chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red (covid toe); Tenderness (covid toe); Swelling (covid toe); This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red (covid toe)), TENDERNESS (Tenderness (covid toe)) and SWELLING (Swelling (covid toe)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced ERYTHEMA (Red (covid toe)), TENDERNESS (Tenderness (covid toe)) and SWELLING (Swelling (covid toe)). On 14-Feb-2021, ERYTHEMA (Red (covid toe)) and SWELLING (Swelling (covid toe)) had resolved. At the time of the report, TENDERNESS (Tenderness (covid toe)) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-262885 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received and contain 2nd dose information.
Information has been received from a physician concerning a 15 year old female patient who in January 2007 was vaccinated with a second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient developed a fever of 102.5F for 3 days after her injection. The patient missed one day of school. Unspecified medical attention was sought. The patient recovered. Additional information has been requested.
LEFT ARM SORENESS AND REDNESS AND WARM DAY AFTER SHOT.  KEPT EXPANDING WITH REDNESS BY  DATE 8/19/23
Mother here at clinic today reporting local 5.5cm x 8.5cm reaction to left arm where Varivax vaccine was given SQ on Monday. Site noted with redness, edema, and heat at site. Mother circled the redness yesterday with a pen and the redness has increased in size. Reported to Dr. who reports to instruct mother to alternate heat and ice and take Motrin for swelling and discomfort. Call immediately and report and red streaking. Mother verbalized understanding.
headache, muscle pain, mostly in left calf area started few days after, hypertension (new onset), chest tightness
I had a fever for 5 days; I felt like I was going to fall down; felt dizzy; headache; had a fever between 99.9°F-100.7°F; felt very tired; my back hurt; my shoulder hurt; my knees hurt; My arm hurt where I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of FALL (I felt like I was going to fall down), DIZZINESS (felt dizzy), VACCINATION SITE PAIN (My arm hurt where I got the shot), HEADACHE (headache) and PYREXIA (had a fever between 99.9°F-100.7°F) in a 41-year-old female patient who received mRNA-1273 (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (My arm hurt where I got the shot). On 11-Apr-2021, the patient experienced FALL (I felt like I was going to fall down), DIZZINESS (felt dizzy), HEADACHE (headache), PYREXIA (had a fever between 99.9°F-100.7°F), FATIGUE (felt very tired), ARTHRALGIA (my back hurt), ARTHRALGIA (my shoulder hurt) and ARTHRALGIA (my knees hurt). On 16-Apr-2021, the patient experienced PYREXIA (I had a fever for 5 days). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, FALL (I felt like I was going to fall down), DIZZINESS (felt dizzy), VACCINATION SITE PAIN (My arm hurt where I got the shot), HEADACHE (headache), PYREXIA (had a fever between 99.9°F-100.7°F), FATIGUE (felt very tired), ARTHRALGIA (my back hurt), ARTHRALGIA (my shoulder hurt), ARTHRALGIA (my knees hurt) and PYREXIA (I had a fever for 5 days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Pyrexia: 99.9°f-100.7° 99.9°F-100.7°. On 14-Apr-2021, COVID-19: negative Negative.     The action taken with mRNA-1273 (Unknown) was unknown.       Treatment for the event included acetaminophen (Tylenol) and increased water intake. Concomitant medication details were not provided.
10 minutes after vaccine administration, patient complained of dizziness. Patient sat down for a few minutes, then felt fine and stated she hadn't eaten anything for quite a while.
left arm down to her hand feels like pinprick and numbness; left arm down to her hand feels like pinprick and numbness; semi pain; Feels like a migraine; intense headache; Headache has her eyes "jacked up"; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (Headache has her eyes "jacked up"), PARAESTHESIA (left arm down to her hand feels like pinprick and numbness), HYPOAESTHESIA (left arm down to her hand feels like pinprick and numbness), PAIN (semi pain) and MIGRAINE (Feels like a migraine) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced EYE DISORDER (Headache has her eyes "jacked up"), MIGRAINE (Feels like a migraine) and HEADACHE (intense headache). On 11-Mar-2021, the patient experienced PARAESTHESIA (left arm down to her hand feels like pinprick and numbness), HYPOAESTHESIA (left arm down to her hand feels like pinprick and numbness) and PAIN (semi pain). At the time of the report, EYE DISORDER (Headache has her eyes "jacked up"), PARAESTHESIA (left arm down to her hand feels like pinprick and numbness), HYPOAESTHESIA (left arm down to her hand feels like pinprick and numbness), PAIN (semi pain), MIGRAINE (Feels like a migraine) and HEADACHE (intense headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. No treatment details were reported.
3rd dose administered  after 6 month  due to COVID pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient did not receive the 3rd dose of Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comments: The pharmacist reported about administration of 3rd Engerix-B vaccine after 6 month for several employees due to COVID pandemic delayed.  The reporter consented to follow up. No additional details were given regarding employees who have had delayed Engerix-B vaccinations.
20 minutes after flu shot had itchy ears/throat progressed to throat tightness, palpitations and dizziness.  Redness to face.
Pt came in for her first dose of COVID vaccine. tongue swelling and wheezing started about 3-5 mins after vaccine injected. Oxygen stat at 93% Room air- Epi pen and IM Benadryl given. Vital signs obtained, EMS called. Oxygen level did improve to 98% BP was 164/82 with a pulse of 88. Pt taken to Pineville ER. Vaccine added to allergy list, pt informed to NOT get 2nd vaccine.
Hives at injection site (right arm) and all over torso.  Took 50mg Benadryl and hives were gone in the morning.
Client received routine immunizations at Health Dept. clinic AM of 01-12-2006. Mother gave child tylenol/motrin throughout the day. Child was up to date on immunizations and no problems were noted during the day or into the evening. Mother had checked his temp during the day and it was normal (97-98 degrees F). At approximately 1:15 AM on 01/13/2006 the client had a grand mal seizure. Mother called 911 and client went to hospital. Mother stated that the seizure lasted 35 minutes. Child was transferred to hospital where he was placed on a respirator. He had 3 more seizures during that day (1/13/06). He was started on Phenobarbitol and stablized. He remained on the respirator until late in the evening of 01/13/2006. He was released from the hospital on Sunday 01/15/2006. Mother related that he remains on the Phenobarbitol and seems to be back to his normal self. Client had done well with all previous immunizations, no problems were noted prior to this. Information receieved from Discharge Summary received 1/31/06 stated patient experienced cyanosis, fever, decreased gag response, serious encephalopathy and URI.
Pain in the opposite arm at the time the shot was administered Nausea, heat, chills, dizziness, pain in both arms while in the waiting room Flu-like symptoms for the next 5 days, which included extreme fatigue, overall muscle pain weakness,  coldness in my extremities , hip pain, lack of appetite, radiating joint pain, dry eyes, dry mouth, neuropathy, etc. Activating of an autoimmune disease flare, which still exist over 2 weeks after the original shot and includes weight loss, radiating joint pain,  severe stomach pain, dry eyes, muscle weakness, extreme coldness in my extremities especially my fingers and toes, hip pain, numbness in my fingers, lower back pain,  difficulty waking up, inability to do daily tasks, lethargy,  soreness in the morning,  etc. Additional symptoms that persist include hair loss, pruney fingers that are extremely painful, and fatigue, continued pain in the left arm where the shot was given and the opposite arm, shakey hands, etc. I have contacted my rheumatologist who has advised me to take ibuprofen and wait a few more weeks to see if symptoms persist for an appointment.
Very sore arm still. Tempature of 103 for about 4 hours then normal again.  Very tired for about 3 days after
developed since then at some pretty severe mobile form on left side; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (developed since then at some pretty severe mobile form on left side) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced VACCINATION COMPLICATION (developed since then at some pretty severe mobile form on left side). At the time of the report, VACCINATION COMPLICATION (developed since then at some pretty severe mobile form on left side) outcome was unknown.      No concomitant medications were reported.  Patient was recent recipient of COVID booster.   No treatment medications were reported.
This non-valid, spontaneous report was received from a registered nurse via a company representative and refers to 2 unspecified patients of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  An unknown dates in 2018 (reported as within the last 3 months), the patients were vaccinated with PNEUMOVAX 23 in the unspecified arm (exact dose, route of administration, lot# and expiration date were not reported) for prophylaxis (reported as routine vaccine) and with influenza virus vaccine (unspecified) (exact dose, route of administration, lot# and expiration date were not reported), both in the same arm. The patients had a return visit to the practice and were diagnosed with cellulitis on an unknown date in 2018. One of the patients might have been admitted to the hospital due to the event, however it could not be confirmed. The patients were treated with unspecified antibiotics. The outcome of the event was unknown. The relatedness between the event and suspect therapies was not provided. Upon internal review, the event of cellulitis was determined to be medically significant. Follow up information has been received from the registered nurse during a phone call on 31-DEC-2018. The registered nurse reported that one of two patients was 23 years old female and was vaccinated with PNEUMOVAX 23 on 06-NOV-2018 (lot # R018731, expiration date: 27-FEB-2020) in right deltoid. Cellulitis was developed on unspecified date. Treatment and current status were unknown to the reporter. The patient was not hospitalized. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1812USA008996: US-009507513-1812USA008994: US-009507513-1812USA008995: US-009507513-1812USA007804:
severe pain in arm, radiating to neck - symptom onset: 2/4/2, 11:00 a.m.; symptom end: by morning of 2/5/21  mild arm soreness only lightheadedness, dizziness, nausea, BP 128/78 - 2/5/21 9:00 a.m.; symptoms lasting until noon vomiting - 2/5/21 12:00 p.m. (Patient reports, "I felt a lot better after vomiting though I was still shaky and lightheaded.")
Gave Moderna vaccine to a 17 year old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave Moderna vaccine to a 17 year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave Moderna vaccine to a 17 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave Moderna vaccine to a 17 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported. T  he treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Follow-up received and added suspect product administration date, batch number, route of administration, anatomical Location and reporter  added.
Information has been received from a female medical assistant who was vaccinated with her first dose of GARDASIL on an unspecified date and her second dose of GARDASIL on 16-SEP-2010. The patient stated she experienced a bit of anxiety and felt a little sick after receiving her first dose of GARDASIL. The patient's outcome was not reported. She experienced dizziness, vomiting, and felt sick after her second dose of GARDASIL on 16-SEP-2010. She had to leave work early on 16-SEP-2010 because of the symptoms. Her symptoms resolved on 18-SEP-2010 (reported as "after 2 days"). She was nervous about receiving her third dose. It was unspecified if the patient sought medical attention. Additional information has been requested.
Received MMR vaccine at pre-employment physical on 6/7/07. Called employee health on 7/2/07 and stated she was having redness at the site of her MMR vaccine; noted R arm soreness immediately after the vaccine and redness starting about 2 weeks after the initial vaccine. Reported that the injection site became more red and indurated with a hard lump; tried ice without much benefit. Further stated the induration is about the "size of a quarter with erythema around it approximately the size of the opening of a paper cup".
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 2003, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 2004, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
Pt was already 7yrs. old. Tdap should have been used instead of KINRIX. Hib was given and was not needed after 4th birthday.
Burning skin; Red splotches; Red splotches; This spontaneous case was reported by a nurse and describes the occurrence of SKIN BURNING SENSATION (Burning skin), RASH (Red splotches) and ERYTHEMA (Red splotches) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced SKIN BURNING SENSATION (Burning skin), RASH (Red splotches) and ERYTHEMA (Red splotches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Burning skin and Patchy rash, at a dose of UNK dosage form. On 05-Jun-2021, SKIN BURNING SENSATION (Burning skin), RASH (Red splotches) and ERYTHEMA (Red splotches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.    This case was linked to MOD-2021-216184 (Patient Link).
PATIENT DIED FROM FLU COMPLICATIONS AFTER HAVING BOTH A FLU VACCINATION AND COVID VACCINATION; A spontaneous report has been received from a consumer concerning a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.     On an unknown date,The patient received Flu Vaccine (influenza vaccine live reassort 3v) (batch number Unknown), via nasal route. On an unknown date, The patient received Covid Vaccine (covid-19 vaccine nrvv ad (chadox1 ncov-19)) (batch number Unknown), via intramuscular route.     No malfunction has been reported for FLU VACCINE.    On an unknown date, the patient died from flu complications after having both a flu vaccination and covid vaccination (preferred term: Influenza).     It is unknown if any action was taken with Flu Vaccine and Covid Vaccine.    On an unspecified date,The patient died from the event.    An autopsy was not performed. The cause of death was patient died from flu complications after having both a flu vaccination and covid vaccination .     The reporter assessed the  event  patient died from flu complications after having both a flu vaccination and covid vaccination as serious due to fatal outcome.    Device Information:     Combination Product Report: Yes    Product As Reported: FLU VACCINE  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Minor correction on 31-Oct-2023: Reporter Name (Vaccination Facility) in association with the Suspect product was link with reporter Vaccination Facility. Narrative amended.; Sender's Comments: Influenza is not listed in the company data sheet for chadox1 ncov-19 and Q/LAIV. Due to limited information on demographics, conditions surrounding reported events, clinical course and treatment provided, medical history, concomitant medications, exact indication and start date of suspect drug, onset dates of events, detailed etiological and diagnostic workup (Complete blood count ,infectious profile and pulmonary workup), the evaluation did not find reasonable evidence to suggest a causal between relationship between the event and suspect drugs.; Reported Cause(s) of Death: PATIENT DIED FROM FLU COMPLICATIONS AFTER HAVING BOTH A FLU VACCINATION AND COVID VACCINATION
Administration of only the adjuvant; Administration of only the adjuvant; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Administration of only the adjuvant) and inappropriate dose of vaccine administered (Verbatim: Administration of only the adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 6-Apr-2023 A vaccine coordinator called in to report that 2 out of 10 patients that received the AS01B adjuvant only of Shingrix. The reporter asked if the patients had to receive a properly reconstituted Shingrix dose. The reporter mentioned that they were not able to identify who the 2 patients were who received the AS01B adjuvant only. Therefore, the reporter did not provide patients identifiers as well as vaccine data (lot number, exp date, date of administration). The reporter consented to follow-up. The case was linked with case US2023050871, reported by same reporter for different patient. The patient received the AS01B adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023050871:Same reporter
Pt presented with severe constant headache, neck pain, malaise and chills s/p 2nd Pfizer mRNA injection.  Injection received yesterday afternoon.  Symptoms developed early this morning.   Minimal improvement with OTC pain relievers.  Pt opted out of further lab work and testing at this time.
Chills, fatigue, and dizziness since three days after the second dose of Moderna.  Has not gone away.
Pain while eating or yawning; Pain under left ear / jaw.; Pain while yawning; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 20Mar2021 at 11:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant past medical history. The patient did not have any known allergies to medications, food, or other products. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, after two weeks, the patient experienced pain while eating or yawning and pain under left ear/jaw. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with unspecified pain killers. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain while eating or yawning and pain under left ear/jaw was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected