chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood sugar levels exceed 200; Body cramps; Left arm soreness at the site of the inejction; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar levels exceed 200), MUSCLE SPASMS (Body cramps), MYALGIA (Left arm soreness at the site of the inejction) and FATIGUE (Extremely tired) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN and GABAPENTIN for an unknown indication.   On 16-Mar-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Mar-2021, the patient experienced MYALGIA (Left arm soreness at the site of the inejction) and FATIGUE (Extremely tired). On 22-Mar-2021, the patient experienced MUSCLE SPASMS (Body cramps). On 22-Mar-2021 at 1:00 PM, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar levels exceed 200). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar levels exceed 200), MUSCLE SPASMS (Body cramps), MYALGIA (Left arm soreness at the site of the inejction) and FATIGUE (Extremely tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was provided as adjustment of Insulin. Patient's carb to insulin ratio is 6 1/2 to 1, correction factor is 30 and insulin duration is 5 hours. Ate 58 carbs took 8.68 units of insulin -2 hrs. Later had to eat an additional 115 carbs to keep sugar above 100. On 09-Apr-2021, diabetic lab work was done and result was awaiting.
This spontaneous report was received from a physician assistant  via a company representative and refers to a 14 or 15-year-old male patient. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On approximately 18-JUL-2018, the patient was vaccinated with a dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not provided) for routine immunization. After receiving GARDASIL 9, the patient fainted. The outcome of the syncope was reported as recovered on an unknown date in July 2018. The relatedness between GARDASIL 9 and syncope was not reported.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: gh9694) at the age of 46 years, in left arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Mar2023, outcome "recovering" and all described as "COVID-19". The event "covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Mar2023) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination.
pt recv vax 13MAY96 & hemoglobin dropped from 12.7 on 26MAR96 to 11.4 on 23MAY96;no tx was given;
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The reporter stated that the patient received 1 dose of CERVARIX on 23-OCT-2013, after which she received a complete 3-dose series of GARDASIL on unspecified dates, for a total of 4 doses of HPV vaccine. No adverse effect reported. Additional information has been requested.
Severe headache, shortness of breath, nausea 1 week Later neurological deficits started The symptoms have never gone away
expired dose of ACTHIB was administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from other health care professional and a consumer/ non-health care professional via Medical Information (MI) (Reference number- 00559372) and transmitted to Sanofi on 13-Apr-2021.  This case involves a 01-year old male patient who received expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered) (lot number: UJ182AAA and expiration date: unknown and lot number: U6685AA and expiration date: 08-Mar-2021] at 0.5 ml dose via intramuscular route in the right thigh for prophylactic vaccination.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).  It was an actual medication error due to expired vaccine used (latency: unknown).  At the time of reporting, patient had no adverse event.  It was not reported if the patient received a corrective treatment.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
15 minutes after receiving the vaccine patient started to feel itchy in her throat but did not have tightening in the throat, hives or shortness of breath.  Patient was taken to the emergency department where IV benadryl and solu-medrol were given.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in May2023 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: "Asthmatic" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jun2023, outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jun2023) Negative, notes: By Sunday, the symptoms were gone, and I tested negative in an antigen test; (13Jun2023) Positive, notes: On 13Jun2023 I tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: To finish patient's previous message-it was apparent that the new COVID strains were immune to the bivalent vaccine. By the way, patient did not have a fever last week or in patient's current Rebound COVID. Patient just thought they should know. In May2023 patient received fifth Pfizer COVID vaccine, the second bivalent. On 13Jun2023 patient tested positive for COVID and received a course of Paxlovid because patient was 69 and asthmatic. By Sunday, the symptoms were gone, and patient tested negative in an antigen test.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300111277 same patient, different drug/event;
Baseball sized, swollen lesion. Painful felt like shingles. Scabbes. Severe pain, chills, fever x 3 days following.
got the flue every time; Initial information received on 12-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).  This case involves a patient with unknown demographics who got the flu (Influenza) every time the patient took INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (Unknown latency), the patient reported that he/she got the flu (Influenza) every time the patient took INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Patient had a 3.5 to 4 inch red area surrounding the vaccination site and a sore arm. He denies any fever, chills, sweating, rash or any other symptoms.
2/18/03 2pm lower rt quadrant abdominal pain, headache, low grade fever. 5pm pain in abdomen worsens, headache 99.5 F. 10pm pain severe. 2/19/03 fatigue, 99.5 F, pain abates. 4pm white, chalky stool. 2/20/03 fatigue only. 2/21/03 fatigue only. 2/22/03 99.5, fatigue. 2/23/03 99.5, pain, fatigue, throat feels swollen.
Patient stated her throat felt like it was closing shortly after she received the vaccine. It was her first time receiving the flu shot. She stated she wasn't having any issues breathing. We gave 25 mg of oral liquid BENADRYL and the patient stated the symptoms were disappearing a few minutes later.
some with severe SOB ongoing; loss of taste and smell; loss of taste and smell; had some symptoms on covid of flu dose #1; fatigue; This is a spontaneous report from a contactable consumer. This consumer reported for two of five patients. A patient of an unspecified age and gender received the first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection), via intramuscular route of administration from 05Feb2021 10:20 (Batch/Lot Number: EL9261) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that "All 5 of us there ongoing fatigue, some with severe SoB, ongoing loss of taste & smell. All had some symptoms of covid of flu dose #1. One sibling is resistant to vaccine based upon our reactions to vaccine". The clinical outcome of the events was unknown.  Information on Lot/Batch number has been requested.
1st Dose -Nausea, Stomach ache, head ache 2nd dose on 2/17/2021 at 8:40 am. Side effects started at Midnight on 2/18-  Fever of 102.0.  Body chills/aches.    2/19- Fever 101.8. Body chills/aches.     2/20 -Fever 100.0. Voice felt froggy (not a sore throat), difficulty talking.   2/21- Fever 99.0.   2/22- Temp 99.0 voice is froggy.  2/23 - Normal temp. Voice is froggy.  2/24 Feeling better.  Stayed in bed took 3.5 days off work, treated myself.
Parents called that she had large local swelling and warmth at site of injection.  Was itching at the time.  Advised to give Benadryl and use cool compress.  Swelling resolved mostly after 3 days upon follow up.
Two days after receiving the vaccine I had a red, itchy spot at the injection site which lasted a day or two. I tested positive for COVID-19 on 09/29/2022 via a home test. I had a sore throat, terrible cough and fatigue. I contacted my doctor, and they did not prescribe PAXLOVID due to side effects. I took MUCINEX and TYLENOL as needed. I continue to have trouble with swelling in throat, chest tightness and fatigue. My doctor put me on a steroid medication to help me with my symptoms. I'm not fully recovered but I am feeling better after starting the steroid.
Felt swelling in arm, third fourth and fifth finger on right arm became numb, tiny pinpoint red bumps appeared on arms and legs.  Right eyebrow and extending down to the right cheekbone feels "puffy"
I recently (9/3) received my first dose of the Pfizer vaccination. The next day I had the normal symptoms of a vaccine. Lethargy, achy, clammy and sweating intermittently, headaches, both ears filled with fluid, muscle pain, pain at the injection site, generalized weakness and a fever of 101 with both Tylenol and ibuprofen together. I increased my fluids and rested all day. Two naps and early to bed, with my wife taking care of the kids for me. However, the next morning when I woke up, I felt lightheaded and sweaty and didn?t feel right. While walking into the bathroom, I lost consciousness and passed out. Falling face first into the floor with my nose breaking my fall first unfortunetly. I arose to my wife shaking my body, laying in a pile of clotty blood from my nose. No other injuries other then facial bruises and rub burns on my face and knees. Felt horrible (remaining symptoms from the day before continued) on top of the new body injury pains.
This spontaneous report was received from a nurse refers to a 3 months old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 05-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M044397, expiry date: 20-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054.
Information has been received from a study for ROTATEQ concerning a 17 week old male who was vaccinated with a second dose of ROTATEQ. Three days after vaccination, the infant experienced one day of vomiting and bright red blood per rectum, on 16-DEC-2007 the patient was hospitalized. Diagnosis was confirmed as intussusception by ultrasound. Reduction via air contrast enema was not successful. Ileo-colic intussusception was surgically resected due to ileocecal enteric duplication cyst. The infant was discharged at day 3. At the time of reporting, the outcome was unknown. Intussusception was considered to be an other important medical event. The relationship of intussusception to ROTATEQ was not reported. No further information is available.
Itching on 11/9/2012.  On 11/13/2012 area became red, hot and swollen 2 3/4 in. diameter, 3 1/4 in. tall.
I woke up around 4AM with fever, cold chills, nausea, and body aches. I had the body aches and chills for two days and then I was okay. My arm was very swollen, red, and painful. I also had a reaction to my first vaccine lot #011J20A where 8 days after the dose my arm had a red rash, very swollen, hot to the touch, and painful. This reaction took about 5 days to go away.
April 10th: Woke up with  "pins and needles"  feeling sensation on all fingertips on my right hand for the entire day.   Woke up the next day sensation went away.     May 13th: Woke up with fingertips on both hands feeling the same   "pins and needles" sensation.   This  "pins and needles"  sensation  is still occurring to this day.  June 13th: I noticed that it was difficult  to turn door knobs, water faucets, and hold certain objects. This phenomenon  got worse and worse  until June 20th where I lost the ability to move my wrists up and had trouble moving my fingers.  Because of this, it is difficult for me grip certain objects, hold on to object such as a glass of water, or even type properly on a keyboard. This is still happening today.  Neurologist have diagnosed me with Acute motor sensory axonal neuropathy, a variant of Guillain-Barré syndrome.  I also began seeing an occupational therapist to help me with day-to-day things like clean myself.
I have a red and itchy blotchy rash all over my torso that started from my vaccination site and spread. It started spreading slowly but it is spreading more rapidly now and is starting to spread lower onto my legs and bikini area as well. It is super itchy and painful, and more and more just keep popping up on my body at alarmingly increasing rates.
Pt presented to office with rash to face, torso, all extremities, itching severly
This non-serious, spontaneous case, initially received from other health professional (nurse) on 08-Oct-2018, concerns a 03-year-old, female child patient. On 08-Oct-2018, the patient (less than 4 years of age) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230 and expiry date: 31-May-2019). At the time of this report, no adverse events were reported. This case was linked to original case 201804369 and 201804369 due to the same reporter. Follow-up report received from the reporter on 12-Nov-2018: The reporter confirmed that the patient had not received partial dose of suspect vaccine. Hence, the event under-dose was deleted. The narrative was amended accordingly.
The patient, who is a resident of another state came in and requested to receive a Moderna booster dose to his first two Moderna doses that he received on 04/22/2021 and 05/19/2021 at clinic. The patient presented his card showing his previous two Moderna doses. I administered the booster dose. Later that day, I was filing paperwork from that day's vaccines and realized that the patient was 17 at the time that he received all three of his Moderna vaccines. I called the patient, who was fine. I then contacted the clinic where he received the previous two vaccines to confirm his age and that he had received Moderna. The clinic confirmed both and said that they would submit VAERS reports.
spiked a temperature of 101.6 at 8:15pm.  Had fairly severe uncontrollable chills and shaking for 45 minutes.
no adverse event; Incorrect product storage; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 05-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) dose/ frequency: 1,  lot # T015598, expiration date 02-NOV-2021, for prophylaxis (route were not reported).  The temperature involved was 16.5 degrees F for 4 hours. The previous temperature excursion was 14.5 degrees F for 2 hours and 45 minutes, 15.6 degrees F for 3 hours and 21 degrees F for 5 hours and 30 minutes. A data logger was involved. No adverse events.  This is one of multiples cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA003878:Original Case : 2104USA003483 US-009507513-2104USA003885:Original Case : 2104USA003483 US-009507513-2104USA003483:Original Case : 2104USA003483 US-009507513-2104USA003881:Original Case : 2104USA003483 US-009507513-2104USA003882:Original Case : 2104USA003483 US-009507513-2104USA003883:Original Case : 2104USA003483 US-009507513-2104USA003884:Original Case : 2104USA003483 US-009507513-2104USA003877:Original Case : 2104USA003483 US-009507513-2104USA003876:Original Case : 2104USA003483 US-009507513-2104USA003879:Original Case : 2104USA003483
tested positive with Covid; tested positive with Covid; This is a spontaneous report from a contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first dose of the vaccine but she got tested positive with COVID on an unspecified date. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sub acute cognitive dysfunction over 8 weeks with dramatic accelerated decline over the last two weeks.  Patient suffers from confusion, memory loss, difficulty understanding/comprehension, balance.  MRI showed abnormal areas of cortical diffusion restriction involving portions of the parietal lobes, left occipital lobe, and left medial temporal lobe with subtle FLAIR hyperintesnsity.  Since this has suddenly occurred, there has been no prior evaluation or workup for dementia or memory loss.  Possible considerations: CJD, encephalitis, vasculitis, other.  Expectations for Hospital:  Additional testing, diagnosis, treatment.
Within 8-10 hours after the vaccine I had an onset of extreme Fatigue and Joint Pain, I have no recollection of 72 hours post vaccine. After which my left knee blew up with fluid, swollen fingers, wrist pain and stiff ankles. I was given  glutathione injection to help with stiffness. In addition I tried Homeopathic therapy and nothing has helped. It takes me a long time to get up from a sitting position and I cannot stand for long periods of time.
severe cramping associated with period; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021(at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus, celiac disease and hypothyroidism. Concomitant medications included insulin lispro (HUMALOG), insulin glargine (LANTUS), levothyroxine sodium (SYNTHROID), spironolactone (MANUFACTURER UNKNOWN) and retinol (MANUFACTURER UNKNOWN); all for unknown indication from unknown date. The past drug history was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021,since getting vaccinated, the patient experienced severe cramping associated with period. The clinical outcome of the event severe cramping associated with period was resolving at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Narrative: Pt is a 68 year old male for whom a ADR to the COVID 19 vaccine was documented in the patient's chart. Patient received a COVID vaccine from a primary care provider in Aug 2021. An ADR was documented in Nov 2021. Unsure if this ADR is for the first or second COVID vaccine.