chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt went home and got nauseated. It also got swollen and red that same night. It is tender to touch.
unable to walk; osteoarthritis; most horrible pain experienced in whole life; swollen lymph nodes of the left arm; severe pain from hip to knee in both legs; severe pain in both shoulders to elbow in both arms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT INABILITY (unable to walk), OSTEOARTHRITIS (osteoarthritis), PAIN (most horrible pain experienced in whole life), ARTHRALGIA (severe pain from hip to knee in both legs) and ARTHRALGIA (severe pain in both shoulders to elbow in both arms) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A) and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer. Concurrent medical conditions included Drug allergy (Prednisone), Drug allergy (Dilaudid) and Drug allergy (sulfa drugs). Concomitant products included LETROZOLE (FEMARA) for Breast cancer, ROSUVASTATIN for Cholesterol, OMEPRAZOLE for an unknown indication, METOPROLOL.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced ARTHRALGIA (severe pain from hip to knee in both legs) and ARTHRALGIA (severe pain in both shoulders to elbow in both arms). On an unknown date, the patient experienced GAIT INABILITY (unable to walk), OSTEOARTHRITIS (osteoarthritis), PAIN (most horrible pain experienced in whole life) and LYMPHADENOPATHY (swollen lymph nodes of the left arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; Physical therapy (HEATING PAD) for Gait inability; Physical therapy (HEATING PAD) for Osteoarthritis; Physical therapy (HEATING PAD) for Pain; Physical therapy (HEATING PAD) for Arthralgia and Physical therapy (HEATING PAD) for Lymphadenopathy. At the time of the report, GAIT INABILITY (unable to walk), OSTEOARTHRITIS (osteoarthritis), PAIN (most horrible pain experienced in whole life), ARTHRALGIA (severe pain from hip to knee in both legs), ARTHRALGIA (severe pain in both shoulders to elbow in both arms) and LYMPHADENOPATHY (swollen lymph nodes of the left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vitamin B12: other (Inconclusive) vit B12 levels.         Patient has taken Tylenol but it didn't work well and used heating pad which help her to relieve pain symptoms. She began deep muscle massage. Health care provider advise not to take moderna covid 19 vaccine again. she doesnot have any kind of symptoms for dose 1
Underarm swelling; This is a spontaneous report from a contactable consumer (patient). This (age: 74; Unit: Unknown) female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on Thursday, 11Feb2021 09:00 (Batch/Lot Number: EM9809; Expiration Date: 30Jun2021) as DOSE 2, SINGLE for covid-19 immunisation. There were no medical history and concomitant medications. Patient previously took first dose of bnt162b2 (Lot number: EL8982, Expiration Date: 31May2021) administered in Left arm on 21Jan2021 for covid-19 immunisation. It was reported that the patient has had both doses of the COVID Vaccine. After the second dose she started to experience under arm swelling in the arm that she received the vaccine, the left arm. She noticed this around 6PM on 14Feb2021. She confirmed she had no reaction with the first dose. The event did not require Emergency Room and Physician's Office visit. None of the additional vaccines administered on the same date of the Pfizer vaccine considered as suspect. The patient had not received any other vaccine within 4 weeks and did not have any adverse events following prior vaccinations. She questioned if this was a common side effect. Stated she did not see it listed as a common side effect. Outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
UNUSUAL  FATIGUE; HEADACHE; SEVERE VERTIGO; DIZZINESS; This spontaneous report received from a patient concerned a 60 year old female. 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced severe vertigo. On 06-APR-2021, the subject experienced dizziness. On 10-APR-2021, treatment medications included: cortisone. On an unspecified date, the subject experienced unusual fatigue, and headache. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe vertigo, and had not recovered from unusual fatigue, headache, and dizziness. This report was non-serious.
chills; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (slight fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, SERTRALINE and BUPROPION for Antidepressant therapy, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT RESPIMAT) for Asthma.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced CHILLS (chills) and PYREXIA (slight fever). At the time of the report, CHILLS (chills) and PYREXIA (slight fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-104036 (E2B Linked Report). This case was linked to MOD-2021-104078 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-104036:dose 2
I just need to lay down I can barely sit up; Headache; I wasn't feeling good; My body is sore; Fever of a 101°F; Diarrhea; I threw up a little bit in the bathroom; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 31Dec2020 for Covid-19 immunisation.  Medical history included Covid-19 in Aug2020. Concomitant medications were not reported.  The patient stated that, on 04Jan2021 developed headache, I wasn't feeling good, my body is sore, fever of a 101°F, diarrhea, I threw up a little bit in the bathroom. The patient also reported that "I just need to lay down I can barely sit up on an unspecified date. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Bruising on both legs since Saturday 1-23-2021. No pain, no bleeding. Only bruises.
About 30 minutes after the vaccination,  I started to feel dizzy, light headed,  and my bottom lip started to tingle and my mouth begin to water.  I also started to notice thickening and drainage in the back of my throat.   I took a Claritin.   When I got home, I was still feeling dizzy and feeling tingling on my bottom lip.  The next day, I was still feeling fatigue and tingling in lips and took another Claritin.  A fews days later at work, I went to work and I was feeling light headed.  My BP was low and my heart rate was high and feeling dizzy.  I also starting having chest pains and pains in my arm and I felt like my skin was crawling.  I called 911.  At the ER, they did blood work,  EKG, and cardiac enzymes.  The blood work came back low in potassium and gave me potassium.  All the other tests came back normal.  The cardiac issues resolved in 2 days, but the other symptoms persisted (lips tingling and skin crawling).   It took about 3 weeks for all symptoms to resolved.  I did go see a neurologist who ruled out any neurological conditions.  I also noticed I am now allergic to peanuts and  hazelnut- oral itching, tingling and increase in phlegm and draining.
headaches; he was dizzy; This is a spontaneous report from a non-contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID--19 VACCINE, Lot number was not reported), via an unspecified route of administration on Jan2021 as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got Pfizer-BioNTech Covid-19 vaccine in Jan2021. He haven't had any problems, until about 2 months ago (2021). The patient started having headaches and he was dizzy. He has had an MRI, EEG, wore a heart monitor, and a carotid artery check and they can't find anything wrong. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Hashimoto's Thyroiditis; patchy redness on my cheek; rash; welts; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), via an unspecified route of administration on an unspecified date as 1st dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced after the first dose on the 3rd day, she had patchy redness on cheek, then had a rash on her face from earlobe to the other earlobe. It started out as red spots that it's so bad that it welts together. It went down on her neck and she had one spot that stayed on her face and one spot on chest and a rash on face. After the 1st dose, she went to a dermatologist and he put to patient on a topical steroid cream and steroid tablet for 5 days. After she had the 2nd vaccine, she didn't have an outbreak until 2 weeks after because she still had that steroid in her system, she believes. The patient had a sore in mouth after the 2nd outbreak. It was also on lips during 2nd one. The patient stated that her lips were really dry, so it was possibly her body just being run down. About 5-6 days ago, she had a rash, but it has appeared only on my lips. Each time she got this outbreak, she had chills for 4 hours and a low-grade fever. Now it's on her lips and on the outer rim of my lips. She will go to the dermatologist. She also had Hashimoto's Thyroiditis, which reduces her immune system. She has been to urgent care, to HCP, and she stated that it was her 3rd trip to the dermatologist. The outcome of the events was reported as an unknown.   Information on the lot/batch number has been requested.
One day after receiving Pneumovax 23 injection right arm (deltoid) the pt noticed right anterior upper arm to be bright red, hot to feel and swollen. 2nd day after RC for eval reported arm very improved, less red, no swelling, not hot. The pt never had pain or fever. The redness never came within 7cm of injection site. reaction was distal to injection. Tx. started with anti-inflammatory cream, pt declined.
flushing; warm; light headed; heart racing; heart palpitations; nurse said she was red; muscular dystrophy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Lot number: ER8736) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BACLOFEN; CLONAZEPAM; DULOXETINE DR; LEVOTHYROXINE; TIZANIDINE; VARENICLINE. Vaccination history included: Bnt162b2 (Dose 1, LOT#, Consumer stated, "The first one is EW0150), administration date: 07Apr2021, when the patient was 54 years old, for Covid-19 immunization. The following information was reported: FLUSHING (non-serious), outcome "recovered", described as "flushing"; FEELING HOT (non-serious), outcome "recovered", described as "warm"; DIZZINESS (non-serious), outcome "recovered", described as "light headed"; PALPITATIONS (non-serious), outcome "recovered", described as "heart racing"; PALPITATIONS (non-serious), outcome "recovered", described as "heart palpitations"; ERYTHEMA (non-serious), outcome "recovered", described as "nurse said she was red"; MUSCULAR DYSTROPHY (non-serious), outcome "unknown", described as "muscular dystrophy". Therapeutic measures were not taken as a result of flushing, feeling hot, dizziness, palpitations, palpitations, erythema, muscular dystrophy. Additional information: Caller is a female consumer who states she had a reaction with both doses of the Pfizer Covid 19 vaccine. With the first dose she experienced after 5-10 minutes flushing, light headed, heart racing, and heart palpitations. It was thought at the time that it was a phycological reaction to the injection. When receiving the second dose she informed the nurse of her previous reaction and they stated it was probably a reaction to the needle but patient reports not having a problem with needles. She relays that almost immediately after the injection the same symptoms began as well as she described it to when you have a CT scan with iodine and you feel flushed and warm. She states that she nurse said she was red. She waited at the doctor for 1 hour after injection. Reaction lasted about 45 minutes. Her nurse practitioner did not recommend that she get any further doses. The doctor stated that since they did not have baseline vitals prior to the injections to compare her post injection vitals to that they cannot made the decision on if she should or should not receive a booster dose after these reactions. She would like to know if these are common reactions and if she should receive a booster dose after these reactions with the initial series?  No follow-up attempts are possible. No further information is expected.
Patient states she had partial arm paralysis of right arm(proximal) for 2.5 hours after leaving the store. She also experienced pain and inflammation in the distal right arm. She went to the emergency room where she was diagnosed as having an allergic reaction to the Prevnar 13 vaccine. No further treatment. Patient has since recovered completely.
Pt vaxed w/Hep B vax (recomb) one half the usual dosage on 30OCT90 & 31OCT90; 27NOV90 pt recd 2nd dose of vax 1ml; @ time of the report there was no adverse rxn; No further details were provided;
Patient passed out for about 30 seconds 2 minutes after getting the vaccine. Patient is coherent and back to normal after regaining consciousness.
Pt. reported tingling in hands and then a warm feeling over body. Pt. taken to treatment room and vitals taken. Pt. placed in chair and leaned back with legs lifted. Pt. reports symptoms improving and feeling better. Pt. Dc'd home with mother.
The vaccine got expired on 11-Feb-2023 and was intially stored in the refrigerator after expiry; No adverse event; 6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vaccine got expired on 11-Feb-2023 and was intially stored in the refrigerator after expiry) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine got expired on 11-Feb-2023 and was intially stored in the refrigerator after expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vaccine got expired on 11-Feb-2023 and was intially stored in the refrigerator after expiry) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vaccine got expired on 11-Feb-2023 and was intially stored in the refrigerator after expiry).    No concomitant medications was reported. Nurse reported that 6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine after 11-FEB-2023. The case involved was combination of first dose and some 2nd primary doses.  The Intact Carton vial size was unknown. Date the vial was initially stored in the refrigerator were 1 vial on 16-FEB-2023; 1 vial on 02-MAR-2023 and 1 vial on 09-MAR-2023. Date(s) of administration of vaccine were 1 Patient on 16-FEB-2023; 2 Patients on 02-MAR-2023; 3 Patients on 09-MAR-2023. The vial did not undergo any temperature excursions. No treatment drug details was reported. This case contains information for the 6th patient out of 6 child patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-715544, US-MODERNATX, INC.-MOD-2023-715549, US-MODERNATX, INC.-MOD-2023-715550, US-MODERNATX, INC.-MOD-2023-715551, US-MODERNATX, INC.-MOD-2023-715545 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715544:Patient 01 (Master case) US-MODERNATX, INC.-MOD-2023-715550:Patient 3 US-MODERNATX, INC.-MOD-2023-715549:Patient 4 US-MODERNATX, INC.-MOD-2023-715551:Patient 5 US-MODERNATX, INC.-MOD-2023-715545:Patient 2
Administered only the adjuvant; Administered only the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2021, the patient received Shingrix. On 9th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided are as follows: The age at vaccination was not reported but patient was older than 50 years old. Pharmacist reported that a nurse from the facility he works at, administered only the adjuvant AS01B from a Shingrix vaccine to a patient, which led to  inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up. The case was linked with case US2021192917 and US2021192920 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192917:Same reporter. US-GLAXOSMITHKLINE-US2021192920:Same reporter.
Slight headache initially.  Over next few days, redness and swelling at injection site.  Heart skip, double beat, hoarse voice and laryngitis by 1/27.  Lasted 3 days, and currently STILL have hoarse voice.  Hear issues stopped finally.  Sore throat now as well.
Suddenly after administering last vaccine MMR around 11:10 AM child experienced a general body rigidity and eyes were noted open but fixed. Was not responsive during this time, suddenly recovered at (sec. later) crying saying "she was scared". Ice packs were placed on neck area. Laid her down on floor with feet elevated. Sent to be evaluated by Hospital. Immediately, after placing last vaccine (MMR) pt. said "it hurts" then child experienced a general body rigidity and her eyes were noted to open but fixed, she was not responsive during this time, this reaction lasted about 10 seconds, as she suddenly recovered, she started crying, stated "she was very scared" mom holding in her arms during this time, then we laid her down on a matt on the floor and elevated her feet. Her B/P was 90/80 and pt. appeared pale. Pt. described experiencing a moment of total black out. Ice packs were positioned on neck area and forehead. Also juice given which she tolerated well. She started regaining pink color on her face and at this time she was verbalizing she was feeling much better. This all was about 10 minutes after reaction. B/P was retaken 100/80. We retained the pt. of total of 30 minutes before letting her go. Pt. was reported "not feeling quite herself and felt nauseous and denied any other symptoms. Due to her complaints, mother to take her to hospital ER for evaluation. We offered to call 911, but mother declined and chose to drive her herself. Pt. left with holding mom's arm and with good spirits, smiling, no problems noted ambulating.
Varivax vaccine was administered following a supported temperature excursion; This spontaneous report was received from a other health professional referring to a 4-year-old male patient. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.     On 26-AUG-2021, the patient was inadvertently administered with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, dose, route of administration, and anatomical location were not reported; lot number T038830 had been verified to be a valid number; expiration date 17-NOV-2022); following a supported temperature excursion on 28-JUN-2021 (product storage error). It was reported the temperature excursion was at 8.4 degrees Fahrenheit (F) for a time frame of 1 hour 30 minutes and 0 seconds. No had previous temperature excursion.
This spontaneous case reported by a dentist (subsequently medically confirmed), describes the occurrence of diarrhea (diarrhea, after 7 hours of injection, passed 5-7 times a day) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization.  The patient's past medical history included no adverse event. On Jan 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Jan 19, 2021,  after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced diarrhea (diarrhea, after 7 hours of injection, passed 5-7 times a day). At the time of the report, diarrhea (diarrhea, after 7 hours of injection, passed 5-7 times a day): resolving. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. The reporter did not provide any causality assessments or concomitant medications. Patient took loperamide to treat symptoms of diarrhea. Now it's much less only 2 times a day.