chrisvoncsefalvay/vaers-outcomes huggingface dataset:
confirmed appendicitis; This is a spontaneous report from a contactable Physician. A 34-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9269), via an unspecified route of administration on 04Feb2021 17:30 at SINGLE DOSE for covid-19 immunisation. Medical history was reported as none.  Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1.5/30), bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10) and folic acid.  The reporter stated that abdominal pain that began at center of abdomen upon waking up at 8 am on 07Feb2021 and progressively got worse throughout the day. Developed nausea and multiple episodes of vomiting around 15:00. Abdominal pain then moved to RLQ, was persistent, dull and achy, worsened with movement (on 07Feb2021, 8:00). Pain was still present throughout the night and the next day, went to the ER for evaluation. There was concern for appendicitis. Labs were overall normal, CT abdomen was equivocal, abdominal and transvaginal ultrasound were normal but examination was concerning. Laparoscopic surgery was performed and confirmed appendicitis on an unspecified date. The patient was hospitalized for the event on an unspecified day. Outcome of the event was unknown.
Joint pain; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (reporter's son and grandson). This is the first of two reports. A male patient (grandson) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The grandson was healthy and fine. The consumer stated that his grandson had the PFIZER Covid vaccine and had joint pain. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021402538 same reporter/drug/event, different patient
This spontaneous report as received from a pharmacist refers to several patients of unknown gender in their seventies. On an unknown date the patients were vaccinated with ZOSTAVAX (lot number, expiration date, dose, route of administration, strength and indication were not reported). The reporter stated that she has known of several instances in which a person received ZOSTAVAX and later (date not specified) developed shingles. She stated that the people were older, in their 70s. The outcome of shingles was unknown. Relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
body aches, chills, rash/hives on palms, slowly worked its way all over, underarms, inner thighs, private areas, back, butt, warm to touch, raised red hives.
This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Received 3rd dose instead of booster) and OFF LABEL USE (received a 3rd dose of 0.5 mL, and the patient is not immunocompromised) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Received 3rd dose instead of booster) and OFF LABEL USE (received a 3rd dose of 0.5 mL, and the patient is not immunocompromised). At the time of the report, ACCIDENTAL OVERDOSE (Received 3rd dose instead of booster) and OFF LABEL USE (received a 3rd dose of 0.5 mL, and the patient is not immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Narrative:  COVID infections following completion of COVID vaccine series 01/05/21 COVID vaccine dose #1 01/27/21 COVID vaccine dose #2 03/24/21 Pt presents to ED reporting left sided neck pain and swelling x3-4 weeks; labs wnl, CT negative; discharged home and advised to continue to use tylenol 04/29/21 Pt presents to ED reporting productive cough with green sputum, intermitten SOB; denies fever, chills, N/V/D, loss of taste/smell; CXR wnl, COVID NEGATIVE; discharged home with rx for albuterol, DM/guiafenesin, azithromycin for bronchitis 05/26/21 COVID NEGATIVE preop 07/23/21 Pt presents to ED reporting weakness, nausea and near syncope x3 days, CXR wnl; treated with IV fluids and discharged for mild dehydration; COVID POSITIVE 07/25/21 Pt reports headache, diminished taste/smell; describes shortness of breath that is normal for him 07/26/21 Pt reports tachypnic and is advised to go to ER 07/27/21 Wife reports pt was sent home from community ED as O2 sat and CXR wnl but pt remains short of breath and unable to complete sentences; o2 sat 96%; reports mild, infrequent cough, fatigue, poor appetite, nausea, vomiting, single episode of diarrhea; rx given for albuterol, famotidine 07/28/21 Pt reports fever (temp 100.9), diarrhea, vomiting; rx given for loperamide and ondansetron 07/30/21 Pt reports doing better, O2 sat 96 08/01/21 Pt reports fatigue and some shortness of breath 08/03/21 Pt is improving and meets CDC criteria for resolution
Fatigue  Fevers and Chills started day 1 and recovered day 3  Headache started day 3 and is ongoing (today is day 3 after vaccine)
On 1/21/08 patient recieved Varivax and Prevnar vaccines.  Woke up morning of 1/30/08 with right thigh redness, and itching.  Seen at our office and diagnosed with ? vaccine releated cellullitis.  Treated with Augmentin.
Gained 50 lbs in the past 8 months after last shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), for COVID-19 Immunization.  The following information was reported: WEIGHT INCREASED (non-serious), outcome "not recovered", described as "Gained 50 lbs in the past 8 months after last shot". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of weight increased.  Additional information: No other vaccine were received in four weeks. No other medications received in two weeks. It was reported that patient gained 50 lbs in the past 8 months after last shot and have not changed routine at work or at home. Diet has been the same before and after. No covid prior vaccination and not tested for covid post vaccination. No Known allergies.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pfizer vaccine was administered - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------- ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 4/24/2023 SARCOIDOSIS
Pt c/o pain at site, swollen lymph nodes, fever and head ache.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an 8-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 27-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine).    No concomitant medications were reported.  The patient in this report did not experience any side effects.  No treatment medications were reported.
1st COVID dose was 5/14/21 and 2nd COVID dose was6/29/21 he started w/ right calf pain on or about 6/21/21.  he came to PCP for appointment on 7/12/21 and a sonogram was ordered to r/o DVT.  he was unable to get to hospital until 7/13/21 and the songram revealed right DVT from groin to knee
STARTED WITH HIVE/RASH ON LEFT ARM.NO CELLULITIS 03/06/03.HAD DTAP VACCINE 03/03/03.RASH AT SITE OF DTAP INJECTION. TREATMENT: BENADRYL ONE AND A HALF TEASPOON BY MOUTH EVERY 6 HOURS X 2-3 DAYS.RETURN IF WORSE OR NO CHANGE.
No illness, no medicine at time of injection. Left arm with intermittent clonic activity (injection arm) started one with after immunization.
Vigorous and persistent crying. Warm pink edematous areas bilateral ant. thigh buttocks posterior thighs lower legs and foot. No respiratory distress.
Patient stated itching about 5-10 minutes later and scratched the injection site. On 10/27/16 around 2pm develop a small knot at injection site rash about 3 inches in diameter and warm to touch.
Patient came in for covid-19 booster patient was to receive bivalent but nurse accidentally pulled monovalent. Patient was then given the vaccination. Later that evening at 4:45 Nurse manager called and informed nurse that monovalent was given instead if bivalent. Patient notified the next day on 11/16/2022 that he was given monovalent instead of bivalent and patient needs to come back into clinic to receive bivalent booster. Patient was accepting at this time.
Mother states child was extremely fussy later in day. Was somewhat consolable but continued to be fussy. Mom states very high fever-unable to take temperature b/c thermometer was broke. Mom never phoned Dr.-Motrin did help to take temperature down, but child remained warm. Child seemed better the next day.
Initial report received on 07 April 2008 from a nurse. A 45 year old male patient received on 02 April 2008 an intramuscular right deltoid injection of ADACEL (lot# C2767AA). No concomitant vaccines administered. By evening, on the day of administration, the patient had an increase in BP to 150/90 and he became confrontational. These symptoms lasted for 24 hours. Corrective measures were not reported. The patient also experienced soreness of the right deltoid, which was the injection site. The patient had no adverse event follow prior vaccination. He was allergic to penicillin, COMPAZINE, and HYDROCODONE. No other medical history was reported. Concomitant medications unknown. On the day of the report, 07 April 2008, the patient had recovered.
Information has been received from a health professional concerning 4 elderly patients who on 29-AUG-2006 were vaccinated with a dose of Pneumovax 23 (lot # 651321/1036F). On 29-AUG-2006 the patient developed swelling, redness and heat in their injection site arms. The patients are being treated with diphenhydramine hydrochloride (BENADRYL), and acetaminophen (TYLENOL). It was reported that the physician "is very concerned" about the lot number and therefore has requested a lot check. No further information was available. The reporter considered the patient's experience to be other important medical events. In follow up information the health professional confirmed that the patient had developed swelling, redness and heat in the injection site arm after receiving a dose of Pneumovax 23 (lot # 651321/1036F). She stated that she had no information regarding each patient and stated she was not able to get that information. She said that the doctor had told her that all 4 patients (WAES #'S 0609USA05102, 0609USA05103, and 0609USA05104) had been seen in the office and have since recovered from the swelling, redness and heat in their injection site arms. The patients are being treated with diphenhydramine hydrochloride (BENADRYL) and acetaminophen (TYLENOL). It was reported that the physician "is very concerned" about the lot number and therefore has requested a lot check. No further information was available. The reporter considered the patient's experiences to be other important medical events. In follow up information the health professional confirmed that the patient had developed swelling, redness and heat in the injection site arm after receiving a dose of Pneumovax 23 (lot # 651321/1036F). She stated that she had no information regarding each patient and stated she was not able to get that information. She said that the doctor had told her that all 4 patients (WAES # 0609USA05102, 0609USA05103, and 0609USA005104) had been seen in the office and have since recovered from the swelling, redness and heat in their injection site arms after treatment with diphenhydramine hydrochloride (BENADRYL) and acetaminophen (TYLENOL0. The health professional was aware that a lot check of concern had been initiated and she stated that she had no further information. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the office of Biologics Research and Review and was released by the regulatory agency. Additional information is not expected.
Information has been received from a physician concerning an 18 year old female who in May 2008 was vaccinated with the third dose of GARDASIL and within 1 week experienced right arm pain (2008). The patient saw an unspecified neurologist who said there of the vaccine was nerve damage. Lab diagnostics performed included MRI and CAT scan. All 3 doses were given in the right arm. Unknown if the patient had any problems with the first or second dose. The patient sought medical attention by visiting the physician's office. Nerve damage was considered to be disabling by the physician because the patient was on the golf team and was unable to participate. Additional information has been requested.
not sure if she has shingles right now; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (not sure if she has shingles right now) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shingles. Concurrent medical conditions included Allergy NOS.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (not sure if she has shingles right now). At the time of the report, HERPES ZOSTER (not sure if she has shingles right now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
She had an adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (She had an adverse reaction) in a female patient of an unknown age who received mRNA-1273  for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273  (unknown route) 1 dosage form and NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced IMMUNISATION REACTION (She had an adverse reaction). At the time of the report, IMMUNISATION REACTION (She had an adverse reaction) outcome was unknown.        The action taken with mRNA-1273(Unknown) was unknown.       Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.    This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
extremely ill; Worse than a flew; stomach and back pain seems unusual; stomach and back pain seems unusual; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (extremely ill), INFLUENZA (Worse than a flew), ABDOMINAL PAIN UPPER (stomach and back pain seems unusual) and BACK PAIN (stomach and back pain seems unusual) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (extremely ill), INFLUENZA (Worse than a flew), ABDOMINAL PAIN UPPER (stomach and back pain seems unusual) and BACK PAIN (stomach and back pain seems unusual). At the time of the report, ILLNESS (extremely ill), INFLUENZA (Worse than a flew), ABDOMINAL PAIN UPPER (stomach and back pain seems unusual) and BACK PAIN (stomach and back pain seems unusual) outcome was unknown.            Concomitant product used was not provided by the reporter.  Treatment information was not provided.  Event outcome was not reported.
This spontaneous report was received from the patient's aunt and the patient's mother and refers to a 11 year old female patient. The patient had no pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions or allergies. On 28-JUN-2018, the patient was vaccinated with GARDASIL 9, 0.5 ml, intramuscular, schedule reported as:0, 2 and 6 months (lot # and expiration date were not provided) for prevention of human papillomavirus (HPV). On 04-JUL-2018, the patient started experience muscular weakness and a lot of pain, which started in the patient's legs and spread later to the her arms (pain in extremity). It was also reported that, the patient could not walk without using a walker. Since on unknown dates in 2018, the patient had not been eating (eating disorder) and was experiencing shortness of breath (dyspnoea). Since then, the patient had been seeing multiple doctors and no one could find anything wrong. It was reported that the patient was given unspecified treatment for the adverse events. Additionally, the patient was admitted to the hospital in an unspecified date in July 2018 and stayed 2 days there. Subsequently, on 22-AUG-2018, the patient was again admitted to the hospital, and was there for a week. The cause of the hospitalization was not reported. On unknown dates, diagnostic test such as brain scans, magnetic resonance imaging (MRI) and unspecified blood work were performed, however results were not provided. The outcome of pain in extremity, muscular weakness, dyspnoea and eating disorder was reported as not recovered/not resolved. The outcome of the adverse event that lead the patient's hospitalization was not reported. The causality between the events and GARDASIL 9 was not reported. Upon internal review the event pain of extremities was considered to be serious as the patient could not walk without using a walker (disability).
DTTAP AND MMRV GIVEN IN R LEG ON 8/4/10 HAS GOTTEN MORE RED AND SWOLLEN SINCE THEN ITCHES AND HURTS.
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. On or about 26-MAR-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended by his physicians for the long-term prevention of shingles during a routine adult health appointment. The ZOSTAVAX did not prevent shingles as intended. Instead the patient contracted a persistent strain of shingles, or herpes zoster. On or about 07-FEB-2016, the patient was treated at medical center for the development of herpes zoster and was prescribed acyclovir for management of his shingles-related symptoms. The outcome of the events is unknown. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Woman realized shortly after receiving the vaccine that she was pregnant.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jun-2021 and was forwarded to Moderna on 28-Jun-2021.    This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Woman realized shortly after receiving the vaccine that she was pregnant.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Woman realized shortly after receiving the vaccine that she was pregnant.). At the time of the report, EXPOSURE DURING PREGNANCY (Woman realized shortly after receiving the vaccine that she was pregnant.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  The patient realized shortly after receiving the vaccine that she was 3weeks pregnant. No treatment information was provided.
Extreme, achey pain in the left shoulder (received the injection) that radiated down to the wrist. Very difficult to raise arm above head. Pain has abated after sleep.
Where MMR was administered after vaccinations, left arm swelling, edema and redness. No fever started last night and patient was seen in next am.
Information has been received from a licensed vocational nurse concerning a 7 year old female who on 10May1999 was vaccinated with a dose of varicella virus vaccine live. On  11Apr2003 the pt present to the dr's office with chickenpox. The reporter indicated that the patient had less than 50 vesicular lesions and no other symptoms. No prescription drugs were required. Additional information has been requested.
Client developed a cough on approximately 3/23. She also has been experiencing diarrhea, nausea, weakness, and confusion. Diagnosed with possible Covid-pneumonia. Client also states that she has been having various symptoms for the previous 4 months. She had been seen by her outpatient primary care doctor and gastroenterology for abdominal pain symptoms, ultimately found to have C. difficile and treated for this.