chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 103; Headache; muscle ache; Weakness; extremely tired; dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 103), HEADACHE (Headache), MYALGIA (muscle ache), ASTHENIA (Weakness) and FATIGUE (extremely tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 24-Oct-2020 and Ileostomy on 02-Oct-2016. Concomitant products included GABAPENTIN from 15-Aug-2010 to an unknown date, DIAZEPAM from 13-Jul-2010 to an unknown date, BACLOFEN from 15-Aug-2020 to an unknown date, LEVOTHYROXINE and LOSARTAN from 12-Jul-2010 to an unknown date for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced PYREXIA (Fever of 103), HEADACHE (Headache), MYALGIA (muscle ache), ASTHENIA (Weakness), FATIGUE (extremely tired), DIZZINESS (dizziness) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 103), HEADACHE (Headache), MYALGIA (muscle ache), ASTHENIA (Weakness), FATIGUE (extremely tired), DIZZINESS (dizziness) and NAUSEA (nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2020, Viral test: positive the patient has been diagnosed with positive for COVID-19. In 2021, Blood pressure measurement: 164/90 (abnormal) 164/90. In 2021, Body temperature: 101.2 (abnormal) 101.2, 102.9 (abnormal) 102.9 and 103 (abnormal) 103. In 2021, Heart rate: 122 (abnormal) 122.         vaccine doses has been injected via Shoulder The patient had no Allergies to medications, food, and other products.   This case was linked to US-MODERNATX, INC.-MOD-2021-089510 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-May-2021 contains non-significant information contact information updated. On 25-Jul-2021: Updated Reporter details, updated Patient demographics, added lab test, added Vaccine Facility information, Suspect product anatomical location has been updated, added Concomitant drugs, added Adverse Event start date, Outcome updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089510:Dose 1
Patient reports, "Received COVID-19 Moderna Vaccine yesterday in my right arm. About 10 minutes after the shot my arm became hot, then numb, and my fingers went cold. Eventually the whole arm numbness resided and only from my elbow up was still numb. However, the numbness radiated to the front of my right chest and back of my right shoulder. I called the Associate health number as instructed by the pharmacy team who then told me to go to the ER for further evaluation. "
pt had a positive COVID test on 1/4/22 at Health Care; pt passed away at home on 2/8/22; no medical records
Developed sudden onset of fever 104 with vomiting approx. 4 hrs after vaccine - Hepatitis A.
Next day woke with tightness in my chest, headache, joint pain, dizziness and extremely tired. Lasted a week with more noticeable joint pain in my right hip and knee.  Third day woke up with a lump on my right palm. It's tender when I grab things. Its been a little over a week and I still have the lump and still hurts.
Information has been received from a licensed practical nurse (LPN) concerning a 16-year-old female who on 08-JAN-2007 was vaccinated SC with a dose of varicella-zoster virus vaccine (lot # 652966/0722F) instead of her second dose of varicella vaccine. Unspecified medical attention was sought.  It was reported that the patient was not experiencing any known symptoms.  The patient was vaccinated with her first dose of varicella vaccine on 22-JAN-1996, at 5 years of age. No product quality complaint was involved.  Additional information has been requested.
Came into our office on 4/12/21 seeking information on who was going to pay for his medical bill to the adverse reaction he had to Moderna. stated that he received his 2nd dose of Moderna on 3/3/2021. Then a few days later he started experiencing very harp headaches. He stated that he did not contacted or seek any medical care. But then he is seeking help to cover his medical expenses. He also stated that he feels like he aged 20 years over night.
Patient is 5 years at time of vaccination. Patient should have received monovalent 5-11 Covid vaccine. Patient was given 6mo-4year Covid vaccination. Parent was notified. Will count as valid dose, needs 2 more doses of monovalent 5-11 Covid vaccine.
Patient became nauseated on 12/24/2020.  She was unable to eat breakfast.  She felt better when lying down.  She became congested on 12/26/2020.  She also had a headache behind the eyes. She took acetaminophen and pseudoephedrine for 3 days (duration of headache/congestion).  She returned to work on 12/29/2020 and took Tylenol only on this day.  No medications on 12/30/2020 and all symptoms were resolved on this day.
Delayed reaction on injection site? one week after I got the first vaccine my arm at the injection sight swelled and had a red ring around it. A small rash formed underneath. Currently, it is still red, but much less swollen and not longer itchy
expired product administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (vaccine was administered from a vial that was first punctured and left at room temperature around 9:15am on 23Jul2021.This would far exceed both the allowed time at room temperature exposure and allowed time of a punctured vaccine vial) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 26-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 26-Jul-2021, the patient experienced PRODUCT STORAGE ERROR (vaccine was administered from a vial that was first punctured and left at room temperature around 9:15am on 23Jul2021.This would far exceed both the allowed time at room temperature exposure and allowed time of a punctured vaccine vial). At the time of the report, PRODUCT STORAGE ERROR (vaccine was administered from a vial that was first punctured and left at room temperature around 9:15am on 23Jul2021.This would far exceed both the allowed time at room temperature exposure and allowed time of a punctured vaccine vial) 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.   Reporter did not allow further contact
Went to urgent care on the 9th said it was EDT, decided to go to an ENT as hearing reduced significantly and was not getting better.   Tinnitus and sudden sensorineural  hearing loss in right ear.
PAIN AT INJECTION SITE; FEELS NUMBNESS FROM INJECTION SITE TO HAND/WRIST; FEELS TINGLING FROM INJECTION SITE TO HAND/WRIST AND WHEN RUN FINGER ACROSS SKIN; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 12-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-OCT-2021, the patient experienced pain at injection site. On 12-OCT-2021, the patient experienced feels numbness from injection site to hand/wrist. On 12-OCT-2021, the patient experienced feels tingling from injection site to hand/wrist and when run finger across skin. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from pain at injection site, feels numbness from injection site to hand/wrist, and feels tingling from injection site to hand/wrist and when run finger across skin. This report was non-serious.
Pt with some tingling  lips noted with mild swelling no tongue involvement or problems speaking . Felt better after Benadryl
Pt recv vax on 1/22/99; approx 4 1/2 hr post vax pt exp lightheaded, warm from chest up, red face &neck, increased heart rate, dizzy, hot flashes; tx=Benadryl, cortisone
COVID-19 vaccine was administered to patient on 4/27/22. Vial was placed in refrigerator on 2/10/22 and NP entered expiration date 5/31/22. 10 week expiration date was 4/21/22. Lot # FK9895; vial exp date 9/2021; NDC: 59267-1025-04.
At 2 AM I woke up with a tight and heavy chest. It was difficult to breathe and I used an oximeter to check my O2, which showed 99% saturation. I checked my temperature but that was normal, around 97 F. I tried different positions to make breathing easier but the pressure would not lift. Around 3 AM I used my (expired) inhaler. Almost immediately I could feel my chest getting lighter. I used my inhaler again around 10 am. The chest tightness did not lift a noticable amount until around 2 PM. By 5 PM all tightness had subsided.
pt recv vax 27JUN95 & on 3FEB97 pt presented to a MD office w/a rash w/four lesions & no fever;the MD dx the pt w/chicken pox;
given a 3rd dose of Havrix on 16Mar2021; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received HAV (Havrix) (batch number B23EA, expiry date 15th May 2022) for prophylaxis.   Previously administered products included Havrix (received 1st dose on an unknown date) and Havrix (received 2n dose on an unknown date).   On 16th March 2021, the patient received the 3rd dose of Havrix. On 16th March 2021, unknown after receiving Havrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional details was reported as follows: The patient was accidentally given 3rd dose of Havrix, which led to extra dose administered. No symptoms were reported. The reporter consented to follow up. This case is linked with case US2021085461, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021085461:same reporter
Covid symptoms returned; Covid symptoms returned; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 at 18:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Mar2021 at 09:00 as dose 2, single (Batch/Lot number: unknown) and on 25Sep2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "High blood pressure" (ongoing); "High Cholesterol" (ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 01Jun2019; ATORVASTATIN, start date: 01Jun2012; METFORMIN, start date: 01Jun2019; JANUMET, start date: 01Jun2012; ASPIRIN 81, start date: 01Jun2012. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 19Apr2022 at 05:00, outcome "recovering" and all described as "Covid symptoms returned". Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  Clinical information: No known allergies reported. Adverse event details was reported as 6 days after completing Paxlovid treatment and feeling much better covid symptoms returned.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HEART ACHE; SORE THROAT; BODY ACHE; SNIFFLES; INJECTION SITE SORENESS; This spontaneous report received from a consumer concerned an 81 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, disabled, emphysema, and seasonal allergy, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced injection site soreness. On 08-MAY-2021, the subject experienced sniffles. On 10-MAY-2021, the subject experienced body ache. On 11-MAY-2021, the subject experienced sore throat. On 12-MAY-2021, the subject experienced heart ache. The action taken with covid-19 vaccine was not applicable. The patient was recovering from injection site soreness, and sniffles, and had not recovered from body ache, heart ache, and sore throat. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
3 shots of vaccine; A spontaneous report was received from a nurse concerning a female patient of unknown age, who received an extra dose of Moderna's COVID-19 vaccine (mRNA-1273) .  The patient's medical history was not provided by the reporter. Concomitant product use was not reported.   On 09-mar-2021, the patient received the dose of mRNA-1273 (Lot number: 014M20A) for prophylaxis of COVID-19 infection. The patient was given with 3 shots of vaccine mistakenly/Extra dose administered.    Treatment details for events was not provided  Action taken with mRNA-1273 in response to the events was not applicable.   The  outcome of the events, extra dose received/3 shots of vaccine was considered to be recovered.; Reporter's Comments: This report refers to a case of extra dose administered for mRNA-1273, lot # 014M20A  with no associated AEs.
Minor muscle aches, ache from top to the bottom of body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Minor muscle aches, ache from top to the bottom of body) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PRAVASTATIN, LISINOPRIL and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Minor muscle aches, ache from top to the bottom of body). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) at an unspecified dose and frequency. At the time of the report, MYALGIA (Minor muscle aches, ache from top to the bottom of body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included unspecified over the counter medications for unknown indication.Action taken with mRNA-1273 in response to the events was not applicable.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 02/08/2021, 03/04/2021, and 11/17/2021. They became symptomatic for COVID-19 on approx 01/22/2022 and tested positive on 01/31/2021 and 02/05/2022. They were admitted to hospital 02/03/2021 and transferred to a different hospital for a higher level of care on 02/06/2022. The individual developed many complications including a deep vein thrombosis, COVID-19 pneumonia, a bacterial urinary tract infection, and A-fib. The individual was transitioned to palliative care and died on 02/21/2022. This individual was immunosuppressed due to medication use.
Subsequent to receiving first and second dose of varicella virus vaccine live a serum varicella zoster antibody test was done and the results were negative.
Don't know if this does matter my first shot that I got, I got the horrible headache like, I was on headache for several days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 (Lot number: FC3181) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Attention deficit disorder" (unspecified if ongoing); "I had asthma when I was child" (unspecified if ongoing), notes: patient don't had like, patient had inhaler when need it but don't use it that often; "Reactive airways disease", start date: 15Nov1984 (unspecified if ongoing), notes: Patient was born with reactive airways disease but yeah as of right now don't have. Concomitant medication(s) included: ADDERALL taken for attention deficit hyperactivity disorder. The following information was reported: HEADACHE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "Don't know if this does matter my first shot that I got, I got the horrible headache like, I was on headache for several days".  Follow-up attempts are completed. No further information is expected.
Severe dizziness, headaches, blurred vision and brain fog. It is 5 weeks and still cannot drive
NERVE PAIN IN NECK INCREASED; SPOT ON BACK/RIB CAGE AND HIP; VERYSORE SHOULDER; This spontaneous case was reported by a consumer and describes the occurrence of CERVICAL RADICULOPATHY (NERVE PAIN IN NECK INCREASED), SKIN DISORDER (SPOT ON BACK/RIB CAGE AND HIP) and ARTHRALGIA (VERYSORE SHOULDER) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced CERVICAL RADICULOPATHY (NERVE PAIN IN NECK INCREASED), SKIN DISORDER (SPOT ON BACK/RIB CAGE AND HIP) and ARTHRALGIA (VERYSORE SHOULDER). At the time of the report, CERVICAL RADICULOPATHY (NERVE PAIN IN NECK INCREASED), SKIN DISORDER (SPOT ON BACK/RIB CAGE AND HIP) and ARTHRALGIA (VERYSORE SHOULDER) had resolved.            No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality with Humira for the events of SPOT ON BACK/RIB CAGE AND HIP, NERVE PAIN IN NECK INCREASED and VERY SORE SHOULDER was not provided. No treatment medication was reported. 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
sibling devel chickenpox on 27NOV97-didn't recv varivax;
Urticaria pruritus. Loratadine, Triamcinolone.
soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 37 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 14Jan2021 (Lot number: EL0142) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, lot no: EH9899, NDC number: 59267100001, Expiry Date: 31Mar2021, intramuscularly at the left deltoid), administration date: 15Dec2020, when the patient was 37 years old, for COVID-19 immunisation, reaction(s): "body ache", "headache", "nausea", "fatigue", "vomiting", "swollen, red, hot painful arm at injection site", "swollen, red, hot painful arm at injection site", "swollen, red, hot painful arm at injection site", "swollen, red, hot painful arm at injection site", "Pain in right hip", "Cellulitis/lefft upper arm cellulitis", "The patient received five times the recommened dosage", "The patient received the unreconstituted dosage", "Photophobia". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Jan2021, outcome "recovered", described as "soreness at injection site". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: Patient reported soreness at injection site that evening and took ibuprofen. Reporter checked on patient on 15Jan2021 and patient said she was fine. No further complaints. Reporter followed up this morning 03Mar2021, and patient was still feeling fine and previous AEs have resolved.  No follow-up attempts are possible. No further information is expected.
Patient had a headache and fever of 101 degrees, numbness from his shoulder down to elbow. The injection site was swollen, measuring 14x9 cm and later in the evening 14x12 cm. The site was warm, red, painful and hardened. Steroids, BENADRYL and pain meds given at Emergency Room.
p/vax rash now goes from joint to joint last 3 days to a week;swelling of the rash, very red, very hot to touch, use ice packs for relief from swelling itch a lot;
I received my Pfizer COVID-19 booster on 12/30/2021. On 12/08/2022, I began to feel like I had a sickness coming on. On 12/9/2022, I started to feel bad at around noon and went home at 3 PM. I had chills, headache, and fever. I took some ibuprofen for the headache and some OTC cold/flu medicine, because I thought I just had the flu. On 12/10/2022, I didn't get out of bed until 11 AM. The symptoms I had were pretty much the same as they had been on 12/9/2022, and I spent most of the time in bed. I would get occasionally get up and move around, but I usually wasn't up long. On 12/11/2022, I took a home antigen test and got a positive result. I slept for the rest of the day. On 12/12/2022, my chills were gone, and my symptoms began to subside, though I still had a headache and fever. My symptoms continually got better for the rest of the week, though the weakness persisted. On 12/13/2022, I had a telehealth visit with my doctor, who prescribed PAXLOVID, which I began taking on 12/14/2022. On 12/13/2022 and 12/15/2022 I took the test again and got positive results. I took another test on 12/17/2022, and the result was negative. By the time I tested negative on 12/17/2022, all of my symptoms were gone, though I still had fatigue and weakness. At the time of this writing, the weakness is pretty much gone, but I still get an occasional headache and an intermittent cough.
Received both flu + pneumonia shots.  Went shopping & came back 2-3 min later, said she "didn't feel right"; face flushed, arms red, some difficulty breathing.  Sat down, ice to neck.  After abt 20 min was better.  No longer flushed & able to breath.  Later she started having flu symptoms- fever, chills, & heat lasted till next day.