chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Was unconscious on the floor; Couldn't get up; muscle loss (rhabdomyolysis); Ear Infection; Fell on ground; Bad reaction to 2nd dose; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Was unconscious on the floor) and RHABDOMYOLYSIS (muscle loss (rhabdomyolysis)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Was unconscious on the floor) (seriousness criteria hospitalization and medically significant), RHABDOMYOLYSIS (muscle loss (rhabdomyolysis)) (seriousness criterion medically significant), EAR INFECTION (Ear Infection), FALL (Fell on ground), VACCINATION COMPLICATION (Bad reaction to 2nd dose) and VERTIGO (vertigo). On an unknown date, the patient experienced MOBILITY DECREASED (Couldn't get up). At the time of the report, LOSS OF CONSCIOUSNESS (Was unconscious on the floor), RHABDOMYOLYSIS (muscle loss (rhabdomyolysis)), EAR INFECTION (Ear Infection), FALL (Fell on ground), VACCINATION COMPLICATION (Bad reaction to 2nd dose), VERTIGO (vertigo) and MOBILITY DECREASED (Couldn't get up) outcome was unknown.            Ear infection at the time and was given 5 days course of steroids and the unknown medications. for other events. The blood work, CT scan, MRI, and other tests were done but none of them could pinpoint it to the vaccine. Patient was hospitalized for 3 days. No concomitant medication was reported by the reporter.  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. Very limited information has been reported at this time. Further information is expected.   This case was linked to MOD-2021-052530 (Patient Link).   Reporter did not allow further contact; 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. Very limited information has been reported at this time. Further information is expected.
The day after pt was vaccinated she began to have flu like symptoms, body aches, tiredness, and arm stiffness. The arm became inflamed and was warm to the touch. Pt went to Md and was diagnosed with Cellulitis and given Keflex.
10 x 6 cm mod erythema with low grade temp of 100.5 degrees.
REALLY PALE; FELT LIKE HAD GOT THE FLU, HEADACHE, TIRED, EXHAUSTED AND HIGH FEVER; DROWSY; VERY SORE ARM TO THE TOUCH; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 11-NOV-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 11-NOV-2021, the patient experienced really pale. On 11-NOV-2021, the patient experienced felt like had got the flu, headache, tired, exhausted and high fever. On 11-NOV-2021, the patient experienced drowsy. On 11-NOV-2021, the patient experienced very sore arm to the touch. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from really pale, felt like had got the flu, headache, tired, exhausted and high fever, very sore arm to the touch, and drowsy. This report was non-serious.
Pt received Pneumovax vaccine, lot 0664N exp: 8/5/05, on 11/14/03 (L) deltoid. After the injection upper arm came red, swollen, painful. Pt did not seek medical care until today 11/18/03. When she came to the clinic x PPD reading.
First day arm itchy on side, but not at inoculation site.  Itched off and on several days.  Itching increased around 02/19/21 and a sore appeared (possibly from scratching) next day.  Intermittent itching persisted.  02/21/21 noticed large red rash on top and side of left arm, well demarked between rash area and non-rash area.  Rash 02/22/21 is fainter but still there.  Itching remains intermittent.  Rash area is slightly sore when pressed.
Injection site redness; Injection site itchiness; could barely walk; Feels like she pulled a muscle; back and legs have been aching since, back and legs hurt really bad, felt like she pulled a muscle; back and legs have been aching since, back and legs hurt really bad, felt like she pulled a muscle; Pain returns with exertion; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could barely walk), MUSCLE DISCOMFORT (Feels like she pulled a muscle), PAIN IN EXTREMITY (back and legs have been aching since, back and legs hurt really bad, felt like she pulled a muscle), BACK PAIN (back and legs have been aching since, back and legs hurt really bad, felt like she pulled a muscle) and PAIN (Pain returns with exertion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LAMOTRIGINE for Bipolar disorder, MIRTAZAPINE (MIRTAZEPINE TEVA), ZOLPIDEM, SERTRALINE, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), ONDANSETRON and ACETYLSALICYLIC ACID, CARISOPRODOL (SOMA CMPD) for an unknown indication.    On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced GAIT DISTURBANCE (could barely walk), MUSCLE DISCOMFORT (Feels like she pulled a muscle), PAIN IN EXTREMITY (back and legs have been aching since, back and legs hurt really bad, felt like she pulled a muscle), BACK PAIN (back and legs have been aching since, back and legs hurt really bad, felt like she pulled a muscle) and PAIN (Pain returns with exertion). On 05-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PRURITUS (Injection site itchiness). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, GAIT DISTURBANCE (could barely walk), MUSCLE DISCOMFORT (Feels like she pulled a muscle), PAIN IN EXTREMITY (back and legs have been aching since, back and legs hurt really bad, felt like she pulled a muscle), BACK PAIN (back and legs have been aching since, back and legs hurt really bad, felt like she pulled a muscle), PAIN (Pain returns with exertion), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PRURITUS (Injection site itchiness) outcome was unknown. Not Provided          This case was linked to MOD-2021-106661 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Added new events. On 22-Jul-2021: TCR received contains no new information
Exposed to COVID on 01/17/22 by either grandson or son-in-law.  Grandson had URI with fever on 1/14/22 but tested negative.  Son-in-law had cough, fever, GI symptoms and tested positive. I developed mild respiratory symptoms of scratchy throat and nasal congestion on 1/21/22, had PCR test that was negative.  Congestion increased with development of harsh productive cough and ear congestion. Had virtual visit on 1/26/22.  Was given OTC drug recommendations and had another PCR test on 1/27/22, also negative.  Symptoms continued to worsen with copious nasal congestion, deep productive cough, no fever. Contacted MD again on 1/28/22, was prescribed prednisone 10 mg x5 days, albuterol inhaler 2 puffs every 6 hrs as needed. Had CXR on 1/29/22 which was normal.  Needed albuterol 2 puffs 3x/day.  Symptoms improved over next 7-10 days but with residual  nasal congestion and productive coughing.  Because of impending travel on 2/11/22, with ear congestion persisting, along with some productive coughing, was seen in clinic on 2/9/22. Only change was another 7 day course of Prednisone 10mg/day and other OTC medications recommended.  Symptoms eventually resolved around 2/21/22
By 4 PM  3/30/2021 , I had chills.  The next morning I had a congested headache that was really bad, chills, and a slight sore throat at times. And a temp of 100.9. A day later I also had a large red area on my arm....under the injection site.  It was smooth....and approximately  3 inches width and height. It itched slightly.  Today 4 days later, it is still red but a slightly smaller area.  I have not gone for any treatment.  I drank gatorade the first two days and took tylenol.  But I have not taken any of that yesterday or today.
Bloated and gassy all evening, diarrhea onset the next morning at about 5:30 AM - 8:00 AM, mild fever.
Began experiencing pain at immunization site (R) deltoid and unable to lift (R) arm that even. (-) swelling or erythema noted at site. Took hydrocodone med due to the amt. of pain at home, that eve slept v. poorly due to the pain. Presented to work 9/25 - and left ay approx 9 am due to (R) arm pain and soreness at deltoid. Armpit and down (R) side of torso. Began improving Friday. Today cont c/o minimal soreness; (-) erythema or swelling at imm site noted.
Red circle hard lump at injection shot of the Pfizer booster; Red circle hard lump at injection shot of the Pfizer booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE MASS (non-serious), outcome "unknown" and all described as "Red circle hard lump at injection shot of the Pfizer booster".  Additional information: Red circle hard lump at injection shot of the Pfizer booster. Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Dyspnea, cough, short of breath, bronchospasm.  May have had reaction before-stated she thought "it was the flu."
Patient received vaccination sitting down. Stood up to move out of the vaccination room went to be seated outside the door. Patient said he felt like he was about to faint and went to sit down and immediately started to slid out the chair once seated.  Patient was out for no less than 15 seconds. Paramedics was called during the fainting. He was responsive and able to breath. Patient was kept on the floor in supine position. no difficulty in breathing and knew who he was and where he was located. No signs of distress just very pale and shaky. Paramedics arrived at scene and O2 stats and HR was normal BP was normal. Patient was taken to hospital for further test. Pharmacist called for follow up at 5:30 with fiancé and she stated that they had diagnosis of vasovagal syncope and that they were running more test. She stated that he was doing fine and that he seemed to be better. They were still in the ER at 5:30 pm.
Case number PHEH2015US001317, is an initial spontaneous report from a medical assistant received on 14 Jan 2015. This report refers to a 12-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: M14070) intramuscularly at a dose of 0.5 ml on 08 Jan 2015. It was reported that patient may have received the MENVEO that reached 32 F for 16 hours. The reporter stated that the vaccine did not freeze. The backup thermometers in the refrigerator did not identify the temperature excursion and the thermometer that identified excursion was faulty. Therefore the reporter was not sure if the excursion had occurred at all. No adverse event was reported following this medication error.
Patient approached nurse in the post vaccination observation room complaining of feeling dizzy and shaky. Patient was able to walk down with the nurse to th second floor clinic for further evaluation and observation. Patient was positioned in a supine position and VS obtained. Care was handed over to another nurse.
Migraine Head aches and Left Arm tingles and hurts from shoulder to finger tips.
I went to dinner with my son at a restaurant on 1/23/2023. As we were on our way there, my son alerted me that he had thrown up earlier that day after lunch at school. I thought that maybe it was because of the food served by the school, because he is a vegetarian, and he previously had vomited after eating food with meat in it. He told me that he felt fine, but while we were at the restaurant, he took just a few bites before he threw up profusely. We ended up having to leave, so we then went home. I tried giving him liquid hydration, but he threw that up, too. I kept him home from school the next day to monitor him. He ate soup and crackers that day, and he was able to keep them down. I gave him some carbonated coconut water, and he felt fine after that. Four days later, his 17-month-old brother also got sick, only he had both diarrhea and vomiting for two days. I knew then that the symptoms weren't caused by food.  On 1/29/2023 at around 6 PM, my son began vomiting profusely again, and so did his sister. I gave my son vegetable broth, electrolyte drink, water, carbonated coconut water, and crackers, but he kept throwing them up. He got to the point at which he was actually throwing up what I later found out to be bile. He became weak and very fatigued, which is unusual for him, as he is normally high-energy. I took my son to the doctor on 1/31/2023, I took my son to the doctor; by this point, my daughter had recovered and was back in school, but my son's vomiting continued. The doctor checked my son and said that he was extremely dehydrated. She told me that I needed to give him 60 oz of liquid; otherwise, he would have to go to the hospital and put on an IV. She gave me a plan to give him the 60 oz of fluid, plus some antinausea medication. I gave my son his first dose of the antinausea medication about 12 PM that day. I was able to give him the 60 oz of liquid, which he was able to keep down. At this point, though, he could not eat solid food. He was just able to consume liquids. Later that evening, he was able to eat crackers and soup and keep them down. The doctor advised me to keep him home from school for one more day to make sure he was able to eat solid food and keep it down, which he was. My son returned to school on 2/2/2023.
chills and shakes,,,, intense total body pain that last from several hours after receiving vaccine #2, until 36 hours later. i did not get any reaction after first vaccine 4 weeks earlier.
2 wks p/receiving flu vax noticed sinus ache, felt heavy also back of eyes next day felt shivery-shaking inside-noticed thick phlegm in back of throat; did not take temp; took meds; no cough; h/a 13DEC91; did not see MD;
I'll never get one again, first flu shot I had, got so sick I actually laid on the bathroom floor for 2 days with my pillow; Initial information received on 22-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional via digital media.  This case involves patient of unknown demographics who reported  sickness ("I will never get one again, first flu shot I had, got so sick I actually laid on the bathroom floor for 2 days with my pillow") after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency, route, lot number and expiry date was unknown) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "i'll never get one again, first flu shot i had, got so sick i actually laid on the bathroom floor for 2 days with my pillow" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was unknown.  It was not reported if the patient received a corrective treatment for the event (I'll never get one again, first flu shot I had, got so sick I actually laid on the bathroom floor for 2 days with my pillow).  At time of reporting, the outcome was Unknown for the event i'll never get one again, first flu shot i had, got so sick i actually laid on the bathroom floor for 2 days with my pillow.
Pt exp local rxn @ deltoid w/pain, swelling & inc'd warmth, stated pain @ site about 3-4 hrs later;
Increased redness, warmth, soreness and slight edema that started day after injection and lasted x 2 days. ADVIL and icepacks were given and applied.
No adverse event; adults received 0.5 ml of Moderna vial intended for ages 6-11; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11) and NO ADVERSE EVENT (No adverse event) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11).    No concomitant medications were reported.  The pharmacist states they accidentally gave a group of people the wrong dosage of the Moderna booster. They wanted the bivalent booster, but they gave the one intended for ages 6-11 years.  No treatment medications were reported.
A 6 year old female was vaccinated with Rabipur (batch 587) 1ml, IM, (deltoid) on 12/20/01 at 17:30, 12/23/01, 12/27/01, 1/3/02 and on 1/19/02, due to a dog bite (3rd category) into the deltoid region of her left arm on 12/19/01 at 10:30. The wound was covered with gauze and a tetanus toxoid was not applied. On 12/27/01, she suffered from a fever; on 1/4/02 she developed convulsion; on 1/15/02 she showed paralytic symptoms and on 1/18/02 she became unconscious. The pt was hospitalized. Some improvement after admission in the hospital on 1/23/02. As on 3/14/02, the pt is unconscious. The stray dog is still alive on 3/14/02 and did not have any symptoms of rabies. On 2/4/02 she was discharged with some improvement. Nasogastric tube feeding. The pt was advised for admission after 1 month follow-up. As of 3/14/02, the pt is unconscious and may be admitted again. Additional info has been requested. Assessment: Seriousness criteria: life threatening; hospitalization. Causality-pending. As no rabies specific immunoglobulin was administered, atypical rabies cannot be ruled out (convulsion, paralysis, fever), though the dog is supposed to be well. As the 5th dose was administered, despite onset of all events reported, it seems that the treating physician did not assume that Rabipur was the cause.
Tdap vaccine given, Patient with h/o fainting with shots, became weak, laid down, had episode of emesis, VSS, patient treated and recovered, mother was present, recovered in stable conditions.
Pt. had redness, swelling and itching at site and surrounding for more than 2 weeks.
The patient developed erythema and swelling of the left thigh at the injection site beginning 24 hours after administration of vaccines.
Patient developed Shortness of breath, fatigue, weight loss, loss of sense of smell, wheezing
Pt exp sudden onset of nausea, vomited times three, cool clammy skin & dry mouth approx 45 mins following dose #1 of Engerix-B; no signs of SOB, wheezing, rash or chest pain; VS WNL;
No adverse symptoms reported; The patient received the first dose of GARDASIL quadrivalent when she was 25 years of age; This spontaneous report has been received from a medical assistant, concerning  a currently 33 years old female patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On an unknown date (also reported as "when she was 25 years of age"),  the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (frequency, anatomical location, lot number and expiration date were not reported) for prophylaxis.   On 15-OCT-2019, she reported that she received her first dose of  quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) when she was 25 years of age. At the reporting time (also reported as "now"), the patient that was 33 years old, would like to continued the series with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration).  No adverse symptoms reported.
8 days after dose 1 of Moderna COVID-19 vaccine developed vertigo with distinct sense of motion even when laying still; accompanied by headache, fatigue, tinnitus, nausea; all symptoms resolved over 5 days EXCEPT tinnitus which has gradually become louder and constant and more annoying.   3 months later tinnitus loud enough to need TV volume louder
No known adverse effects; received a dose of PROQUAD and a dose of VARIVAX; This spontaneous report was received from a licensed practical nurse referring to a child patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 14-DEC-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S013712 with expiration date on 01-NOV-2020; and varicella virus vaccine live (oka/merck) (VARIVAX) lot # S004862 with expiration date on 18-FEB-2021. Both vaccines were administered for prophylaxis, however, for both vaccines the dosage schedule, route of administration and anatomical location were not reported (vaccination error). No adverse event was reported.  This is one of two cases received from the same source.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Chills-Mild, Systemic: Diarrhea-Mild, Systemic: Exhaustion / Lethargy-Mild, Additional Details: diffuse rash over left deltoid region, hot to touch in initial days but has since resolved.