chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm soreness; pounding heart beat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) and PALPITATIONS (pounding heart beat) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (ALLERGIC TO TAMOXIFEN AND LIDOCAINE.). Concomitant products included ROSUVASTATIN for Cholesterol, ASCORBIC ACID (VITAMIN C ACID), VITAMIN D NOS and CALCIUM for Supplementation therapy.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and PALPITATIONS (pounding heart beat). At the time of the report, PAIN IN EXTREMITY (arm soreness) and PALPITATIONS (pounding heart beat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not reported by the reporter.
For three days I became more I?ll than when I actually had Covid.  Fever 102, nausea/vomiting, body aches with terrible headache.  My headaches and fatigue have continued to this day.  I later tested positive for covid 19 on 1/4/22.
Rash, ErythemaMultiform, UrticariaPruritus, Chills, Feverish, Body Aches Narrative:
WOKE UP THE NEXT MORNING SICK- VOMITING-CHILLING-PATIENT STATED SHE THOUGHT SHE WAS GOING TO DIE.
Hives - Torso, neck, head, arms, legs. Initial treatment - Benadryl 25 mg. every 6 hrs. Symptoms worsened. Treated with prednisone 10mg. taper and Hydroyzine 9 ml. every 8 hours
Discussed suspect local reaction, but can also have early secondary infection at site, would Rx Keflex 500 mg po BID x 7 days, also recommend using Ibu 600 - 800 mg BID - TID, Benadryl po, warm compress, rest. Work excuse note written and printed for patient, would excuse today and tomorrow. No current obvious ill symptoms to account for chills, sweating, vomiting, if symptoms recurring, then would recheck at that time.  Recommend submit VAERs form for reaction left upper arm - relayed to MA working with provider today. Return in about 2 days (around 9/15/2023) for if not improving.
Administration error: not immunocompromised patient was administered with a 3rd full dose instead of a booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Administration error: not immunocompromised patient was administered with a 3rd full dose instead of a booster dose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 032M20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergic to fatty products), Drug allergy (Allergic to antidepressant drugs (not all of them), anxiety and depression medications.), Drug allergy (Allergic to Novocaine), Allergy to antibiotic, Lactose intolerant, Caffeine allergy, Meat allergy (Allergic to pork products), Diabetes (No recent change in status such as improvement or worsening) since 2016, Blood pressure high (No recent change in status such as improvement or worsening) since 2019 and Arthritis. Concomitant products included CORTISONE for Arthritis, AMLODIPINE BESYLATE for Blood pressure high, CLONAZEPAM, LOSARTAN, PARACETAMOL (TYLENOL [PARACETAMOL]), CALCIUM, NICOTINAMIDE (VITAMIN B3), MULTIVITAMIN [VITAMINS NOS] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Administration error: not immunocompromised patient was administered with a 3rd full dose instead of a booster dose). On 28-Oct-2021, ACCIDENTAL OVERDOSE (Administration error: not immunocompromised patient was administered with a 3rd full dose instead of a booster dose) had resolved.            The patient stated that they received a 3rd full dose of Moderna COVID-19 vaccine instead of a booster shot on 28-Oct-2021, but the patient was not an immunocompromised person. It was also reported that the patient was currently taking cortisone shots on their knees for arthritis every 3 months.  It was reported that the patient never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The Adverse events didn't cause patient to seek medical care and the patient had not experienced a similar event in the past. The adverse event outcome was reported as recovered and the symptoms had recovered.  The patient's height reported as 5 feet 3 inch.  Reportedly, no treatment was given for any of the symptoms after vaccination.   This case was linked to MOD-2022-484121, MOD-2022-484143 (Patient Link).
Patient reported rash that was diagnosed as chicken pox at an office on 7-7-18. Patient is seeing her primary care doctor on 7-9-18 to confirm diagnosis and determine course of treatment.
rash and itching on legs, light headed, difficulty breathing, nausea and abdominal cramping. given EPI pen in clinic and transported to hospital ER by EMS. given solumedrol, Benadryl and Pepcid in the ED. was eventually discharged. continue steroids, Benadryl, and Pepcid.
Intermittent short term memory loss. Per mother, could not remember certain events for up to 1 month after vaccination.  Symptoms resolved.
Neuological! constant pain and pressure behind my eyes 24 / 7  blurred vision, chronic fatigue, memory loss, shortness of breath and general weakness.   My doctors have no idea what is wrong with me.  Two Mri's, many different types of blood work, spinal fluid tap and no diagnosis! More testing is going to scheduled....
Large area of swelling at the injection site one week post injection. Itchy, warm and raised.
Headache; Experiencing a swollen lymph node in the armpit; Fever; Chills; body ache; experiencing pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), LYMPHADENOPATHY (Experiencing a swollen lymph node in the armpit), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (body ache) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (LOT: first dose ER8730) on 22-Mar-2021 and Pfizer (LOT: second dose ER8737) on 12-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concomitant products included OLMESARTAN for an unknown indication.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), LYMPHADENOPATHY (Experiencing a swollen lymph node in the armpit), PYREXIA (Fever), CHILLS (Chills), MYALGIA (body ache) and INJECTION SITE PAIN (experiencing pain at injection site). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, HEADACHE (Headache) had not resolved and LYMPHADENOPATHY (Experiencing a swollen lymph node in the armpit), PYREXIA (Fever), CHILLS (Chills), MYALGIA (body ache) and INJECTION SITE PAIN (experiencing pain at injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 22-Mar-2021, patient received first dose of Pfizer (batch no. ER8730). On 12-APR-2021, received the second dose of Pfizer (batch no. ER8737). Patient got both doses of Pfizer on left dominant arm.
Patient fell out of chair in post vac after vaccination. Patient hit head on floor, loss of consciousness noted. No visible injury noted. Patient regained consciousness. Neuro functions intact. Pupils equal and reactive to light eyes open spontaneously. Motor response intact. BP 110/55, P 76, R 16, O2 99%. 911 and mother called. EMS assessed patient. BP 75/48, P 61, R 18, O2 99%. Alert and oriented x 3. EMS recommended transport to hospital. Patient refused to be transported to hospital, patient educated. Patient left AMA and released to his mother's care. Patient assisted to car in wheelchair. Stable condition, no visible injury, refused further care.
Starting having body aches and a moderate headache. Ran fever from early afternoon saturday until late sunday evening with mod body aches and a headache that wasn't going away with ibuprofen
Info has been received from a physician concerning a 42 year old male with no known drug allergies who on 5/31/02 was vaccinated with the 3rd dose of Hep-B. On 6/3/02, the pt presented with rash, blisters, arthralgias and muscle pains. The outcome of the pt's rash, blisters, arthralgias and muscle pains was unknown. It was reported that the pt sought unspecified medical attention. It was also reported that the pt was subsequently being referred to an allergist. Additional info has been requested.
Within 30 minutes I noticed my neck felt funny.  By the time I got home my face was tingly and my tongue was numb.   I did not even think about it being a reaction to the shot.  I took some Benadryl and a beta blocker because my heart was racing.   I laid down and about an hour later it was better.   I checked with my pcp dr.  She recommended that I take Benadryl before the next dose and ordered an epipen.   I have had anaphalxis previously due to a mango allergy.   I took the Benadryl before and was very nervous.  Eskenazi was amazing.  They assigned me a special watch person and kept me for 30 min.  I felt a little funny.... tingly face and my tongue was not normal.  When I got home I took a second Benadryl and a nap and then felt fine.
Patient came in apprehensive and anxious about recieving shot, fearful of needles. After administration of the vaccine she appeared relieved afterwards and recieved a card with a note to wait for 15 minutes for any reactions. Her mother escorted her to her car, 10 minutes later, her mother came in saying "she's having a seizure!" We had a certified nurse that was administering the shots that went out to check on her and we had a technician call 911. Patient appeared disoriented in the car and clammy to touch. We checked her blood pressure, and the nurse reported it was a little low. After paramedics arrived was being treated as a vaso-vagal response and she was transported to the nearby hospital.
Went to PCP due to persistent elevated blood pressure. Now on 4 different medications for blood pressure Narrative:
received first dose on 04apr21 and still did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received first dose on 04apr21 and still did not get the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received first dose on 04apr21 and still did not get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received first dose on 04apr21 and still did not get the second dose) had resolved.            Concomitant medication was not provided. Treatment medication  was not provided .
On 02/10/2021-in the morning,  I started feeling queasy, sluggish, chills, headache and I had no appetite and I was fatigue.  I was just feeling really, really bad.  I called my doctor and he told me it will pass, she said it's your body making antibodies. After about 3 day I started feeling better.
Large area of redness, induration, tenderness, and increased warmth at site vaccine was administered (right tricep area).  Size of reaction site is 4.5 cm x 7 cm.
Mom calling 2nd day red, raised, warm to touch.  Swollen size of "1/2 baseball", + itching, + tenderness at site.
Administered expired dose of moderna to patient. Vial expired at 0358AM on 10/22/21 and the vaccine was administered at 08:50AM on 10/22/21. Vial opened at 1558 on 10/22/21 and placed in room temperature
No additional AE details; PNEUVMOAX 23 were administered after a supported temp excursion occurred.; 2 doses of PNEUVMOAX 23 were administered; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-AUG-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #U026796, expiration date: 28-JAN-2023; dose, strength and route of administration were unknown) for prophylaxis after a supported temperature excursion occurred (product storage error). The temperature was 9.2 C and time frame was 48 minutes. No previous temperature excursion. It was reported that the patient was vaccinated with 2 doses (extra dose administered) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #U026796, expiration date: 28-JAN-2023; dose, strength and route of administration were unknown) and the vaccination date of another dose was unknown. No additional adverse event (AE) details or product quality compliant (PQC).
Information has been received from a 78 year old male patient with a history of "heart bypass" and with no drug reactions or allergies who in May 2009 ("two years ago") was vaccinated subcutaneously with a "once" dose of ZOSTAVAX (Merck) (dose and lot # not reported). Concomitant medication included "heart, cholesterol and blood pressure medication". The patient reported that on approximately 11-APR-2011 ("the second week of April") he had experienced a lot of the same symptoms from shingles even though he had received the ZOSTAVAX (Merck) shot. The patient had had tingling sensations on the lips and face and the left side of the back. The patient had sought medical attention and the doctor was following up with the patient to discover the reason for the effects. The patient had not ruled out the possibility of shingles but there was an absence of the rash associated with the condition. The patient had ruled out brain cancer, stroke, and transient ischemic attack (TIA). The patient had consulted with ear, nose, and throat doctors, and with a dentist. The patient had had blood tests and a full range of other tests. Lab diagnostics studies included "magnetic resonance imaging (MRI), blood tests and stroke tests". At the time of reporting, the patient's status was unknown. Additional information has been requested.
pt recvd vax; 24 hrs p/dose 1,exp arm redness & arm warmth; sxs resolved; 24 hrs p/ dose 2,exp arm welts & swollen arm; sxs resolved;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive at home test; Negative, notes: after I had recovered and had negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immediately I felt left jaw ache, left-arm shot site, left eye watery, fatigue, tingling sensation in my left arm down through my fingers. My legs feel very weak. When I'm laying down in bed the weakness in my legs becomes more intense and heavy. I've noticed some rash on my arms.
Vaccines where not stored at correct temperature they had been stored in freezer instead of refrigerator.
Had vomiting, diarrhea, abd pain and red/swollen deltoid area on L arm within 12 hours of vaccine. Symptoms continue to date.
Moderna COVID-19 vaccine EUA "I think my heart has been racing since about 0200." Reports fatigue and general weakness. Got second COVID injection on 1/21/2021
It started with symptoms on March 1, I had body aches, developed a scratchy throat, couldn't sleep and heavy coughing. Too the test because I felt so bad and was positive. I scheduled a telehealth appointment and was prescribed Paxlovid. I started the medication that evening, which helped me get better. I had a hard time getting rid of the cough. About nine days later I tested negative then March 13 I tested positive again.
skin rashes; This spontaneous case was reported by a patient and describes the occurrence of RASH (skin rashes) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third 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 and 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 RASH (skin rashes). At the time of the report, RASH (skin rashes) was resolving.            No concomitant medication was reported. After 4 weeks the skin doctor did a biopsy for which they are still awaiting results. The patient was prescribed 2 weeks of an antibiotic & a non steroid cream.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer. A male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunisation. Patient received the Pfizer-BioNTech COVID-19 Vaccine first dose but tested positive for COVID-19. Wanted to know if it is okay to get the second dose tomorrow, as scheduled or do they have to wait. Outcome of the events was unknown.  Information about lot/batch number has been requested.
pt had elevated t103 or higher mom didn't take temp when pt sickest but had 103 later, diarrhea, cold sx, conjunctivitis, vomiting; pt started having elevated temp 6 days p/shots had cold sx & a few days sooner was treated w/ATB & APAP;
Pt showed at the ER on 12/25/2020 after falling mid walk.  Pt left hand was rhythmically opening and closing.  Head was twitching and left arm and left leg twitching-sx lasted 10min.  Fever of 103 documented by EMS, vaccines 1 wk prior to the ER visit.  Sx resolved 2 hrs after seizure. Diagnosed with ? atypical febrile seizure.  Patient then sent to Center where he had an EEG and neurology consult.  Dx with complex febrile seizure- had felt possible febrile seizure vs epilepsy vs genetic predisposition secondary to TMPRSS3 genetic mutation.
4 days after receiving vaccine, patient developed urticaria. Went to ER. Received oral prednisolone and famotidine on Day 5 and seen in the office on day 6 post vaccination. Recommended continuing treatment as directed by the ER to complete 5 days for steroid and oral antihistimines
I feel throat tightness, dry throat since vaccinated. i hope this is not serious. Sorry if i should not report this.
Fussy, acting "blah", and runny nose x2-3 days per mother. Vaccines administered yesterday at 4pm and this morning at 9am had 103 fever and acted inconsolable. Gave acetaminophen and temp came down to 101.
Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On unspecified dates, the patients were administered improperly stored doses of ROTATEQ (lot # and dose unknown) orally. The vaccines were exposed at 63 Fahrenheit for 156 hours. There was no previous temperature excursion. No adverse effect was reported. This is one two reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a physician referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (lot#, dose, frequency and route of administration were unspecified) for prophylaxis. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). No adverse effects reported. No product quality complaint was involved. The vaccines were exposed to a temperature excursion of 51 Fahrenheit degrees for a time frame of 1.5 hours, identified because of a digital data logger. There was no previous temperature excursion. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA008155: US-009507513-1709USA008156: US-009507513-1709USA007978:
I received the vaccine on 04/27/2022. On 07/13/2022 I woke up with stuffy nose, congestion, cough and tired. On the 07/15/2022 I took a home test for Covid-19 and was positive. After I went to my local clinic and was prescribed cough medicine and NOHIST DM liq. Was told to take 5mil. 3x a day as needed. Symptoms lasted 3-4 days.
Painful swelling of left arm to fingers. Rapid pulse rate 100 with palpitations. Symptoms subsided on 11/16/02. ice packs applied and Tylenol taken TID. Body aches and pains also subsided.
MYALGIA/MUSCLE PAIN; FEVER; NAUSEA; FATIGUE; INJECTION SITE PAIN; INJECTION SITE ITCHING; CHILLS; HEADACHE; BODY ACHE; This spontaneous report received from a patient via a company representative concerned a 35 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced body ache. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced injection site itching, myalgia/muscle pain, fever, nausea, fatigue, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, nausea, and fatigue, and the outcome of myalgia/muscle pain, chills, fever, injection site pain, injection site itching and body ache was not reported. This report was non-serious.