chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the injection site (upper left arm) was warm and tender; the injection site (upper left arm) was warm and tender; her left arm was very sore; her left arm was so swollen; list the product as an allergy; severe local reaction; arm was red down both side; discomfort; This spontaneous report was received from a 73-year-old female patient, who was referring to herself. The patient's concurrent conditions included diabetes mellitus, coronary artery disease and allergy to tetracycline. Her medical history included stent placement in 2008. Concomitant therapies included metformin, carvedilol, lisinopril (manufacturer unknown), simvastatin (manufacturer unknown), aspirin and vitamin D (unspecified). Her historical vaccines included regular straight pneumonia shot (manufacturer unknown) in October 2008 and pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) in August 2015 and in approximately August 2016 (reported as year after). The patient reported no adverse events with any of the previously mentioned vaccinations.  On 23-JUN-2020, the patient was vaccinated with a one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered in the left arm (lot #, expiration date, strength, dose and route of administration were not provided) for precautionary because of age and medical problems.      On the same date, upon initial injection, the injection site became warm and tender. On 23-JUN-2020 in the evening, her left arm was very sore and by bedtime, her left arm was so swollen that it could be seen where the band aid was. She stated her arm was twice the size of right arm. The patient put an ice pack on arm and was taking acetaminophen (TYLENOL). She reported her left arm was continuously aching and sore and she had swelling from her elbow to her shoulder, and her arm was red down both side. On 23-JUN-2020 at night, she went to emergency room (ER), but she was not admitted to the hospital. In the ER, she was told she had a local reaction and to "keep an eye on it." On 24-JUN-2020, the patient went to see a pharmacist, who advised her to continue using ice and acetaminophen (TYLENOL) for discomfort. On 25-JUN-2020, she visited her physician who advised her that she had a severe local reaction and advised her not to get pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) again and to list the product as an allergy. The patient stated that at this time the swelling had "drained down" to her lower left arm. No lab diagnostics/ studies were performed. On 28-JUN-2020, the patient recovered from the events.  The reporter considered allergy to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) to be related to the suspect vaccine. The relatedness between other events and the suspect vaccine was not reported.
71-year-old female with history of chronic obstructive pulmonary disease, CVA, type 2 diabetes hypertension who presented with hypoxia and altered mental status. At baseline she is alert and oriented to self, she has a guardian. It appears she was noted to be more somnolent than usual at her facility and found to be hypoxemic so was sent to ER for further evaluation. She required 4L oxygen via nasal cannula to maintain saturation. On arrival to ER, her labs were notable for mild AKI, troponin elevation, leukocytosis and positive COVID19 PCR. Chest xray was consistent with patchy bilateral lower lobe airspace disease. CT Head showed a chronic large right MCA infarct without acute hemorrhagic changes
2/4/21  Low grade fever, muscle aches, joint aches, mild headache, fatigue, lasting about 36 hours, out of work.  2/12/21 Mild eczema to ears, elbows, and knuckles Self resolved after 1 week. 2/19/21 with Tinnitus, slight hearing loss still occurring.
Induration 3 x 2.5 inches, redness, erythema. Swollen.
Immediately after injection metallic taste in mouth by 1 hour after returning home marked urticaria LUE and induration and extended rash L rib cage and flank.  Rash persisted 10+ days; pt took photos and reported to V-Safe.  Presented for second vaccination - deemed ineligible b/o immediate allergic reaction per CDC criteria.
Approximately 2 weeks after receiving the vaccine patient began to have headaches. We did not get the 2nd and 3rd in the series due to her feeling poorly. She reported general malaise, fatigue and significant headaches. Over the course of the next year her health has continued to deteriorate. She was a previously active high school student and athlete. She was healthy without any health issues. She has developed chronic migraines, ongoing nausea, diminished appetite, intermittent shortness of breath, intermittent lymphadenopathy, pale appearance, chronic fatigue, generalized body aches, hand tremors, numbness in both hands and her left leg, memory deficits, ongoing dizziness and seizures. She had her first grand mal seizure on 7/13/17 and her second on 8/15/17. She is now diagnosed with epilepsy with no known cause. She continues to suffer from chronic fatigue and debilitating migraine headaches. She has had to stop all extracurricular activities and quit her job. She continues to have intermittent absence seizures and significant memory deficits as well.
Patient was sitting on the exam table, RN who administered HPV and Hep A vaccines had her back to the pt. talking with mother of pt. 1-2 minutes after vaccine administered pt. fainted and fell face first off the exam table. Loss of consciousness for 5-10 seconds, Dr. was summoned to the room immediately and pt. was moved to the exam table and examined by Dr.
pt recvd vax & was very pale; limp & lethargic; called ofc & seen by MD; pt was vomiting & inc t 98.4;
SWEATING; FEELING OFF/HIGH; FLU LIKE SYMPTOMS; FEVER; NAUSEA; DIZZINESS AND LIGHT HEADEDNESS; HEADACHE; COUGH; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's past medical history included pertussis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A) dose was not reported, administered on 08-APR-2021 12:00 for prophylactic vaccination. Concomitant medications included salbutamol. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced dizziness and light headedness. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced feeling off/high. On 09-APR-2021, the subject experienced flu like symptoms. On 09-APR-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 102.7 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 09-APR-2021, was recovering from sweating, dizziness and light headedness, and headache, had not recovered from cough, feeling off/high, and flu like symptoms, and the outcome of fever was not reported. This report was non-serious.
Maculopapular rash to all his body, that he developed within 2 weeks after administration. No fever.
Patient complained of pain upon administration of shot & came back into pharmacy complaining on 12/16 still had pain & had to have a cortisone shot.
pt recv vax 24JAN96 & 1OCT97 pt exp a clinical varicella w/more than 50 lesions & was seen by MD 7OCT97;
reconstituted with sterile water with no reported adverse event; Initial information was received on 14-Feb-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and unknown gender patient who reported reconstitution of vaccine HIB (PRP/T) Vaccine [ACT-HIB] with sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles, mumps and rubella vaccine (live) (MMR vaccine) as prophylactic vaccination.  On 20-Jan-2022, the patient received a dose of suspect HIB (PRP/T) Vaccine (formulation: Powder and solvent for solution for injection, dose: 0.5 ml, 4th dose, lot: UJ589AA, Expiration date: 25Oct2022) (frequency,strength: unknown) via intramuscular route in the right thigh as prophylactic vaccination  On 20-JAN-2022 the patient reported reconstitution with sterile water with no reported adverse event (product preparation error) (latency: same day) of HIB (PRP/T) Vaccine.  Action Taken: not applicable.  At time of reporting, the outcome was Unknown for the event reconstituted with sterile water with no reported adverse event.  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 the 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.
Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) and CHILLS (Chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches) and CHILLS (Chills). At the time of the report, PAIN (Body aches) and CHILLS (Chills) outcome was unknown.            No concomitant medications provided. No treatment information provided.
7-10 days after vaccination patient developed multiple small purpuric lesions, concnentrated mostly on scalp and forehead but also scattered throughout body; no petechiae, no bleeding; referred to Hospital ER on 8/10/03 - CBC revealed plt count of 3K, normal smear; diagnosed with ITP (ideopathic thrombocytopenic purpura), given infusion of anti-D antibody(Rho-gam); repeat CBC 12 hrs later plts 23K, 5 days later (8/15) plts 173K
A few hours after vaccinated, patient began feeling sick & developed a red circle on opposite side of right arm that vaccine was given. Called me on 8/30 around 4pm & is feeling better, does have small rash still.
genital herpes vesicles; Not sexually active; This case was reported by a pharmacist via call center representative and described the occurrence of genital herpes in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number BY2Y4, expiry date 13th November 2021) for prophylaxis.   On 11th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than 3 weeks after receiving Shingrix, the patient experienced not sexually active. On 31st October 2019, the patient experienced genital herpes. On an unknown date, the outcome of the genital herpes and not sexually active were unknown.   It was unknown if the reporter considered the genital herpes and not sexually active to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient was diagnosed with genital herpes after vaccination. The patient was not sexually active. The reporter consented to follow up.
pt recv vax; 24 hr later, inc erythema, warmth & pain; now erythema & induration;mouth ulcers
I had a stroke three weeks after the vaccine. I didn't think they were related, but I figured I should report it based on the recent news. TEE determined PFO. Heart monitor was placed to check for arrhythmia.  High cholesterol was noted and medication for that was given. I was also given blood thinners and aspirin.
The patient thigh has been swollen, red, & warm to the touch. Family advised to put cool compresses on the reaction site. Also advised to give IBU & benadryl.
Inappropriate age at vaccine administration; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-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 ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved.        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 concomitant medication listed.   No treatment information provided.
CRAZY DREAMS; SHORT OF BREATH; HIGH FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced crazy dreams, short of breath, and high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, crazy dreams and short of breath was not reported. This report was non-serious. This case, from the same reporter is linked to 20210714512.
Entered observation @ 1420.  Patient voiced mouth tingling @ 1438.  Stated that mouth had been tingling 5 minutes before she said something.  Benadryl 50mg was given @ 1440.  This nurse asked pt how she was feeling @ 1451.  Stated that the Benadryl had alleviated some of the s/s of her mouth tingling, but she felt "light-headed".  Around 1505, this nurse stated to pt that she looked very "flushed'.  Pt stated she felt very fatigue.  This nurse and staff laid pt on stretcher in observation room.  Cold compress applied to forehead and chest.  Vitals were checked @ 1510 BP-133/93, P-89, O2-89%.  Stated she felt better @ 1515.  Explained to patient that she needed to lay down for a little bit longer, due to her feeling "woozy" upon standing up.  @ 1530, patient stated that she felt much better.  She stood up from bed and walked a short distance from bed to observation registration desk back to bed, balance was steady.  Stated she felt a little "short-winded", and did take 2 puffs of her in haler, in which she does suffer from Asthma.  Pt left observation @ 1535, accompanied by staff to her office.  Denies any s/s of distress to mouth, feeling fatigue, SOB, nor chest pain upon leaving.  Pt takes Singular daily for seasonal allergies.  Does have allergies to Peanuts,Nuts, PCN, and Sulfa.
Persistent itchiness and redness at vaccination site. It started a 8-10 hours after injection and it still occurring 48 hours later.
Treatment of COVID-19; Treatment of 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 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 3 (booster), single (Lot number: GJ2524) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Treatment with Paxlovid, from 07Feb2023 to 12Feb2023. Known allergies and Other medical history: no. Other medication in 2weeks: No.
Head to toe hives; This case was reported by a consumer via call center representative and described the occurrence of generalized urticaria in a 35-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2013-2014) (batch number fj94n, expiry date 1st June 2014) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th September 2013, the patient received FluLaval Tetra 2013-2014 (intramuscular) and Flulaval Tetra Pre-Filled Syringe Device. On 1st June 2014, 257 days after receiving FluLaval Tetra 2013-2014 and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced generalized urticaria. On an unknown date, the outcome of the generalized urticaria was recovered/resolved.   It was unknown if the reporter considered the generalized urticaria to be related to FluLaval Tetra 2013-2014 and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by the patient herself. The patient had a adverse reaction of head to toe hives. The patient required IV antiallergy medication, Pepto-Bismol and ER visit. The patient enquired about the 2013 Flulaval product information to compare product description to current Covid-19 vaccines.  The reporter did not consent to follow-up.
Tiredness- 48 hours ongoing  Fever of 102- 48 hours ongoing  Headache- 24 hours ongoing  Bodyache- 48 hours ongoing  Nausea- on and off  Chills- 48 hours on and off  No appetite - 48 hours ongoing  Exhaustion- 48 hours ongoing
Rash at injection site that started on 01/24/2021 (redness, minor swelling/bumps)
It started on 9-10-15 at 1:00A.M. A burning pain in one spot on my back between my right shoulder blade and my spine. For the next 2 days I had increased pain that traveled up my back to my neck and over to my right shoulder. On 9-12-15 I went to E.R. with a level 10 pain. They gave me a morphine shot, muscle relaxer pills and pain pills. On 9-13-15 I was groggie and couldn't use my right arm. On 9-14-15 I was back in E.R. because I completely loss the use of my right arm. They checked my heart, checked my right arm for a blood clot, everything was o.k, then they saw a rash on my arm and realized I had shingles. The E.R. doctor took me off the other pain pills and gave me pills to help with the virus. The rash went from my wrist under arm to my elbow then up to my shoulder, across the top of my shoulder and spread out over my shoulder blade down to where the pain started. For the next 3-4 weeks I could only sleep for 30 min. at a time because of the burning pain in my arm and shoulder. In Nov. I called Dr. office and they gave me gabapentin 100 mg. For nerve pain. Mid November I could touch my arm so I started Phy. therapy, 3 x a week. In mid Dec. Dr office made an appointment (at P.T. request) for me to see a Neurologist. That appointment was for 1-28-16 with Dr. She examined me and was surprised to see how bad my shoulder muscles had atrophied. She increased the Gabapentin to 300 mg. for pain and healing, have an MRI on Feb 5th, (that's done) see an Occ. Therapist on Feb 9th (did that) have an EMG on Feb. 23 (next week) and continue with P.T. My right arm is still not working correctly.
Information has been received from a physician and the office manager concerning a 6 month old male patient who on 02-APR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events were reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
A little arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 2020 (Batch/Lot number: unknown) as dose 1, single and administered in arm right, administration date 2020 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bipolar disorder" (unspecified if ongoing), notes: Verbatim: Bipolar disorder; "Thyroid cancer", start date: 1997 (unspecified if ongoing), notes: Since 1997 thyroid cancer; "GERD" (unspecified if ongoing), notes: I take an Omeprazole which is for GERD its for stomach if you had acid reflux.; "having trouble sleeping" (unspecified if ongoing), notes: having trouble sleeping; "some mental condition" (unspecified if ongoing), notes: I have some mental condition. Concomitant medication(s) included: GABAPENTIN; SYNTHROID; OMEPRAZOLE taken for gastrooesophageal reflux disease; XANAX taken for initial insomnia; NEURONTIN. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "A little arm pain".  Additional information: Patient's arm was really bad she could hardly lift it.Expiry Date of COVID-19 Vaccine: 28Feb2022.Patient got her booster in morning at about 10 O'clock. She had thyroid cancer history but that's been gone since 1997.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient states that the site of the injection is still sore a week after receiving the vaccination. He states he has trouble lifting his arm above his head. He states the reaction is getting better.
Stomach upset; Increased forgetfulness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), MEMORY IMPAIRMENT (Increased forgetfulness) and FATIGUE (Fatigue) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), MEMORY IMPAIRMENT (Increased forgetfulness) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset), MEMORY IMPAIRMENT (Increased forgetfulness) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medications included unspecified blood pressure medications and vitamin supplements.  No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-060898 (Patient Link).
Patient presented with out of hospital cardiac arrest 8/8/22. She suffered VT arrest with shock x2 then asystole then ROSC. She suffered hypoxic ischemic encephalopathy. She underwent targeted temperature management to 33C and was rewarmed.  Cardiology was consulted. She was started on heparin for ACS protocol. She remains comatose with prognosis still pending.