chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Circular red rash around the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Circular red rash around the vaccine) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE RASH (Circular red rash around the vaccine). At the time of the report, INJECTION SITE RASH (Circular red rash around the vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; 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.
inappropriate age at vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at vaccine administration) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at vaccine administration) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines reported. No treatment medication reported.
pt recv vax & devel a low grade fever, h/a, myalgia, gen rash & an inj site rxn;MD believes pt other sx are tetanus related & has referred pt to infect disease specialist;
patient stated she has localized heat, swelling and pain at the injection site and that she had an appointment with her PCP the next day.
12/13 Thur am - vaccination at Care Center (Dr.'s nurse). Fri am - swam as normal; perhaps some general malaise and muscle soreness. Sat - muscle soreness. Sun - woke at 1:55 am after 3 hours of sleep. Throat raw/dry. General tiredness all day. Mon - slept ~4 hours; swam as normal; sore; voice weak. Tue-Fri - laryngitis; less than normal sleep; sore muscles began settling in neck (sore to turn head); took 4 ibuprofen early in week, 2 aceteminophen Friday.  Fri sore to swallow, laryngitis improving. Sat - visited walk-in clinic (Dr.) to rule out bacterial infection ahead of holiday.  Dx="J02.9 Pharyngitis, unspecified etiology"; no throat culture.  Feeling better but neck muscles still sore and voice not yet strong.
red large mark; itching; large red mark at the injection site; little itchy; . A spontaneous report was received on 8 Mar 2021, from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events large red mark at the injection site, little itchy, red large mark, itching.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Feb 2021,  prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced the event(s) large red mark at the injection site. little itchy. On 7 Mar 2021, the patient experienced the event(s) red large mark. itching.  Treatment details included, mRNA-1273 mRNA-1273 Safety Clinical Trial, AEs.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), large red mark at the injection site, little itchy,red large mark,itching was unknown.
Pain; lymph nodes inflammation.; Throughout the rest of your body: Tiredness; Headache; Muscle pain; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as N/A. Concomitant medications included levothyroxine sodium (SYNTHROID) and lisinopril (MANUFACTURER UNKNOWN), both for unknown indications on unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 10Mar2021 at 10:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 05Apr2021 at 22:00, the patient experienced pain, lymph nodes inflammation, throughout the rest of the body tiredness, headache, muscle pain, chills and fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events  pain, lymph nodes inflammation, throughout the rest of the body tiredness, headache, muscle pain, chills and fever was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Vaccine administered in higher dose than recommended in the 12-year-old and up formulation.
A spontaneous report (United States) was received from a Consumer concerning a 38-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events could not sleep, difficulty breathing, pain at the injection site, arm hurts when she moves it, fever of 102.2, headache, chills, bone pains, feels tired, nausea. The patient's medical history was not provided. Concomitant medications reported were vitamins for drug use for unknown indication. On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) in left arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the events could not sleep. difficulty breathing. On 27 Jan 2021, the patient experienced the events pain at the injection site. arm hurts when she moves it, fever of 102.2, headache, chills, bone pains, feels tired, nausea.  No treatment information was provided.  On 27-Jan-2021, the patient's body temperature was 102.2.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, could not sleep, difficulty breathing, pain at the injection site, arm hurts when she moves it, fever of 102.2, headache, chills, bone pains, feels tired, nausea was unknown.; Reporter'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.
Td on 7/16/02. 10 days post vaccine noticed golf ball (Lt. del) size purple/red bruising, hot to touch. Went to ER for check. Cephelexin (sp) q 8 hours x 7 days for abscess to arm (7/29) red/bruised area extends from mid upper arm to elbow anterior surface. History of bruising easily.
soreness in arm; Information has been received from a pharmacist referring to a male patient of unknown age. Concomitant therapies included sterile diluent. Information about medical history and drug reactions/allergies was unknown by the reporter.     On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose in series unknown, frequency, anatomical location, route of administration, lot number and expiration date were unknown) for prophylaxis at another pharmacy.      On 05-NOV-2019, the patient experienced soreness in arm. The patient sought medical attention.  The outcome of soreness in arm was unknown. The causality assessment was not reported.
Patient received expired dose of ADACEL/ with no adverse event; Initial information was received on 04-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and non-healthcare professional via call center via Medical Information (MI) (reference number- 00796310).  This case involves a patient of (unknown demographics) who received patient vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  On 03-Oct-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number not reported and expiry date: 17-SEP-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was of actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event reported.   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.  There will be no information available on the batch number for this case.
I received the Moderna vaccine on Wednesday, 03.03.2021 @ 1:00 pm.  At around 3:00 am I woke up throwing up and having diarrhea.  I could not even hold water down and just kept throwing up and having diarrhea until after 8:00 am Thursday morning.  I had chills so bad to where I was shaking and my fever went up to 103 F.  I was in bed all day and could not go back to work on Friday due to still having high fever.  By Friday evening, my fever finally broke; however, my started getting red and swollen.  It just kept getting redder in a larger area.  It is very red today and this is five (5) days after the shot.
After patient received MENACTRA vaccine she became "foggy" in her words. Offered her to lay down, but refused. I told her to wait in office for a few minutes. She sat in chair in room. About 5 min later Mom rang for help and patient was passing out. Entered room and got patient to floor and elevated legs. As soon as legs were elevated patient came to. Dr. entered room and asked patient a few questions. Patient oriented to time and place, knew her name. Got patient up on table. At 5 minutes checked vitals sitting and BP was 90/62 P-74. Checked on patient again at 30 min, stood up and felt much better. Standing BP 104/60 P-74.
Patient was under-dosed and given 0.25mL rather than the required 0.5mL dose.
pins and needles throughout body.  started 3 days post vaccination and continues 1 week after.   had low grade fever and fatigue in 24hrs post.
being sick aint fun / its not fun indeed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: ILLNESS (non-serious) with onset 26Dec2021, outcome "unknown", described as "being sick aint fun / its not fun indeed". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: individual on stream live in PM  yesterday said being sick ain't fun and another on stream said "its not fun indeed". Unsure vaccine status of either, or what exactly they were talking about.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
4/23/21 at 1435: Pt. has h/o allergic reactions to Codeine & most antibiotic Does not carry an Epi-pen. No other significant Med. Hx 1315: Covid vaccine #2 given. Pt. instructed to wait 30 minutes d/t allergy history. 1340: Pt. c/o rapid pulse. HR - 124. 1343: VS: BP - 183/102 - LA (reg. cuff) HR - 109 R - 22 1345: VS: BP - 174/85 - RA (Lg. cuff) HR - 94 Pt. denies any tingling in lips 1350: VS: BP - 174-93 HR - 94 R - 18 1400: Pt. states still 0 feeling well, likeheart racing again. VS: BP - 164/97 HR - 101 Given 50mg liquid Benadryl PO - Husband arrived 1401: Pt. states she is having difficulty breathing. Called emergency number - Epinephrine drawn up & ready 1405: VS BP-171/89 HR -102 EMS arrived Pt. began feeling better upon EMS arrival. VS improving. EMS stayed ~15-20min. & pt. feeling well, deciding 0 ambulance ride to hospital. Husband took pt. home ~1425 & will monitor wife for any s/s resp. distress. Couple lives 2 blocks from EMS headquarters. Instructed to call office if any ?s, & call emergency number if any respiratory distress.
Sore arm; Warmth at injection site; Fatigued; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 29Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced sore arm, warmth at injection site and fatigued on 30Mar2021. Outcome of the events was not reported.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
emotionally unstable; Hypersensitivity; rash on both lower legs; diarrhea; headache; nausea; soreness of left arm; muscle fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of left arm), MUSCLE FATIGUE (muscle fatigue), DIARRHOEA (diarrhea), RASH (rash on both lower legs) and EMOTIONAL DISORDER (emotionally unstable) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness of left arm) and MUSCLE FATIGUE (muscle fatigue). On 19-Feb-2021, the patient experienced HEADACHE (headache) and NAUSEA (nausea). On 22-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 24-Feb-2021, the patient experienced RASH (rash on both lower legs). On an unknown date, the patient experienced EMOTIONAL DISORDER (emotionally unstable) and HYPERSENSITIVITY (Hypersensitivity). At the time of the report, PAIN IN EXTREMITY (soreness of left arm), MUSCLE FATIGUE (muscle fatigue), DIARRHOEA (diarrhea), RASH (rash on both lower legs), EMOTIONAL DISORDER (emotionally unstable), HYPERSENSITIVITY (Hypersensitivity), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Narrative: 51 year old female with PMH of hyperlipidemia, hearing loss, PTSD, anxiety, HTN and stress incontinence who came to the ED on 2/17/2021, 4 days after her second dose of COVID19 PFIZER vaccine (2/13/21) second dose EL9265, 1/23/21 first dose EL3249 ) because of intermittent fever post vaccine. Pt said she has become more febrile the past 48 hours (hence she came to the ED  for evaluation). No other symptoms noted. Patient received the first and second  dose of covid19 vaccine without complications. The patient denied any prior  severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy. Patient was discharged with Tylenol prn and naproxen 500 mg BID prn for her fever. Pt to f/u with PCP prn.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (Lot number: J6739) at the age of 78 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6205), in left arm, on 19Aug2021 as dose 3 (booster), single (Lot number: FC3183), in left arm and on 25Jan2022 as dose 4 (booster), single (Lot number: FJ5682), in left arm for covid-19 immunisation. The patient's relevant medical history included: "autoimmune hepatitis" (unspecified if ongoing); "mastectomy" (unspecified if ongoing), notes: mastectomy 1986. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jan2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. From 27Dec2022 to 31Dec2022, the patient received Paxlovid as treatment of COVID-19.
No complaint of sign effects. Upon due date of second dose in series it was noticed patient had originally received wrong vaccine at initial dose.  Patient and parent were notified. Patient was advised we would report this to the correct agencies and we will notify them of corrective action going forward. Follow up was obtained and patient will be returning for his dose but it was advised it will need to be the Pfizer at scheduled second shot date along with the Pfizer booster to follow.
About 6 days after 2nd shot I noticed red spots on my legs (below the knee) and tops of my feet on both legs, They are bright red, do not itch and are not raised. It is now three weeks and they are not going away. Had a video call with Dr. this morning and showed him, he asked Diff w/o Pit and I answered no new soaps or anything else. So he ordered an ESR blood test and a CBCwith Diff w/o Pit.He also said to contact the CDC which In tried to do on the phone.
GBS (Miller-Fisher Variant). Flu like symptoms, numbness in legs, up to knee, ache, night sweats, double vision.
I had a headache and body aches - about two days after vaccine. That lasted 24th, 25th, 26th. I was fine by the 27th.
This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received FLULAVAL TETRA 2018-2019 season for prophylaxis. On an unknown date, the patient received FLULAVAL TETRA 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLULAVAL TETRA 2018-2019 season, the patient experienced influenza-like symptoms and injection site stinging. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the injection site stinging was unknown. It was unknown if the reporter considered the influenza-like symptoms and injection site stinging to be related to FLULAVAL TETRA 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms which lasted for 2 to 3 days and stinging at time of injection.
sporadic rashes on both hands which have spread in tiny places all over her body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (sporadic rashes on both hands which have spread in tiny places all over her body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced RASH (sporadic rashes on both hands which have spread in tiny places all over her body). At the time of the report, RASH (sporadic rashes on both hands which have spread in tiny places all over her body) outcome was unknown.        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.   No Concomitant  information was  provided. No Treatment information was  provided.
The patient had a severe headache and lot's of pain after receiving 2 Covid boosters at the same time. The patient visited her doctor the next day.
Aches ,sore arm/slight fever/1 day...tired,sore arm.6 days loss of taste and smell 1 week. 2 weeks later rash on inner arms and legs...better but still have it on day day 18
Paresthesias at the left arm injection site 1 minute after injection.  1 hour later throat tingeling and peri-oral tingeling.  At two hours after injection tip of tongue tingeling then at 3 hours upper trunk and bilateral arm/hand tingeling that was intermittent and traveling from place to place lasting several minutes.  This facial, tongue, and peri oral tingeling sensations continued and are still occurring constantly for hours to a few minutes, waxing and waning , after third day from injection
This case was reported by a consumer and described the occurrence of ear pain in a 59-year-old female subject who was vaccinated with Influenza vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included codeine allergy, penicillin allergy and sulfa allergy. On 8 October 2007 at 08:15 the subject received unspecified dose of Influenza vaccine (.5 ml, unknown, left arm) that has expired in the summer of 2007 (expired vaccine used). On 22 October 2007, 14 days after vaccination with Influenza vaccine, the subject experienced ear pain, throat pain, and was sick. The subject was treated with Levaquin for her sickness and it took a week for her to recover. At the time of reporting the events were resolved.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-NOV-2015, the patient was vaccinated with an improperly stored GARDASIL 9 lot # L017407, expiration date: 15-AUG-2017 or lot # L016428, expiration date: 30-JUL-2017 (it was not specified by the reporter which lot was administered)(dose, route of administration and location were not reported). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.