chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Patient with allergic rhinitis who can never smell anything can smell for 2 days after getting the vaccine) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 043B21A) for COVID-19 vaccination. Concurrent medical conditions included Allergic rhinitis (can never smell anything). On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Patient with allergic rhinitis who can never smell anything can smell for 2 days after getting the vaccine). On 14-Jan-2022, THERAPEUTIC RESPONSE UNEXPECTED (Patient with allergic rhinitis who can never smell anything can smell for 2 days after getting the vaccine) had resolved.    No Concomitant medication were reported. No treatment medication were reported. This case was linked to MOD-2022-455408, MOD-2022-455409 (Patient Link).
Patient reports problems with her right eye 7 to 10 days after vaccination. She tried lubricating drops for her burning eye (right). Went to an eye specialist who believes it is related to her shingles vaccination.
I  was suspected to have Covid infection Feb 2020.   About 2 months after the 2nd dose vaccination, I started having pain in my ear, very bad pressure and I took my nasal spray since I thought it was allergies.  The pain increase and I developed a dry cough,  nasal congestion,fever, vetigo, nausea, fatigue,  and  feeling sick.  I went to see the doctor and both my ears were perforated and inflammed and I was  treated for sinus infection.  I was prescribed Amoxicillin for 10 days. Infection did not go away.  I was prescribed  Cefdinir 300mg  twice a day for 7day.  The Cedfinir did help to resolve my infection.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (Merck) temperature excursion and two patients of unspecified age and gender who were vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J003711, exp date: 27-MAR-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
45min after taking the vaccine her tongue and mouth swole up with big welts.  Fever for 2 days. 10 months later her tongue has small bumps.
Patient has significant history for syncopal and near syncopal episodes when getting injections and blood drawn.  Patient experienced syncopal episode today and was asissted the ground.  Patient denied any complaints and signed a refusal of care.
Fever, myalgia, area of erythema, warmth, LUE 5 x 5 inches.
chills, legs shaking, fever 101.8 w/weird dreams;fever & chills lasted several hr;
Pt c/o arm discomfort from day of injection 11/5 through today 11/8. Today mother looked at arm and identified redness and swelling. Exam 10cm x 4cm area of induration, bicep muscle area.
This spontaneous report as received from a nurse refers to a 17 year old female patient with sulfa and peanuts allergy. Patient had no pertinent medical history and did not use concomitant medication. On 19-AUG-2013 the patient was vaccinated with GARDASIL lot # H021608 (expiry date 13-AUG-2013) dose 4, 0.5 ml, intramuscular in the left arm. Patient's mother stated the GARDASIL series had been completed at an unspecified time in the past and this was fourth dose to be received by patient. Nurse stated that there was no information available about the prior doses of GARDASIL. The patient passed out after fourth dose was administered on 19-AUG-2013. Unspecified staff monitored blood pressure prior to allowing patient to leave office. Patient experienced no other symptoms and patient was doing fine then. Furthermore, it was reported that the patient did not seek medical attention. It was also reported that the patient had a sexually transmitted disease (STD) screening for gonorrhea and chlamydia. Upon internal review the case was assessed as medically significant. Additional information has been requested.
Connection between syringe and needle was not tight, contents of syringe leaked down patient's arm.  Neither patient nor vaccinator believe that the patient got any vaccine administered.
This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. On 03-AUG-2015, 05-AUG-2015 and 06-AUG-2015 patients were vaccinated with improperly stored doses of ROTATEQ orally (lot # L000569 and expiration date 13-JUL-2016; lot # K019372 and expiration date 16-JUL-2016; lot # K015816 and expiration date 29-MAY-2016; dose not provided; information on which lot number correspondence to each date of administration was not reported). No adverse experiences were reported. This is one of two reports received from the same source. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 54-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. The patient's past medical history included influenza (in 2003). Previously administered products included Flu vaccine (present yearly flu shot, received from 2004 and every year without any adverse event). On 1st October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On 3rd October 2018, 2 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site warmth were not recovered/not resolved. The reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site warmth to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: In 2003, the patient got flu infection and every year since then she has received the flu shot but never had a side effect until now. On Monday, the patient received the FLUARIX QUADRIVALENT 2018-2019 season vaccine. It was asked to the patient that which arm vaccine was administered and she said left. Also, if it was the left deltoid and she said it seemed lower than the deltoid, like the triceps. The patient said it was about 4 to 5 inches above the elbow and about 4 to 5 inches below the shoulder. The patient was not sure if vaccine was given subcutaneously or intramuscularly. On the day of reporting, the patient noticed that where she got the vaccine it was red and swollen about a 4 to 5 inch diameter. It was hot to the touch. It was not painful and not itchy. The patient has denied permission to contact their physician (because she was switching doctors).
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No further information was provided.   Reporter did not allow further contact
inadvertedly administrated Kinrix instead of Infanrix; Kinrix was administrated to 15 month old; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3dz45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 12th November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: 15 month old male patient was inadvertedly administrated Kinrix instead of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. No further events were reported.  The reporter agreed to be contacted for follow- up.
Side effects; This case was reported by a consumer and described the occurrence of adverse drug reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix shot and the side effects were worse than what he/she thought. The patient wanted to know what are the chances of getting shingles if he/she did not receive 2nd shot.
Sharp, pounding chest/heart pain, episodes of tachycardia at rest, chest tightness, shortness of breath, dizziness, fatigue, hot flashes, headache. All worse on exertion.
Seizure like symptom 8 hours after shot, high fever, bp up to 196/126 woth no history of high BP, extreme fatigue, severe headache, stomach upset, chest/heart pain, full body pain.  All symptoms starting with in 12  hours of vacine.   Symptoms lasted 36-48hours
MD called to report seeing pt in office w/t104, vomiting; localized swelling, & tenderness in area of DTP; observed 4 hrs; no neurologic complications; mom reports pt was also groggy & difficult to wake; states pt ran  t w/prev vax;
Within 5 minutes of receiving the COVID shot, Pt began to feel lightheaded.  She mentioned to monitor on recovery and nurse came over to assess.  VS: BP=170/88 HR=64 and regular, RR=14 HR=56-58 as is on the atenolol for her blood pressure.  After drinking a bottle of water and fruit snacks, she started to feel better and was released on own.  Contact information given if further problems this evening.
Patient reported fever of 102 degrees F and nausea and vomiting with some diarrhea. This lasted the night of vaccination throughout the next day. As of 5:00pm next day patient states fever is gone but still feeling nauseous. Patient is contacting MD.
Abnormal cardiovascular response during exercise for 45 days post injection - elevated heart rate, reduced lung capacity - unable to safely exercise.   100 degree fever for 2 days post infection.  Unusual / rare fungal eye infection also occured 3 weeks post-infection, but this could be a coincidence.
Have had a sore arm for while and now have notice a red spot where got shot. It's been almost 2 weeks since shot.
Moderna COVID-19 Vaccine EUA dose given 56 days after BUD for refrigeration
Red, hard, hot area at injection site 7 days after injection. Area was normal until 7 days.
Initial literature report received on 01 Mar 2010: This article described acute posterior multifocal placoid pigment epitheliopathy following influenza vaccination. This patient received vaccination with influenza vaccine (manufacturer unknown) Unspecified dose intramuscular on an unknown date. One week after vaccination, the patient experienced flu-like symptoms. The patient experienced bilateral photophobia, metamorphopsia, and scotomas that were more prominent in the left eye 14 days after vaccination. The patient's best-corrected visual acuity was 20/20 bilaterally and slit-lamp anterior segment examination revealed <1+ cells and dilated fundus examination revealed mild vitritis and multiple deep yellow-white placoid lesions of variable size at the level of the retinal pigment epithelium in both eyes. The patient's fluorescein angiography showed bilateral multifocal early hypofluorescent lesions with late staining and Indocyanine-green angiography showed bilateral lesions that remained hypofluorescent at the late phase. On the basis of the clinical findings and history, and the normality of an extensive laboratory work-up, the patient was diagnosed with APMPPE and started treatment with oral PREDNISONE 0.5 mg/kg/day that was decreased gradually over 1 month. Over that period, the patient noticed significant improvement of his visual symptoms. The patient's anterior and posterior segment inflammation regressed and most of the fundus lesions disappeared. Three months after the first symptom, the patient was reported to be asymptomatic, the patient's, the patient's BCVA was still 20/20 and repeated FA and ICG angiography showed marked regression of the lesions with some remaining RPE changes. No further information available.
Information has been received from a physician concerning a 58 year old female who on 09-OCT-2007 was vaccinated SC on upper right arm with a 0.65 mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included a dose of influenza virus vaccine (unspecified) on left arm. On approximately 11-OCT-2007, 48 hours after vaccination the patient complained of pain and bruising at the injection site of the right arm. The patient was seen in the office on 12-OCT-2007 and in addition the patient also had burning and vesicles at the injection site of the right arm which the physician thought as shingles. The patient was treated with famciclovir. At the time of report the patient had not recovered. No diagnostic laboratory tests were undertaken. A product quality test was not involved. Additional information has been requested. Initial and follow-up information has been received from a physician concerning a 58 year old female who on 09-OCT-2007 was vaccinated SC in the upper right arm with a 0.65 ml first dose of ZOSTAVAX (lot # 658084/0888U). Concomitant vaccination included a first dose of influenza virus vaccine (unspecified) (U2440AA) given IM in the left deltoid. There was no illness at the time of vaccination. On 10-OCT-2007 (also reported as 48 hours after vaccination) the patient complained of pain and bruising at the injection site of the right arm. The patient was seen in the office on 12-OCT-2007 and in addition the patient also had burning and vesicles at the injection site of right arm which the physician thought was shingles. The patient was treated with fameiclovir. No diagnostic laboratory tests were performed. The patient recovered on an unspecified date within one week. There was no product quality complaint involved. Additional information is not expected.
Right arm pain/hot arm starting the next day for 5 days. It was severe for 4 days. Fever 3 days 99.3-102.8. Chills with cold hands and feet for 3 days with fever. Treated with Aleve and Ibuprofen 4 days. Hot pack on 4th day to arm with moderate relief
Conjunctivitis - probably virus and possibly impetigo or early varicella modified by varicella vaccine. 2 red papules (drying) left arm, upper chest. Cluster of 5-6 red papules without vesicular component to them. Bactroban - rash polytrim ophthalmic GTTS; eyes.
Reported itching in arms.  Hives noted to neck and side of neck.  Complained of slight tightness to chest but did say this was 'normal' with nerves.
diarrhea every other day; fever; fatigue; had shakes all over her body but not from cold; Felt like palsy; strange; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea every other day), TREMOR (had shakes all over her body but not from cold; Felt like palsy), FEELING ABNORMAL (strange), FATIGUE (fatigue) and PYREXIA (fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced FEELING ABNORMAL (strange). On 13-Mar-2021, the patient experienced TREMOR (had shakes all over her body but not from cold; Felt like palsy). On 14-Mar-2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced DIARRHOEA (diarrhea every other day) and PYREXIA (fever). At the time of the report, DIARRHOEA (diarrhea every other day), TREMOR (had shakes all over her body but not from cold; Felt like palsy), FEELING ABNORMAL (strange) and PYREXIA (fever) outcome was unknown and FATIGUE (fatigue) had resolved.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a physician concerning an 18 year old female patient with sulfonamide allergy who on 19-MAR-2007 was vaccinated with the first 0.5 mL dose of GARDASIL (Lot # 655619/1427F) intramuscularly (expiration date: 29-JUN-2009). On 21-MAY-2007, the patient received the second 0.5 mL dose of GARDASIL (Lot # 660200/1886U, valid for ROTATEQ) intramuscularly (expiration date: 21-NOV-2009) and on 27-SEP-2007 the patient received the third 0.5 mL dose of GARDASIL (Lot # 658554/0928U) intramuscularly (expiration date: 12-APR-2010). There was no concomitant medication reported. It was reported that the patient received the 3 doses prior to sexual contact, and had an abnormal pap smear on 28-APR-2010. The Pap smear revealed low grade, mild dysplasia with HPV effect. The patient sought medical attention with an office visit. At the time of the report the patient had not recovered. The patient will be referred to a gynecologist for evaluation. Follow up information was received from a physician concerning an 18 year old female patient. It was reported that the patient had vaccine and was not sexually active. There were no illnesses at the time of vaccination. It was reported that she finished the vaccination a year later and had positive HPV on a PAP smear test performed on 28-APR-2010. The interpretation of result was: low grade squamous intraepithelial lesion mild dysplasia with HPV cytopathic effect. This PAP test has been evaluated with the assistance of the ThinPrep Pap, Test Imagin System. It was also reported that the patient did not require an emergency room/doctor visit (previously reported as the patient went to an office visit). No further information is available.
Chills; Fever started about 14 hours post vaccine; Body aches started about 10 hours post vaccine.; Sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 30Mar2021 at 11:00 (Batch/Lot Number: EL3247) at 38-years-old as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient previously took bnt162b2 for COVID-19 immunization on 09Mar2021 (Dose 1, 11:00, left arm, Lot EL3247). On 30Mar2021 at 21:00, the patient experienced body aches started about 10 hours post vaccine (non-serious). On 31Mar2021 at 01:00, the patient experienced chills (non-serious) and fever started about 14 hours post vaccine (non-serious). On an unspecified date in 2021, the patient experienced sore arm (non-serious).  The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
1140 - Pt states experiencing dizziness and "neck tightness" - clarified this is outside of the throat - and warmth over bilat shoulders post vaccine. Began in observation area within 5 minutes of receiving vax (admin time at 11:3. Pt states has a h/o significant back pain and balance issues including multiple surgeries, and is currently being evaluated for similar episodes. Thinks contributing factors include 20 min wait in car (sitting) for appt time, and long ramp incline at clinic entrance.    1141 -Pt taken to first aid area via WC. Offered water (refused). VS: BP - 160/78, P 69, O2 sat 98-99%, RR 14. Appears calm, AAOx3 - no s/o erythema, diaphoresis, edema  Denies SOB, dyspnea, urticaria, nausea, CP    1150 - Pt states dizziness resolved. Fells "at his baseline. VS: BP - 158/76, P - 69, O2 sat 98%  Call to Pts wife at home. Feels well enough to drive. Observed to car
I had the first shot 3 months ago- it is safe to get 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I had the first shot 3 months ago- it is safe to get 2nd shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I had the first shot 3 months ago- it is safe to get 2nd shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I had the first shot 3 months ago- it is safe to get 2nd shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
I developed back pain, it is very painful. The pain started in my lower back and spread through my legs and around my belly
Arm and shoulder pain, limited range of motion arm weakness - received shot 12-12-14 still having pain 1-28-15. Can't sleep on that side cause of pain. Went to doctor 1-26-15, doctor prescribed methylprednisone.
Pt received an expired dose of Fluvirin vaccine and experienced chills, low grade fever, achiness and headache, within 24 hours post vax. Symptoms resolved quickly.