chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever / low grade fever; aches; fatigue; This case was reported by a physician via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced fever, pain and fatigue. On an unknown date, the outcome of the fever, pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the fever, pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix and experienced fever, pain and fatigue which was resolved. The reporter consented to follow up directly with physician. No further information was available. This case was linked with case US2020223956,US2020223951 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223956:same reporter US-GLAXOSMITHKLINE-US2020223951:same reporter
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 23-JUL-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -0.55 Celsius Degrees for 40 hours, 0.55 Celsius Degrees for 40 hours, 1.11 Celsius Degrees for 88 hours and 0 Celsius Degrees for 152 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
arm got swollen; shaking her head and hands; shaking her head and hands; This is a spontaneous report from a contactable consumer (parent). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown. The patient medical history included lennox gastaut syndrome (has a special condition) from an unspecified date. Concomitant medications were not reported. The patient experienced arm got swollen, and shaking her head and hands continuously for 5-7 minutes on Apr2021 after getting the first dose. Outcome of the events was unknown. She will get the 2nd dose on 26Apr2021.  Information on the lot/ batch number has been requested.
Information has been received from a physician concerning a male patient who was vaccinated with a dose of GARDASIL. The physician reported that after receiving the vaccination, the patient fainted, hit her head and ended up getting a skull fracture. The patient sought unspecified medical attention. The reporting physician is not the physician of the patient. At the time of this report, the outcome was unknown. No product quality complaint was involved. No further information is available.
Beginning about 4:00 p.m., 8 days post-jab, vaginal bleeding began.  There was approximately 1 Tbsp. bright red blood with small clots noted, which lessened, eventually to minor pink tinged discharge lasting 48-72 hours. No cramping or discomfort was noted.  I am 63 years old and post-menopauasal.   I have not menstruated for almost 10 years. I have no history of gynocological issues.
Woke up December 2nd with chills, sore throat, congestion, sneezing, coughing, fatigue, achy. After getting up, my husband had gotten some tests so we both tested and came up positive for COVID-19. I called my doctor and she prescribed PAXLOVID and I was able to start it the next day. Yesterday, 12/8, was the first day that I didn't feel ill, although I am still experiencing fatigue. PAXLOVID definitely left a terrible taste in my mouth as well.
High fevers (T max 104). Fussy, irritable, not feeding well. Swelling, warmth, bump at injection site.
This spontaneous report was received from a pharmacist referring to one unspecified patient of unknown age and gender. Pertinent medical history and concurrent conditions were unspecified. On an unknown date the patient was vaccinated with PNEUMOVAX 23, vial (SDV, MDV OR ADDITIVE) (EA) 25, (dose and route not reported). Concomitant therapies were unspecified. On an unknown date the patient experienced abscess at injection site. Treatment for the adverse event and lab diagnostic tests were unspecified. There was no intervention required to prevent the seriousness criteria. There was no significant disability, no hospitalization and event was not life threatening. The outcome of abscess at injection site was recovered. The causality was unspecified. No PQC reported. The case has been linked with the cases (same reporter link) # 1407USA003898 and 1407USA004450. Additional information has been requested.
Extremely sick; Heart racing; Very bad sore throat; Very bad cough; Lymph nodes are swollen; Very fatigued; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely sick), PALPITATIONS (Heart racing), OROPHARYNGEAL PAIN (Very bad sore throat), COUGH (Very bad cough) and LYMPHADENOPATHY (Lymph nodes are swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced ILLNESS (Extremely sick), PALPITATIONS (Heart racing), OROPHARYNGEAL PAIN (Very bad sore throat), COUGH (Very bad cough), LYMPHADENOPATHY (Lymph nodes are swollen), FATIGUE (Very fatigued) and MYALGIA (Sore arm). At the time of the report, ILLNESS (Extremely sick), PALPITATIONS (Heart racing), OROPHARYNGEAL PAIN (Very bad sore throat), COUGH (Very bad cough), LYMPHADENOPATHY (Lymph nodes are swollen), FATIGUE (Very fatigued) and MYALGIA (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) NEGATIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
20FEB95 mom called & stated pt started vomiting 20 mins p/vax on 17FEB95; devel hives & inc resp on 17FEB95 mom instructed to take pt to ER 21FEB95 called & father stated MD @ ER told mom pt had react to vax; pt changed to another formula
After removing needle, the patient's arm (right) began to bleed. A bubble developed under the skin, as if filled with blood about the size of a quarter. (Applied light pressure and band aid.)
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-FEB-2014 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # J011272, expiration date 21-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
she developed diarrhea/viscous diarrhea; Patient can not eat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021583281 (Pfizer).  A 79 year-old female patient received bnt162b2 (BNT162B2), administration date 14May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 18May2021, outcome "not recovered", described as "she developed diarrhea/viscous diarrhea"; FEEDING DISORDER (non-serious) with onset May2021, outcome "unknown", described as "Patient can not eat".  Additional information: Reporter states that patient had the covid vaccine on 14May2021. Patient went over to (vaccine facility name withheld), Facility and got the first dose of the covid vaccine. Since 18May2021, patient has had viscous diarrhea. Patient is still having diarrhea. Patient can not eat. Patient is having diarrhea four to six times a day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 8AUG95 & immed devel redness, itching, dizziness & was not feeling well & was shaky;the reporter thought they were going to have to give pt Epi however they gave pt DPH & ice packs;
7NOV91 @ 8PM devel sore throat, temp, chills; occasional chills during next wk; on 14NOV temp spiked to 103 went to ER & was dx w/UTI & anemia;
No symptoms reported by any of the patients; temperature excursion; This spontaneous report was received from a registered nurse referring to a 7-year-old patient. The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T037643 with an expiration date on 06-NOV-2022) for prophylaxis (strength, dose, frequency, and route of administration were not reported).  The dose of varicella virus vaccine live (oka/merck)(VARIVAX) were exposed on 11-AUG-2021 to a temperature excursion of 8 degrees Fahrenheit (°F) during a time frame of 2 hours and 15 minutes. There was no prior temperature excursion.  No symptoms were reported.
Swollen lymph node; She experiencing rash/leg rash/Rash on legs & arms/around her ankle; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node) and RASH (She experiencing rash/leg rash/Rash on legs & arms/around her ankle) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Lupus erythematosus (Lupus).   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 LYMPHADENOPATHY (Swollen lymph node) and RASH (She experiencing rash/leg rash/Rash on legs & arms/around her ankle). At the time of the report, LYMPHADENOPATHY (Swollen lymph node) and RASH (She experiencing rash/leg rash/Rash on legs & arms/around her ankle) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The patient was received Moderna vaccine second shot in a different arm.  No concomitant medication was reported.  Couple of weeks later the patient was experienced rash all over body and rash anywhere elastic was. It was reported that treatment medication was prescribed to the patient for rash.  The patient wants to know if she can get the Pfizer COVID booster shot. She was 73 years old, about to turn 74.   This case was linked to MOD-2022-622773 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2022: Significant live follow up - medical history was added.
At appx. 8:00 am on  10/12/21 patient began to have diarrhea and continued having diarrhea all day long and stopping at approximately 9:30 pm.  At appx 1:45 am on 10/13/21 Patient vomited alot. But no more vomiting after the one time.
Picky,tingling sensation in face upon injection. Tickle in throat shortly after,  with coughing. Pharmacy watched me for 30 minutes and gave me water. Pharmacist said I could take benadryl at home. I took 2, 25mg liqui-gels benadryl capsules at home. The benadryl worked and no more coughing or itchy throat. I didn't need to use my ventoline HFA inhaler.My arm was sore, with a red hard lump  about the size of a half dollar coin, appearing and stayed red for a few days with pain and itching at the injection site. I felt weak and tired and unwell for a couple days.Also could not type all my medication list in the above area or all my allergies. Lovastatin, VentolineHFA medications , vitamine D,B12,C for list 9. List 10:allergies:CtDye,Latex,Lialda,pecans,walnuts,pineapple,bananas,coconut,mgs,cashews,metals.
14 year old received the Moderna COVID19 Vaccine; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received the Moderna COVID19 Vaccine) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received the Moderna COVID19 Vaccine). On 24-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received the Moderna COVID19 Vaccine) had resolved. Not Provided      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.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD21-069865, MOD-2021-067272, US-MODERNATX, INC.-MOD-2021-067272 (E2B Linked Report).; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot #016B21A with no associated AEs. MOD21-069865: MOD-2021-067272:Same reporter US-MODERNATX, INC.-MOD-2021-067272:Sister case
This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling in right shoulder joint), MUSCULOSKELETAL DISCOMFORT (right should joint pain that gets worse with movement), ARTHRALGIA (left shoulder joint pain that comes and goes, shoulder still hurts when move in certain ways) and MYALGIA (still hurts when i move my arm certain ways.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 013M20A) for COVID-19 vaccination. No medical history provided by reporter. Concomitant products included LOSARTAN, METOPROLOL, ACETYLSALICYLIC ACID (BABY ASPIRIN), METFORMIN, CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]), ATORVASTATIN, FISH OIL, MULTIVITAMINS [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], UBIDECARENONE (COQ10 [UBIDECARENONE]), CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), ALLIUM SATIVUM POWDER (GARLIC (ODOURLESS)) and ASCORBIC ACID, ZINC OXIDE (IMMUNE BOOST) for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced ARTHRALGIA (left shoulder joint pain that comes and goes, shoulder still hurts when move in certain ways). On an unknown date, the patient experienced JOINT SWELLING (swelling in right shoulder joint), MUSCULOSKELETAL DISCOMFORT (right should joint pain that gets worse with movement) and MYALGIA (still hurts when i move my arm certain ways.). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (MORTIN) for Joint pain, at an unspecified dose and frequency; Physical therapy for Musculoskeletal discomfort and Physical therapy for Arthralgia. At the time of the report, JOINT SWELLING (swelling in right shoulder joint) and MYALGIA (still hurts when i move my arm certain ways.) outcome was unknown and MUSCULOSKELETAL DISCOMFORT (right should joint pain that gets worse with movement) and ARTHRALGIA (left shoulder joint pain that comes and goes, shoulder still hurts when move in certain ways) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: Follow up was received added new events and treatment information.
diarrhea; lethargic; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 26Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Apr2021 the patient experienced diarrhea and lethargic. It was reported that second dose was scheduled on 22Apr2021 and patient has had diarrhea and been lethargic for three weeks at the time of reporting. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial case report received from a pharmacist on 13 NOV 2009. A 93-year-old female patient was vaccinated i.m with 0.5ml FLUVIRIN 2009/2010 (batch no. 98448P1) on 12 NOV 2009 Immediately after the vaccination the patient became ill and was reported with a blood sugar close to 0mg/dl. She was admitted to hospital where blood sugar was treated and subsequently improved. The patient had recovered at time of this report.
throat closure three weeks after second dose; has lost the ability to swallow.; hernia; A spontaneous report was received from a consumer concerning an 88-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat closure three weeks after second dose/obstruction, hernia, and lost ability to swallow/dyphagia.  The patient's medical history included an aortic valve replacement. Concomitant medications were not provided by the reporter.   On 13 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 01120A) intramuscularly for prophylaxis of COVID-19 infection. On 10 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection  On an unknown date, the patient had lost the ability to swallow. Patient was taken to the ER and ER doctors thought it was a hernia and suggested a surgery. This was three weeks post dose of the vaccine. The reporter reported that the patient was taken to the hospital on 4 Mar 2021. The doctor diagnosed hernia, but they didn't explain the throat closing. They told him to take the patient to a GI doctor. The GI didn't think it was necessary to do a surgery and scheduled a colonoscopy.  The reporter disagreed with the colonoscopy because it didn't address the throat swelling. The hospital had put the patient on IV fluids but didn't have a lot of answers. On 8 Mar 2021, the hospital prescribed antibiotics and speech therapy.   Treatment activities reported by the reporter included IV fluids, antibiotics, and speech therapy .  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, obstruction, hernia, and dysphagia were considered unknown.; Reporter's Comments: The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
RASH ON LEGS AND NECK; This spontaneous case was reported by a consumer and describes the occurrence of RASH (RASH ON LEGS AND NECK) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.  No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RASH (RASH ON LEGS AND NECK). At the time of the report, RASH (RASH ON LEGS AND NECK) was resolving.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: blood work was good.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was interrupted on an unknown date.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was provided.  The patient had not psoriasis but a rash legs and neck. The patient buy a new necklace and after it wore it was a rash. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.
Swollen lower lips, feeling a sensation of numbness and burn.; feeling a sensation of numbness; feeling a sensation of burn; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration on 18Mar2021 at 13:30 in left arm for COVID-19 immunisation. Medical history of the patient included chronic pelvic pain and endometriosis. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration on 25Feb2021 at 11:00 in left arm for COVID-19 immunisation. The patient had no allergies to medication, food or other products. The patient did not receive any other vaccine within 4 weeks of receiving COVID-19 vaccine. The patient did not have COVID-19 test prior to vaccination. The patient was not tested positive for COVID-19 since having the vaccination. The patient experienced swollen lower lips, feeling of a sensation of numbness and burn on 19Mar2021. Therapeutic measures taken as a result of events included unknown medication for allergies prior to vaccination. The clinical outcome of swollen lower lips, feeling a sensation of numbness and burn was not recovered.   No follow-up attempts are needed. No further information is expected.