chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unknown disorder; This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. The patient was treated with immunoglobulin human normal, immunoglobulin human normal (Gammaglobulin). On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The pharmacist stated that after receiving the 1st dose of Shingrix, the patient was diagnosed with a new disorder (precise diagnosis unknown to pharmacist) and was started on Gammaglobulin infusions. The pharmacist became notably frustrated when specialist attempted to collect more details for the adverse event.  The pharmacist stated that she did not know what the diagnosis was, only that the patient was not diagnosed with this disorder prior to receiving the first dose of Shingrix.  The pharmacist was transferred to second line specialist for further discussion regarding her inquiry. The specialist neglected to ask whether safety had permission to follow up.
Pt experienced shortness of breath and swelling of right deltoid 2 hours after leaving clinic. Treated with Benadryl. Pt continues to have shortness of breath one week later.
Hives and redness on face--both cheeks and above and below both eyes. Symptoms returned in the evening of 12/18/2009, and to a much lesser extent the evening of 12/20/2009.
Chills, fever, headache, body aches from 8:00 PM Friday till Sunday 9:00 AM Tylenol was taken every 4-6 hours.  Chills and fever stopped Saturday night. Body aches continue to Sunday morning
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 06-NOV-2013 the patient was vaccinated with ZOSTAVAX lot # J006827, expiry date 14-SEP-2014 subcutaneously. No concomitant medications were reported. The pharmacist reported that reconstituted product was difficult to withdraw from ZOSTAVAX vial because of resistance from the vial. Product quality complaint (PQC) was filed. Despite this PQC, she was able to fully withdraw the reconstituted product from the ZOSTAVAX vial, but some reconstituted product was lost when cap of the syringe needle was removed and therefore only 0.5ml of reconstituted ZOSTAVAX product remained which was administered to the patient. No adverse effect was reported. Additional information has been requested.
Information has been received from a physician's assistant (P.A.) concerning a approximately 23 month old white male with no other medical history and no drug allergies who in February 2008, was vaccinated with the first dose of VARIVAX (Merck).  There was no concomitant medication.  There was no illness at the time of vaccination.  Five weeks after vaccination in March 2008, the patient experienced VARICELLA rash.  The VARICELLA rash persisted through June 2008, when the lesions gradually resolved.  Never any fever or illness.  No product quality complaint was involved.  Additional information is not expected.
patient received an expired Pentacel, no adverse event; Initial information was received on 26-May-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 4 month old female patient who received 0.5 ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot UJ29AAA, expiry date: 14-May-2021) via intramuscular route in left leg for prophylactic vaccination on 26-May-2021  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  It was a case of an actual medication error due to Expired product administered (latency same day)  The reporter asked if the patient need to be revaccinated  At the time of report, no adverse event was reported.  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.
Cardiogenic shock ; ED visit and hospital admission. This visit was within 6 weeks of receiving a COVID vaccine.
Had a stroke on my left side; Had a stroke on my left side; This is a spontaneous report from a contactable consumer (Patient).  A 34-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08Aug2021 15:30 at the age of 34-year-old as dose 1, single for covid-19 immunisation from pharmacy or drug store. Medical history included stroke (blockage), aneurism and patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination. The patient had a stroke on my left side on 27Aug2021 21:30 which result in emergency room/department or urgent care. The patient was hospitalized for the event for 3 days and had disability or permanent damage. Patient was treated with unspecified medicines in response to the event. The patient underwent lab tests and procedures which included covid test (nasal swab) was negative on 28Aug2021. The outcome of the event was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Hives on most body parts beginning about 4 hrs post-vaccine. Even eye lids were swollen. Red and itchy. Treated with Benadryl. Gone by morning.
tested positive for COVID; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 25Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Mar2021 patient had sars-cov-2 test and she tested positive for COVID. She was positive that it was not from the vaccine. The event considered as medically significant. She was wondering if she can receive the second dose on 18Mar2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
could not move my arm past my head; On Day 2, patient had a fever of 100.2 degrees F; Arm was very sore; This is a spontaneous report from a contactable pharmacist, the patient. A 28-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration on 25Mar2021(at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. Concomitant medications included ethinylestradiol, levonorgestrel (ORSYTHIA) received within 2 weeks of vaccination. The patient had no known allergies to food, medication or other product. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration on 06Mar2021(at the age of 28-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, the patient experienced sore arm. On 26Mar2021 (day 2), the patient could not move arm past her head, however this resided by day 3. On 26Mar2021 the patient also experienced fever of 100.2 degrees F. Therapeutic measures were taken as a result of adverse events and included treatment with naproxen for fever. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event arm was very sore was recovered on unknown date in Mar2021. The clinical outcome of event could not move arm past head (arm discomfort) was recovered on 27March2021. The clinical outcome of the event fever was recovered on 26March2021.   No follow-up attempts are needed. No further information is expected
Vaccine administered 10/14/15. Patient admitted to hospital, on 10/17/15 - 10/20/15. Diagnosed with Guillain-Barre. Patient admitted to hospital 10/21/15 - 10/23/15 for side effects of treatment medications.
Patient reported feeling "woozy" after vaccine adminstration. Patient denies any allergies or any significant medical history. Patient reports not having breakfast. Patient's feet was propped up on a chair to help with dizziness. Officer witness the patient's vasovagal episode and called EMS at 10:44am. Upon EMS arrival, patient was improving. Vital signs were stable and patient declined EMS services to the ED.
PATIENT DEVELOPED MILD HIVES AND DR GAVE HIM BENADRYL.
PATIENT RECEIVED VACCINATION AT 12 PM ON 3/31/2019. SHE SAID HER LOW GRADE FEVER (99.2 - 99.3) AND A HEADACHE. SHE WOKE UP 4/1/2019 AND SAID HER VISION WAS NOT BLURRY, BUT THAT COLORS DID NOT LOOK CORRECT. SHE FELL AT 6:30 AM AND HIT HER HEAD, ELBOW, AND BACK FROM WHEN SHE BECAME UNCONSCIOUS. SHE SAID SHE WAS UNCONSCIOUS FOR APPROX. 10 MINUTES. SHE DID NOT EAT ON 3/31/2019 AND SLEPT MOST OF 4/1/2019. SHE SAID HER ARM WAS SWOLLEN ON 3/31/2019 BUT IS BACK TO NORMAL NOW.
Urticaria noted on back areas from shoulders to mid-thigh,; red, slightly raised itchy patches; itch relieved by diphenhydramine but patches remain today. Wondering if unusual pattern on body is due to increased circulation to back area due to use of car seat warmer.
Varicella vaccine given 10/1/08, RUA - SQ. Pt. to ER, 10/1/08, evening after pain, redness, warmth, swelling. Followed up with VNA - CS, 10/3/08. Advised ice, TYLENOL, MOTRIN, BENADRYL. Spoke with mom, 10/6/08 - arm much better.
Pt received varicalla vaccine 9/25/12 - no history of varicella disease. Diagnosed with shingles 10/13/14.
High fever, chills, headache, body ache, brain fog, sensation of havimg neddles all over, stomach pain...
This spontaneous report was received from a medical assistant and refers to an unknown number of patients (age and gender were not reported). Pertinent medical history or drug allergy/drug reactions were not reported. On an unknown date, the patients were inadvertently vaccinated with improperly stored GARDASIL (confirmed not GARDASIL 9) (lot number, expiration date, dose and route of administration were not reported). Concomitant medication was not reported. No adverse effects were reported. It was unknown if the patients sought medical attention. This is one of three reports from the same reporter. Additional information has been requested.
Seen at PMD for adb pain (pt had menses at this time) on 1/30/15. Dx with UTI, started Bactrim and patient was stopped from meds after a few days due to neg urine cx and the patient also was feeling better. On Wed 2/4/15 the abd pain returned and the patient then developed a fever of 102.6 and an all over body rash (non-pruritic). Seen at PMD on that day and was dx with suspect viral illness. Abd ultrasound was also done at the PMD and negative. On Thurs 2/5 the patient came in to the hospital due to dramatic altered mental status and vomiting stomach contents. The mental status worsened throught out hospitalization. Patient passed away.
Patient experienced excessive thirst, appetite and urination 2-3 prior to 9/7/06. Weight loss 11 lbs in 5 weeks. Seen in office and diagnosed with Diabetes. Sent to hospital immediately for hospitalization and work up.
She got her vaccine, it was fine, went to the grocery store, came back home and put up her groceries and felt a little itch, which she didn't think much of as she has dry skin, eczema.  Sunday morning is when the trouble started.  She started itching in the morning and took a Benadryl, called the pharmacy and talked to them and they told her to give it 3 days.  Yesterday, she called rescue yesterday morning and they came and told her to get some cream as she was just using the Benadryl.  Last night about 10:00 PM she could not get the itching to stop and wasn't going to take the Benadryl as it was not working.  She called her doctors office and they told her to see her doctor in the morning, which she did and they are calling in her the steroid cream and prescribed some lotion.    She has had her pneumonia vaccines and flu vaccines with no reactions.
Sense of impending doom started 30 minutes after the vaccination. Racing heart beat, nausea, high blood pressure, vomiting, body numbness, feeling like I was going to die. Repeated panic attacks for 48 hours. Emergency visit, was given Xanax, had a teledoc visit & was prescribed hydrozozine. Still anxious.
2nd dose of SHINGRIX vaccine. Awoke in middle of night with severe, uncontrolled shaking that lasted 5-10 minutes. I have epilepsy and I don't know if what I experienced was a seizure. I finally went back to sleep and the shaking subsided sometime after I fell asleep.
Fall, initial encounter     2. Laceration of forehead, initial encounter    3. Abrasion of both knees
Reaction pertussis; seizures 103 degrees fever throat swelling difficulty breathing. Rx Tylenol.
p/vax pt devel nausea, vomiting, diarrhea; required iv fluids; small lump at inj site;
On Jan 21 my upper arm began swelling and became hard and hot to the touch.  After 2 - 3 days swelling subsided and now there is an area of approximately 4 x 6" that is red, itchy and hot to the touch.
Grandma called to report redness and blistering at injection site.  Child has been "crabby" also.  No fever.  Redness did not start until 4 days after injection.  Injections given on Thursday afternoon and redness started on Monday then fluid filled blisters appeared at site.
About five hours after receiving the vaccine my ears started to ring. At the same time I felt a rush of heat through my body and I became short of breath. But I experience shortness of breath quite often with my asthma so this is not unusual. But the tinnitus has not gone away after over two weeks ofter receiving the shot. I am worried it will get worse if I have a second shot.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/0294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 09-OCT-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
Redness in the injection site; It was also hot to touch; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 3R774, expiry date 8th March 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date and patient did not present symptoms after 1st dose).   On 27th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacist reported that a patient received the 2nd dose of Shingrix on 27th October 2020 and started to experienced redness in the injection site and it was also hot to touch.  Pharmacist said that patient did not present symptoms after the 1st dose. The reporter consented to follow up.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021 at 9:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2021 at 9:43 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  The age of patient was provided as 27.62.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021, Excursion time was 09 AM, temperature was 33, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 27-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 AM: 35, 1PM: 35, 2 PM: 35, 3 PM: 34, 4 PM: 34 and 5 PM: 35.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
c/o right arm & chest with + urticarial patches + 2 cm swelling @ injection site  lungs clear- no wheezing  Given SOLUMEDROL 125 mg IM.  ALBUTEROL NEB TX.  EPI 0.3cc SQ After EPI rash almost completely resolved
Patient's response was suspected to be more directly related to her daughters reaction see VAERS #124194. I treated pt as though it was a reaction to the vaccine. PT received her vaccine approximately 4:35pm and assisted with her daughters vasovagal syncope episode but began to feel lightheaded and faint herself. Pt was able to seat herself and slumped backward in the chair.  Eyes were open and fixed. Pulse was weak in the right wrist and upon evaluation was estimated around 50. We the automatic BP cuff was able to assess PT's vitals the BP was 90/70 and pulse 58.  Pt began to look and interact with the staff after 3-5 minutes and was alert to place and time.  A second evaluation with the automatic BP kit was recorded with 101/79 and pulse of 65. PT noted the lightheaded feeling was going away and was feeling better. At 5:15pm the patient was able to leave on her own without an assistance. At 6:30pm the pharmacy make contact with Pt and discussed the event. No further follow-up with pt was needed or requested.
19SEP94 pt recvd vax & devel macular rash generalized; 19SEP erythematous hives like rash on trunk & extremities;
Following vaccination patient experienced itching and swelling of her eyes which she self treated with antihistamines.  The following day she developed a large lump at the site of injection . Today she called complaining of unusual sternum pain .
Itching, numbness of mouth, scratchy throat, obvious rash over chest, arms, neck, and back.
In July of 2022, I noticed loss of sensitivity of left index finger and right middle finger. I am seeing a doctor on Thursday regarding this. I saw my PCP and they referred me to Neurology.
Case number PHHY2011US69685 is an initial spontaneous report received from a health care professional on 28 Jul 2011. This report refers to a female patient of unknown age group. She was given only the CYW-135 liquid component of MENVEO (batch number: X10051 and expiry date: Jan 2013) intramuscularly on 21 Jul 2011. No other adverse reaction was reported.
Report 2001015262-1 described RA in a pt who rec'd Lyme disease vaccine recombinant OSPA (Lymerix) for the prevention of Lyme disease. This report was rec'd from the pt and has been verified by a physician or other HCP. The pt is allergic to penicillin. Reportedly, he has had colitis for 30 yrs, it was treated with sulfasalazine (Azulfidine). He did not have a history of Lyme disease. His brother had Crohn's disease and his grandfather had arthritis (NOS). In 8/01, the pt rec'd his 3rd dose of Lymerix. Six months later in 2/01, he reported experienced arthralgia's . He reportedly experienced pain in the shoulders traveling to the legs, hips, knees,and ankles. The pt was seen by an arthritis specialist. The pt reported that swollen shoulders, ankles, hips and knees were noted on physical exam. No warm joints were noted and no joint fluid was obtained. Unspecified lab analyses were performed. The pt reported that the specialist recently made a diagnosis of RA and does not feel the symptoms were related to Lymerix. The pt was treated with methotrexate daily (dose unk), Celecoxib (Celebrex) 200mg twice daily, and Prednisone 15mg daily. As of 6/25/01, the event was ongoing. The adverse event RA does not meet ICH serious criteria, but is being submitted as a expedited report by special FDA request per the 6/28/00 letter. The follow-up states that on 06/02/1999, 07/02/1999 and 05/31/2000, the vaccinee received his first, second, and third doses of LYMErix, respectively. On 09/12/2001, the physician stated that the MTP joints of feet were noted to be swollen on physical exam. No warm joints were noted on physical exam. No joint fluid was obtained. As of 09/12/2001, the outcome of the event was unknown. The most recent info was received from the rheumatologist on 11/14/2001. He wrote,"The pt is treated with methotrexate and prednisone for his rheumatoid arthritis which is currently well controlled. He is having no synovitis. His disease has been relatively stable recently."
Narrative:  COVID infection following COVID vaccine series 04/08 Janssen, dose #1 12/27 COVID swab, result: detected 12/27 pt cc: fever, cough, headache, diffuse myalgias, and fatigue exposure: unknown 12/27 pt admit to ED cc: fever, cough, headache, diffuse myalgias, and fatigue DX: Covid - 19 LOS: 1 day 12/30 SARS-COV-2 Variant Sequencing: pending