chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting one  day after vaccine, developed electrical pain starting behind left ear inferiorly and going up to near top of the ear then radiating back towards the back of the skull.  Intermittently painful, shooting/zinging pain, severe.  Also hypersensitivity of the skin behind the left ear.  Sx c/w occipital neuralgia.
infection; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (infection) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient tested positive for COVID-19 in Oct2020).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFECTION (infection). The patient was treated with AMOXICILLIN TRIHYDRATE (AMOXIL 12 H) at an unspecified dose and frequency. At the time of the report, INFECTION (infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Arm hurt really bad; Little bit of fever; Little bit of body aches; vitamin D deficiency; stage 4 chronic kidney disease; This is a spontaneous report from a contactable consumer.  A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 57-years-old via an unspecified route of administration, administered in arm left on 23Feb2021 10:30 (Batch/Lot Number: EL9267, expiry date not reported) as single dose for covid-19 immunisation. Medical history included ongoing diabetic, heart patient from 2005 and ongoing, cardiomyopathy from 2005 and ongoing, covid-19 from 14Jan2021 to an unknown date. The patient's concomitant medications were not reported. The reporter reported that her husband (patient) was diagnosed 2 days ago with a vitamin D deficiency and diagnosed at the end of last week with stage 4 chronic kidney disease. The patient just started on his Vitamin D pill until yesterday. He didn't know he was lacking Vitamin D until the doctor found out. She wants to know if her husband should go ahead and get the second vaccine tomorrow or should he wait a week and let the Vitamin D pill kick in. It was also reported that the patient's arm started hurting about 5 or 6 hours later after getting the shot on 23Feb2021. The next day, it felt really bad. The patient also had a little bit of fever and body aches on 23Feb2021. The patient had a bunch of labs done and is going back again on 25Mar2021 to have another extensive tests done. It was clarified that it was for the chronic kidney disease and this was also when he found out he had the vitamin D Deficiency. The patient is also getting an ultrasound done on his kidneys to see what is going on. Therapeutic measure were taken as a result of vitamin D deficiency which included treatment with vitamin D pill and for little bit of fever and body aches which included Tylenol PM. The patient did not recover from stage 4 chronic kidney disease and vitamin D deficiency, recovered from arm hurt really bad and little bit of body aches on 25Feb2021, a little bit of fever on 24Feb2021.
my son went into kidney failure less then a week after getting the vaccination, with no other cause to be found!
No additional AE reported; Temperature excursion 47.9 degrees Farenheit; This spontaneous report has been received from a office manager, regarding a 1-years-old female patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 15-DEC-2022, the patient was vaccinated with an improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (PROQUAD) oral liquid orally as prophylaxis (lot number: 1892784, which was determined to be valid, with an expiration date on 03-DEC-2023) (product storage error).  On 01-DEC-2022, the administered dose underwent a temperature excursion of 47.9 degrees Fahrenheit (F) (storage in clinical practice) for 47 minutes. Data logger was involved. The operator of the vaccine was a healthcare professional, and the vaccine was used according to the instruction leaflet. No adverse event was reported.  This is one of several reports received from the same reporter.
minor bleeding after the administration of her 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE HAEMORRHAGE (minor bleeding after the administration of her 2nd dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (minor bleeding after the administration of her 2nd dose). At the time of the report, VACCINATION SITE HAEMORRHAGE (minor bleeding after the administration of her 2nd dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up information received on 24-MAY-2021, contains no new information.
Approximate ten minutes after receiving injection, complained of "wave-like feeling inside body and need to clear throat." Later (several days) "cold chills, prespiring, feeling of water in lungs with difficulty breathing off and on".
My body began to ache and I started feeling work and lost my appetite with series of headaches and chills
p/vax mom started to notice that child's face had gotten red & splotchy before recv vax;about 10min p/vax face became bright red & appeared to have welts on it;sl rash on arms;saw MD & given DPH p/10min rash was worse;having no resp problem
Arm swollen big as baseball ball redness stay that way for 5 days and hurts when arm was used. Some of information don't know as my doctor at clinic.
Headache, diarrhea, fever 1-2 days post injection 2-3 days post injection face swelling, LA at flu site - 1-2 inches redness.
On June 2, 2021, he awoke and complained of feeling hot, tired, and not hungry. His mother had been sick with acute gastroenteritis symptoms 2 days earlier. Over the course of the day, he had a fever to 101.6 F, and began to have loose stools (twice). He received Ibuprofen 400 mg by mouth every 6 hours for the fever, and drank plenty of fluids. On June 3, 2021, he continued to have fevers to 101.5 F, loose stools (twice again), and poor oral intake of food. I canceled his scheduled 2nd Pfizer-BioNTech vaccine, and got him a NP swab test for SARS-CoV-2 through the health department. On June 4, 2021, he had no fever but now complained of a rubbing left parasternal chest pain. On physical examination, his BP was elevated (130s/90s), he had a slight tachycardia (90s), and was afebrile. On auscultation, I heard a S4 gallop and took him immediately to the local ER.
Fainted after immunization. Father stated he usually faints after shots. "Always get queasy with needles". "All sibling experience shot anxiety".
Redness, Swelling, and itching from a little above the injection site almost down to patients elbow. Indentation in arm at injection site.  Dr. prescribed an antibiotic and antihistamine to treat reaction
I haven't had an actual period for over a year since I got my IUD. 1 week after the vaccine, I started getting a heavy painful period which lasted 2 weeks, stopped for two weeks, and then continued every two weeks for 3+ months.
2/1/21  sore arm 2/2/21  sore arm and itchy rash at site  2/3/21  sore arm and very itchy rash at site that became raised and redder 2/4/21  still have rash and soreness
Headache, rigors, chills, fever, body aches, dizziness, fatigue for 2 days
He recieved these shots and again got a fever, high pitched scream and a few days later a double ear infection. Then he began to lose his speech, eye contact, and receptive language. He was later diagnosed with PDD-NOS, on the autism spectrum.  3/25/08 Reviewed developmental pediatrician medical records which consisted of H&P & vax records. FINAL DX: neurological disorder, developmental language disorder, PDD. Records reveal patient was in early intervention school & ST when evaluated on 4/12/2004.  Behaviors included: hyperactivity, self stimulation, repetitive movements & sounds, difficult to control.  Recommended continued early intervention, ST/OT. 4/8/08 Reviewed peds neurologist report of 2/3/2003. FINAL DX: PDD/autistic disorder. Record reveals patient experienced  developmental delays, speech loss at approx 12-20 mo, loss of social skills, poor eye contact, parallel or individual play. Patient was able to follow simple commands & cooperate w/examination.  Noted to have mild hypotonicity.
Local rxn w/heat, swelling & tenderness, 4th day had some paresthesias T4 area, then fever to 102 & headache, day 6 lumbar puncture showed viral type meningitis.
pt recv vax; unable to walk; lt leg swollen; T 100.6;to MD;swelling due to pt moving leg at time of inject per grandma;
Initial unsolicited report received from a consumer (patient) on 10 October 2016. This case involves a 70-year-old female patient who was vaccinated with first dose of FLUZONE HD intramuscularly (batch number, expiry date of product, dose, dose in series and site of administration were not reported) on 04 October 2016. The patient had a medical history of arthritis. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects were reported as none. The patient had not received any other vaccination within four weeks of above vaccination. Other concomitant medications were unknown. On 07 October 2016, 3 days following vaccination, the patient started shivering. On afternoon of 08 October 2016, 4 days after vaccination, patient began shaking violently, could not control her arms and hands, was thirsty but could hold a cup. The patient could not warm up or stop shaking which lasted for 45 min and had 101.2 degree F fever. Tylenol stopped fever. At 2 am on 09 October 2016, 5 days after vaccination, she had a 100.2 degree F fever. After medication, fever broke with sweating. On late afternoon of 09 October 2016, she again started shivering and fever was 100 degree F. On 09 Oct 2016, five days following vaccination, the patient reported her arm was pretty sore at injection site without redness heat or swelling. Laboratory data was reported as none. The patient received corrective treatment with Tylenol for fever. The outcome of the events was reported as unknown. List of documents held by sender: none. Follow up unsolicited report received from a pharmacist on 07 November 2016. The patient had a medical history of hyperthyroidism. Any other vaccination within 4 weeks prior was reported as none. Concomitant medications include Premarin, levothyroxine, Celebrex and Allegra. It was reported as patient was thirsty but could not hold a cup and patient arm was mildly sore. The patient was vaccinated with 0.5 ml dose of FLUZONE HD (batch number UI663AB, expiry date of product 04-APR-2017) on left upper arm. On 10 October 2016, 6 days after vaccination, the patieint had a 100.2 degree F fever from 2:00 am and 5:00 pm. on 11 October 2016, the patient had no fever. On 12 October 2016, at 10:00 am the patient had fever of 100.3 degree F fever. It was reported that on 11 October 2016, the physician had priscribed prednisone for 5 Days. It was reported that the patient had began with prednisone at afternoon. On 13, 14, 15 and 16 of October 2016, the patient had no fever and the event was recovered. List of documents held by sender: none.
vaccine administered left deltoid @ 1409 1414 c/o rash to left hand at the thumb.  Slight itchy on arm, not at the injection site.  Left posterior thumb with small blotchy red spot.  No additional rash observed.  No SOB or difficulty breathing.  No discomfort in throat or difficulty swallowing. No chest pain or pressure.  No HA, dizziness, or lightheadedness. - HR 107, SAT 98% RA - A&Ox3, HRR, S1S2, LS clear, resp. even and non-labored - Some increase in rash with blotchy, light red areas noted to left arm area, no additional rash to trunk or back.  No hives. 1415 Benadryl 25 mg PO administered 1425 HR 104, BP 122/96, SAT 99% RA - itching maybe slightly better, no new symptoms 1445 HR 101, BP 100/78, SAT 98%, rash appears nearly completely resolved, no new symptoms, feels essentially normal.  Reviewed S/S to cont. to monitor at home.  Stated good understanding and denied questions.  Ambulated out of clinic without difficulty.
pt hospitalized within 6 weeks of COVID vaccine.  ED to hosp admissions 3/27/21 and 4/2/21
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the deadline for her second dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), ATORVASTATIN, METOPROLOL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), LISINOPRIL, DULOXETINE HYDROCHLORIDE (CYMBALTA) and ANASTROZOLE for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the deadline for her second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the deadline for her second dose) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. This case was linked to MOD-2021-053134.
It came out of nowhere. I had a pinching feeling on my nose for a couple of days, then on Sunday I had a blister on my forehead that then opened and scabbed. Then the following days I began to show clusters of spots on my nose, forehead and eyelid. The pain is pinching and itchy.
At 8:45 PM Suddenly cold, shivers, headache, slight fever, and stomach ache which lasted all night and headache and slight fever and body aches continue the following day to present.  I took a Covid test this morning and it was negative.  This is the worse reaction I have ever had to a vaccine and wouldn't recommend this vaccine to anyone.
Red blotchy rash all over his back; Pretty bad skin rash mostly on my back and little bit on my chest; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red blotchy rash all over his back) and RASH (Pretty bad skin rash mostly on my back and little bit on my chest) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 007B21A) for COVID-19 vaccination.     The patient's past medical history included Lichen planus. Concurrent medical conditions included Neuropathy. Concomitant products included PREGABALIN (LYRICA) and GABAPENTIN for Neuropathy.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced ERYTHEMA (Red blotchy rash all over his back) and RASH (Pretty bad skin rash mostly on my back and little bit on my chest). At the time of the report, ERYTHEMA (Red blotchy rash all over his back) and RASH (Pretty bad skin rash mostly on my back and little bit on my chest) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable.  Treatment information included skin cream.   This case was linked to MOD-2021-085633 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Additional information received  on 26-05-2021 included second dose batch number, concomitant medications, treatment medication and additional event was updated. On 20-Jul-2021: Follow up received on 20-JUL-2021 contains no significant information.
9 x 5" red, warm area to left gluteal area that started on 6-18-19. Body aches started on 6-18-19 with chills and pain down left leg. Patient instructed to take Tylenol/Ibuprofen + Benadryl. redness almost completely gone on 6-24-19. Body aches, chills, leg pain lasted 3 days.
Shooting pains in legs and buttocks.  Unable to walk.  Hospital does nothing.  Doctor just scratches his hed.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Pfizer product on 03/10/2021 and 04/30/2021. They tested positive for COVID-19 via antigen test on 08/11/2021 at the assisted living facility at which they were a resident. By 028/23/2021, they were described as recovered from the COVID-19 infection. About 2 months later, the individual was transported to hospital on 11/10/2021 for general weakness. They were admitted to the hospital same day. The individual had been in overall poor health for some time, and had barely been eating or drinking as well as refusing to take medication. They were found to have had a kidney injury and were in kidney failure. They were discharged to Hospice care back at the assisted living facility on 11/12/2021. The individual died on 11/15/2021. COVID-19 is in part II of the death certificate.
some back pain; This case was reported by a consumer via call center representative and described the occurrence of back pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hashimoto's disease.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a day after receiving Shingrix, the patient experienced back pain. On an unknown date, the outcome of the back pain was recovered/resolved.   It was unknown if the reporter considered the back pain to be related to Shingrix.  Additional details was reported as follows: Age at vaccination was not reported. After receiving 1 st dose of Shingrix and experienced back pain,that resolved the same day. The reported did not consent to follow up. For tolerance of 2nd dose, refer case US2021AMR053971; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR053971:same patient,2nd dose
fatigue; slightly achey; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 13:30 (Lot number: ER8730) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRAVASTATIN; CENTRUM [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;IRON;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]; CITICHOLINE [CITICOLINE]; XALATAN; TIMOLOL. Vaccination history included: Covid-19 vaccine (DOSE X MANUFACTUERER UNKNOWN (where X=1)), for covid-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 04Apr2021 11:00, outcome "recovering", described as "fatigue"; PAIN (non-serious) with onset 04Apr2021 11:00, outcome "recovering", described as "slightly achey". Therapeutic measures were not taken as a result of fatigue, pain.  Additional information: It was reported that 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. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient information about allergies to medications, food or other products was not available. The patient did not receive any treatment for the event.  No follow-up attempts are possible. No further information is expected.
Over the next 4 days, showed a lack of smiling/laughing/playing, markedly increased sleep, began making bubbles. Slightly improving on 5th to 6th day, but still longer sleep patterns. On day 6, made "cooing" noise while being burped, then became unresponsive. Transported to the hospital and brain death pronounced the next day. Cause of death unknown.
chills; bad headache; body aches; She felt cold; Her arm felt so heavy; This is a spontaneous report from a contactable other health professional reporting for herself. A 46-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), intramuscular in arm right, on 28Dec2020 morning, at single dose, for COVID-19 immunisation. Medical history included COVID-19 from the end of May2020 to unknown date in 2020 (not ongoing) and ongoing hypertension. Concomitant medication included losartan (LOSARTAN) from an unspecified date and ongoing, for hypertension. On 28Dec2020 evening, around 08:00 or 09:00 PM, the patient experienced chills with outcome of recovering, bad headache with outcome of not recovered, body aches with outcome of recovering, she felt cold with outcome of recovering, her arm felt so heavy with outcome of recovered in Dec2020. Therapeutic measures were taken as a result of bad headache and included laying down, ice on her back and neck. The second dose is scheduled on 18Jan2020.
Severe pain in his right eye and was diagnosed with herpes simplex dendritic keratitis; Double vision; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 01-MAY-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of singles. On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered severe pain in his right eye and was diagnosed with herpes simplex dendritic keratitis. He also suffered double visión as a result of this diagnosis. It was also specified that the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events were considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Upon internal review, ophthalmic herpes simplex was considered medically significant. Additionally, the events were considered to be disabling due to serious, permanent and incurable injuries.
Feeling of "wooziness" within hour of vaccination - patient taken by wheelchair to ER - started feeling better in the ER - said the feeling went away so she left the ER.  Upon follow up she denied any other adverse reactions after leaving the hospital.
pt recvd vax & crying approx 6hrs p/vax; pt vomited 3-4x & was whiny & cranky; t 101-102; when pt woke up, did not stand on RL & L was red & inject site was swollen had knot & was red soreness & crankiness gone same time as fever;
Injection site red, swollen, warm and redness spreading down arm to wrist.  Antibiotics given but rxn seems to be allergic.  Given pneumococcal vaccine.
Vaccine was administered on 1/15/2021 and death occurred on 1/31/2021.
Pt reports that am of 9/18/15 she noticed a red, puffy, warm spot twice as large as a silver dollar BELOW Injection site, and believes is due to receipt of flu shot on 9/16/15.