chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Less appetite; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DECREASED APPETITE (Less appetite) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L21A, 071F21A, 023M20A and 032L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included blood pressure and prostate. Patient never tested positive or diagnosed with COVID-19. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Diabetic, Drug allergy (Allergies to some medicines), Pain, Stomach discomfort and Short-term memory loss. Concomitant products included AMLODIPINE for Blood pressure, METFORMIN for Diabetes, MELOXICAM for Pain, DONEPEZIL for Short-term memory loss, FAMOTIDINE (PEPCID [FAMOTIDINE]) for Stomach discomfort, ACETYLSALICYLIC ACID (BABY ASPIRIN), COLECALCIFEROL (VITAMIN D3), SIMVASTATIN and FINASTERIDE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Less appetite). At the time of the report, DECREASED APPETITE (Less appetite) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Weight: lost 20 pounds lost 20 pounds. In April 2022, Blood glucose: elevated glucose elevated glucose around the time of the second booster dose.         The concomitant medications finasteride was used for the prostate.  It was reported that, the patient was diabetic and had started having an elevated glucose level around the time patient got the second Moderna COVID-19 booster. Now it was going down, but it was still elevated, and it was a normal elevation for the patient. Further it was stated that, patient had less appetite because patient was old and had lost 20 pounds since January. Glucose was still elevated but normal high.  No treatment medications were reported.
At approximately 20 hours following injection developed high fever (102+) rapidly. Fever ceased at 12:00 pm. Accompanied by severe body aches and uncontrollable shivering. Today I have extreme muscle soreness in mid to lower back and in joints of my limbs. Also severe headache that ibuprofen could help. I had covid in July of 2020 with moderate symptoms.
Day 1 - very slight nausea, fatigue. Day 2 - fatigue, shivers, fever (101 degrees), lack of appetite. Day 3 - no symptoms.
PFIZER VACCINE WAS PLACED IN FREEZER 05062021 AND DUE TO BE MOVED TO REFRIGERATOR 05192021.  VACCINE WAS LEFT IN FREEZER UNTIL 05212021 THEN MOVED TO REFRIGERATOR.  IMMUNIZATION PROGRAM WAS NOTIFIED OF ISSUE ON 05252021 AND SENT EMAIL STATING  VACCINE AS SAFE TO USE .   05272021 TIP EMAILED  VACCINE WAS NOT SAFE TO USE AND TO DESTROY THE VACCINE.  THEN TIP EMAILED 05282021 THAT PFIZER PHARMACIST HAD DEEMED VACCINE STABLE AND IT WAS SAFE TO USE SO DOSES GIVEN 05252021 WERE GOOD.
12/22/21 presents to ED for "cough, fever, shortness of breath, generalized body aches". PMHx of "metabolic disorder, obesity"
The vial which was expired on 11-Feb-2023 ,was initially stored in the refrigerator on 30-Mar-2023 and was administered on 31-Mar-2023; No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial which was expired on 11-Feb-2023 ,was initially stored in the refrigerator on 30-Mar-2023 and was administered on 31-Mar-2023) and NO ADVERSE EVENT (No adverse event) in an 8-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial which was expired on 11-Feb-2023 ,was initially stored in the refrigerator on 30-Mar-2023 and was administered on 31-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial which was expired on 11-Feb-2023 ,was initially stored in the refrigerator on 30-Mar-2023 and was administered on 31-Mar-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial which was expired on 11-Feb-2023 ,was initially stored in the refrigerator on 30-Mar-2023 and was administered on 31-Mar-2023).    No concomitant information was reported. The 2.5 ml vial was initially stored in refrigerator on 30-Mar-2023 and did not underwent any temperature excursions. No treatment information was provided. This case is reported for patient 4.   This case was linked to US-MODERNATX, INC.-MOD-2023-718009, US-MODERNATX, INC.-MOD-2023-718157, US-MODERNATX, INC.-MOD-2023-718179 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718009:same reporter, patient 1 US-MODERNATX, INC.-MOD-2023-718157:same reporter, patient 3 US-MODERNATX, INC.-MOD-2023-718179:same reporter, patient 2
This spontaneous report as received from nurse practitioner refers to unspecified number of patients of unknown age and gender. No information provided regarding medical history and concurrent conditions. On an unknown date three times unspecified number of patients were vaccinated with improperly stored (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous. The (Oka/Merck) VARIVAX doses have been exposed to temperature as high as 38F for total of 38 hours and 45 minutes. No adverse effects reported. It was reported that this service request (SR) was opened on 01-MAY-2014 for temperature excursion inquiry only and at that time, no adverse event (AE) was identified. However, when nurse called back on 12-JUN-2014 to report third temperature excursion (second excursion reported don 07-MAY-2014 and no AE at that time), she reported that improperly stored (Oka/Merck) VARIVAX doses have been administered to patients since first two temperature excursions and therefore AE was filed on 12-JUN-2014. Additional information has been requested.
patient called today stating she developed nausea and fatigue that has lasted over a week from the first shot. she also has a rash on her shoulder from the injection site. Moderna covid vaccine
Mild rash at around 15 mins after getting vaccine. Took benadryl rash went away
pt recvd vax & devel feeling of being unwell w/ fever & body aches; same symptoms occured w/ 2nd dose of vax;
Patient first noticed nausea. Patient then felt like she was going to throw up and was sweating. We provided patient with a bottle of water and garbage can. Patient left after her 15 minutes stating she was feeling better.
Extreme exhaustion,  exaggerated pain where arthritis is, headaches, constant jaw moving, trouble thinking
breasts had reduced, by one cup size; no longer lactating; Tenderness at the injection site and some joint pains; Tenderness at the injection site and some joint pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Apr2021 14:30 (Lot number: EW0153) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart murmur" (unspecified if ongoing); "asthma" (unspecified if ongoing); "allergies: Penicillin" (unspecified if ongoing); "seafood" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Aleve, reaction(s): "Drug allergy". The following information was reported: BREAST ATROPHY (non-serious) with onset 21Apr2021 07:00, outcome "not recovered", described as "breasts had reduced, by one cup size"; LACTATION DISORDER (non-serious) with onset 21Apr2021 07:00, outcome "not recovered", described as "no longer lactating"; VACCINATION SITE PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 21Apr2021 07:00, outcome "not recovered" and all described as "Tenderness at the injection site and some joint pains". Therapeutic measures were not taken as a result of breast atrophy, lactation disorder, vaccination site pain, arthralgia.  Additional information: Facility type vaccine was reported as Pharmacy or Drug Store. Patient did not received other vaccine in four weeks. Patient did not receive other medications in two weeks. Patient had no COVID prior vaccination. Patient was not tested COVID post vaccination. Patient was breastfeeding until yesterday (as reported). Morning after getting the vaccine, the patient experienced above events. Patient had no fever or sore throat, so far.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021458617 mother
The vaccine was exposed to sunlight; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (The vaccine was exposed to sunlight) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 039B21A) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included PRAVASTATIN for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The vaccine was exposed to sunlight). On 11-May-2021, POOR QUALITY PRODUCT ADMINISTERED (The vaccine was exposed to sunlight) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported receiving the second dose of the Moderna COVID-19 vaccine on 11-May-2021, 10 minutes prior to reporting. As of the time when he called in, he had not experienced any side effects. When he received the second dose, the vaccination provider had a box of syringes ready to go in the sunlight, and was opening and closing the box to get a syringe out under the sun. The patient received both doses of the vaccine at a fire department parking lot, through the county health department.
Narrative: Myalgia Sore throat, metallic taste in mouth, runny nose
Youth was administered the Covid19 Moderna vaccine and he is 17 years old. No adverse side effects post vaccine and mistake was noticed on 4/15/2021
Information has been received from a 60 year old male with duoenal ulcer, high cholesterol and allergic to some antibiotics who on 15-SEP-2007 was vaccinated SC on right arm with a 0.65 ml dose of zoster vaccine live (Oka/Merck). Concomitant therapy included ezetimibe (MSD), simvastatin (MSD) and lansoprazole (PREVACID). On approximately 25-SEP2007 the patient developed pimple like red spots on right upper arm at the injection site. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information is not expected.
Patient received Pediarix but was only due for DTaP. Patient had already finished HepB series and was not due for IPV until 12 or 2024. No adverse effects at this time reported.
detachment of the retina; having problems with the left eye; she feels a line a curved line on the left side that moves and it is very painful; having problems with the left eye;  it is very painful; This is a spontaneous report from a non-contactable physician. A female patient (physician's wife) of an unspecified age received BNT162B2 (Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot number was not reported), on an unspecified date as single dose for COVID-19 immunization. The patient experienced detachment of the retina and having problems with the left eye; she feels a line a curved line on the left side that moves and it is very painful, all on an unspecified date. The patient received the second dose of Pfizer Vaccine she was having symptoms. She had problems with the left eye. The physician measured the pressure of the eyes and they are equal, so it is not a glaucoma and she feels a line a curved line on the left side that moves and it is very painful like they hear and it moves permanently and does not disappear and when she closes the eye, she feels that line. The physician had seen the detachment of the retina. The outcome of the events was unknown.  No Follow-up attempts are possible. Information on lot/batch number cannot be obtained.; Sender's Comments: The information provided is limited and does not allow a full medically meaningful assessment. Considering temporal relationship, a possible contribution role of BNT162B2 to the onset of the eye events cannot be completely excluded. The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from a registered nurse via a field representative concerning a patient of unknown age and gender. On 10-FEB-2015 the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 lot # J011799 that had expired on 09-FEB-2015 (dose and route not provided). No adverse effect was reported. Additional information has been requested.
Pt presented to EMS with a complaint of dizziness and heart palpitations. Pt states she has no past medical and no known drug allergies. She was taken into the hallway where she stated she was already feeling better. She was given water, and vitals were obtained.  First set:  BP136/78 right arm  HR100 SPO2-100% Second set: BP102/79 left arm HR96 SPO2-100% Pt is boreline tachy, she is concerned about her blood pressure being higher than normal. Blood pressure was taken on both arms so she can see that the BP can differ depending on which arm its taken on. No signs or symptoms of an allergic reaction or anaphylaxis noted.  Pt was cleared from EMS and she stated she was good to go. She was assisted to the exit.
This spontaneous report was received from a medical assistant referring to a 14 year old male patient. The patient had no medical history, concurrent conditions, drug reactions/allergies or concomitant medications. The medical assistant reported that the patient's mother stated the patient was light headed in the waiting room before receiving the vaccine. On 27-APR-2018, the patient was vaccinated with one dose of GARDASIL 9 lot # N021572, expiration date on 01-MAY-2020, (strength, route or anatomical location were not reported) for prevention of HPV related disease and cervical cancer. On the same date, the patient passed out (non-serious adverse event-NSAE) and fell face first on the floor (NSAE), hitting his face and chin shortly (face injury-NSAE) after receiving the vaccine. The patient was transported from the Physician office to an unspecified emergency room by ambulance on the same day. Later, the patient was diagnosed with a concussion (NSAE) in the emergency room but the patient was not admitted to the hospital. On an unknown date in 2018, the patient recovered from all the events. The causal relationship between all the events and the suspect therapy was not provided.
myocarditis and pericarditis over the course of 5-6 weeks after the vaccines was given
low-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low-grade fever) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included VITAMINS NOS, ASPIRIN [ACETYLSALICYLIC ACID] and TAMSULOSIN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (low-grade fever). On 06-Mar-2021, PYREXIA (low-grade fever) had resolved.            Patient stated that concomitant medication vitamins are used for eyes  Treatment medication were not reported.  Patient stated he became weak from the COVID-19 infection and is still weak today. He was prescribed an inhaler while he had COVID-19.   This case was linked to MOD-2021-408571 (Patient Link).
On 10/25/19 noticed a rash around injection site on left arm.  Approx. 4 in. in diameter.  No itching and did not receive any follow up care
Throat is swollen, seemed to partially block her throat; Tongue felt bigger and seemed to partially block throat; Ulcer in mouth between her teeth and gums; Little rashes on chin and arms that were very itchy,itchy rash; Horrible sinus; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Throat is swollen, seemed to partially block her throat), PARAESTHESIA ORAL (Tongue felt bigger and seemed to partially block throat), MOUTH ULCERATION (Ulcer in mouth between her teeth and gums), RASH PRURITIC (Little rashes on chin and arms that were very itchy,itchy rash) and SINUS DISORDER (Horrible sinus) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced PYREXIA (Fever). On 17-May-2021, the patient experienced PHARYNGEAL SWELLING (Throat is swollen, seemed to partially block her throat), PARAESTHESIA ORAL (Tongue felt bigger and seemed to partially block throat), MOUTH ULCERATION (Ulcer in mouth between her teeth and gums), RASH PRURITIC (Little rashes on chin and arms that were very itchy,itchy rash) and SINUS DISORDER (Horrible sinus). The patient was treated with PARACETAMOL (TYLENOL) in May 2021 for Fever, at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) in May 2021 for Sinus disorder, at an unspecified dose and frequency. On 17-May-2021, PYREXIA (Fever) had resolved. On 29-May-2021, SINUS DISORDER (Horrible sinus) had resolved. At the time of the report, PHARYNGEAL SWELLING (Throat is swollen, seemed to partially block her throat), PARAESTHESIA ORAL (Tongue felt bigger and seemed to partially block throat), MOUTH ULCERATION (Ulcer in mouth between her teeth and gums) and RASH PRURITIC (Little rashes on chin and arms that were very itchy,itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.   The treatment information was reported as some unknown antibiotic cream.
This spontaneous report as received from a medical assistant refers to a three unspecified patients on unknown gender and age. In September 2014 (reported as since the temperature event), the patients were vaccinated with GARDASIL (dose, dose number, route, lot/batch number, expiration date were not reported) that were improperly stored on 08-SEP-2014. No adverse effects were reported. No product quality complaint (PQC) involved. Follow-up information has been received from the reporting medical assistant, who provided patient's identifiers (age and gender), dates of vaccinations and lot numbers. This report concerns a 53 years old male patient. No information on his medical history, concurrent conditions or concomitant drugs was provided. It was reported that the PNEUMOVAX 23 underwent the temperature excursion on 08-AUG-2014. On 02-SEP-2014, the patient received a dose of PNEUMOVAX 23 which underwent temperature excursion (dose, site and route of administration unknown; lot# J008799, expiration date 16-APR-2014). This is one of several reports from the same reporter. Additional information has been requested.
arm pain; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm pain) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Diabetes mellitus. Concomitant products included GABAPENTIN, PARACETAMOL (TYLENOL), HYDROMORPHONE HYDROCHLORIDE (DILAUDID), ATORVASTATIN CALCIUM (LIPITOR), Low dose Aspirin, LOSARTAN, LEVOTHYROXINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), METFORMIN, ATENOLOL, HCTZ, LATANOPROST, TIMOLOL MALEATE, dorzolamide and BRIMONIDINE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 06-Feb-2021, PAIN IN EXTREMITY (arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
This spontaneous report as received from a pharmacist refers to a female pediatric patient unknown age. On 28-Apr-2014 the patient was administered a dose of (Oka/Merck) PROQUAD (lot reported as J013357, expiry date: 01-MAY-2015). On 29-APR-2014, the patient developed a fever with a "weeping blister that was red and firm" at the injection site. On the same day patient was sent to an unspecified hospital where the patient was treated with intravenous (IV) fluids, and unspecified intravenous (IV) antibiotics. The patient was admitted to hospital for one night and discharged on 30-APR-2014. The event outcome of fever and weeping blister that was red and firm was reported as recovering. the relatedness between event and PROQUAD was not reported. It has been determined that lot # J013357 is an invalid lot for (Oka-Merck) PROQUAD. Additional information is not expected.