chrisvoncsefalvay/vaers-outcomes huggingface dataset:
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for an unknown indication.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.   This case was linked to (Patient Link).
Quadracel vaccine given to 18 month old patient/ NO AE; Initial information received on 29-Apr-2021 regarding an unsolicited valid  non-serious case received from a nurse via call-center.  This case involves a 18 months old female patient who received 0.5 mL DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (frequency: once, strength: standard, batch number: C5772AA and expiry date: 17-Sep-2022) (inappropriate age at vaccine administration) via an intramuscular route in left thigh for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt received Moderna bivalent 0.25ml of the 50mcg/0.5ml bottle. Pt had 2 doses of Moderna monovalent vaccines previously.
PATIENT HAS SUBSEQUENT SWELLING, REDNESS, PAIN ACROSS THE DELTOID OF INJECTION ARM (RIGHT) THAT WRAPPED AROUND ARM. THIS LASTED FOR APPROXIMATELY A WEEK BEFORE SUBSIDING.
Left arm red, swollen from elbow to upper arm. Central blanching (4 cm diameter) at injection site. Low grade fever 24 hours after shot. Arm is swollen significantly now 2 days after shot.
Initial unsolicited report received from a consumer on 10 SEP 2015. This case involved a 74 years old female patient, who was vaccinated with an intramuscular first dose of FLUZONE HD in the left deltoid (batch number, expiry date, and dose details were not provided) on 08-SEP-2015. There was no known allergy at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions included mitral valve infarction. Concomitant medications included "pentapril melate" and "amlodiire besylate". On 08-SEP-2015, in the evening, same day post-vaccination, the patient's eyes were itching and she developed hives on the arms and back. She was seen by a physician on 10-SEP-2015 and would be referred to an allergist. It was reported that the patient never  had flu vaccine before. Laboratory investigations were not reported. The patient required ER/doctor visit. The patient had not yet recovered from the above mentioned events. List of documents held by sender: none.
right after the vaccine, I had heart palpitation and a headache but I thought it was my anxious acting up. Later that night, my arm became quite sore but I got itchy and the headache became a severe migraine so I took a Tylenol and the Rizatriptan 4 hrs later. The following day, I could not get out of bed with severe body ache, light headedness, heart palpitation and slight difficulty breathing. I have been in bed since but the heart palpitation and more difficulty breathing and wheezing are intermediate but strong at onset. I am also still itchy.
SHE HAD VACCINE AT 3:30 FRIDAY THEN SATURDAY AM AT 10:00 AM SHE DEVELOPED FEVER AND SEVERE GENERALIZED ACHINESS.  ON SUNDAY SHE DEVELOPED ITCHING ON HER  PALMS AND SOLES.  SHE HAD HIVES ON HER DISTAL EXTREMITIES AND TRUNK ON  MONDAY MORNING. HIVES IMPROVED TO MILD ON NECK WITH ERYTHEMA ON DISTAL EXTREMITIES TODAY (11/2/2021).
This case was reported by a nurse via call center representative and described the occurrence of shoulder pain in a 18-year-old male patient who received BEXSERO (batch number 16B401, expiry date 28th February 2019) for prophylaxis. On 3rd August 2018, the patient received the 1st dose of BEXSERO (intramuscular). In August 2018, less than a week after receiving BEXSERO, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was unknown.  It was unknown if the reporter considered the shoulder pain to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in the left deltoid and experienced shoulder pain (with movement) following vaccination. The pain did not limit his range of movement or degree of physical activity. This was reported to the healthcare professional by patient's mother on 10th August 2018 but the healthcare professional was uncertain when the symptoms began. She also has not yet heard back from the mother, regarding whether the symptoms have resolved or not.
Redness on her nose and cheeks with butterfly pattern; Arem was itching at the injection site/ The sire was very itchy; Rash; Large red area around the injection site about 5 in. long and 2 in. wide; Soremess at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on her nose and cheeks with butterfly pattern), VACCINATION SITE PRURITUS (Arem was itching at the injection site/ The sire was very itchy), RASH (Rash), VACCINATION SITE ERYTHEMA (Large red area around the injection site about 5 in. long and 2 in. wide) and VACCINATION SITE PAIN (Soremess at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Ampicille (rash)) since 1982, Ulcerative colitis since 1982 and Hypercholesterolemia. Concomitant products included LORATADINE for Allergy, PRAVASTATIN for Hypercholesterolemia, MESALAMINE for Ulcerative colitis, VITAMIN D [VITAMIN D NOS] and CHLORPHENIRAMINE [CHLORPHENAMINE] for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soremess at the injection site). On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Arem was itching at the injection site/ The sire was very itchy), RASH (Rash) and VACCINATION SITE ERYTHEMA (Large red area around the injection site about 5 in. long and 2 in. wide). On 21-Jan-2021, the patient experienced ERYTHEMA (Redness on her nose and cheeks with butterfly pattern). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at a dose of cream and tablets. On 26-Jan-2021, ERYTHEMA (Redness on her nose and cheeks with butterfly pattern), VACCINATION SITE PRURITUS (Arem was itching at the injection site/ The sire was very itchy), RASH (Rash) and VACCINATION SITE ERYTHEMA (Large red area around the injection site about 5 in. long and 2 in. wide) had resolved. At the time of the report, VACCINATION SITE PAIN (Soremess at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       A day after the first dose of vaccine, the patient had slight soreness at the injection site and that was the only reaction until one week after the shot. The patient treated it with diphenhydramine cream and tablets.  On 9-Feb-2021, the patient received second dose of Moderna COVID-19 vaccine with lot number 013M20A intramuscularly at right arm.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up information received included patient demographic details, medical history, vaccine dose details, concomitant medication and events outcome.
Pt came in 10/12/2013. Pt's right arm has a raised patch about 4 (length) x 2 (width) (inches), red and hot/warm when touched. Small area of the red patch (approximately 0.5 x 0.5 inch) is hard. The red patch is about 1" left to the PNEUMOVAX injection site. Pt felt sore.
06/09/2021 - shortness of breath, increased heart rate, slightly itchy but not red or swollen eyes - Pharmacy called ambulance but I refused to go to the ER and get epinephrine shot because it wasn?t severe at this time 06/10/2021 - anaphylaxis upon waking up the next morning, severe swollen red eyes and obstructed vision as result, swollen cheeks and lips, difficulty breathing with light throat swelling, no tongue swelling present, no hives present. went to medical centers emergency department, received IV pepsid and prednisone, was prescribed oral prednisone for 5 days, no reoccurring reactions after treatment
Aches all over L side to R. L upper extremity aches, headache, feels like skin is hot, decreased appetite. Central scab, erythema 1.5cm, Temp 99F. Given quarters X 48 hrs, Motrin 800mg TID alternate with Tylenol, Vioxx if symptoms persist.  P 98- BP 130/58.
MISSED SECOND DOSE; This spontaneous case (PVX2019-955) was received from a pharmacist on 22-Apr-2019. It describes a female consumer who "missed second dose", while being on Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 19-Apr-2019, then she stored Vivotif in freezer, thus missed to take the second dose, which was due on 21-Apr-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "missed second dose" was unknown.  Company's Comment: The causality of the event "missed second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed second dose" was considered as not applicable.
Changes in menstrual cycles for several months after vaccination. Miscarriage occurred June 2021.
PATIENT REFERS: HEADACHE, NAUSEA, VOMITING AND HIGH BLOOD PRESSURE TOOK VYSTARYL, HYZAAR
pt recv vax;exp full papular rash (pityriasis rosea), rash on chest, arms & buttocks;mostly on face, little on lower legs;
Really sick; Diarrhea; Sweats; Cough; Vomiting; Chills; surgery on knee; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of KNEE OPERATION (surgery on knee), ILLNESS (Really sick), DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweats) and COUGH (Cough) 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 was provided by the reporter.  Concurrent medical conditions included Diabetes. Concomitant products included GLIMEPIRIDE for Diabetes.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced KNEE OPERATION (surgery on knee). On 17-Apr-2021, the patient experienced ILLNESS (Really sick), DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweats), COUGH (Cough), VOMITING (Vomiting) and CHILLS (Chills). The patient was treated with MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, KNEE OPERATION (surgery on knee), ILLNESS (Really sick), DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweats), COUGH (Cough), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       it was reported that one week after surgery, patient became really sick. The patient's symptoms continued into third week.
Recvd a phone call from client c/o lt entire arm swollen up to neck down to hand; It was red, painful; pt also stated had body aches, fever, chills; called wanted to know what to do;
One week after vaccine, I developed a bright red, burning, and itchy rash in my left arm. My armpit is extremely sore and the left side of my neck is swollen and sore at 2+ weeks since first dose.
PATIENT WAS IN THE OFFICE AT THE TIME OF INCIDENT  PATIENT HAD NO ADVERSE REACTIONS TO VACCINE.
C/O left shoulder pain described as cramping/tightening subsiding after 2 minutes
Her injection site symptoms are swollen, red and itch and didn't go away after taking allegra, hydrocortisone 1% cr and ice therapy.
Abdominal pain starting on 8/25/2022. Abdominal ultrasound demonstrates inferior vena cava thrombus.  The patient was scheduled for a venogram and possible thrombectomy. Caval venography and pulmonary artery angiography demonstrates no thrombus, indicating interval resolution of the previously seen thrombus.
fever 102 x 2 days 13MAR to 14MAR95; rash stomach back-neck x 3 days; 17MAR to 19MAR95;
Sore arm, chills, fatigue, headache lasting more than 72 hours.
ER visit on 10-14-07 with local redness, swelling & rash.  Dx. was cellulitis, pt. given Benadryl 25 mg & Keflex 500 mg.  In today with (10-16-07) redness & swelling c/o pain, did not advise nurse she had reaction 25 yr. ago with TD before getting Tdap on 10-12-07.
Flu like symptoms, headache, sore muscles and joints, lethargic, stuffy nose, painful injection site with rash at site of injection.
I didn't feel well all night, had muscle aches and pains and thirst. In the am I felt very unwell. So I was staying in bed and resting and drinking water. I got up had light headedness, I Was greyish color, I was confused and disoriented and mostly very light headed laying on bathroom floor. I had a friend come drive me to urgent care location, when I got to urgent care I declined IV fluids I felt like I was hydrated and I took Tylenol brought my temp and blood pressure down. I had  high resting heart rate and low blood pressure .They sent me home. By that evening I was able to eat real food. I started feeling a little better. At this point I thought I was going to be fine. I have not been back to myself since then, I have been having a really bad anxiety, I'm on a medical leave. I tried some anxiety meds that haven't helped.  I'm on gabapentin now , I have had some GI distress since February.  I have a lot of brain fog now.
Patient received the second dose of the Moderna Covid 19 vaccine more than 35 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the Moderna Covid 19 vaccine more than 35 days after the first dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C1A and 204C21I) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the Moderna Covid 19 vaccine more than 35 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the Moderna Covid 19 vaccine more than 35 days after the first dose) outcome was unknown.            Patient was not an immunocompromised patient  No concomitant medication was provided  Treatment medication was not provided by the reporter  It was reported that the patient would like to know when would it be appropriate for him to receive the booster
No additional AEs reported; MMRII that expired was administered to a patient; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 19-OCT-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (rHA) (M-M-R II) (0.5 mL; lot# S031483 has been verified to be a valid lot number and expiration date was 07-OCT-2021) for prophylaxis (expired product administered). The vaccine was reconstituted with our Company sterile diluent (0.5 mL; lot# U003874 has been verified to be a valid lot number and expiration date was 26-JUN-2023). The vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (rHA) (M-M-R II) had not had any temperature excursions. The reporter was provided with the expired supported disclaimer. No additional adverse events were reported.
a little achey; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a little achey) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (a little achey). At the time of the report, PAIN (a little achey) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.    This case was linked to MOD-2021-080278 (Patient Link).
fever; she was dehydrated; unable to sleep until 3:30am; Headache; body aches; Chills; Pain / received the vaccine on 18Dec2020, at that time she only had symptoms of pain; This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number CJ1685) via an unspecified route of administration on 18Dec2020 at single dose in the right arm for COVID-19 immunization. Medical history included gum surgery on 29Dec2020. Concomitant medication included amoxicillin trihydrate (AMOCILLINE) from 29Dec2020 post gum surgery. The patient received the vaccine on 18Dec2020. At that time she only had symptoms of pain (onset date 19Dec2020). On the night of 04Jan2021, she had chills and needed 3 blankets and 2 robes. Three hours later her chills were gone and she had a temperature of 105 degrees (fever onset date 05Jan2021). She also had a headache (headache onset date 04Jan2021). She took two paracetamol (TYLENOL) and was unable to sleep until 3:30am. She woke at 9am (05Jan2021). She checked her temperature again and it was 99.2. This was after going 12 hours without taking paracetamol. Then she had body aches (body aches onset date 04Jan2021) but no headache. She thought she was dehydrated and she drank some water. Her headache was gone. She was scheduled for the second vaccine on 08Jan2021. She was told that her body would respond stronger and the symptoms be worse since she responded 17 days after getting the vaccine. The event pain (after vaccination, on 19Dec2020) was resolved on 19Dec2020, chills was resolved on 05Jan2021, fever was resolving, headache was resolved on 05Jan2021, body aches was resolved on 05Jan2021. The outcome of "unable to sleep" and "she thought she was dehydrated" was unknown.
Approximately 24 hours after receiving his Covid he developed chest pain. This initially was intermittent and then became persistent and severe approximately 48 hours after receiving his vaccine. In the emergency department labs were drawn that showed an elevated troponin to 18 and EKG consistent with myocarditis. He was then admitted to the intermediate care unit
notes from patient: "I got my second Moderna shot on Sunday, Feb. 21. Had a one day fever and fatigue that was gone on Weds and fatigue was back on Thursday. Also had red blotches on my torso that faded on Tuesday."
Left thigh has local reaction to vaccine a redness and dime size rash around the local area of the thigh.
Pt had fingerstick for hgb, then rec'd MCV4 (L) deltoid and began to feel lightheaded & nauseous. Pt placed in recumbent position BP 116/54 cool clothes on forehead & shortly felt better.
Fever >100.4,  New loss of taste or smell,  Runny nose/Congestion,  Sore throat,  Shortness of breath or difficulty breathing,  Fatigue or tiredness,  Headache
This spontaneous report as received from a consumer regarding her daughter refers to a female patient of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. On an unknown date the patient was vaccinated with GARDASIL lot # J007354, 3 doses (specific dates and times of vaccine administration was not reported). On an unknown date the patient experienced trouble breathing (Hospitalization) after receiving a dose of GARDASIL and was admitted into ER (location, duration, demographics unknown). The reporter stated that her daughter had reaction after receiving the recalled lot, lot # J007354. It was unspecified by the reporter after which dose she had the event as she had no specific information about which dose of GARDASIL was the recalled lot. The reporter was also concerned about the letter in the mail which she had received, stating about the recall from Merck. The reporter explained that she wanted Merck to contact the responsible physician in regards to the AE reported. The outcome of trouble breathing was reported as recovering/resolving. The patient had not sought medical attention. No product quality compliant was involved. The causality assessment was not provided. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 30-JAN-2015, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (dose, frequency and route were not reported) (lot # K014834 and expiry date: 15-DEC-2014). No adverse effect was reported. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information has been requested.
Received DTAP shot (5th shot) on 8-3-09. On 8-4-09, arm was very swollen about 4 inches long with red and white in the middle. No drainage, tender to the touch. On 8-5-09, she had blisters around the injection site - small 1mm lesions. Seen in office on 8-5-09.
pt recvd 1st dose of Hep B 02JUL90 & exp h/a,fatigue,malaise & could not raise head from bed.