chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. On 25th March 2019, the patient received SHINGRIX (intramuscular). On 26th March 2019, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: On Monday, the patient received the SHINGRIX dose in the left arm. The patient experienced 2 inch by 2 inch patch of redness at the injection site and the area of redness was hot to touch. The patient put some ice on the affected area and it helped. The reporter consented to follow up.
This spontaneous report as received from a physician refers to a 4 weeks old patient. The patient was vaccinated with a dose of M-M-R II on 04-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
PRODUCT OPENED ON PREVIOUS DAY OF REPORTING WAS LEFT IN THE FRIDGE AND USED ON NEXT DAY; This spontaneous report received from a pharmacist concerned a 66 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced product opened on previous day of reporting was left in the fridge and used on next day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of product opened on previous day of reporting was left in the fridge and used on next day was not reported. This report was non-serious.
BOOSTER SHOT.  Left arm sore from 12/16-2021 to present. 12/17/ muscle pain from feet to shoulders, joint cramps in legs, hot & cold, fatigue, no appetite 12/18/21, fatigue, chills hot & cold, diarrhea all night, very week, no appetite, 12/19/2021,, fatigue, weakness, moderate pain in neck shoulder area,  no appetite.  In bed for hours.
I had the vaccine on 06/09/2021 . I had plantar fasciitis which had been managed and it just started to hurt a lot worse and I pulled a tendon or stretch it too far on the left foot. I hadn't really done anything out of the ordinary to overworked them.  On Wednesday I went to the doctor and they did an x-ray and physical examination o f the foot. They prescribed an oral steroid.
he slept/ Increased sleep; arm was swollen; muscle pain like falling off a bike; Fever; really lethargic; threw up dinner first couple days; was very tired; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 12-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included DIPHTHERIA TOXOID + PERTUSSIS TOXOID + TETANUS TOXOID (ADACEL) for prophylaxis and MENACTRA for prophylaxis.   On 15th March 2017, the patient received Bexsero, ADACEL (intramuscular) and MENACTRA (intramuscular). On an unknown date, unknown after receiving Bexsero, the patient experienced swelling arm, muscle pain, fever, lethargy, vomiting, tiredness and sleep excessive. On an unknown date, the outcome of the swelling arm, muscle pain, fever, lethargy, vomiting, tiredness and sleep excessive were recovered/resolved.   It was unknown if the reporter considered the swelling arm, muscle pain, fever, lethargy, vomiting, tiredness and sleep excessive to be related to Bexsero.  Additional details were provided as follows: The patient's mother reported that the patient received Bexsero, Menactra and Adacel all on 15th March 2017. Two vaccines were received in one arm, and one shot in the other arm. The reporter stated the patient's arm was swollen, he slept, was very tired, he threw up dinner first couple days, he was really lethargic, fever, and he had muscle pain like falling off a bike. The mother reported that it took her son a week to recover.
On 12/2/2022, I did a home Covid-19 test and the result was positive. I contacted my PCP and he started me on PAXLOVID. I was monitoring my blood oxygen levels and I was falling below 90 percent. On 12/05/2022, I went to the ER based on that. That was my first visit to the ER. I continued to monitor my oxygen levels and I was still having complications. I went back the next day to the ER and they decided to admit me. I was in a normal ward for two days and then moved to ICU. I was in ICU for three days. While in the hospital, I was given a breathing aid/ BiPAP and they were still having trouble keeping my oxygen level above 80. I was also given steroids. They were considering intubating me, but I rallied at that point and was not. I started feeling much better the following day and was released to an infectious disease ward and was sent home the following day. As of today, I am still testing positive on the rapid test. My oxygen levels have returned to the high 90's.
Patient stated he felt nauseous. A minute later fainted briefly. Approximately 10 seconds and revived.  Patient was seated at the time.  Emergency Medical services were called.  His vitals were checked and determined the patient could leave.  Patient did not want to go to hospital.
Site reaction to DTaP/Hib #3 given right thigh IM, 25 hours later, red, swollen, warm, firm knot. Cefzil 250/5mg tsp  BID Benadryl 3/4 tsp q 6 hours.
Patient was 17 when received the vaccine. Moderna is not indicated for patients under 18 years of age.
Moderna COVID-19 Vaccine EUA,  Injection Site pain, headache, body aches, dizziness, light headed. Still having symptoms since they just started this morning.
Patient reports her cycle started one week early, lasted two weeks and was extremely heavy the entire time, she had to change her pad she bought about every 30 minutes.  normally she has a one week light cycle on her current bcps.  she went to see her gyn Dr and had an ultrasound.
Fever  INJECTION SITE PAIN, CHILLS  Narrative:  WENT TO ED 2 DAYS LATER AND TESTED POSITIVE FOR COVID
Seizures; This is a spontaneous report from a contactable consumer (patient's mother). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy dates unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had seizures. The patient's mother was worried that patient might develop fever; and was asking how soon after the vaccination could she give paracetamol (TYLENOL). The outcome of the event, seizures, was unknown.  Follow-up attempts are completed. No further information is expected.
Initial report received on 05 May 2011 from a consumer. Two unidentified patients each received a left arm injection of TYPHIM Vi (lot number E1288-1) on 04 or 05 May 2011. Immediately afterwards, each patient developed injection site redness which extended toward the elbow and the area was warm to touch. No other information was provided.
Case number PHEH2016US031085 is an initial spontaneous report received from consumer on 22 Nov 2016. This case refers to female patient of unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (lot number: 168904, expiry date: not reported) at a dose of 0.5 ml intramuscular on 20 Oct 2016. On the same day, the patient experienced significant arm pain in the left arm where the injection was given. It was reported that, the patient had still significant arm pain. The outcome of the events was reported as condition unchanged. The seriousness of the event was not reported. Seriousness assessment of event vaccination site pain was upgraded (medically significant) as per information available in source document. The causality of the event was not reported.
dizziness; malaise; Body aches; This is a spontaneous report from a contactable nurse reported for herself. This 23-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Jan2021 at single dose for covid-19 immunisation. Concomitant medications included Sertraline, Iron supplement, calcium levomefolate (DEPLIN). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. The patient experienced Body aches, malaise, dizziness on 10Jan2021 08:00 AM. Treatments Ibuprofen, Acetaminophen were received. Outcome of the event was recovered in Jan2021.  Information about lot/batch number has been requested.
This spontaneous report was received from a health care worker (medical assistant) refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 which had lot # L014415 with expiry: 25-JUL-2017 and lot # L037554 with expiry: 25-DEC-2017, (dosing details not reported). No adverse effect was reported. The vaccine was exposed to a temperature excursion of 12.4 degree Celsius for 2 hours and 30 minutes, and it had no previous temperature excursion. The call was because of data logger. No further details provided. This is one of the three reports received from the same reporter. Additional information has been requested.
Had extreme chest/back pain 24 hours following the vaccine, that was some relieved by positioning and resolved by the following day. Was 24 weeks pregnant at time of vaccine. Due date is 9/2/21.
Received 2nd booster on 4/28/22.  Received another 0.3ml booster on 5/25/22.  Staff had not documented him getting booster last month.
Mild joint achiness, face flushed/feverish for several hours. Some fatigue.
No adverse event; 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-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 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant medications were reported. The vial was initially thawed on 10-Jun-2023.  Treatment medications were not reported.  This case is for 2nd patient out of 30 patients reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow-up significant information received: Date of administration was updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
Dizziness, weakness after vaccinated, c/o cold, and cold to touch, inability to raise arms or legs, oriented to place, time and location. BP at 3:40 130/82, approximately 10 min later BP 140/90. Sent patient via 911 rescue to hospital.
1:00 am, patient woke us up screaming, she had a fever of 104.5. She screamed and cried with her eyes halfway open until 6am. She was unable to speak during that time. Since then her stools have been very loose, light colored and malodorous.
Tightness in arm, from wrist all the way up to the shoulder. Red spots on upper arm.
Pfizer COVID Vaccine EUA: Formulation/Dosage Error. Patient received Pfizer vaccines on 1/22/2022 and 3/5/2022. The product provided on 3/5/2022 was 0.3 ml of the adult formulation.
Patient reported stiff neck on the side opposite of where she received the injection. The pain was decreased after taking OTC TYLENOL, but the pain has still persisted for 2 days so far. I confirmed no other areas of pain and no chest pain to exclude from any potential signs of myocardial infarction.
Patient received PROQUAD 1-31-14 and mom called 2-7-14 to report break out of varicella - 20-25 lesions.
About 2 weeks after first COVID-19 vaccine, patient states he had trouble breathing and called 911. He states he was diagnosed with multiple blood clots at the hospital. He doesn't recall exact dates, states the difficulty breathing started at 2am. Was taken to on .
Information had been received from a letter (received on 04-APR-2014) written by a female who got a ZOSTAVAX vaccination at her local pharmacy (date not reported). Patient noted "Your scary commercials convinced me I should get your vaccination". Ten days later that patient reported she wound up in the emergency room on a Sunday morning with shingles in her left eye. She noted that before last Summer, she never had the shingles. Patient was treated and reported that she seemed to recover. Currently, patient noted as she sat at her computer she struggled to type a letter with vision only in one ye because the shingles had recurred and the inflammation in her left eye had blurred her vision to the extent that she could barely make out the largest E on the chart. Patient noted she had been treated with ophthalmic prednisolone, COMBIGAN solutions, valacyclovir and sterile lubricant eye drops. Patient's physician told her that after this occurrence was cured, she would need to go on long term low daily doses of valacyclovir. Additional information has been requested.
Skin rash and bruising. Hair loss almost immediately.  Came out in circular quarter sized patches at first and by July 2019 she was half bald. By October,  her eyebrows and lashes went, too. Dermatologist and rheumatologist seen. Steroids not used per parental decision. Blood tests show no autoimmune.
Information has been received from a registered nurse concerning a female patient who was vaccinated with a dose of GARDASIL vaccine. Subsequently the patient experienced sore throat and fever after the first and second dose. No medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. Additional information is not expected.
Pain at injection site; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: FLUCELVAX, on 26Sep2023 as dose 1, single; ATENOLOL; AMLODIPINE. The following information was reported: NAUSEA (non-serious) with onset 27Sep2023 at 12:00, outcome "recovering"; INJECTION SITE PAIN (non-serious) with onset 27Sep2023 at 12:00, outcome "recovering", described as "Pain at injection site". Therapeutic measures were not taken as a result of injection site pain, nausea. Additional information: Patient was not diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Injection site soreness but returned 7 days later. Even more sore this time.; Injection site soreness  but returned 7 days later. Even more sore this time.; Injection site soreness  but returned 7 days later. Even more sore this time.; This is a spontaneous report from a non-contactable consumer, the patient. A 71-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 at 13:15 hours (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Apr2021, the patient experienced injection site soreness which was normal at first and subsided quickly. On 12Apr2021, the patient experienced the same which returned 7 days later and was even more sore this time. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event injection site soreness was recovered on an unknown date in Apr2021. The clinical outcome of the events symptom recurrence and pain aggravated was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
right cranial nerve 6 palsy. Symptoms began within a week of 9/21/2020 visit
Patient reports unusual bruising and redness of the arm/site of injection persisting for 2 weeks.
Tender circular induration on (L) deltoid where vaccine was administered - seen in ED also.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Date of refrigeration of vaccine was reported as 7-May-2021.
fever 101.7, stuffy head, nasal congestion, dry cough, sore throat x 2 days.
EMS, who was working in the clinic, stated that the patient had a partial seizure and directed the Clinic Lead Nurse to call EMS.  Patient became pale, 5 second seizure, dizziness and vomiting.  EMS was called and vital signs were taken but patient declined to go to the hospital. Patient recovered and drank some water and ate some crackers.  Patient waited another 30 minutes and stated he felt much better.  Clinic Lead Nurse called the patient, on April 13, 2012, who stated that he went home, ate some food and relax the rest of the day.  He stated he felt better and had no more problems.  He did not seek additional medical care.
Nausea, diarrhea, vomiting, major joint pain, weakness, dizziness, loss of appetite, chills, sweats.  Took anti-nausea med.
The wrong FLUZONE was given to the patient. All vaccines stored in same fridge and I grabbed and gave the wrong one. Patient was intended to get the FLUZONE QUAD. I immediately called Dr. who is my pediatric vaccination protocol doctor. Her nurse said to inform patients care giver/mom about incident otherwise no other action. Patient left pharmacy fine. I contacted her mom and informed her of the error. I told her if she had any questions or other concerns she could either contact myself, Dr. or her doctor.
Vaccine- strain measles viral infection. Seizure and convulsion within hours. Constant diarrhea, within hours and continues until the present. Loss of speech, change in eating habits and personality. The annual follow-up states "diarrhea, not talking at all, not relating understanding, mental retardation, allergy symptoms severe."
Metallic tatste in mouth lasting 4-6 hours the day patient received 1st dose on 19Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic tatste in mouth lasting 4-6 hours the day patient received 1st dose on 19Apr2021) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced DYSGEUSIA (Metallic tatste in mouth lasting 4-6 hours the day patient received 1st dose on 19Apr2021). On 19-Apr-2021, DYSGEUSIA (Metallic tatste in mouth lasting 4-6 hours the day patient received 1st dose on 19Apr2021) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medication not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up document received contains No New Information.
"two other patients couldn't even stand"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA ("two other patients couldn't even stand") in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSSTASIA ("two other patients couldn't even stand"). At the time of the report, DYSSTASIA ("two other patients couldn't even stand") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.