chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This serious spontaneous case, initially received from other health professional on 15-Jan-2018, concerning a 17-year-old, female adolescent patient. On 01-Nov-2017, the patient was administered with FLUCELVAX QIV (anatomical location: right deltoid, indicated for 4 years old and above, batch number: 195250, expiry date: 30-Jun-2018, dose and route of administration: not reported). On 13-Jan-2018, 2 months 13 days after vaccination, nasal swab was performed, and the patient diagnosed with type A flu (Influenza), considered as vaccination failure. The patient was treated with TAMIFLU (reported that, first dose taken within 48 hours of event). This case was associated with QA (Quality Assurance) reference number: 1027392. Based on the investigation performed, it was concluded that FLUCELVAX 195250 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE (lack of efficacy) complaint was the result of the fill finish or bulk manufacturing process and no trends were identified for the batch (195250), or any other FLUCELVAX QIV batches from the 2017-2018 FLUCELVAX commercial season. Therefore, no internal root cause was confirmed. It was reported that, the patient recovered from the event (type A flu) within 72-96 hours of symptom onset (36-50 hrs post TAMIFLU treatment). Non-significant follow-up received from other health professional on 25-Jan-2018: Added QA reference number: 1027392 in the additional information tab. The narrative was amended accordingly. Follow-up received from other health professional on 08-Feb-2018: The age of patient (17), anatomical location (right deltoid) and expiry date of vaccine (Jun-2018) were updated. Nasal swab confirmed type A influenza. Treatment drug (TAMIFLU) added. It was reported that, the patient recovered from the event (type A flu) within 72-96 hours of symptom onset (36-50 hrs post TAMIFLU treatment). Narrative amended accordingly. QA investigation report received from QA (Quality Assurance) on 08-Mar-2018: Based on the investigation performed, it was concluded that FLUCELVAX 195250 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the fill finish or bulk manufacturing process and no trends were identified for the batch (195250), or any other FLUCELVAX QIV batches from the 2017-2018 FLUCELVAX commercial season. Therefore, no internal root cause was confirmed. The narrative was amended accordingly. Update 04-Jul-2018: Non-significant case correction received 15-Jan-2018: The case comment was corrected. No changes were done in the narrative.
Patient was not eating and barely responsive. I called Dr. he told me to watch patient. I work in health care and ended up preforming CPR. He was brought to hospital placed on IVs. Several tests preformed which were all normal. He had gone into shock. He received a Heptavax that morning.
RECENT TIA AND OPEN HEART SURGERY AND THYROIDECTOMY, FEEL PRESSURE IN HER CHEST, BP 96/69, HR 63, EMS CAME, EKG LOOKS LIKE AFIB. TRANSPORTED TO HOSPITAL.
Mother called 8/21/23 & reported patient had 2 seizures on 8/17/23, the day after receiving the HPV shot. Mom states patient does have epilepsy but hasn't had any recent seizure & feels the seizures on 8/17/23 are vaccine related.
I feel cold, it wakes me up at night; I feel shoulder aches; pain at the injection site that won't go away; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Oct-2021 and was forwarded to Moderna on 01-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (I feel cold, it wakes me up at night), ARTHRALGIA (I feel shoulder aches) and VACCINATION SITE PAIN (pain at the injection site that won't go away) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D32M20A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LISINOPRIL, LATANOPROST and TIMOLOL for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING COLD (I feel cold, it wakes me up at night), ARTHRALGIA (I feel shoulder aches) and VACCINATION SITE PAIN (pain at the injection site that won't go away). At the time of the report, FEELING COLD (I feel cold, it wakes me up at night) outcome was unknown and ARTHRALGIA (I feel shoulder aches) and VACCINATION SITE PAIN (pain at the injection site that won't go away) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included Metformin-Glyburide for an unknown indication. No treatment medications were reported.
pt recvd vax & devel burning, redness, & swelling @ inj site which lasted for a couple of days & required ice; also devel h/a, nausea, upset stomach, & cold; had to stay in bed 3-4 days due to symptoms & couldn't use arm;
Kinrix given instead of pediarix. No adverse reaction noted. Patient will require additional vaccine at regularly scheduled interval.
approximately 3-6 wks after vaccination number 2 in september 2008. i had migraines, nausea, vomitting, fatique with no probable cause that lasted 3-4 times a week for about 3 months. followed by severe sob with no probable cause in jan 2009. i recieved vaccine number 3, 3 days ago and pain and redness at injection site.shortness of breath continues. no other symptoms have occured since 3rd vaccination
Swelling, pain, burning sensations under skin, sore/tight muscles, headache, nausea, irritability, tired
Sometime following the vax, the pt's injection site became reddened, swollen, painful and warm to the touch, and developed a hard knot.
Headache, chills, body aches, temperature of 100.9, vomiting
Syncopal episode, sent to ED via ambulance where she was treated and released. Returned to hospital and was admitted on 4/12/2021 and stayed  5 days.
I had a normal pain reaction at site of injection (similar to flu shots) for first three days. Then nothing until a week after injection.  Then itching started. It has itched for 2 days and there is now an egg sized area with a fine red rash. There are no blisters or hives, and it is annoying rather than painful. I have a history of eczema  on my hands. I would not report this if I were not scheduled for a second dose Feb 15. I desperately want to get that vaccine. This may be an expected reaction, but I don't know who to ask but you.
I developed symptoms I believe on 12/14, a scratchy throat. The next day I had body aches, no temperature but a really bad headache and I started coughing and developed some congestion. Took at home COVID-19 test, was positive. I called my doctor and he gave me a prescription antibiotic and a cough medicine. About a week later I would say I am about 80% recovered. I still have the cough and some congestion but that is about it.
Diarrhea started 10:30am 3/7/21 Chills began 12 noon 3/7/21 Took Extra-Strength Tylenol 2 x 500mg at 12:30pm 3/7/21
slight pain at injection site, extreme fatigue, muscle and joint pain in areas where arthritis had caused discomfort, abdominal pain, one incident of vomiting, and most concerning, I felt "foggy" till March 1.
The day after receiving my first dose of the Pfizer vaccine, I noticed a rash had started on the right side of my face and also on the third finger (the one closest to my pinky) on the right hand. The rash grew progressively worse over the course of the week, where now it covers a major portion of my torso, forming two triangle-shaped peaks rising from my hip bones to just below the under-arm, a rash running from my left bicep to the first quarter of my left forearm, on my left wrist, on my right wrist, a patch on my right forearm, a patch down the outside of my right leg, thigh to knee, and a small patch under my left knee.
got shot 1PM fell asleep for about 10min or so;woke up crying;cried unconsolably until 930; no fever; sore legs; had APAP prior to shot & q 4hrs p/wards; fell asleep 830 p/bath & ok;did eat also in between 1 & 8PM
Heaviness in chest for 6 hours, swollen left arm -  pneumonia shot, soreness - 4 days, rash - 2nd day very itchy.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Oct 16, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medication not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunisation. The patient experienced vaccination site reaction (arm at the injection site is very red), onset Oct 2021, with outcome of not recovered. Additional information: Patient received the booster dose of the Pfizer COVID-19 vaccine on Saturday afternoon. She noticed her arm at the injection site is very red. It doesn't seem to be getting better. She wondered if there's anything she can do. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 24-year-old female patient who received FLUARIX Quadrivalent (batch number 329TN, expiry date 30th June 2016). Concomitant products included ADDERALL, LEXAPRO and Birth Control. On 4th December 2015, the patient received FLUARIX Quadrivalent (intramuscular) .5 ml. On 4th December 2015, less than a day after receiving FLUARIX Quadrivalent, the patient experienced injection site pain (serious criteria disability), shoulder pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, shoulder pain and injected limb mobility decreased were not recovered/not resolved. The reporter considered the injection site pain, shoulder pain and injected limb mobility decreased to be probably related to FLUARIX Quadrivalent. Additional details were provided as follows: The pharmacist reported that the patient was experiencing pain in her upper arm and shoulder where she received her vaccination. The pain was so bad she was not able to pick up anything and it was limiting her range of motion. It hurt for her to  move the arm at all. The pain started the same day she received the vaccine and has gotten progressively worse.
AS STATED IN ONLINE INFO....EXCEPT I AM NOT A Toddler ....The most commonly reported serious adverse events in infants and toddlers were bronchiolitis (an infection of the lungs) (0.9%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%), and pneumonia (0.9%) BOTH TIMES I GOT IT AND COULD HARDLY BREATHE.
Dizziness. Noticeable / moderate on 4/5/21 lying in bed and for hours after waking, slight on days prior.  On morning after  injection there was just some fatigue and soreness at injection site.
Began with difficulty "clearing throat" progressed to tingling/dry sensation in throat and  general flushing.  Slight swelling of R cheek noticeable to patient. Patient reported numbness in feet R>L and tingling in fingers .  BP in range of 148/98 throughout with pulse of 88 -89.  Mild tremor noted in hands.  Lungs clear, good air exchange. Pulse oximetery  98-99 throughout.  Pt reported difficulty swallowing.  Was able to drink about 8 oz of fluid.  After consultation with MD, EMS was summoned  arriving  at approx 10:30 and pt was transported to Hospital emergency department.
April 10:  stomach cramping in the late afternoon/evening.  diarrhea in the evening throughout the night.  April 11:  no more diarrhea, but general fatigue and muscle ache.  slight headache
This spontaneous report as received from a physician refers to a patient of unknown age. The physician reported that a patient on unknown dates was vaccinated with first dose ROTARIX and was vaccinated with second dose of ROTATEQ. The third dose of Rotavirus vaccine had not yet been administered. The pharmacy staff stated there was no adverse experience reported from the patient after administration of vaccines. Additional information is not expected.
Approximately 15 minutes following immunization, this recipient complained of itching and began developing hives. Two 50 mgm. doses of Benadryl were given 10 minutes apart and her symptoms progressed. Anambulance then transported her to the Emergency Department. She was treated, evaluated for a period of time and released home in good condition.
I have a red oval on my arm at the vaccination site about 4 inches by 2 inches wide.  It itches, but not horribly.  I only am reporting because  I was vaccinated on 2/16/21 and it still persists on 3/1/21...longer than most flu shot reactions last.  I have felt minor flu -like symptons  a couple of days, but no other adverse reactions
This spontaneous report as received from another refers to a 35 year old patient (gender unknown). On 03-MAY-2013 the patient was inadvertently vaccinated with ZOSTAVAX 5 ml, subcutaneous (lot # J000432, exp date: 10-APR-2013) 5 ml, subcutaneous. The patient was supposed to receive another unspecified vaccine. No adverse effect reported. Additional information has been requested.
J96.00 ACUTE RESPIRATORY FAILURE 7/5/2022 BIPOLAR 1 DISORDER, UNSPECIFIED EPISODE R57.9 SHOCK, UNSPECIFIED 7/5/2022 BIPOLAR 1 DISORDER, UNSPECIFIED EPISODE
Faulty syringe,  medication did not go in his arm.    Gave a second injection.
A health professional report has been received. The report concerns a 10 year old, female consumer, who had been received nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The reporter stated inadvertently gave expired FLUMIST QUADRIVALENT (Preferred Term: Expired drug administered) which started on 12-Dec-2013. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Severe joint pain (7pm on 1/27/2021 through 1/28/2021). Nausea, severe chills, no appetite (7am-10pm on 1/28/2021). Vomiting (2pm-7pm on 1/28/2021). Headache (7am-2pm on 1/29/2021).
fever of 101.8; This is a spontaneous report from a contactable consumer. This consumer (Patient)of unknown age and gender reported that he/she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 24Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. On 25Mar2021, about 24 hours later the patient developed a fever of 101.8. The event outcome was unknown.  No follow-up attempts were possible. information about lot/batch number could not be obtained.
polyps on ovaries; Prolonged period; polyps; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot Number: EWO165), dose 2 via an unspecified route of administration, administered in Arm Right on 26Apr2021 at 10:30 (at the age of 32-years-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included allergies from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing and chronic back spasms from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot Number: ER8729), dose 1, via an unspecified route of administration in Arm Right on 07Apr2021 at 12:15 as DOSE 1, SINGLE for COVID-19 immunization with no reported adverse effects. The patient did not receive any other vaccines within four weeks prior to the vaccination. No other medications were received within 2 weeks of the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05May2021, the patient experienced polyps on ovaries and prolonged period that lasted for 5.5 weeks and didn't stop until she was put on a hormone (unspecified). She had several transvaginal ultrasounds found with fluid and polyps on ovaries. She was also informed that, she would not be able to get pregnant with out help from a specialist. The patient underwent lab tests and procedures which included sars-cov-2 test (Jun2021): negative (rapid test, nasal swab) and ultrasound scan vagina (Unknown date): found with fluid and polyps on ovaries. The adverse events resulted in a Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Clinical outcome of the events was resolved with sequelae (reported as lasting effects).   Follow-up attempts are completed. No further information is expected.
Initial information was received on 20 October 2008 from a health care professional. A 51 year old female patient received an intramuscular injection of FLUZONE (lot number U2765AA) on 16 October 2008. On 17 October 2008 the patient complained of itching with "welts" on the palms of her hands, axillary area, back, upper trunk, and abdomen approximately 24 hours post vaccination. The patient self medicated with Benadryl and had some relief. the patient continued to take the Benadryl and the symptoms persisted. The patient was not recovered at the time of the report. Follow-up information received on 31 December 2008 from a health care professional. The patient had no past medical history, or use of other medications at the time of vaccination on 16 October 2008. The adverse events of welts and itching were treated with Solu-Medrol injection and Prednisone tapering dose pack. No final overall diagnosis was made. The patient fully recovered on 24 October 2008, which was seven days after onset of first symptoms. Per this new information, this case was upgraded to serious. List of Documents held by Sender: None.
Severe pain in the left shoulder unable to have any range of motion or strength in the left arm.  Stream pain unable to sleep. On the third day is slight improvement.
Sudden hematuria that appeared sometime 12-24 hours after receiving my second dose of the vaccine. Urine output seemed normal, but color was pink and orange. Urine remained pink and/or orange on Saturday (March 20) and all day Sunday (March 21) and persisted until Monday mid-morning. Color completely returned to a more normal color and all apparent symptoms were resolved by Wednesday.    There was no flank pain or pain with urination at any point during the time course of these symptoms.
SWELLING AT THE SITE STARTING SATURDAY NIGHT (ERYTHEMA). REPORTED ITCHING AT THE VACCINATION SITE AND REDNESS.
vomited; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administration date 10Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for Covid-19 immunisation. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "vomited".  Additional Information: Patient reported that afterward vomited once, and that only saw 'nausea' in the listed AEs so called to ask us if this had been reported before. Confirmed that this was a commonly reported AE.  Spoke from Fact Sheet, Table 2 which lists the frequency of vomiting after the second dose as 1.9 percentage.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient became ill and no one knew why, Fever muscle aches and very weak. She tried to push through but couldn't. She started having a headache and could not sleep, just when she thought she was feeling better her condition worsen. We took her to the emergency twice . She became extremely confused and disorientated . They then admitted her for observation to the Medical Center and after days of trying to find the piece to the puzzle and answer came. Patient had a shot on Friday when she went to her medical doctor and the shot was a tainted batch or it was just a sever reaction to the medication which became toxic in her body and brain. i thought The doctors were  trying to set a course of seeing if there is a reversal shot or a needed  blood infusion. But, nothing of that sort has been done.  They have just kept her hospitalized  and are not running the needed test to set a course or action. My sister was completely fine up until the point she has the TDap vaccine. She is still the the hospital and the doctors are ignoring that fact that the vaccine had something to do with my sister's newly discovered conditions. Please I Beg you guys to help my sister. Because the doctors are not!
Pt received the flu shot on 1/11/13 next day she was complaining of swelling of arm, chest pain and itchy. Pt took BENADRYL followed up with pt 1/13/13 she said she was feeling better her arm does not hurt and swelling is going down slowly.
Flu like symptoms that night. Woke up with bruised feeling. Progressed into severe cramping. Could not use arm. Limited mobility. Can lift anything. Can't lay on it. Lay on right side and left arm in continuous pain. Goes numb and fingers swell. Pain has progressed to shoulder joint up to my neck and collar bone. Worst pain ever.
Guardian called to report pt began to have "blisters" all over body after pt's appt. Per grandmother's report, pt looks like he has "burns." No other issues reported. Guardian was directed to take pt to hospital ER.
MY SON HAS HAD A FEVER FOR OVER 2 DAYS NOW AND IT WAS AS HIGH AS 105.2.
patient said he has had arm pain/ talked to someone about it but they said it was normal after receiving the shot, today he came in and talked to a pharmacist (myself) and he said he is hearing clicking in his arm, and having shoulder/arm pain still and wanted to let us know. I told him to call his primary care dr
Cough; voice sounded different; not feeling great; Chest congestion; Nasal congestion; sore arm; Fatigue; body ache; This is a spontaneous report from a contactable consumer, the patient.  A 27-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration in the left arm on 20Dec2020 (at the age of 27-years-old) as a single dose for COVID-19 immunisation.  The patient did not have any relevant medical history. She never had any reactions to any vaccines prior. Prior to this vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included loratadine (CLARITIN) and unspecified birth control.  The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 21Dec2020, the patient experienced sore arm, fatigue, and body ache. On 22Dec2020, the patient developed nasal congestion and chest congestion. On 23Dec2020, the patient had a cough, her voice sounded different, and was not feeling great. Since the vaccination, the patient had not been tested for COVID-19.  However, in May2020, she was tested for COVID-19 antibodies and was negative.  The clinical outcomes of fatigue, body ache, nasal congestion, chest congestion, cough, voice sounded different, and not feeling great were not recovered; while that of the sore arm was recovered on 22Dec2020.