chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very red; slightly raised; hot to the touch; Covid arm; large rash; arm itching/itching; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Very red), INJECTION SITE MASS (slightly raised), FEELING HOT (hot to the touch), DERMATITIS ALLERGIC (Covid arm) and RASH (large rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE PRURITUS (arm itching/itching). On 28-Feb-2021, the patient experienced ERYTHEMA (Very red), INJECTION SITE MASS (slightly raised), FEELING HOT (hot to the touch), DERMATITIS ALLERGIC (Covid arm) and RASH (large rash). At the time of the report, ERYTHEMA (Very red), INJECTION SITE MASS (slightly raised), FEELING HOT (hot to the touch), DERMATITIS ALLERGIC (Covid arm), RASH (large rash) and INJECTION SITE PRURITUS (arm itching/itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.   Reporter did not allow further contact
Information has been received from a registered nurse referring to 18 years old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions, and allergies were not reported. On 19-FEB-2017, the patient was vaccinated with the first dose of GARDASIL intramuscularly for prophylaxis. (Dosage schedule, strength, lot number, and expiration date were not reported). On 11-AUG-2017 and 13-NOV-2017, the patient was vaccinated with the second and third dose of GARDASIL 9 respectively, intramuscularly in the left deltoid, for prophylaxis (Lot numbers: N004799 and N017833 expiration dates: 15-NOV-2019 and 16-NOV-2019; however the dosage schedule and strength were not reported). By the time of the report, the patient did not experience any adverse events.
pt recv vax 20APR98 & devel rash to arms, abd, back, neck & face beginning 20APR evening raised/red itchy rash;applying DPH cream;
a little ache in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a little ache in the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (a little ache in the injection site). On 07-Jan-2021, VACCINATION SITE PAIN (a little ache in the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Information has been received from a medical assistant via facility referring to a 13 year old female patient. The patient had no medical history, concurrent condition and past drug history. On 14-MAR-2016 the patient was vaccinated with an adult dose of VAQTA (1 ml, once, lot # L017757, expiry date: 08-APR-2018, route unknown) (overdose). There was no concomitant therapy reported. There was no relevant lab work. Additional information has been requested.
Headache, slight general soreness, slight fatigue, mild fever, painful bumps and lesions on head and face
Two days following dose one of Moderna vaccine, patient loss consciousness due to buildup of CO2. Upon arrival at ED, it was discovered that patient was taking antibiotics for UTI, and was nonadherent with antibiotic regimen or breathing treatment for underlying COPD. Patient was intubated but has since recovered.
This spontaneous report as received from a consumer of unknown age and gender reporting on her/himself. Medical history and concurrent conditions were not provided. On 19-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (1 injection), (dose, route, lot number and expiry date were not reported). There was no concomitant medication provided. The consumer stated that "now" (in May 2015) was experiencing a rash at the injection site (injection site rash), then the rash was spreading from the injection site to the "back" of the body (rash) and was "like a prickly heat rash" (miliaria). It was also reported having issues sleeping at night (sleep disorder) due to the discomfort. The consumer sought unspecified medical attention but the provider was not available until 27-MAY-2015 reported as "tomorrow". The outcome of discomfort, rash, miliaria, sleep disorder and injection site rash was unknown at the time of the report. The relatedness between the events and ZOSTAVAX was not provided. Additional information is not expected because no reporter details were provided.
The site was tender; She developed a nodule at the vaccination site. The nodule continually got "bigger and worse"; This spontaneous report was received from a medical assistant, via company representative, referring to a 42-year-old female patient. Information about the patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions, or allergies were unknown by the reporter.  On 25-MAY-2021, the patient received her first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) in the left arm (administered dose, vaccination scheme, route of administration, lot number and expiration date were unknown by the reporter) as prophylaxis (reported as "vaccination"). Subsequently, on an unknown date in 2021, the patient developed a nodule at the vaccination site. The nodule continually got "bigger and worse". On 29-JUN-2021, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) in her right arm (administered dose, vaccination scheme, route of administration, lot number and expiration date were unknown by the reporter) as prophylaxis. There wasn't a reaction to that injection site.   On 24-AUG-2021, the patient went to the physician's office, and the site was tender (vaccination site pain). The doctor prescribed sulfamethoxazole, trimethoprim (BACTRIM) as treatment. The outcome of the events was not reported.  The reporter did not provide a causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), vaccination site nodule and vaccination site pain.
patient says she started having a headache the day of the first vaccine, and the headache has still not gone away. Says she received the vaccine in her left arm, and pain in her left arm has also not resolved.
dizziness, heaviness behind the eyes. symptoms resolved Narrative:  1513: BP 156/89 HR 63. 1527: 156/91 HR 64. Pt c/o of dizziness and heaviness behind eyes. Pt reports irritated before arriving over a situation. Still irritated. Improved-stated symptoms resolved-BP likely r/t irritation over situation at home.
This spontaneous report as received from a Nurse Practitioner refers to an unknown number of patients were inadvertently vaccinated with GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB had been improperly stored. No further information was provided. Additional information was received from Nurse practitioner, who reported that GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB went through multiple unsupported temperature excursions from 10/09/2013 to 10/17/2013. The Nurse practitioner reported GARDASIL (Lot# J003727, expiration date 11/07/2015) was administered to 2 unspecified patients on 10/10/13 (MARRS# 1310USA015162), 2 unspecified patients on 10/12/13 (MARRS # 1401USA000269), 1 unspecified patient on 10/14/13 (MARRS# 1410USA000273), 1 unspecified patient on 10/17/13 (MARRS#1401USA000271) and 1 unspecified patient on 10/19/13 (MARRS# 1401USA000272). GARDASIL (Lot# J008423, expiration date 01/21/2016) was administered to 3 unspecified patients on 10/25/13 (MARRS# 1401USA000268) and 1 unspecified patient on 10/26/13 (MARRS# 1401USA00027). VAQTA (Lot# J008090, expiration date 08/23/2015) was administered to 1 unspecified patient on 10/17/2013 and 1 unspecified patient on 0/25/2013 (MARRS# 1401USA000278). RECOMBIVAX (Lot# H012250, expiration date 02/06/2015) was administered to 1 unspecified patient on 10/26/2013 (MARRS# 1401USA000277). PEDVAXHIB (Lot# J005670, expiration 12/17/2015) was administered to 1 unspecified patient on 10/15/2013 (MARRS# 1401USA000275), 1 unspecified patient on 10/25/2013 (MARRS# 1401USA000276) and 1 unspecified patient on 10/29/2013 (MARRS# 1401USA000280). No adverse effects reported. No further information was provided. Additional information has been requested.
12-10-07 Received Zostavax, Lot # 1414U Right Subq, Treatment: Benadryl PRN. 12-11-07 Slight redness, sore to touch. 12-12-07 Induration, 8cm x 3cm, warm to touch, knot felt, fiery red, Outside of induration, 12cm x 6cm, warm to touch, red, itching. 12-13-07 Same as 12-12 except tiny blisters in induration. 12-14-07 Same. 12-15-07 Same. 12-16-07 Same. 12-17-07 Induration, 6cm x 2.5cm, redness getting lighter, outer redness gone, no heat noted, only few blisters remain, slight itching. 12-18-07 Induration, 6cm x 2.5cm, redness getting lighter, all blisters gone, itching occasional. 12-19-24-07 Same as 12-18-07. 12-25-07 Same except redness is still visible but is peeling as if blistered from the sun. 12-26-29-07 Redness is still visible, but no peeling, itching. 12-30-07 Same as 29th, but I am going to submit report.
Felt left shoulder blade discomfort on 10/21/15.  Felt numbness in left index finger on 10/19/2015. Numbness and tingling radiated down from shoulder to arm and to rest of fingers over the next few days.  The discomfort from left should blade down to arm and fingers is on-going and is worsening as of Oct 25, 2015).  I also experienced a mild cold-like symptom started on Oct 15, 2015.
Erythema, extreme itching, warmth at injection site. Patient did present with a cough, but after discussion had been seen by doctor approximately 3-4 weeks prior with a virus and still had a lingering cough. Patient given 50mg IM Benadryl and monitored. Discharged without any distress noted.
This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On unspecified dates since 24-OCT-2015, the patients were vaccinated with doses of VAQTA (Lot# K014696; expiration date 11-NOV-2015) (dose and route of administration were not reported), which were exposed to temperatures outside of the recommended range and expired currently but not expired at the time of administration. Concomitant therapies were not reported. No adverse experiences have been reported. There was no product quality complaint (PQC) involved. This is one of several reports from the same source. Additional information has been requested.
PATIENT'S ARM AT THIS TIME IS VERY SWOLLEN AND HOT TO TOUCH. PATIENT STATES ALSO VERY PAINFUL.
Fever, rapid heart rate, dizziness, bad shivers, bad chills overnight into next day. Dizziness often again over the next week. Exhausted sore throat severe headache for 2 days following injection
Vaccine was stored in refrigerator beyond 30 day use.; Vaccine was received in refrigerator on 03/07/2022/ received  Moderna vaccine  Booster on 04/08/2022/used beyond 20 day use; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator beyond 30 day use.) and EXPIRED PRODUCT ADMINISTERED (Vaccine was received in refrigerator on 03/07/2022/ received  Moderna vaccine  Booster on 04/08/2022/used beyond 20 day use) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 004C21A and 031B21A) for COVID-19 vaccination.     It was unknown that patient was diagnosed or tested positive for COVID-19. Diagnosed acute illness at the time of vaccination and up to one month before was unknown. Chronic or long-standing health conditions was unknown.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 08-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was received in refrigerator on 03/07/2022/ received  Moderna vaccine  Booster on 04/08/2022/used beyond 20 day use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator beyond 30 day use.). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator beyond 30 day use.) and EXPIRED PRODUCT ADMINISTERED (Vaccine was received in refrigerator on 03/07/2022/ received  Moderna vaccine  Booster on 04/08/2022/used beyond 20 day use) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Patient race was reported as private and patient received booster dose. Adverse event did not cause the patient to seek medical care. There was no any potential causes was reported. It was reported vaccine was received in refrigerator on 07 Mar 2022 in appropriate temperature (2-8 Celsius).  Vials did not undergone any temperature excursions. No treatment information was reported.
pt. recvd. vax & developed ringing & burning sensation in ears,dizziness,hot flashes,pallor,& tingling in fingers.
Information has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt developed mild breakthrough chickenpox. No other details were available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
An orange, red area on the injection site; Swollen area on the injection site; red area on the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (An orange, red area on the injection site), VACCINATION SITE SWELLING (Swollen area on the injection site) and INJECTION SITE ERYTHEMA (red area on the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) for an unknown indication.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (An orange, red area on the injection site), VACCINATION SITE SWELLING (Swollen area on the injection site) and INJECTION SITE ERYTHEMA (red area on the injection site). On 22-Jan-2021, VACCINATION SITE ERYTHEMA (An orange, red area on the injection site), VACCINATION SITE SWELLING (Swollen area on the injection site) and INJECTION SITE ERYTHEMA (red area on the injection site) had resolved.        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.
adult administered a pediatric dose; adult administered a pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 87-year-old female patient who received HBV (Engerix B 10 mcg) (batch number 25N39, expiry date 16th March 2024) for prophylaxis.   Previously administered products included Engerix B with an associated reaction of therapy non-responder (previously completed the series on an unknown date, but titer testing was negative, refer link case US2022AMR044159) and Engerix B (1st dose received on an unknown date of readministered series).   On 7th February 2022, the patient received the 2nd dose of Engerix B 10 mcg. On 7th February 2022, unknown after receiving Engerix B 10 mcg, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.   Additional details were reported as follows: The medical assistant reported that, an adult patient was inadvertently administered a pediatric dose of Engerix-B, which led to accidental underdose and adult use of a child product.  At the time of reporting, this dose had not been repeated. This patient previously completed the series, but titer testing was negative, so the series was being re-administered, refer linked case US2022AMR044159.   The reporter consented to follow up. This case had been linked with case US2022018153, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022018153:Same reporter US-GLAXOSMITHKLINE-US2022AMR044159:same reporter
Redness, swelling, pain from elbow to armpit, swollen lymph nodes, hot to touch symptoms became worse and redness spread between 8am-230pm.
Localized hives to left upper arm; Top hive is 2.5 X 2cm; Lower 1.5 X 1.25cm. Arm pain and muscle soreness. Doctor told patient to take clairitin or zyrtec daily until resolved.
Pt. states that after receiving the 3rd dose Booster of Phizer 09/27/2021, started experiencing symptoms 10/10/2021 of headache, body aches, left arm pain at injection site to the elbow, nausea, and weakness. Emergency Room visit due to slurred speech, diagnosed with a TIA, admitted for observation *Released 10/11/2021. MRI, Cat-Scan, Blood Work, Ultrasound preformed, damage imaged to the Frontal Lobe. Slurred speech resolved. Cardiologist appt. 10/20/2021, Follow-Up with Neurologist still awaiting appt.
On or around 8/28/2021, I was playing golf that day and experienced lightheaded, unbalanced, feeling as well as the feeling of being faint to the point of passing out. I did not pass out, and from that day on, every day when I have been in a standing or sitting position, I have felt unbalanced. And a few times even had the feeling of passing out. Two weeks after the initial feeling of imbalance and faintness, I went to my general practitioner. At that point, he ordered a full work up of blood and urine. All results were negative. At that point, he requested I see an ear, nose, and throat specialist. One week later after visiting ENT, there was nothing determined as an issue with my ear, nose, or throat. He also ordered me to see a cardiologist based on me feeling faint. That was ordered two weeks after the initial episode. So, he asked me to go see the ENT and recommended a cardiologist. Moving forward, after the results from the ENT, he recommended to see a neurologist. At that point, my meeting with the neurologist, he requested that I have an MRI of my lower back, my neck, and my brain. All those x-rays have showed nothing significant. All 3 MRIs did not show anything that would have caused my current condition. The neurologist also ordered a brain wave test that also came back negative. I have since had a stress test, a corroded artery test, and an echocardiogram. And the last one was a halter monitor which is a 24-hour monitor of my heart. I've had 3 of the exams. Tomorrow 10/28/2021 I go for the halter 24 hour. I have not been given any of the findings from the cardiovascular tests. The symptoms are sometimes greater and sometimes not as great, but if I'm not lying down or sleeping, I have these symptoms. So, If I've driving, walking, or sitting, these symptoms of unbalance and slight headache are present. I would describe it as the feeling after 3 martinis or feels like I'm on a boat. The cardiologist is Dr.; Neurologist Dr.; ENT Dr.
Kinrix was administrated to 6 month baby; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th April 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 4th April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Medical assistance reported that ,Kinrix was administered to 6 month patient, which led to inappropriate age at vaccine administration. No adverse event was reported.  The patient's identifiers, lot number, expiration date and vaccination date was not provided. The reporter consented to follow up.
Has developed a rash with about 23 bumps. New ones are developing every day. The night of onset he also had fever and vomiting.
Patient has history of passing out with injections/seeing needles. Patient passed out minutes after receiving vaccine. Patient was given water and time to feel better.
Injection site became red, swollen, sore, and hot 1 day after administration. The patient saw her MD 2 days later and was diagnosed with an infection at the injection site.  Patient was treated with antibiotics.
Swollen, red and painful lymph nodes in armpit, vesicular varicella like rash over trunk and buttocks.
Patient called stating that her arm (left) swelled after vaccine was given. Swelling is gone now.
Breakthrough case admission after 2 vaccines Moderna 2/5/21 Lot# 007M20A;  Moderna 3/5/21 Lot# 023M20A
No additional adverse symptoms reported; an expired dose od M-M-R-II was administered to patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.      On 22-JAN-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose and administration route were not provided) lot # N034002 expiration date 02-DEC-2019, for prophylaxis. No additional adverse symptoms were reported.
Whelps all over body including lips. They did not give any treatment. Mom called me at 1:00pm on 9/16/2016-I informed to give Benadryl and go straight to ER.
Patient received a dose of Pfizer COVID-19 Vaccine  Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the Agency, due to lack of stability data, it was advised to revaccinate the patient.