chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Crohns disease return; Arthritis; Both COVID-19 vaccination made his body felt weird; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohns disease return), ARTHRITIS (Arthritis) and FEELING ABNORMAL (Both COVID-19 vaccination made his body felt weird) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Rheumatoid arthritis.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced CROHN'S DISEASE (Crohns disease return), ARTHRITIS (Arthritis) and FEELING ABNORMAL (Both COVID-19 vaccination made his body felt weird). At the time of the report, CROHN'S DISEASE (Crohns disease return) outcome was unknown, ARTHRITIS (Arthritis) was resolving and FEELING ABNORMAL (Both COVID-19 vaccination made his body felt weird) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medications were reported.  Company comment: This spontaneous case concerns a male patient of unspecified age with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of Arthritis which occurred at an unspecified date after receiving a dose of mRNA1273 as first dose of COVID -19 vaccine. Crohn's disease (described as Crohn's disease return) was also reported as an additional event in this case and may be in relation with Arthritis. Further details on the clinical course, diagnostic test and treatment regimen were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a male patient of unspecified age with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of Arthritis which occurred at an unspecified date after receiving a dose of mRNA1273 as first dose of COVID -19 vaccine. Crohn's disease (described as Crohn's disease return) was also reported as an additional event in this case and may be in relation with Arthritis. Further details on the clinical course, diagnostic test and treatment regimen were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.
pt recv vax 19FEB98 & pt exp myocardial infarction;The reporting nurse noted that pt MD recommended pt not recv 3rd dose for as long as possible;
Initial pregnancy unsolicited literature report received on 03 Feb 2015. This case is linked to 2015SA020610 (same reported). Forty two pregnant female patients (age not reported) whose medical history and concomitant medication were not reported, had received a dose of Seasonal Influenza Vaccine (batch number, route and site of vaccination was not reported) on an unspecified date. CONCLUSION: Influenza had a greater negative impact on pregnant women than non-influenza ARIs, as indicated by symptom severity and greater likelihood of elevated temperature. These results highlight the importance of preventing and treating influenza illnesses in pregnant women. The case concerns with forty two pregnant female patients who were identified to be influenza positive on an unspecified date. Corrective treatment and laboratory investigations were not reported. Documents held by sender: none.
Flu like symptoms for 7 days following 1st dose but not 2nd dose; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Flu like symptoms for 7 days following 1st dose but not 2nd dose".  Additional information: Patient also received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. Reportedly, it was unknown if patient had COVID prior to vaccination and it was also unknown if patient was tested post vaccination.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Due to me having a previous reaction 48 years to Penicillin they asked me to wait 30 minutes after vaccination instead of 15 minutes. I left and about 10 minutes after I left, all of sudden I started feeling, I started feeling hives on the roof of my mouth. I could feel with my tongue blister things on the roof in my mouth. Within in a few minutes they began to burst and liquid came out. I did call my doctor and they had someone call me and to make an appointment with an allergist. I do not remember the Allergist's name but I am scheduled to see her tomorrow 2/11/2021 at 8:30 AM.  I spoke with my doctor and 2 people.  As of today my mouth is still a little sore, my tongue feels funny and swollen.
About a month after the booster shot I noticed pretty severe joint pain around the knees. After standing all day the pain was excruciating with ice and ibuprofen being of little to. I relied. Pain occurred daily for about three months but did subside.
Hives, itching, shortness of breath, tired, no appetite, fast heart rate, hoarseness, sore throat.
Pt received PNEUMOVAX on 1/28/2016. On 01/29/2016 pt called complaining of severe pain and soreness at site of injection. Pt later came in store to show sore arm. There were no signs of bruising. No redness or breaking out. Pt then went to her PCP on the afternoon of 1/29/16. I called pt next day - MD told her to work out the soreness and gave her a steroid shot. Dr told pt. she should be better in 4-5 days.
"Patient reports fatigue, subjective fever, redness in the cheeks, sensitivity to smell and swollen lips since pt received the moderna vaccine on 2/11/21.  She also states she has burning in the chest. pt feels like she is very hot and then very cold. PCP found patient to be back at baseline now.
Upper lip swelling and right cheek swelling, duration 1-2 hours, upon awaking 5/1/08. Hep A vaccine given at 130pm 4/30/08. No airway compose.
patient came up to rx counter stated he wasn't feeling well his eyes rolled into the back of his head and he passed out we called 911 he was assessed and they recommended to not transport him since vitals were okay
1 dose in 2020, another dose today; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received first dose in 2020).   On 3rd November 2022, the patient received the 2nd dose of Shingles vaccine. On 3rd November 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 3-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had 1 dose of Shingrix in 2020 according to his/her records.  The patient did not remember getting a second shot and forgot about the first and had another first dose on day of reporting.  The patient asked that was it ok or he/she still need another shot. Additional supportive information: The patient received the second shot later than the recommended interval, which led to lengthening of vaccine schedule. The follow-up could not be possible as no contact details were available.
Swollen lymph node (in arm pit, same side as shot). Diarrhea. Fatigue. Muscle soreness. Mild fever (100F) w/ brain fog.
Received Vx after temp excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 1-day-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   In January 2023, the patient received Engerix B pediatric (intramuscular) and Engerix B Pre-Filled Syringe Device. In January 2023, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date : 20 Jan 2023 Reporters comment: The physician reported that the patient received Engerix B after a temperature excursion of too cold. All patients were one day old. Reporter consented to follow up. Additional supportive information: As patient received Engerix B after a temperature excursion of too cold, which led to incorrect storage of drug. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023008733:Same reporter US-GSK-US2023008735:Same reporter US-GSK-US2023AMR009449:same reporter - female patient US-GSK-US2023AMR009450:same reporter - female case US-GSK-US2023008733:same reporter - female patient
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Paxlovid rebound 3 days after finishing treatment) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 prophylaxis. Concurrent medical conditions included Undifferentiated connective tissue disease and Allergy to plants (Allergic to wheatgrass). Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) from December 2021 to an unknown date and FLUVOXAMINE MALEATE (LUVOX CR) from 24-Apr-2022 to an unknown date for an unknown indication. On 23-Nov-2021 at 1:15 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On 02-May-2022 at 8:00 AM, the patient experienced COVID-19 (Paxlovid rebound 3 days after finishing treatment). On 11-May-2022, COVID-19 (Paxlovid rebound 3 days after finishing treatment) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient date of birth was reported as Feb 1964. It was reported that patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Treatment received second dose of Paxlovid device date on 14 May 2022. Company comment: This spontaneous case concerns a 58 year old female patient with relevant medical history of undifferentiated connective tissue disorder, who experienced the unexpected non serious AESI of COVID-19, about 5 months and 7 days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient was taking Paxlovid for COVID-19 infection However, had rebound COVID-19, 3 days after finishing treatment. No further information on details pertaining to the previous doses was available in the report. Ongoing COVID-19 pandemic and medical history of undifferentiated connective tissue disorder could be risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 58 year old female patient with relevant medical history of undifferentiated connective tissue disorder, who experienced the unexpected non serious AESI of COVID-19, about 5 months and 7 days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient was taking Paxlovid for COVID-19 infection However, had rebound COVID-19, 3 days after finishing treatment. No further information on details pertaining to the previous doses was available in the report. Ongoing COVID-19 pandemic and medical history of undifferentiated connective tissue disorder could be risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pt recvd vax on 3JAN93 & 16JAN93 pt exp a sore throat, fatigue, & malaise, devel a fever & a rash; lab eval revealed WBC count 2800, segmented neutrophils 69, lymphocytes 19%;
Scratchy throat; Head cold; Achy; Miserable/ felt poppy; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on 5th August 2019 and experienced events, refer case US2020AMR000607). Concurrent medical conditions included sinus infection.   On 27th December 2019, the patient received the 2nd dose of Shingrix. On 28th December 2019, 1 days after receiving Shingrix, the patient experienced general body pain and feeling abnormal. On 29th December 2019, the patient experienced throat irritation and head cold. The patient was treated with antibiotics nos (Antibiotic (Details Unknown)) and steroids nos (Steroid (Not Specified)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain and feeling abnormal were unknown and the outcome of the throat irritation and head cold were recovering/resolving.   It was unknown if the reporter considered the general body pain, feeling abnormal, throat irritation and head cold to be related to Shingrix.  Additional details were received as follows: The patient after vaccination was achy and miserable. The patient felt poopy and had a scratchy throat and a head cold. The patient already had a sinus infection going on before the second dose. The patient seen an ENT physician who instructed her to take an antibiotic and a steroid. The patient stated that the pharmacist pharmacist told her needed to wait to take the meds since she had the  Shingrix shot. The patient stated that she did not believe she had ever had chicken pox. The patient stated that the she felt the scratchy throat and head cold were getting better, but she still feels poopy. The patient consented to follow up.
This spontaneous report as received from a medical assistant refers to a 46 year old male patient with a history of recurring HPV who about a month ago in approximately May 2013, was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported). The medical assistant reported that the patient had had a history of recurring HPV since before GARDASIL was administered and she did not specify if any HPV outbreaks had occurred since GARDASIL was administered. No adverse effects were reported. Additional information has been requested.
Bilateral shoulder and wrist pain.  Elevated troponins.  Diagnosed as myocarditis.
Irregular menstrual cycle: extended/exacerbated pms symptoms, 3+ day delay in period onset, heavier bleeding (incl. larger clots), bleeding has returned 2 days post-late period. Higher inflammation for longer time has adversely affected chronic conditions (Crohn's: intestinal bleeding, extreme fatigue, diarrhea, bloating/discomfort, likely dehydration).  With bleeding having returned, cycle irregularities have seemed to continue to nearly 2 weeks post-2nd dose.  Additionally: Prior to late period, had incidence of Raynauds Phenomenon (one finger of one hand) 3 days post-2nd dose following brief cold exposure; lasted 20-30mins. No prior history.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 10-AUG-2017 the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M044347, expiration date: 04-NOV-2018) for prophylaxis. Temperature and time frame: 6 F to 14 F for 1 hour 36 minutes. There was no previous temperature excursion. The sterile diluent vials used for reconstitution did not undergo a temperature excursion. No adverse effects reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA007000.
Pt. states severe soreness, lite "pleurisy". Says when pulls arm up feels like yanking right out of socket. Cannot sleep on left side of arm. Pt got shot on 11/6/17. Notified pharmacy on 12/4/17. Pt using TYLENOL.
A report had been received from a Health Professional concerning a 3 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 13-OCT-2014. The patient experienced tested positive for influenza A which started on 05-DEC-2014. The outcome of the event of tested positive for  influenza A was unknown. The report was considered to be non-serious.
Nursing notes and discharge summary submitted. Patient had not tested positive to COVID since 12/2020.
On the morning of the fourth day after the vaccination, I woke up with a chicken pox like rash on my trunk (abdomen). This spread and got worse the following day. The itching was minimal (cortisone.10 took away all itch; the rash then started to get less red on the third day. Day four- still there, but fading.
have developed Sweet Syndrome; This spontaneous case was reported by a patient and describes the occurrence of ACUTE FEBRILE NEUTROPHILIC DERMATOSIS (have developed Sweet Syndrome) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: COVID-19 Vaccine (Dose 2, received 2 COVID vaccines), COVID-19 Vaccine (Dose 1 and received 2 COVID vaccines). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine and COVID-19 Vaccine.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACUTE FEBRILE NEUTROPHILIC DERMATOSIS (have developed Sweet Syndrome) (seriousness criterion medically significant). At the time of the report, ACUTE FEBRILE NEUTROPHILIC DERMATOSIS (have developed Sweet Syndrome) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Company comment- This spontaneous case concerns a patient of unknown gender and age with no medical history reported who experienced the serious unexpected (medically significant) event acute febrile neutrophilic dermatosis after a dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, given as a booster dose of COVID vaccine schedule, was administered. It was reported that after receiving 2 COVID vaccines and one booster patient developed Sweet Syndrome. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
red, swollen, bruised at injection site (currently). Patient stated she felt really awful and couldn't sleep that night (could not give more details)
In a wheelchair totally paralyzed; This case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced paralysis (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the paralysis was unknown.   The reporter considered the paralysis to be related to Flu vaccine.  Additional details were provided as follows: This case reported by the reporter's friend sister. The age at vaccination was not reported. The patient was in a wheelchair and totally paralyzed from the Flu shot. The reporter stated that the reporter knew too many people getting lupus and auto-immune disease after an unspecified vaccine. The reporter stated that there was massive aluminum in vaccines (name not specified) and 1 in 3 get Alzheimers and they found the aluminum in their brains at autopsies.
Small rash at injection site approximately 3 inch diameter circle, mildly itchy for 30 mins, resolved by the next morning
Admitted 08/05/2021. Deceased 08/18/2021. Diagnosis was Covid-19.
Soreness, pain, stiffness, limited range of motion in the left deltoid/ shoulder area.
Covid positive through house hold contact.  Client did receive booster but not within 2 weeks of getting sick
Initial report received from a physician on 27 October 2010. A 6-year-old female patient received an injection of FLUZONE (lot number, date, and route of administration not reported), and one day post-vaccination experienced a bullous delayed rash at the injection site with scattered bullous lesions around the immediate site. The patient had no history of allergies. She was treated with antibiotic ointment, and the event resolved within a few days. According to the reporter, the most likely diagnosis was "delayed hypersensitivity reaction secondary to thimerosal", and the physician planned to perform patch testing on the patient to confirm the diagnosis. Follow-up information received from a physician on 13 December 2010. The patient had no known illnesses at the time of the influenza vaccination. Follow-up information was received from a physician on 24 January 2011. The patient had received an intramuscular left deltoid injection FLUZONE, lot number UH180AA. The patient was evaluated by a physician. No further information was available at the time of report. The patient's outcome remained recovered. Documents held by sender: None.
Pain in left arm since injection. Sore to lift arm. Painful to sleep on left side. Fingers tingle at night.
Information was received from a certified medical assistant via a company representative referring to a teenage patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 07-JUL-2016, at the same office visit, the teenage patient was inadvertently administered one dose of (Oka-Merck) PROQUAD (lot#, expiry and route unknown) injection and one dose of (Oka/Merck) VARIVAX (lot#, expiry and route unknown) (accidental overdose). No adverse effect was reported. Additional information has been requested.
Arm is so extremely sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm is so extremely sore) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced MYALGIA (Arm is so extremely sore). At the time of the report, MYALGIA (Arm is so extremely sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported.  Treatment information were not reported.