chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm two or three days; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm two or three days on an unspecified date. The outcome of the event was recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Raised rash bumps, particularly on extremities,  mostly found on finger joints, elbows, knees , and to area of injection. Symptoms occurred approximately 1 week after vaccination
Had the chills, body aches, and cramping. I had the heat up and was still freezing cold and took some NyQuil
4 HOURS AFTER SHE GOT HER VACCINE AFTER DINNER SHE HAD A BAD HEADACHE, CHILLS, SHAKING, WEAKNESS, ACHES AND VOMITING.
This spontaneous report as received from a nurse refers to unspecified number of patients. Their pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II lot# M007277, expiration date 09-FEB-2018 (dose and route of administration were not reported). Vaccines were stored at the temperature of 8.5 Celsius degrees for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient was admitted in observation after receiving her second dose vaccine at 11:20am, patient was standing up , and nurse went over to pt, pt complaint of chest tightness (mid sternum) at 11:34am. Patient denies pain, and sat back down, vital signs were taken, patient was alerted oriented x 4. Patient stated she did not take her 10 cardiac medications this morning in fear that her meds will interfere. Patient states pressure is lessening, states feels better, denies sternal pressure/ tightness. Patient was encouraged to take prescribed medications, asked to go to ER for EKG and cardiac enzymes. Patient states she would rather call the cardiologist and make an appointment. patient's friend was here, Vitals taken again, continued monitoring.Patient signed Against Medical Advice form. Patient felt better released with friend at 12:10pm, Patient did not want to give name of her friend. Patients states she has a cardiac workup needed for surgery.
Patient arm swollen very large, intense redness and itching - afraid the skin will deteriorate. Advised antihistamine, cold pack, TYLENOL.
Patient came in on 08/01/2023 at 10:47 am to report a reaction to a vaccination she received on 07/08/2023. She stated that on the 2nd day, she had a few bumps appear, which increased in size. They were itchy and burning. It was localized to the area underneath the injection size. After around 3 days, blisters started appearing. She stated that she tried over the counter Benadryl, Calamine, and Neosporin cream. She had a consultation with her primary care physician (Dr.) on 8/1/23, who prescribed Valtrex and Gabapentin. The patient stated that it appeared as if the patient was having a shingles outbreak.
This spontaneous case reported by a consumer, describes the occurrence of back pain (pain in both side of her lower back), pain in extremity (little sore arm), arthralgia (joint pain), pain in extremity (pain in her right shoulder and goes down to her hand and fingers) and myalgia (muscle pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 011J20A) for COVID-19 immunization. No medical history reported. On Jan 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 13, 2021, patient experienced pain in extremity (little sore arm). On Jan 15, 2021, patient experienced back pain (pain in both side of her lower back). On Jan 17, 2021, patient experienced arthralgia (joint pain) and myalgia (muscle pain). On Jan 18, 2021, patient experienced pain in extremity (pain in her right shoulder and goes down to her hand and fingers). The patient treated with ibuprofen on Jan 17, 2021 for adverse event, unknown dosage form. On Jan 17, 2021, pain in extremity (little sore arm) had resolved. At the time of the report, back pain (pain in both side of her lower back), arthralgia (joint pain), pain in extremity (pain in her right shoulder and goes down to her hand and fingers) and myalgia (muscle pain): not resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medication included blood pressure pills. On Wednesday and Thursday, patient was fine only with little sore arm. On Friday, patient felt pain in both side of her lower back. This continued on Saturday morning. The day prior to report experienced join pain and muscle pain. On the day of report she felt pain in her right shoulder that goes down to her hand and fingers, she put a heating pad. On the day of report, the symptoms was still ongoing in her right-side, lower back. She could not stand up and was difficult to move. Reporter did not allow further contact. Sender's comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
received a Bivalent Moderna COVID-19 vaccine instead of the 2nd primary dose; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (received a Bivalent Moderna COVID-19 vaccine instead of the 2nd primary dose) and NO ADVERSE EVENT (No Adverse Event) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (received a Bivalent Moderna COVID-19 vaccine instead of the 2nd primary dose) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (received a Bivalent Moderna COVID-19 vaccine instead of the 2nd primary dose) 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 WRONG PRODUCT ADMINISTERED (received a Bivalent Moderna COVID-19 vaccine instead of the 2nd primary dose).    Concomitant medications were not reported.  Patient received Bivalent Moderna COVID-19 vaccine instead of the 2nd primary dose in another state. Reporter does not have any information as to the date of administration and the lot number of the Moderna COVID-19 Bivalent Shot.   Treatment information was not provided.   Reporter did not allow further contact
Mild but persistent bi-aural tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 12:30 (Lot number: EW0150) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Dose/Time: 15Mar2021 12:30, Site and route of injection: Left shoulder, Batch/Lot number: EN6207), administration date: 15Mar2021, when the patient was 50 years old, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 16Apr2021 18:00, outcome "not recovered", described as "Mild but persistent bi-aural tinnitus". The event "mild but persistent bi-aural tinnitus" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient had not taken other vaccine in two or four weeks. The patient had neither covid prior vaccination nor tested for covid post vaccination. The patient stated that a day after he was vaccinated, he noticed that he was hearing a high pitched and constant ringing. It wasn't loud (and remains the same volume) but it was constant 6 months later, I have the same constant ringing. The family doctor of the patient indicated that no treatment was suitable to the high pitched ringing especially since it was not loud enough to interfere with everyday hearing/activities.   No follow-up attempts are possible. No further information is expected.
Client reports she had 1 small cold sore along corner of upper lip starting 1/11 evening 1/12 morning time, then rec'd flu vaccine 1/12/04 around 2:40 pm. Went home after work around 3pm and noticed her cold sore was "rapidly worsening and lip started to swell." 1/13 8 am exam by PHN upper lip swollen, cold sore lesion 4- along upper lip. received prescription for anti-viral per MD specified, prn with relief by 1st day of talking med.
Two weeks ago, she was diagnosed with RA.; Now in pain and it is hard to walk; Has limited mobility and it is getting worse as weeks go by; Had acute pain and prior to the vaccine she had no pain; After her 2nd dose she starting experiencing a lot of joint pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Two weeks ago, she was diagnosed with RA.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Rheumatoid arthritis (Family history of rheumatoid arthritis) since an unknown date.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Two weeks ago, she was diagnosed with RA.) (seriousness criterion medically significant), GAIT DISTURBANCE (Now in pain and it is hard to walk), MOBILITY DECREASED (Has limited mobility and it is getting worse as weeks go by), PAIN (Had acute pain and prior to the vaccine she had no pain) and ARTHRALGIA (After her 2nd dose she starting experiencing a lot of joint pain). At the time of the report, RHEUMATOID ARTHRITIS (Two weeks ago, she was diagnosed with RA.), GAIT DISTURBANCE (Now in pain and it is hard to walk), MOBILITY DECREASED (Has limited mobility and it is getting worse as weeks go by), PAIN (Had acute pain and prior to the vaccine she had no pain) and ARTHRALGIA (After her 2nd dose she starting experiencing a lot of joint pain) outcome was unknown.            No concomitant medication provided.  Treatment information mentioned anti-inflammatory medication NOS.  Patient reported that after the second dose she experienced joint pain and found it hard to walk. Was diagnosed with rheumatoid arthritis and she states she has a family history of the same.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED. At the time of the report, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
w/in 24hr of vax arm felt bruised, blotchy redness w/swelling than subsided to confluent redness et swelling subsided in 72hr;
On the first two doses i felt cramps/bad circulationon my legs. I also felt tiredness, headache.  On third dose, moderna, I felt pain on the left lside of the lower back,pain in the left kidney, swollen left armpit with sharp pain. In summary. pain on my whole body and very tired.
This spontaneous report was received from a pharmacist via the patient's wife referring to a 55 year old male patient with diabetes mellitus. On 07-MAR-2017, the patient was vaccinated with the 2nd dose of PNEUMOVAX23 (lot # M040804, expiry date 20-MAY-2018) 0.5 ml, intramuscular for vaccination because the patient is diabetic. Other co-suspect or concomitant medications were not reported. On 08-MAR-2017, the patient was experiencing low-grade fever (pyrexia) and injection site reaction. The patient's wife told to the pharmacist that the patient has already received a 1st dose of PNEUMOVAX23 sometime in the fall of 2016 (unspecified date) but the patient had forgotten he had received that previous dose (inappropriate schedule of drug administration). The pharmacist recommended that the patient should take ibuprofen for his symptoms but it was not known if he had taken any yet. At the time of reporting the outcome of inappropriate schedule of drug administration, injection site reaction and pyrexia was unknown. Additional information has been requested.
This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 12:00 (Lot number: EW0179) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "known allergies: Shell fish" (unspecified if ongoing). Concomitant medication(s) included: AZOR [ALPRAZOLAM]. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EW0179, administration time: 12:00 PM, vaccine location: Left arm), administration date: 18May2021, when the patient was 64 years old, for COVID-19 immunisation, reaction(s): "Moderate Stomach cramps", "Nausea", "diarrhea", "Severe Fatigue", "IBS symptoms after first". The following information was reported: FATIGUE (non-serious) with onset 08Jun2021 12:00, outcome "not recovered", described as "severe fatigue"; ABDOMINAL PAIN UPPER (non-serious) with onset 08Jun2021 12:00, outcome "not recovered", described as "Moderate Stomach cramps"; NAUSEA (non-serious) with onset 08Jun2021 12:00, outcome "not recovered", described as "nausea"; DIARRHOEA (non-serious) with onset 08Jun2021 12:00, outcome "not recovered", described as "diarrhea/loose stools"; IRRITABLE BOWEL SYNDROME (non-serious) with onset 08Jun2021 12:00, outcome "not recovered", described as "IBS symptoms"; GASTROINTESTINAL DISORDER (non-serious) with onset 08Jun2021 12:00, outcome "not recovered", described as "GI symptoms". The events "severe fatigue", "moderate stomach cramps", "nausea", "diarrhea/loose stools", "ibs symptoms" and "gi symptoms" were evaluated at the physician office visit. Therapeutic measures were taken as a result of nausea. Additional information: Zofran was taken as treatment for nausea. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021723359 similar report from same reporter.
The report concerning a Male subject, who had been receiving FLUMIST, 0.2 Millilitres, Unknown. FLUMIST started on an unknown date. It was reported that administration of expired dose and product quality complaint. The outcome of the event of ADMINISTRATION OF EXPIRED DOSE and PRODUCT QUALITY COMPLAINT is unknown. An investigation is not required for a medication error unless it is a confirmed combined complaint. The report was considered to be non-serious by the company physician. Follow-up of insignificant information received by AstraZeneca/Medimmune 18-Mar-2016 from a Health Professional: PQC investigation summary report received.
Dizziness and lightheartedness/ Mild dizziness; This is a spontaneous report from a contactable pharmacist. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an intramuscular route of administration in the left arm on 27Feb2021 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, diabetes and obstructed sleep apnoea. The patient previously took ciprofloxacin (MANUFACTURER UNKNOWN) and metformin (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Feb2021,  the patient experienced dizziness and light heartedness that was not treated with medications. 20 minutes later patient reported mild dizziness. Patient drank 2 bottles of water. The events did not result in doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of event and included drinking 2 bottles of water. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.The clinical outcome of dizziness, light heartedness and 20 minutes later mild dizziness was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
ear pain; This is a spontaneous report from a contactable consumer reported for a female patient (sister). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took 1st shot of bnt162b2 for COVID-19 immunisation and she might experience pain in her arm but there was nothing about no ear nothing. The patient experienced ear pain on an unspecified date. The clinical course of the event was reported as her sister had her second dose of the Pfizer COVID vaccine over a month ago (did not know the date) and she had ear pain since then. Her sister's physician stated that ear pain had been reported with (university name) and a side effect of the vaccine. The reporter wanted to know if this was true and what should the patient do. The reporter stated that she herself took the Pfizer shot and she was a veteran and got it at the hospital and had no problems and her sister got hers from a drug store. The reporter stated what the doctor told her and that it was doing that was not right and that was why she was calling and a lot of people did not want to get it. The reporter stated that she went to an ear doctor and they could not find anything and then she went to her primary doctor and he found a study that found that it caused ear pain. She stated her husband also had the shot and did not have any problems. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Splitting headache. Mild headache at midnight the day/night after, pounding headache morning after Moderately sore arm
pt recv vax NOV97 & approx 23NOV97 pt exp a red pruritic generalized rash;pt went to MD for 2nd dose;pt given DPH & allegra;JAN & FEb98 devel redness & swelling of finger joints;dx cellulitis;
Developed 1/2 dollar size hive around area of injection - c/o pain & itching.
PFIZER-BIONTECH COVID- 19 VACCINE EUA.  PATIENT REPORTS RED RASH ON CHEST/NECK AREA THAT APPEARED 20-30 MINS FOLLOWING VACCINATION AND WORSENED OVER A COUPLE OF DAYS.  PATIENT DESCRIBES RED AREA AS HOT, BURNING AND IRRITATED LIKE SUNBURN OR BLISTERED.  NO SWELLING OR ITCHING NOTED.
Found sleeping with movements of extremities-Awoke and became stiff with some peripheral cyanosis-regained spont. breathing and became very flushed in the face with congested sound and vomited up mucus.  07/02/2007 MR received for 2 night admit 4/26-28/2007 for an episode apnea with color change and stiffening.  Parents noted large amt. of mucus in child's mouth.  PE WNL. On apnea and cardiac monitors during admission with no alarms.  Impression: ALTE: workup (-) so far.
minor sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient experienced minor sore arm after receiving his Shingrix vaccine The reporter did not consent to follow up. The reporter provided limited information and reporter did not wish to provide personal information. This case is 1 out of 4 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022026673:same reporter US-GLAXOSMITHKLINE-US2022026665:same reporter US-GLAXOSMITHKLINE-US2022026668:same reporter
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching) and FATIGUE (Extremely fatigued) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 011A21A) for COVID-19 vaccination. The patient's past medical history included Infusion (Entyvio (vedolizumab) infusion every week) since an unknown date. Concurrent medical conditions included Crohn's disease. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Extremely fatigued). On an unknown date, the patient experienced PAIN (Aching). At the time of the report, PAIN (Aching) and FATIGUE (Extremely fatigued) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. No concomitant medication reported. No treatment medication reported.
Fever of 99.and chills.  Lasted approximately 24 hours.  Took Advil and Tylenol before fever got higher and it helped with symptoms.
Developed vitiligo, subdermal cysts and joint pain. Patient also had the following symptoms: Insomnia, headache (general), joint pain (multiple joints), depression, memory loss (short term) and fatigue, malaise for more than 60 days.