chrisvoncsefalvay/vaers-outcomes huggingface dataset:
89-year-old male presents the emergency department with right mid back pain and constipation.  Patient was seen 1 week ago for abdominal pain with constipation at that time he did have a bowel movement after receiving magnesium citrate.  He states since then his abdominal pain has improved however he continues to have right middle back pain.  Patient does have a history of CAD, hyperlipidemia, hypertension, MI and GERD.  He denies injury.  He does have an occasional cough however that is not new.  No fever or chills. Associated Symptoms: back pain, constipation, weakness
Mild localized reaction aeb 3"x3" area of erythema and edema
Fifteen minutes after the vax was administered, I broke out in a red blotchy rash all over my torso. From there I became extremely dizzy, nauseous, vomiting, photosensitive. This all eventually subsided after taking Benadryl but then I developed a baseball-sized, warm, red knot on my arm where the vax had been injected. Redness continued to spread over the course of a day or so.
pt began to exp focal sz w/hyperflexion of RUE & eye deviation to the lt; taken to ER where given anticonvulsants & subsequent intubation;
Pt presented with uncontrollable coughing and reported lightheadedness 30 minutes after vaccine administration. RN treated w/ 50 mg Benadryl PO. Cough and lightheadedness gradually improved and was resolved 45 minutes after Benadryl administration.
The pt received the third injection of Lymerix on 2/1/00. At some time during the end of 2/00, he threw snowballs while not wearing gloves and reports that his hands became puffy, red, stiff and swollen. He was seen by his physician who reportedly made a diagnosis of carpal tunnel syndrome. the pt then went surfing in cold water st some time during the spring of 2000, and reports that his feet became puffy, red, stiff and swollen, He was seen by his Physician, who reportedly made a diagnosis of possible Raynaud phenomenon. As of 11/21/00, the pt experienced symptoms more frequently. The pt reported that his physician had not witnessed joint redness, stiffness or swelling. No fluid was obtained from his joints, and no lab evaluation for arthritis was made.
severe shoulder pain, unable to move without sharp piercing pain, cannot lift or move whatsoever. Also had sharp chest pain and shortness of breath. Admitted to ER on 5/30/21 to hospital. Tested abnormal for D-Dimer, going to get CT scan and MRI.
A booster dose was administered instead of 2nd dose on 11/22/2021. Pt was made aware of error and dose was repeated on 11/24 according to cdc guidelines
Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. Since 14-OCT-2015 the patients were vaccinated with doses of GARDASIL 9 (lot # L007560 with expiration date of 15-JUN-2017; strength, dosage and frequency unspecified) which were improperly stored (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I am 7 years post-menopausal, and 6 weeks after the vaccine I had a week-long, full-fledged menstrual period. Then for the next five or six weeks, I had 4 or 5 hot flashes every day (I never had any in my 7 years of being post-menopausal).  I also had a migraine  mid morning every day after the menstrual period. They have lessened now (tapered and mostly stopped by end of June 2021).  I also have slight balance problems now, that are still ongoing.
Tingling in lower part of arm that shots were administered (upper arm, muscle). Often when arm was suddenly moved or the elbow was placed on a desk.
Abdominal pain started @ 8:30pm on the evening of 3-24-2021 followed by severe continuous emesis into the early A.M. Zofran and Toradol were given along with 1 liter of normal saline. Symptoms subsided for approximately 2 hours and then returned. Doctor ordered a CT scan which indicated free fluid in the abdomen along with possible small bowel obstruction. During this time I (the patient) also experienced unusual hypertension along with hyperglycemia and was transported to hospital, for a diagnostic laparotomy. Findings of the surgery were reactive fluid in the abdomen along with an inflamed bowel.  Hypertension remained days after even when given medication to help lower it and continues at this time. I (the patient) have never had a history of hypertension. Never have I had any previous surgery's or abdomen related issues.
Speech started to slur, and then trouble speaking at all. Tremors in limbs. Motor skills severly affected.(writing as an example)  Multiple episodes of this ranging over two days, in two hospitals. Longest episode was about 80 minutes. Shortest episode was 2 minutes.
This case was reported by a healthcare professional and described the occurrence of swimming sensation in head in a 21-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included ZYRTEC. On 14 September 2010 at 12:00 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm). On 14 September 2010, one hour after vaccination with FLULAVAL, the subject experienced head felt swimmy, dizziness and nose poured clear liquid. At the time of the report, the subject's vital signs were good. On 14 September 2010, the swimming sensation in head, dizziness and clear runny nose were resolved. The nurse reported two additional patients, see cases A0882394A and A0882706A.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm), VACCINATION SITE WARMTH (hot to touch), ORAL HERPES (fever blister(cold sore)), VACCINATION SITE INDURATION (hard to touch) and VACCINATION SITE ERYTHEMA (red swatch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (very sore arm). On 14-Apr-2021, the patient experienced ORAL HERPES (fever blister(cold sore)). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE INDURATION (hard to touch), VACCINATION SITE ERYTHEMA (red swatch) and VACCINATION SITE SWELLING (size of peach in diameter). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Mar-2021, PAIN IN EXTREMITY (very sore arm) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot to touch), ORAL HERPES (fever blister(cold sore)), VACCINATION SITE INDURATION (hard to touch), VACCINATION SITE ERYTHEMA (red swatch) and VACCINATION SITE SWELLING (size of peach in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Product was none.  Treatment included as tylenol and ice pack
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 02-FEB-2009, the healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 17-MAR-2014, the patient was treated by her healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
hives, periorbital swelling;rx DPH on 29SEP added pred on 30SEP;
On Friday, June 18th, 2021 patient (DOB: 05/15/1990) received her first dose of Pfizer COVID vaccine (LOT # EW0187, EXP 07/10/2021) at approximately 12:24 pm. After vaccine was administered, client was to wait in the Observation Area for 15 minutes. At around 12:35 pm, client and her husband walked up to EMTs and her husband stated the client was "feeling light-headed and dizzy." Client spoke broken English as she is primarily a Spanish speaker which is why her husband was speaking for her. Client was advised to sit in the anti-gravity chair and was given a bottle of water. Upon assessment by EMTs, client's last meal was at 9:00 am. EMTs also noticed the client was diaphoretic and pale in color, but was A&O x 4. At 12:40 pm vitals were taken: BP: 80/40, Hr: 68, RR: 16, O2 sat: 100%. Lead RN was notified and advised client to be watched for an additional 30 minutes. At 12:40pm the client was given salty chips in hopes of raising her blood pressure. At approximately 12:50 pm, client stated she was ?feeling a lot better?. Vitals at 12:55 pm: BP: 98/60, HR: 82, O2 sat: 100%, RR: 16. Vitals were the same at 1:05 pm: BP: 98/0, HR: 82, O2 sat: 100%, RR: 16. Lead RN was concerned about the low blood pressure reading but was told by the client?s husband that her blood pressure is usually on the lower side. No further interventions indicated. Client has a history of a thyroidectomy and takes Levothyroxine. She is not usually nervous with needles or about vaccines/immunizations. Client was educated by Lead RN & EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was able to ambulate with her husband to the car unassisted with a steady gait at approximately 1:10 pm.
Rash on torso - front and back and neck; some of the nodules have a jagged edge; few have a center eye;
Henoch Schonlein purpura 12.23.16 following vaccines 12.14.16. URI SX/cough SX approximately 12.16.16. Platelets stable, trace blood UA.
Fever of 102, sore injection spot and red area about 2 square inches with a little rash. AS OF TODAY 03/09/2015 fever is down but arm is sore and red rash.
have had all the vaccines for shingles but I keep getting it.; I keep getting it; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had all the Shingles vaccines for shingles but keep getting shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Hardening in area of injection with swelling, redness and emitted heat.; Hardening in area of injection with swelling, redness and emitted heat.; Hardening in area of injection with swelling, redness and emitted heat.; Hardening in area of injection with swelling, redness and emitted heat.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318, expiration date: 31May2021) via an unspecified route of administration in the arm left on 08Mar2021 at 00:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included heart disorder, myelodysplasia, soy allergy, contrast media allergy (contrast dye), allergic reaction to antibiotic (synthetic antibiotics) and drug allergy (statin drugs). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246, expiration date: 30Apr2021) via an unspecified route of administration in the arm left on 15Feb2021 at 12:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. On 08Mar2021 at 12:30, after the second dose of vaccination, the patient experienced a hardening in area of injection with swelling, redness and emitted heat. It was also reported that side effects persisted even at the time of this report (12Mar2021). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vaccination site induration, vaccination site swelling, vaccination site erythema and vaccination site warmth was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Feels feverish; Redness at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Feels feverish) and VACCINATION SITE ERYTHEMA (Redness at site of injection) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-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 PYREXIA (Feels feverish) and VACCINATION SITE ERYTHEMA (Redness at site of injection). At the time of the report, PYREXIA (Feels feverish) and VACCINATION SITE ERYTHEMA (Redness at site of injection) outcome was unknown.            No concomitant medications were reported.  The patient had not yet undergone any treatment for the events.
Patient has sore arm from being vaccinated on 2/11/22; The vaccine vial used to vaccinate was at room temperature for about 31 hours. It still falls in the 36 hour range allowed; The vaccine vial used to vaccinate was at room temperature for about 31 hours. It still falls in the 36 hour range allowed; This is a spontaneous report from a contactable reporter (Pharmacist).  A 15-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Feb2022 (Lot number: FK9729) at the age of 15 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: None reported; Known allergies: None reported. Concomitant medication was reported as none. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), administration date: 29May2021, when the patient was 14 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), administration date: 19Jun2021, when the patient was 14 years old, for COVID-19 immunisation.  The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 11Feb2022, outcome "unknown" and all described as "The vaccine vial used to vaccinate was at room temperature for about 31 hours. It still falls in the 36 hour range allowed"; PAIN IN EXTREMITY (non-serious) with onset 12Feb2022, outcome "recovered" (12Feb2022), described as "Patient has sore arm from being vaccinated on 2/11/22". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.
This spontaneous report was received from a 69 year old female patient regarding herself. On 27-FEB-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date was not reported and route was subcutaneous). On 28-FEB-2013, the patient developed oval hive at the injection site by about 2 inches by 1 1/2 inches. The patient that she felt that it was going away since her doctor advised her it was common. Treatment rendered for the event was CORTIZONE cream. The outcome of the event was reported as recovering. The patient sought medical attention. Additional information has been requested.
Dx: Vaccinia-related myopericarditis Patient experienced acute onset 9/10 substernal chest pain on the evening of 26April with no other symptoms.  The pain was worse with lying down and did not relieve with rest.  ER evaluation revealed elevated troponin and ECG consistent with pericarditis.   An echocardiogram was done and revealed normal LV and RV size and function without wall motion abnormality.  Observation for 48 hours with minor arrhythmia (non-sustained ventricular tachycardia x3 beats on 2 episodes).  He has follow-up with Cardiology and a planned cardiac MRI
Pt noted abdominal cramps 10/30/03 about 8 PM. All day 10/31/03 and 11/01/03 she experienced frequent abdominal cramping and a bloating feeling but denied symptoms of vomiting or diarrhea. Symptoms gone by 11/01/03 and pt did not seek any medical attention or treatment. Pt reported to State Health Center on 11/3/03.
Stay in bed; Difficult to move; Pain; off label use; This case was reported by a pharmacist via call center representative and described the occurrence of bedridden in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced bedridden, mobility decreased, pain and off label use. On an unknown date, the outcome of the bedridden, mobility decreased, pain and off label use were unknown.   It was unknown if the reporter considered the bedridden, mobility decreased and pain to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix 2 months ago. The patient experienced an adverse reaction as stay in bed with difficult to move, pain following the dose of Shingrix.  The health care professional wanted to know if the patient should receive the 2nd dose, and in the case she received it, if the same adverse reaction was going to happen. The health care professional also stated that the patient had Shingles prior the administration of the first dose of the vaccine, that the patient went to a doctor who recommended her to receive the Shingrix shot, which led to off label use. Consented to follow up was provided.
feeling off balance; not feeling good overall; Light-headed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Mar2021 14:30 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing); "anxiety" (ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension (ongoing); BUSPAR taken for anxiety (ongoing). The following information was reported: BALANCE DISORDER (non-serious) with onset 17Mar2021, outcome "not recovered", described as "feeling off balance"; DIZZINESS (non-serious) with onset Mar2021, outcome "not recovered", described as "Light-headed"; MALAISE (non-serious) with onset 15Mar2021, outcome "not recovered", described as "not feeling good overall".  Additional information: The report was not related to a study or programme. NDC number and expiry date were unknown. No investigation assessment. Consumer called because she was not feeling good. States she had the vaccine on Monday afternoon, and she had been feeling off balance; light headed; and not feeling good overall. She called for some advice and asked what she should do. Advised caller to follow up with her HCP for medical advice but that Pfizer can provide product specific information. Clarified she received the first dose of the Pfizer COVID 19 vaccine on 15Mar2021 at 14:30 in the right arm. She noticed feeling off balance yesterday, but she had not been feeling well since Monday evening. Adds she was going to call her HCP next as she was not feeling well. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect was reported as none. AE(s) does not require a visit to physician or ER. No prior Vaccinations (within 4 weeks). No family history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 47 years old female patient and reported that inadvertently administered a dose of DAPTACEL instead of ADACEL and inappropriate age at vaccine administration, while she received vaccine DAPTACEL. 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 DAPTACEL (lot number, expiry date, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. 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 and Module VI of the 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.