chrisvoncsefalvay/vaers-outcomes huggingface dataset:
can't move her arm; Myalgia; severe pain from injection site up to her neck, pain was nonstop pain for 3 days, could not even touch the arm; swollen lymph node; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (can't move her arm), MYALGIA (Myalgia), VACCINATION SITE PAIN (severe pain from injection site up to her neck, pain was nonstop pain for 3 days, could not even touch the arm) and LYMPHADENOPATHY (swollen lymph node) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Drug allergy and Drug allergy. Concomitant products included HYDROCHLOROTHIAZIDE, FLUOXETINE HYDROCHLORIDE (PROZAC) and LISINOPRIL for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (can't move her arm), MYALGIA (Myalgia), VACCINATION SITE PAIN (severe pain from injection site up to her neck, pain was nonstop pain for 3 days, could not even touch the arm) and LYMPHADENOPATHY (swollen lymph node). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (can't move her arm), MYALGIA (Myalgia), VACCINATION SITE PAIN (severe pain from injection site up to her neck, pain was nonstop pain for 3 days, could not even touch the arm) and LYMPHADENOPATHY (swollen lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Dtap shot.  Hard red lump formed 2 days after shot at site of injection.
Mild soreness at injection site; fever; chills; muscle pain; joint pain; nausea; vomiting; headache; sweats; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 at 12:00 as dose: 1, single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy: Terbinafine and related corticosteroids, penicillins, prednisone, sulfa antibiotics" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering", described as "Mild soreness at injection site"; CHILLS (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering"; PYREXIA (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering"; ARTHRALGIA (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering", described as "joint pain"; MYALGIA (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering", described as "muscle pain"; NAUSEA (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering"; HYPERHIDROSIS (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering", described as "sweats"; VOMITING (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering"; ASTHENIA (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering", described as "weakness". Therapeutic measures were not taken as a result of vaccination site pain, pyrexia, chills, myalgia, arthralgia, nausea, vomiting, headache, hyperhidrosis, asthenia. Additional information: No other vaccine in four weeks. No other medications in two weeks. Mild soreness at injection site. Less than 24 hrs later, fever, chills, muscle pain, joint pain, nausea, vomiting, headache, sweats, weakness. Lasting two full days. No covid prior vaccination. Not covid tested post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
received dose two of shingrix late; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number H54CA, expiry date 18th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2019).   On 18th December 2021, the patient received the 2nd dose of Shingrix. On 18th December 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The medical assistant reported that, the patient received 2nd dose of Shingrix late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
3rd dose on 10th sep/ second dose on 10-Feb-2021; slight headache, flu like symptoms, very tired and feeling out of sorts; slight headache, flu like symptoms, very tired and feeling out of sorts; slight headache, flu like symptoms, very tired and feeling out of sorts; slight headache, flu like symptoms, very tired and feeling out of sorts; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (slight headache, flu like symptoms, very tired and feeling out of sorts), INFLUENZA LIKE ILLNESS (slight headache, flu like symptoms, very tired and feeling out of sorts), FATIGUE (slight headache, flu like symptoms, very tired and feeling out of sorts), HEADACHE (slight headache, flu like symptoms, very tired and feeling out of sorts) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose on 10th sep/ second dose on 10-Feb-2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced MALAISE (slight headache, flu like symptoms, very tired and feeling out of sorts), INFLUENZA LIKE ILLNESS (slight headache, flu like symptoms, very tired and feeling out of sorts), FATIGUE (slight headache, flu like symptoms, very tired and feeling out of sorts) and HEADACHE (slight headache, flu like symptoms, very tired and feeling out of sorts). On 10-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose on 10th sep/ second dose on 10-Feb-2021). On 16-Sep-2021, MALAISE (slight headache, flu like symptoms, very tired and feeling out of sorts), INFLUENZA LIKE ILLNESS (slight headache, flu like symptoms, very tired and feeling out of sorts), FATIGUE (slight headache, flu like symptoms, very tired and feeling out of sorts) and HEADACHE (slight headache, flu like symptoms, very tired and feeling out of sorts) was resolving. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose on 10th sep/ second dose on 10-Feb-2021) outcome was unknown. Not Provided          Patient History contained no known allergies.  No concomitant medications were reported.  No treatment medications were reported.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0020B20A and 007C21A0) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-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 experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were not provided No treatment medication information were not provided
Missed 2 appointments/ delayed 2nd shot of Moderna Covid-19 vaccine beyond 42 days; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Missed 2 appointments/ delayed 2nd shot of Moderna Covid-19 vaccine beyond 42 days) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Missed 2 appointments/ delayed 2nd shot of Moderna Covid-19 vaccine beyond 42 days). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Missed 2 appointments/ delayed 2nd shot of Moderna Covid-19 vaccine beyond 42 days) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient wanted to know Can he take the 2nd dose?   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up was received on 16-JUN-2021. It contains no new information.
Fever, cough, fatigue, loss of appetite, nausea, diarrhea, chest pains, plural effusion.
Mar 24, 2021 very slight soreness, spose noted burgundy, swollen area R deltoid site. assoc with slight h/a, very slightly swollen glands in posterior neck. March 25, 2021 warm to touch, increased size and soreness at site 69.85mm x 76.2mm, swelling with no discoloration 95.25mm with and slight soreness axillary nodes. March 26, 2021 No change size, hot to touch, uncomfortable, less red, itchy entire pink area.
First Gardasil given 2-14-07 pt returned 4-11-07. Informed nurse of episode of dizziness severe with diaphoresis - near syncope - within 3 days of 1st injection - ER visit - DX possible seizure - referred to neurology. Neuro cleared pt feels not related to Gardasil event occurred actually 3wks after injection.
pt recvd  4th dose of vax 22FEB93 & lab eval on 23APR93 revealed rubeola virus IGG AB less than 0.8, rubella virus IGG AB 2.53 & mumps virus IGG AB 1.68;
Patient woke up the next day and experienced a brief amount of swelling. Arm appeared red in a 3 inch around sit of infection consistent with an allergic reaction.  Site is described as warm or hot to touch.  Described as tolerable, will seek attention if needed; does not feel benadryl or cortisone cream over the counter was required but she would keep in mind. She does not have an md at this time but will go to an urgent care if condition worsens.
Day of shot no symptoms, pain 10/16/13 bruise started 10/17/13 bruise grew to 3-4" and painful lump appeared, 10/18/132 felt achy and back of neck stiff. This lasted only until the end of day and may not be related. 10/21/13 knot went away. Arm no longer painful and bruise is lightening.
This spontaneous report as received from a physician via company representative and refers to a 2-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-SEP-2018, the patient was vaccinated with an "adult dose" of VAQTA 50/1.0 U/ml, lot # N028743, expiration date: 23-NOV-2018 (anatomical location, dose and route of administration were not reported) for prophylaxis. The physician reported that the patient was fine, he was not hospitalized. No adverse effects were reported.
Having trouble breathing/feel like my breathing is labored; feeling like I was in an Earthquake; I felt tired; Had a headache; Felt very sleepy; felt like I had a hangover and felt like I was in an earthquake; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Felt very sleepy), FEELING ABNORMAL (felt like I had a hangover and felt like I was in an earthquake), DYSPNOEA (Having trouble breathing/feel like my breathing is labored), TREMOR (feeling like I was in an Earthquake) and FATIGUE (I felt tired) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939676) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced SOMNOLENCE (Felt very sleepy), FATIGUE (I felt tired) and HEADACHE (Had a headache). 12-Aug-2021, the patient experienced FEELING ABNORMAL (felt like I had a hangover and felt like I was in an earthquake). On 25-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Having trouble breathing/feel like my breathing is labored). 25-Aug-2021, the patient experienced TREMOR (feeling like I was in an Earthquake). On 14-Aug-2021, SOMNOLENCE (Felt very sleepy), FEELING ABNORMAL (felt like I had a hangover and felt like I was in an earthquake), FATIGUE (I felt tired) and HEADACHE (Had a headache) had resolved. At the time of the report, DYSPNOEA (Having trouble breathing/feel like my breathing is labored) and TREMOR (feeling like I was in an Earthquake) had not resolved.            Concomitant medications was not provided by the reporter. Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-300209 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt returned 10-9-20 reporting itching, redness, and swelling. Tender at injection site. Achiness for a couple days. Referred to PCP for immediate care due to possible cellulitis. Pt filled scrip for Keflex.
Local swelling and burning + lymphadenopathy of anterior/posterior cervical LNs as well as supraclavicular LNs all on left side (same side of vaccine)
GENERAL FLU LIKE SYMPTOMS; INJECTION SITE PAIN; FELT LIKE THROAT CLOSING; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced felt like throat closing. On 07-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced general flu like symptoms. Treatment medications (dates unspecified) included: acetylsalicylic acid/chlorphenamine maleate/phenylpropanolamine hydrochloride, and oxymetazoline hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on APR-2021, and was recovering from felt like throat closing, and general flu like symptoms. This report was non-serious.
pt devel inj site rxn p/vax;this is one of three pt from this site;
violently ill; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (violently ill) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (violently ill). At the time of the report, ILLNESS (violently ill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  On an unknown date, reporterd neighbour was violently ill.  It was reported that they were thinking this may have been a latent reaction.  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 adverse outcomes or side effects were reported or observed by the patients; HCP (nurse) called to report TE for VARIVAX (lot: W031813 expiration: 10/05/2024) that occurred on 05/11/2023 but she was not made aware by the VFC until today (06/26/2023).  The product was stored at 10.8F for 8 hours, 23 minutes and 0 seconds with; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 11-MAY-2023, varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot number W031813 was verified to be valid, expiration date reported and confirmed as 05-OCT-2024) suffered a temperature excursion (TE).   On 20-JUN-2023, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 mL via injection (lot number W031813, expiration date 05-OCT-2024), administered as prophylaxis (route of administration and anatomical location were not provided) (product storage error). The reporter was not made aware of the TE until 26-JUN-2023 (reported as "today"). The product was stored at 10.8F for 8 hours, 23 minutes and 0 seconds with a supported TE stability evaluation, and there were not any previous excursions, and 8 doses total were administered. No adverse outcomes or side effects were reported or observed by the patient (no adverse event), who received the administered dose by an experienced health care professional (HCP). Permission received to follow up with primary HCP (pediatrician).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA012362: US-009507513-2306USA012702: US-009507513-2306USA012560: US-009507513-2306USA012318: US-009507513-2306USA012351: US-009507513-2306USA012355: US-009507513-2306USA012732: US-009507513-2306USA012753:
Vaccine was administered after being stored between 3.4°C and 6.9°C for 76 days. Ten days at these temps was on 5/26/22. Vaccine was administered on 6/1/22. Parents were contacted and reported no adverse events.
I had my third baby, had elevated bp surrounding delivery, then received vax on 1/13, and 2/3 and they thought it was just post partum HTN should go away by 6 weeks, it persisted, received dose 3 on 10/26/2021, finished nursing  1/2022 and still have HTN, no hx of previous HTN,  young, healthy, no family hx in parents.
Headache, nausea, bad back ache. Heart rate racing, difficulty breathing. I've seen multiple doctors including my family doctor, hematologist, and cardiologist.
Severe chest pain, dizziness, dramatic personality change, temporary loss of consciousness, no memory of several hours during chest pain and personality change.
inadvertently administered an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired vaccine) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired vaccine). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.
Generalized itching, advised to take OTC Benadryl-Cleared by EMS
Patient less than 18 administered Moderna Covid-19 vaccine; drowsiness; typical reactions; pain in his left injection site arm; pain in his left injection site arm and swelling; headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (drowsiness), VACCINATION COMPLICATION (typical reactions), VACCINATION SITE PAIN (pain in his left injection site arm), VACCINATION SITE SWELLING (pain in his left injection site arm and swelling) and HEADACHE (headache) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced SOMNOLENCE (drowsiness), VACCINATION COMPLICATION (typical reactions), VACCINATION SITE PAIN (pain in his left injection site arm), VACCINATION SITE SWELLING (pain in his left injection site arm and swelling), HEADACHE (headache) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient less than 18 administered Moderna Covid-19 vaccine). On 18-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient less than 18 administered Moderna Covid-19 vaccine) had resolved. At the time of the report, SOMNOLENCE (drowsiness), VACCINATION COMPLICATION (typical reactions), VACCINATION SITE PAIN (pain in his left injection site arm), VACCINATION SITE SWELLING (pain in his left injection site arm and swelling) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-366125 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Non Significant follow up - AE contact information updated