chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered an expired vaccine; Patient received first dose of primary series from Moderna Bivalent vaccine; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccine), WRONG PRODUCT ADMINISTERED (Patient received first dose of primary series from Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccine), WRONG PRODUCT ADMINISTERED (Patient received first dose of primary series from Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccine), WRONG PRODUCT ADMINISTERED (Patient received first dose of primary series from Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccine) and WRONG PRODUCT ADMINISTERED (Patient received first dose of primary series from Moderna Bivalent vaccine).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730480 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730480:Same reporter
patient faint and vomited informed leadership on duty. leadership tried to call emergency services but the patient declined and walked away on his own to wait for his girlfriend to pick him up.
Shaky, sore muscles, dizzy, light headed, lethargic. The feeling of the onset of a cold or flu.
A few months after 2nd dose of HPV vaccine patient started having irregular periods after about a year she stopped having a period all togather. We are now working with doctors to see why ovulation has stopped and why no medications will get ovulation to start back up.
This spontaneous report as received from a consumer reporting on a friends child, a 23 week old male patient. Information regarding the patient's medical history and concurrent conditions was not provided. On an unknown date in January 2016, after fifteen weeks of age, the patient was vaccinated with his first dose of ROTATEQ, oral. She stated that the child was "irritable" after he was vaccinated . No laboratory tests were reported. No product quality assessment (PQC) was involved. The outcome of the event irritability was unknown. The causality assessment was not provided. Additional information has been requested.
Soreness in the right arm; right pectoral muscles soreness; Fatigue; Weakness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 1 day after receiving Shingrix, the patient experienced pain in arm, fatigue, weakness and muscle pain. In April 2019, the outcome of the fatigue and weakness were recovered/resolved. On an unknown date, the outcome of the pain in arm and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fatigue, weakness and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm. The patient experienced mild fatigue and weakness which lasted for two to three days. Also, the first two days after receiving Shingrix, the patient experienced soreness in the right arm and that soreness has spread to the right pectoral muscles. No further details were provided. The reporter did not consent to follow-up.
Developed large areas of hives/rash all over body that lasted for 2 1/2 - 3 weeks.
chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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 an unknown date, the patient experienced CHILLS (chills) and HEADACHE (headaches). At the time of the report, CHILLS (chills) and HEADACHE (headaches) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
abdomen: burning sensation; abdomen, cramps; ache: bones; blood in stool; ache: joints; ache: joints and muscles; aches: muscles; aches: whole body; acid reflux; skin acne; allergies; alpha intrusion; high cholesterol; blood dyscrasia; bursitis; amblyopia; appetite loss; arm hot to touch; heart arrythmia; autoinoculation face; loss of concentration; difficulty concentrating; trouble concentrating; constipation; leg cramps; blood pressure varies; blood pressure high; depression; dermatitis; constant diarrhea; constant fatigue; muscle fatigue; pain and fatigue; indigestion; hair loss; continuous headaches; poor tolerance for loud noises; heart palpitations; energy loss; low energy levels; exhaustion; memory difficulty; memory loss; memory bad; memory loss with dizziness; troube remembering recent information; short-term memory loss; fungal infection; disorientation; depression; confusion; joint aches; leg pain; lower back pain; right shoulder, hip and leg pain; right hip and chest pain; groin pain; back pain; knee and hip pain; lower back pain; rash; stomach pain; bone and joint pain; joint pain; muscle and joint pain; muscle pain and stiffness; seizure-like spasms; leg pain; neck pain; pelvic pain; skin itching; dry and flaky skin; abdominal pain; chest pain; charlie horse; palpitations; sores on skin; urinary frequency; sleep problems; poor tolerance for bright lights; vision problems; unable to sleep flat without medication; stomach problems; weakness; weight gain;
Expired PCV20 administered. Situation explained to client via in-person interpreter. Vaccine repeated same clinic day as recommended. Client in agreement with plan.
Headache, Fever, Diarrhea & NauseaVomiting Narrative:
Rash was back on shoulder and chest; Rash on shoulder and chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash was back on shoulder and chest) and RASH (Rash on shoulder and chest) in an 80-year-old female patient who received mRNA-1273 (MODERA COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hernia. Concomitant products included OMEPRAZOLE for Hernia, LEVOFLOXACIN (LEVOXIN), ATORVASTATIN, CALCIUM and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced RASH (Rash on shoulder and chest). On 09-Feb-2021, the patient experienced RASH (Rash was back on shoulder and chest). At the time of the report, RASH (Rash was back on shoulder and chest) and RASH (Rash on shoulder and chest) 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.   Treatment included Benadryl
This spontaneous case reported by a consumer, describes the occurrence of fatigue and vaccination site rash in a 109-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# unknown) for COVID-19 immunization. No medical history reported. On Jan 14, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 14, 2021, patient experienced fatigue. On Jan 24, 2021, patient experienced vaccination site rash. On Jan 17, 2021, fatigue resolved. At the time of the report, vaccination site rash outcome: unknown.The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
After patient was given vaccination, he reported a funny taste in his mouth, asked if it was metallic, he said no just a funny taste.
patient stated that 24 hours after the vaccine started to experience fatigue, fever, runny nose, headache, cough.  pt hasn't taken a body temp but thinks we feels warm.
Immediately after vaccine site became raised, red and hot. Seemed hotter after 24 hrs. After raised area subsided area of redness became larger and felt hard.
Patient reported back to pharmacy 2 days after vaccination.  her arm was swollen about half way down her arm and I could see a bruise where IMZ was placed.  The patient's arm was also red and warm. I recommended her to continue the tylenol she was taking and try icing the arm.  I also advised to call back/talk to doctor if is persists more than 3 additional days.
05/04/2021-> MY BOTH EYE STARTED EACHY LITTLE  BIT ON SAME DAY  OF 1ST DOSE COVID19 VACCINATION .  05/05/2021-> FEEL BETTER TILL  AFTER NOON THEN SLOWLY BECAME MORE RED, MORE EACHY AND I NOTICE MY RIGT EYE HAS SWELLING UNDER EYE BY THE TIME OF 9.30 PM,  I TOOK BENADRY FOR RELIVE  05/06/2021-> CONSULT MY PRIMARY DR, SHE HAS PRISCRIBED ME ORAL MEDICINES AND EYE DROP: PREDNISONE 20 MG-TWICE A DAY                              LORTADINE 10 MG- ONCE A DAY                              NEOMYCIN-POLYMYXIN-HC DROP-TWICE A DAY
This spontaneous report was received from an unspecified reporter referring to an 11 year old patient of unknown gender. Information about the patient's medical history or concurrent conditions were not reported. On 04-AUG-2015, the patient was vaccinated with GARDASIL, (dose, route of adminstation, lot # and expiration date were not provided). Concomitant medication was not reported. On an unknown date, the patient experienced a vaccine adverse experience. At the time of reporting, the outcome of vaccine adverse experience was unknown. The causality between vaccine adverse experience and GARDASIL was unknown. This is one of several reports received from the same source. Additional information has been requested.
After one week of getting the first dose I started getting a little bump/rash on my right arm which is where the vaccine was given
some stomach cramps; Bit of dizziness; Diarrhea issues; Arm Soreness; This is a spontaneous report freceived rom a contactable other health care professional. A 61-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN5318) via an unspecified route of administration and administered in left arm on 05Feb2021 10:00 (at age of 61 years) as dose 1, single for COVID-19 immunization. The patient didnot had covid-19 and was not tested for covid-19 prior vaccination. The patient was not tested covid post vaccination. The patient had no other vaccines in 4 weeks. The reporter was not aware of known allergies. The patient medical history was not reported. Concomitant medications included levothyroxine (LEVOTHYROXINE), vitamin D NOS (VITAMIN D NOS). The patient experienced arm Soreness, some diarrhea issues the first 2 days with some stomach cramps, he have a bit of dizziness that he awoke to this morning. The patient didnt received any treatment for events. The outcome of events was recovering.  Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.
pt exp stiff neck w/swollen glands, nausea, back ache + achy joints; fever, 99.9f-100.5f; sx lasted 4-5 days accompanied by lethargy; Per follow-up: No residual effects - symptoms totally resolved. Had positive titer after immu so did not do a 2nd.
9//27/2019: Day of the Tdap injection 12:30 pm: Stomach ache, back pain, pain at the injection site as well as injection site feeling hot and red. 3:00 pm: continued symptoms from 12:30 pm   9/28/2019:  All day: Back and side pain, pain at the injection site, swelling of the right arm where the injection was, joint pain, and difficulties using the right arm. There was nausea and feelings of being weak around 10:00 pm until 4:00 am.    9/29/2019:  4:00 am drying heaving, nausea, vomiting, back pain, struggling with feeling weak, and difficulties in staying asleep. Difficulties all day with feeling ill. I thought that I had food poisoning and did not realize it was connected to the Tdap immunization.    9/30/2019:  All day: I had to miss work because I was weak, vomiting, gland swelling, headaches, heart rate increased, having severe cramping in my stomach, back pain, side pain, and struggling to get out of bed all day. Again I thought it was due to my alleged food poisoning the day previously.    10/01/2019 to 10/15/2019: Coninutes struggling with severe cramping, diaherra, crying spells, lack of appetite, back pain, nausea, feeling week, and struggling with sleeping.    10/16/2019: I continued to have symptoms and talked with the (PA). PA took blood and urine for analysis.
I woke at midnight. I was all sweaty & felt like I couldn?t breathe, my heart was pounding. I ran downstairs and outside to get air and the earth felt like it was spinning under me and everything was moving. I felt nauseous and confused and had racing thoughts. I fell back and hit my head and got up and tried to come inside and ended up falling again and urinating while on the floor. I believe I lost consciousness.  I couldn?t stand and vomited several times in the ER.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. Since 21-JUN-2017 the patients were vaccinated with improperly stored ROTATEQ(dose, lot # and expiration date were unknown, oral) for prophylaxis. No adverse effects were reported. The coldest temperature was 32 Fahrenheit, time frame was unknown. There were multiple temperature excursions previously. The call was because of a data logger. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA004183: US-009507513-1708USA004184: US-009507513-1708USA003696:
Covid-19; Pregnant when given the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant when given the vaccine) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced COVID-19 (Covid-19) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant when given the vaccine). At the time of the report, COVID-19 (Covid-19) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant when given the vaccine) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Relevant concomitant and treatment medications were not reported.  Company Comment:  This spontaneous case concerns an adult female patient with no reported medical history, who experienced the unexpected, non-serious  event of Maternal exposure during pregnancy (reported as Pregnant when given the vaccine) on an unknown date after receiving an unspecified dose of mRNA-1273 vaccine.  Onset latency for the event could not be determined as both the dates of vaccine administration and onset date of event were not disclosed.  Last menstrual period, estimated date of delivery, pregnancy test, and ultrasound dating of gestational age were not reported.  No information on any other doses of COVID-19 vaccination was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-660893, US-MODERNATX, INC.-MOD-2022-660889, US-MODERNATX, INC.-MOD-2022-660877 (Patient Link).; Sender's Comments: This spontaneous case concerns an adult female patient with no reported medical history, who experienced the unexpected, non-serious  event of Maternal exposure during pregnancy (reported as Pregnant when given the vaccine) on an unknown date after receiving an unspecified dose of mRNA-1273 vaccine.  Onset latency for the event could not be determined as both the dates of vaccine administration and onset date of event were not disclosed.  Last menstrual period, estimated date of delivery, pregnancy test, and ultrasound dating of gestational age were not reported.  No information on any other doses of COVID-19 vaccination was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
pt recvd vax & passed out & had sz like activity for 15 seconds then became alert;
About a week after getting my second dose I developed a severe, very itchy, swelling and raised bumps on my front and back torso, my face and my arms. My doctor put me on hydroxyzine and Pep-Cid because they felt Prednisone would suppress my immune system. Two weeks later he has put me on Prednisone because the first course of action did not work. I've gotten through two days worth of Prednisone.
felt very achy all over her body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Sep2023, outcome "unknown", described as "felt very achy all over her body".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
24 hours, post vax, pt had a seizure with subsequent seizures on the following 2 days; described as tonic/clonic. Pt was taken to local ER when phenobarbital was given.
At 2100 on the date of my vaccination, I started to feel body aches, chills, feverish, weak, and skin sensitivity. I was very shaky and weak all night into the next day and night. I also experienced abdominal cramping at certain times and dehydration from sweating profusely (showed by a fast heart rate and dark urine). I treated my symptoms with rest, water/hydration, and regular doses of ibuprofen.
pt recv vax 5JAN99 & 16JAN99 devel rash on face & trunk, swollen glands in neck, body aches & low grade temp 99.9 states that otherwise felt fine & thinks this is a rxn to MMR;did not seek tx;
Armpit behind injection site felt like it has a aching cyst, severe headache, ringing in ears, confusion, severe joint pain in knees, elbows, mid back, cough, ankles, neck, eye sockets, nausea, feverish, difficulty staying asleep because of headache, nausea and joint pain. Dizzy/wobbly, slight couch.
Patient stated 4 -5 hours after vaccine seemed to have loss of range of motion of arm and pain for 1 day. Still soreness at times in arm today after 4 months.
Pt recvd measles vax on 18FEB91 & on 27FEB91 pt exp congestion, cough & an inc temp; Pt presented to MD who dx BOM; pt given Ceclor; 2MAR91 Koplik's spots were present & dx w/measles;
Fever of 102 degrees which rose to 105 degrees by the evening of the 17th. Ibuprofen was given, luke-warm bath, doctor visit on the 17th.
STARTED CHILLS & FATIGUE ON 12/15/18, 7PM. PROGRESSED TO NAUSEA AND 2 EPISODES OF VOMITING. ONCE ON 12/15 AND ONCE ON 12/16. SYMPTOMS MOSTLY RESOLVED 48 HOURS LATER.  PATIENT FEELS MUCH BETTER TODAY (12/17/18), STILL SOME HEADACHE AND MILD FATIGUE.
Patient came in 11 days after vaccine with rash to body. Patient was taking Cephalexin and cough medicine. The rash was measle like and the patient was afebrile. The doctor prescribed Atarax for 5 days and to follow up in 72 hours. 1/20/05 Diagnosis: Vaccine side effect to MMR.
Had sinsus congestion for two to three weeks and on on 9/27 developed a stye in right eye.  My wife woke up on 10/4 with a 102 temperature and cough.  My sinus issue had turned into an infection and the stye had resulted in eye red. We both went to be COVID tested on 10/4 found out 10/5 both positive.  My wife had two doses of Moderna several months before I got vaccinated as a teacher.
PATIENT WAS 15 YEARS AND 8 MMONTHS AT THE TIME WHEN THEY RECEIVED A PFIZER BOOSTER VACCINE.
Day 4 so far. With severe nausea. Severe tiredness. Lightheaded. Runny nose. Headaches. Body aches. Chest pain. Hard to breath. Like I have the flu. I was tested for flu. Negative.
flu symptoms; This is a spontaneous report from contactable consumer via Pfizer Sales Representative. A female patient of age 08 decades (reported as late 70s) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as single dose on an unknown date for COVID-19 immunization. Medical history included: thyroid condition. On an unknown date patient felt like she had flu symptoms. Outcome of event was unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
had vaccine and still got shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The patient self-reported this case.                                        The age at vaccination was not reported. The patient had Shingle vaccine and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available
Initially, about 24 hours after vaccination, redness, pain and swelling, hot to touch - felt chills for about 12 hours. Redness spread to an area of about 3 inches. The next morning, I felt fine. Through the week, this area faded but did not disappear completely. About a week later, on Sunday, Feb 21, the area on my arm grew to around 6 inches or more: red, swollen, itchy, warm to the touch, worse than the week before. I saw my family doctor on Monday, Feb 22 and they determined it was not infected, just a local histamine reaction. They advised Benadryl and a topical steroid to deal with symptoms.