chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very sore left arm after the second vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore left arm after the second vaccination) 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 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (very sore left arm after the second vaccination). At the time of the report, PAIN IN EXTREMITY (very sore left arm after the second vaccination) outcome was unknown.            No concomitant medications were provided by the reporter.  Treatment information was not provided.
3 days p/receiving vax pt had a sudden episode of stiffening whole body, legs red, frothing @ mouth lasted 5 mins; taken to ER;
This spontaneous report as received from an other healthcare worker refers to an unspecified number of patients of unknown age and gender. No information on patients' pertinent medical history, drug reactions or allergies was provided. On an unknown date, multiple unspecified patients were vaccinated with a doses of RECOMBIVAX HB (lot # M0101671, expiry date 02-JUN-2018) that were improperly stored. Concomitant therapies were not provided. No adverse effects were reported. This is one of several reports from the same reporter source. Additional information has been requested.
Patient inadvertently received Kinrix instead of Infanrix.  Patient had received 3 prior doses of both DTaP and IPV in combination of Pediarix.  Kinrix is not currently approved for children under 4 years; however, upon research into the potential effect of the vaccine in the 15-18 month age group, no untoward events are expected.
pt return to clinic PM w/ c/o swollen rt leg, red & tender to touch, crying/irritable examined pulses;tx cool compresses APAP;f/u 2MAY97 pt fussy when leg is touched, swollen & warm to touch;
Rash and irritation started to back and neck approximately 3 hours after vaccine. Soreness to vaccine site started at the same time.  No other complaints.
Product temperature excursion issue; This non-serious case was reported by a other health professional and described the occurrence of intercepted product storage error in a patient who received DTPa (Infanrix) (batch number A5573, expiry date 13-JUL-2025) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number A32BB, expiry date 10-AUG-2025) for prophylaxis, DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis, HAV (Havrix) (batch number 2YS34, expiry date 02-MAR-2025) for prophylaxis, HBV (Engerix B) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis, Hib (Hiberix) (batch number G3453, expiry date 12-NOV-2024) for prophylaxis, Men ACWY-CRM NVS (Menveo) (batch number 9C2KP, expiry date 31-DEC-2024) for prophylaxis, Men B NVS (Bexsero) (batch number 2X955, expiry date 31-JAN-2026) for prophylaxis and Rota (Rotarix lyophilized formulation) (batch number Y4NG3, expiry date 03-OCT-2025) for prophylaxis.   On an unknown date, the patient did not receive Infanrix .5 ml, Pediarix .5 ml, Kinrix .5 ml, Havrix .5 ml, Engerix B .5 ml, Hiberix .5 ml, Menveo .5 ml, Bexsero .5 ml and Rotarix lyophilized formulation .5 ml. On an unknown date, an unknown time after receiving Infanrix, Pediarix, Kinrix, Havrix, Engerix B, Hiberix, Menveo, Bexsero and Rotarix lyophilized formulation, the patient experienced intercepted product storage error (Verbatim: Product temperature excursion issue).  The outcome of the intercepted product storage error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 4-Oct-2023 The pharmacy technician reaching out to GlaxoSmithKline to inquired about a temperature excursion and to verify validation of stability. There were several GlaxoSmithKline vaccines that were affected. Excursion started on 30th September 2023 at 7:21 pm 8.0 C thru 1st October 2023 11:55 pm reaching 28.5C. The several GlaxoSmithKline vaccines had temperature excursion and all medications had been removed to recommended storage and quarantined, which led to intercepted product storage error.
One hour after getting the 3rd dose of the vaccine, I was at the store and I got very dizzy. I managed to get home during the dizzy period which lasted for the rest of the day. The next day I felt better. On the second day after the shot I got vertigo and everything was spinning. I was diagnosed with Acute Vertigo I was taken to the hospital and the Vertigo lasted for three days. I could not do anything and I was in the hospital for four days. I was prescribed a medication Meclizine. I am still experiencing dizziness and I have to move slowly especially when I stand up.
fatigue, chills, muscle aches, nausea, vomiting, joint pain, lymph node swelling
Right arm -severe pain at injection site with redness started by 4pm on 5/17 at Pneumovax site. Left arm developed redness at Zostavax injection site next am with "heat in it".
Received High dose flu shot 9/9/11 within 12 hr had chest pain, hoarseness, wheezing, decreased movement arm/shoulder, decreased movement in face, body ache, tongue swelling. Daughter reporting.
chicken poxn(bumps with pus) first & some itchy reddish bumps 6 weeks later after chicken pox. First treatment was a antibiotic name unknown for 10 days. 2nd visit to dermatologist  practitionerfor triamcinolone acetonide cream 0.1%
12NOV91 became congested suctioned for lg amt thick mucus & peaches x 2 @ 210 & 545PM, also had emesis 545PM t103.3 R; transferred to Hosp & was admitted w/pneumonia & peripherial vascular disease;
Pt rec. seasonal influenza IM vaccine on 10/29/09 @ 08:45.  Mom called office at 14:00, Pt with generalized hives, fussiness, coughing, increased mucus production.  Advised mom to take pt to ED.  11/05/09 and 04/01/10 MR received for DOS 10/30/09. DX: Medication adverse effect, persistent vomiting. Pt c/o vomiting, diarrhea, cramping. Tx: Zofran. Pt with clear liquid diet. Pt discharged home.
Tingling shock sensations, followed by temporary paralysis of face, hands and legs. Unable to speak clearly. Onset while operating motor vehicle. Fever and chills. Wife called paramedics, but couldn't properly speak, so she couldn't explain exactly what had happened. recovered at home. Use of body recovered after about four hours.
11/13: Pain in left lymph node, temp 100.3 11/14: Pain in left lymph node, sore throat, diarrhea,  temp 99.9 11/15-11/17: Sore throat, white spots in throat, tested negative for Strep, Flu, Covid at Dr's office 12/4-12/8: Sore throat, no white spots. Negative for Covid. 12/28-1/11: Sore throat, post nasal drip. Negative Covid test.
arm was bruised; My arm was swollen; m delayed injection site warm; delayed injection site red; delayed injection site itchy; delayed injection site rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB INJURY (arm was bruised), PERIPHERAL SWELLING (My arm was swollen), VACCINATION SITE WARMTH (m delayed injection site warm), VACCINATION SITE ERYTHEMA (delayed injection site red) and VACCINATION SITE PRURITUS (delayed injection site itchy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB INJURY (arm was bruised), PERIPHERAL SWELLING (My arm was swollen), VACCINATION SITE WARMTH (m delayed injection site warm), VACCINATION SITE ERYTHEMA (delayed injection site red), VACCINATION SITE PRURITUS (delayed injection site itchy) and VACCINATION SITE RASH (delayed injection site rash). At the time of the report, LIMB INJURY (arm was bruised), PERIPHERAL SWELLING (My arm was swollen), VACCINATION SITE WARMTH (m delayed injection site warm), VACCINATION SITE ERYTHEMA (delayed injection site red), VACCINATION SITE PRURITUS (delayed injection site itchy) and VACCINATION SITE RASH (delayed injection site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Systemic: Allergic: Itch Generalized-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: vasovagal syncope-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Pt received 2nd dose of Moderna 0.5ml IM to right deltoid. He then sat in a chair. After approx 5 min. pt was extremely pale and started leaning to one side. Pharmacist got to pt & his eyes were closed and he was sweating profusely. After saying his name he opened his eyes and was responsive but dizzy/lightheaded. Pt was assisted to a bench (6ft away) and lied down with legs slightly elevated. Pt was given apple juice. His hands started to itch so Benadryl 25mg was given. Monitored for 30min
Headaches, nervous condition, high blood pressure, sleep apnea, running nose, stomach condition, bipolar condition, depression, skin acne.
A report was received from a health care professional in the USA on 7/5/04 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 10/28/03. This report was received as follow up and involves a group of 10 children under the age of 4 who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.
This spontaneous report was received from a medical assistant and refers to a 73-year-old female patient with drug reaction/allergy to penicillin (unspecified), sulfa, iodine, tetracycline, diphenhydramine hydrochloride (BENADRYL), aspirin (manufacturer unknown) (captured in MARRS # 1706USA009785), tramadol, ibuprofen (MOTRIN), diltiazem, citalopram hydrobromide (CELEXA) and erythromycin. No information regarding the patient's pertinent medical history and concomitant medications was reported. On 01-JUN-2017, the patient was administered a dose of PNEUMOVAX 23 injected intramuscularly in the right upper extremity (lot # N004564 with expiration date at 22-OCT-2018; dose and exact anatomical location were not reported), for pneumonia prevention. On 02-JUN-2017, the patient called the office reporting that she developed redness and swelling at the injection site in the right upper extremity. On the same date, the nurse practitioner instructed the patient to use warm compresses on that site and take acetaminophen (TYLENOL) as a treatment. On 03-JUN-2017, the patient was seen at unspecified emergency room, due to above noted adverse reactions. While being at the emergency room, the patient was diagnosed with cellulitis at the PNEUMOVAX 23 injection site and she was given clindamycin as a treatment. The reporter stated that the patient was not admitted to the hospital and on 03-JUN-2017, the patient was discharged from the emergency room. The outcome of redness and swelling at the injection site, as well as, cellulitis at injection site was reported as not recovered at the time of the report. The causality assessment between aforementioned events and the vaccination with PNEUMOVAX 23 was not reported. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA009785:
I started having breast tenderness on 5/14/2022. On 5/15/2022, I had vaginal bleeding. I went the doctor and discovered my base fell. I was hospitalized. Some days later I had very massive bleeding at home which caused me to go back to the doctor. I had a transfusion and my base line fell again. I had a total of 3 transfusions. They did not find any cancer or anything causing the bleeding. I had a D&C which stopped the bleeding.
Baby started crying soon after vaccines given. Given at 11:30 AM. Seen back in office at 4:30 PM still crying. Mom gave TYLENOL 160/5 1/4 tsp at 2:30 pm. No swelling or redness of legs. Child given bottle & ate well. Mom to f/u in AM - Ice to legs, TYLENOL q 4h. Mom no show next day. Called & said baby did well after leaving office.
Approx 2 inch in diameter redness, pain, hot to touch at injection sight.  Pain lifting left arm. Average fever of 101.5 since day 1.  Only way to keep fever down is to alternate Tylenol and motrin every two hours.  Back pain and muscle aches.
A non-serious spontaneous report of sore throat, body aches and low grade temperature has been received from a consumer concerning a 43 year-old female, subsequent to FLUMIST. No medical history or concomitant medication information was provided. The patient received FLUMIST on 5-Nov-2008. Less than 24 hours after receiving FLUMIST, the patient reported developing symptoms of sore throat, body aches and low grade temperature. The outcome of these events was not reported. The causality was not reported.
Dizziness, pruritis of the face and neck, globus sensation, nausea / vomiting, hypertension.  Treated with 50mg Diphenhydramine IM, patient's symptoms subsided within 15 minutes of administration.
Adverse events:   Fever (104 degrees Fahrenheit unresolved by medication)  Fatigue Weakness Confusion  High Blood Glucose (350)  Loss of motor control (shaking, inability to hold posture or to sit, stand, or walk without assistance)  Elevated white blood cell count Low blood sodium  Lab results indicating liver health were not good Jaundice  Treatments: IV saline solution, antibiotics, steroids, increase Prednisone, change intake of insulin Outcome: The patient returned home after a week of hospitalization experiencing less confusion and no fever. Motor function has improved since hospitalization and complexion shows less jaundice. Liver numbers have improved and the patient has decreased Prednisone dose. The patient still experiences fatigue and body weakness.
Shortly after vaccination, Patient had a vasovagal response and subsequently vomited. Patient's vitals were stable and quickly recovered. Did not lose consciousness.
could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself.  This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.
Death occurred on 01/14/2022, tested positive for COVID-19 post-mortem on 01/14/2022, had been exposed to COVID-19 in household for 3+ weeks, received booster vaccination on 01/11/2022 (had NO prior COVID-19 vaccinations).
Severe dizziness; nausea; severe headache; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 31Mar2021 at 16:45 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder and latex allergy since an unknown date. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 17:30, the patient experienced severe dizziness, nausea and severe headache. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Patient did not receive any treatment for the events. The clinical outcome of the events severe dizziness, nausea and severe headache were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Vertigo. Brain fog. Palpitations. Cough. Muscle aches. Confusion. Insomnia.  Exhaustion. Bloating.
first dose of vaccine administered after excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) had resolved.        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.   No concomitant medications reported.  It was reported that approximately 250 to 300 hundred patients were administered  with first dose of the Moderna COVID-19 vaccine.  Treatment information not reported.   This case was linked to MOD-2021-250688 (Patient Link).
felt shakey & weak; went home from work; felt sick/vomiting, fever of 103, tired following day;
having some side effects such as diarrhea; feeling really tired and I fall asleep; I am feeling weak; feeling a little hot; Dizzy; This is a spontaneous report from contactable consumer (Patient). A 46-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, and Lot number: EW0187) via unspecified route of administration, administered in left arm on 01Jul2021 10:10 (at age of 46-year-old) as dose 2, single for COVID-19 Immunization. Patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were none. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0173) via unspecified route of administration in left arm on 10Jun2021 (at age of 46-years), as Dose 1 single, for COVID-19 Immunization. On 01Jul2021, the patient stated that she received the second dose yesterday and she had been having diarrhea ever since, it had not stopped and she was feeling weak, it seems like anything that she eats or drink it just did not stay in her stomach and she asked that what should she do and how long was this going to last. On the same day, the caller stated that she was feeling dizzy and weak; she was feeling really tired, and she fell asleep, and when she woke up, she was feeling a little hot, but she washed her face to cool off and she was okay. She was asking for recommendations on what she should do about the side effects she was experiencing. The caller was still experiencing events and was enquired about how long this was going to last. Patient did not receive treatment for events. The outcome of event feeling hot was considered as resolved, on an unspecified date in Jul2021, while the outcome of the rest of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.
Pt got routine BOOSTRIX vaccine at his request due to hand laceration when working on his lawnmower (time approx 11am). Pt was requested to wait in store for at least 20 minutes. After approximately 10 minutes (time approx 11:10-11:15), pt returned to pharmacy, stated he was starting to have trouble breathing. Rph had pt lie on floor and had technician call 911. Pt breathing became more labored and face had some swelling and hands were drawing closed. Rph administered at dose of epinephrine 0.3mg via pen in right thigh (through clothing) at 11:22am. Epinephrine worked quickly, pt breathing began to slow and hands began to relax. EMS arrived and took over with patient and recommended pt go to hospital. Pt was alert and oriented when he was taken away.
Tdap given 6/17/14 at 6 PM at 610 pt stated she was having a reaction. (L) deltoid swollen and hard. No redness seen Dr evaluated area - determined it looked like a muscle spasm. Ice applied - swelling looked to increase. Warm compress applied. pt felt a little better - discharged at 625 with hot/cold packs. Advised to alternate cold/hot pks - and to take ADVIL if needed.
Headaches, body aches and tiredness.  Rest at home. Treated with Acetaminophen 500 mg, 2 tabs ,orally q6hrs PRN
Patient woke up Saturday am and right foot felt like it was sprained, painful at ankle joint, slightly red. Sunday morning, she could not put any weight on right foot, more red/all toes red (except one), redness is traveling down right big toe, right foot appears slightly swollen.