
Arm is still sore after 3 weeks. Patient states "it hurts to use her arm" and "the pain is comparable to a toothache". Arm is not swollen or red.
Headache; Low grade fever; Stayed in bed all day; Was very fatigued; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Stayed in bed all day), FATIGUE (Was very fatigued), HEADACHE (Headache) and PYREXIA (Low grade fever) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced SOMNOLENCE (Stayed in bed all day), FATIGUE (Was very fatigued) and PYREXIA (Low grade fever). On 17-May-2021, the patient experienced HEADACHE (Headache). The patient was treated with IBUPROFEN for Fever and Fatigue, at an unspecified dose and frequency and GATIFLOXACIN (GATOR) at an unspecified dose and frequency. On 16-May-2021, SOMNOLENCE (Stayed in bed all day) and PYREXIA (Low grade fever) had resolved. At the time of the report, FATIGUE (Was very fatigued) had not resolved and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. Treatment included use of Ginger ale and Gator aide.
2-3 inches length & width redness & swelling and pimply rash at injection site with little larger than pea sized knot that improved over a 4 day period. No fever pt iced area as directed for comfort.
pt developed raised red patch, warm to the touch since the evening of 8/20/19. Instructed potential allergic reaction and to administer ice patch and Ibuprofen
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. In approximately August 2015 (reported as since 06-AUG-2015), the patients has been administered doses of improperly stored GARDASIL 9 lot # K026247, expiration date reported as 29-JAN-2017 (dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient presented to the ER with mother for evaluation of possible seizure. Patient had been sleeping on mother's lap for about an hour when the child went stiff and then began to have rigid uncontrolled movements of extremities, eyes rolled back in his head, and would not respond to verbal commands. Mother stated this lasted approximately 3-4 minutes. Patient was fatigued and mildly confused after the episode. Denies any incontinence, nausea, dental/oral trauma during the incident. Mother informed the ER that child had received immunizations at office 3/27/18 and denies any history of seizures with prior immunizations. At the time of the ER visit patient was alert and per mother is at baseline. Mother also denies any recent illness, recent travel, fever, or other ill family members.
Pt only relieved half a dose. Diluent used was Sterile water and not the supplied Diluent. Parents notified Jan 15, 2020 when error was discovered, and are returning to clinic for correct dose on Jan 17, 2020.
pain; Fever; This spontaneous case was reported by a physician and describes the occurrence of PAIN (pain) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Concentration impaired.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (pain) and PYREXIA (Fever). At the time of the report, PAIN (pain) and PYREXIA (Fever) 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.   No concomitant medication was reported.   The caller knows a lady who was the veterans' care coordinator in hospice. In November 2020 the patient had covid for about a couple of months and now she has concentration problems. In early 2021, 4 months after the patient was sick with covid, she took the two part Moderna covid vaccine. After the first shot she had a reaction to it- a fever and pain. The patient had a similar reaction to the second shot but not the same. The patient is over it now and fine.   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.
Pt. described feeling a numbness, tingling, and occasional pain in the left arm - beginning a few weeks after flu shot was given.
Had soreness the next day deep in shoulder. That night i woke up at 3AM with a feeling of a dead arm in my shoulder. I had to leave work the following day because it felt like a constant dead arm. It gradually got better of the next week but I lost motion and its alot weaker than it use to be. Please have somebody contact me on this. I will have to go to the doctor before long and id like to talk to you guys first.
1 of 2 nurse employees vaxed from the same vial in mid November who exp nausea, h/a & inj site rxn w/in 24hrs;inj site rxn consisted of erythema & swelling: covered entire deltoid muscle;rx APAP/warm compresses;w/in 72hrs rxn had resolved;
This spontaneous report was received from a physician and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, approximately in December 2017, about two and a half weeks ago, the patient was vaccinated with ZOSTAVAX in the left upper arm (dose, frequency, route of administration, lot# and expiration date were not reported). The ZOSTAVAX was reconstituted with sterile diluent (manufacturer unknown). On an unknown date, in January 2018, about 5 days ago, the patient experienced a burning sensation in his left upper thigh. On 09-JAN-2018 the patient was seen by the physician who observed a vesicular rash on the patient's upper left thigh.  On 09-JAN-2018, Varicella-zoster virus (VZV) packet was offered to the patient and the physician stated it was "not needed". On 09-JAN-2018, in the morning, the patient had performed a rapid culture for varicella, the result was not provided. The outcome of burning sensation and rash vesicular was unknown. The relatedness between burning sensation and vesicular rash and ZOSTAVAX was not reported.
6 yo patient received a Fluzone HD, no ad verse event; 6 yo patient received a Fluzone HD, no ad verse event; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a 6 years old female patient who received 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Lot no: lot UJ274AB  and Expiry date: 26-May-2020) via unknown route on 31-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration and Overdose. It was reported that INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]. It was reported that flozaone high dose administered to child patient of 6year old with no ae.   At the time of reporting, the patient had no adverse 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 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.
Patient expired 08/29/2021. Vaccinated with Johnson and Johnson in "spring" per medical record
When I woke up on March 31, I discovered I had lost total hearing in my right ear.  I went immediately to see my doctor.  There was no wax buildup, and the outer ear was clear.  I went the same day to see my Audiologist (since I wear hearing aids), and upon testing discovered there was a total loss of hearing in the right ear.  The left ear was the same as test results in October, 2020.  On April 2 I went to see dr.  He determined that I had suffered SSNHL, Sudden Sensory Neural Hearing Loss.  Dr. prescribed Prednisone, 10 mg tablets: 6 at one time for 4 days, then 4 at one time for 4 days, then 2 tablets for 4 days, then 1, then 1/2.   As of this date, April 6 there is yet no improvement
Pt had a syncopal event w/ associated flushing/sweating Vitals: 16:02 113/60, 76, 16, 98% -- > 16:12 121/72, 91, 14, 99%, 96.0 Pt stable and released from the vaccination site.
No additional AE reported; inadvertently administered to an 11-year old patient.; This spontaneous report was received from a nurse referring to an 11-year-old patient of unspecified gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.  On 19-JUN-2023, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliters (ml) as prophylaxis (route of administration and anatomical site of vaccination were not reported; lot number W028534 has been verified to be valid, expiration date reported and established as 10-MAY-2025) (product administered to patient of inappropriate age). No additional adverse event was reported (no adverse event).
Dose 1: Soreness at injection site. Dose 2: Soreness at injection site, - 12 hours: Soreness at injection site, achiness in lower back, shoulders and butt - 24 hours: Soreness at injection site, achiness in lower back, shoulders and butt, fever of 100.4 degrees F - 32 hours: Soreness at injection site, achiness in lower back, shoulders and butt, chills lasting about 1.5 hours with shaking
pain on site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain on site of injection) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain on site of injection). At the time of the report, VACCINATION SITE PAIN (pain on site of injection) had resolved.            No concomitant medication/lab results were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-062179 (E2B Linked Report). This case was linked to MOD-2021-062348 (Patient Link).
tingling & painful sensation Narrative: As reported by employee on 6/23/2021: ******************************************** "Tingling/painful sensation in left hand (index and middle fingers) and left foot- administration side (left arm both doses)."