chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; received Bivalent Moderna COVID-19 vaccine as her first primary dose on 28OCT2022; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received Bivalent Moderna COVID-19 vaccine as her first primary dose on 28OCT2022) and NO ADVERSE EVENT (No adverse event) in a 21-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received Bivalent Moderna COVID-19 vaccine as her first primary dose on 28OCT2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received Bivalent Moderna COVID-19 vaccine as her first primary dose on 28OCT2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received Bivalent Moderna COVID-19 vaccine as her first primary dose on 28OCT2022).    No concomitant medication was reported.  The parental vaccine exposure was reported as no.  On 28-Oct-2022, a 21-year-old patient received Bivalent Moderna COVID-19 vaccine as first primary dose. Pharmacist asked about what should be done or to get re-vaccination.  No treatment medication was reported.
Inflammation of the lining of the brain; Been sick; Inflamed auditory nerves; Extreme vertigo; hypersensitivity to her muscles; Muscle jerk; Quality of life has severely diminished; migraines; This case was reported by a consumer and described the occurrence of brain inflammation in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced brain inflammation (serious criteria GSK medically significant), malaise, auditory nerve disorder, vertigo, muscle spasm, myoclonus, quality of life decreased and migraine. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the brain inflammation, malaise, auditory nerve disorder, vertigo, muscle spasm, myoclonus, quality of life decreased and migraine were not recovered/not resolved.   It was unknown if the reporter considered the brain inflammation, malaise, auditory nerve disorder, vertigo, muscle spasm, myoclonus, quality of life decreased and migraine to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, for the past 11 months from the date of reporting, the patient was sick. The patient also experienced inflammation of the lining of the brain and inflamed auditory nerves.  The patient also experienced extreme vertigo and hypersensitivity to her muscles to the point where her leg muscles jerk. The patient had to have trips to the hospital, underwent MRI's, spinal taps, concussion therapy and migraines, along with high doses of steroids before having any relief. At the time of reporting, it was 11 months and she is still having problems.  It was reported that, people should be warned  before giving them Shingrix that these were the possible side effects.  This has been life changing for her and her family. Her quality of life has severely diminished.      Lab Comments: on an unknown date, the patient underwent MRI's, spinal taps.
Complete Alopecia Had very hairy body prior and no hair anywhere now! No balding in family history Nails, fingers and toes falling apart and splinter. Dermatology issues, thin skin, sun spots, wrinkles that were not there and should not be for a long time, per dermatologist Immune deficiency,  Kidney function drop from 90 to 60  Tire and worn out all the time. Severe Neuropathy in hands and feet
pt had small sz, stopped breathing & was put into medically induced coma;sent to hosp 3JUL96;no known cause as of 9JUL96;pt is on ventilator & is critical;
pt recv vax approx 2:30 on 2OCT97 during employee flu vax day @ 3PM pt c/o redness @ site of inj & c/o pain from site up into side of neck & face;given DPH & EPI;
Narrative:  COVID infection following COVID vaccine series and after previous COVID infection or 02/11, Pfizer, dose #1 03/23, Pfizer, dose #2 08/10 08/30 COVID swab, result: detected 08/10 pt cc: unknown (Cognitively impaired) exposure: unknown 08/11 SARS-COV-2 TOTAL AB, SPIKE SEMI QN result >2500.0 08/11 SARS-COV2 IGG results: 6.54 08/20 clinically resolved 08/27 COVID swab, result: not detected 08/30 COVID swab, result: detected
Patient received first dose Pfizer Vaccine and developed a reaction about 5 minutes later. patient complained of "dizziness" and "weakness" . Vitals checked: BP 90/50, HR 72, O2 sat 88%. EMS was called.  Five minutes later BP 90/60, HR 72, O2 Sat 98%. Patient was alert and oriented to time, place and person. Ten minutes later, BP 110/70, HR 80, O2 Sat 99%.  Fully alert, oriented and stable. Patient said she had not eaten since morning.   EMS arrived, checked Patient and declared patient ok. Patient was asked to go home in a very stable condition
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 11-AUG-2014 the patient was vaccinated with first dose of VAQTA (25/0.5 (units not provided), 0.5 ml, intramuscular). On 11-AUG-2014 the patient was vaccinated with second dose of VAQTA (dose, strength, route and site of administration not reported). On 27-MAr-2015 the patient was accidentally vaccinated with third dose of VAQTA (dose, strength, route and site of administration not reported). No adverse effects reported. Additional information has been requested.
Pt recvd Engerix-B & soon p/1st dose exp generalized rash; No other dose given;
pt recv vax & exp elevated liver enzymes;pt was dx w/mononucleosis;It was noted that the pt had sx prior to receiving the vax;No further details are available;
I had an unusual few days of unexplained deep depression. I think it may be a side effect. It's better now.
Saturday, Feb. 13th at 7:00am - woke up with arm soreness, nausea, weakness, body aches, fever, and chills.  10am - attempted to eat, but loss of appetite, weakness, body aches (including back pain) and continued fever. 4:00pm - ate 12 oz of wonton soup, fever continued, headache began. 9:00pm - fever continued, strength returned, appetite returned and ate a slice of cheese with crackers. Sunday, Feb. 14th at 8:00am - swollen, deformed arm like a small golf ball and rash, fever ended, light appetite. 12/12 at 7am took Extra Strength 200mg Tylenol (3 w/ginger ale); 4pm took Goodie Powder
Injection site reaction, redness and swelling. Pt. felt weak with pain on left arm with red blotches on injection arm. Symptoms occurred a "few" days after administration. Pt went to hospital, received treatment and recovered.
Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No medical history information was provided.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment information was provided by the reporter.
redness and swelling to thigh tx with keflex 125/5 x 10 days
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 03Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive; (05Jun2022) Positive, notes: tested positive for Covid 6 days post Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Other medication in 2weeks were none. The patient received anti-viral product for COVID 19 Treatment, brand: Paxlovid, treatment start date: 24May2022, treatment stop date: 29May2022, lot number:1024502. Pfizer BioNTech for dose 1 and dose 2 vaccine and for Moderna dose 3 lot unknown reason was not available or provided to reporter at the time of report completion. The adverse event was reported as tested positive for Covid 6 days post Paxlovid. The patient went to get tested because she felt worse that she did when she went to got tested 24May2022. Adverse event start date: 05Jun2022, AE resulted in: None of the above, Patient recovered: Not Recovered, Treatment ae: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
3 OF MY FRIENDS ALL WENT TO HAVE. VACCINATION WITHIN A DAY OFR 2 OF EACH OTHER WITHIN 7 DAYS WE ALL HAD CONFIRMED COVID.   ALL VERY ILL. STILL IN HOUSE NOW ON DAY 7
Fever, chills, cold sweats, fatigue, dry cough, headache, muscle pain, and weakness lasting 12 hours starting at around  24 hours after vaccine administration. Patient took two Tylenol 500mg to some relief at 2pm and again at 7pm.
chills, rigors, fever 100.4, myalgias, epistaxis 9 hours after second dose.
On July 9th, 2006, patient was brought to the ER because he was experiencing a "trance" state. He was difficult to arouse and then while able to verbalize did not recognize his mother. He was continent but remained at a lower level of conciousness for approximately 3 hours and then returned to a normal state. This was called an absent seizure by the physician and is to be followed up by a neurologist. Hospitalized overnight.
Joint pain began at 10pm followed quickly by chills. At 1 am on 3/8, fever and increased heart rate (120bpm). Those lasted until 5:30 am. Then I experienced dizziness until 8 am and headache until 2 pm.
Patient reported having  "burning pain in veins." She called her doctor who told her it was an allergic reaction.
Horse voice; Inflammation in the ear; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Horse voice) and EAR INFLAMMATION (Inflammation in the ear) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPHONIA (Horse voice) and EAR INFLAMMATION (Inflammation in the ear). At the time of the report, DYSPHONIA (Horse voice) and EAR INFLAMMATION (Inflammation in the ear) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant drug details were reported. No treatment details were reported.
pt recvd vax & w/in 4hrs p/vax pt exp a shingles rash over rt shoulder;pt was seen by MD;rash was treated w/calamine lotion;shingles are crusting over & resolving;
Had jerky movements with altered sensorium at 4.30Am and at 8.30 AM had another brief episode with vomiting. Acting normal in between and later so far.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 6 (booster), single (Lot number: GH9693) at the age of 70 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CLL stage zero (0)" (unspecified if ongoing). The patient's concomitant medications were not reported. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
When I got the vaccination for dose 2, I notice that I had started having hearing problems with my left ear. I notice that I couldn't hear very well in that ear. I started having Vertigo as well. When I did notice this symptom, I realized that I had this same thing with dose 1 vaccine as well. The doctor that did the hearing test showed that I had a lot of hearing lost in my left ear. She prescribe some prednisone and that didn't work. She then suggest that I need to get hearing aids. So, am just waiting to go back to see her in June 2022.
Patient received vaccination on Monday. On Tuesday, rash developed. By Wednesday rash had spread from under arm to elbow. Swelling, redness and tender to touch. Today rash is still spreading down arm. Patient is experiencing joint pain and itching still today. Burning at rash site also.
Initial reaction- had a metallic taste in throat then trouble swallowing - progressed to having some difficulty breathing.  Administered 0.3 ml of EPI to R deltoid, O2 at 1.5  L via nasal cannulla., BENADRYL 25mg po.
Patient reports swelling, redness, warmth, and pain the day after vaccination on the whole upper part of the arm.
Fever 103 - Rt arm red at site and hard. Went to Urgent Care Dx infection and put on doxycycline 100mg BID x 10 days.
PATIENT REPORTED RINGING IN HER RIGHT EAR ABOUT 7 MINUTES AFTER GETTING HER SHOT. SHE LATER REPORTED THAT SHE STARTED DEVELOPING AN EARACHE SHORTLY THEREAFTER.
A report has been received from a health professional concerning a 50 year old, female patient. Medical history of the patient was not reported. There was no information on her concomitant medication. On 30-Oct-2013 she received nasal FLUMIST QUADRIVALENT, was outside of approved age indication. Action taken with FLUMIST and outcome was unknown. The report was considered to be non-serious.
Same day - no rxn. Day 1 - temp 101-102, Day 2 - Temp 101-102/anorexia/diarrhea, Infant Tylenol was given as directed on package.  Day 3 - Same as day 2 and misses school, Infant Tylenol given. Day 4 - Temp normalized/anorexia/diarrhea, Day 5 - Same as day 4 plus erythematous cheeks, Day 6 - began eating again/diarrhea/non-palpable rash on chest neck and stomach/red streaks appear under diaper area that look like scratches but out of reachable area of child, Day 7 - same as day 6, Day 10 - symptoms gradually resolved by this time.  Patient did not present to clinic until day 14 at which time these symptoms had resolved.  He now has a runny nose and a mild cough.  Full physical exam was done and was all normal.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:1/12/2021.pfizer Lot#EL3248 2nd dose:02/02/21.pfizerLot#EN5318 Diagnosed covid positive: 03/10/21 Exposure:Family Symptoms:congestion, cough, fatigue,  body ache,Runny Nose, Abdominal Pain, Sweats
Severe intractable nausea vomiting, aches pains, fever of 102 F day after vaccination, went to ER after a few days due to dehydration
Intense sadness, tearfulness. Lasted about 20-30 mins, resolved. Just mentioning it because it was not listed in the possible side effects - didn't know what effect it might have in a child with depression.
Patient up to date on COVID vaccinations admitted to hospital with incidental positive COVID test during admission testing.  No s/s of COVID during stay.  Provider d/c note below:  "87 yo M, hx of atrial flutter on warfarin, colon cancer s/p cholectomy and ileostomy, T2DM, and CKDIIIb who came to hospital on 12/20 because of red stool in his ostomy. Of note, he had epistaxis a few days before admission. In the ED, his vital signs were stable, initial CBC was unremarkable, BMP showed acute on chronic kidney injury, coag panel showed an INR of 2. He was started on Vitamin K and warfarin was held. He continued to have melanotic streaking, repeat CBC demonstrated worsening anemia and was started on Protonix GGT. Tested positive for COVID in the ED but denied any symptoms of fever, chills, cough, or SOB. GI was consulted, notes that he had epistaxis a few days prior and recommended observing. He developed significant hyperkalemia in the ED and an EKG showed peaked T waves, given dose of calcium gluconate and lokelma.  He later got a dose of lasix, but the patient was not urinating adequately. He was found to have significant urinary retention with 2 L of urine being excreted with a straight catheter. The urinary retention continued, and a foley catheter was placed. He continued to have drops in his hemoglobin with continued melena. Dr. performed a EGD and Ileoscopy and found a non-bleeding gastric ulcer. His melena resolved and his hemoglobin remained stable after the procedure. His foley catheter remained indwelling on discharge because of concern for continued urinary rentention on discharge. Family will help with his care of his foley catheter with follow up from urology in the future for voiding trial. He was sent home in stable medical condition."
This spontaneous report as received from an advanced Registered Nurse Practitioner (A.R.N.P) refers to an approximately 6-8 years female patient. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (Merck) (dose, route and lot number were not provided). The patient received her second dose of VARIVAX (Merck) (dose, route and lot number were not provided) when she was around 4-6 years of age. The advanced Registered Nurse Practitioner reported that about 2-3 weeks, approximately in June 2013, the child who had both VARIVAX (Merck), was exposed to her grandmother who had a herpes zoster breakout. The patient developed full blown cases of varicella, a pretty significant case of varicella. At the time of the report, the outcome of full blown case of varicella, a pretty significant case of varicella is unknown. Additional information has been requested.
Pt recvd 1st dose of Hep B vax on 16MAY91 & on 29MAY91 pt exp chest pain & devel elevated liver enzymes; pt treated w/unspecified drugs;
Mild body aches started about seven hours after vaccine administered. Fever 101; body aches; malaise; nausea 19 hours after vaccine administered.  Fever & nausea lasted 6 hours. Body aches lasted 32 hours. Malaise lasted 48 hours and then felt fine.
At 5pm my fatigue started on day I got my 2nd vaccine. At 10pm I started shivering and had a fever. At 4am my fever got up to 104. My lower back was throbbing, head was throbbing, and sore throat.  Lasted for two full days. I actually felt like I was dying.
Moderna Covid -19 vaccine with pink swollen rectangular shape for 8-9 days on upper left arm
Hospitalized 12-15-06 with a diagnosis of Guillain Barre - On a ventilator with Respiratory Complications.  1/22/07 Received medical records from hospital which reveal patient admitted 12/15/06-1/12/07 for dizziness, ascending numbness & tingling of his hands & feet for a couple of days.  Had been seen in outlying hospital ER & released 3 days prior to admit w/o diagnosis.   Patient stated he had viral infection for a few days & felt lousy.  Patient also stated he received his first & only flu vax on 11/30/06.  On admission, CPK/MB were very elevated.  Neuro, cardio, pulmo, nephro, ENT & GI consults were obtained.  Was areflexia throughout & had stocking/glove distribution paresthesia.Patient developed respiratory distress.  Treated w/plasmaphoresis & IVIG. Patient was trached & had G tube placement.  Developed MRSA URI, UTI & sepsis.  Patient was transferred to Special Care Unit upon d/c from ICU on 1/12/07. FINAL DX: Axonal Guillian Barre Syndrome. Per information received from annual follow up,  full social security disability was granted in June 2007. Was seen in Outpatient theapy and discharged 7-26-07. Was hospitalized in May with a DVT. Has pain in his feet-fells they are "asleep" all the time. Walks with a cane. Is indepent in self care (struggles with his shoes and socks). He can't sit, stand or walk for very long.
Right after vaccine was given a small rash came at the injection sight then exactly 2 weeks later baby woke up covered in a full body rash no fever
Headache, Arthralgia, Fever, extremely sore arm, swelling at injection site, chills, fatigue and swollen glands Narrative:
Rash maculopapular; Pain; Headache; Pyrexia; Incorrect route of drug administration; Musculoskeletal stiffness. Information has been received from a physician concerning a 17 year old white male with no allergies or medical conditions who on 10-AUG-2005 was vaccinated IM in the left arm with a dose of varicella virus vaccine live (Oka/Merck) (lot #645288/0689N). On approximately 31-AUG-2005, the patient experienced about eight maculopapular lesions and achiness. On 31-AUG-2005, the patient was seen in the emergency and had not recovered. A product quality complaint was not involved. Follow up information indicated that on 30-AUG-2005, the patient developed 7 or 8 sporadic varicella like lesions that were maculopapular on the trunk and extremities. They were noted on exam on 30-AOG-2005. The patient also complained of a headache, achiness and a stiff neck with a low grade fever. The patient went to the ER on 31-AUG-2005 but no treatment was required. It was felt the symptoms were secondary to a side effect of the vaccine and that his age group can get a rash after vaccination. The patient's symptoms resolved and he is doing well. Additional information is not expected.