chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number# PHEH2014US025977, is an initial spontaneous report from a pharmacist received on 26 Dec 2014. This report refers to female patient of unknown age. Medical history was not reported. No concomitant medication was reported. The patient received XOLAIR injection for the treatment of asthma from an unknown date at an unknown dose BIW (subcutaneous). The patient received influenza vaccine (unknown manufacturer) on an unknown date at an unknown dose. It was reported that on an unspecified date, when she was supposed to receive her XOLAIR injection, she received influenza vaccine. XOLAIR was not administered on that day and she went to the emergency room. One week later, she was hospitalized for an acute illness. The reporter mentioned that the patient was treated for pneumonia. The pharmacist enquired whether XOLAIR could be given a week after the scheduled dose. Action taken with XOLAIR was unknown. The outcome of the events was unknown. The seriousness of the events was reported as hospitalization. The causality of the events was not reported.
Pt felt the vaccine was given too high and she woke up around 3AM that night with intense sharp pain in her left arm that lasted throughout the day. Since then the pain has decreased but she has limited range of motion and has been taking ibuprofen to help the pain.
10 days later spontaneous urticaria.  Random locations.  Started legs, groin, base of neck, under arms.  Itchy palms, soles of feet.  Started topical triamcinolone & Benadryl and oral Allegra.  Would still get break thru hives. Went to see Dr 3 days later- prescribed oral methylprednisolone.  Had to discontinue after 2 days due to side effects (everything was tingly and lips swelled.  Called MD with teledoc who recommended I stop the steroid due to unwanted neuro effect).  Now taking 180 mg Allegra BID.  If I do only 1 Allegra- will get break through hives after about 12 hours.  Awaiting further allergy testing
My brother started with some swelling in the legs/feet, followed by chest pains that led him into a heart attack, followed by cardiac arrest.   He was shocked back to life where he lay in a coma.  His kidneys stopped functioning followed by his lungs and liver?he was kept alive on life support and dialysis, he died after having 4 more heart attacks back to back on June 4, 2021.
Patient was given 0.5 ml prefilled FLUBLOK syringe at age earlier than current recommended guidelines. No adverse reactions or symptoms noted.
I received the vaccine on Tuesday, April 27. On Wednesday I had a fever of 102 F, body aches, and chills. By Thursday my fever had gone away and I was beginning to feel better. Friday morning at 6 AM I woke up to intense chest pain. I considered going to the hospital but by 10 AM the pain had gone away. Around midnight the intense chest pain came back and I went to a Hospital at around 1:00 Saturday.
Patient experienced sharp pain at a specific spot on head the evening after vaccination. Loud ringing in the right ear was also observed. Patient had a headache that lasted 3 days. There was redness under the injection site that went down the arm. Patient has been taking acetaminophen to help with symptoms.
Diabetes with reading 7.4; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (Diabetes with reading 7.4) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A20A) for COVID-19 vaccination.     No Medical history was reported by the reporter.  Concomitant products included PAROXETINE, ROSUVASTATIN CALCIUM (CRESTOR), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and LATANOPROST for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced DIABETES MELLITUS (Diabetes with reading 7.4). At the time of the report, DIABETES MELLITUS (Diabetes with reading 7.4) outcome was unknown.            Treatment information was not provided.  Additional information included that the patient was diagnosed with Diabetes with the reading 7.4 and the doctor prescribed to check her diet until the next office visit which was scheduled in June.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
On 03/23/21 STARTING AT 12 PM I started feeling with flu like symptoms, light fever 99.7 by a thermometer, joint pain, headache,
PATIENT CAME IN REQUESTING MENINGOCOCCAL VACCINE, ALONG WITH INFLUENZA AND PNEUMOCOCCAL ON A TINY PIECE OF PAPER. SHE DID SAY SHE WAS GETTING PREVNAR 13 SO THAT ONE AND INFLUENZA WAS GIVEN. WHEN MENINGOCOCCAL VACCINE WAS GIVEN, TRUMENBA WAS GIVEN INSTEAD OF MENACTRA. TRUMENBA IS RECOMMENDED FOR AGES 10 THROUGH 25, OR OFF LABEL USE IF DOCTOR DECIDES IT IS BENEFICIAL TO PATIENT. PATIENT THOUGHT VACCINES HAD TO BE ADMINISTERED WITHIN 14 DAYS BUT THEN CALLED TO SAY THAT HER HUSBAND WAS THE ONE WHO HAD GOTTEN THE INFO AND SHE WASN'T SURE IF SHE NEEDED TO GET THEM. PATIENT GAVE US A NUMBER TO CALL AND I CALLED AND LEFT A MESSAGE FOR THE DOCTOR TO CALL US BACK BUT HE DID NOT RETURN OUR CALL. IT WAS NOT HER PRIMARY DOCTOR, BUT THE ONE SHE HAD WHILE IN THE HOSPITAL. SPOKE WITH PATIENT DAY OF INJECTION, NEXT DAY AND TWO DAYS LATER AND NO ADVERSE EFFECTS EXCEPT NORMAL PAIN AT INJECTION SITE.
Venous thromboembolism; This literature-non-study case was reported in a literature article and describes the occurrence of EMBOLISM VENOUS (Venous thromboembolism) in a 31-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:  No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EMBOLISM VENOUS (Venous thromboembolism) (seriousness criterion medically significant). At the time of the report, EMBOLISM VENOUS (Venous thromboembolism) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Author stated that there has been limited information regarding thrombosis development after receiving a messenger RNA (mRNA)-based vaccine. This case series highlights four different patients who received an mRNA-based COVID-19 vaccine and subsequently developed venous thromboembolism. Therefore, author hope that after reviewing this article, physicians will be more aware of thrombosis-related developments following mRNA vaccine administration for COVID-19. Fortunately, with early diagnosis and prompt treatment, patients can still expect full recovery from any vaccine thrombosis-associated complications, and the benefits of receiving an mRNA-based COVID-19 vaccine still outweigh the risks of post-vaccination complications.  Company comment: This is a literature non-study case concerning a 31-year-old female patient with No Medical History reported, who experienced the serious unexpected medically significant AESI embolism venous (reported as venous thromboembolism). The event occurred after receiving the second dose of mRNA-1273 vaccine (event and vaccine date was not provided). No treatment or concomitant medication was provided. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-732788 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732788:58-Y-M
Cellulitis to right deltoid area.  Clindamycin and Cetirizine prescribed.
Started at night as I went to bed about 11 p.m.  My arm became much sorer and swollen and also very itchy. My heart was beating rapidly and I couldn't slow it down with breathing.  Then It was hard to breathe,  I felt off balance/dizzy, and finally I could feel my throat closing up. I drank lots of water, did yoga,  diaphragmatic breathing walked around somewhat. I knew I should go to the hospital but I didn't have anyone to take me and I didn't want to call 911, so I tuffed it out for several hours.
22JAN99 started w/papules on face & torso;also temp 102 papules spread to full torso, upper arms & upper legs, positive itch;devel vesicles on erythematous base;
Patient received full vial of undiluted Pfizer vaccine. Patient was called on 1/20/2022, to inform of adverse event. During phone call patient expressed experiencing a sore injection site that has gotten better each day and headaches that she has been treating with Tylenol or aspirin. Patient did not express any other symptoms.
Patient presented to the ED and was subsequently hospitalized for cerebral infarction within 6 weeks of receiving COVID vaccination.
Anaphylaxis- throat tightness , nausea , rash , pruritis , chest tightness, wheezing . 9-11 called epinephrine x 2 , decade on , IV Benadryl , duo-nebs, famotidine, admission to icu high dose prednisone , nebulizers , zofran , duo-neb nebulizers
This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 09-APR-2014, the patient was vaccinated with a dose of improperly stored VARIVAX (lot# J003532, expiration date: 25-MAR-2015, 0.5 milliliters (ml), subcutaneous) (strength and indication not reported). The VARIVAX has been stored at -10 C (Celsius) above recommended temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Arm became sore almost immediately. Next morning after being awake for a few hours I started feeling sick; headache and sore throat at first, achiness came on strong soon after followed by a fever that comes and goes. My temp is currently 102.9
9 DAYS POST VACCINATIONS, CHILD DEVELOPED FULL BODY RASH THAT APPEARED TO BE AN ATYPICAL CHICHEN POX, MACULOPAPULAR. GREATER THAT 100 LESIONS, MILD FEVER. NO TREATMENT.
Patient was given a vaccine that was kept in the refrigerator for longer than what the manufacture requires.
PATIENT SAID THE PNEUMONIA VACCINE MADE HER ARM, BUMPY, SWOLLEN, RED AND WARM TO TOUCH. IT WAS VERY PAINFUL FOR A WEEK. HER PAIN HAS SUBSIDED NOW.
This case was reported by a healthcare professional (also the subject and consumer) and described the occurrence of a 49-year-old female subject feeling strange following vaccination with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On November 2007 it was reported that the subject received unspecified dose of Fluarix and approximately one to two hours following vaccination reported feeling strange with waves of nausea, scratchy throat and heavy headedness which continued three hours after the injection and had not resolved at the time of reporting at 15:00 hours. On 7 November 2007, at 09:00 hours, the subject reported that her ears were burning and she had nausea all night long. Her throat remained sore and scratchy. At the time of reporting the events were unresolved. Follow-up received on 10 January 2008 via the nurse. SHe reported that on 08 November 2007 she experienced strange feeling, nausea, scatchy throat, heavy  headedness. Oora burning and sore throat. The events resolved on 13 November 2007. The reporter noted that the events were not serious.
Day 1: sore arm, fatigue, headache Day 2: headache, fatigue, chills, mild nausea, body aches,  joint stiffness  Day 3: sore arm, fatigue, lower back pain, chills at night  Day 4: sore arm, a period of body aches, a phase of fatigue, sudden lower back, neck, and knee pain Day 5: sore arm, fever, chills, lower back pain, stiff joints, neck pain, headache
Headaches for 6 days so far. This morning the injection site started bleeding. Also had two bloody nose incidents since the injection site started bleeding. The bleeding was light and stopped within minutes.  Still experiencing an itching sensation and a knot at the injection site.
01/22/22 presents to Birth Center Triage for "ctxs". PMHx of "Panic attacks"
Patient stated feeling lightheaded the night of the vaccine Patient stated on Day 2 she experienced Body aches/ chills/ a headache/ and a fever greater than 100 deg. cel. Patient stated on Day 3 the fever remained along with the headache
Shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 72-years-old female patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 06-JUL-2017, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the prophylaxis.  In February 2019, subsequent to the patient vaccination, the patient was treated by a physician for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) vaccination: shingles, including any and all of its sequelae. As a result of her receipt of the zoster vaccine live (ZOSTAVAX) vaccine, Plaintiff had severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages, other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. At the reporting time, the outcome of the event was unknown.  The reporter considered the events of shingles to be related to zoster vaccine live (ZOSTAVAX).
This case was reported by a pharmacist via call center representative and described the occurrence of anaphylaxis in a adult male patient who received Flu Seasonal TIV Dresden for prophylaxis. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu trivalent vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the anaphylaxis to be related to Flu trivalent vaccine. Additional information received as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced anaphylaxis to an unknown flu vaccine in 2012. The healthcare professional did not have any further information.
It was reported that a 3 month old female patient received an IPOL vaccination on 02/09/01 in doctor's office. 45 minutes later when the patient's mother got home with the patient ,she was covered with an overall  body rash. She went back to the doctor's office and the rash was already dissipating. The patient has normal skin and coloring now hours later. No antihistamine given.
t102.7, rash; anaphylaxis; 1 convuls post immun; unconscious, unresponsive; stopped breathing intubated & bagged & transported;
COVID-19; COVID-19; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for 28 patients. This is one of 28 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN,SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date. The reporter stated that 28 people from a certain location tested positive.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101237061 Same reporter/product/events, different patient;US-PFIZER INC-202101237061 Same reporter/product/events, different patient
Alfuria Quadrivalent MDV 0.25ml was given to a child between the age of 6 months-35 months.  On the vial, box the vaccine came in and the Instructions sheet. It states okay to give this vaccine to these age groups.     6 month - 35 months 0.25 ml    36 months and older 0.50 ml The state does not approve this vaccine for the age group of 6 months - 35 months.  -Due to the Amount of Mercury and its not preservative free. -The vaccine is prepared from virus grown in embryonated chicken egg and inactivated with beta propiolactone. Each 0.25 ml dose contains 12.25 mcg mercury/dose  3-13-2023 Patients mother states that patient did have a low grade fever for 3 days after the vaccine. She stated that she did give him Tylenol for the fever. States that he is doing fine now. She will contact the office PRN.
Patient's wife reports patient never reported feeling unwell. He had been working on painting the basement all week and on 02.12.2021 came in from outside, ate, and they sat down to watch TV. Around 9:30 patient reported being extremely tired and went to bed. Was found unresponsive the following morning, 02.13.2021. Patient's wife reports the doctor said it was a heart attack.
My daughter received her second GARDASIL vaccine and had 2 30-45 second seizure 15 minutes after the injection in the doctors office on the floor. She became pale, disoriented, her pupils were dilated and she kept saying she doesn't feel good thereafter the whole night long. She experienced a glaze for hour after, slow movement numbness to both legs and a headache and has twitching in her left arm still at the present time. I took her to the ER on my own judgement because the pediatrician said there was no need this was normal following this vaccine and she had bloodwork drawn and now has to have an EEG today. Something has to be said to this company.  5/5/09 Received medical records DOS 1/2/09 to 4/23/09. Includes imminzation records.  FINAL DX: Seizures Two 'quick seizures' post vaccination. Also several episodes of eyes rolling, and twitching.   6/2/09 Received ER medical records for 4/21/2009. FINAL DX: seizure Records reveal patient experienced back to back seizures each lasting approx 15-20 secs w/no postictal period.  Pt had dizziness s/p vaccination & then had seizure.  No further seizure activity, no meds while in ER & d/c to home w/PCP f/u.  Follow-up - Patient recovered. Patient's address updated.
about 1 hour after the vaccine, I noticed my right ear felt full and dry mouth.  after 1hr and 45 minute the right side of my mouth felt tight and tingly (kind of like after you get a numbed at the dentist but your not completely numb) my right thumb felt the same way, and as the night went on the tight, tingly, numb feeling grew across the right side of my face from my lips to my ear.   the next morning it was still there, and as the day progressed that feeling grew up to my eye. that is when I was seen by a doctor , who confirmed that what I was experiencing was not a muscle reaction, but a nerve reaction. I can still move my lips and eyes, but it just feels very weird and tight, and almost like I have to work hard to make them move.
In addition to the typical side effects of fevers, chills, body aches, sweats that started that night around midnight, I also developed a headache. I thought it would go away within a few days, but since that day, the headaches have not gone away. I also have now blurry vision that started along with the headaches. The blurry vision comes and goes, lasting up to seconds, minutes or hours and then it clears up on its own.  Due to the headaches, I was worried about the blood clot warning in the brain regarding Johnson and Johnson vaccine and had an MRI of the brain which was normal. I do have migraines but these are different and daily, constant headaches.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-NOV-2015, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD with lot number: L030587, expiry date: 10-FEB-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
patient was inadvertently administered a dose of VARIVAX that had been impropertly stored; No additional adverse effect reported; patient was inadvertently administered a dose of VARIVAX that had been impropertly stored; This spontaneous report was received from a Registered Nurse (RN) referring to a 12 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies.  Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).   On 20-JAN-2020, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) lot # S015464, expiring on 20-MAY-2021, for prophylaxis (dose, route of administration, and injection site were not reported).   The administered dose of the vaccine experienced a temperature excursion of -13 degrees Celsius for 5 minutes, and 4.69 degrees Celsius for 1  hour and 45 minutes, as recorded by a data logger. The vaccines had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
Bleeding nose/he had bleeding in his nose very bad; This is a spontaneous report from a contactable consumer (patient's brother). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date around 3:25 o'clock as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced bleeding nose/he had bleeding in his nose very bad. The seriousness for Bleeding nose was unspecified. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
night of, had arm soreness. next morning, had slight subjective fevers/chills, and throughout day had intermittent fatigue and constant mild myalgias
Pfizer dose 1 administered.  Vaccinator went to start observation timer.  Patient stated she felt light headed, patient passed out.  Patient was carried to stretcher, regained consciousness.  Vital Signs obtained BP 115/73, HR 84, O2 sat 100.  Patient was observed 30 minutes and then released to the care of her mother.
Paresthesia of part of tongue starting about 5 min. after injection; no swelling or airway problem.  No other signs of allergic reaction.  Observed x 30 min. w/o worsening.  Given 25 mg diphenhydramine as precaution.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
pt recvd vax 2DEC93 & 1/2 hr p/vax pt exp tachycardia, flushing, h/a, sensation of warmth & abn ECG; BP nl 110/70 was 140/90 & pulse rate was 125 & irregular; pt given DPH & MSD
difficulty initiating swallowing of solids beginning a few hr p/vax;large local rxn @ deltoid;
SARS-CoV-2 RNA Resp Ql NAA+probe~2019 Coronavirus SARS-CoV-2 performed on 07/09/2021 and came back positive. Case investigation interview with patient has not been conducted at the time of this note.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE HYPOXEMIC RESPIRATORY FAILURE