chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough case after Covid vaccination. Dose #1 3/3/2021 Dose # 2 3/21/2021. C/O fever, runny nose, loss of taste/smell, headache, fatigue, cough, and sore throat/ onset 8/24/2021
Patient developed nausea/vomited during 15 minute observation period, chest pain worsened and patient was taken by EMS to nearby hospital for evaluation due to recent history of chest pain prior to vaccine and 2 months prior.  Diagnosed with MI when she arrived at the outside hospital.
I received my Moderna COVID-19 booster on 12/5/2021. A few days after getting the booster, I experienced shortness of breath, and I assumed it was caused by anxiety. On the night of 12/20/2021, I woke up 3 times to go urinate, which is very unusual for me. On the night of 12/22/2021, it happened again; I had to get up to urinate about 3 or 4 times. While I was urinating, I noticed that my urine had a different smell; it actually had a sweet scent. I work at a hospital, so when I went to work on the morning of 12/23/2021, I asked a coworker to check my blood sugar with a blood glucose meter; when he did, my blood glucose was at 442. I was in disbelief, and since I had had a caramel macchiato earlier that morning, I felt that that must have been the cause of the high reading. On 12/23/2021, when I came to work, I again asked my coworker to check my blood glucose level. This time, I had previously fasted for 12 hours to ensure an accurate reading; this time, my blood glucose measured at 412. I was now very concerned, so I asked a doctor I work with to order some lab work (blood work, urinalysis) for me. When the lab work was done, it was found that my A1C level was 9.2, plus my urine tested positive for the presence of ketones. The doctor was very concerned, so he sent me to a general practitioner to have further tests done. The doctor who had run the tests gave me a diagnosis of type II diabetes. After the GP did further lab work, though, the diagnosis was changed to type I diabetes. The doctor who had done the first lab work immediately put me on insulin. Ever since then, I have regularly taken insulin, cut out carbs, exercised, and watched my diet very carefully. I was really surprised to get the diabetes diagnosis, though, because I take pretty good care of myself. I don't smoke or drink, and I have always had a pretty healthy diet. I don't know if there is a relationship between the booster and my diabetes, but it is strange that I didn't begin having the symptoms of diabetes until shortly after getting the booster. I also still experience shortness of breath, though it's not as frequent now as it was in the beginning. I now wonder if the shortness of breath was caused by something other than anxiety.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38-year-old male patient received BNT162b2 (BNT162B2), on 16Sep2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Oct2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 19Mar2022 as dose 3 (booster), single (Lot number: FK9896) at the age of 38 years, in left arm for Covid-19 immunisation; Janssen CoviD-19 vaccine (JANSSEN COVID-19 VACCINE), from 19Mar2021 (Lot number: 180525) to 19Mar2021 at 1 single (dose 1, single) for Covid-19 immunisation. The patient's relevant medical history included: "Hyperprolactinemia" (unspecified if ongoing). Concomitant medication(s) included: Zyrtec [Cetirizine Hydrochloride]; Flonase [Fluticasone Propionate]; Cabergoline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient admitted to hospital as inpatient on 6-18-21 due to AMS. Patient was tested for COVID-19 and was positive on 9-24-21.   Received monoclonal treatment
12/25/21 presents to ED for "chest pain". PMHx of "hypertension, hyperlipidemia, mitral valve prolapse, and celiac disease"
Redness and swelling at injection site appx. one hour following vaccination. It worsened x 2 days, then began to improve. Mom of patient treated with BENADRYL, MOTRIN, and cool compresses at home.
Bronchopneumonia, Cough. SOB, FEVER, ABD PAIN, NAUSEA, VOMITING AND DIARRHEA  ED to Hosp-Admission Current 8/27/2021 - present (5 days) Hospital Acute respiratory failure with hypoxia (CMS/HCC  Patient presents with ? Shortness of Breath      is an 75 y.o. female.   HPI: Patient is a 75-year-old female with a history of morbid obesity/hypertension/OSA who presents to the ER with complaints of worsening shortness of breath.  History goes that patient was well until approximately 6 days ago when she began feeling ill.  At the time she was experiencing cough, shortness of breath, as well as dyspnea on exertion with reduced exercise tolerance.  She was evaluated at the urgent care on 8/25 where plain chest x-ray was performed which showed no evidence of infiltrate.     She was started on azithromycin and COVID-19 test was ordered.   Recommendations was made for her to get OTC medications for symptom relief.  She was called on 8/27 and informed that she had COVID-19.  During all this her symptoms did not get any better with progressively worsening symptoms with body aches and pains, progressively worsening shortness of breath, cough, and fatigue.  Due to worsening symptoms 911 call was made prior to arrival to the ER.  EMTs found patient to to be dyspneic with pulse ox reading of 80% on room air requiring supportive oxygen of up to 6 L/min prior to transport.  She was transported to the ER where she was started on noninvasive mechanical ventilation.     Upon arrival she was tachypneic, with visible work of breathing.  She was afebrile.  Her labs were nonacute on hematology, chemistries showed magnesium of 1.6, BNP of 101, with elevated AST of 69.  Her UA showed hazy urine, positive for leukocyte esterase and nitrites, she also has proteinuria with hematuria pyuria and bacteriuria.  Plain chest imaging showed chronic lung changes.  Patient is being admitted for further management.   Of note patient lives with her son who was recently hospitalized with COVID-19 pneumonia.   Review of Systems  Constitutional: Positive for activity change, appetite change and fatigue.  HENT: Positive for congestion, postnasal drip and rhinorrhea.   Eyes: Negative.   Respiratory: Positive for cough and shortness of breath.   Cardiovascular: Negative.   Gastrointestinal: Positive for diarrhea and nausea.  Endocrine: Negative.   Genitourinary: Negative.   Musculoskeletal: Negative.   Skin: Negative.   Allergic/Immunologic: Negative.   Neurological: Positive for dizziness, weakness, light-headedness and headaches.  Hematological: Negative.   Psychiatric/Behavioral: Negative.
Fever, muscle aches, chills, Heart palpitations, heart racing, red sore throat, cough,
Patient manifested a 3.5x3 inch red, swollen, warm lesion on the anterior aspect of her left thigh. She otherwise manifested no systemic signs or symptoms of illness and was generally well appearing.
inc fussiness overnoc; diaphoresis (resolved gradually); temp not measured 99.5 in ofc; mom brought pt in to ofc given following day given reassurance
The following day (after) the shot, I had a welt with a red circle on my shoulder at the spot where I had the shot. I also found that I could not raise my arm at all - my shoulder hurt but it was also locked (wouldn't move).
Shot administered left arm, a week later left ear filled up with water. Doctor gave me zpack for fluid collection of middle ear. Water seemed to go away but was hearing echo when listening to others. A week later water was gone, echo was gone but felt like ear was stuffed with cotton. Hearing was still impaired. Appointment with ENT specialist in 4 days.
Patient received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml).    No concomitant information was reported.  It was reported that none of the patients were pregnant.  No treatment information was provided.  This case was reported for 15th patient out of 20 patients.
Information has been received from a licensed practical nurse concerning her 12 year old daughter with a history of diarrhea and chronic intermittent abdominal pain who on 07-NOV-2007 was vaccinated IM in the left deltoid with a 0.5 mL dose of Gardasil (lot # 655165/1425F). There was no concomitant medication. On 07-NOV-2007 the patient "developed muscle pain and weakness with some dizziness following vaccination with Gardasil. The nurse reported that her daughter experienced immediate pain at the injection site and the injection site arm was sore for the next couple of days. It was also reported that her daughter experienced muscle weakness and "muscle bruising" below the injection site about one week after vaccination with Gardasil. The nurse reported that her daughter's elbow was sore and she could not straighten her elbow. The muscle pain then moved to the other arm 2 to 3 days ago and currently both elbows and upper arms are sore. The patient has also experienced occasional dizziness." At the time of the report the patient had not recovered. The patient's muscle pain, weakness below injection site, dizziness, injection site pain, weakness and injection site arm soreness and sore elbow and upper arms were considered to be disabling. Additional information has been requested.
Initial fever for 3 days.  Subsequent persistent nausea before and after eating.  Extreme fatigue.   Complete loss of taste sensing only salt or sugar.
hard 4inches diameter; swollen; also have headache that last all day; Injection site became red; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE INDURATION (hard 4inches diameter), VACCINATION SITE ERYTHEMA (Injection site became red), VACCINATION SITE SWELLING (swollen) and HEADACHE (also have headache that last all day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 22-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site became red). On 23-Jan-2021, the patient experienced VACCINATION SITE INDURATION (hard 4inches diameter), VACCINATION SITE SWELLING (swollen) and HEADACHE (also have headache that last all day). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) 23-Jan-2021 for Adverse event, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) 23-Jan-2021 for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE INDURATION (hard 4inches diameter), VACCINATION SITE ERYTHEMA (Injection site became red) and VACCINATION SITE SWELLING (swollen) had not resolved and HEADACHE (also have headache that last all day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  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.; Sender'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.
Raised rash observed 9/17/21 by parents, going down right leg. Child seen in office on 9/20/21 with erythematous raised papules on right leg, right low abdomen, and right hip sparing padded area of diaper area. Patents reported several bouts of diarrhea the evening of 9/19/21
COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID arm) in an 86-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (COVID arm). At the time of the report, VACCINATION COMPLICATION (COVID arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Fever less than 8 hours after injection, severe fatigue with body aches. 3 days after each injection, I started a menstrual cycle which was very heavy. I have not had a menstrual cycle in 8 years due to having the IUD. Since covid and the vaccinations, I have endured headaches daily which turn into migraines at least once a week.
Blotchy red rash on face, body, arms and legs; if itchy to get Zyrtec liquid 1/2 to 3/4 tea sp once a day. Was to see allergist as had a "sunburn" like rash on neck after egg whites on 8/7/2013.
My arm has swollen at the injection site. It is red and hot and the rash is the size of the palm of my hand. This was the intradermal vaccine rather than the intramuscular. I have had the intramuscular for several years with no reaction.
Right deltoid warm to touch, itchy to patient, roughly 4 inch delineated circle around injection site, with bandaid residue still seen. No discharge. BENADRYL Allergy Tablet, 25 MG, 1 tablet as needed, Orally, every 8 hrs, Hydrocortisone Cream, 1 %, 1 application to affected area, Externally, Twice a day.
hives @ 3AM with itch all over body-to ER given "steroid inj".  Benadryl po cleaned up by 12 noon next day.  Next day rash reappeared-treated @ home with Benadryl x 3days.  Since then not felt well- fatigue symptoms.
waited the 15 min - only thing was my arm hurt from the time I got the needle until 2 days later (very painful entire time but could slowly move arm). While driving home after waiting 15 min my mouth went dry and lips were tingling felt like they were swelling. Got home, drank some water. Took about 2 hrs for the dryness to go away. The tingling went away after about 20 min.
Tender node palpable at the base of the neck above clavicle (lymphadenopathy).
This spontaneous report as received from a health care professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, (dose, route, lot number and expiration date not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Patient had vaccine and within 10 hours started to have a reaction. Her arm started to hurt and become red. painful to rotate around. Patient then called her PCP and informed patient to take benadryl every 4-6 hours as needed until it disappeared and to call if it got worse. Patient called the next morning with redness down to her elbow which had surpassed the redness from the night before. Still red swollen and hot to touch. She also now has feelings of malaise and low grade fever
Am unsure if in any way related. Onset of Shingles on 5/21/21. Right side of face and eye .
Immediately following my daughter had a a sore arm and pain with low grade fever,  within a month a virus was contracted by my daughter COVID-19, STREP and influenza  tests were all negative.
12/21/20- I experienced slight tiredness 12/22/20- Coincidentally,  Menstrual Period started today. I experienced symptoms starting around230pm including, tiredness, headache, chills, body aches including diaphragm muscle aching, mild nausea, feeling unwell, swollen lymph node under left axilla, and fever as high as 102.2.
Patient received a 5-11 years bivalent booster 0.3mL instead of a 12+  bivalent booster. Patient was notified with error and correct dose was administered.
Fever, lethargy, 24 hours later had diarrhea x 3, episodic irritability and lethargy, at 06:00 AM 11/8/14 had bloody diarrheal stool, then vomited x 3 and was taken to E.D.
CDC reports: 6 yo child developed fever to 105, pain @ inject site & lethargy following DTP/OPV immunization. Duration of illness 2 days.
Rash with blisters. Itching. Facial Pain. Pain. Treatment: Valtrex, Bactrim, Keflex, Neurontin.
Wrong  formulation of Vaccine was used for child in this age group. No adverse side effect noted in Child.
ITP, diagnosed with a platelet count of 4 approximately 3 weeks after receiving MMR vaccine.
Initial and follow up information has been received for the pregnancy registry for GARDASIL from a registered nurse concerning a 26 year old female with allergies, bipolar, depression, Von Willebrand disease type 1 due to aspirin intake, genital herpes, irritable bowel syndrome, migraine headaches, panic attacks and allergies to Pseudophedrine, Ibuprofen and Aspirin who on 15-MAY-2007 was vaccinated IM with 0.5 mL GARDASIL (lot # 655205/1426F).  Concomitant therapy included ZYRTEC and EFFEXOR.  On 29-MAY-2007 the patient had a positive pregnancy test (LMP 21-APR-2007, EDD 26-Jan-2008) and therapy with venlafaxine HCL was discontinued.  On 02-AUG-2007 an ultrasound revealed a subchorionic hemorrhage which resolved without intervention on unspecified date.  A maternal serum alpha fetoprotein test on 15-AUG-2007 was normal.  On 11-OCT-2007 the patient was diagnosed with a urinary tract infection and treated with Ceftin, 250 mg, PO, BID.  On 03-JAN-2008 the patient began treatment with Acyclovir, 400 mg, BID for herpes simplex virus.  On 05-JAN-2008 at 37 weeks the patient had a spontaneous rupture of membranes and gave birth to a normal male infant who weighed 7 lbs. 5 oz.  His apgar scores were 9/9.  The patient completed therapy with Acyclovir on 15-JAN-2008.  Additional information has been requested.
6-15-07 pt came to urgent care and reported having side effect from TD injection given at ER hospital. 6/13/07 to report tingling to forehead, lips aching in chest.
pt recvd vax 10AUG93 10AM; about 1 1/2 hrs ;later started screaming high pitched & not consoleable for 4  hrs; also vomited x 3; t100, leg sore; fussy;
Woke up with severe chills, felt lousy. The chills eventually subsided after a few hours and then started to sweat, like breaking a fever. Felt pretty much back to normal by around noon or 1. No other issues since.
Pt reports that she had the Moderna COVID19 vaccine 3/16/21 and then again on 4/13/21. Pt developed stiffness and pain in her hips, thighs, shoulders, arm, and neck over the next several days. She was eventually diagnosed with Polymyalgia Rheumatica.
26 hrs p/vax pt devel welted rash, warm to touch, spots 1-2 on chest, each leg, elbow to wrist; c/o itching t99ax; 8DEC 830AM mom reports rash completely gone; MD office & clinic notified;
Pt called on call service with "severe joint pain" throughout entire body.  OTC product instructions given via Dr.
Headache three hours after injection, next morning severe dizziness felt like vertigo when I got out of bed left side of body felt weak could not walk to the right felt pulled to the left. When eyes closed felt dizzy and nauseous. Tried to contact doctor cannot get through to on-call doctor . Continue to drink fluids, stayed  flat,  slept. dizziness and headache manageable by 5 o?clock in the evening. Next day felt better but tired presently have Covid arm. Rash is continuing to grow
6 days later after vaccination experienced, headache, muscle pain, fever of 104 degrees, chills sweating, large erythematous area around site with lymphangitis. Missed one day of work. Still sick with fever 101 degrees.
On the second morning after vaccination (3/14/21) I started have weakness on my two legs. I needed to hold on to furniture/walls for the about an hour. This is similar but much, much, much less acute than with previous allergic reactions after I had Guillain Barre (1975/ age 10). My leg weakness has taken place 2 more times in the last few day but for just a few minutes at the time. I also had a very sharp neck pain the day after vaccination lasting about 24 hours.
Pt received vaccine 9/27/11 4 pm. States around 8pm 9/27/11 area where received vaccine on (L) arm starting throbbing, also with difficulty lifting left arm.
Initial report was received from a health care professional on 27 June 2011 which involves the administration of the wrong vaccine. A female patient (date of birth not reported) had received ADACEL, lot number U3553CA (sanofi pasteur Ltd. lot number C3677) which was inadvertently administered intradermal for 'PPD instead of TUBERSOL" and at the time of the injection, the patient experienced redness and swelling at the injection site. The patient was evaluated by a physician. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
10/30/21 reports feeling worse in the last few days with worsening cough, with associated fevers and decreased appetite. PMHx of PAD s/p R midfoot amputation with debridement initially presented to HCF on 10/18/21 due to persistent LLE ulcer on foot.
2 x 4 area of erythema w/mild swelling, limping, temp 101.2F; 3 prior DTP; Recovered in 48hrs;
PER PT CAME TO GFP TO GET JANNSEN IN APRIL, ABOUT A MONTH LATER PT REPORTS ABOUT A MONTH AFTER VACCINE HE STARTED HAVING BACK PAIN THEN DOWN INTO LEFT KNEE AND FOOT OVER TO RIGHT LEG AND KNEE. PT THEN STATES HE WENT TO THE ER 11/27 DUE TO TINGLING IN HANDS AND PAIN IN NECK AND BACK. DISCHARGED - SUSPECTED BP MEDS TO BE THE CAUSE; TO F/U WITH PCP - PCP TOLD PT THEY NEEDED TO CALL PHARMACY TO REPORT - REGARDLESS PT STILL GOT MODERNA BOOSTER 12/17 AT BLACKS DRUG. HES REPORTING NOW HE CANNOT WALK OR PUT PRESSURE ON LEGS - TENDER AND SORE AROUND JOINTS. HAS NOT FOLLOWED UP AGAIN WITH PCP. BELIEVES GBS IS CAUSE PARTICULARLY FROM JANSSEN GIVEN IN APRIL.
NauseaVomiting, myalgia, joint pain Narrative: Developed flu-like symptoms for 3 days after the inital vaccination. This was described as low grade fever, myalgia, and nausea. After this abated, she continued to have myalgia/joint pains for an additional 3 weeks. Patient spike with her rheumatologist, who offered 10 day course of steroids, which was politely declined. She reviewed risk vs benefit with her rheumatologist, who offered 10 day course of steroids, which was politely declined. She reviewed risk vs benefit with her rheumatologist(not on any maintenance therapy at this time) and decided to proceed with 2nd dose. Her rheumatologist has advised to please reach out if she has 2x wks of joint pains so that she can be prescribed a 10 day course of steroids after the 2nd vaccination.