chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt took nap woke up with chills, nausea, vomiting, and low blood pressure, went to ER. Treated for reaction with decadron, Benadryl, Epi Pen, started throwing PVC did chest x-ray and inflitrates found. Has been in hospital for 48 hours.
Presented to hospital with chief complaints of diarrhea, blood in stool as well as abdominal pain; has current COVID infection but asymptomatic.
Slight cold/small cold; stuffy nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 21Mar2021, outcome "unknown", described as "Slight cold/small cold"; NASAL CONGESTION (non-serious) with onset 21Mar2021, outcome "unknown", described as "stuffy nose". Additional information: The patient's cold was "not bad" but "worse on Monday" (22Mar2021). The patient was supposed to receive his second dose on 24Mar2021 and wanted his appointment changed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At 22:00 hrs on the 24th (my shot was at 11:30 am that day), I started having a fever, my entire body was in great pain, it felt like fire ants or acid running through my veins, and cement in my lymphatic system. Completely unable to sleep, weak as a kitten. Maximum recorded temperature: 103 F. Freezing cold, boiling hot, swollen abdomen, out of breath, very frequent urination & inconsistent bowel movements. Fever persisted until later in the morning of the 28th. However, the evening of the 25th a tremendous pain in my lower back & pelvis became overwhelming - as of writing this still persists. I have only been able to lie down on my back for most of the time. My whole abdomen has been swollen out of proportion & I've had difficulty eating  - as of writing this still persists. Congestion, a chesty cough, & tickly throat.   Normally, I am very athletic swimming 3 km a day, cycling to commute, and diving. I've been 90% bed-ridden since the evening of the 24th & am very concerned for my welfare, particularly my abdomen and lower back pain, which is uncompromising. I do not earn enough money for health insurance.
Information has been received from a medical assistant concerning a 12 month old male who on an unspecified date was inadvertently vaccinated with PNEUMOVAX 23 instead of his third dose of PREVNAR. It was unspecified if the patient sought medical attention. No adverse effect was reported. Additional information has been requested.
Product storage error; Poor quality product administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Product storage error) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On 25-Jun-2021, PRODUCT STORAGE ERROR (Product storage error) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  The temperature log had a date when the refrigerator reached 34 and 32 degrees F.
I DEVELOPED A FEVER, COUGH, BACK PAIN, ACHINESS AND COUGH WITHIN 24 HOURS.  A DAY LATER I HAD RINGING IN THE EARS.  BY DAY THREE I HAD WORSENING OF RINGING IN THE EAR ACCOMPANIED BY HEARING LOSS AND SYMPTOMS EXCEPT FOR BACK PAIN.  I ALSO DEVELOPPED A TWITCH AND DECREASED SENSATION ON THE LEFT SIDE OF MY FACE.  I STARTED ANTIBIOTICS AND HAD NO RELIEF.  I RETURNED TO THE DOCTOR ON DAY SEVEN- TODAY AND WAS TOLD I HAD VARICELLA IN MY EAR AFFECTING MY FACIAL NERVE RESULTING IN MY SYMPTOMS.  THE DOCTOR PRESCRIBED ACYCLOVIR AND SENT ME HOME AND TO FOLLOW UP WITH HER IN 8 DAYS. 8/15/06 Received medical records from hospital which consisted only of MRI of brain & audiology report.  MRI revealed left oto-mastoiditis with evidence of labyrinthitis.  Mucosal thickening in bilateral maxillary & left sphenoid sinuses/ss
patient was expecting to receive the updated booster the bivalent one and ended up receiving the monovalent
a rash began developing the day after my vaccination was administered. (a little over 24 hours later).    The rash is on my chest, arms, back primarily.    I have been taking Benadryl to ease the itching.    Now on Day 5, the rash is subsiding.   NO rash at site of injection.  NO other symptoms.
Determined that this patient was 16 yrs of age and given a Moderna Vaccine-which has the  recommendation for 18 yrs and up. She is also pregnant and her OB physician recommended the vaccine. (didn't have Pfizer in stock- Modern given without realizing age.
6 pm the night of vaccine - fatigue; body pain; headaches and low grade fever. These were the exact same symptoms I had for COVID but at about 75%  as bad  and that lasted until the exact same time the next day, 24 hours. And then I started having kidney pain the end of January and the beginning of February and I was also having stomach  pain. I saw my doctor and the doctor ran a Metabolic panel - my kidney function was lower. No treatment. Just not taking NSAIDS and I'm drinking more water. My kidney function is back to before the first shot levels - I'm back up to 70- which is my normal. Currently I'm experiencing with Gastroparesis - it may be post viral from having COVID. It started getting really bad in February. It showed I had delayed stomach emptying.  I first tried Reglan - it didn't help and made me feel kind of weird. Other than that, I have changed my diet and drink liquids only for food. Take a lot of anti-nausea and vomiting medication. It seems to be flaring up less now so I think I'm coming out of it. It's difficult to know if it's helping. For kidneys, I am recovered to back to normal. I am dealing with something that may be autoimmune - I'm being tested for lupus. My grandma had lupus and so it may be a possibility for me. I think the kidney issue was more vaccination orientated.  I had a bag of fluid at work - as I was badly dehydrated - so that was like an Urgent care visit except Urgent care was closed - that was June 8th.  Note: my second COVID vaccine was February 20th, 2021.
MMR administered in Right leg.  Mtr noted swelling and redness begining around 7 pm.  Area  around injection swollen >5 inches, redness and itching present.  Swelling spread into groin area and was warm to touch.  Child unable to ambulate.  Child seen in the emergency room and by MD (the following day). Oral Benadryl was given and a topical cream was applied prn.  Reaction resolved after approximately 1 wk.
Information has been received on 15-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2012, the patient's healthcare provider at a clinic administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 18-DEC-2016, the patient was treated by a healthcare provider at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the Zoster Vaccine Live (ZOSTAVAX), and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Left arm - red, swollen, positive for itching and rash 2 cm raised erythematous. Patient instruction: Apply ice to area and prednisone also take BENADRYL.
Information has been received from a medical assistant concerning unspecified number of patients of unknown age and gender. Information regarding the patients' relevant medical history and concomitant medications was not reported. On unknown dates, the patients were vaccinated with GARDASIL (dose, strength and route were not reported, lot # L001442 and expiration date: 04-NOV-2016) that was improperly stored. No adverse events were reported. No PQC (product quality complaint) was involved. Follow up information has been received from a medical assistant via a phone call on 02-APR-2015. The medical assistant provided that vaccination information was not readily available at the time of the call. The medical assistant provided that patient identification information was not readily available at the time of the call. Follow up information has been received from the medical assistant on 01-MAY-2015, concerning a 24 year old female patient. On 26-FEB-2015 at 15:45 o'clock, the patient was vaccinated with the first dose of GARDASIL, that was improperly stored. This is one of several reports received from the same reporter. Additional information is not expected, an no more information was available.
PATIENT STATED ARM SORE THE NIGHT OF RECEIVING VACCINES & "FELT LIKE HAD FLU". WENT TO WORK ON TUESDAY AND HIS BOSS WAS MESSING WITH ARM AND TEASING HIM ABOUT GETTING OVER THE SORENESS. AS DAY PROGRESSED HE CONTINUED TO FEEL WORSE. HE WENT TO URGENT CARE AND HE STATED HIS WBC WAS 23, SO THEY SENT HIM TO THE ER. HE WENT HOME FIRST TO CHANGE CLOTHES THEN WENT TO ER. HE STATED THEY ASKED QUESTIONS AND RAN TEST. CHECKED HIM FOR STREP THROAT & WAS QUESTIONING HIM ABOUT CAMPING & IF HE HAD TICK BITES. HE STATED THE DR QUESTIONED IF THE IMMUNIZER CLEANED THE SITE & IF EVERYTHING WAS STERILE. HE STATED HE TOLD THEM YES HE WATCHED EVERYTHING. HE STATED ALL TESTS CAME BACK FINE & THE DIAGNOSIS THE DR GAVE HIM WAS CELLULITIS DUE TO ONE OF THE VACCINATIONS. THERE WAS NO DIRECT SWELLING AT INJECTION SITE. PATIENT CAME TO PHARMACY TO REPORT ON 9/29/17 AT ABOUT 1PM. INJECTION SITE WAS LOOKED AT, BUT NO VISIBLE POINT OF ENTRY OR SWELLING. HE STATED HE'S FEELING BETTER AND THE DR PUT HIM ON ANTIBIOTICS.
Temperature 100.4, chills, body aches. Then muscle weakness, fatigue extreme, headache. Right arm stiffness,  pain and tightness spreading to right axilla. Chest discomfort,  dizziness, lightheaded, palpitations. Lasting 7 days so far
Vaccines received in the am.  Mom reports at 1PM patient complaining of being achy and lips being swollen.  No breathing difficulties - cheeks a little red.
On 2-12-21 I received my first injection. The next day I had a red area on my arm and it felt like a lump underneath it.  It lasted two or three days then went away.  However, on 2-23-21 another red area appeared in the same place with a lump underneath and it felt hot.  It is still that way today 2-25-21 and seems to be spreading a little.    No itching either time.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 06-OCT-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # J016232, expiration date, dose, anatomical location and route of administration were not reported). The reason for the temperature excursion was, because the daily vaccine counts caused the storage unit to have temperature fluctuations because of door opening. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information is not expected, as no further information is available.
My husband had the vaccine on 3-2 and on 3-21 his platelets had dropped quite a bit.   On 5-30 he was admitted to hospital with Leukemia   I checked back 2 years of bloodwork and no issues til then.   He passed away on 6-26-2022.   I strongly suspect the vaccine.   He had no blood issues til then.
10/12 Headache, redness and swelling at injection site. 10/14 Low back pain. 10/15 Leg pain. 10/16 Severe leg and back pain, deep ache with burning sensation - to hosp. E.R. 10/19 Increased severe leg and back pain with weakness - to PMD. 10/20 Admitted to hospital. 1/22/08-records received for DOS 10/20-10/30/07 DC DX: Guillain-Barre syndrome with severe paresthesias and pain, bialteral muscle weakness, plsmapheresis. Pain, anxiety, plasmapheresis catheter infection with methicillin-sesnsitive Staphylococcus epiermidis. Dysuria with normal urinalysis, severe constipation, left foot pain with swelling, general deconditioning and symmetric peripheral weakness including facial weakness and pocketing food during meals. Then traveled out of state at which time had severe pain in buttock and thigh. Tingling and numbness.Transferred to rehab.   9/19/08 Received additional medical records. ER records of 10/16/07 reveal patient had HA & diarrhea week before.  Then developed low back pain, knee pain & skin sensitivity.  Labs were unremarkable.  Tx w/pain meds & d/c to home.  Rehab records of 10/30-11/5/2007 reveal patient tx w/IVIG x 5.  D/C to home w/walker & TENS unit.  Had continued paresthesias
Inflammation of hands and feet, redness and severe itching.  Redness and mosquito bite like bumps on the back of legs, small of back and upper arms that itch.
fever, muscle aches, localized reddness with warmth at injection site left arm Narrative:
Same side lymph node swelling at axilla and clavicle - ice applied x 5 days.  Now (8/1) experiencing a pericarditis flare the cardiologist believes could be attributed to the booster.
allergic reaction; Side effects in arm; hurts very badly; Can barely lift my arm; Nausea; really sick like bedridden for 2 days; it's continuing to increase in size and it is red and swollen and hard now; it's continuing to increase in size and it is red and swollen and hard now; it's continuing to increase in size and it is red and swollen and hard now; it's huge and it's purple; This is a spontaneous report from a contactable Other HCP (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142) , via an unspecified route of administration on 10Jan2021 10:30 to at single dose at arm for covid-19 immunisation .  Medical history included spot on arm.  The patient's concomitant medications were not reported.  The patient experienced side effects in my arm and it hurts very badly on 10Jan2021. The patient can barely lift arm. The patient got vaccinated 10Jan2021 around 10:30 and it came up on around 3:30 or 4 o' clock this afternoon. The patient got nauseated but no fever. The Vaccine made patient really sick like bedridden for 2 days. But the spot on arm where patient got the vaccine, it was probably 4 days ago that patient got it and it's continuing to increase in size and it is red and swollen and hard now. The patient reported that this is not like a normal injection site reaction, it's huge and it's purple and red and it feels like bee sting, it feels like an allergic reaction. The outcome of events was unknown.
8 minutes after injection, pt c/o dizzness.  Pt was escorted to lie on gurney.  Pt c/o room spinning, blurred vision, chest tightness.  9:31- BP checked while in gurney was 180/96, HR 117, O2 Sat 99%.  9:40- VS while lying in gurney: 202/112, HR 131, 100% O2.  9:46- 216/112, HR 118, 100%.  Pt agreed to be seen in ED.  ED staff arrived to bring pt @ 10:00.
Began with joint pain and swelling in 2/2021, leading to diagnosis of rheumatoid arthritis in 4/2021.
Day of shot later in the afternoon: Pain in right arm at injection site Day after shot: 2:00 pm- fever. 7:30 pm severe fatigue 2 Days after shot: 9:00am-11:00pm- nausea, fatigue, headache, low grade fever
This spontaneous report as received from a medical assistant refers to unspecified number patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or pertinent medical histories provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX lot# N014630, expiration date 11-MAY-2019 (dose and route of administration were not reported). Concomitant therapies included properly stored sterile diluent. No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of -14 to - 10 degrees Celsius for 562 hours 16 minutes. There were previous temperature excursion. Digital data logger was involved. The outcome of incorrect product storage was unknown. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA006159.
MD started it was cellulitis (red, warm to touch) txt'ed w/Amox.
This spontaneous report as received from a certified medical assistant refers to a 11 years old male patient with no pertinent medical history reported. On 25-MAR-2013, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) in the left arm. The patient also received meningococcal conj vaccine (unspecified) (manufacturer unknown) (Lot number, expiry date, and dose were not reported) in the right arm on the same day. Certified Medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Ringing and hissing sound in ears; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included gluten allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced ringing and hissing sound in ears on 24Mar2021, which was reported as non-serious. The patient did not receive any treatment as a result of the event. The clinical outcome of ringing and hissing sound in ears was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
shortness of breath and sensation of throat swelling along with cough. patient was given duoneb treatment, benadryl and steroids with resolutions of symptoms.
Day after injection terrible pain in shoulder neck and jaw on left side. Heart attack ruled out. Five days later, pancreatits attack. Seven days later, second pancreatitis attack - worst pain ever!
Shingles erupted in April of 2021. There were no other known stressors at the time, may be unrelated to vaccine, reporting as I received a call after reporting a health event on V-Safe.
shortness of breath approx 3 weeks after 3rd booster.  Will not receive 4th.  Will be going for chest x-ray, blood work
MMR was ordered, MMRV given.  Pt started with  fever 103.7  6 days later 7/17/19.  Swelling into armpit, parents report size of tennis ball.  Hot to touch. resolved 2 days later 7/19/19
fluid on the knee; itches/whole body is itchy like a dog with fleas; armpit was sore; big sacks underneath armpit/like fluid in the sack/it's skin but a sack underneath; arms were sore; This spontaneous case was reported by a patient family member or friend and describes the occurrence of JOINT SWELLING (fluid on the knee), PRURITUS (itches/whole body is itchy like a dog with fleas), PAIN IN EXTREMITY (arms were sore), AXILLARY PAIN (armpit was sore) and AXILLARY MASS (big sacks underneath armpit/like fluid in the sack/it's skin but a sack underneath) in a 57-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Moderna (Dose 1, Lot No.040B21A) on 16-Apr-2021, Moderna (Dose 2 and Lot No. 022C21A) on 14-May-2021. Past adverse reactions to the above products included No adverse event with Moderna and Moderna.    On 31-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Nov-2022, the patient experienced PAIN IN EXTREMITY (arms were sore). On 02-Nov-2022, the patient experienced JOINT SWELLING (fluid on the knee), PRURITUS (itches/whole body is itchy like a dog with fleas), AXILLARY PAIN (armpit was sore) and AXILLARY MASS (big sacks underneath armpit/like fluid in the sack/it's skin but a sack underneath). At the time of the report, JOINT SWELLING (fluid on the knee), PRURITUS (itches/whole body is itchy like a dog with fleas), PAIN IN EXTREMITY (arms were sore), AXILLARY PAIN (armpit was sore) and AXILLARY MASS (big sacks underneath armpit/like fluid in the sack/it's skin but a sack underneath) outcome was unknown.            No concomitant information was reported. It was reported that patient had not taken any medications following the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2022-668061 (E2B Linked Report).
Information has been received from a physician concerning a 17 month old male with asthma and no known allergies who on 30-MAR-2007 was vaccinated SC in the right leg with a one time 0.5 ml dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot#656651/0143U).  Concomitant therapy included hepatitis A virus vaccine (manufacturer unknown) and PREVNAR.  On 02-SEP-2007 the patient developed shingles on the right leg where he received the vaccination.  The patient was seen by the physician on 05-SEP-2007.  No lab studies were performed.  Subsequently, on 09-SEP-2007, the patient recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.