chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 14 year old female patient. The patient concurrent condition included headache, reflux sympathetic dystrophy (RSD), slurred speech and vomiting. On 10-OCT-2013 the patient was vaccinated with GARDASIL (dose unknown). No concomitant medications were reported. Approximately on 11-OCT-2013, the day after vaccination, the patient experienced worsening of slurred speech, vomiting and headache. The outcome of the events was reported not recovered/not resolved. The patient sought medical attention and was taken to an emergency department in which CAT scan was conducted. CAT scan showed no irregularities and the patient was discharged. The event was ongoing. The patient had follow up scheduled with an unspecified neurologist on an unknown date. Additional information has been requested.
Picture sent of injection site & reaction. 4 inch wide lump with a 3 inch wide red-welt. Patient is in no distress. Hot to the touch with red appearance. Reaction came during sleep hours.
Chest burning sensation anterior chest. NOT reflux, heart burn, abdominal pain, coughing, wheezing, rash. It was a burning in anterior chest sensation per patient
PATIENT RECEIVED VACCINATION AND SAT DOWN FOR HER 15 MINUTE WAIT.  WITHIN 5 MINUTES PT WAS VERY LIGHT HEADED, HAVING TROUBLE BREATHING (NOT DUE TO SWELLING), AND PINS AND NEEDLES IN HER HANDS
her right arm extremely sore; achy; tiredness; they both felt like flu-like symptoms; partial loss of taste; don't feel good; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (they both felt like flu-like symptoms), AGEUSIA (partial loss of taste), FEELING ABNORMAL (don't feel good), DECREASED APPETITE (no appetite) and PAIN IN EXTREMITY (her right arm extremely sore) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer. Concurrent medical conditions included Diabetic. Concomitant products included INSULIN, VITAMIN D NOS and VITAMIN B COMPLEX (B COMPLEX (B50)) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (they both felt like flu-like symptoms), AGEUSIA (partial loss of taste), FEELING ABNORMAL (don't feel good), DECREASED APPETITE (no appetite), PAIN (achy) and FATIGUE (tiredness). On an unknown date, the patient experienced PAIN IN EXTREMITY (her right arm extremely sore). On 06-Mar-2021, INFLUENZA LIKE ILLNESS (they both felt like flu-like symptoms), AGEUSIA (partial loss of taste), FEELING ABNORMAL (don't feel good), DECREASED APPETITE (no appetite), PAIN (achy) and FATIGUE (tiredness) had resolved. At the time of the report, PAIN IN EXTREMITY (her right arm extremely sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I went to the vaccination facility for my 2nd Shot. I waited 30 minutes due to my allergies. I went home. When I woke the next day I was with nausea, dizzy and foggy. That lasted 3 days and it went away and was feeling better.
Headache, Myalgia, Arthralgia, Fever, chills, fatigue, injection site pain/arm pain, swelling at injection site Narrative:  Other Relevant History:
Spend most of that day sleeping; Had fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Spend most of that day sleeping) and PYREXIA (Had fever) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Spend most of that day sleeping) and PYREXIA (Had fever). At the time of the report, SOMNOLENCE (Spend most of that day sleeping) and PYREXIA (Had fever) had resolved.            Treatment information was not provided.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Fever is consistent with the known safety profile of the vaccine
Starting 4 hours after injection, Severe pain in entire arm of injection site, particularly the shoulder. No mobility achieved without major pain for about 14 hours. Only comfortable when laying down as gravity pull from standing was excruciating. Pain subsided and arm mobility increased as the day went on.   Also, Fever suspected after 30 hours of the injection, soaked bedsheets twice from sweat with 4 hours of between events.
Patient was given her second shot. After waiting 15 minutes she reported feeling sweaty and a little trouble swallowing.  We had her apply an ice pack and elevated her feet. After waiting another 15  minutes, she was also given water to drink.  After another 10 minutes she felt fine and could leave the pharmacy indepently.
24 hours after receiving vaccine, child had fever of 104 degrees for 2 days.
Immediate internal burning pain in right shoulder and right arm and right forearm and right hand lasting 72 hours. Right arm hot to touch for 72 hours after injection. Unable to raise right arm for 72 hours due to intense right arm pain. 100.2 fever starting 4 hours after injection, lasting about 24 hours. Nausea starting 4 hours after injection, lasting 6 hours. Prickly red rash on right inner thigh started 16 hours after injection, lasting 72 hours.
No adverse event; A second dose of the Moderna COVID-19 vaccines was given after the published expiration date on 20-MAR-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A second dose of the Moderna COVID-19 vaccines was given after the published expiration date on 20-MAR-2023) and NO ADVERSE EVENT (No adverse event) in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 063B22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 20-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Mar-2023, after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (A second dose of the Moderna COVID-19 vaccines was given after the published expiration date on 20-MAR-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A second dose of the Moderna COVID-19 vaccines was given after the published expiration date on 20-MAR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A second dose of the Moderna COVID-19 vaccines was given after the published expiration date on 20-MAR-2023).    No concomitant medications were reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment information was provided.
This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm killing me), PALPITATIONS (Heart was pounding), POOR QUALITY SLEEP (I didn't sleep well), NIGHTMARE (I felt like I was in a dream state) and ASTHENIA (Weak) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044R21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder (Had a Thyroid issue.) and COVID-19 (Had COVID in July.) in July 2020. Concurrent medical conditions included Eczema (eczema from childhood.   worsening cut on fingers), Degenerative bone disease (undergoing PT for pain) since 2015 and Blood pressure high. Concomitant products included LOSARTAN for Blood pressure high, LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) for Hypothyroidism.    On 22-Mar-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced LIMB DISCOMFORT (Arm killing me), PALPITATIONS (Heart was pounding), POOR QUALITY SLEEP (I didn't sleep well), NIGHTMARE (I felt like I was in a dream state), ASTHENIA (Weak), VACCINATION SITE WARMTH (Injection site warmness), FATIGUE (Fatigue) and HEADACHE (Head is killing me). 22-Mar-2021, the patient experienced FEELING COLD (I was so cold) and VACCINATION SITE ERYTHEMA (Injection site red in color). On 24-Mar-2021, LIMB DISCOMFORT (Arm killing me), PALPITATIONS (Heart was pounding), POOR QUALITY SLEEP (I didn't sleep well), NIGHTMARE (I felt like I was in a dream state), ASTHENIA (Weak), FEELING COLD (I was so cold), VACCINATION SITE WARMTH (Injection site warmness), VACCINATION SITE ERYTHEMA (Injection site red in color), FATIGUE (Fatigue) and HEADACHE (Head is killing me) had resolved.            No treatment information was provided.   This case was linked to MOD-2021-135260, MOD-2021-054796 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Follow-up information received included patient demographics, concurrent conditions, concomitant medications, addition of new event and the outcome of the event..
Grandmother states had fever, vomiting, no appetite, which continued through to noon of next day after receiving vaccines. (Grandmother did not actually check temp.)
Dose administered >12(US)hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12hours post puncture) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jun-2022 at 10:07 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2022 at 10:07 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12(US)hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12(US)hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient received drug from the vials which were drew from more than 12 hours. There were 2 Booster doses. Vial was initially stored in the refrigerator on 15-Jun-2022. The vial was first punctured on 24-Jun-2022 10:10 AM. The vial was stored in the Fridge post punctured. The vial did not undergo any temperature excursions.Total amount of time the vial was exposed to room temperature range 8° to 25°C= 46° to 77°F for More than 24 hours. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-595070 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-595070:Patient-2
Vaccine was given at 4:10pm, about 2 minutes later, patient began to complain of chest pain and shortness of breath.
Stomach upset, diarrhea feverish started 9/25/2022.  Developed numbness, tingling in fingertips and feet on 9/26/2022. Symptoms worsened w numbness in mouth on 9/27 and weakness in lower legs w progressive numbness 9/28/22. Evaluation by Dr of Neurology 9/29 w admission to hospital and EMG confirmed dx of Guillain Barre Syndrome. Weakness worsened despite treatment w IVIG and pt was transferred to Medical Center for further treatment.
No additional AEs/no PQCs.; HCP called in and reported that an expired dose of VARIVAX was administered on 10/31/2022. Caller did not report any temperature excursion.; This spontaneous report was received from a nurse referring to patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 31-OCT-2022, the patient was vaccinated with a expired second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number 1742084 has been verified to be a valid lot number with expiration date reported and established as 05-OCT-2022) (dose, strength, route of administration, anatomical injection site and vaccination scheme were not reported), administered for prophylaxis (expired product administered). There was not any temperature excursion reported. No additional adverse events were reported.; Sender's Comments:  US-009507513-2211USA000204:
Information has been received from a health care professional concerning an 18 year old Caucasian female who on 01/04/00 was vaccinated with a 3rd dose of Hepatitis B vaccine recombinant. On 01/09/00, the patient complained of abdominal pain, a fever of 102.9 F, and swollen lymph nodes. On 01/11/00 she was seen by her physician and started on therapy with Cipro. Follow up information on 01/27/00 indicated that the patient was diagnosed with mononeucleosis. At the time of the report she was still complaining of abdominal discomfort and fatigue. No further info is available.
A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health professional concerning a 92 year old female vaccine who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.
Muscle ache and redness at site of injection (ie left deltoid muscle), possible fever, body ache.
Pt recv vax on 10/29/98; post vax pt exp shortness of breath, flushing, nausea, clutching throat & cough
SHOT GIVEN IN RIGHT ARM WITH REGULAR FLU SHOT; AT ONSET DATE/TIME (BOX 11), HEADACHE, ACHING, NAUSEA, FATIGUE; ALL NEXT DAY, FELT "AWFUL", LYMPH GLAND RIGHT ARMPIT VERY SWOLLEN/ENLARGED; INJECTION SITE RED, HOT, SWOLLEN, RED "STRIPES" APPROX 1 INCH EXTENDED FROM INJ SITE TOWARDS ARMPIT AND AROUND BACK OF ARM BY TRICEPS; BY 12/12/09 10 PM, LYMPH NODE LESS SWOLLEN/HOT, ALL "STRIPING" LOWER TOWARDS ARMPIT, EXTENDED ONTO TOP OF RIGHT BREAST; BY 12/13/09, REDNESS SIGNIFICANTLY FADED, SWELLING RESOLVED; 12/14/09 AM FELT NORMAL.
heart attack; This is a spontaneous report received from a contactable reporter (consumer) for a Pfizer sponsored program (003110).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal," described as "heart attack." The patient date of death was unknown. The reported cause of death was myocardial infarction. It was not reported if an autopsy was performed.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101881775 Same reporter/ drug/ event, different patient;US-PFIZER INC-202101881804 Same reporter/ drug/ event, different patient; Reported Cause(s) of Death: heart attack
Nausea, Brain Fog, sore arm, shoulder and neck, tingling and burning in hands and feet occasionally and pain in hip joint
A couple days after receiving the 1st dose I started to have low back pain. It came and went between then and my second does. After receiving my second dose it has been and is still back with full force. The low back pain has been consistent ever since the second dose. I have take inflammatory medication prescribed from my doctor and have also had physical therapy.
1st dose on 20Sep2022, 2nd on 14Nov2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number B97G2, expiry date 26th January 2024) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 14th November 2022, the patient received the 2nd dose of Shingrix. On 14th November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 15-Nov-2022 Reporter's comment: The pharmacist stated that the patient came in stated that she had not received the first dose of Shingrix and a dose was administered. When the pharmacist checked the patient had received 1st dose and 2nd dose one day before reporting date. The reporter consented to follow-up via postal. Additional supportive information:  The patient received 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccine schedule.
Couple hours of chills; a little bit of body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I had allergic reactions" (unspecified if ongoing), notes: I had allergic reactions. Not to vaccines but to IV antibiotics; "anaphylactic reactions" (unspecified if ongoing), notes: I have had anaphylactic reactions. I seemed to do ok, no anaphylaxis; "type 1 diabetes" (unspecified if ongoing); "congestive heart failure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "recovered", described as "Couple hours of chills"; PAIN (non-serious), outcome "recovered", described as "a little bit of body aches".  Additional information: It was reported that patient received both doses, one a month ago and one a week ago. Did pretty well considering she got them late because she had allergic reactions. Not to vaccines but to IV antibiotics. She had had anaphylactic reactions. she seemed to do ok, no anaphylaxis. Couple hours of chills and maybe a little bit of body aches then she was fine. She had question and wanted to report symptoms that may or may not be weird. She had her first dose of Pfizer Covid-19 Vaccine a month ago, and her second dose of Pfizer Covid-19 Vaccine a week ago today. After the first dose of Pfizer Covid-19 Vaccine she was fine, it doesn't matter, but she had a mild chill and a little bit of body aches for an hour and then she was good.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Affected individual received Pfizer COVID-19 vaccine 4-16-2021 lot EW0162, 5-7-2021 lot EW0176. On 7-15-2021 affected individual reported beginning approximately one week after 5-7-2021 COVID-19 Pfizer vaccination, began having headaches several times a week; altered taste at times; body ache on and off; occasional upset stomach. Takes OTC pain reliever for headache and body ache. Denied fever, loss of taste or smell.
Body aches, joint pain, fatigue, chills, throbbing, starting at 6:30pm and continuing into the following day
Information regarding PREVNAR 13 was received from a nurse regarding an unknown number of patients who experienced painful reaction during vaccine administration. The patient received a dose in 2010. The patient experienced painful reaction during vaccine administration (pain) in 2010. The outcome was unknown. No additional information was available at the time of this report.
Case number PHEH2015US022671, is an initial spontaneous report received from a pharmacy student on 02 Nov 2015. This report refers to a male patient of unknown age. Medical history and concomitant medication was not reported. The patient brought the MDV of FLUVIRIN (batch number: 1515401) to home and left it out at room temperature for up to 12-13 hours. The patient later administered the FLUVIRIN on 31 Oct 2015. No adverse event was reported. No further information was provided.
chills; fatigue; Severe headache; fever after getting the shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (chills), FATIGUE (fatigue), HEADACHE (Severe headache) and PYREXIA (fever after getting the shot) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CHILLS (chills), FATIGUE (fatigue), HEADACHE (Severe headache) and PYREXIA (fever after getting the shot). The patient was treated with PARACETAMOL (TYLENOL) for Pain relief, at a dose of 200 milligram four times per day. At the time of the report, CHILLS (chills), FATIGUE (fatigue), HEADACHE (Severe headache) and PYREXIA (fever after getting the shot) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test positive: positive Positive.     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.