chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnancy (received vaccine); This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy (received vaccine)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 30-Dec-2020 and the estimated date of delivery was 07-Oct-2021. On 30-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy (received vaccine)). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 30-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy (received vaccine)) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications and treatment medications were reported. Lab tests include Genetic testing.
Fever, tiredness, body ache, headache. Used Ibuprofen for pain. Fever was gone morning of October 31. Only some tiredness remained.
Within 2 mins of the injection, a severe headache occurred, then as pt. got home, chills, fever, 103 - 104F, sore throat, cough and severe fatigue. pt. reported symptoms lasting 4-5 days when sha ewas assessed by her physician. Pt. had several asthma attacks during this period and had to use a nebulizer to help her breathe. Pt. reported that she couldn't walk five ft. without becoming extremely fatigued. Pt. continues to have a dry cough. MD assessment resulted only in instructions to drink plenty of hot liquids and rest.
Pt developed chills Monday evening with Temp 102.4 that night. Parent treated temp with Ibuprofen alternated with TYLENOL. Child slept a lot 7/14/09. Pt seen back in clinic 7-15-09. No redness, no edema of injection sites. No c/o pain. Temp 99 degrees.
I have had a fever with chills. Body aches and sinus drainage with a cough. I also had a little bit of a headache but not much. and I am also tired.
Itching in left arm. Broke out in welts from feet to top of head. Used caladryl. Still has hives.
Patient complained of a hard lump on her arm. Same arm as she received the injection but not at the injection site.
Narrative: PATIENT REPORT INITIALLY BRUSING, SWELLING AND PAIN AT INJECTION SITE. EXTREME HEADACHE AND SHAKINESS X 4 DAYS, REDNESS AT INJECTION SITE 4X3 INCHES 6 DAYS POST INJECTION. STILL HAS JOINT PAIN WITH DAILY USE
No additional adverse event reported; MMR II and VARIVAX were administered to a patient after tenperature excursion; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 05-JAN-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (Lot# U015846 and expiration date 19-MAY-2023) (exact dose and frequency were not reported) as prophylaxis. The vaccine a temperature excursion and time frame were unknown. There was no previous temperature excursion. The patient also vaccinated on 05-JAN-2022 with improperly stored measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) Lot# T033814 and expiration date 05-OCT-2022) (exact dose and frequency were not reported) as prophylaxis (product storage error). The vaccine underwent a temperature excursion of 47.5 Fahrenheit for 1 hours. There was no previous temperature excursion. No additional adverse event reported.
Rash in arm; Arm stay hot, arm be warm to touch; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingles vaccine. In APR-2023, less than a week after receiving Shingles vaccine, the patient experienced rash (Verbatim: Rash in arm) and extremities hot feeling of (Verbatim: Arm stay hot, arm be warm to touch). The outcome of the rash and extremities hot feeling of were not resolved.   It was unknown if the reporter considered the rash and extremities hot feeling of to be related to Shingles vaccine.     It was unknown if the company considered the rash and extremities hot feeling of to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-APR-2023 The patient wanted to know that how many days his or her arm would stay hot with rash or warm to touch with a rash, as it had been 4 days since first shingles vaccine
Severe myalgia, began with muscles of neck, thigh. Over next 3 days also involved legs, arms.  Difficult to rise from supine position; had to used my hands to flex my thighs.  Malaise.  Never had anything as generalized as this before,  Temp of 100.4 F.  on 10/26.  NO OTHER SYMPTOMS.  Started to improve on 10/29.  Almost totally resolved by 10/31.  Ibuprofen, Tylenol did not help.
Approximately 48 hours after receiving immunizations. (R) deltoid became swollen & red. Patient was seen in office 7/27/2010 with lingering swelling but redness had resolved. Afebrile in office but mom stated temp had been up to 104 degrees at night x 2 nights.
Began as H/A and some overall achiness, nausea, moved quickly to severe chilling for several hrs, did hv small episode of vomiting. Took Tylenol ES 2 caps+ 1 generic maximum strength acid reducer ice chips, comforter blankets and heating pad. By Midnite, chilling, n/v subsided. Just remained for the nite w/multiple blankets. Woke up in am w/o issue
This prospective pregnancy case was reported by a consumer (pregnant mother) and described the occurrence of trisomy 18 in a foetus subject of unspecified gender who was exposed to FLUARIX quadrivalent (GlaxoSmithKline) in utero when the mother received. A physician or other health care professional has not verified this report. On 16 September 2013 the 33-year-old mother of the fetal subject received a dose of FLUARIX Quadrivalent (.5 ml, intramuscularly). On 22 December 2013, 97 days after vaccination with FLUARIX Quadrivalent, the subject experienced trisomy 18 and maternal vaccine exposure. The mother's estimated delivery date was 09 June 2014. Her last menstrual period (LMP) was not provided; calculations based on estimated delivery date estimate the LMP to be 02 September 2013 and 16 September possible date of conception. Prenatal diagnostic tests revealed evidence of a defect. A blood test done and on 22 December 2013 the mother was told that the fetus was positive for Trisomy 18 and Trisomy 22. The test was repeated and ruled out Trisomy 22, however Trisomy 18 showed up. The mother had an amniocentesis done on 06 February 2014, but she does not know the result of that test yet. The mother saw a genetic counselor after receiving her blood test results and the counselor discussed what her options were at this point. At the time of the reporting the Trisomy 18 was unresolved; the pregnancy was ongoing. Please see report A1060745A for details regarding the mother case.
Sore/Tender injection Site Pain on the left arm up to the neck Fatigue and Weakness for 48hrs
My whole, that really my back, it is not my side, it's like a muscle, all muscle don't tighten up; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date in 2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient just got a shot on Wednesday at the patient's job and over maybe two hours ago, the whole, that really the back, it was not the side, it's like a muscle, all muscle don't tighten up like, so was that, can be one of the side effects, like the joint was (sentence Incomplete). The outcome of the event was unknown.  Information about lot/batch number has been requested.
Numbness, tingling, pain, warmth at injection site. Symptoms sometimes travel across and down arm, with or without movement. Symptoms began on 01/02/2021, event was reported on 02/17/21. Ice, heat and range of motion exercises used and symptoms have slowly improved since they began. Symptoms are still present today though.
The night of 3/23/21 at 5pm I had chills in my Brady and numbness and tingling in my toes. I looked at my toes and noticed they were turning very pale.  One minute later the bottoms of my feet started turning yellow and within one more minute the bottoms of my feet souls were completely yellow. I have never had this reaction before. It was shocking and looked like I had stepped in yellow paint.
heavy rash on upper body with hives.  Treatment with prednisone 10 mg tablets for 9 days.  Total tablets - 21
Gave Novartis H1N1 vaccine (4 years and older) 0.5ml IM. Should have given Sanofi Pasteur H1N1 for ages 6 months and older 0.5ml IM.
COVID antigen test which came out positive; COVID antigen test which came out positive; This is a spontaneous report from a contactable consumer. This consumer reported for 36-year-old female patient. A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8734), dose 1 intramuscularly on 31Mar2021 (age at the time of vaccination was 36-year-old) as dose 1, single for COVID-19 immunization and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8729) dose 2 intramuscularly on 21Apr2021 (age at the time of vaccination was 36-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received by the patient within 2 weeks of vaccination. The patient did not test COVID-19 positive prior to vaccination. The patient had been tested for COVID-19 since the vaccination. It was reported that on 17Aug2021, the patient took an at-home COVID antigen test (Abbott BinaxNow Antigen Self Test) which came out positive on 17Aug2021. Patient was experiencing COVID-19 symptoms which included fever, aches, loss of smell and taste, fatigue, congestion and cough. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17Aug2021 (Nasal Swab). Treatment medications included OTC DayQuil and NyQuil to treat symptoms. Outcome of the event COVID-19 was reported as not recovered at this time of the report.     Follow-up attempts are completed. No further information is expected.
Extreme itching, similar to a mosquito bite. Swelling (approx 3 inch in diameter) with redness and warmth. Itching lasted two days, redness resolved in four days.
Complains of severe flu-like symptoms- fever, chills, nausea, bodyaches, hoarseness. Also rash to neck and chest with tightness in chest.
Patient received dose 1 of the Pfizer COVID vaccine (lot EW0175, exp 8/2021) at approximately 1430. At 1440, patient reported feeling hot and sweaty to Pharmacist who then walked patient unassisted to zero-gravity chair. Paramedic and PHN approached to assess patient. At 1442, vital signs: blood pressure 144/82, O2 96%, pulse 96, respirations 18. Patient drank water. Patient reported history of COPD, having seasonal allergies, and denied taking medication. Patient reported feeling anxious and having tinitus. PHN offered patient Benadryl which patient declined. patient reported never experiencing similar symptoms previously. PHN encouraged patient to follow up with provider and when to call 911. At 1450, patient reported an improvement in symptoms. Vital signs: blood pressure 132/76, respirations 18, O2 91%, pulse 92. Patient offered Sunchips but did not eat them. At 1505, vital signs: respirations 18, blood pressure 132/84, pulse 88, O2 93%. Patient reported symptoms continuing to improve but remaining tinitus that was also improving from previously. PHN encouraged patient to remain for monitoring for 30min from onset of symptoms. Patient left walking with steady gait at 1510.
Face especially and other parts of my body got really red, started itching,  felt a little quaesy, left arm swollen. Later that day and through today a headache that won?t go away and queasiness occasionally.
The patient started getting itchy on her face and neck 40 minutes after receiving the vaccination.  Soon after in the evening the patient had rash and hives on her upper torso and neck.  The hives spread the next day to eventually cover her entire body.  The pt. took a Benadryl and went to the hospital because of the severity of the hives and itching on day 2.   The staff told her that she should use hydrocortisone cream and should possibly not get the second dose of the vaccination.  The pt. continued to use both the Benadryl and hydrocortisone the following day, but still the hives persisted.   Pt. is on Day 4 and will let us know further details on her condition as time goes on.
low grade fever; bad headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) and HEADACHE (bad headache) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (low grade fever) and HEADACHE (bad headache). At the time of the report, PYREXIA (low grade fever) and HEADACHE (bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
After receiving the GARDASIL vaccine, pt is losing lots of hair. It has been a year and she is still losing hair. She has diarrhea often and vomits weekly. She has also been experiencing lower right ab pain. She has also been hurting in her chest right side.
So, At the end of November I started with heart palpitations, then I started with some between the should blades pressure. I had a stress test on 12/06/2021. I went back to be seen at the doctor's office on 12/20/2021. By that time in December, I had more palpitations and between the shoulder pressure, chest pressure, not pain. At that time my doctor wanted to do a heart cath and my insurance denied it at that time because I was not having any heart blockage. So they put a heart monitor on me for a week. That brought me to the week of Christmas, this showed that I was having 2nd & 3rd degree heart block. On January 13, 2022 I had my heart cath. It showed one coronary artery with a 70% heart blockage and the put a stent in me. That cleared up the heart palpitations. They continued to watch me from 01/13/2022 to my surgery appointment. They brought me to a specialist who watches the heart rhythm and it showed that the heart block was getting worse rather than better. The conduction system of my heat was not working. On 02/16/2022 my pacemaker went in. I started to feel much better.
Information has been received from a medical center concerning a 6 year old female who on 10-SPE-2001 was vaccinated with Varicella. On 21-MAR-2006 the patient experienced chicken pox. She was diagnosed on 23-MAR-2006. No additional information was provided. The patient's sibling (WAES 0604USA02512) had a similar experience after vaccination with Varivax. Follow-up information from the licensed practical nurse indicated that all information is available.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unspecified dates in October 2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # K019933 and expiration date 20-APR-2016; lot # reported as L014420 and expiration date 23-FEB-2017; exact doses and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received has been requested. Additional information has been requested.
joint pain in his elbow on his right side, and on the right side of his body in his hip and leg; right leg numb and his right upper thigh time to time; sometime hard to walk; right wrist pops sometimes; right knee locks up; Muscle pain; This is a spontaneous report from a contactable consumer or other non hcp.     A 69-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot Number: EM9810) as dose 1 single for an unspecified indication. Medical history included hypertension from 2008, Blood pressure high, cardiac disorder. The patient's concomitant medications were not reported. It was Reported,  Caller stated first dose was injected into his left arm, and he is having joint pain in his elbow on his right side, and on the right side of his body in his hip and leg and at his right leg is numb, and his right upper thigh time to time it is sometime hard to walk and also had his right wrist pops sometimes when he moves it, and it seems to give out in his arm. He said his right knee locks up sometimes. Caller says his vaccine card is handwritten, he can't read it, and needs to get his glasses. He says that the card says his first date was 03Feb2021, but he thought it was the 04Feb2021. He says that the second dose is scheduled for 24Feb2021.Caller say that he has just been taking his regular prescribed meds. He said that they took him off Aspirin and stuff like that. He says that they were giving him pain pills, and he can't take Tylenol, but he doesn't have pain pills, them things are hard to get these days. Caller does not clarify these statements, no further details provided about Aspirin, Tylenol, or pain pills. The outcome of the events was unknown on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Patient was given 0.5ml instead of 0.25ml booster vaccine, called patient on 1/19/22 and she denied any problems since vaccination and a letter was sent to inform patient what dosage she was given
BlurredVision, Headache, Myalgia, Arthralgia, NauseaVomiting, Fatigue, Peripheral Numbness/Tingling Narrative: No further details given
his is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No adverse event" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 15Sep2022, stop date: 19Dec2022. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) strong positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:  Patient had received other medication in 2 weeks.Patient was treated with Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 12 months old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 06-DEC-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Mom reports a knot at injection site of left leg about the size of a fist. Warm compresses, Benadryl, Tylenol as needed, call back if any
Fever, body aches and swelling and a rash about 6? wide below the injection site
Chills, fever (101.2), headache, muscular pain, tiredness and fatigue. Overall felt like being very sick with a flu for 24 hours.
pain just like the sore arm; This is a spontaneous report from a contactable other healthcare professional. A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (at the age of 32-Years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (at the age of 32-Years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient' s medical history and concomitant medications. On an unspecified date, the patient experienced pain just like the sore arm. At the time of this report, the outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a IR Administrator of the clinic, and refers to a 10 month old infant patient of unknown gender. No medical history, concurrent condition and concomitant medications were reported. On 07-JUN-2016, the patient was vaccinated with improperly stored dose of VARIVAX lot # L048468 (strength, dosing details, anatomical location were unknown). All the VARIVAX vaccines with lot # L048468, were moved to the backup freezer on 15-APR-2016 and moved back at the end of AUG-2016. This is one of the several reports reported by the same reporter. Additional information has been requested.