chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Area was also warm; Area was also itchy; Red circle at the injection site; Injection site swollen; Injection site soreness; Injection site sensitivity; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Injection site sensitivity), VACCINATION SITE WARMTH (Area was also warm), VACCINATION SITE PRURITUS (Area was also itchy), VACCINATION SITE ERYTHEMA (Red circle at the injection site) and VACCINATION SITE SWELLING (Injection site swollen) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Obesity.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced VACCINATION SITE REACTION (Injection site sensitivity) and VACCINATION SITE PAIN (Injection site soreness). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Area was also warm), VACCINATION SITE PRURITUS (Area was also itchy), VACCINATION SITE ERYTHEMA (Red circle at the injection site) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, VACCINATION SITE REACTION (Injection site sensitivity), VACCINATION SITE WARMTH (Area was also warm), VACCINATION SITE PRURITUS (Area was also itchy), VACCINATION SITE ERYTHEMA (Red circle at the injection site), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PAIN (Injection site soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication included Doxycycline.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.
Information has been received from a pharmacist concerning a 46 year old female with history of morphine allergy who on 09-JUN-2008 was vaccinated with a dose of VARIVAX (Merck) (lot# 658182/1559U) 0.5ml SQ. Concomitant therapy included Lisinopril-HCTZ (manufacturer unknown), pravastatin Na, omega-3 marine trglycerides (Omega-3), vitamins (unspecified), vitamin D (unspecified) and ginkgo. On 10-JUN-2008 the patient experienced an injection site reaction consisting of slight swelling, induration, warmth to the touch, and pruritus at the injection site. The pharmacist has requested a lot check to see if there were any similar reports made with this lot. The patient was recovering. The patient sought medical attention at the practice. A lot check has been initiated. A standard lot check investigation was performed. All in-process quality checks for the number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
FELT HORRIBLE; BODY ACHES; CHILLS; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unknown) dose was not reported, 1 total, administered on 24-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced felt horrible. On 25-MAR-2021, the subject experienced body aches. On 25-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt horrible, chills and body aches was not reported. This report was non-serious.
Diarrhea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and CHILLS (Chills). At the time of the report, DIARRHOEA (Diarrhea) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment was provided.
ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 5/6/2022 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURE UNKNOWN), for COVId-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURE UNKNOWN), for COVId-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURE UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURE UNKNOWN), for COVId-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURE UNKNOWN), for COVId-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid treatment from 05Nov2023 to 09Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367514 same patient, different drug/event (Paxlovid case);
Pt developed urticaria, dizziness and pallor 15 min after injection. He was given 2 liters IV fluid (lactated ringers) and 25mg of Benadryl with reversal after 30 minutes. He resumed activity after 8 hours.
This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions or allergies, concomitant and historical drugs was not provided. On 25-JUL-2018, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N025719, expiration date 17-MAR-2019, subcutaneouslly (dose was not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to a temperature of -14°C to -10°C for 15 hours and 57 minutes, and in the range of -9°C to 8°C for 27 hours and 48 minutes. There was not previous temperature excursion. It was reported that data logger was involved. No adverse effect was reported.
Rash started on my legs and neck.  By the next morning I was covered with the rash, no fever, but very itchy.  Not on my face or hands, but everywhere else and very, very itchy.
Rash on entire body from face (including scalp) to ankle. Rash began on torso - entire torso is red. Rash went down both legs getting more diffuse below knee. Neck and arms are blotchy.
Side effects; This case was reported by a consumer and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient asked how long do the side effects last. The reporter was not a health care professional. The reporter did not gave permission to follow up.
Less than 24 hours after getting  his 2nd vaccine patients ICD went off and he went into Ventricular tachycardia and had to be admitted to the hospital for several days.
Was administering a flu vaccine on 7 yr old. Took about 10 minute for patient stay still for vaccine. After I already had needle in patients L arm, She moved away from me across the room. I pulled out neddle and notice that I had only injected half of flu doses into the patients arm.  I directly went to my supervisor and made her aware of the situation
Information has been received from a female consumer (age not reported) who on 04-JAN-2017 (reported as "last Wednesday") was vaccinated with a dose of ZOSTAVAX (site and route not reported) for prophylaxis and had been experiencing itchiness. The patient did not state were the itchiness was. No product quality complaint involved. The relationship between itchiness and vaccination with ZOSTAVAX was not reported. Additional information is not expected as no consent to follow up was obtained.
On Tuesday, Oct 14th, (R) thigh was red, swollen, hurting, itchy and warm to touch. Raised area on (R) thigh size of soft ball. Wednesday, Oct 15th, less redness noted, however, swelling remain the same. Still hurting and warm to touch and itchy. Thursday, Oct 16th (R) thigh remain the same, swollen, painful, itchy and war to touch.
Patient was due for Infanrix, HIB and Prevnar 13.  Gardasil 9 inadvertently removed from vaccine storage instead of Prevnar 13.  Gardasil 9 was inadvertently administered.
headache; fever; This spontaneous report was received from a physician and refers to a 13-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-JUN-2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular for prophylaxis (strength, frequency, lot # and expiration date were not reported).  Within 12 hours (on the same date), the patient presented with a 101.3 degrees Fahrenheit (F) fever and headache.  At the time of reporting the patient still had a low grade fever of 99 degrees Fahrenheit (F). The outcome of headache was not reported, the outcome of fever was not recovered. The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
This spontaneous report was received from a Registered Nurse referring to a 24 year old patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of PROQUAD subcutaneouslly, lot # M031942, expiration date on 27-DEC-2017 (strength, dose number and anatomical location were not provided) for prophylaxis. Other suspect therapies included sterile diluent(manufacturer unknown) (strength, dose number and anatomical location were not provided) for prophylaxis. No adverse event reported. No product quality complaint was involved. Additional information has been requested.
Intense shivering followed by 2 hours and continuing of a hard, pounding heartbeat that will not relax. Have been drinking plenty of water no probably not dehydration. Had a very similar weird reaction to a muscle relaxer I cannot remember the name of about a year ago.  Oth instances have occurred at night. Heartbeat seema stable, just fast and so hard that I can feel it pulsing up my neck.
I BROKE OUT THREE DAYS AFTER  WITH SORES ON MY TONGUE AND THROAT. THE GLANDS IN MY NECK WERE SORE FOR DAYS, STILL HAVE SOME PAIN IN MY EARS AND MOUTH IS STILL VERY SORE.   I HAD HEAD ACHES FOR FIRST FEW DAYS.  THE SORE MOUTH IS VERY BOTHERSOME. WENT TO DR BUT THEY SAID I HAD TO JUST RIDE IT OUT. IT HAS BEEN FOUR WEEKS NOW AND NOT ANY BETTER. I DID HAVE A COVID TEST JUST FOR PEACE OF MIND BUT IT WAS NEGATIVE.
Arm swelled up to 1 and 1/2 inch square and 1/2" thick lump within 30 seconds. Gave 2 BENADRYL capsules 25mg and kept patient her to monitor for 15 minutes.
10-15 min. after vaccination she became very pale - lost color in her skin and lips, became drowsy, her eyes rolled back; tremors occurred, she went limp and lost her consciousness for about 2-3 minutes.
Sore arm; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Feeling tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 012A214) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included CARBIDOPA, LEVODOPA (LEVODOPA/CARBIDOPA), INSULIN, ESCITALOPRAM OXALATE (LEXAPRO), COLECALCIFEROL (VITAMIN D 3), ACETYLSALICYLIC ACID (BABY ASPIRIN), RIVASTIGMINE, SIMVASTATIN, MELATONIN, CALCIUM LEVOMEFOLATE (DEPLIN [CALCIUM LEVOMEFOLATE]) and MULTI VIT for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-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 PAIN IN EXTREMITY (Sore arm) and FATIGUE (Feeling tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Feeling tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-051280 (Patient Link).
mild case of the shingles on chest; warm to touch area around injection site; red area around injection site the size of the palm of hand; swollen area around injection site the size of the palm of the hand; in the middle of this spot, he also developed a hard spot approximately 3/4 round in diameter; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (mild case of the shingles on chest), VACCINATION SITE WARMTH (warm to touch area around injection site), VACCINATION SITE ERYTHEMA (red area around injection site the size of the palm of hand), VACCINATION SITE SWELLING (swollen area around injection site the size of the palm of the hand) and VACCINATION SITE INDURATION (in the middle of this spot, he also developed a hard spot approximately 3/4 round in diameter) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 017B21A) for COVID-19 vaccination.     The patient's past medical history included Stroke (history of strokes and mini strokes) and Cerebrovascular stenosis NOS (History of narrowed blood vessel in brain causing strokes). Concomitant products included TICAGRELOR (BRILINTA) and ACETYLSALICYLIC ACID (ASPIRIN 81) for Anticoagulant therapy, EVOLOCUMAB (REPATHA) for Cholesterol blood increased.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch area around injection site), VACCINATION SITE ERYTHEMA (red area around injection site the size of the palm of hand), VACCINATION SITE SWELLING (swollen area around injection site the size of the palm of the hand) and VACCINATION SITE INDURATION (in the middle of this spot, he also developed a hard spot approximately 3/4 round in diameter). On 04-Apr-2021, the patient experienced HERPES ZOSTER (mild case of the shingles on chest). The patient was treated with MUPIROCIN (BACTROBAN OINTMENT) on 04-Apr-2021 for Shingles, at a dose of UNK, prn. On 18-Apr-2021, VACCINATION SITE WARMTH (warm to touch area around injection site), VACCINATION SITE ERYTHEMA (red area around injection site the size of the palm of hand), VACCINATION SITE SWELLING (swollen area around injection site the size of the palm of the hand) and VACCINATION SITE INDURATION (in the middle of this spot, he also developed a hard spot approximately 3/4 round in diameter) had resolved. At the time of the report, HERPES ZOSTER (mild case of the shingles on chest) had not resolved.         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.   This case was linked to MOD-2021-209373 (Patient Link).; 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.
having significant fatigue and muscle soreness/ tiredness/ high fatigue; having significant fatigue and muscle soreness/She feels like she has been fighting a war with the muscle aches/ Muscle pain; have a headache; feel like crap; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021381327 (Pfizer).  A 62-year-old female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Lot number: ER8732) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "having significant fatigue and muscle soreness/ tiredness/ high fatigue"; MYALGIA (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "having significant fatigue and muscle soreness/She feels like she has been fighting a war with the muscle aches/ Muscle pain"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "have a headache"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "feel bad".  Additional information: Caller is a 62-year-old female who had the first dose of the Pfizer Covid 19 vaccine on 26Mar2021. She realized this past week she is having significant fatigue and muscle soreness. She did have a headache, but it has resolved. "How long will this last? I feel like crap. And I'd like to know how long I'm going to not feel good. She has been feeling not good for a while and then today all of the sudden she thought maybe it may be from the vaccine. She feels like she has been fighting a war with the muscle aches and fatigue. States she just wants to know how long she can expect it to last. Patient mentioned above lasted for 7 days and that she started to feel better on day 8.   No follow-up attempts are possible. No further information is expected.
Had tetanus shot after receiving stitches in left thumb. Area in left arm where shot administered has remained red, swollen, sore since day after.
A 12 year old patient was given a low dose (orange top) for 5-11 years of  age  Covid Vaccine.  Patient had no symptoms of the 30 minutes being observed. Patient was discharged shortly after.  Supervisor called mother and informed that low dose (orange top) 5- 11 year old covid vaccine was administered and would returned 21 days after last dose for full dose (purple top) 12 and up.
Pt felt nauseated and achy in back, arms and chest. Also some pain at vaccine site. Tiny bump and sm amt bruising at site sl under 1 cm. No treatment. Pt also ate chicken salad sandwich last night with a caffeine slushy.
Hospitalized twice (1/4/2022-1/12/2022 and 1/26/2022-2/2/2022) with the following symptoms: multisystem inflammatory syndrome, pericardial errusion, bilateral pleural effusions, tachycardia, transaminitis, leukocytosis, fever, shortness of breath, tachypnea, abdominal pain, bloating, shoulder pain, arthritis, joint swelling, skin rash, fatigue.  Treatments: ceftriaxone/azithromycin, fluconazole, levofloxacin, lidocaine, prednisone, ursodiol.  The elevated liver enzymes remain unresolved. Possible case of primary biliary cirrhosis with possible additional case of autoimmune hepatitis.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 14-DEC-2015 the patient was vaccinated with an improperly stored dose of VAQTA 10Pk 25 U/0.5 mL (lot # L004439, expiration date: 15-FEB-2016; dose and route were unknown). No adverse effects were reported. The vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours. The lowest recorded temperature was 34 Celsius degree. The storage criteria of the vaccine and the type of excursion were refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
pains in his stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "wound on his leg thats oozing" (unspecified if ongoing), notes: His doctor prescribed Cephalexin 500 mg for a wound on his leg that's oozing. Concomitant medication(s) included: CEPHALEXINE. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset Mar2021, outcome "unknown", described as "pains in his stomach".  Additional Information: HIs doctor prescribed Cephalexin 500mg for a wound on his leg that was oozing.  Can he take vaccine along with antibiotic?  HCP was unsure.  He does not want to mess up the vaccine from working.    No follow-up attempts are possible; information on the lot/batch number cannot be obtained. No further information is expected.
pericarditis per ct scan two months later.  after injection severe tiredness, fever ,  chest pain and shortness of breath for a couple of months
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hypotension-Severe, Systemic: Weakness-Mild
Patient symptoms of worsening erythema of left thigh at injection site 1 day after receiving vaccine. Patient came in 2 days to urgent care after vaccine was given at their PCP clinic because of worsening redness of skin, warmth, swelling, and  tenderness of injection site and blistering. Denies fever.  Treatment: Wound care to area in clinic and antibiotics prescribed Cephalexin TID x 7 days  Outcome: child followed up the next day in UC with improvement of symptoms and continued wound care
Patient was very irritable, not sleeping, vomited x2, & had elevated temperature. These symptoms started 36 hrs after vaccines. Then 2 days after patient became more congested & started coughing. Highest temperature was 99.9 rectally.
Pt vaccinated w/TTox developed large area of induration & erythema extending from shoulder to elbow & central bullae. Marked tenderness. prescribed tegopen & warm saline soaks.
After receiving the vaccination I received a tiny rash on my face. It's located down my forehead and down the chest; this is ongoing.
Sneezing, coughing, wheezing, swelling of face, tongue, gums and lips. Took Advil at 3:45 P.M. and one Claritin at 8:45 PM.  Took second Claritin after ER visit.
Pt's arm became swollen and they said it is the size of a baseball. Red and hot to the touch and itches.
Dizziness followed by fainting. Black vision for a 20 seconds after regaining consciousness.