chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Johnson & Johnson single dose shot at 1:45pm Friday 3/5/2021. Mild injection site pain and fatigue for the next two days. Patient then present with one-sided rash, painful extending from right shoulder, down past right buttock and onto right thigh.  Shingles was excluded as possible diagnosis (patient has history of shingles and has also received the shingles vaccine).  Topical ointment and spray was prescribed. No change as of yet. Patient reports water and clothing causes intense pain.  Rash is a deep reddish purple color.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR]; PANTOPRAZOLE; ESCITALOPRAM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19.  Additional information: Treatment with Paxlovid from 28May2022 to 29May2022 for COVID-19. No known allergies reported for the patient. Visit to the ER and given Benadryl. Device Date mentioned as 30May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Redness at site, warmth, swelling.  Tylenol as needed for discomfort.
Reaction to the 1st dose that made her decide not to take the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Reaction to the 1st dose that made her decide not to take the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Reaction to the 1st dose that made her decide not to take the 2nd dose). At the time of the report, ADVERSE EVENT (Reaction to the 1st dose that made her decide not to take the 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
Synchopal episode followed by perspiration, pallor and nausea. Ambulance called to home by husband follow up at Hospital ER.
Twitching and fever started on 03/11/2002. Has not seen MD.
On 1/14/01, lost peripheral vision in right eye for 20-30 minutes. Rash on chest on 1/16/01. Upper left arm hurts on occasion; possibly pulled muscle?
This spontaneous report as received from an office manager refers to multiple patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9 (lot # M044717, expiry date: 19-JUL-2019) (dosing details were not reported) for prophylaxis at a temperature of 35 degree Fahrenheit for 5 full days (incorrect product stored). No adverse effects reported. No previous temperature excursions reported. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1708USA002323.
Patient had headache and muscle pains following vaccination. On day 11, patient had a syncopal episode after which she woke up laying on her left hand. Patient was seen in the urgent care and transferred to Medical Center.
This spontaneous report was received from a quality control individual at a medical facility refers to a patient of unknown age. On 06-NOV-2012, the patient was vaccinated with a dose of M-M-R II (lot # 0682AE, exp: 26-JAN-2014) (Dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. The reported called for a patient who were administered M-M-R II that was exposed to an unsupported temperature excursion (10.1C for 96 hours). No adverse effect reported. This is one of seven reports from the same source. Additional information has been requested.
Pt had 55 macules/papule lesions; fever of 100; no cold, vomiting or diarrhea; no medication of underlying conditions; source of exposure to vaccine strain is unknown.
Patient reported to PCP that she received Moderna Covid19 vaccine (lot 006C21A) at another facility on 5/20/21 and then received one dose of Pfizer vaccine as documented here on 7/1/21. Patient denied adverse reaction to either, simply concerned whether further doses would be required. No further doses administered of either product.
This spontaneous report as received from a pharmacist refers to a 73 years old female patient. The patient was vaccinated with a dose of ZOSTAVAX (lot number, dose and route not reported) on 21-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. On 21-JUN-2012 the patient experienced cellulitis. The patient sought medical attention by visiting emergency room and was treated with CIPRO. The outcome of cellulitis was reported as recovered/resolved. The relatedness for cellulitis was unknown for ZOSTAVAX. Additional information has been requested.
This spontaneous report was received from a physician via a company representative concerning a patient of unknown age and gender. No concurrent condition or medical history were described. On an unknown date, the patient was vaccinated with ZOSTAVAX, (dose or anatomical location were not provided) subcutaneous. Concomitant therapy was not reported. On an unknown date, the patient experienced "small shingles like rash". The patient sought for medical attention by called the physician. At the reporting time, the outcome of small shingles like rash was not informed. Additional information has been requested.
Information has been received from a school registered nurse concerning a 12 year old female student in the sixth grade who on 8/24/96 was vaccinated with a dose of varicella virus vaccine live. The school registered nurse reported that on 5/3/04 at 08:30 AM the student presented with multiple vesicles on her torso, palms of hands and legs. The school nurse reported that the student had breakthrough chicken pox and described the rash as 20 or less pox that were unusual in appearance and unusual in location. The nurse noted the student did not have fever or malaise. The school nurse mentioned that the student had been seen by her family practice for the diagnosis of breakthrough chicken pox. It was noted that the student lost five days of school, however, no treatment was required for the adverse event of breakthrough chicken pox. The breakthrough chicken pox abated and the student recovered on 5/10/04. There was no product quality complaint reported. Unspecified medical attention was sought. No additional information is expected.
patient received VAQTA and PROQUAD that had undergone temperature excursion; No additional AE reported.; This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Recombinant Human Albumin (rHA) (PROQUAD) administered as prophylaxis, lot number W006584 with reported expiration date of 12-NOV-2022, however, upon internal review it was confirmed to be 23-AUG-2023 (dosage regimen and route of administration were not provided), and a dose of Hepatitis A Vaccine, Inactivated (VAQTA) administered as prophylaxis, lot number U026792 with expiration date 28-OCT-2022 (dosage regimen and route of administration were not provided). The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Recombinant Human Albumin (rHA) (PROQUAD) vaccine underwent a temperature excursion of 76.1 degrees Fahrenheit (F) for 322 hours and 15 minutes, the Hepatitis A Vaccine, Inactivated (VAQTA) vaccine underwent a temperature excursion of 21.9 F for 147 hours. Both vaccines experienced previous temperature excursions (Product storage error). No additional adverse events were reported (No adverse event).
I currently have COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I currently have COVID-19) 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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced COVID-19 (I currently have COVID-19). At the time of the report, COVID-19 (I currently have COVID-19) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.  It was reported that the patient was about to get second Moderno shot on August 22.
Systemic: Other- unknown, depot store received call from facility on 1/22 that patient passed around 7pm
pt recv vax 4DEC98 925AM & fell down on elbow;got up & fell down again;felt dizzy cold & clammy;BP 88/50;
CHILLS; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and slight headache was not reported. This report was non-serious.
cried from 230PM until 730PM; temp 100 ax was all right the following morning;
-AMENORRHEA (NO PERIOD AT ALL) LASTING FROM JUNE 2021 TO MARCH 2022 (9 MONTHS) -SUDDEN VISION CHANGE IN ONE EYE, RESULTING IN INABILITY TO SEE/SCINTILLATING SCOTOMA; WITH HEADACHE. LASTED 2 HOURS.
Info from patient: 51 year old healthy woman went Nov 16,2005, for a routine flu shot that was offered by Employee Benefits section of the County. She states that the injection was given very rapidly and with force that seemed like "stabbing." This was much more forceful and fast than previous shots she had received. She had local soreness that day and then had increasing soreness and weakness of her left arm. She states that since then she cannot lift heavy items with that arm and sometimes her arm is so weak that she has trouble getting her arm into a sleeve. She states that the pain varies between discomfort and more severe pain and is sometimes up into her shoulder and down to her wrist. She was seen at the office of her primary care doctor in December, 2005. She reports that the doctor said her symptoms could be from the shot, or could be tendon damage but that there were no specific answers. Ibuprofen was prescribed. She will return to her doctor because she still has the weakness and pain as of January 27,2006.
Information has been received from a Publicis employee and a pharmacy technician referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX lot# reported as L001477 with expiry date 10-JUL-2016(dose, frequency and route were not reported), which was improperly stored. No adverse effects were reported. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypotension (BP 88/73, HR 91), Amnesia? Did not remember what occured.-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Pt was layed on floor and feet elevated. BP during incident was 88/73, HR was 91. Pt recovered briefly after, but did not remember what happened.
Fever of 102+, chills, body pain throughout entire body with what I would call "hot spots", left hip and left lower back. Headache that felt like no other I've had primarily on left side above my ear. Vomiting and urination. Fatigue. Weakness.  I was on the verge of going to ER called on-call doctor instead. They advised me to try and get through the next few hours. They also ended up calling me in a medication to help with my vomiting. I was sick for a little over 24 hours with main symptoms. Still feel worn down.
Later in the night of 03/18/2021, after my vaccine, I ran a fever of 102, had severe stomach pain, I couldn't sleep and my head felt like it was going to burst. I sat in my recliner after using the restroom and I noticed that my body started to involuntarily shake. This went on for an hour.  After about an hour I then started to get chills. The only thing I could do at that point was go to bed and stay there. The next morning I phoned my doctor and the doctor advised to take acetaminophen. This feeling of uneasiness went on for about 5 days. I just felt like I wasn't myself. My left arm was also super sore right below the elbow. I do have Achalasia, a condition where I am unable to throw up, and I think that is why my stomach was in so much pain. I did not go in to my doctor's office.
Fever of 100.5 axillary on 1-22-15 only for the one date. Next day patient was fine.
OBSTRUCTIVE SLEEP APNEA ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE  07/24/2022 - same adverse events reoccurred
Pt had skin infection at injection site, came with complain of started swelling, pain, tenderness and warm to touch increasing in size at site of injection in last 2 days.
Almost immediately after vaccine (GARDASIL) was administered, the patient passed out & developed seizure activity (clonic-tonic), which lasted for about 10 seconds. No treatment needed.
I have been feeling foggy and slightly dizzy. Pressure in my left ear. Ringing in my left ear. ad 2 vertigo spells to the point where I could not drive and one where I had to lie down immediately to prevent falling. I have been anxious, having waves of anxiety.
Upon give the injection, the syringe failed and part of the dose leaked out of the side of the syringe. The patient did not received a full dose.  The patient will try at a later date to get a full dose at a different pharmacy.
swollen glands in groin, arms, chin, neck & behind ears; low grade temp 99 F; lethergy, h/a, muscleache, chills;
covid; covid; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 37-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 12Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years for COVID-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "BMI 45" (unspecified if ongoing), notes: Other medical history: BMI 45; "GERD" (unspecified if ongoing), notes: Other medical history: GERD; "OSA" (unspecified if ongoing), notes: Other medical history: OSA; "HSV" (unspecified if ongoing), notes: Other medical history: HSV. Concomitant medication(s) included: SEMAGLUTIDE; VALACYCLOVIR [VALACICLOVIR]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (24May2022) Negative; (28May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: Paxlovid Rebound, after taking paxlovid he had negative test on 24May2022 and felt he had recovered fully without any more symptoms. Then 4 days later on 28May2022, then had redevelopment of symptoms and positive test again. Now had mild symptoms and recovering. He had no known allergies. Other medical history: Obesity BMI 45, GERD, OSA, HSV and VV.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
No additional AE reported; patient was inadvertently administered a dose of MMR II after its labeled expiry date; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 04-MAY-2021, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S007813, expiration date 14-MAR-2021; strength, dose, route of administration and anatomical location were not reported) for prophylaxis after its labeled expiry date (expired product administered). There were no known temperature excursions. No additional adverse event reported (no adverse event).
Facial weakness (left side), lip paralysis (left side), decreased sense of taste, eye leakage (left side), facial tingling (left side). Onset 1/4/2021 with symptoms worsening through the week. Noticeable lip paralysis starting on the afternoon of 1/10/2021. 2nd vaccine received at 8:00AM on 1/10/2021.
Extreme skin sensitivity to clothing.  Alternating hot/cold flashes that lasted 30 minutes to several hours.  Symptoms started about 36 hours after injection.  The symptoms were extreme for the first 2-3 hours and mild for another 24 hours.
This non-valid, spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information concerning patients' pertinent medical history, concurrent conditions or concomitant drugs was provided. On an unknown date, the patients were vaccinated with GARDASIL 9 (lot# reported as 17457 and expiration date: unknown day in April 2021) (dose and route of administration not provided) for prophylaxis. The staff at the reporter's clinic had difficulty holding the syringe with GARDASIL 9 since there was not much of a lip or area to put your fingers to get a good grip on it. A couple of the members of the staff almost dropped the syringe or it slipped as the health care professionals were starting to give the injection. The outcome of the event was unknown. Lot # 17457 is an invalid lot # for GARDASIL 9.
four days post vax pt awakened with great degree of stiffness and pain in arm muscles above and below the elbow and muscles in buttocks. Pt still experiencing same problems at the time of report.
dizziness; arm soreness; fatigue; feeling like "the walls are caving in"; My son is 10 and was given the 12+ vaccine; My son is 10 and was given the 12+ vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 10-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Nov2023 as dose 1, single (Lot number: HF9298) at the age of 10 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing), notes: unknown past drug. Concomitant medication(s) included: CLARITIN [LORATADINE]. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 13Nov2023, outcome "unknown" and all described as "My son is 10 and was given the 12+ vaccine"; PAIN IN EXTREMITY (non-serious) with onset 13Nov2023 at 06:30, outcome "recovering", described as "arm soreness"; DIZZINESS (non-serious) with onset 13Nov2023 at 06:30, outcome "recovering"; FATIGUE (non-serious) with onset 13Nov2023 at 06:30, outcome "recovering"; FEELING ABNORMAL (non-serious) with onset 13Nov2023 at 06:30, outcome "recovering", described as "feeling like "the walls are caving in"". Therapeutic measures were not taken as a result of product administered to patient of inappropriate age, overdose. Therapeutic measures were taken as a result of dizziness, pain in extremity, fatigue, feeling abnormal. Additional information: He was given acetaminophen last night before bed.
patient was fully vaccinated with moderna as of April. Patient is symptomatic and has tested positive as of 8/24
transient transaminitis from4OCT90 to 7OCT91; benign liver cysts found on ultrasound of the liver;
WINTHIN AN HOUR OF GETING OF RECIEING THE FLU VACCINE I STARTED FEELING REALLY DIZZING I WENT TO GET MY HUSBAND THEN MY LEGS GOT SO WEAAK THEY FOLDED UP AND GOT REALLY PALE. MY NEWPHE SAID CALL 911 SHES'S BOUT TO  PASS OUT. RESCURED SQUAD CAME AND CHECK MY OXYGEN WAS LOW  THEN TOOK ME TO THE HOSPITAL. THE EKG SHOWED  MY HEART REPEATLY DROPPING. ONCE THE DIZZY NESS PAST THE EKG WAS FINE.  THEY GAVE ME A BAG OF FLUID, CHECKECD MY BLOOD PRESSURE AND DREW BLOOD THEN SENT ME HOME.   10/15/2022
4 1/2 yo CF presented with swollen, red, and warm (L) deltoid. Tender to touch. Symptoms occurred 1 day after vaccination administration (4/12/08). Doctor visit 4/14/08. Keflex prescribed.
Below my shoulder blades on my back down to my waste swelled up and got all red and blotchy and its incredibly painful to the touch. It feels like my skin would fall off. I can barely stand. I had rolls of swollen skin. Slightly itchy but cant itch because of the discomfort of touching my skin. Since Friday when it started it is getting better. Today is Monday. I took a Benadryl Friday night.
Fever, Chills, Headache, Body Aches, Chest tightness and shortness of breath for about 72 hours