chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route of administratration were not reported, lot # M031557 with expiration date: 07-ARP-2019 and M037770, 01-JUN-2019 ). No adverse effects were reported. Data logger was involved. There was a previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004333: US-009507513-1705USA004589: US-009507513-1705USA004590: US-009507513-1705USA004589:
Day after 2nd dose patient developed erythematous rash with underlying edema on legs and back. 7 days later patient developed similar rashes on forearms and arms. Rash is made up of papules with surround erythema/edema (~5cm max diameter) and is pruritic and burning.  Associated myalgias and fatigue
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 11:05 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 11:05 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The age of patient was provided as 83.52.  It was reported that unknown number of patients were 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 time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 17-Feb-2021, Excursion time was 08AM and temperature was 20 and 09 AM, temperature was 22, total doses given for the day was 62, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021 and 11-Feb-2021, vial was moved to clinic on 17-Feb-2021. 6 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021 and 13-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Began with tingling sensation in left foot, eventually moved to internal vibrations throughout the entire body, general fatigue, brain foginess, and muscle weakness.  Symptoms started in June 2021 and have gotten progressively worse over time.
Information has been received from a registered nurse concerning a 5 year old female who on 18-DEC-2001 was vaccinated SC in the left thigh with a 0.5 ml first dose of Varivax (lot# 638653/1890K). Concomitant vaccination included a 0.5 ml third dose of Comvax (lot # 638434/1639K), and a 0.5 ml third dose of IPOL (lot # T1273-2). Concomitant therapy also included tuberculin purified protein derivative. On 29-JAN-2006 the patient developed break through chickenpox. No medical attention was sought. Subsequently, the patient recovered. No further information was available. The patient's additional vaccination history includes: First, second, third, fourth, and fifth doses of Infanrix (lot # 992A2), 24-SEP-2001 (Infanrix) (lot #998A), 12-JUN-2002 (Tripedia) (lot # UO543BA), and 03-AUG-2005 (manufacturer unspecified) respectively. One dose of hepatitis B virus (manufacturer unspecified) on 25-OCT-2000. One dose of Hib (lot # 639027/0267L). First, second and third doses of Comvax on 25-OCT-2000 (manufacturer unspecified), 08-JAN-2001 (lot # 637687/1408K), and 18-DEC-2001 (lot # 638434/1693K) respectively. Doses of Fluzone on 01-DEC-2003 (lot # U1098AA), 07-JAN-2004 (lot # U1098AA), and 19-DEC-2005 (lot # U1936AA). First, second, third, and fourth doses on 08-JAN-2001 IPOL (lot # T01202), 26-APR-2001 (IPOL) (lot # T04843), 18-DEC-2001 (IPOL) (lot # T12732) and 03-AUG-2005 (manufacturer unspecified) respectively. First and second doses of MMR II on 12-JUN-2005 (lot# 641462/0128M) and 13-AUG-2005 (manufacturer unspecified). One dose of pneumococcal conj vaccine (unspecified) (manufacturer unspecified) (lot # 472-045) on 08-JAN-2001. Additional information is not expected.
Upper left arm at injection site swollen and red extending to left armpit with swelling/lump the size of a small lemon.
Completed only 3 out of the 4 Vivotif doses as he accidentally bit into the fourth capsule/ he won't be taking it; Accidentally bit into the fourth capsule; A spontaneous report was received from a nurse on 29JUN2022. It described a male patient (unknown age) who "completed only 3 out of the 4 Vivotif doses as he accidentally bit into the fourth capsule/ he won't be taking it" (PT: Incomplete course of vaccination and PT: Wrong technique in product usage process). The patient took the Vivotif capsule (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took only 3 out of the 4 Vivotif doses as he accidentally bit into the fourth capsule, and it cracked. Reportedly, he would not take that fourth dose of Vivotif. The outcome of the reported events was unknown.  Action taken with Vivotif with respect to the reported events was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer had completed only 3 out of the 4 Vivotif doses (incomplete course of vaccination) as he accidentally bit into the fourth capsule (wrong technique in product usage process). Considering the case information, the causality of incomplete course of vaccination and wrong technique in product usage process is assessed as not applicable with Vivotif considering the nature of the events.; Sender's Comments: It was reported that a consumer had completed only 3 out of the 4 Vivotif doses (incomplete course of vaccination) as he accidentally bit into the fourth capsule (wrong technique in product usage process). Considering the case information, the causality of incomplete course of vaccination and wrong technique in product usage process is assessed as not applicable with Vivotif considering the nature of the events.
PAIN ON LEFT BREAST; PAIN IN LEFT SIDE OF CHEST ON SIDE  OF INJECTION; PAIN UNDER LEFT ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced pain on left breast. On 15-MAR-2021, the subject experienced pain in left side of chest on side of injection. On 15-MAR-2021, the subject experienced pain under left arm. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) awaiting result, and Mammogram (NR: not provided) awaiting result. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain on left breast, pain in left side of chest on side of injection, and pain under left arm. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non serious.
Got flu shot in am. By afternoon, had body aches. By early evening, had fever, chills, nausea and weakness lasting until early morning. No fever by 7am next morning.
Fever and rash approximately 5 hrs after injection. Treated fever with Tylenol, skin reaction with oral Benadryl.
Soreness in arm directly afterward, lethargy following day. Day 4, diarrhea, dizziness, headache, runny nose & eyes, tiredness, ache all over - especially upper body. 100.1 fever.  Flu-like symptoms however this is NOT the flu.
* Soreness at injection site * Swollen lymphnodes in left armpit * Mild pain in left arm
Day after vaccine I had flu like symptoms; Arm was really really sore for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Day after vaccine I had flu like symptoms) and MYALGIA (Arm was really really sore for 3 days) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Autoimmune disorder. Concomitant products included MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]), PREDNISONE, IMMUNOGLOBULIN [IMMUNOGLOBULINS NOS] and UPADACITINIB (RINVOQ) for Immunosuppression NOS.   On 19-Jan-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced MYALGIA (Arm was really really sore for 3 days). On 17-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Day after vaccine I had flu like symptoms). On 18-Feb-2021, INFLUENZA LIKE ILLNESS (Day after vaccine I had flu like symptoms) had resolved. On 19-Feb-2021, MYALGIA (Arm was really really sore for 3 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.
A report received from a Health Professional via MedImmune representative concerns, female patient. Patient received unknown FluMist Quadrivalent (influenza virus vaccine live, intranasal) on an unknown date. HCP reported that her daughter had flu. The outcome of flu was unknown. The report was considered to be non-serious by company physician.
itchy rash on lower back; herpes on her lip; This non-serious case was reported by a physician via sales rep and described the occurrence of itchy rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced itchy rash (Verbatim: itchy rash on lower back) and herpes on lip (Verbatim: herpes on her lip). The outcome of the itchy rash and herpes on lip were not reported.   It was unknown if the reporter considered the itchy rash and herpes on lip to be related to Shingrix.     It was unknown if the company considered the itchy rash and herpes on lip to be related to Shingrix.   Additional Information: GSK receipt date: 27-OCT-2023 The reporter reported that right after the vaccine the patient developed an itchy rash on lower back and a herpes on her lip. The reporter did not consented to follow up.
Respiratory distress, rhinorrhea, rash, reddened skin on arms, face, neck, chest. O2 Sat dropped. Was given inhaler, oxygen and 911 called. Patient was transported via ambulance to the ER.
Patient indicated she was 18 at time of primary series by entering 5/4/2002 as her birthday during self registration process and Moderna vaccine was administered. She received Moderna vaccine on 4/19/2021 and 6/02/21. The inconsistency with her birthday was noted when she returned for a booster on 1/5/2022 and she was administered Pfizer vaccine (30ug) as a booster.   No adverse effects were noted after the initial series.
Per pt's portal message from his wife "After 2nd COVID shot, patient became disoriented, confused and physically impaired from walking or standing.  The following day he was fine but admitted to "losing a day".  Following the 3rd shot, 24 hrs later, he lost physical ability to get out of a chair, walk, or get into bed.  It was like he "forgot" how to walk.  Mental capability was fine.  He was better the following day, with some wobbly walking that improved as the day went on.  Both episodes seem to be related to the shot"
shock like feeling keeps shooting down my arms; It felt like from the very first evening it gave me some sort of brain damage; They think I had a basal artery stroke since half my face is numb; Skin hypersensitivity; pain all over my body; severe muscle weakness; pain in my upper teeth; dizziness; feeling like I was going to faint and thrown up; my muscles feel weird like when you have the flu; I haven't been able to focus my eyes; The right side of my face, eyebrow, cheek, side of my nose, mouth, ear, scalp, roof of mouth, gums are all numb on one side/half of  face  and half of my my tongue; Chills; low blood pressure with a high pulse; low blood pressure with a high pulse; my head and my brain doesn't feel right; They think I had a basal artery stroke since half my face is numb; I was really sick; severe flu like symptoms; This is a spontaneous report from a contactable consumer reporting for herself. This consumer reported different events with first and second dose. This is the first of 2 reports. Only this case is serious. This female patient of unknown age received in Apr2021 second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient had first dose of BNT162B2 for Covid-19 immunization in Mar2021 and experienced arm pain and fatigue. In Apr2021, she's had, skin hypersensitivity, pain all over her body, severe muscle weakness, pain in my upper teeth, dizziness, feeling like I was going to faint and thrown up, that only lasted for a day, her muscles feel weird like when you have the flu, and ever since then she had been able to focus her eyes. The right side of my face, eyebrow, cheek, side of my nose, mouth, ear, scalp, roof of mouth, gums are all numb on one side/half of face and half of my tongue. Chills, shock like feeling keeps shooting down my arms, low blood pressure with a high pulse. Half of my head and face numb months later and severe weak muscles. It felt like from the very first evening it gave me some sort of brain damage. my head and my brain doesn't feel right. All of this started the evening after the second dose and by the time I woke up the next morning I was really sick (2021). The patient expected to have severe flu like symptoms  (2021) for a few days but those symptoms went away and all the others have stayed. The patient have seen doctors, urgent cares, emergency rooms. The patient had in 2021 cat scan, MRI and visited Neurologists who think she had a basal artery stroke since half face is numb. The ER doctors told me that and so did both of my neurologists. Final outcome for all the events was reported as unknown. Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021907988 same patient/drug, different event/dose
Had no reaction to 1st dose of Moderna COVID vaccine 1/6/2021.  2nd dose Moderna COVID vaccine 2/4/2021 had no immediate reaction but developed fever and fatigue that lasted 36 hr 1 d after vaccination.  On 2/7  had redness and local swelling at site of injection.  Next day 2/8 rash on chest then broke out face, neck , abdomen, back.  Was seen in local ER where she was diagnosed with an allergic reaction to the vaccine.  Treated Solumedrol, Toradol, lorazepam, Benadryl  and Pepcid and dishcarged with Rx for Prednisone and advised to continue Benadryl and Pepcid.  Rash worsened, became purple and morbilliform on face, arms, legs, back and abdomen over next 3 d.  Was seen by PCP on 2/11.  Prednisone increased to 40 mg x 3 d.  Rash improved with this and was resolving by the time I examined her on 2/15/2021.  Face was beginning to peel but had no  mucosal surface involvement.
Pt. recieved vaccine that was drawn up for more than 12 hours. No adverse event.
Myalgia, Nausea Vomiting, fatigue, chills Narrative:
Pt developed rash more than 2-3 inches, reported on 12/21/16 2:39 pm. Pt checked with her dr and dr said to contact VAERS.
Pfizer vaccine was given as a second dose of COVID-19 to a patient who had received the Moderna vaccine as her first dose.
36 weeks pregnant at time of vaccines. 38 weeks pregnant when gave birth. Went into hospital because I had not felt baby move and was feeling really hot, was told there was no heartbeat for baby.
tested positive for the COVID; tested positive for the COVID; This is a spontaneous report from a contactable consumer. An unknown age female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number were not reported) dose 2 via unknown route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. the patient past drug therapy included bnt162b2 (dose 1, single) for COVID-19 Immunisation on an unspecified date. The patient would like to submit a complaint about there isn't a site that the patient can report that she have severe symptoms and tested positive for the COVID-19, 5 months after the second dose. She would like to be part of the trial to show why some people we get sick with the COVID-19 even already fully vaccinated with pfizer. The patient underwent lab tests and procedures which included COVID-19 test was positive on an unknown date. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
enlarge lymph node; 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 LYMPHADENOPATHY (enlarge lymph node) 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) (Intramuscular) 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 LYMPHADENOPATHY (enlarge lymph node). At the time of the report, LYMPHADENOPATHY (enlarge lymph node) outcome was unknown.            No concomitant drugs and treatment medications were reported.
Patient administered vaccine - was about to sit down - had syncopal/seizure episode - fell to ground with few seconds of tonic-clonic activity.  Patient assisted by medical staff in clinic  - ED physician, RN/NP, rolled to side - patient bit lip, mouth bleeding, unresponsive for a few seconds.  Woke up - able to respond appropriately, coherent - alert, oriented to person, place and time - patient did not recall falling to floor.  Pt denied hx of prior seizures or any allergies or other significant medical history.  Taken by wheelchair to emergency dept by staff.
Shingles from neck to the top of head after first shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles from neck to the top of head after first shot) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for Hypertension, APIXABAN (ELIQUIS) for Thrombus.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced HERPES ZOSTER (Shingles from neck to the top of head after first shot). At the time of the report, HERPES ZOSTER (Shingles from neck to the top of head after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-017250 (E2B Linked Report).; Sender's Comments:  MOD-2021-017250:Same patient, second dose
pain in jaw bone; pain in the area of the injection site/still has pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (pain in jaw bone) and VACCINATION SITE PAIN (pain in the area of the injection site/still has pain in the arm) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 013A21A and 028A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer and Immunodeficiency.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PAIN IN JAW (pain in jaw bone) and VACCINATION SITE PAIN (pain in the area of the injection site/still has pain in the arm). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN JAW (pain in jaw bone) had resolved and VACCINATION SITE PAIN (pain in the area of the injection site/still has pain in the arm) had not resolved.            No concomitant medication details was provided.   This case was linked to MOD-2021-403258 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Follow up received on 30-NOV-2021 included No New Information
Woke up every muscle hurt I was chilled and extremely exhausted.  By 3:30-4:00 pm I ran a fever of 100.9 it finally broke about 9:30pm  I am feeling fine today August 5 2021.
16 days post vax, the pt tested positive for pregnancy. A doctor visit was required and no treatment was given. Pt reported that this was an unexpected pregnancy. The most recent information reports the outcome of the event as ongoing.