chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bad muscle pain in legs, back and shoulders.; Headache; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA, HEADACHE, and FATIGUE in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (The patient takes allergy shots every 6 weeks). Concomitant products included CYMBALTA for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced MYALGIA, HEADACHE, and FATIGUE. The patient was treated with MOBIC on 04-Mar-2021 for Headache, Myalgia and Fatigue, at an unspecified dose and frequency and FLEXERIL on 04-Mar-2021 for Headache, Myalgia and Fatigue, at an unspecified dose and frequency. At the time of the report, MYALGIA, HEADACHE, and FATIGUE had not resolved.
Not long after receiving Dtap, MMr, & Ipv his father and I began noticing some unusual facial grimacing.  We attributed it to allergies or something.  They continued to increase in occurance and serverity.  A little over a month ago I had him checked by his Medical Doctor.  He diagnosis him with tourette's syndrome. Upon reading I see it to be mainly heriditary in nature but none of his syptoms where noticed untill after his last set of shots.  He has a large number of facial tics which occur at least 20 to 40 times daily.  His verbal utterances are coughing, and clearing the throat.  They are frequent but not as frequent as the facial tics. We have chosen to not medicate at this time and are having developmental testing done though the school. Because I am a RN working in the imunization program in our county, My supervisor and I felt filing a vaers report would be in order.  I have not discussed this (i.e. this vaers report or linkage with his immuns) with my doctor or his office.
Patient is experiencing soreness/discomfort that did not go away. She is currently still feeling the discomfort. Patient insisted on receiving the second dose today because she felt that the benefit of the vaccine was worth discomfort.
Admit from NH for +COVID. Zinc, Vit-C. Documented as asymptomatic COVID, had to be admitted due to positive status as resident at facility. On RA not requiring supplemental O2. Awaiting placement at memory care unit who can take COVID patients.
after a below freezing temperature excursion; Inappropriate age at vaccine administration; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7p5j5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th July 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 28th July 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the inappropriate age at vaccine administration and incorrect storage of drug were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The physician reported that, 4 years old patient was administrated with Boostrix after a below freezing temperature excursion, which led to inappropriate age at vaccine administration and incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case is one of 28 cases, reported by same reporter for different patients. There was discrepancy in suspect reported in narrative as Boostrix and in structured field as Kinrix.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164795:Same reporter. US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164797:Same reporter. US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164798:Same reporter. US-GLAXOSMITHKLINE-US2021164799:Same reporter. US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient reported she had been fasting and was afraid of needles. She fainted briefly, then several minutes later vomited. Her bp and pulse were good. She stayed 45 minutes extra time, then told us she was feeling better and left.
She did not have a reaction to the vaccine. She tested positive with a home test for COVID-19 on 05/24/2022. She started feeling symptoms on 05/23 with being exhausted and had a fever.  I gave her Children's Motrin to bring down her fever, Flonase, cough syrup and Vicks vapor rub.
Patient wasn't able to move her hands for max of 15 minutes after getting vaccine then slowly we she started moving and everything was fine, she had panic attack due to this event. we gave her Twizzlers and water which she consumed and we asked her to relax. she was fine after 15 minutes. observe her for about an our before she leave
WBC count was normal prior to vaccine covid Physer. White blood count began to rise after second dose in January. By August after several more blood test and WBC count rising, I was diagnosed with cll. Currently on wait and watch no treatment at present.
pt recvd Hep B vax 15SEP88.On 16SEP88 pt devel pain from inject site to neck & ear.On 21SEP88 pt dx w/ neuralgia.On 01OCT88 pt devel rash on neck.Recvd 2nd & 3rd doses of Hep B vax 17OCT88 & 16MAR89 w/ no ADR.
Shingles: pain in the right left along sciatic nerve. Rash on right buttocks, and on right ankle. Still occurring, it has been 8 days since the pain in my right leg began.
spinning sensation woke up in the middle of the night continued all night.  Have experienced episodes of dizziness as well as spinning.  I have had a high pitched ringing in my left ear ever since this happened.
Diagnosed with Lupus in August; This spontaneous case was reported by a consumer and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Diagnosed with Lupus in August) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hypothyroidism. Concomitant products included AMLODIPINE BESILATE (AMLODIPINE [AMLODIPINE BESILATE]) for Hypertension, LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) for Thyroid function abnormal, ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]) for an unknown indication.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Diagnosed with Lupus in August) (seriousness criterion medically significant). The patient was treated with HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE [HYDROXYCHLOROQUINE SULFATE]) for Lupus erythematosus, at a dose of 200 milligram 1 tab twice a day. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Diagnosed with Lupus in August) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company Comment: This case concerns a 60-year-old, male with a history of hypothyroidism and hypertension, who experienced the unexpected serious (medically significant) event of Lupus erythematosus. The event occurred approximately 4 months after the second dose of mRNA-1273 Moderna vaccine (Spikevax). The rechallenge was not applicable since the event hasn´t resolved.  The events were considered related to the study drug per the reporter's assessment. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report   This case was linked to MOD-2021-339211 (Patient Link).; Sender's Comments: This case concerns a 60-year-old, male with a history of hypothyroidism and hypertension, who experienced the unexpected serious (medically significant) event of Lupus erythematosus. The event occurred approximately 4 months after the second dose of mRNA-1273 Moderna vaccine (Spikevax). The rechallenge was not applicable since the event hasn´t resolved.  The events were considered related to the study drug per the reporter's assessment. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report
This was 2nd dose.  Same day: Arm hurt at shot location, giggle fit.  Next day: Headache, light-headedness, 102.1 fever, fatigue. 2-3 day later: Hives on arms & legs.  Gave Tylenol for pain and fever the first 2-3 days, then gave generic Benadryl once we saw the hives on day 2-3 for another 3-4 days.  FYI: 1st dose was 6/27/2021 and there were little to no side-effects notes except pain in arm where shot was given.
FEVER 101, BODY ACHES, CHILLS, AND NAUSEA X 24 HRS.
Information has been received from a male physician of unknown age referring to himself. Information about medical history and concurrent conditions were unspecified. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, dose and route were unknown). Concomitant medications were unspecified. On an unknown date, three years after receiving ZOSTAVAX, the patient experienced a mild case of shingles. The patient stated that he "self-treated" with unspecified treatment and the event was resolved on an unspecified date. The causality between the event and ZOSTAVAX was unspecified. Additional information has been requested.
Baby became very fussy, crying and turned gray lasting approx 20 min.  No apnea, or limpness, lips looked pink.
Patient was given an extra Dtap which consisted of the Dtap and the Pediarix.
Wife arrives at clinic today to report after pneumonia vaccine 9-10-12 at noon, at 2 o'clock PM, pt had severe arm and upper right sided back pain that lasted 10 hours before going to E.R. Given IV pain med and kept for 4 hours then sent home with PO pain medication. Wife states Dr. said it was because of "the way it was injected".
I have joint pain and it worsens with exercise. I take ALEVE, multivitamins, and fish oil for my symptoms.
p/vax pt exp myalgia;arthralgia(especially hips;but all joints except elbow per pt); woke up x3 @ night w/chills;sweats; tx: ibuprofen;
Red local swelling at both sites, c/o HA, 3 1/2 x 4 cm deltoid, 4 1/2 x 5 cm LUA SQ erythema and edema. Alt cold/heat at site, acetamenophin 325 mg x 2 26 hours prn
This spontaneous report as received from a nurse practitioner refers to a 11 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 07-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
101-103 fever, migraines, severe aches, constipation, chest tightness, extreme fatigue. MIssed a whole week of work.
Patient had one occurrence of thrombotic thrombocytopenic purpura in 1996 for which she had plasma exchange therapy in 1996.   No other occurrence since 1996 until she received her first dose of the Pfizer covid vaccine.
mom states approx 2 hrs p/vax pt began vomiting & had fever; laid on couch most of time & cried & whined; states still vomiting & unable to keep anything down including pedialyte; advised to call MD;
Headache heartburn/dyspepsia; injection site pain and stiffness of the left arm Narrative:
pt recv vax & became very sleepy & had temp 101;also had loose stool attack like mom has never seen;
Pt describes feeling lightheaded and slightly dizzy. Felt fearful that she would fall. Symptoms began in late afternoon on date of vaccine. Also noted aching in legs and soreness in one shoulder. On 3/19/03, is still having some slight dizziness.
Patient experience an anxiety attack about 20 minutes post vaccination. He had elevated BP of 170/120 intially and requested EMT services. EMT came 10 minutes later and attended to the patient. His BP was 140/120 at that time and they determined he was stable. The offered to drive him home. Patinet refused. Patient's mother offered to drive him home but he also refused. She followed him driving home.
Fever; Chills; Headache; Extreme fatigue; Pain all over her body; After the vaccine her fibromyalgia symptoms seemed to get worse/flare up and have not gone away,Her fibromyalgia exacerbation symptoms included headaches, brain fogs, extreme fatigue, and pain all over her body.; Hasn't felt good for 7 weeks; Heart palpitations as if she had 10 cups of coffee; Racing/ skipping heartbeat for 8-9 days; Brain fogs; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (After the vaccine her fibromyalgia symptoms seemed to get worse/flare up and have not gone away,Her fibromyalgia exacerbation symptoms included headaches, brain fogs, extreme fatigue, and pain all over her body.), MALAISE (Hasn't felt good for 7 weeks), PALPITATIONS (Heart palpitations as if she had 10 cups of coffee), EXTRASYSTOLES (Racing/ skipping heartbeat for 8-9 days) and FEELING ABNORMAL (Brain fogs) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced FIBROMYALGIA (After the vaccine her fibromyalgia symptoms seemed to get worse/flare up and have not gone away,Her fibromyalgia exacerbation symptoms included headaches, brain fogs, extreme fatigue, and pain all over her body.), MALAISE (Hasn't felt good for 7 weeks), PALPITATIONS (Heart palpitations as if she had 10 cups of coffee), EXTRASYSTOLES (Racing/ skipping heartbeat for 8-9 days), FEELING ABNORMAL (Brain fogs), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Extreme fatigue) and MYALGIA (Pain all over her body). On 14-Jan-2021, the patient experienced PYREXIA (Fever ). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 UNK. At the time of the report, FIBROMYALGIA (After the vaccine her fibromyalgia symptoms seemed to get worse/flare up and have not gone away,Her fibromyalgia exacerbation symptoms included headaches, brain fogs, extreme fatigue, and pain all over her body.), MALAISE (Hasn't felt good for 7 weeks), PALPITATIONS (Heart palpitations as if she had 10 cups of coffee), FEELING ABNORMAL (Brain fogs), PYREXIA (Fever ), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Extreme fatigue) and MYALGIA (Pain all over her body) outcome was unknown and EXTRASYSTOLES (Racing/ skipping heartbeat for 8-9 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's fibromyalgia was controlled before the vaccine with supplements and a special diet. After vaccination, she restarted Tylenol around the clock to treat her pain.
First symptoms 22Jun22/rebound positive antigen tests 01Jul, 03Jul, 04Jul, 06Jul continuing; First symptoms 22Jun22/rebound positive antigen tests 01Jul, 03Jul, 04Jul, 06Jul continuing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 at 12:00 as dose 3 (booster), single (Lot number: F15682) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE, start date: 02Jun1995, stop date: 06Jul2022; HYDROCHLOROTHIAZIDE, start date: 01Jul2011, stop date: 06Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jun2022, outcome "not recovered" and all described as "First symptoms 22Jun22/rebound positive antigen tests 01Jul, 03Jul, 04Jul, 06Jul continuing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2022) Positive, notes: First symptoms 22Jun2022; (30Jun2022) Negative, notes: Negative antigen test 30Jun; (01Jul2022) Positive, notes: rebound positive antigen tests 01Jul, 03Jul, 04Jul, 06Jul continuing; (03Jul2022) Positive, notes: rebound positive antigen tests 01Jul, 03Jul, 04Jul, 06Jul continuing; (04Jul2022) Positive, notes: rebound positive antigen tests 01Jul, 03Jul, 04Jul, 06Jul continuing; (06Jul2022) Positive, notes: rebound positive antigen tests 01Jul, 03Jul, 04Jul, 06Jul continuing. Therapeutic measures were taken as a result of drug ineffective, covid-19. Rebound covid post paxlovid. First symptoms 22Jun22; paxlovid 23Jun-29Jun: Negative antigen test 30Jun; rebound positive antien tests 01Jul, 03Jul, 04Jul, 06Jul continuing.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the  reported events and  suspect drug  cannot be excluded. The case will be reviewed further with FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Profuse nose bleed/ I woke up with another profuse nose bleed. Bled very heavily for 1/2 hour; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 75-year-old female patient who received first dose of bnt162b2 (Covid-19, Lot#: EL3247), via an unspecified route of administration on 16Jan2021 at 05:30 PM on Right arm at single dose for covid-19 immunisation. She is not pregnant. Facility type vaccine was other. No other vaccine in four weeks. Medical history included Known allergies and pacemaker, a-fib, pulmonary embolism. Concomitant medications included apixaban (ELIQUIS), fexofenadine hydrochloride (ALLEGRA), simvastatin and escitalopram. The following day she had a profuse nose bleed. Ended up at Urgent Care. They were able to stop it after 15 min. An ENT Dr cauterized one of her nostrils. On Sunday, 24Jan, at 3:00 am, she woke up with another profuse nose bleed. Bled very heavily for 1/2 hour. Drs. are trying to find reason for this profuse bleeding. Unknown yet. The event started from 17Jan2021 02:00 PM. AE resulted in: [Emergency room/department or urgent care]. The outcome of the event was not recovered. Treatment was received included Dr.'s visit. Nose bleeding stopper. Saline drops. No covid prior vaccination. No covid tested post vaccination.
7/8 cm of inflammation/swelling (L) upper thigh both anterior and lateral aspect.
Itching with red, hot, burning rash all over body. She reports itching began two days after receiving her booster shot. She has been seen in urgent care x2 and was prescribed antihistamines and prednisone . Reports seeing a dermatologist on 1/17/22 who identified etiology as the histamines in the vaccine reacting to the histamines in the body. Patient was prescribed oral medications. She did not disclose the name of the medication prescribed.
Swelling and pain of bilateral tonsils, lymph  nodes in the neck, armpits, breast and groin that has lasted 5 days and is ongoing
Pt reported red bump at injection site. The site stayed red and never "healed" properly. Pt was checked out by his physician and had the site removed. Pt reported that the site was biopsied and came back as basal cell carcinoma.
Vaccine arm is a little tired; Vaccine arm is a little sore; This is a spontaneous report from a contactable consumer. A non-pregnant 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 26Jan2021 at 14:45 (02:45 PM), at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient was taking quite a few unspecified concomitant medications. The patient was not diagnosed with COVID-19 prior vaccination. The vaccine was administered in a clinic facility. On 27Jan2021, the patient's vaccine arm was a little tired and sore - typical of a shot. No problem, however. No treatment was administered for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient was recovering from the events.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
A big rash at the injection site about 3-inches in diameter; A little itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (A big rash at the injection site about 3-inches in diameter) and INJECTION SITE PRURITUS (A little itchy) in a 20-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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE RASH (A big rash at the injection site about 3-inches in diameter) and INJECTION SITE PRURITUS (A little itchy). At the time of the report, INJECTION SITE RASH (A big rash at the injection site about 3-inches in diameter) and INJECTION SITE PRURITUS (A little itchy) 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.   No relevant concomitant medications were reported.   No treatment information was provided.