chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vomiting; fever of 103; severe chills; my chest was on fire; severe cough; sore throat; body aches; headache; oxygen hovered at 88 for 18 hours; laryngitis; suffered severe exhausted.; i couldn't ever roll ever on my bed; i couldn't catch my breath; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), dose 1 intramuscular, administered in the left arm on 24Mar2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included pneumonia from 17Jan2009 and ongoing (antibiotics some hospitalisation), renal lithiasis prophylaxis from 01Sep2010 to 01Sep2010, headache from an unknown date and unknown if ongoing. Concomitant medications included paroxetine hydrochloride (PAXIL) for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient reported that on 24Mar2021, within 4 hours of first vaccine, I suffered severe exhausted. Within 6 hours, my chest was on fire with severe cough and sore throat, body aches, headache, fever of 103.  My oxygen hovered at 88 for 18 hours and my resting heart rate was 118.  This lasted for a full 18 hours and then very gradually subsided.  Oxygen came back up slowly and I was able to walk around my house for a few minutes on day 2.  By day 4, I was almost back to normal except for laryngitis, which lasted a full 7 days. The patient also reported shot received at 3:30 by 20:00 I was extremely tired. I woke up at 1:00 am with a fever of 103 degrees, severe chills that were so bad I bit my tongue. I also had a horrible cough and sore throat. I couldn't catch my breath. I couldn't ever roll over in my bed because I couldn't breath or catch my breath. Vomiting began at 4 am and lasted 1 hour. Oxygen level was 84 to 88 for 18 hours. Treatment for the events included unspecified nebulizer, paracetamol (TYLENOL), and cough syrup. The patient recovered from all the events.   Follow-up attempts are completed. No further information is expected.
fainting; weakness; nausea  after 2 days of injection.  one fainting, several spells of weakness for 2 more days.
Information has been received from an investigator concerning an 8 month old female who received her 3rd doses of Prevnar, Hib-Titer and Infanrix on 5/18/01. That same day, the infant developed a fever of 103F and was treated with Tylenol. Approx. 5 hours, post vax, she started having "shaky movement" of her whole body for 10 to 15 minutes. Afterwards, the infant had a "starry look" which lasted about 30 minutes. She was seen in an ER and treated with Valium. The infant was hospitalized with a dx of febrile seizure and treated with IV fluids and ceftriaxone. A head CT was normal. CSF studies showed WBC count of 0 cells/mm^3, RBC count of 310 cells/mm^3, protein at <10 mg/dl, and glucose of 60 mg/dl. A CBC showed no abnormalities. She recovered. The investigator considered febrile seizure to be possibly related to vaccine administration. The medical monitor's assessment of relationship is unknown. Information regarding this event, has been forwarded to manufacturer.
Next day fever of 100.3, headache, fatigue all lasted 24 hours. On Monday became nauseous and this has lasted 48 hours.
entire lt upper arm mild erythematous & mild induration entire deltoid, warm;cheerful not ill;on APAP & DPH;7SEP96 all gone-arm back to nl;
Redness, pain, edema, local area & generalized fatigue & arthralgia.
Mild light-headedness and numbness/tingling in left arm. Vitals stable. Neurological exam benign. Cardiac and respiratory exam unremarkable. Before leaving light-headedness improved; arm numbness remained. No follow up needed; resolved by second shot.
This spontaneous report was received from a licensed practitioner nurse referring to a 4 month-old child of unknown gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 29-JUL-2015, the patient was administered an improperly stored dose of LIQUID PEDVAXHIB injection (lot # K026533, with expiration date: 07-AUG-2017; dose , frequency and route were not reported). No adverse effects were reported. IT was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from Registered Nurse referred to a patient of unknown age. The patient was vaccinated with an expired dose of 0.65 ml ZOSTAVAX (lot # unspecified, EXP date 25-OCT-2012, subcutaneous) on 02-JAN-2013. No adverse effects reported. No treatment information was reported. The outcome was unknown. This was one of several reports that received from the same source. Additional information is not expected.
None reported, vaccine given in error after 8/31/2022 as a booster dose.
I experienced after my J&J vaccine, 12 hours after injection, felt like allergies. I felt my throat was closing up a bit, and my heart rate was fast, 80-90bpm for a few hours. On the next day, I also had a low grade headache which lasted 6 days.  I took Aspirin which temporarily relieved my headaches.  I have history of blood clotting issues in the family, with antiphospholipid. I am being monitoring by my PCP. .
have facial tingling on right side of face form cheek bone to jaw bone; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the first dose of BNT162B2 via an unspecified route of administration on Apr2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, shortly after dose, the patient started to have facial tingling on right side of face from cheek bone to jaw bone. Tingling was still intermittently ongoing. The patient would like to know if this something that has been experienced or reported by others and would also like to know if he should get second dose of vaccine or not. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
Information has been received from a consumer concerning his/her 6 month old grand daughter with pulmonary lymphangiectasia and gastrostomy tube (G-tube) "normally gets things administered through the tube. She does not receive anything by the mouth" and with no drug reactions or allergies who on 22-NOV-2010 was vaccinated orally with a first dose of ROTATEQ (manufacturer unknown) (Lot# unknown). There was no concomitant medication. The consumer reported that the patient threw up while getting the 1st dose of ROTATEQ. There were no laboratory tests or diagnostic studies performed. The consumer stated that after some time passed, the patient seemed to be ok. It was also reported that the patient was back to her present state afterwards. The patient did not seek medical attention. No further information is available.
Information was received on 25-NOV-2016 from a pharmacist regarding a 70 year old female patient who received a PNEUMOVAX23 injection on 23-NOV-2016. The pharmacist reported that another pharmacist gave the injection. Medical history, concurrent conditions and concurrent medication were not reported. The pharmacist said the patient reported that late on the afternoon of 23-NOV-2016, she noticed redness running down the outside of her arm, not at the injection site, of course and she had a sore muscle. On 25-NOV-2016, the patient came to the pharmacy and the pharmacist documented that she still had a red rash from the top of her arm to the elbow, on the outside, that felt feverish, it was red, like a reaction, and itching, some pain and discomfort running down her arm, similar to that at the injection site. She had no trouble breathing nor had any other serious reaction but felt a little bit jittery. The pharmacist asked her to take BENADRYL for a couple of days. No further details were noted. Additional information is not expected.
Myalgia, Diarrhea,  fatigue, low temp, neck sore, sore throat Narrative:   Other Relevant History:
Baby developed fever to 103 (axillary) at 05:00.  Checked by me at 16:30, rectal temp 101.6.  Baby with no other symptoms.  Appeared well.
Information has been received from an immunization official concerning an adult female patient who, several years ago, received an adult two dose vaccination SC, each dose 0.5 mL of varicella virus vaccine live (Oka/Merck). It was noted that a recent titer was done and does not show seroconversion. There was no product quality complaint reported. The patient sought unspecified medical attention. Additional information has been requested.
Patient describes this is her 2nd dose and she is experiencing Joint pain, Arm numbness, range of motion in lifting her arm, very fatigued and also reports headache and  her blood suger shot up to the 300 range, patient is an insulin dependent diabetic and this is her main concern.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 04-APR-2013, patient received improperly stored VARIVAX dose 1, from batch/lot # 0610AE (expiry date, dose units, route and anatomical location were not specified), on 09-MAY-2013, patient received improperly stored VARIVAX dose 2, from batch/lot # 0610AE (incorrect product storage). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Arm in which PNEUMOVAX 23 was injected has become red, warm, and inflamed.
pt recv vax 17JUN96 & mom reported spots on pt torso, face & arms & pt exposed to chicken pox from daycare 2 wk ago;
Client received 1st MMR on 8/8/02. Symptoms started on 8/15/02 with c/o jaw stiffness, tenderness, (B) ear. Client noticed swollen lymph gland one day later under (R) ear. Symptoms persist today. Has dr's appoint. today. 8/22/02 saw PMD toda. PMD diagnosed parotitis, severe infection and ordered client not to receive 2nd MMR.
Suspected vaccination failure; Got sick from shingles; Dr implied / anti viral meds were a factor / Every nutrients in my body seemed depleted; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and malnutrition. On an unknown date, the outcome of the vaccination failure, shingles and malnutrition were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and malnutrition to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient got sick from shingles but the patient's husband was convinced that the vaccine caused the patient to get shingles and the patient's cardiac doctor implied that the anti-viral medications were a factor every nutrients in the patient's body seemed depleted but not sure what caused all of it. Antiviral medications were also considered suspect for depletion of nutrients in body. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
A non-serious spontaneous report of a dose of H1N1 LAIV was inadvertently administered to a 17 month old was received from a physician concerning a 17-month-old female. The patient had no significant medical history and no concomitant medications was received by patient. On 22-Dec-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter's causality assessments are not applicable and the event was considered resolved. Additional information was received on 5-Jan-2010 and incorporated in the narrative: Medical history and concomitant medications. Other additional information received was reporter address and phone number.
Headache, body aches, lethargy started approx. 6 hours after admin. Facial swelling (mostly around eyes) and redness present 15 hours after admin. Progressed through 48 hours after admin.
Pt recvd 3 doses of Engerix-B & was determined to be a non-responder;
This spontaneous report was received from a consumer refers to a female patient of unknown age. Past drug history included: ZOSTAVAX. The patient explained she had a shingles outbreak that started in her pubic area in a thin band-like rash with excruciating pain that extended along her body in 200 and she went to an unidentified clinic where she thinks she was given ZOSTAVAX as treatment for her diagnosed shingles. The clinic could not confirm or deny that she was given the ZOSTAVAX vaccine. The patient did not wish to participate in the AE survey and gave limited information because of this reason. On an unknown date the patient was vaccinated with ZOSTAVAX, 1 DF, subcutaneous. Concomitant medication was not reported. On an unknown date the patient experienced she had a shingles outbreak. The outcome of she had a shingles outbreak is unknown. Action taken with the vaccine ZOSTAVAX were not reported. Additional information is not expected.
accidentally administered TENIVAC and Boostrix together with no reported adverse event; Initial information received on 16-Dec-2022 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 11 years old female patient who was accidentally administered tenivac and boostrix together with no reported adverse event after receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Immunisation; HPV VACCINE (HPV VACCINE) for Immunisation; MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) for Immunisation; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On 15-Dec-2022, the patient received suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult 0.5 ML 1X and Drug Treatment Duration: ONCE (batch number: U7183AA) in unknown administration site for Immunization.  On 15-Dec-2022 the patient diagnosed with a non-serious accidentally administered tenivac and boostrix together with no reported adverse event (off label use) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  Action taken was not applicable.  At time of reporting, the outcome was Unknown
Inadvertently administered 2nd dose 9 days after initial dose. Lack of communication from this provider with daughter; this provider did not know that the patient already received first dose. No adverse effects noted so far.
Pt counseled about HPV vaccine and consented to injection.  Has never received HPV vaccine in the past.  No known drug or vaccine allergies.  Reported she sometimes feels faint around needles.  Pt counseled about side efects including possible pain at insertion site and possibility of feeling faint.  Written info given.  MA gave injection and after approximetly 20 sec pt stated she felt dizzy and her eyes began to widen.  At that point MA brought me back in the room where I was there with the patient and her brotehr and patient was lying on the table making jerking movements of extremities and moaning.  I immedietly had the front desk call for an ambulance.  After about 1 -2 minutes the patient began to stop moaning and movements ceased.  She was breathing heavily but was able to speak and said she felt sick.  Her breathing then started to slow to a normal pace and after about another minute she vomitted into a bucket.  After about 7 minutes paramedics came.  Pt was able to walk to the stretcher with assistance.  BP was 93/60.  Pt denies any hx of seizure activy, but states she has fainted after vaccinations in the past.  Pt brought the emergency room for evaluation.  Possible adverse reaction to GARDASIL submitted to the FDA adverse reaction reporting system.
Client reported redness and knot at site within 15" after vaccination. After left clinic client reported shortness of breath and was taken to the Emergency Room
hives (1 hive on chest); This is a spontaneous report received from a non-contactable other healthcare professional. A 54 years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205, Solution for injection) via an unspecified route administration on 22Mar2021 (at the age of 54-years-old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. On 22Mar2021 (during 15 minutes waiting period after the injection), the patient experienced hives; she complained about 1 hive on chest. The patient denied difficulty breathing, difficulty swallowing, wheezing and throat tight-ness. Therapeutic measures were taken as a result of hives and included treatment with antihistamines (unspecified). Follow up response to treatment was good. The patient was stable to go home and followed up with PCP (primary care provider). The clinical outcome of the event hive on chest was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information:  Event term "hive on chest" updated as "hives (1 hive on chest)" per source reported; Outcome previously captured as "Recovering/Resolving" per verbatim "Stable to go home", pending PSSR review and Final sentence "No follow-up attempts are needed. No further information was expected." updated as "No follow-up attempts are possible. No further information is expected."
Patient reports that about an hour and a half after receiving his flu vaccination, he started to develop a headache and bilateral eye itching, swelling, burning and redness. Patient also states that he started to have itching and redness on his neck. Patient denied any respiratory symptoms. Patient's first set of vitals was obtained at approximately 08:45; his BP was 132/80 and HR was 79 BPM. Per doctor's orders, 50 mg/ML of Diphenhydramine (Lot # 4296463, Exp: Oct 2016) was administered IM in the R arm at 0900 to the patient. Vital signs were re-assessed at 09:14; BP was 118/78, HR was 75 BPM and 02 was 96%. Patient was taken to the urgent care per doctor's recommendation at approximately 09:30 for further follow-up.
Patient received Janssen COVID vaccine on 6/15/21. On 1/21/22, patient admitted to our inpatient facility (CCU) for acute respiratory failure with hypoxemia and pneumonia due to COVID-19 virus (patient intubated from AFH), shock, AKI on CKD 3, and acute metabolic encephalopathy. As of today, patient is still ventilated in CCU.
Pt had a dizzy spell, fell down and about 20-30 sec later had a seizure involving all extremities and twitching of mouth and eyes lasted for approx 1-2-min. Pt was transferred to ER. CT scan / labs - normal. Discharged.
Headache starting day after vaccine.  06-26-21 Vomiting started without warning before dinner along with headache.  Never felt sick to stomach and hadn't ate anything since lunch time that day. Continued to vomit for a few hours, no other symptoms followed that evening or next day.
Upper eyelids slightly swollen and intensely burning beginning around 5pm 4/11. Morning of 4/12, burning continuing and eyelids are a little more swollen. Bruises appeared under eyes. I have not had a fever at all, but have had intense fatigue each morning and evening since the vaccine on 4/9. I tried hydrocortisone on my eyelids, but it didn't help. Tylenol and ibuprofen help relieve the burning sensation a little.
The patient accidentally received pneumovax23 instead of prevnar13 during her pediatrician visit on 5/1/23.  She had a fever and a small, localized reaction with pain and mild redness at the site of the vaccination that improved after Tylenol and a cold compress. She was seen in the ED on 5/2/23, over 24 hours after the vaccines had been administered.
L arm site. Mother called Health Dept. today to report that child had been checked at hospital after calling nurse hotline after hours. Evening of vaccination, site became reddened, swollen and tender (Thursday) by Saturday, had increased severity and went to ER. Recommended MOTRIN. Today (Monday) symptoms resolve.
I had the ZOSTAVAX vaccine on 12-11-09. Began to notice breaking out & itching on left side of neck. The rash looked similar to pin heads - no large blisters. It began to spread around hairline, back, & on right side of neck also. Itched terribly. Used calamine lotion, took BENADRYL, & used ZNP Soap Bar. Saw Dr-diagnosed as Shingles. Took 4 weeks to recover.
day 5 vertigo just morning  dizziness all day better the next day.  very tired no energy feeling crummy, migraines by day 6, 7 and 8... worst than normal  and lasting longer than normal. usually get relief after 1 dose but it would take at least 2 before feeling somewhat better.  some diarrhea, body aches. pain in my left arm and side  around lung area. had chest x-ray on 1-11-21 clear.  this all lasted until 1-27 or 1-28 felling a lot better today 1-29-21....  these are all the symptoms i had when i had covid in Nov. it was like having it all over again......
Anaphylactic reaction and subsequent shock. ACLS Protocol: Epi, Benadryl, Solu-cortef, Atropine, Sod. Bicarb, Cricothyrotomy. The hospital discharge summary received on 1/28/04 states cyanotic, dyspnea, apneic and limpness.
This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.  It was unknown if the reporter considered the anaphylactic reaction to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient experienced a documented anaphylaxis to influenza vaccine.
My adverse event started on 02/05/2023 in the morning. My lower left leg was burning and painful. My cellulitis was acting up so in the afternoon I went to the ER because I was having chills and fever. I do have pre-existing health condition this might not be related.   I felt like the infection was spreading. My AFIV was also acting up. Since I am a heart failure patient. Everything acts up quickly.   Late March my air ways  flared up. At the ER  they gave me an inhaler and nebulizer to come down my air ways since I was coughing.  On 03/28/20223 I got a  virus  where my oxygen level  came down to  82% .  It caused  Acute Respiratory Failure. I wasn't able to walk or do anything. I came back from the ER on April 1 feeling better.  At the ER they gave me more breathing  treatment, Antibiotics, and Oxygen.  As  of today I still feel wiped out. I just have to let my body fight it off slowly.