chrisvoncsefalvay/vaers-outcomes huggingface dataset:
painful injection: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "painful injection".  Additional information: Age group was reported as Adult (18 to less than 65 years). Pfizer product name: Comirnaty.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tested NAAT positive for COVID 10/6/21 after being fully vaccinated.
Slight ataxia; Fluish (under the weather); Developed sensitivity to the medications that she has been using for years without any prior incidence; Her body is turned on itself; confusion; increased tinnitus; Severe Chills/ Chills sporadically; TIredness; Headaches / top of head and back of the head/Mild headache/Unbearable headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Severe Chills/ Chills sporadically), PYREXIA (Fever), FATIGUE (TIredness), HEADACHE (Headaches / top of head and back of the head/Mild headache/Unbearable headache) and TINNITUS (increased tinnitus) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), EZETIMIBE and TRAVOPROST (TRAVATAN Z) for an unknown indication.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headaches / top of head and back of the head/Mild headache/Unbearable headache). On 21-Mar-2021, the patient experienced CHILLS (Severe Chills/ Chills sporadically), FATIGUE (TIredness) and TINNITUS (increased tinnitus). On 26-Mar-2021, the patient experienced CONFUSIONAL STATE (confusion), INFLUENZA LIKE ILLNESS (Fluish (under the weather)), ADVERSE REACTION (Developed sensitivity to the medications that she has been using for years without any prior incidence) and FEELING ABNORMAL (Her body is turned on itself). On 26-Apr-2021, the patient experienced ATAXIA (Slight ataxia). At the time of the report, CHILLS (Severe Chills/ Chills sporadically), PYREXIA (Fever), FATIGUE (TIredness), HEADACHE (Headaches / top of head and back of the head/Mild headache/Unbearable headache), TINNITUS (increased tinnitus), CONFUSIONAL STATE (confusion), ATAXIA (Slight ataxia), INFLUENZA LIKE ILLNESS (Fluish (under the weather)), ADVERSE REACTION (Developed sensitivity to the medications that she has been using for years without any prior incidence) and FEELING ABNORMAL (Her body is turned on itself) outcome was unknown.            No treatment details were provided   This case was linked to MOD-2021-092195 (Patient Link).
Vaccinee rec'd a first dose on 6JUN90. Elevation of liver enzymes occurred "around AUG90"; No treatment was given; Vaccinee wants second & third dose;
Pt. said that his arm got sore and start feeling locked about 6 to 8 hours after vaccine. It has progressively gotten worse. He can still move it, but it is sore and he says he has a high pain tolerance. He has been doing exercises, but it is still sore and it has been over a month
pt recv vax 9DEC96 & 3 days later to ER w/GBS in the lower extremities which progressed to resp musculature;hosp is presumed, although not documented;
This case was reported by a physician and described the occurrence of decreased therapeutic response in a 62 year old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified) for prophylaxis approximately 15 years ago. The subject's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date, approximately 15 years ago, the subject received a three dose immunization series of hepatitis B vaccine (unknown dosing, lot numbers and expiration). In October of 200f, the patient had a hepatitis B antibody level of 7 versus the recommended level of 10 following a complete hepatitis B vaccination series. This was considered to be a decreased therapeutic response. No additional information was provided at the time of reporting. Follow up information received on 12 May 2006 indicated that the subject received a booster vaccine. Specified details were not provided. It was also reported that the patient had a concurrent condition of hypercholesterolemia. No additional information was provided.
fever headache, sore throat, muscle soreness, lasted overnight, stayed home from work next day, fatigue and muscle soreness remained thru day 2
HYPOXEMIA 1/15/2023 ATRIAL FIBRILLATION, UNSPECIFIED HYPOXEMIA 1/15/2023 SYSTOLIC HEART FAILURE, CHRONIC HYPOXEMIA 1/15/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED HYPOXEMIA 1/15/2023 JAUNDICE HYPOXEMIA 1/15/2023 ATHEROSCLEROSIS OF AORTA
Chills; Fever; Pounding headache; Swollen lymph nodes on left side; This is a spontaneous report from a contactable consumer.   A 61-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 09:45 AM (Batch/Lot Number: EL3247), at the age of 61-year-old at the time of vaccination, as SINGLE DOSE for covid-19 immunisation  .  Medical history included chronic lymphocytic leukaemia (CLL) and former breast cancer. Concomitant medication included tamoxifen 20 mg taken for an unspecified indication, start and stop date were not reported. The patient received dose 1 of vaccine on 15Jan2021 01:00 PM at left arm, lot number: EL1283. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. On 05Feb2021 22:00, the patient experienced chills, fever, pounding headache, swollen lymph nodes on left side. The outcome of the events was recovered. The patient took Tylenol as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19.
GI inflammation, nausea, vomiting  x2 the evening of. The next day hives over my abdominal region worsening each day and continue to be present.
Pt vaccinated with MMR developed acute onset of bronchio & laryngospasm 1/2 hr after vaccine. SC Eprinephrine & Benadyrl.
This case was reported by a healthcare professional and described the occurrence of vomiting in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 05 or 21 November 2008 the subject received a dose of FLULAVAL at 0.5 ml. On 26 November 2008, the subject developed severe nausea, vomiting, diarrhea and body pain. The nursing supervisor of the facility was concerned that the outbreak was related to vaccination with FLULAVAL. This was considered to be a product complaint. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were unresolved, but the outcome of nausea was not specifically reported. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. A health educator requested information for a specific lot of FLULAVAL. A retirement home vaccinated a number of adults and elderly subjects on two different dates. On 26 November 2008, approximately 40 of these individuals (staff and residents) developed severe nausea, vomiting and diarrhea. Body aches were also documented. The nursing supervisor of the facility was concerned that these outbreaks were related to vaccination with FLULAVAL. Three of the subjects developed dehydration and were also hospitalized. The facility was ruling out viral causes also. Linked cases numbers include: A0758812A, A0758823A, A0758824A and A0758825A.
visual disturbance/blurry, cold feet, dizzy, sob, dry throat. Evaluated by EMS-Cleared
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 26-DEC-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), for routine health maintenance and for the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX, the patient began to suffer headaches, fatigue, feeling of his nerve endings shooting off' throughout his whole body, burning in his arm, and a rash which started on his right hip and traveled all over his body. As a result, the patient was diagnosed with shingles on or about 15-MAY-2017. As a direct and proximate result of the ZOSTAVAX, the patients symptoms have resulted in physical limitations not present prior to the ZOSTAVAX. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Shingles was considered disabling. Additional information has been requested.
Increased weakness since 10/31/03, starting with feet and numbness. 11/11-started with numbness of fingers. Hospitalized 11/03, 2 days in ICU, then out to unit. 11/21-still weak, definite dx of GBS. Still hospitalized.
Pt received vaccine at a clinic and was waiting the required 15 minutes in a chair. After about 7-8 minutes, another pt alerted  that pt was having a reaction and was losing consciousness. Patient could not speak and was showing signs of passing out. RPH was able to keep pt conscious and within 5 minutes pt could say his name and count backwards from 10.
2 days after vaccine started with rash, body aches, joint pain. Treated but continues
Intense itching, dermatographia, urticaria full body 10 days after booster dose. Began in scalp and spread to neck, ears, rest of body. Throat tightening but no angioedema or difficulty breathing. Over 1 month since onset of symptoms and little to no change of symptoms after hydrocortisone, prednisone, and daily antihistamine (Zyrtec).
L arm sore after receiving hep B on 9/17/02. By the next day 9/18 had increase soreness and by 9/19 in the am, his arm was red, inflamed swollen and itchy. Taken to family physician on 9/19/02 who reportedly diagnosed allergic reaction and started antibiotic (Keflex) for low grade fever 99.2.
Numbness in both legs and face, heavy feeling in the neck, neuropathic constant body burning, nausea.
Patient received J&J vaccine on 5/11/21 and pfizer vaccine on 4/25/22. Presented to ER on 6/29/22. COVID positive on 6/16/22. admitted on 6/29/2022 presented from nursing home with with generalized weakness, fatigue, altered mentation  Poor oral intake for weeks             Recently came off of quarantine for COVID.  Was initially positive 06/16/2022. Screening COVID-19 test positive 06/29/22.  Clinically asymptomatic             Sepsis- lethargic Tachycardia,WBC 24 K, Lactic acid 2.1 CRP 32 procalcitonin 0.2,  BP 89/53 -s/p IV bolus .  UA suggestive UTI, chest x-ray streaky opacity left lung base Low BP Hypernatremia Sodium 153-hemoconcentration Hb 15-likely from dehydration-improved with IV hydration.             Initially was hyperkalemia, subsequently developed hypokalemia, hypomagnesemia-supplement             Fentanyl patch, Norco-was not given while in hospital. Hypoglycemia episodes-insulin held initially.              Sepsis resolved,  BP improved, altered mental status improved, tolerating diet.  Low-dose insulin restarted.  BP medicine restarted, blood culture urine cultures no growth, repeat UA improved. Antibiotic changed orally (was on vanc and cefepime). Discharged on 7/4/22.
Pt developed elevated temperature of 104, fixed eyes, stiffness and unresponsiveness. He was taken to ER and diagnosed with seizure.
fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heartbeat) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced HEART RATE INCREASED (fast heartbeat). At the time of the report, HEART RATE INCREASED (fast heartbeat) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.    This case was linked to US-MODERNATX, INC.-MOD-2021-103594 (E2B Linked Report). This case was linked to MOD-2021-163599 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103594:WIFE CASE
Client received 4th Dtap on 01/28/2003. Called 01/29/2003 stated child's left leg, reddened, hot to touch. Advised to have MD look at leg. Mother returned to clinic 01/30/2003: stated MD said reaction normal, but mother now says leg itchy. Noted redden, swollen area apprx. 125mm length by 100 mm width, warm to touch. Advised cool compresses. Children's Advil for discomfort and inflammation.  NOTE ATTACHED Client's mother called on 01/29/2003 apprx. 1:35pm, and stated that child left leg was redden, swollen and hot. Client was asked if any Tylenol or Advil was given? Client stated "no". Child received his 4th Dtap on 01/28/2003 on left leg. Nurse explained that since this was the fourth Dtap, the body tends to reacts more when it has been given more doses of the vaccine. Client was advised to take child to his pediatrician. Per client stated teh leg was hot to touch: that way the M.D. could better assess if this is a vaccine adverse reaction or not. Client advised to bring IZ record to the M.D., so he knows what vaccine was given. Mother came into clinic on 01/30/2003, stated that she took child to his pediatrician and that the M.D. stated, it was a normal reaction. Mother stated that the area was itchy and requested for a nurse to assess. Noted redden area of left leg apprx 125mm length by 100mm width, warm to touch and a scratch apprx. 30mm in length. Advised client to put cool compresses, give Children's Advil for discomfort and inflammation, and to keep pants on child to avoid increased area of scratches. Advised mother if condition worsen or doesn't improve to call pediatrician to follow up.
Maculopapular rash started on face and has now spread to trunk follow scheduled for 10-16-17.
No adverse effects; the patient was inadvertently adrninistered an expired dose of MMRII; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-MAY-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) subcutaneously (lot # N013281, expiration date: 28-APR-2019, dose was not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent. No adverse effects or temperature excursion were reported.
101 fever; Body aches; Swelling and redness around injection site; Swelling and redness around injection site; This is a spontaneous report from a contactable consumer received via a sales representative. A 12-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 on an unspecified date administered for COVID-19 Immunization. The reporter stated that patient experienced 101 fever, body aches, swelling and redness around injection site. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date. Therapeutic measures were taken for the events with Motrin and symptoms were improved after use. The outcome of the events was resolved on an unspecified date.  Information on the lot/batch number has been requested.
This report was received from a health professional. SERIOUNESS CRITERIA: OTHER-MEDICALLY SIGNIFICANT A 17-year-old female patient received an intramuscular injection of MENACTRA (lot number U2619AA) and a subcutaneous injection of VARIVAX (Merck, lot number 1855U) on 19 May 2008. Within five to ten minutes of vaccination, she had a syncopal episode in her physician's office lasting less than one minute. She was monitored, and subsequently recovered and was sent home. She was not ill at the time of vaccination, was not taking any concomitant medications, and had no pre-existing conditions.
Information has been received from a woman in a clinic concerning a patient who was vaccinated with ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) and had unspecified adverse experiences (also reported as cellulitis).  It was noted that "the experiences were not recent so she doesn't remember patient details".  Additional information has been requested.
Clients arm started sweeling and hurting 9:00 p.m. - 11-2-07.  He couldn't sleep - couldn't lift his arm or wear his shirt.  The arm was swollen down to his hand.  He went to the ER 11-05-07 and was given a steroid injection and pain meds.  He started having some relief that evening and gradually felt better.  Missed several days of work.
Patient received the vaccine at 11:15am and then returned to waiting area to wait 15 minutes before leaving store. Patient fainted at 11:20am  and emergency help was provided/EMS was called. Patient became alert and oriented but still left with EMS.
Angina, palpitations and right arm numbness. Pt stated feeling was coming back.
Noticed the first rashes on body while bathing. The swelling increased in the left knee which had been injured previously. It got so bad that patient had to be sent home on convalescent leave. While home on leave, was doing physical therapy in the water and after four hours in the sun, the next day patient could not get out of bed, had a rash all over body and severe joint pain. Patient has documentation from the ER where seen. Went through many flare ups of lupus. Patient was never diagnosed. Went through literally hell trying to get better and post medical discharge, almost a year to the date of discharge patient had another severe reaction to the sun and was finally was diagnosed and treated for lupus. Is now dealing with the agency not recognizing the lupus as a service connected condition where the obvious cause is the vaccination reaction but also am dealing with the agency not making a decision either. Patient left to deal with this on own.
Swelling her feet; Severe Itching; Excessive scratching; Oozing of pus out from the area that was scratched; Rash on body and legs; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling her feet), PRURITUS (Severe Itching), SCRATCH (Excessive scratching), RASH PUSTULAR (Oozing of pus out from the area that was scratched) and RASH (Rash on body and legs) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swelling her feet), PRURITUS (Severe Itching), SCRATCH (Excessive scratching), RASH PUSTULAR (Oozing of pus out from the area that was scratched) and RASH (Rash on body and legs). At the time of the report, PERIPHERAL SWELLING (Swelling her feet), PRURITUS (Severe Itching), SCRATCH (Excessive scratching), RASH PUSTULAR (Oozing of pus out from the area that was scratched) and RASH (Rash on body and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up received on 04-MAY-2021. Adverse events updated.
patient was given the bivalent shot as their initial Covid vaccination rather than the original monovalent vaccine
NSTEMI; tested positive for covid 10/1/21 (received the vaccine 9/23/21).
got sick from the shot; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovering/resolving.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-AUG-2022 Reporter's Comment: This case was reported by the consumer via interactive digital media. The patient received a dose of Shingles vaccine and felt sick from the shot and felt better soon. Additional Supportive Information: This case was linked with case US2022AMR126039 reported by same reporter. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR126039:Same reporter
4 patients was administered open Ipol that reached 11.3 degrees Celsius for 6 hours and 32 minutes because a mobile vaccine truck had a temperature excursion in their refrigerator; Initial information received on 25-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 4 patients who was administered open IPV (VERO) [IPOL] that reached 11.3 degrees celsius for 6 hours and 32 minutes because a mobile vaccine truck had a temperature excursion in their refrigerator lot number not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number was requested.  List of documents held by sender: none.