chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via an other company representative refers to a 60 year old male patient. There was no information about concomitant medications and pertinent medical history reported. On 02-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX dose, route, lot #, expiration date were not reported. On 01-JUN-2015, the patient experienced an aching feeling under his arm. The patient reported that on a pain scale from 1-10 with 10 being the strong pain, he was experiencing a 2. Patient sought medical attention in an office visit on unknown date. No specific treatment or lab diagnostic tests were performed. The outcome of event was unknown. The relatedness between ZOSTAVAX and event was not reported. Additional information has been requested.
Information has been received from a physician concerning a 17 year old female who in approximately 2006 was vaccinated with a dose of VAQTA. On that same day, 3 to 4 hours post vaccination the patient developed a measles like rash from her feet to all over her body but not her face. The rash lasted for 2 months and seemed to worsen with sun exposure. The patient sought medical attention at a dermatologist who thought the rash was viral in nature. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Tight, sore throat, complete loss of voice, nasal congestion, very painful left ear, bloodshot/runny eyes all within 1/2 hr of 6:00 PM. Later in evening intense shivering, 101 temp, body aches. All symptoms gone by 10/03/2015.
RLE edema started on 6-30-2021. Extensive RLE deep vein thrombosis was diagnosed through the ER.  Due to the extensive DVT, this has been growing for longer than the symptoms have shown.
Parent described pt as having 104 fever, head pain, hallucinations and vomiting late last night 8/4/04.
Numbness on left side of face. Unable to keep left eye open. This lasted 2 hours. Went home went to sleep for 3 hours and woke up and it was gone.
Initial report received on 30-Nov-2005 from a health care professional in USA. A 62 year old female patient with ongoing knee and joint pain complained of severe leg pain on 29-Nov2005 i.e. the day after the influenza vaccine (Fluzone SV 2005-2006)), lot no:U1815AA administration in the right gluteal site. Consulting physician evaluated on 30-Nov-2005. Outcome was unknown at the time of the report.
pt began sniffling & sneezing when woke up the morning post vax;t100.9;devel redness & a rash @ the inj site;pt became irritable,yelling @ everyone & exp diarrhea & vomiting several days post vax;sx lasted about 1wk;
Patient passed out after leaving the vaccination area.  She was in front of the pharmacy.  Her mom caught her as she was going down, and my staff and I went out immediately.  She had already become conscious at this time. We got her water, gatorade and a wet cloth.  She knew her name and birthday, but said she was hot and was pale. When she was able, I had her move to the immunization where she could sit and eat some apple slices and drink her gatorade.  As she cooled down, after about 15 minutes, she stated she was feeling better and her mom took her home.
Pretty bad spine pain; Migraine; Leg numbness; Leg weakness; Ocular migraines; Seeing shapesand has difficulty seeing; Muscle weakness; Could not get up; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (Pretty bad spine pain), MIGRAINE (Migraine), HYPOAESTHESIA (Leg numbness), MUSCULAR WEAKNESS (Leg weakness) and OPHTHALMIC MIGRAINE (Ocular migraines) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IMMUNOGLOBULIN HUMAN NORMAL (CUTAQUIG), ATENOLOL, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), AMITRIPTYLINE, DIAZEPAM and OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for an unknown indication.    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, the patient experienced SPINAL PAIN (Pretty bad spine pain), MIGRAINE (Migraine), HYPOAESTHESIA (Leg numbness), MUSCULAR WEAKNESS (Leg weakness), OPHTHALMIC MIGRAINE (Ocular migraines), VISUAL IMPAIRMENT (Seeing shapesand has difficulty seeing), MUSCULAR WEAKNESS (Muscle weakness), DYSSTASIA (Could not get up) and VOMITING (Vomiting). At the time of the report, SPINAL PAIN (Pretty bad spine pain), MIGRAINE (Migraine), HYPOAESTHESIA (Leg numbness), MUSCULAR WEAKNESS (Leg weakness), OPHTHALMIC MIGRAINE (Ocular migraines), VISUAL IMPAIRMENT (Seeing shapesand has difficulty seeing), MUSCULAR WEAKNESS (Muscle weakness), DYSSTASIA (Could not get up) and VOMITING (Vomiting) outcome was unknown.            Treatment information was not provided.
16 year old boy died after receving moderna vaccine; Inappropriate age at vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (16 year old boy died after receving moderna vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (16 year old boy died after receving moderna vaccine) (seriousness criteria death and medically significant) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment information was reported.   Reporter did not allow further contact; Reported Cause(s) of Death: unknown cause of death
2 pm c/o (R) upper arm itching and headache - no rash/hives present. 2:05 pm 50 mg BENADRYL given - 2:10 BP 122/78 Pulse=62 - 2:15 pm R upper arm around injection site c/o feeling hot but no longer itching. 2:20 pm c/o numbness (R) hand fingers. No itching - 2:25 pm grandfather pick her up - report with s/s to watch for and when to go to MD if needed.
A non-serious spontaneous report of inadvertently given half dose of H1N1 was received from a nurse/health professional concerning a 37-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose (0.1 ml) of H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved.
pfizer-BioNTechCOVID-19 VaccineEUA    daihrea 36 hours posst injection
fever, migraines, chronic pain in lower body resulting in limited mobility. Symptoms started about 12 hours after vaccine. The lower body pain was extremely severe in knees which is where RSD diagnosis occurred. OTC pain medication did not help during this time. This severe pain lasted 36 hours. Migraines lasted 5 days.
This spontaneous report as received from a Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 26-FEB-2018, the patient was vaccinated with improperly stored VARIVAX lot # N022981, expiration date: 23-AUG-2019, dose 1 for prophylaxis. Concomitant therapies included sterile diluent. The vaccine had temperature excursion of -14 degree C to -10 degree C for 10 hours 15 minutes. Previous temperature excursion of -14 degree C to -10 degree C for 135 Hours and 45 Minutes. The call was due to the digital data logger. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001739.
Started seeing pools of blood underneath the skin / little blue spots underneath the skin on the legs; was not well overall; Rash; Congestion; her body felt very very strange, like something was moving, the body just felt so different; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion), FEELING ABNORMAL (her body felt very very strange, like something was moving, the body just felt so different), PURPURA (Started seeing pools of blood underneath the skin / little blue spots underneath the skin on the legs), MALAISE (was not well overall) and RASH (Rash) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054LZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Low platelets (She has low platelets (condition prior to the vaccination), has always suffered with low platelets, not low to the point of being hospitalized,  always around 105000.).    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Congestion), FEELING ABNORMAL (her body felt very very strange, like something was moving, the body just felt so different), PURPURA (Started seeing pools of blood underneath the skin / little blue spots underneath the skin on the legs), MALAISE (was not well overall) and RASH (Rash). At the time of the report, NASAL CONGESTION (Congestion), FEELING ABNORMAL (her body felt very very strange, like something was moving, the body just felt so different), MALAISE (was not well overall) and RASH (Rash) outcome was unknown and PURPURA (Started seeing pools of blood underneath the skin / little blue spots underneath the skin on the legs) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
This is a spontaneous report from a contactable nurse. This nurse reported similar events for 2 patients. This is the 2nd of 2 reports.  A 20-year-old patient of an unspecified and gender started to receive TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe headache. The outcome of the event was unknown. Information on the lot number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019059786 Same reporter/drugs/events, different patient.
Initial unsolicited report received from a consumer on 17-Aug-2017. This case involves 38-year-old male patient who was vaccinated with a first, second, third and fourth dose of IMOVAX (batch number unknown by reporter) for bat exposure in shoulder area via intramuscular route on 21-Jul-2017, 24-Jul-2017, 28-Jul-2017, and 04-Aug-2017 respectively. Illness at time of vaccination reported as bat exposure. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) denied by the patient. The patient received concomitant vaccine as first dose of HUMAN RABIES IMMUNOGLOBULIN (HRIG) (batch number unknown) in thigh and deltoid on 21-Jul-2017. On 11-Aug-2017, 21 days following the vaccination, the patient developed fatigue weakness, shakiness in fingers and toes 7 days post the last dose of rabies vaccine. The patient's laboratory data and corrective treatment were not reported. The events outcome was unknown. List of documents held by sender: none.
Day after 2nd injection, a rash in the chest area that has persisted as of today 5/3/21; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0117) via an unspecified route of administration in the left arm on 28Apr2021 at 08:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. 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. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 08:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 09:00, day after 2nd injection the patient experienced a rash in the chest area that persisted as on the day of reporting on 03May2021. Therapeutic measures were taken as a result of event and included treatment with hydrocortisone (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (BENADRYL) dose. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event a rash in the chest area was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Patient initially recevied Janssen covid vaccine on  3/22/21 and came in today to get booster dose of Moderna. She has a history of feinting after vaccinations. After the injection patient felt lightheaded and about a minute later she said she was going to feint and she did.  Paramedics were called at this point.  Patient was out for about 10 seconds and never stopped breathing.  She came too and broke out into a sweat. She continued to be lethargic (almost like she wanted to sleep). Whenever I called her name she would open her eyes and when asked if she could hear me she would respond "yes".  Paramedics came and transported her to hospital.
Hospitalized with acute respiratory failure related to COVID-19 infection. Increased dyspnea on remdesivir and dexamethasone.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient were vaccinated with GARDASIL. Dose, route, lot number and expiration date were not reported. The physician reported that improperly stored GARDASIL was administered to unspecified patients on unspecified dates. No adverse effect reported. It was also reported that Td vaccine had been improperly stored. This is one of two reports from the same source (other case # 1407USA000389). Additional information has been requested.
Expired vaccine used; product storage error; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (product storage error) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (product storage error). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (product storage error) 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.
Amnesia; Cardiac disorder; Thrombosis; Transient ischaemic attack; This case was received via another Manufacturer (Reference number: vsafe) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of AMNESIA (Amnesia), CARDIAC DISORDER (Cardiac disorder), THROMBOSIS (Thrombosis) and TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Glaucoma and Hypothyroidism. Concurrent medical conditions included Stroke. Concomitant products included LEVOTHYROXINE, BRIMONIDINE, LATANOPROST and TIMOLOL for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced AMNESIA (Amnesia) (seriousness criterion hospitalization), CARDIAC DISORDER (Cardiac disorder) (seriousness criterion hospitalization), THROMBOSIS (Thrombosis) (seriousness criteria hospitalization and medically significant) and TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) (seriousness criteria hospitalization and medically significant). At the time of the report, AMNESIA (Amnesia), CARDIAC DISORDER (Cardiac disorder), THROMBOSIS (Thrombosis) and TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Catheterisation cardiac: inconclusive. On 14-Jan-2021, Echocardiogram: inconclusive. On 14-Jan-2021, Magnetic resonance imaging: inconclusive. On 14-Jan-2021, Ultrasound scan: inconclusive.     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.   The next day, the patient had short term memory loss, patient went to the hospital, and they said patient had some type of heart episode. The patient was taken by ambulance to the hospital and was told  had a blood clot in brain and had suffered a mini stroke. The patient was hospitalized for 4 nights. The patient was given blood thinner and got improved.  Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine, the onset of the reported events, a causal relationship cannot be excluded.  However patient had an underlying risk in the past history of stroke.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine, the onset of the reported events, a causal relationship cannot be excluded.  However patient had an underlying risk in the past history of stroke.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:53 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:53 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 34.98. Concomitant products were not provided. On 31-Mar-2021, Excursion time were 08 AM and 09 AM, temperature were 32 and 32 respectively, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 31-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 AM: 43, 1PM: 44, 2 PM: 46, 3 PM: 46, 4 PM: 44 and 5 PM: 44. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Beginning around 12 noon 7/24/12 after Tdap vaccine administered began with headache, body aches and nausea with slight fever. Began taking Tylenol every 4 hours. Symptoms intensified over the course of the evening to include "severe" headache, dry cough, scratchy throat, fever 101.2, increased nausea, with no vomiting, body aches, chills and sweats. At 4:00 AM awoke to feel as if she had a migraine headache. Felt as if running a higher fever than earlier. (did not take temperature with thermometer), hard chills and sweating. Some relief with Tylenol. Was able to go to work today, but still has headache, feels feverish, non- productive cough, nauseous and scratchy throat. Continuing to take Tylenol every 4 hours.
Myalgia, Arthralgia, NauseaVomiting, CHILLS AND FATIGUE, EDEMA AT INJECTION SITE Narrative:  PT W C/O EVERYTHING HURTING, AFEBRILE LASTING NOT QUITE 24HOURS.
Patient received the Hep A vaccine and came up to the front window. While the patient was waiting the patient fell forward and fainted. During this time the patient was pulseless for a second where Dr. had to perform CPR. The Paramedic came and took her to the ER for future evaluation.
Headache; covid arm: huge rash/ swelling of left shoulder, its swollen, bumpy and hot to the touch. Size: approx 4"x5"
vaginally blood spotting; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (vaginally blood spotting) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced VAGINAL HAEMORRHAGE (vaginally blood spotting). On 04-Sep-2021, VAGINAL HAEMORRHAGE (vaginally blood spotting) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received second dose of Moderna on 09-SEP-2019 in her right arm. (LOT # 020F21A) No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-317480 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Sep-2021: Significant Follow-up on 11-sep-2021: reporter details, route of administration for dose 1, and dose 2 details
Received second booster shot; next morning had mild flu-like symptoms - headache; body aches; weakness and sore throat with swelling on right side.  Teledoc visit with primary care office with a resultant prescription for Amoxicillin