chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna Covid 19 vaccine - Got first dose 1-8-2021 -   Side effects.  Right arm is very sore.  Weakness in arm.  More painful than the ankle surgery.  Took a couple hours then it started  1-9-21 at about 1130pm got headache. Took two Advil 1-10-21 at 11am got a headache  1-11-21 around 830pm shoulder and arm finally started feeling less pain 1-13-21 headache around 134.  Took Advil 1-14: arm and shoulder still cracking. Got really bad constipation. Forced it out. Hurt like hell. Tore something took 2 senna plus pills  1-15. Morning had thick and super long poop again. Forced it out a lil quicker but tore again or hemorrhoids  or both. Took 2 senna pills. Moved my neck wrong way.  All muscles are super super tight in my neck. Cracked with shoulder.  Now I can?t move my neck to the right   1-16: poop was pretty normal. Came out nice.  Still some in rectum wasn?t ready to expel. Had to use badee three or four times and lots of wiping to get clean.  1-18: right arm hurting again about half as bad. Still very painful when I lift etc.   Neck is a lot better  1-19: arm still hurts.  Can?t lift up without pain. Weak to lift other things pain actually seems to be in my shoulder and cracking a lot.  Not in my arm itself.  By the nighttime the pain became more intense in my shoulder and very difficult to lift it or move it.  Like the first day I got the vaccine.  1-20: shoulder hurts worse than ever.  Worst pain ever even if I keep it still has some pain. Horrible.    Became worse over the day  1-21:  at 330pm had loose bowels.  1-22-21 at 1118am.  Loose bowels again after an initial drop of on bowels.   1-23.  Normal poops.    2-5-21.  Got second dose at 1250am in left arm this time instead of right.  At 215pm still fine. But as I got up slight headache. Arm not hurting yet  247pm started having some pain just at injection site. Later at night around 9 or so I got really tired also felt slightly nauseous  2-6-21 at 1207pm.  Arm is sore but bearable.  Can move it fine.   Doable.  At 1221pm felt nauseous.  Sick to my stomach.  130pm or so was able to eat Mac n cheese.  Had raspberries about a half hour earlier to settle my tummy  2/7 at 122am:  laying in bed.  Got a bad headache since I got up.  Arm pain is minor. So long as I don?t touch it it?s fine.   I am tired.  Worn out. Congested.  Left arm and shoulder starting hurting around 2-15?   Once I started working out. Hurt like hell.  800mg Advil helped some but still hurt.  2-26: shoulder left still hurts and tight.  Did not take Advil.   Tried to stretch it.  Feels a little better at 9pm 2-28-21: slight nausea Again.  Still sore arm on and off.  Dried out.  Tired.  Drinking tons of water 3-3.  Last day I worked out and did cardio.  3-5.  Left arm still hurts a bit at injection site.
Gout flared up, both knees; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout flared up, both knees) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical history information was reported.  Concurrent medical conditions included Borderline diabetes.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GOUT (Gout flared up, both knees). The patient was treated with INDOMETHACIN [INDOMETACIN] for Gout flare, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Gout flare, at an unspecified dose and frequency. At the time of the report, GOUT (Gout flared up, both knees) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication of the patient was not reported. The patient had no known allergies.   This case was linked to MOD-2021-323257 (Patient Link).
Narrative: Covid+, SOB, fall with 3 broken ribs, weakness, dizziness, impt treatment unclear. discharged home with home health, Pfizer #2.
Five days after getting the vaccine I got up, had breakfast and suddenly got really lightheaded and dizzy, then I got nauseous and began to vomit three times in a 15-min period. I was sweating. too. I kept my phone next to me in case I needed to call 911. I took a  pill of Dimenhydranate  for the nausea. I did not eat anything unusual, only home-cooked meals. I went back to bed for 1 hour and all the symptoms went away.
No pain or abnormalities upon administration.  Pharmacist covered with bandage.  The next day the patient noticed a bruse underneath the bandage.  It was a little achy and slightly warm.  It didn't bother her otherwise had no pain or sensation.  Kept moving her arm.  Has no pain/sensation like a normal bruise.  Bowling didn't irritate it.  Just has a visual bruise and it feels a little bit warm.   Patient has tried icing but it didn't change the size.  It is however turning yellow (healing) and starting to get slightly smaller.  As long as it continues to get smaller, no further medical action is necessary.  If patient develops a fever, or experiences pain/tenderness advised her to be checked out.
SORE ARM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to.
Patient felt immediate pain at the Lt deltoid site with the injection. She then noted she was having difficulty lifting her arm the next morning to get dressed. She experienced a dull constant ache and increase in pain with lifting her arm.  Physical Therapy started, Voltaren Gel QID, Ibuprofen
heart rate increased to 150; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of HEART RATE INCREASED (heart rate increased to 150) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes since an unknown date and Atrial fibrillation since an unknown date. Concurrent medical conditions included Egg allergy and Allergic reaction (allergic reaction to swine flu that resulted in hospitalization).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced HEART RATE INCREASED (heart rate increased to 150) and HEADACHE (Headache). On 06-Mar-2021, HEART RATE INCREASED (heart rate increased to 150) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Heart rate: 150 (High) increased heart rate to 150.     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.   Concomitant medications included calcium channel blockers and unspecified medications for atrial fibrillation and diabetes.  Treatment medication was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 09-Mar-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of HEART RATE INCREASED (heart rate increased to 150) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes since an unknown date and Atrial fibrillation since an unknown date. Concurrent medical conditions included Egg allergy and Allergic reaction (allergic reaction to swine flu that resulted in hospitalization).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced HEART RATE INCREASED (heart rate increased to 150) and HEADACHE (Headache). On 06-Mar-2021, HEART RATE INCREASED (heart rate increased to 150) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Heart rate: 150 (High) increased heart rate to 150.     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.   Concomitant medications included calcium channel blockers and unspecified medications for atrial fibrillation and diabetes.  Treatment medication was not provided.
This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. On 05-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX dose, route and lot # not reported. On 06-NOV-2013, the following day, the patient presented with hives on his face. The outcome of adverse event was unknown. The pharmacist advised the patient to seek care from his unspecified primary healthcare provider. The relatedness between adverse event and ZOSTAVAX was unknown. Additional information has been requested.
6 days after shot got cloudy head and ringing in persistent ringing in ears, particularly my right ear.  Now been 15 days since shot and still have steady ringing.  Went to emt last week, my hearing is ok but they can't do anything directly about my ear ringing.   Head has mostly cleared at this point but ear still ringing.  Can't sleep at night.
Approx. 30 minutes after receiving DTap, IPV & MMR, Patient developed hives on chin, forehead & trunk. Mother took pt. to medical clinic where he was treated with liquid Benadryl and instructed to take throughout day.  Hives resolved after 2 doses.  Running low grade temp morning after shots given.
My first period was a 3 days late and lasted for twice as long (7days) as it normally does, and then my period after that was 10 days early. Both of them were much heavier, with a lot heavier bleeding than normally.
Moderna Bivalent Vaccine given, vaccine expired on 06/12/2023. Error discussed with patient during the time of this visit. Patient has verbalized understanding , and agrees to repeat vaccine dose at another time.
Patient presented for his second dose and noted lingering arm pain and difficulty raising left arm to shoulder height.
Discomfort. Body and Muscle aches. Nausea, vomiting, headache, fever, chills, abdominal pain, light headedness followed by fainting.
got sick; lost my appetite; legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger; Skin is peeling off; legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger; didn't move about 3-4 days; throw up easily; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick), DECREASED APPETITE (lost my appetite), BLISTER (legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger), SKIN EXFOLIATION (Skin is peeling off) and RASH MACULAR (legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced ILLNESS (got sick), DECREASED APPETITE (lost my appetite), BLISTER (legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger), SKIN EXFOLIATION (Skin is peeling off), RASH MACULAR (legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger), MOBILITY DECREASED (didn't move about 3-4 days) and VOMITING (throw up easily). At the time of the report, ILLNESS (got sick), DECREASED APPETITE (lost my appetite), BLISTER (legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger), SKIN EXFOLIATION (Skin is peeling off), RASH MACULAR (legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger), MOBILITY DECREASED (didn't move about 3-4 days) and VOMITING (throw up easily) outcome was unknown.            Concomitant product use was not provided by the reporter.  After the second shot, he got sick and didn't move for about 3-4 days. He lost his appetite and had vomiting. His legs had red marks all over until his waist and now they're bumps. It has fluid in them and they started bursting. Skin is peeling off. They're getting bigger.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Fluctuating hearing loss, arthritis in hands, elbows, shoulders and hips. Night sweats-developed cataracts in both eyes, general fatigue and soreness, droop in left side of face and fuzzy thinking. Long term Lyme in 6/03.
Angioedema; swelling; Difficulty breathing; Tight chest; Facial flushing; Dry eyes and unsettled stomach; Dry eyes and unsettled stomach; This is a spontaneous report from a contactable nurse.  A 27-years-old non-pregnant female patient started treceive bnt162b2 (BNT162B2), Lot number: EL9266,  intramuscular in left arm on 15Feb2021 at 0900 (at the age of 27 years-old) for COVID-19 immunzation. The vaccination was administered at a workplace clinic.  Medical history included Allergy/Sports-Induced Asthma, Lactose Intolerant and food allergies of Kiwi, Lactose Intolerant, Cherry.  The patient had a positive COVID-19 test prior to vaccination on 14Nov2020. There was no other vaccinations given within 4 week and concomitant medications within 2 weeks included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), fish oil (FISH OIL).  On 15Feb2021 at 10:00, the patient experienced Angioedema/swelling, Difficulty breathing/tight chest, facial flushing, dry eyes and unsettled stomach. Experienced symptoms of flushing 1hour post-vaccination. The clinical course was as follows: She reported that she experienced symptoms of flushing 1hour post-vaccination. About 4 hours later swelling persisted and took Zyrtec to alleviate symptoms, which provided minimal relief. 24 hours post vaccination resulted in ER admission advised per Occupational Medicine at (name). IV SoluMedrol, Bendaryl and Pepcid administered. Overall stay in ER 3 hours. On 17Feb2021, 24 hours post admission rebound symptoms occurring with facial flushing and swelling. Will repeat allergy medication to relieve symptoms PRN.  The clinical outcome of the events was recovered with sequalae (as reported by patient: recovered with lasting effects).
Cytomegalovirus infection/CMV Pneumonitis; This is a literature report for the following literature source(s):  A 53-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Type of transplant-Heart" (unspecified if ongoing), notes: Time since transplant-9 months; "Nonischemic cardiomyopathy" (unspecified if ongoing); "Cessation of prophylaxis mo/y before first CMV vaccine" (unspecified if ongoing), notes: 4 months; "Admission" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tacrolimus for Immunosuppression, notes: 500 mg; twice a day; Mycophenolate for Immunosuppression, notes: 500 mg; twice a day; Prednisone for Immunosuppression, notes: 5 mg. Vaccination history included: Bnt162b2, for COVID-19 immunization.  The following information was reported: PNEUMONIA CYTOMEGALOVIRAL (hospitalization, medically significant), outcome "unknown", described as "Cytomegalovirus infection/CMV Pneumonitis". The patient underwent the following laboratory tests and procedures: Cytomegalovirus test: No; Lymphocyte count: 1.01, notes: Units: Unknown; Polymerase chain reaction: 272 IU/ml; SARS-CoV-2 antibody test: Negative; Transplant evaluation: +-; White blood cell count: 8.3, notes: Units: Unknown. Therapeutic measures were taken as a result of pneumonia cytomegaloviral.  No follow-up attempts are needed. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the event Pneumonia Cytomegalovirus and the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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. Linked Report(s) : PFIZER INC-PV202200004629 Same article/ drug/event and different patient;
Expired vaccine is stored and then administered; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provider by the reporter.  Patient did not reported any adverse events. The vials did not undergo any temperature excursion. The vaccine was kept in the refrigerator on 29/10/2021.  No treatment information were provided.
This is a spontaneous report from a contactable consumer. A female patient (unknown if was pregnant) received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her limbs felt heavy on an unknown date, aching joints, severe headache, nausea, congestion, difficulty sleeping, was laying on her chest on 11Apr2021. Reported as: Reporter says that patient experience symptoms after 2nd dose of Comirnaty. Her limbs felt heavy, aching joints, severe headache, nausea and congestion. She had difficulty sleeping because it felt like something was laying on her chest. Her symptoms lasted for over 24 hours. Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Cellulitis at vaccine site right deltoid. Treated today w/ prednisone and cephalexin.
Severe headache after vaccine; required evaluation  at ER . Headache improved with oral analgesic nlgesic
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6205), in right arm, on 31Mar2021 as dose 2, single (Lot number: ER8733), on 08Nov2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 12May2022 as dose 4 (booster), single (Lot number: Fk9894) at the age of 55 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure and covid-19 (treatment with Paxlovid from 22Jul2022 to 27Jul2022).
None stated.  8/11/08 Gross autopsy findings:  Visceral congestion.  Diaper rash.  Full report pending. 10/20/2008 Autopsy received. COD-Sudden unexplained death in infancy. Manner of death natural.  Infant found unresponsive with abundant vomitus.
No additional AEs; 45 year old patient received a dose of PROQUAD; This spontaneous report as received from a nurse prescriber refers to a 45-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-SEP-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 mL, once (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (LLT: Inappropriate age at vaccine administration). No adverse event was reported.
This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with GARDASIL. Dose, route lot number and expiration date were not reported. The health care worker reported that GARDASIL was improperly stored and administered to unspecified number of patients on unspecified dates. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a licensed practical nurse (L.P.N.) concerning a 22 week old female who on 31-MAR-2009 was vaccinated with a first dose of ROTATEQ (lot# not reported). The patient sought an unspecified medical attention. No adverse effects noted. Additional information has been requested.
Itchiness to multiple sites followed by rash and swollen eyes.  Saw PCP placed on steroid course x 7 days plus antihistamines.