chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an expired dose of ZOSTAVAX (strength, indication, route, lot number and expiration date not reported). The healthcare student stated that the ZOSTAVAX expired approximately in April 2014 two months ago. No adverse effects were reported. Additional information has been requested.
I had a red, itchy rash show up exactly 1 week after getting my shot. After reading up on it, it seems consistent with what has been deemed ?covid arm.? It was mostly just swollen itchy and red, not painful. Got bigger for a few days and then went away.
Pt received Pfizer Primary Series w/ Moderna Booster  20mins post vaccination pt c/o throat swelling.  No tongue or lip swelling noted or reported Vitals: 143/85, 70, 20, 99% Pt declined benadryl stating " I have allergy meds at home".  Vitals remained stable, O2 above 98% throughout observation.  pt talking and breathing normally.  Pt released to husband and daughter in stable condition w/ instructions to f/u w/ PCP and ER precautions.
Shakiness and weakness on left side, inability to stand or walk. Diagnosed as Creutzfeldt - Jacob Disease resulting in death on 02/21/2022
Extremely itchy eyes. Area around eyes swelled up. Eyes were still itchy the next day. Took antihistamine and used eye drops.
UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age, race, and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, after receiving the vaccine, the patient experienced side effects (unspecified), and was hospitalized (date unspecified). The patient was discharged from the hospital on 18-JUN-2021. The patient reported that she had read up on the vaccine online and was being afraid to die. No additional information about the side effects was reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210643142- covid-19 vaccine ad26.cov2.s- unspecified side effects. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
"I received my flu shot in my left arm and it was sore and never got better". Employee reported to EH one and half months later with complaint of sore arm, sent to occupational health and currently in their care.
rash on fingers; 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 RASH (rash on fingers) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash on fingers). At the time of the report, RASH (rash on fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable
Sunday night: Low grade fever; Arm swollen at injection site; Migraine Headache; Joint pain and stiffness; Body aches, Nauseous feeling. Monday: Headache; Arm swollen, red, and warm at injection site; Very tired; and body aches, Nauseous feeling. Tuesday: Brain fog; Arm Swollen, red, and warm at injection site (also red spot bigger than on Monday); Nauseous feeling; joint pain and stiffness; Body aches.  It really hasn't changed much since Sunday night other than not having a low grade fever.
Entire upper arm turned red. Started as a circle around the injection site and spread to cover my upper arm. Lasted approximately 1-1.5 weeks. It was hot to the touch and itchy
Initial unsolicited report received from a pharmacist on 12 Oct 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848 (same lot number). This case involves a 60 patients (age and gender not reported) who was vaccinated with a dose of Fluzone Quadrivalent (batch number: UI669AA, expiry date: 30 Jun 2017, dose and site was not reported) via intramuscular route on 04 Oct 2016 (also reported as over the past month). Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at time of vaccination was unknown. Concomitant medications were not reported. On an unspecified date (reported as over the past month), following the vaccination, the patients had site and systemic reactions i.e sore arm, red, hot, swelling around injection site, febrile, headache and generalized body aches. It was reported that, patient do not required ER/ doctor visit. Lab data and corrective treatment was not reported. The patient's event outcome was reported as unknown. List of documents held by sender: none.
lip swelling; Booster / 3rd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 21Dec2021 18:50 (Lot number: FE3590) at the age of 39 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Hyaluronic lip filler (juvederm ultra plus xc), start date: 01Mar2021, stop date: 01Mar2021. Vaccination history included: Bnt162b2 (Dose: 01, Lot: EL3249, Expiration: May2021), administration date: 18Jan2021, when the patient was 38 years old, for Covid-19 immunization; Bnt162b2 (Dose: 02, Lot: EN6200, Expiration: Jun2021), administration date: 13Feb2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021 18:50, outcome "unknown", described as "Booster / 3rd dose"; LIP SWELLING (non-serious) with onset 23Dec2021 03:00, outcome "not recovered", described as "lip swelling". Therapeutic measures were not taken as a result of lip swelling.  Additional Information: The caller was reported to be a Pfizer Employee. She was calling about the Covid vaccine for adult, it was for her. She wanted to report an adverse reaction on herself. She provided that, she had hyaluronic lip filler (was called Juvederm ultra plus xc) but that last time she had the lip filler was on 01Mar2021. It was reported that, 32 hours after the booster dose of the covid vaccine she experienced swelling in her lips. She did not experience this with the first two doses. Lip swelling started 32 hours the booster dose, clarified that lip swelling started at 3 am this morning. Confirmed she became aware today 23Dec2021, since the lip swelling started at 3am. The patient declined receiving any treatment, she had not taken anything. No investigation assessment was performed.  Follow-up attempts are completed. No further information is expected.
Trigeminal neuralgia; The pain was sharp and shooting into forehead, right side only/chewing caused excruciating pain in forehead; Intense pain beside nose, possibly ethnoid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Oct2021 11:15 (Lot number: 30130BA) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLUCELVAX QUADRIVALENT, administration date 14Sep2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0153, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 03Apr2021, when the patient was 63 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6206, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 06Mar2021, when the patient was 63 years old, for COVID-19 immunization. The following information was reported: RHINALGIA (non-serious) with onset 11Oct2021 12:00, outcome "not recovered", described as "Intense pain beside nose, possibly ethnoid"; HEADACHE (non-serious) with onset 14Oct2021, outcome "not recovered", described as "The pain was sharp and shooting into forehead, right side only/chewing caused excruciating pain in forehead"; TRIGEMINAL NEURALGIA (non-serious) with onset 18Oct2021, outcome "not recovered", described as "Trigeminal neuralgia". The events "intense pain beside nose, possibly ethnoid", "the pain was sharp and shooting into forehead, right side only/chewing caused excruciating pain in forehead" and "trigeminal neuralgia" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rhinalgia, headache, trigeminal neuralgia. No follow-up attempts are possible. No further information is expected.
very swollen arm/ reaction to vaccine; arm deep red/ reaction to vaccine; arm hot/ reaction to vaccine; arm painful/ reaction to vaccine; arm burning/ reaction to vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient had shingles two times).   On 21st October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced swelling arm, erythema of extremities, feeling hot, pain in arm and burning sensation. On an unknown date, the outcome of the swelling arm, erythema of extremities, feeling hot, pain in arm and burning sensation were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, feeling hot, pain in arm and burning sensation to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient prior to reporting had shingles two times. The patient prior to reporting would get vaccine 3 days ago. The patient had very swollen arm deep red, hot and painful burning. The patient would go to urgent care, never had reaction before any vaccine.
Burping; stomach upset; indigestion; he is losing a lot of weight; This spontaneous case was reported by a consumer and describes the occurrence of ERUCTATION (Burping), ABDOMINAL DISCOMFORT (stomach upset), DYSPEPSIA (indigestion) and WEIGHT DECREASED (he is losing a lot of weight) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 ERUCTATION (Burping), ABDOMINAL DISCOMFORT (stomach upset), DYSPEPSIA (indigestion) and WEIGHT DECREASED (he is losing a lot of weight). The patient was treated with OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) at an unspecified dose and frequency. At the time of the report, ERUCTATION (Burping), ABDOMINAL DISCOMFORT (stomach upset), DYSPEPSIA (indigestion) and WEIGHT DECREASED (he is losing a lot of weight) outcome was unknown.            Concomitant medications were not provided.
15 minutes after vaccine pt c/o mild SOB, no tongue swelling noted, rapid response team called
A child aged 13 was given a booster dose after being brought in by his parent for a booster dose.  The child has a sore arm, and no other reported symptoms.
Positive for COVID on 28-DEC-2021 and 15-FEB-2022.; Lack of drug effect; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive for COVID on 28-DEC-2021 and 15-FEB-2022.) and DRUG INEFFECTIVE (Lack of drug effect) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 028L20A) for COVID-19 vaccination.     The patient had no allergies.  Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 28-Dec-2021, the patient experienced COVID-19 (Positive for COVID on 28-DEC-2021 and 15-FEB-2022.) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Positive for COVID on 28-DEC-2021 and 15-FEB-2022.) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive. On 15-Feb-2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient had not received other vaccines within 1 month prior to Moderna COVID-19 vaccine.  No treatment information was reported.  Company comment: This case concerns a 44-year-old female patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 9 months after the second dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-583164 (Patient Link).; Sender's Comments: This case concerns a 44-year-old female patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 9 months after the second dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
THE MOTHER OF THE PATIENT REFERS THAT THE GIRL DEVELOPED A HIGH FEVER (100° F) THAT LASTED FOR 2 DAYS. THE GIRL WAS ALSO IRRITABLE AND WITHOUT APPETITE.  BY THE THIRD DAY THE GIRL DEVELOPED A RASH IN FACE AND BODY AS WELL A SWOLLEN EYES.
initially face was swollen (wk p/shot) then started getting bumps all over face & body
Tired; Feeling ill/Not feeling well; My lips became tingly; Throat got swollen; Nausea; Tightness; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 40-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6198 and  Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 05Mar2021 at 09:40 as dose 1, single for covid-19 immunisation. Medical history included eczema (I had little bit of eczema but it is not bad.) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced throat got swollen, nausea on 05Mar2021 and tired, not feeling well and feeling ill on an unspecified date, tightness and my lips became tingly on 05Mar2021 at 09:45. The reporter stated, she had the first Pfizer shot on 05Mar2021 and within 5 minutes his throat got a bit swollen, her breathing was fine able to eat and drink with no problem and then at 9:45am within an hour her lips became tingly about 12:30PM she took some Motrin, and symptoms went away. Took Motrin the first time and then it happened again about 6 hours later that evening and took Benadryl and Motrin (treatment) and it gone away. She had the first shot at 9:40 AM and then at 12:30 took Motrin and that helped his throat and the lip at 18:00 both symptoms came back again and took Benadryl and Motrin and that help and 06Mar2021 and 07Mar2021 had regular symptoms feeling ill, not really unwell no more sore throat. That evening about 6pm -7pm my throat began to feel tight and her lips tingly at the same time, took Benadryl and Motrin, it went away, on March 6 and 7th had regular usual side effects, nausea, tired, and overall not feeling well and no other reactions. Consumer stated, That was the first shot. Didn't get the second shot. She took Benadryl and Motrin as a treatment for event. Therapeutic measures were taken as a result of event tightness, my lips became tingly. The outcome of the event were recovered  on an unspecified date and rest of the event were unknown.  Information on the lot/batch number has been requested.
bad head pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad head pain) 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 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced HEADACHE (bad head pain). On 26-Apr-2021, HEADACHE (bad head pain) had resolved. Not Provided          No relevant concomitant medications were reported. No treatment information was reported.    This case was linked to MOD-2021-061077 (Patient Link).
Narrative:  A 39yo female with PMH of Knee pain, Cholecystectomy and disorder of the Pituitary She received Pfizer Covid-19 vaccine per policy procedure First dose on April 15, 2021 and developed generalized rash on face chest and neck which developed 20 minutes afte receiving the shot . she was evaluated in the ER. received methylprednisolone 125mg iv, Diphenhydramine 25mg iv push and was hydrated with 1 L of NS and Pepcid 20mg she was discharged with Benadryl 25mg po every 6 hrs as needed for rash, Pepcid 20mg po twice a day and to f/u with her primary physician. The patient recived the second dose of Covid-19 on May 6, 2021
The day after the vaccine, I felt a bit fatigued. Then for 2 days, I felt fine. Then starting on the 3rd day until present, I feel extremely light-headed and unsteady with a persistent severe headache.  Almost feels like there is pressure in my head for lack of a better description. I feel feverish as well but do not have a fever.  I have difficulty maintaining balance on my feet so it is difficult to walk.   I did seek medical attention yet since I live alone and do not feel comfortable to drive. Although the symptoms are difficult, I also don't consider them an emergency to warrant calling an ambulance.
Information has been received from a nurse concerning one of twins patients (gender and age unknown). On unknown date, the patient was vaccinated with VARIVAX (Merck) (lot number not provided). No other co-suspects were reported. No concomitant medications were reported. It was reported that their county was experienced an outbreak of chickenpox. Also, the twins developed chickenpox. The nurse stated that this county had a very high rate of parents who opt-out of vaccines. At the time of the report, the outcome of chickenpox was unknown. The relatedness for chickenpox was unknown for VARIVAX (Merck). Additional information has been requested. This is one of the several reports of the same source.
Information has been received from a medical assistant concerning an approximately 15 year old female patient who was vaccinated with the first and the second dose of GARDASIL (dose, route and lot numbers not reported) in 2010 and in 2011, respectively. No adverse effects reported. Follow-up information has been received from the medical assistant via B-form, concerning a 16 year old female patient, who was vaccinated with the first dose of GARDASIL on 20-AUG-2010 (dose, route and lot # not reported), with the second dose of GARDASIL I.M. in her left arm (dose not reported) (lot # 1009AA) on 19-AUG-2011 at 09:27 AM and with the third dose of GARDASIL (dose, route and lot # not reported) on 29-JUN-2012. No adverse reaction reported. Additional information is not expected.
Patient has been on Revlimid since 2012 with no issues which had the potential to increase coagulopathy. Patient has been on appropriate prophylaxis with aspirin daily with no previous clots. Patient got second dose of Moderna COVID vaccine on 3/5/21. Beginning ~2 weeks ago (late May) from current admission (6/10), patient began developing right leg swelling. Patient underwent lower extremity ultrasound at outside hospital on 6/9 and was found to have extensive deep vein thrombosis throughout right leg. Patient started on Eliquis and referred to the hospital. Patient started on argatroban for concerns of post-COVID vaccine coagulopathy.
Vaccine expired on 13-OCT-2021 and placed in refrigerator on 12-NOV-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-OCT-2021 and placed in refrigerator on 12-NOV-2021) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-OCT-2021 and placed in refrigerator on 12-NOV-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-OCT-2021 and placed in refrigerator on 12-NOV-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.