chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt under the weather after first dose, second dose , first booster dose; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Felt under the weather after first dose, second dose , first booster dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 007B21A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included Metastatic melanoma (On immunotherapy between OCT 2020 - DEC2021 to treat Metastatic Melanoma. Otherwise patient has been totally Healthy and Cancer was gone.).   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MALAISE (Felt under the weather after first dose, second dose , first booster dose). In 2021, MALAISE (Felt under the weather after first dose, second dose , first booster dose) had resolved.            No concomitant medications were reported, and Patient was not on any medications at the time of vaccinations.  It was reported that patient felt under the weather for 1 day after the first dose on 21-Feb-2021 and resolved on 22-Feb-2021. On 22-Mar-2021, the patient felt under the weather after second dose and resolved on 23-Mar-2021. On 08-Nov-2021, the patient felt under the weather after first booster dose and resolved on 09-Nov-2021.  No treatment details were reported. .   This case was linked to MOD-2022-610541 (Patient Link).
Fever, severe aches, sore back, sore shoulders, sore joints, fatigue.  Took Tylenol. Really kicked in after about 10 hours; started to improve after about 14 hours, but didn?t feel ok until about 36 hours after injection.  Stomach issues (gas, mild diarrhea) continued for 2 days.
12AUG93 feverish w/in 1 to 2 hrs p/receiving vax (temp not taken-felt very warm); very fussy, crying alot that evening & next day; 13AUG93 8AM t104 R;
This spontaneous report was received from a pharmacist and refers to 2 patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not provided) for prevention of shingles. On unknown dates, after receiving the ZOSTAVAX, the patients developed shingles. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Right upper arm red warm to touch, X 24 hours (approximately). Denies fever, pain, ROM of right arm-WNL. Advised warm compresses and anagelics. See MD if symptoms worsen
Doses administered after more than 1 temperature excursion; It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 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) and POOR QUALITY PRODUCT ADMINISTERED (It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 11:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 11:47 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 71.26  No concomitant medication was reported.  On 24-Feb-2021,vaccine moved to fridge and vaccine BUD date was reported as 26-Mar-2021. Condition of vaccine prior to administration was reported Not frozen.  On 27-Feb-2021,vaccine excursion time were 9am,11am,12pm,1pm,2pm,3pm,4pm,5pm at 33,35,35,35,35,34,34,35 degree F temperature. On 28-Feb-2021,vaccine excursion time was 9am,1pm at 27,26 degree F temperature. On 2-Mar-2021,vaccine excursion time were 9am,10am,11am,12pm, 2pm,3pm at 27,29,32,33,35,36 degree F temperature. On 3-Mar-2021,vaccine excursion time were 9am,10am,1pm at 51,34,35 degree F temperature.  The vials were only punctured right before administration. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 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 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
pain in left breast; worried/panicked about the breast pain; achy; chills; really tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BREAST PAIN (pain in left breast), ANXIETY (worried/panicked about the breast pain), PAIN (achy), CHILLS (chills) and FATIGUE (really tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 006B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Breast cancer. Concomitant products included VENLAFAXINE, ROSUVASTATIN and LEVOTHYROXINE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced PAIN (achy), CHILLS (chills) and FATIGUE (really tired). On an unknown date, the patient experienced BREAST PAIN (pain in left breast) and ANXIETY (worried/panicked about the breast pain). At the time of the report, BREAST PAIN (pain in left breast) and ANXIETY (worried/panicked about the breast pain) outcome was unknown and PAIN (achy), CHILLS (chills) and FATIGUE (really tired) had resolved.            Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-103585 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-103585:Case for dose 1
Had a little bit side effect; A little bit like my heart, I have the butterfly, a butterfly feeling; You are giving me more pain than, from my head to toe; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot no: FF8839), for COVID-19 immunization, reaction(s): "Symptoms that I had from both are different". The following information was reported: CARDIAC DISCOMFORT (non-serious), outcome "unknown", described as "Had a little bit side effect; A little bit like my heart, I have the butterfly, a butterfly feeling"; PAIN (non-serious), outcome "unknown", described as "You are giving me more pain than, from my head to toe".  Additional information: Patient stated, "First one was, PF12 or 1ZER and then it says FF8839, there was a more letters to it. It says a LOT# but it says two numbers in one. The first time the patient got it, there was two numbers and then the second one, there was two numbers." Patient stated, "I had to let you know that I did the Covid vaccine, the second one and just after the second one, I had a little bit side effect. So, I talked to the doctor today and she wants me to report the side effect. So, where do I report this information related to side effect. When again probed for the concern, Patient stated, "So, I took the Pfizer vaccine both one and two and now, I had a little side effect and the doctor want me to report it but she did not told me where to report it. So, where do I report this side effect information. Reporter type could not be probed as consumer hung up the call abruptly, hence reporter type captured as consumer or non-healthcare professional by default.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no adverse event; HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.).    The case contains the information regarding patient 5th of 16 reported.  Concomitant products were not reported.  No adverse event was reported from any of the patients involved.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:Master case
I woke up in the middle of the night very itchy with a rash. At first it was on my stomach and chest but over the course of hours and days it would disappear from one area and appear somewhere else. Very itchy and red and hot to touch. That was on a Sunday morning. It wasn't terrible so I didn't call the doctor. Monday it began getting worse and I went to the doctor on Tuesday. By this time, there was always a spot with the rash at any given time of the day and it would change locations. He gave me an allergy shot (2/1/2022). And a prescription hydrocortisone 2.5% cream (started 2/2/2022). I called back a few days later because the allergy shot wasn't working so he also gave me a prescription for the tapering prednisone (started 2/4/2022). I also have a number of over-the-counter hydrocortisone 1% cream. I used the prescription fast over time. I found that ice packs help a lot. The worst day was day 5. It has been lessening each day but once in a while I get a flare up. Mostly when I get up in the morning and during changes in temperature. I'm still having an issue but there is nothing else the doctor can do for me because I don't want to take more prednisone at this time. Now I'm considering waiting it out and also looking to see a dermatologist. It has improved so I'm back at work but it's still there.
pt recvd flu vax & devel a three-inch reddish circle that was hot & pruritic @ the inject site;
red splotchy itchy face; red splotchy itchy face; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 17Dec2020 at 16:00 (at the age of 29-years-old) as a single dose for Covid-19 vaccination. Medical history included Premenstrual dysphoric depression syndrome from an unknown date. The patient did not have any allergies to medications, food or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications included citalopram (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Dec2020 at 21:00, the patient experienced red splotchy itchy face. Therapeutic measures were taken for the red splotchy itchy face which included allergy medicine (unspecified). The clinical outcome of the events red splotchy itchy face was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Ct reported that  for 3 days following the vaccine she felt like she had "bugs crawling under her skin" then had headache and nausea x 1 day, then asymtomatic on next day
Headache, Sedation, Myalgia, Arthralgia, Fever, Swollen glands, pain at the injection site Narrative:
5 MINUTES AFTER GIVING TH HPV VACCINE PT. STARTED FEELING LIGHT HEADED, PALE, EYES STARTED ROLLING BACK, STARTED MAKING MOVEMENTS WITH HIS HANDS AND TWITCHING , PT. COLD AND SWEATY.  IT ONLY LASTED FOR ABOUT 30 SECONDS AND RECOVERED IMMEDIATLY AFTER
doses were kept in room temperature for greater than 12 hours; thought they had been newly drawn and administered them; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were kept in room temperature for greater than 12 hours) and PRODUCT STORAGE ERROR (thought they had been newly drawn and administered them) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 037B21A) 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were kept in room temperature for greater than 12 hours) and PRODUCT STORAGE ERROR (thought they had been newly drawn and administered them). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were kept in room temperature for greater than 12 hours) and PRODUCT STORAGE ERROR (thought they had been newly drawn and administered them) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): The vials were thawed by 9:30 AM EST yesterday morning.   This case was linked to MOD-2021-353230 (Patient Link).
A few days after receiving the first dose of Lymerix the pt experienced mild flu like symptoms which resolved. Subsequent to receiving the second dose of Lymerix the pt experienced sever itching which kept him awake all night. The pt has been seen by a dermatologist with no relief to his symptoms. The reporter states that there was no redness, swelling or indication of a rash. As of 09/08/2000 the itching and insomnia are ongoing.
PATIENT RECEIVED MORE THAN THE RECOMMENDED DOSES OF COVID-19 VACCINE. THE MODERNA SERIES WAS ADMINISTERED ON 2/2/2021 AND 3/2/2021, THEN THE PFIZER SERIES WAS ADMINISTERED ON 4/21/2021 AND 5/12/2021.
Employee has experienced palpitations and dyspnea, and recently has been diagnosed with ventricular bigeminy and trigemini.
This spontaneous report was received from a consumer regarding her daughter of unknown age. The patient's pertinent medical conditions and concomitant medications were not reported. On unknown dates, the patient was vaccinated two doses with GARDASIL 9 or GARDASIL for prophylaxis (dosing details were not reported). The patient missed her last dose of vaccine. Reporter enquired whether the patient could still take her last dose. No product quality complaint was reported.
1) Pain in penis, mid shaft, "pressure", particularly on muscle contraction, resolving. 2) Several sudden, small pinhead sized, wart type sores on left thumb, palm side, middle, resolving.
Inward itchy on arms, back and legs without rash; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Inward itchy on arms, back and legs without rash) and PYREXIA (Low grade fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder and Allergy. Concomitant products included LORATADINE (CLARATYNE) for Allergy, ASCORBIC ACID (VIT C), VITAMIN D NOS and ZINC for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PRURITUS (Inward itchy on arms, back and legs without rash) and PYREXIA (Low grade fever). At the time of the report, PRURITUS (Inward itchy on arms, back and legs without rash) and PYREXIA (Low grade fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient mentioned that she has lot of bad allergy problems to unspecified antibiotics which causes rash, itchy and takes claratyne and other unspecified medicines not for allergy such as supplements. The patient also takes unspecified medicine for heart problems. Treatment medication included was claratyne before going to bed for the event pruritus. The patient has a schedule to receive the second dose of vaccine on 25 Feb 2021 and would like to know if it interferes with Benadryl the day before with the second vaccine. The patient´s doctor was aware that the patient was about to receive the second vaccine.
After the 2nd dose vaccine, I felt really sick and could not work. I had flu like symptoms, very tired, headache, low grade fever, body aches and chills. It took 2-3 days for these symptoms to resolve. On 7/15/2021, I woke up unable to walk or speak. My husband called 911. I was taken to the hospital. They ran multiple tests and did a surgical procedure called thrombectomy to remove the clot. The procedure was successful. I was in the ICU for 1 night and discharged the following day. I was discharged with a diagnosed of stroke to follow up with neurologist and cardiologist and prescription for low dose aspirin and Lipitor. The cause of the stroke is of unknown nature since I do not have any risk factors or chronic medical conditions.
Diarrhea (gone to bathroom roughly 8 times today. Intense cramping along with it); Diarrhea (gone to bathroom roughly 8 times today. Intense cramping along with it); light headed; overall feeling unwell; This is a spontaneous report from a contactable other health care professional (patient). A 31-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6201, patient was 31-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 16Feb2021 at 07:30 PM as DOSE 2, SINGLE for covid-19 immunisation. Medical history reported as no. Concomitant medication(s) included amlodipine (AMLODIPINE); methylphenidate (METHYLPHENIDATE); omeprazole (OMEPRAZOLE) all taken within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3246, patient was 31-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 16Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. No other vaccine received in four weeks. No Covid prior vaccination, not tested covid post vaccination. No Known allergies reported. On 17Feb2021, the patient experienced diarrhea (gone to bathroom roughly 8 times today. intense cramping along with it), lightheaded, overall feeling unwell. No treatments were received for events. The outcomes of events were not recovered.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a nine-year-old female. Neither medical history nor concomitant medication was reported for this patient. The product expired on 06-Dec-2010. On 20-Dec-2010, the patient received the expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information received on 04-Mar-2011 and incorporated into case: no late occurring adverse events.
Flushing, redness of face and neck, shortness of breath. Patient given epinephrine and solumedrol for allergic reaction in ER.