chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Full shot when got the booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Full shot when got the booster) 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 03-Sep-2021, the patient received third 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 an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (Full shot when got the booster). At the time of the report, ACCIDENTAL OVERDOSE (Full shot when got the booster) outcome was unknown.            It was reported that patient not immunocompromised. Concomitant product information was not provided. Treatment information was not provided.
Patient was to receive a Moderna vaccination for her 2nd Covid-19 vaccine dose but a Pfizer was given by mistake
Morning on 04/08 patient reported that she had lumps on her arms and buttocks... 04/13 she saw her PNP who was concerned of Blood Clot and was refer to Hospital and they stated it wasn't blood clots...  results came back subcutaneous sarcoidosse
Information has been received from a health professional concerning a 67 year old female who on Oct 28 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). it was reported that the patient was seen on Nov 01 2004 and her arm was swollen down to mid forearm, red warm to the touch. unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Information has been received from a registered nurse concerning a 14 month old male patient with no pertinent medical history and known allergies who on 01-OCT-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (Lot # 660944/0512X).  Concomitant therapy included MMR II, PREVNAR and COMVAX received on the same day (01-OCT-2008).  Around 26-DEC-2008 the patient developed a rash described as papular with some vesicles, erythematous on his chest and back.  In the information received on 05-JAN-2009 contained the following adverse experiences: ear infection (in December 2008) and was prescribed antibiotics.  Additional information has been requested.
She has developed recurrent bouts of severe angioedema which the doctor has deemed to be possibly life threatening. Her face, eyes, and lips swell to the point that the skin breaks leaving sores on her lips. The Dr has prescribed an EPI-PEN due the possibility of sudden anaphylaxis. Pain occurs in the hands and feet as well making it difficult to walk and hold objects.
Parent called today at 2pm. Child's R arm is swollen, hot, red the diameter of an apple. Temp=100.5 deg F. Child vomited x 1 last night coughing, had red, hot, itchy feet last night, gone today. Parent gave Benadryl and children's Motrin. Child is lethargic denies c/o pain.
8 days after receiving vaccine I have a large bump at the injection site. Also warm and itch
22 Dec 22 Sore arm and minor body aches the day of the shot. 23 Dec 22 Body aches and sore arm the following morning followed by extreme tiredness low grade fever (99.7), chills and a higher degree of soreness by the afternoon. By night, 100.9 temp, extreme fatigue, chills and body soreness.
I felt really bad; I felt body pain; Arm pain that lasted about three days; Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain that lasted about three days), DISCOMFORT (Discomfort), FEELING ABNORMAL (I felt really bad) and PAIN (I felt body pain) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain that lasted about three days), DISCOMFORT (Discomfort) and PAIN (I felt body pain). On 18-Apr-2021, the patient experienced FEELING ABNORMAL (I felt really bad). On 20-Apr-2021, PAIN IN EXTREMITY (Arm pain that lasted about three days), DISCOMFORT (Discomfort), FEELING ABNORMAL (I felt really bad) and PAIN (I felt body pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter.The patient did not take any medication to alleviate the symptoms
Contacted Covid after their first vaccine; Contacted Covid after their first vaccine; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). This consumer reported similar events for two patients. This is the first of two reports.  A patient (reported as: healthcare professional) of unspecified age and gender received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced: contacted COVID after their first vaccine (medically significant). The clinical outcome of the events, drug ineffective and COVID-19, was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082538 same reporter, drugs and events.; different patient.
Onset of generalized flu-like symptoms withing 6-12 hours following vaccination. A non-painful area of redness, approximately 2 inches in diameter with some bumps was discovered approximately 24-48 hours after vaccination. Flu-like symptoms resolved within 1 day. Redness is still present 48 hours following vaccination. Denies any fever, denies injection site to be warm to the touch. Did not seek medical attention.
Got shingles; Injection site reactions; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Got shingles) and VACCINATION SITE REACTION (Injection site reactions) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Got shingles) and VACCINATION SITE REACTION (Injection site reactions). The patient was treated with ANTIVIRALS ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Got shingles) and VACCINATION SITE REACTION (Injection site reactions) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. description of injection site reaction was not provided.  Patient's medical history including any past history of shingles is lacking . Further information has been requested.
Red rash around injection site that is firm and warm to the touch. Symptoms were first noticed around 7:45 am on 3/19. I have just started taking Tylenol.
Narrative: Patient found deceased at home on 6/28/22. Death was determined to be natural. Patient received Moderna COVID vaccine #4 on 6/14/22. No side effects were reported. Patient reported mild illness after 3rd dose, no mention of side effects with dose 1 or 2. No known history of covid. PMH significant for 1. Moderate aortic stenosis 2. HFpEF (EF 60% @ 14 Jun 2022) 3. T2 Diabetes mellitus 4. CKD (CrCl 44.8 ml/min; Cr 1.75 eGRF 38.5 K 4.3 @ 13 Jun 2022) 5. Hypertension 6. Obesity (276 lb BMI 44 @ Jun 2022) 7. Dyslipidemia 8. Varicose veins 9. Knee osteoarthritis (h/o infected knee replacement) 10. H/o melanoma R leg (chronic swelling)
Developed baseball sized red area, hot and tender with irregular borders slightly elevated at injection site medical diagnosed as cellulitis and was put on Keflex.
Information has been received from a registered nurse (R.N), concerning an unspecified patient (unknown age and gender). The patient's pertinent medical history and concurrent conditions were not provided. On 15-AUG-2016 the patient was vaccinated with an improperly stored dose of VARIVAX lot # M002063, expiration date 12-JAN-2018, (concentration, dosage and therapy route were not provided). There was no concomitant therapies reported. No adverse effects were reported. The vaccine was exposed to 11.7 F for 2 hours and 48 minutes and the call was made because of digital data logger. There were no previous exposures. No product quality complaint (PQC) was involved. This is one of two reports from the same source (MARRS#1608USA008365). Additional information has been requested.
a noticeable indentation was seen at the site of the first injection; This spontaneous report has been received from a physician via field representative referring to a 29-year-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 19-JUN-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1602283, expiration date reported as 16-AUG-2021, but upon internal validation established as 18-AUG-2021; dose not reported) intramuscularly for prevent human papillomavirus (HPV).         The patient was seen in the office on 22-AUG-2019 (reported as today) for the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1602283, expiration date reported as 16-AUG-2021, but upon internal validation established as 18-AUG-2021; dose not reported) intramuscularly for prevent human papillomavirus (HPV). On that date, a noticeable indentation was seen at the site of the first injection. The patient was in no pain and there was just a depression (indentation) at the site. There was no treatment given to the patient. There was no lab diagnostics or studies performed. The patient sought medical attention. No product quality complaint (PQC) involved.   The outcome of the event was recovering. The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
This spontaneous report received from a licensed practical nurse refers to two unspecified patients of unknown age and gender who on unknown dates were vaccinated with two improperly stored doses of VARIVAX (Merck) (dose, lot #, expiration date and route of administration were not reported). No adverse effects reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. Follow up information has been received on 05-MAR-2015 from a licensed practical nurse refers to a male patient of unknown age. On 26-JAN-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # K009758, expiration date 26-JAN-2016) that had experienced a temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
1:12pm Fast heartbeat, clamy hands, chills, sinus drainage, 1:26pm coughing, chest tightness, raspy voice, tingling/itchy nose, flush cheeks, chills 2:30pm slight fever, extremely tired 6:00pm sweating, loss of appetite, coughing,  drainage, and tightness continued through night 9:00pm severe back ache (all over), injection site, bruised, tender, and throbbing  8/24/21 @6:30am after a restless evening woke up with a cough, extended hoarse voice, extreme thirst,  and complete body aches. As of 6:20pm (8/24/21) complete body muscle/ joints ache, tired, sinus drainage continues, chest is tight with light wheezing periodically, voice remains raspy, and dry coughing continies, small hives appear on face and back,
103 degree temp taken rectally starting around 5 hours after vaccine was administered to present-2 days-11hours after vaccine. Congestion, loss of appetite, extreme fatigue, fussiness, restless sleep, crying out randomly, especially when asleep, difficulty breathing.
I had a pneumonia vaccine injection in my right upper arm. It is extremely sore, swollen, red and painful at the injection sit all the way down my arm to elbow. I have flu like symptoms, the pain and redness keep growing. I was not told that this can occur. Will go to the emergency hospital as it is getting out of control.
patient developed shingles; had a fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 33-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concomitant products included upadacitinib (Rinvoq).   In JUN-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: patient developed shingles) and fever (Verbatim: had a fever).  The outcome of the shingles and fever were unknown.   It was unknown if the reporter considered the shingles and fever to be related to Shingrix.     It was unknown if the company considered the shingles and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-OCT-2023 This case was reported by patient for herself. The patient was receiving Shingrix vaccine because the patient receives Rinvoq and was at an increased risk for shingles. The patient received the 1st Shingrix dose in last week of June 2023 and was to receive the second dose on 22nd September 2023, but had a fever and canceled the vaccination. A couple of days later, the patient developed shingles. At the time of call, the patient had not yet received the second dose. The reporter consented to follow up with Healthcare professional (MD).
Ten minutes after pt. received six vaccines prior to moving abroad pt. had a vasovagal reaction & needed to lie down for 15-20 minutes before recovering.  She had not been crying hysterically at the time; was calmer & ready to leave.  In 31 years of pediatric nursing, I have not seen a child this young nearly faint.
21NOV91 8(?) days p/2nd dose pt exp thrombocytopenia w/petechiae, bleeding gums & hematuria; Pt hospitalized & anti-platelet antibodies detected; 7th day of admission pt suddenly collapsed w/a fit; cerebral bleeding suspected; mass MI & VF;
Information has been received from a healthcare worker concerning an 87 year old female patient who in approximately 15-OCT-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # and route no reported). The healthcare worker reported that earlier this year the patient developed shingles. The nurse could only verify that the patient was given a prescription to receive the vaccine on 15-OCT-2010. She stated that she did not have records that the patient actually received the vaccine. At the time of the report, the outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Breakthrough case admission after 4 doses Moderna 2/16/21 Lot# 013M20A; Moderan 3/16/21 Lot# 030A21A;  Moderan 11/5/21 Lot# 077C21B;  Moderna 4/18/22 Lot# 027L21A
About 8 hours after the vaccine injection, my arms and especially my legs began to feel very weak.  10 hours after the injection, I had to crawl up the stairs on my hands and knees, and my husband had to help lift me into bed.  The next day, my arms and legs were still weak.  So I called my family doctor and he wasn't aware of this side-effect of the vaccine.  About 3 days after the injection, I started to feel normal strength in my legs and arms.
Tennitis.   At my doctor appt on Feb 22 or next appt. I reported to her I had just started having ringing in left ear...tennitis.it has gitten worse now 5/9/21.
I had tachycardia within the first 5 minutes of receiving the vaccine. Heart rate increased to 151
Lost complete shoulder mobility and not just sore, but pain level a 10, out of I to 10. On day two zero improvement.  Can't sleep pain is so severe. Called dr and she said the same thing happened her and to give it a few days to see if improvement. Don't think I can wait a third day the pain is so great.
None.  Patient received 1 dose on 7/25/07 and a second dose on 7/14/08.
Information has been received from a pharmacist concerning a 66 year old male patient with no pertinent medical history and no known drug allergies/drug reactions who on 15-SEP-2009 was vaccinated with a dose of PNEUMOVAX (Lot # 663888/0627Y) intramuscularly into his left arm. There was no concomitant medication reported. It was reported that on 15-SEP-2009 (in the night) the patient's arm developed tingling/numbness. The patient stated that he had difficulty moving his arm. The pharmacist instructed him go to the emergency room. There were no laboratory diagnostic tests performed. The patient had not recovered at the time of the report. Difficulty moving his arm, numbness and tingling were considered to be disabling. Additional information has been requested.
Few minutes post vaccine, patient stared shaking uncontrollably, Clinician assisted immediately, Patient pale and diaphoretic, BP 77/60 P:56, Placed in semi trendelenburg position. BP re checked after 10m minutes-100/59 P:62, patient offered crackers, refused.  Spouse in car states patient has history of severe anxiety,  Patient states he did not have breakfast .Patient states he is feeling better, monitored for additional 30 minutes, last BP 110/72, P. 63, Patient reports feeling much better, no longer pale or diaphoretic.
Single seizure episode next morning at 11am, child napping, mother heard noise checked on child, baby was shaking, eyes rolled back lasting aprox. 1 min after mother entered room. Paramedics were called and transported child to Hospital.
Diagnosis of pericarditis after symptoms that included shortness of breathe, heavy crushing feeling of chest, back, clavicle, jaw and ear.
vaccine was mixed with bacteriostatic saline and given to the patient, directed by CDC and pfizer to readminister.
his doctor recommended him not getting the second dose, and he did want to know if he should or should not get the second dose, since it's been so long.; his doctor recommended him not getting the second dose, and he did want to know if he should or should not get the second dose, since it's been so long.; felt heaviness on his head; having a hard time breathing; very dizzy; felt a little weak; This is a spontaneous report from a Pfizer sponsored program from contactable consumer (patient, reported himself). A male patient of an unspecified age, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, LOT number and expiry dates were not provided), via an unspecified route of administration, on 22Dec2020, as single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On 22Dec2020, the patient experienced felt heaviness on his head, having a hard time breathing, very dizzy and felt a little weak. Patient described that about five minutes after he got the first vaccine, he felt a heaviness on his head, and a couple minutes later, they gave him a snack to see if it would help at all, and he was having a hard time breathing at that point. Patient was into the ER and poured water on his back, and he was very dizzy. And then about ten minutes after, he started to feel better, felt a little weak, but starting to feel better. When he was in the ER, they gave him some fluids, and that's what he thinks made him feel better. Patient reported his doctor recommended him not getting the second dose, and he did want to know if he should or should not get the second dose, since it's been so long. No further details provided or able to be obtained to complete report. Outcome of the events was unknown.   Information about batch/ lot number has been requested.
Headache, sweaty and dizzy. In observation with medics for 30 minutes. BP 105/72 . Went home on his own.
Body aches and headache  after 20 hours, fever of 99.9 after 44 hours, swelling and redness at injection site and under same arm, soreness in armpit. Migraine after72 hours.
Fever, chills, redness at the site of injection, fever at the site of injection, confusion, sleepy,
Rec'd vaccine in afternoon by that evening area swollen and red and painful. Next morning arm swollen below elbow, red, warm, extremely pain. Seen by PMD given Prednisone, Zyrles and Amoxy. Pain decreased by 3rd day but swelling cont. to wrist area (slight swelling). 11/3/03 pt dates complete resolution.
has broken to hives; This is a spontaneous report from a contactable pharmacist. A 59-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an intramuscular route of administration in the left arm on 31Mar2021 at 01:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was unknown and also unknown if the patient received any other medications within 2 weeks of vaccination. It was unknown if the patient was pregnant at the time of vaccination and also unknown if the patient had any allergies to medications, food, or other products. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient had broken to hives. The event resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the event and included treatment with prednisone tablet (tab). The clinical outcome of the event broken to hives was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
a blotchy rash on my torso; 2 hive-like blisters on my upper chest; no appetite; nausea; vomiting; I felt washed out; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (a blotchy rash on my torso), BLISTER (2 hive-like blisters on my upper chest), DECREASED APPETITE (no appetite), NAUSEA (nausea) and VOMITING (vomiting) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced RASH MACULAR (a blotchy rash on my torso), BLISTER (2 hive-like blisters on my upper chest), DECREASED APPETITE (no appetite), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (I felt washed out). At the time of the report, RASH MACULAR (a blotchy rash on my torso), BLISTER (2 hive-like blisters on my upper chest), DECREASED APPETITE (no appetite), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (I felt washed out) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Lower back pain very severe. Weakness and difficulty walking. The pain and unusual sensations in the right leg. Felt like having Covid. Saw the doctor. Symptoms got better with increased dose of prednisone.