chrisvoncsefalvay/vaers-outcomes huggingface dataset:
piercing sudden pain in her ankle; right leg is feeling funny like a cramping in her lower leg; heart Palpitations; This spontaneous case was reported by a physician and describes the occurrence of PALPITATIONS (heart Palpitations), MUSCLE SPASMS (right leg is feeling funny like a cramping in her lower leg) and ARTHRALGIA (piercing sudden pain in her ankle) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Menopausal (patient is pre-menopausal). Concomitant products included CETIRIZINE for Allergy NOS, ESCITALOPRAM for Anxiety, LOSARTAN for Blood pressure high.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PALPITATIONS (heart Palpitations). On 10-Apr-2021, the patient experienced MUSCLE SPASMS (right leg is feeling funny like a cramping in her lower leg). On an unknown date, the patient experienced ARTHRALGIA (piercing sudden pain in her ankle). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE 325 MG) for Pain, at a dose of 325 mg. On 30-Mar-2021, PALPITATIONS (heart Palpitations) had resolved. At the time of the report, MUSCLE SPASMS (right leg is feeling funny like a cramping in her lower leg) had not resolved and ARTHRALGIA (piercing sudden pain in her ankle) had resolved. Not Provided      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.
After administering vaccination pt asked to stay in pharmacy to monitor. While patient was sitting in waiting area about 10 minutes saw her wiggling so I approached  her and asked if she was doing ok, She said no I am getting like I usually get and did not bring epipen. I asked her if had reaction to vaccines before ? Saw pt flushed and agitated, I asked to remain sitted and offfered some water. Gave a bottle of water and asked her if she would be ok to take zyrtec or benadryl to conteract reaction. or I could call 911 . She agreed to cetirizine and she took it.  Continued to monitor patient , started to calm down a bit. Continued to monitor for 45 minutes , asked if we could call someone to pick her up and she did . Advised pt to seek medical care next day with primary or seek emergency care if needed
The morning of April 3, staff at the Clinic discovered a discrepancy in the preparation of Pfizer vaccine doses. It was discovered that several undiluted vaccine doses were administered. Staff accounted for all unused undiluted vaccine doses. Unfortunately, 10 undiluted vaccine doses had been administered to patients and were not able to be retrieved. This patient received one of the undiluted doses.   The medical team contacted the CDC to determine the potential side effects and observation requirements of receiving an undiluted vaccine. The CDC confirmed that the recipients of the undiluted doses may experience stronger side effects and symptoms than someone who received the diluted dose (sore arm, flu-like symptoms, etc.).  The site public health officer spoke with suspected recipients of the undiluted vaccine to explain potential medical side effects. District will follow up to monitor their status.
pt recvd vax 9OCT95 pt was found unresponsive & pale 11OCT95 hospitalized to r/o infection; evaluated was neg;
Headache turning into a low grade few between 99-101 with chills that lasted until early evening.  Took three course of Tylenol on 4/7 and did light activities the next day.
Patient stated he received vaccine on Saturday 11 Sep 2021 at 1118.  When he arrived home at 1630, he had no energy and was experiencing all over body aches and pain. He went to sleep and didn't wake up until the next morning.  Once he arrived at work the next day he had a severe headache, fever, chills, feeling hot and cold at the same time, loss of appetite and difficulty breathing.  Patient left work at 0720 and went to clinic.
LIGHTHEADED AND DIZZY LEADING TO FAINTING. NEEDED ADDITIONAL OBSERVATION FOR 30 MINUTES AND NO FURHTER MEDICAL ATTENTION
Localized site reaction noted on 2/22/01. Left arm with 2cm reddish, warm, and tender area. Denies itching or fever. No evidence of breathing difficulty at this time and denies ever having any. Full ROM. Treatment: Benadryl prn.
COVID 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID 19) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039d21a) for COVID-19 vaccination.     Concurrent medical conditions included Sleep apnea, Blood pressure high and Drug allergy (Unspecified historical drug.).    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID 19) had resolved.            No concomitant medications were reported.  It was reported that, the patient had rebound COVID after the Paxlovid treatment and no treatment details were provided for the rebound of COVID.  Company Comment: This is a Spontaneous case concerning a 48-year-old male patient, with medical history of Sleep apnea, Blood pressure high and Drug allergy, RITONAVIR as Treatment of COVID-19, unspecified dose and frequency who experienced the non-serious unexpected AESI of COVID-19  in an unknown date in the context of the administration of the 3rd. dose of the mRNA-1273 vaccine (in an unknown dose and schedule of administration). Very limited information is available regarding diagnostic work-up to support the current diagnosis of COVID-19, severity and treatment received. No information regarding relevant lab data and treatment details was provided at this time. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 48-year-old male patient, with medical history of Sleep apnea, Blood pressure high and Drug allergy, RITONAVIR as Treatment of COVID-19, unspecified dose and frequency who experienced the non-serious unexpected AESI of COVID-19  in an unknown date in the context of the administration of the 3rd. dose of the mRNA-1273 vaccine (in an unknown dose and schedule of administration). Very limited information is available regarding diagnostic work-up to support the current diagnosis of COVID-19, severity and treatment received. No information regarding relevant lab data and treatment details was provided at this time. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Lightheadedness, with seizure like symptoms, then fainting, lasted approx 10 sec 911 called; I laid her down on floor with feet raised, the 911 techs took over, ambulance & tech took her from store.
Macropapular rash occurring on back, upper extremities and thighs with flesh colored papules; Macropapular rash occurring on back,upper extremities and thighs w/ flesh colored papules; lesions that have lasted for greater than 3 weeks; This is a spontaneous report from a contactable nurse. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via intramuscular route of administration in the left arm on 16Mar2021 at 14:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included prenatal pills (MANUFACTURER UNKNOWN) and fiber supplement (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously took nifedipine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via intramuscular route of administration in the left arm on 23Feb2021 at 15:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. In Mar2021 (reported as 15Mar2021 at 00:00), the patient experienced macropapular rash occurring on back, upper extremities and thighs with flesh-colored papules and lesions that have lasted for greater than 3 weeks. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event macropapular rash occurring on back, upper extremities and thighs with flesh-colored papules and lesions that have lasted for greater than 3 weeks was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
On 10/19/2020, the morning after receiving the vaccine, patient stated to feel sick. She had fever/chills and felt sick. The next day (10/20/2020), patient broke out in a rash that went from her breast down her abdomen and fully covered her back. Patient went to her family physician on 10/20/2020 who said he suspected this to be an allergic reaction to the vaccine. According to patient, family doctor did not prescribe her any medications as he didn't want to suppress immune response to vaccine.
Pain in shoulder was typical the day of and day after. Two weeks later, on 10/24/21 she experienced a lot of pain in left arm, could not lift above her head.  It subsided over the following days, mobility increased, but still had pain when lifting it above her head.
DEVELOPED A RASH, PHARAMIST ADMINISTER OVER THE COUNTER BENEDRYL
I am having chest palpitations, irregular heartbeats, and SOB and this made it worse because I have asthma. This started in August of 2021.
Pt vaccinatd w/1st dose of Hepatitis B in 1989 developed systemic rxn, later hyperpigmented macular rash on his trunk & axillae; MD felt not related to vax rather incomplete pityriasis rosea; tx Lotrisone;
1 of 3 pts immunized who exp a nodule @ the DTP inject site; also had 1-2" area of induration & erythema; event occurred in this pt w/in 48 hrs of immun;
No problems reported during the 15 minute wait post vaccination but when client got out to her car she reported feeling short of breath, dizzy and tightness in throat.  Nurses assessed, administered Benadryl 50 mg p.o. and transported her back into the clinic via wheelchair for observation. Client reported symptom improvement within 30 minutes post onset and was released to home with her daughter 65 minutes post vaccination. Client was instructed per Dr. recommendation, to take a longer acting antihistimine (Allegra or Zyrtec) to last through the day.  Client was cautioned about drowsiness with the Benadryl and additional antihistimine. She was also asked to check her blood sugar when she got home and to monitor more frequently than normal today. Client was contacted at 5:19 pm today and reports that she is doing well. She did not check her blood sugar until 2 hours post return to home and it was 48. Her provider's nurse and Dr. were contacted during this event.
No adverse effects; the patient inadvertently received an expired dose of VAQTA; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 19-AUG-2019, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA), lot # R018775, expiration date 09-AUG-2019 (strength, exact dose and route of administration were not reported) for prophylaxis. No adverse effects were reported.
Flu-like symptoms - chills, achiness, poor appetite, temp 99.6. Blood sugar 411 (very elevated).
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # M042853 for prophylaxis. On an unknown date the patient experienced incorrect product storage. The outcome of incorrect product storage was unknown.
My aunt got her 2nd shot on 4/7. She was admitted to hospital 4/10 stroke. I am led to believe she spent 2 days on her homes floor between those 2 dates. She has been in a nursing and rehab facility since April 20th and not getting much better. I am convinced that the shot could have put her where she is today. Her insurance ran out early may and this care is costing her money per day with no end in sight. She was an extremely independent woman who lived alone before this happened. Please contact me for more info . This warrants an investigation.
Experienced sudden onset sensorineural hearing loss in left ear starting 8/17/21.  Treated with high dose prednisone x 1 week starting 8/20/21. MRI of brain negative. Lab work negative for Lyme disease .  No improvement following treatment. Hearing in left ear worsened after retesting 2 weeks later.
Fever shortly after vaccine given that is still present 4 days later, body aches, headache, left knee swelling.
This spontaneous report was received from a nurse referring to a 16 year old patient of unknown gender. The patient's medical history, drug reactions/allergies and concurrent conditions were not reported. On 14-NOV-2016, the patient was vaccinated with a dose of VARIVAX lot # L048463, expiration date: 02-DEC-2017 (strenght, dose, frequency and route of administration were not reported) for prophylaxis and then inadvertently received a dose of PROQUAD lot # M022399, expiration date: 01-NOV-2017 (strenght, dose, frequency and route of administration were not reported) for prophylaxis, instead of the intended dose of M-M-R II, because the medical assistant "grabbed the wrong vaccine". No adverse events were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
I had a fever of 101 on February 7. I also had a headache, muscle aches, chills, and fatigue. my arm was very sore. On Feb 10 I developed a large red circle at the injection site and it was quite itchy.
Patient received 0.5ml of Covid vaccine instead of recommended 0.25ml for their age.
Redness, swelling not at the site of injection, it was on the injected arm.
Swelling on injection site; Swelling several inches below injection site; Red inflammation; Red inflammation; Swellings were hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling on injection site), SWELLING (Swelling several inches below injection site), VACCINATION SITE ERYTHEMA (Red inflammation), INFLAMMATION (Red inflammation) and INDURATION (Swellings were hard) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CALCIUM for an unknown indication, CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID).    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling on injection site), SWELLING (Swelling several inches below injection site), VACCINATION SITE ERYTHEMA (Red inflammation), INFLAMMATION (Red inflammation) and INDURATION (Swellings were hard). At the time of the report, VACCINATION SITE SWELLING (Swelling on injection site), SWELLING (Swelling several inches below injection site), VACCINATION SITE ERYTHEMA (Red inflammation) and INFLAMMATION (Red inflammation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications includes:Blood pressure meds Heart meds Meds for restless leg syndrome Osteoporosis meds Antibiotics, there is no treatment povided   Reporter did not allow further contact
Fairly substantial body aches and slight fever. I had a similar reaction with the first shot, only worse. It started about 24 hours after the shot and I thought it was a virus. It was so strong that I went to the doctor thinking I had the flu. 101F fever and major body aches. Same thing this time though and to a lesser degree, so now I think the first incident was due to the vaccination.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/22/2023 CARDIOGENIC SHOCK R57.0 CARDIOGENIC SHOCK 2/27/2023 CARDIOGENIC SHOCK
Sore muscles around injection site, about 3 inch diameter, for about 5 days.  My Chronic Fatigue Syndrome makes me a slow healer, so I'm not surprised I hurt more than average and for longer.
allergic reaction; Itching in the Lips and entire body; Swollen Lips Feeling ( in the mirror they did not appear swollen); This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergic reaction), PRURITUS (Itching in the Lips and entire body) and LIP SWELLING (Swollen Lips Feeling ( in the mirror they did not appear swollen)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic shock.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ALLERGY TO VACCINE (allergic reaction), PRURITUS (Itching in the Lips and entire body) and LIP SWELLING (Swollen Lips Feeling ( in the mirror they did not appear swollen)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency. On 13-Feb-2021, ALLERGY TO VACCINE (allergic reaction), PRURITUS (Itching in the Lips and entire body) and LIP SWELLING (Swollen Lips Feeling ( in the mirror they did not appear swollen)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Her Allergist told her that she might be allergic to PEG2000 in Moderna COVID-19 vaccine and recommended to get the Johnson & Johnson Vaccine (does not contain PEG) as the second shot.
This spontaneous report received from a patient concerned a male 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, the patient experienced irritable bowel syndrome. On JAN-2022, Laboratory data included: Laboratory test Negative, Negative, Negative. Laboratory data (dates unspecified) included: Weight loss losing 20 LBS. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from irritable bowel syndrome. This report was non-serious. Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
parents took pt home following clinic; pt immed took nap, sleeping for several hrs & upon awakening, parent noted rt leg to be swollen from hip to ankle & pt would not bear weight; took to ER that PM; no treatment; next day swelling gone;
pt recv vax;had fever of 102; HA, body aches, chills & induration & erythema at inject site;white blood cell count 31,000; required 2 visits to er;
I95.9 HYPOTENSION 5/2/2023 HX OF SUBSTANCE USE DISORDER
severe edema over lt deltoid muscle (site of inject), erythema & pain down to elbow;
The patient stood up after vaccine, did not feel well, had a seat and then fell forward onto the floor because she passed out.
Approximately 5 minutes after receiving vaccine, patient developed numbness and tingling around her mouth, inside her mouth and in her throat. She did feel like it was difficult to swallow due to not being able to feel the inside of her mouth, but denied any swelling. BP was elevated initially to the 170s/90s, SpO2 remained >92 throughout. Lungs were clear on exam, there was no asymmetry to her face and no visible swelling. She was given 50mg IM Benadryl and symptoms improved within 20 min. She was advised to take another 50mg of Benadryl at home and go to ED if symptoms returned. Symptoms did not return, but one day after vaccine did develop mild diarrhea.
It is now one big mass; it "welted up"; welts are now hard to touch; red; rash; throat felt like it was clogging up; "itched like crazy"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (throat felt like it was clogging up), VACCINATION SITE MASS (It is now one big mass), VACCINATION SITE RASH (rash), VACCINATION SITE PRURITUS ("itched like crazy") and VACCINATION SITE URTICARIA (it "welted up") in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Acid reflux (oesophageal), Hypotension, Cholesterol, Penicillin allergy, Seasonal allergy and Hay fever. Concomitant products included OMEPRAZOLE for an unknown indication.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced VACCINATION SITE PRURITUS ("itched like crazy"). On 23-Jul-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (throat felt like it was clogging up). On 28-Jul-2021, the patient experienced VACCINATION SITE RASH (rash). On an unknown date, the patient experienced VACCINATION SITE MASS (It is now one big mass), VACCINATION SITE URTICARIA (it "welted up"), VACCINATION SITE INDURATION (welts are now hard to touch) and VACCINATION SITE ERYTHEMA (red). The patient was treated with CORTISONE for Rash and Itch, at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL DISCOMFORT (throat felt like it was clogging up), VACCINATION SITE MASS (It is now one big mass), VACCINATION SITE RASH (rash), VACCINATION SITE URTICARIA (it "welted up"), VACCINATION SITE INDURATION (welts are now hard to touch) and VACCINATION SITE ERYTHEMA (red) outcome was unknown and VACCINATION SITE PRURITUS ("itched like crazy") was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been received from a physician concerning a 18 year old female with no allergies reported and a history of high pelvic pressure especially with menses who on 02-AUG-2007 was vaccinated with a first dose of GARDASIL (lot number: 658222/0927U) in the left deltoid. On 11-OCT-2007, the patient was vaccinated with the second dose of GARDASIL (lot number: 658554/0928U) in the left deltoid and on 12-FEB-2008 the patient received the third dose of GARDASIL (lot number not reported) in the left deltoid. Suspect vaccine included a dose of MENACTRA in the right deltoid on 02-AUG-2007 (lot number: U2340CA). There was no concomitant medication reported. There was no illness at the time of vaccination. On 07-OCT-2008 the patient experienced ovarian cyst and required emergency room visit. The physician reported that the patient removal ovarian cyst 12X12X9cm after history of pelvic pressure especially with menses and the cyst was benign. At the time of the report the outcome of the patient was unknown. No further information is expected.