chrisvoncsefalvay/vaers-outcomes huggingface dataset:
That night after the vaccine, patient developed swelling and pain to the lymph nodes in her right axillae, which then worsened over the next few days, developed redness to the breast.  This over the course of a week started to resolve.  Currently is still swollen, mildly tender, and some redness still present but not as bad as initial.
On 01/17/2001 the patient presented to the physician's office, and Infectious Disease practice, with Herpes Zoster on the left arm. To the nurses' knowledge, the patient was a normal, healthy child, with no history of recent varicella exposure, including no in utero exposure, and no known immunosuppression. The nurse noted that the lesions extended from the left shoulder area down his arm towards the fingers. Additionally, the child has itching and fussiness. Information from the VZV ID program stated that the final PCR results for the vesicular specimen was positive for OKA vaccine strain VZV. Additional information has been requested.
Started feeling ill 02/21/2023 with cold symptoms and nausea treated myself by taking DAYQUIL or NYQUIL or medication for my stomach, nausea went away 02/23/2023 runny nose and headache, more congestion as my stomach got better, 02/24/2023 morning did at home Covid test got strong positive result contacted my doctor who prescribed PAXLOVID started taking it Saturday morning 02/25/2023.
My daughter had a large hive at the site of injection immediately following the injection. She then over the course of the next 2-3weeks had worsening coughing, sneezing and nasal congestion of which I asked the MD if she should receive the vaccines because she was feeling sick. I was advised to have her receive the vaccines. Hive-like inflammation returned to my daughter's right thigh where injections were given on Jan 7, 2023.
Approximately one minute after vaccination patient lost color and was placed on the ground with feet elevated. Patient briefly lost consciousness. Blood pressure dropped, lowest point was 100/43. Patient resumed consciousness and stated ?this happens all the time, I think I?m going to faint again?. Patient lost consciousness again. Patient resumed consciousness. Color returned to face, BP began to rise and return to baseline of 120s/60s per patient report. EMS arrived at 1620, evaluated patient and determined they were stable.
Patient reported small watery blisters, one behind ear, a couple on arm, on her back and under breast. Patient was seen by primary MD on 6/14/2018 and MD does not think reaction is caused by vaccine. Diagnosis unspecified angioedema. Patient prescribed Clobetasol Cream to apply as directed.
This spontaneous report has been received from a Nurse via a Company Representative, concerning a patient of unknown age and gender. The patient's medical history, concurrent condition an concomitant medications were not provided. On 20-APR-2017, an unspecified health care provider was administering a dose of properly stored vaccine of GARDASIL 9 (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis; and while drawing up the vaccine from the vial into a syringe, lost some of the vaccine liquid which spilled onto the surface of the patient's arm. The remainder of the incomplete dose was "wasted" and the patient was administered a new fresh dose of GARDASIL 9 with no problems. No adverse effects reported. There was no product quality complaint involved. Additional information is not expected as the reporter did not wish further contact.
55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant mediations were not reported. Dose given at time of puncture 9/3/21, was obtained 6/1/21 and kept in freezer until date of puncture, then stored in refrigerator.
A physician reported that a 57 year old female received an injection of Pnu-Imune 23 on 9/26/00. The next day, the pt developed an injection site reaction characterized by a red welt, "covering her entire arm from shoulder to elbow", swelling, warmth and pain. She was seen by the physician. This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23 lot 466788.
VENOUS CLOT AND THROMBOSIS; This spontaneous report received from a physician via a company representative concerned a patient of unspecified age, ethnicity, 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, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced venous clot and thrombosis, and was hospitalized (date unspecified). It was reported that the patient was currently hospitalized and the physician was asking for information in regards to anticoagulation therapy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of venous clot and thrombosis was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: A patient of unspecified age, ethnicity, and sex experienced venous clot and thrombosis an unknown time after vaccine. This was reported by a physician to a company representative. No laboratory values are reported. No clinical history, medical history, medications, or details are reported. There is insufficient information to make a meaningful medical assessment. Additional information has been requested including attempted contact with the treating physician.
7-year-old child received the flubok (with no reported adverse event); Initial information regarding an unsolicited valid non-serious case received via health professional on 14-Oct-2022. GMI number: 01322654  This case involves a 7-year-old male child received Influenza Quadrivalent Recombinant Vaccine [Flublok] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Oct-2022, the 7-year-old male child received suspect Flublok vaccine at dose 0.5ml once (lot: UJ893AB, expiry date: 09-Jun-2023) via intramuscular route in the right deltoid for Immunization with no reported adverse event) (product use issue) at same day latency.  It was reported that "Physician office staff is calling to report that a 7-year-old child received the FLUBLOK. Caller is wanting to know what to do and what side effects the child may have. This situation is reported as a medication error due to giving the medication to not approved age."   Action taken: Not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Warmness and tingling in arm and face. Redness to face and chest.  Informed to seek medical help if any further symptoms arise with concern.
Left arm below the deltoid (injection site) began to swell, turn red, and felt warm to the touch. Patient went to primary care MD on 11/7/14 for a DECADRON IM.
shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 67-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 12-DEC-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a healthcare professional for the following injuries resulting from patient's zoster vaccine live (ZOSTAVAX) use: shingles. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
I developed tinnitus about 2 weeks after the 3rd dose of Pfizer shot. I have never experienced tinnitus before. It has been ongoing till now. Saw neurologist who thought it was vaccine related. I am myself a doctor.
Groin pain on right side. To touch feels like 2 small pebbles. Ongoing since week after 1st dose of vaccine.
Within 25 hours of the second vaccine my head throbbed, and a loud high-pitched sound engulfed my head. The sound has lessened but is still present. I have been diagnosed with tinnitus. I have been to the doctor three times and have had audiology appointment and an MRI. I have hearing loss in my left ear and slight hearing loss in my right ear. Today 12/20/2021 my doctor recommended that I no longer get mRNA vaccines. He said to get the Johnson & Johnson vaccine if I have to get a booster.
Heart attack / she had a MI / diagnosed as a NSTEMI; This is a spontaneous report from a contactable healthcare professional (patient). This 52-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm, on 07Jan2021, for COVID-19 vaccination. Medical history included autoimmune thyroiditis (Hashimoto's thyroiditis) from 1998 and vitiligo from 1988. She was overweight. She had really no other risk factors. Concomitant medications were not reported. On 08Jan2021 the patient experienced heart attack and she had a MI, then a cardiac catherization that was normal and a normal echo as well. She said it was diagnosed as a NSTEMI and not a large MI, the smaller version. These events required hospitalization from 08Jan2021 to 12Jan2021. MI occurred after she finished clinic and she was not standing or doing anything, just sitting and she had chest pain. Her office was right next to the ER, so she received treatment within an hour and they were able to help her. She said that her hospital couldn't do a cardiac cath, so on 11Jan2021 they moved her to an hospital which was another treatment facility. When she had her MI they gave her acetylsalicylic acid (ASPIRIN) and sublingual nitroglycerin. They tested her troponin and did an EKG which was abnormal on an unspecified date in Jan2021. On 08Jan2021 troponin was increased. When they treated her with nitroglycerin and Aspirin, two hours later her EKG was normal and her troponin came down overnight on 09Jan2021, which was when they said for sure that she had a heart attack. The patient said it was very scary to have a heart attack, but thankfully there was not a lot of damage done and she was able to get treatment quickly. She did not think the event was disabling since they did not see much damage to her heart muscle, it was a near miss kind of thing. She said it was life changing in that she will now be on medication forever, she will be on at least a baby Aspirin and probably something like a statin for the rest of her life. She was recovering, it was unknown what the lasting effects may be, she felt normal but tired from her hospital stay. Heart attack resolved on 08Jan2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event acute myocardial infarction cannot be excluded. The contributory role of the patient age and background of obesity cannot be excluded as well. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Presents flushed, reports "heart racing";  vitals obtained/ stable, po hydration, rest, monitor x 30 minutes symptoms subside/ status improves/ reports "feels better" released from facility to home
WHen the vaccine was administered, I told the nurse and doctor that it was the most painful vaccine shot I ever had on my arm. I don't have a lot of fat as I exercise. I woke up early next day around 4 am to an excruciating pain in my head. It was very painful and I took ibuprofen. The pain did not go away. It has been throbbing and excruciating. The pain feels like it travels from one side to the other below my skull. I took pain meds but the pain remains the same. I went to urgent care and was told it was just muscle maybe from work out but it has not decreased in severity. This pain is going on to this day and it is really painful and has affected my daily activity and sleep since.  I need help and what treatment is needed to alleviate this excruciating pain.
This was an error in Administration.  Moderna dose given to Patient under the age of 18 contrary to MFG recommendations
gave the child Quadracel thinking that was the answer and realized afterwards that is is only; The child was supposed to get DTap and Polio vaccines; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 22 months 21 days old female patient and reported that gave the child Quadracel thinking that was the answer and realized afterwards that is is only and received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] but the child was supposed to get Dtap and polio vaccines.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5500CA and 16-Aug-2020 via intramuscular route in the left thigh.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
injection site became very red and inflamed Large circle of red about 2" diameter. Hot and swollen. Subsided over 10 days. Still have light red spot.
Within 15-minutes of vaccination, the patient reported difficulty swallowing, No difficulty breathing, pain, or other complaints voiced. EMS evaluated the patient on-site. The patient was hypertensive (208/103). EMS noted that the patient was visibly anxious and that they elected to be transported to Emergency Department for evaluation. When contacted for medical records, ED stated that the patient never was checked into the hospital and did not have records available. Assumed lost to follow-up.
This spontaneous report was received from a female consumer (also reported as mother) regarding her husband's coworker daughter of unknown age. The patient's current conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot #, expiry date, dose strength, dose number, vaccination site, route not provided). It was reported that, after the vaccination of GARDASIL, the patient began having problems (unspecified adverse event). The outcome of the adverse event was unknown. Causality assessment was not provided. Additional information is not expected since there is no consent for follow up.
I was 16 weeks along when I found out I had a miscarriage. The doctors said the baby stopped growing at 15 weeks. The clinic measured the baby stopping growing at 14 weeks, right after my second dose. I?ve had 3 vaginal on time healthy deliveries. No previous pregnancy issues. This was definitely unusual.
Redness at site of injection; Swollen injection site; Soreness on arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on arm of injection), VACCINATION SITE ERYTHEMA (Redness at site of injection) and VACCINATION SITE SWELLING (Swollen injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness on arm of injection). On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at site of injection) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, VACCINATION SITE PAIN (Soreness on arm of injection), VACCINATION SITE ERYTHEMA (Redness at site of injection) and VACCINATION SITE SWELLING (Swollen injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a physician concerning a female in her 50's who was vaccinated with Pneumovax 23.  Subsequently the patient experienced injection site reaction.  The patient's left upper arm became red and swollen.  The patient also experienced swollen lymph nodes.  Unspecified medical attention was sought.  Additional information has been requested.
a week after bot vaccines total body aches . went to er and doctor was given a walker wit seat . unable to stand or walk for long periods . ccould not tolerate solid foods , liquids only . Diagnosis hyperactive syndrome
Pt recvd 2 doses Hep B vax 10JUL91 & 10AUG91 following 2nd dose exp nausea, vomiting, fatigue, dizziness, diarrhea & gastorintestinal cramps; lab eval revealed elevated liver enzyme of 36; sonogram of gallbladder, kidney & liver was neg;
About 6 weeks after my second dose I had a flare of my auto immune disease which had been in remission for 5 years previously. Cartilage and my eyes were affected first and then I developed neuropathy in my hands, feet and one leg.
Caller states her husband got the moderna booster dose. He does not feel well; He does not feel well and is achy all over; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Caller states her husband got the moderna booster dose. He does not feel well) and MYALGIA (He does not feel well and is achy all over) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Caller states her husband got the moderna booster dose. He does not feel well) and MYALGIA (He does not feel well and is achy all over). At the time of the report, MALAISE (Caller states her husband got the moderna booster dose. He does not feel well) and MYALGIA (He does not feel well and is achy all over) outcome was unknown.            No treatment and concomitant medications were provided.
Shortness of Breath, Weakness, Lightheadedness. BP was 76/49 , after 10 mins bp was 105/79. o2 sat 96%, gave 500ml water orally, the patient was stable after 15 mins. The patient  was advised to seek medical help if needed
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were provided. On an unspecified date, the patients were vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX, (dose, route of administration were not reported), (Lot # K018959, expiration date 15-OCT-2016). At the time of this report, no adverse effects were reported. Additional information has been requested.
My neck is swollen; hurting on the side of injection; This spontaneous case was reported by a pharmacist and describes the occurrence of SWELLING (My neck is swollen) and INJECTION SITE PAIN (hurting on the side of injection) 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 SWELLING (My neck is swollen) and INJECTION SITE PAIN (hurting on the side of injection). At the time of the report, SWELLING (My neck is swollen) and INJECTION SITE PAIN (hurting on the side of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported  Treatment information was not reported