chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very painful; swelling of the lymphoid; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (very painful) and LYMPHADENOPATHY (swelling of the lymphoid) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (very painful) and LYMPHADENOPATHY (swelling of the lymphoid). At the time of the report, PAIN (very painful) and LYMPHADENOPATHY (swelling of the lymphoid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment information was provided.
first day after sore arm and swelling with redness at injection site. Next days increased swelling, hotness and redness and intense itching. The swelling and redness increased in area from shoulder to elbow front and back of arm. Slight and persistent headache. Notified health department.
Peripheral neuropathy and insomnia developed in March 2021 and continues. Tingling, pain and heat in feet, hands and up the neck.  PCP prescribed 300 mg  gabapentin 3 times daily and 10 mg Ambien. Neurologist increased gabapentin to 4 times daily and reduced Ambien to 5 mg. He could not sleep with 5 mg and increased back up to 10 mg.
She got her vaccine, about a few days later she started having a regular bleeding, it was then heavy with cramps.   She then got her booster, had severe bleeding, coming out of the pad onto the floor, that stopped and she has not had a period since that for 2 months.  She has never had issues with her period not coming on a regular basis.
Acute respiratory failure with hypoxia--Resolved Aspiration pneumonia  COVID -19 Virus infection -Developed acute decompensation on 12/2 following aspiration event -CTPA negative for PE -Positive test at RMH 11/27/22 -O2 demand improving, weaned off of HHF and now on LFNC intermittently -completed Decadron 12/8  -Completed remdesivir 12/5 -Completed antibiotic therapy with Vanc/Cefepime/Unasyn    Weakness/Fall UE Tremor Confusion -Presented to the ED from home with worsening confusion, generalized weakness, shuffling gait, UE tremor, and mechanical falls -Etiology uncertain, possible acute illness (COVID), meds (depakote), possible NPH -CTH on admission with dilated ventricles, most likely d/t cerebral volume loss but possible NPH -MRI brain showing mild ventriculomegaly should be closely clinically correlated to exclude NPH. -Neuro Dr consulted and rec possible dc depakote but defer to OP neurologist; possible NPH eval once recovers from illness -Outpatient Movement Disorders referral and neurology department will arrange -MRI C-spine showing neuroforaminal stenosis, recommended following up with Dr. in 6 weeks   Metabolic encephalopathy related to infection, resolved -noted since admission. Possible underlying neurological condition, with superimposed metabolic encephalopathy 2/2 covid 19 infection -supportive care, meds as above   Leukocytosis, resolved -Patient with increasing WBCs, recently completed IV steroids on 12/8.  WBC increased to 32, now 7.82. -No signs of diarrhea to indicate C. Difficile -sputum cx 12/4 neg. Blood cx 12/2 and 12/10 neg. Neg MRSA swab -CT chest, abd and pelvis 12/11 neg for obvious infection -will hold on further antibiotics given no indication of infection.   -UA and urine cx negative   Rhabdomyolysis, resolved -CPK noted to be >6K on admission, possibly in setting of fall, acute illness -Resolved  Malnutrition Dysphagia -Patient with dysphagia and signs of ongoing aspiration. SLP following -Pt had NG, removed 12/10 due to coiling. Repeat MBS 12/13 and failed. New Corflo placed 12/14 and back on tube feeding -Repeat MBS on the 20th still with persistent aspiration risk. - Discussed with patient and spouse, PEG placed 12/22 -Continue speech therapy and tube feeds on discharge   Essential Hypertension - Noted, was previously on Losartan 100mg daily. - Orthostatics positive on 12/20, holding for now. - Orthostatics improved 12/21. - Will continue to titrate as necessary.   CAD -Per history, continue aspirin and statin   Diabetes Mellitus, Type 2 -Hold metformin, cont SS. Controlled.   Bipolar Disorder -home meds: Depakote 1000 mg bid. Seroquel 3 tabs(75 mg) q hs. Meds currently reduced due to lethargy-now on Depakote 250mg nightly, Seroquel 25mg nightly. Behavioral med followed.   Left sided abdominal tenderness Constipation -ongoing for a few days since PEG tube placement near site of PEG tube -PEG tube in appropriate position with small amount of dried blood, no clinical suggestion of infection -abdominal x ray 12/26  showing large stool load in colon, with PEG tube in position -suppository x1, continue bowel regimen
She still feels off balance; Jaw ache; Teeth ache; Mouth ache; Dizzy; Trembling; Hot flashes; Fast heart rate; 3 cases of diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (3 cases of diarrhea), TREMOR (Trembling), HOT FLUSH (Hot flashes), HEART RATE INCREASED (Fast heart rate) and DIZZINESS (Dizzy) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIARRHOEA (3 cases of diarrhea). On 04-Mar-2021, the patient experienced HOT FLUSH (Hot flashes) and HEART RATE INCREASED (Fast heart rate). On 04-Mar-2021 at 3:00 AM, the patient experienced TREMOR (Trembling). On 05-Mar-2021, the patient experienced DIZZINESS (Dizzy). On 06-Mar-2021, the patient experienced ORAL PAIN (Mouth ache), PAIN IN JAW (Jaw ache) and TOOTHACHE (Teeth ache). On 12-Mar-2021, the patient experienced FEELING ABNORMAL (She still feels off balance). On 04-Mar-2021, DIARRHOEA (3 cases of diarrhea) had resolved. On 05-Mar-2021, TREMOR (Trembling), HOT FLUSH (Hot flashes) and HEART RATE INCREASED (Fast heart rate) had resolved. On 06-Mar-2021, DIZZINESS (Dizzy), ORAL PAIN (Mouth ache), PAIN IN JAW (Jaw ache) and TOOTHACHE (Teeth ache) had resolved. At the time of the report, FEELING ABNORMAL (She still feels off balance) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
Patient came in to receive 2nd dose of Moderna. Instead, Pfizer vaccine was given in error.
Fever Chills Sweats Light arm pain Headache Horrible muscle Aches Horrible muscle fatigue Low grade fever while taking extra strength tylenol 99.7 Nauseousness Light headed   Tossed and turned all night in such pain and chills and sweats   Felt like I was going to pass out on my commute home could barely walk my limbs were so heavy  and tired  and numb
Case number PHEH2014US015714, is an initial spontaneous report received from a pharmacist on 05 Aug 2014 with a follow-up received from a nurse on 20 Oct 2014. This report refers to a 14-year-old female patient. Her medical history and concomitant medications were not reported. She was inadvertently vaccinated only with MenCYW-135 liquid component of MENVEO (batch number: X13054) intramuscularly into left deltoid on 04 Aug 2014 at 12:40 pm without reconstituting it with MenA lyophilized conjugate. On the same day, within the minutes of vaccination, she experienced mild dizziness and a headache. After 20 to 30 minutes of vaccination, the symptoms improved with drinking juice at the clinic. Outcome of the events was reported as improving. Seriousness and causality of the events was not reported. Follow-up received from a nurse on 20 Oct 2014: New events (dizziness, headache), patient demographics (height and weight), reporter details (nurse), site and time of vaccination were updated.
9pm pain at injection site R arm, sore from deltoid to elbow. Redness, swelling shoulder to 3/4 way toward elbow. Hot to touch. Pt is 17 wks pregnant recommended motrin, ice, cold compresses. She will check with OB re: use of motrin.
2/13/21 severe Vertigo - starts , 3/2/21  sought medical attention dr. office,  3/8/21 second appt. to address severe vertigo,   3/8/21 heart murmur discovered at vertigo appointment, referred to head & neck dept. and referred for an echocardiogram,  and physical therapy,  3/9/21, Physical therapy appt.,   3/19/21 brain scan,  4/12/21 echocardiogram
felt weak; some side effects from the vaccine; lethargic; This spontaneous case was reported by a physician concerning a 83-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt weak/asthenia, lethargic/lethargy.  No Medical History information was reported.  Concomitant medications were not reported.  On an unknown date, prior to the onset of the events, the patient received a dose of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, 3 days after receiving mRNA-1273, patient just felt weak, lethargic, had some side effects, and patient was taken to hospital and has been in the hospital for 3 weeks now. Doctors could not find anything wrong with them; they're going through the last set of labs which they think is going to be normal also. Caller's mother got the vaccine through the primary contact on this case. Treatment was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events felt weak, had some side effects, and lethargic is 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.
First vaccine 28Dec2020 and got Covid toes - Second dose 19Jan2021 and 5 weeks later got covid toes on 26Feb2021 and then today again; First vaccine 28Dec2020 and got Covid toes - Second dose 19Jan2021 and 5 weeks later got covid toes on 26Feb2021 and then today again; Covid toes; This is a spontaneous report from a contactable consumer from a female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) on 28Dec2020 and her second dose on 19Jan2021, both via an unspecified route of administration at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose on 28Dec2020 and experienced COVID toes on an unspecified date. On 26Feb2021, five weeks after receiving the second dose, she again experienced COVID toes. At the time of reporting, it was reported that the patient has COVID toes again. The reported wanted to know if there were any studies on this or if this was normal. The outcome of the event "COVID toes" was not recovered and unknown for all other events.   Information on the lot/batch number has been requested.
Blood clots in stool, weird bloody stringy thing, rash on left arm that appeared days earlier and hasn't gone away.
Fever, chills that started the night of the vaccinations. As per patient, these symptoms were mild and not especially severe. However, patient is more concerned about the intermittent pain she has started having  in her back and in her left arm (NOT the arm she received the vaccine in). Patient has been taking Tylenol and Motrin  to treat it. Patient verified she is not having any other symptoms.  Patient also reported that she has been diagnosed with Fibromyalgia.
Dr self disclosed that he administered Patient  0.1 ml IM of Moderna vaccine .  Patient was notified via telephone and instructed to return to the site were she received a full dose (0.50 ml) of the Moderna vaccine as instructed by STATE. No side effects reported by patient after administration or during resting period of 15 minutes. Supervisor notified and all vaccinators reminded that 0.5ml is the recommended dose for the Moderna vaccine.
This spontaneous prospective pregnancy report was received from a physician referring to a 26 year old female patient. The patient's medical history included sickle cell trait, migraines and history of pregnancy related hypertension. The gravida reported as 4, para reported as 2 and elective termination reported as 1. Information about concomitant medication and drug reactions/allergies was not provided. The patient became pregnant and the last menstrual period (LMP) was reported as 20-SEP-2018 and estimated due date (EDD) was auto-calculated on 27-JUN-2019. On 15-OCT-2018, the patient was vaccinated with 1 dose of GARDASIL 9 (lot # reported as R0003557 was an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast); strength, dose detail, route, and expiration date were not reported) for prophylaxis (exposure during pregnancy). Initial exposure to GARDASIL 9 was at 3 weeks. The patient took prenatal vitamin daily from 20-NOV-2018. The patient performed ultrasound on 27-NOV-2018, result was EDD was 11-APR-2019, dating not consistent with LMP. The patient performed cell free fetal (cff) deoxyribonucleic acid (DNA) on 05-DEC-2018, result was positive of trisomy18. The patient took aspirin (ASA) daily from 05-DEC-2018. The patient performed Maternal Serum Alpha Fetoprotein (MSAFP) on 18-DEC-2018, result was less than 1:5000.  The pregnancy outcome was outcome pending. The fetal outcome was unknown. The causality of the event was not provided.
hard of hearing; rash; faint; being hot; short of breath; headache; was achy; extremely tired/extremely exhausted; This is a spontaneous report from a contactable nurse (reporting for mother). An 89-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 11Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The first dose of BNT162B2 as COVID-19 immunization was received on an unknown date. Reporter was calling regarding side effects of the Pfizer COVID vaccine. Reporter stated that her mother (patient) is 89 years old and her mother was hard of hearing since an unknown date. Her mother got the second dose of the product 11Feb2021 and she was fine that Thursday, and by Friday (12Feb2021) her mother had a headache, was achy, and extremely tired. On Saturday, her mother felt a little bit better. On Sunday (14Feb2021), her mother had an episode of being hot and faint, and short of breath and extremely exhausted. This morning (15Feb2021), her mother was experiencing shortness of breath, and a rash and was exhausted. Reporter wa wondering if shortness of breath could be a side effect of the product. The outcome of the events headache, achy, and "extremely tired/extremely exhausted" was recovering, while for events hard of hearing, being hot, faint, short of breath and rash was unknown.   Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event syncope cannot be excluded.  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.
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 05Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 65 years, in right arm 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 included: "Hypertension" (unspecified if ongoing); "Known allergies" (unspecified if ongoing), notes: Known allergies: yes. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: After recovering from symptoms and testing negative; Positive, notes: I again tested positive; Positive, notes: COVID 19 Treatment. I again tested positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. No follow-up attempts are possible. No further information is expected.
Moderna Booster vaccine expired on 11/9/21 (prior to administration).  No adverse effects noted with pt.
Pt received injection #2 on 2/17/2015 and developed headache on 2/21/2015 not resolved with MOTRIN, pt's mother contacted office on 2/24/2015 to report headache.
Information has been received from a health professional concerning a 12 year old male who on 22-SEP-1999 was vaccinated with VARIVAX (Merck). On 03-JUL-2008 the patient started  to feel sick. On 04-JUL-2008 the patient had about 65 spots on his back, neck and forehead. The patient was diagnosed with a classic case of varicella. On 08-JUL-2008 the patient recovered from varicella. On 23-JUL-2008 the patient was seen in the office for a physical and was fine. No further information is available.
Patient had the delta variant; Patient had the delta variant; This is a spontaneous report received from a contactable reporter (Physician) from medical information team.  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "ulcerative colitis" (ongoing), notes: since 10 years. Concomitant medication(s) included: ENTYVIO taken for colitis ulcerative (ongoing). Vaccination history included: Comirnaty (DOSE 1, SINGLE), administration date: Jan2021, for COVID-19 immunization; Comirnaty (DOSE 2, SINGLE), administration date: Feb2021, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "Patient had the delta variant". The patient underwent the following laboratory tests and procedures: laboratory test: (Nov2021) delta variant. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received 3rd dose in end of Aug. The patient was wondering if they should consider a 4th dose of the Pfizer Covid vaccine in March 5 months after the August vaccine. Caller said that she was looking for data whether this patient should or should not consider a 4th dose in March prior to travelling. Caller mentioned that she found data on 3rd doses, not necessarily on 4th doses. Caller also mentioned that the patient should wait for 90 days after the monoclonal antibody infusion before getting a vaccine. The reporter wanted to know how much the 4th dose would increase efficacy over the 3rd dose and what potential side effects it could have. The reporter stated that that she was looking for data and recommendation that insist would be more robust for Pfizer than any cross-over study.   The lot number for bnt162b2 was not provided and will be requested during follow up.
PATIENT REPORTED HAVING DIZZINESS INITIALLY THEN FASTER HEART BEAT & BODY TINGLING; PARAMEDIC TOOK PATIENT TO HOSPITAL FOR MEDICAL CARE
Within 15-minutes of vaccination, the patient reported nausea and felt that their heart was racing. EMS managed patient's condition on-site.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 12-SEP-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J014131 and expiry date:07-NOV-2015, reported as 01-JUL-2015) which was improperly stored. Primary reporter was reporting excursion of 6 since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Left fingers tingling  10 minutes post vaccine.  Next day felt it spread to whole left side and left eye felt "weird."  Took Advil, got better after no difference with Tylenol.  Then stopped the Advil and symptoms persisted.  Then had tingling of head and neck.  Saw her physician and Carotid flow study was normal.  Waiting for MRI approval.  Has been working  with the symptoms.
Red, hot, swollen leg from groin to thigh 24 hrs post vaccine left leg no treatment needed.
Bronchitis.  Came on with other more typical side effects symptoms on 2nd day.  Chronic dry cough.  Other side effects resolved within a day or two but bronchitis persisted for 7 weeks. Initial treatment with antibiotics, prednisone after 3 weeks but no effect.  At about 4 weeks began using Trelegy inhaler which seems to have helped.  Seems to be mostly resolved at 8 weeks but will continue to use inhaler for another week.  Have some continued congestion but that may be due to regular allergies.
Within 1/2 - 1 hour after receiving vaccine, child continued with non-stop crying x 3-4 hours. No fevers. Unable to console child. Tylenol given every 4 ATC x 24 hours. After child calmed down, remained fussy, crying, agitated x 1-2 days later.
Per patient report: 1.  Rec'd second vaccine shot Thursday 13 May at 13:30 2.  Had no side effects, besides a small discomfort on the arm where I received the shot (Thursday). 3.  Friday 14 May, had minor headache and muscle pain through the day.  No fever.  4.  Friday 14 May, approximately 4 pm (over 24 hours since the vaccine) developed intense itching on the bottom of my feet and palm of the hands.  5.  Friday 14 May, 5 pm, took two Benadryl 25mg.  Had minor relief until approximately 9 pm. 6.  Friday 14 May, 11:45 pm, skin started to flare up with red rash and blister-looking spots through the wrists, arms, knees, and near the underarm.  Itch was very intense.  Took another Benadryl, making the total 3 Benadryl tabs in about 5 hours.  No relief from Benadryl. Went to Medical Center. 7.  Doctor gave me an IV of what he said was an anti-histamine and prescribed Olopatadine 5mg-- one tablet at night and one after breakfast for three days.  8.  Got home around 2 am (Sat 15 May) still had some itch but not bad enough to prevent me from sleeping. 9.  Woke up at 7 am, no itch and rash had cleared up about 60%.  10.  By 9 am on Saturday 15 May itch began again but not as intense as the day prior.  Took the morning Olopatadine.  (Waiting for Olopatadine to kick in!).