chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; Sneezing; Feeling hot; Flushing; HIVES; Redness; Chill; Nausea; I had the same reaction to the second dose for the rash, although not as extensive on the arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), SNEEZING (Sneezing), FEELING HOT (Feeling hot), FLUSHING (Flushing) and URTICARIA (HIVES) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 3IL20A and 01B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Malabsorption (Fructose malabsorption). Concurrent medical conditions included Allergy to metals, GERD since 01-Jan-2015, Allergy to chemicals (MCI allergy), Allergy (Balsam) and Allergy to chemicals (Limonene allergy).   On 20-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021 at 6:30 AM, the patient experienced RASH (I had the same reaction to the second dose for the rash, although not as extensive on the arm). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), SNEEZING (Sneezing), FEELING HOT (Feeling hot), FLUSHING (Flushing), URTICARIA (HIVES), ERYTHEMA (Redness), CHILLS (Chill) and NAUSEA (Nausea). On 01-Mar-2021 at 6:30 AM, RASH (I had the same reaction to the second dose for the rash, although not as extensive on the arm) had resolved. At the time of the report, DIARRHOEA (Diarrhea), SNEEZING (Sneezing), FEELING HOT (Feeling hot), FLUSHING (Flushing), URTICARIA (HIVES), ERYTHEMA (Redness), CHILLS (Chill) and NAUSEA (Nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Antihistamines are used as treatment medication.
Vaccine expired at time of administration. It was past the bud of 10 weeks in the fridge. Expired 3/30/22. Called patient to discuss CDC recommendation of re-vaccination. Patient did not want re-vaccinated.
Within one hour I experienced tingling in my throat and increased heart rate.  I felt very sick for a month with a low grade fever, diarrhea, weakness, felt like my whole body was inflamed. It was difficulty to hold my head up most days. My neck and chest developed redness and a rash. I had a dry cough that persisted for at least 6 months and could not speak without coughing.
the patient received his first dose of GARDASIL 9 at 15 or 16 years old and is now 18 years old and needing his second dose; This spontaneous report was received from a pharmacy intern and refers to an 18-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  Approximately in 2015 (reported as when he was 15 or 16 years old), the patient was vaccinated with a first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. As for the day of this report, he needed the second dose of the vaccine, because he did not receive it yet. The reporter wanted to know if the vaccination regimen should be started over.
The COVID-19 vaccine administered through Catalent's vaccine administrator between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
Could not do anything but sleep; Headache; Severe fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Could not do anything but sleep), HEADACHE (Headache) and FATIGUE (Severe fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Strawberries), Drug allergy (NSAIDS) and Drug allergy (Percocet).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 02-Apr-2021, the patient experienced HYPERSOMNIA (Could not do anything but sleep), HEADACHE (Headache) and FATIGUE (Severe fatigue). On 04-Apr-2021, HYPERSOMNIA (Could not do anything but sleep), HEADACHE (Headache) and FATIGUE (Severe fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided by the reporter   This case was linked to MOD-2021-122483 (Patient Link).
This spontaneous report was received from a pharmacist via Pfizer and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, route, anatomical location, lot# and expiry date were not reported) together with flu shot (influenza virus vaccine (unspecified)) on the same arm for prophylaxis. On an unknown date in 2018, the patient experienced rash and it extended all over her arms for which she was hospitalized for a couple of days. It was reported that people in the Emergency Room marked the area and told her to come back if the rash extended beyond the marked site. The outcome of the event was unknown. Causality assessment was not reported.
Information has been received from a physician concerning a 15 year old female with no previous medical, family, or social history who on 19-NOV-2007 was vaccinated with a first dose of GARDASIL IM. The patient's mother told the physician that a few weeks after the GARDASIL, the patient had body aches and generalized pain. The patient was seen by her pediatrician and a neurologist, and they both thought that it was from GARDASIL. The neurologist had diagnosed the patient with fibromyalgia. CPK was elevated. At the time of reporting, the patient was being treated with cyclobenzapine hydrochloride (MSD), melatonin, imipramine, and chiropractic therapy for the pain and insomnia. The patient has missed many days from school and volleyball because of the fibromyalgia. At the time of reporting, fibromyalgia persisted. The reporter considered fibromyalgia to be disabling. Additional information has been requested.  1/29/09-According to the general practitioner, fibromyalgia persisted while insomnia was being controlled on medication (not recovered).Onset Date: Approximately December 2007 ("a few weeks after Gardasil", per pt's mother) 2/17/09-records received for DOS 7/23/08-neurology notes-C/O muscle aches and pains as well as sleep disturbance. Previously evaluated on 5/12/08, continues with pain on an almost daily basis. However no discomfort in past few days. Impression:history of severe pain in legs and arms and along cervical spine. Sleep disturbance resolved with use of Seroquel. No neurological cause of pain. No rheumatology consult at this time due to insurance issues.
Event: Red welt approximately 1" below injection site after 2nd shot. (There was no reaction after the first shot.) Timeline: After 2nd shot on Wed. did not notice welt until Sat. morning (3 days after shot).   Welt was a red, well-defined area and warm, ~3" long and 2" wide.  Over the next 24 hours it grew bigger, darker red and warmer; also a hard lump underneath the skin developed.   Beginning on Monday (2 days after welt was noticed) and (slowly) over the next week welt became less defined, less red, smaller and not as warm.  At times the arm was itchy or had some pain. After 7 days welt basically had disappeared.   Lump underneath skin continued for 3 days (after it was first noticed and with no change in size) but then (on day 4) began to get smaller and was gone about 9 days after I first noticed symptoms.
Menactra given to each patient other that they are currently around 60 years of age with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received via health professional on 28-Jul-2022. (Agency Inquiry Number: 01211040)  This case involves adult male currently around 60 years of age who received vaccine Bexsero and Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra] given to each patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Related case ID 2022SA312085 for second patient.  Concomitant medications included Octinoxate, Octocrilene (Solaris) for Immunization.  On an unknown date in 2020, the patient currently around 60 years of age  received a 1 dosage form of suspect Menactra vaccine and 1 dosage form of suspect Bexsero not produced by Sanofi Pasteur at (unknown: formulation, strength, lot number, route in unknown administration site) as prophylactic vaccination (product administered to patient of inappropriate age) at same day latency. No adverse event was reported. Lot numbers were requested.  It was reported that "Caller had 2 male patients who were on Solaris and would be going switch to Ultomiris, which would pose an increased risk for meningitis. Both patients received 1 dose of MENACTRA and 1 dose of Bexsero 2 years ago and that they never received their second doses. Caller stated she thinks that both patients need to repeat the entire series because the guidelines state that a booster was recommended at different years after vaccination but that these 2 patients were never fully vaccinated. Caller stated it is unknown why neither patient received their second dose. Caller stated: Can you just confirm that they need to have the full series and the ACWY (full form not reported) says at least 8 weeks after day zero, because if you just get 1 dose of those, it's not truly a booster since they were not fully vaccinated. Off label use for Menactra due to age. There was no specific information on each patient other that they are currently around 60 years of age and received the dose within the past 2 to 3-years. The patients are immunocompromised and following guidelines for the medication Ultomiris (ravulizumab-cwvz) and being at higher risk for meningitis."  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt mother reported "red blotches all over her face, pink on her eyebrows, eyelids and she had a big huge blotch of red on the side of head"
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Oct2021 at 16:00 as dose number unknown, single (Lot number: 301458A) at the age of 50 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing); "Known allergies: Sulfa/sulfides" (unspecified if ongoing). Concomitant medication(s) included: AMBIEN; ZEGERID; YAZ; LEVOTHYROXINE; PAXLOVID taken for Covid-19, start date: 19Apr2022, stop date: 23Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28Apr2022 at 12:00, outcome "unknown", COVID-19 (medically significant) with onset 28Apr2022 at 12:00, outcome "recovering" and all described as "A week later testing Covid positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative; positive. Therapeutic measures were not taken as a result of Covid-19. Clinical information: Relapsed after taking Paxlovid and testing negative. A week later testing Covid positive. No follow-up attempts are possible. No further information is expected.
51 hours after the injection, I began to experience fevers (102), severe lower abdominal pain, extreme chilling and vomiting. This lasted throughout the night and the next AM. At around noon on January 29, my husband took me to the ER. There I underwent an abdominal CT, labs ,IV's, zofran and reglan for nausea, and Fentanyl for pain.  I was discharged mid afternoon to my husband and sent home on ondansetron.
Information has been received from a physician concerning a female who was vaccinated with GARDASIL, all three doses, on unspecified dates (dose, route and lot # not reported). At some period after all three doses, the patient had an abnormal Papanicolau (PAP) study which showed a new onset of HPV. Patient's present status was not specified by reporter. Additional information has been requested.
she was so sick; She had stomach problem; she's sore on her left arm /First time it was real bad, sharp pain for like 4 days and than went away.; Tender on the injection site,Sore on the injection site; Had a bad soreness in her chest; Diarrhea; Had chills for a week; Was very very tired.; Near her breast there is a gland like Swollen glands; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she was so sick), ABDOMINAL DISCOMFORT (She had stomach problem), PAIN IN EXTREMITY (she's sore on her left arm /First time it was real bad, sharp pain for like 4 days and than went away.), VACCINATION SITE PAIN (Tender on the injection site,Sore on the injection site) and CHEST PAIN (Had a bad soreness in her chest) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (she was so sick), ABDOMINAL DISCOMFORT (She had stomach problem), PAIN IN EXTREMITY (she's sore on her left arm /First time it was real bad, sharp pain for like 4 days and than went away.), VACCINATION SITE PAIN (Tender on the injection site,Sore on the injection site), CHEST PAIN (Had a bad soreness in her chest), DIARRHOEA (Diarrhea), CHILLS (Had chills for a week), FATIGUE (Was very very tired.) and LYMPHADENOPATHY (Near her breast there is a gland like Swollen glands). At the time of the report, ILLNESS (she was so sick), ABDOMINAL DISCOMFORT (She had stomach problem), VACCINATION SITE PAIN (Tender on the injection site,Sore on the injection site), CHEST PAIN (Had a bad soreness in her chest), DIARRHOEA (Diarrhea), FATIGUE (Was very very tired.) and LYMPHADENOPATHY (Near her breast there is a gland like Swollen glands) outcome was unknown and PAIN IN EXTREMITY (she's sore on her left arm /First time it was real bad, sharp pain for like 4 days and than went away.) and CHILLS (Had chills for a week) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient concomitant medication reported  3 high blood pressure pills. she did not had fever. Sore goes under the armpit and it makes that, and stated it hurts, and she had that before. Paitent reported that had given her no treatment, just told her to take a couple Tylenols because it is sore. Paitent states that around the breast it was sore and hopes it was not her heart because she takes 3 high blood pressure pills. About Symptom it was stated that half hour after it started and went away, now its sore. feels like had a bruise. near her breast. Second dose received on 5April2021, Lot: 044A21A.   This case was linked to MOD-2021-435737 (Patient Link).
Cellulitis at injection site and progressed down my arm to just above my elbow.  Swollen, hot, red and itchy., lasting a week now . This happened to my left arm for my first covid vaccine Feb 18th, 2021, which I did not report at the time. Same symptoms but more severe and lasted for about 10 days I did not seek medical attention,  I  had this same reaction to the super pneumonia vaccine several years ago,, which was more severe than either of the covid vaccinations. I did seek medical attention for this incident. Tried to enter info on line 23 but couldn't so listed here.
heart palpitations started saturday the 23rd of Jan  very subtle on satuday, by monday quite often . Progressively got worse. by Wednesday night it felt as if my heart was beating upside down. they were probably every 6 beats . went to medical center, where they did chest xray and EKG, along with blood work to see if I was having a heart attack. They diagnosed them as premature beats. Sent me home on a pepcid and magnesium  Followed up on Friday the 29th with a cardiologist as they were continuing every 10 beats. He prescribed metoprolol   25mg  They subdued after another week. They flared up for second shot but not as bad . I no longer take metoprolol
The day following pt.'s booster, he woke up, showered and got dressed. While eating his breakfast he slumped down off his chair onto the floor. He had lost all strength and was unable to lift himself up. The paramedics assumed he had a stroke and rushed him to a local hospital. They did a CT scan and didn't see any signs of a stroke. After 2 hours his strength had returned to normal. He was kept overnight for observation. He was able to leave the hospital the next day fully recovered.
Adverse effect of other vaccines and biological substances, initial encounter on 2022-10-08.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 16May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Sep2022 at 16:30 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Positive lupus anticoagulant" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022 at 16:30, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Chills, fever over 102.5, body aches, joint pain, severe headache, nausea, whole body aches, pain and swelling in arm
Service Member had arm pain and limited range of motion at the shoulder after receiving his second anthrax shot. Slowly improved. Did not cause loss of work but did keep him up at night. Treated with motrin. No sequelae.
Sweats, cough, clear, lots of coughing. Told to take BENADRYL. No symptoms at injection site (onset 4 hrs later).
Patient complained of burning at the time of injection and was advised to use ice/Tylenol and to call if symptoms persisted. She called later that night asking if it was okay to use Naproxen instead (yes). On 9/30/16 she developed a red rash adjacent to the vaccine administration site. The patient was also unable to sleep due to pain. On 10/1/16 the rash moved down her arm, further away from the injection site, so the patient went to the Urgent Care and was give Keflex/Norco and told to use Benadryl.
This case was reported by a consumer (the mother of a vaccinated patient) and described the occurrence of explosive diarrhea in an 8 year old male subject (sibling of the patient) who was exposed to ROTARIX (GlaxoSmithKline) given to his two month old sister. A physician or other health care professional has not verified this report. Concurrent vaccination received by the vaccinated child included HIB (manufacturer unspecified), DTaP (manufacturer unspecified), poliomyelitis vaccine (manufacturer unspecified) and pneumococcal vaccine (manufacturer unspecified) all given to the patient on 10 June 2011, same day as ROTARIX vaccination. There were no concurrent medications taken by the vaccinated child. On 10 June 2011 at 09:30 the vaccinated child received 1st dose of ROTARIX (oral). On 13 June 2011, 3 days after vaccination with ROTARIX, the brother of the vaccinated child experienced explosive diarrhea and nausea. The reporter suspected that the live oral ROTARIX vaccine given to her child infected the "entire household" (infection via vaccinated person). At the time of reporting the events were unresolved. The vaccinated child did not experience any symptoms from vaccination with ROTARIX.
small redness near vaccine location (about quarter size) noticed around 2 days after...appeared to go away/not noticeable.  Nine days after vaccination noticed a fist size redness on/around vaccination location...redness is warm to touch.  Contacted doctor, had a video appointment, currently on antibiotic, was advised by doctor to contact you.
SHORTNESS OF BREATH; RUNNY NOSE; FOGGY HEAD/THINKING; EXHAUSTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: respiratory problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-AUG-2021, the patient experienced shortness of breath. On 01-AUG-2021, the patient experienced runny nose. On 01-AUG-2021, the patient experienced foggy head/thinking. On 01-AUG-2021, the patient experienced exhaustion. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) NEGATIVE, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, runny nose, exhaustion, and foggy head/thinking. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.