chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it's been more than 35 days since caller got the first dose and still does not have the second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (it's been more than 35 days since caller got the first dose and still does not have the second) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (it's been more than 35 days since caller got the first dose and still does not have the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (it's been more than 35 days since caller got the first dose and still does not have the second) had resolved.            Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.  Patient wants to get the second dose of the Moderna COVID-19 vaccine, but patient lost the appointment for the second. It was reported that patient had to wait to start all over again.
Day #1 Right arm site bright red rash Day #2-4 Entire right arm red and fever Day #5 Became short of breath and weak all over and fever.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored M-M-R II (lot # L036851 with expiration date 23-SEP-2017 and lot # 037356 with expiration date 28-SEP-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
SPENT THREE STRAIGHT DAYS IN EMERGENCY ROOM; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced spent three straight days in emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of spent three straight days in emergency room was not reported. This report was non-serious.; Sender's Comments: MAC; V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Received both immunizations on 4-15-19, then on 4-21-10 pt. complained of injection site itching. (Right thigh) when mom looked she could see red rash all over thigh, that then spread over body.
PNEUMOVAX administered 8/2/16 to right deltoid. Presented to office 8/4/16. Injection site erythema, edema and warmth noted.
She developed high fever and body aches, and so on 10/30 she went and had a positive COVID-19 test. She continued to have ear pain, cough, headache. She seemed to get better for one day or two earlier this week, but symptoms got worse yesterday. She had a Tmax of 103.6 last night. Her cough is worse, she is getting thick brown mucus production but then came back. . has loss of taste and smell and diarrhea..
Received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021 at 3:49 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 17-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Non-significant follow-up received includes reporters address updated and email address confirmed.
Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 13-JAN-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Information has been received from a consumer for the pregnancy registry concerning her 25 year old daughter, who was vaccinated with the first dose of GARDASIL (Lot and batch # not reported).  It was reported that the patient got her GARDASIL vaccine "two weeks ago", was tested and had negative pregnancy test, now has found she is six weeks pregnant, "is a nervous wreck".  No further information is available.
Took shot on Wednesday. Started to get ill on Thursday by midnight, temp 103, vomiting, diarrhea all night, swelling in the arm to elbow and very sore. All day on Friday, some what better.
My grandmother was perfectly healthy prior to the covid shots.  She lived alone, independently and was driving and active.  Her most recent annual physical examination revealed NO health issues, and she took NO medications.  Immediately after taking the covid shots, she became weakened, unstable and unable to walk safely.   She repeatedly told me she felt different & could not look up without falling backwards.  She complained of dizziness and feeling unwell.  In August 2021, she fell and broke her right wrist.  She never fully recovered from that fall & required home care and assistance from that point forward.  On February 24, 2023, she fell in her kitchen and suffered multiple brain strokes.  Once transported to Hospital, she continued to decline, suffering additional brain strokes. Nine days later, on March 5, 2023, she passed away in the hospital.
Information has been received from a pharmacist via Pfizer Inc. referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date, dose and route not reported). Concomitant therapies included PREVNAR 13. On an unknown date in 2011 the patient experienced a local severe reaction with excess swelling and redness. The patient required treatment with MEDROL the following day. The outcome of the events was unknown. Additional information has been requested.
Patient developed redness the size of a silver dollar at site of Hib #4. On 6/4/01, the reddness was down to the size of a pea, and he was doing fine.
Sore throat; Runny nose; Congestion; Chills; Fatigue; Felt very depleted; Headache; Muscle aches; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), NASAL CONGESTION (Congestion), CHILLS (Chills) and FATIGUE (Fatigue) in a 71-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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), NASAL CONGESTION (Congestion), CHILLS (Chills), FATIGUE (Fatigue), FATIGUE (Felt very depleted), HEADACHE (Headache), MYALGIA (Muscle aches), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), NASAL CONGESTION (Congestion), CHILLS (Chills), FATIGUE (Fatigue), FATIGUE (Felt very depleted), HEADACHE (Headache), MYALGIA (Muscle aches), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications taken by the patient were not provided. Treatment information was not provided.   Reporter did not allow further contact
1 hour and 15 minutes after I received the vaccine, without any warning I began to throw up.  I was not nauseous before or after.; This is a spontaneous report from a contactable consumer (patient). A 58-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EM9810) dose 1 via an unspecified route of administration, administered in Arm Left on 02Feb2021 at 17:45 (at the age of 58-years-old ) as 1ST DOSE, SINGLE for covid-19 immunization in school or Student Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Patient relevant medical history included allergies to medications, food, or other products was penicillin, Sulfa, Bactrim. The patient previously took bactrim and experienced drug hypersensitivity.The patient concomitant medication(s) included lisinopril (LISINOPRIL) 10 mg; ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN); krill oil (KRILL OIL). On 02Feb2021 19:00, The patient experienced 1 hour and 15 minutes after vaccination, without any warning  the patient began to throw up.The patient was not nauseous before or after. No treatment received for the adverse event. The outcome of event was recovered. The reporter assessed the event as non serious. Follow-up attempts are completed. No further information is expected.
arm was itching at the injection site and was really red with heat; arm was itching at the injection site and was really red with heat; Huge knot like the medicine is just right there; arm was itching at the injection site and was really red with heat; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm on 15Jun2021 09:40 (Batch/Lot Number: EW0167) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 25May2021 Batch/Lot Number: EW0172) for covid-19 immunisation. The patient experienced arm was itching at the injection site, really red with heat and huge knot like the medicine is just right there on 16Jun2021. The reporter stated she got the vaccine on the 15Jun2021 at 9:40 am and the next day her arm was itching at the injection site and was really red with heat and there is a huge knot like the medicine is just right there. Reporter stated she was not sure if it did not get in the muscle and was just in the tissue. Reporter stated her shot still good and absorbed in her body and she was not sure why the knot is there. The outcome of the events was reported as unknown.   Information about lot/batch number is available. Follow-up attempts are needed.
After shot 5-6cm indurated red (R) thigh. Redness almost all (R) thigh.
No additional AE reported; Temp excursion of 47.9 degree Fahrenheit for 47 min on 01-DEC-2022; This spontaneous report was received from a healthcare professional and refers to a 6-month-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 29-DEC-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) first dose administered orally (strength, dose, lot #, and expiration date were not provided) for prophylaxis. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) second dose administered orally (strength, dose, lot #, and expiration date were not provided) for prophylaxis. On 21-DEC-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #1892784, expiration date: 03-DEC-2023, administered orally (strength was not provided) for prophylaxis (Product storage error).  On 01-DEC-2022, the vaccine underwent a temperature excursion at 47.9 Fahrenheit degrees (F) for 47 minutes. The temperature excursion occurred as a result of reading from a Digital Data Logger. No previous temperature excursions were reported. No adverse events (No adverse event).
presents with fever x 1 day. fever range 103.6 and 105. She has been taking ibuprofen 400mg daily with last dose at 4:15pm today. She received the pfizer covid vaccine on her right arm on 2/18/2021 and she developed fever last night. Temp during video visit was 104.8. Denies swelling, redness, itching, or rash to injection. She only had slight fever after the first vaccine. Did not contact covid throughout the covid season. Denies headache, sinus pain, nasal congestion, chest congestion, cough, shortness of breath, difficulty breathing, neck stiffness/pain, chest pain, loss of taste or smell, n/v, diarrhea.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # m041990 with expiry date: 28-JUN-2019 Lot# n014470 with expiry date:17-JUN-2019 and lot# n004798 with expiry date: 31-OCT-2019 (dosing details, anatomical location and route were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 31F or colder (31.2F) for 2 hours and 32F to 35F for 356.5 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1709USA002052: US-009507513-1709USA002053.
Patient felt Lightheaded after 2nd Covid vaccine. Passed out ~ 15 minutes after vaccine (looked very pale) Called emergency + monitored pt. Pt refused any medical treatment from EMT. Dad took Pt Home
Projectile vomiting at bed time 9 pm and fever 99.7 underarm at 9:45 pm will take to Dr in morning if not better.
Ringing in my left ear, that is the arm I got the shot in. Happening every couple hours
At 4:41 AM,11 hours after injection, extreme joint pain all over my body including spine, ankles, toes, elbows, wrists, fingers. On a scale of 1-10, it was 8-9.Woke me up from a deep sleep. Took 10 minutes to walk to bathroom (approximately 15 feet away) to get ibuprofen.  Could not get comfortable lying, sitting or standing. Eventually fell back asleep. Woke up four hours later, and pain had subsided. Probably a 2-3 on the scale.
First vaccine 18Feb2021, raised rash inner arms, arm pits, body sides, stomach inner thighs.  After second dose moved to upper thighs and back; This is a spontaneous report from a contactable consumer.   A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 11Mar2021 (Batch/Lot Number: En6199) as dose 2, single (at the age of 78 years old) for COVID-19 immunisation.  Medical history included osteoporosis taking pravastatin, gabapentin, omeprazole.  The patient's concomitant medications included pravastatin, gabapentin, omeprazole start and stop date not reported for unknown indication.  The patient previously took first vaccine 18Feb2021 BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) for COVID-19 immunisation and experienced raised rash inner arms, arm pits, body sides, stomach inner thighs. From first vaccine, raised rash inner arms, arm pits, body sides, stomach inner thighs and after second dose moved to upper thighs and back on Mar2021. Resulted in doctor or other healthcare professional office/clinic visit. Treatment was first a steroid shot, then on 29Mar2021, prednisone.  The outcome of event was not recovered.   No follow-up attempts are possible. No further information is expected.
pt recv vax 24SEP96 & 7OCT96 pt exp a maculopapular rash on the face, chest, abd & upper back;itchiness on the face & sl temp;
pt has swollen red blotch rt deltoid p/vax 15OCT97;
Narrative: The patient reported an itchy, vesicular type rash that started about 3 weeks after receiving his ZOSTAVAX injection. Samples were sent for viral culture (these were negative). Samples were sent for analysis using PCR techniques but the samples were inadequate for testing. The infectious disease specialist felt the lesions could be insect bites or psychotropic itching (lesions are all present in areas accessible to his scratching). He was treated with an injection of hydroxyzine, oral hydroxyzine and camphor/menthal lotion topically. Symptoms Symptoms 1. Rash, 2 intense pruritus. Treatment Drugs Used: 1 - Hydroxyzine dose: 25 Units. MG Freq: Once Route: IM. 2 - Hydroxyzine Dose. SQ Units MG Freq. QID Route. PO. 3 - Camphor/Menthal Dose: Units. Freq. TID Route Top.
Client received vaccines at County Health Department on 9-19-13.  Per phone call from mom, client woke up at 6:00am on 9-20-13 c/o arms and chest hurting, feeling sluggish. On 9-21-13 client still felt tired.  On 9-22-13 in am client developed an itchy rash that mom thought was chickenpox but the rash went away with Benadryl. A very-itchy hive-like rash still appears when the next dose of Benadryl is due.  Client c/o headache, no cough or fever.  Referred client to a healthcare provider for evaluation.
Sore arm at injection site for 2-3 days.; Itchy; Hives all over my bodyincluding, arms stomach, breast, back,thighs buttocks.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot no: UNKNOWN) via an unspecified route of administration in left arm on 23Mar2021 at 10:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN) and cetirizine (MANUFACTURER UNKNOWN) both taken for an unknown indication since an unspecified date. It was reported that the patient was allergic to codeine. Prior to vaccination, the patient had not tested for COVID-19. The patient had not tested for COVID-19 since having the vaccine. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 08:00, the patient experienced vaccination site pain, itchy and hives. The patient had sore arm at injection site for 2-3 days, Itchy, hives all over my body including, arms stomach, breast, back, thighs and buttocks. The events had not resulted in visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measure was taken as a result of the adverse events vaccination site pain, itchy and hives. The clinical outcome of the events vaccination site pain, itchy and hives were not recovered at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
hot to the touch; sore; hard; 1 inch below the injection site swelled up; "fiery red"; painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), PAIN (sore), VACCINATION SITE INDURATION (hard), VACCINATION SITE SWELLING (1 inch below the injection site swelled up) and VACCINATION SITE ERYTHEMA ("fiery red") in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch), PAIN (sore), VACCINATION SITE INDURATION (hard), VACCINATION SITE SWELLING (1 inch below the injection site swelled up), VACCINATION SITE ERYTHEMA ("fiery red") and VACCINATION SITE PAIN (painful). At the time of the report, VACCINATION SITE WARMTH (hot to the touch), PAIN (sore), VACCINATION SITE INDURATION (hard), VACCINATION SITE SWELLING (1 inch below the injection site swelled up), VACCINATION SITE ERYTHEMA ("fiery red") and VACCINATION SITE PAIN (painful) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
Sore arm; Left boob was very tender; 1st dose wasn't given properly/not clear of how much I got; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BREAST PAIN (Left boob was very tender) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (1st dose wasn't given properly/not clear of how much I got) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (1st dose wasn't given properly/not clear of how much I got). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and BREAST PAIN (Left boob was very tender). On 30-Jan-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (1st dose wasn't given properly/not clear of how much I got) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and BREAST PAIN (Left boob was very tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       . Concomitant and treatment medication were not provided.   This case was linked to MOD-2021-039293 (Patient Link).
At 48 hours after administration of vaccine redness of 1.5 inches diameter, swelling, warmth to the touch, and pain at the site on the right deltoid.  Patient noted this reaction about 44 hours after administration.