chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SHAKING UNCONTROLLABLY; WOKE UP IN THE MIDDLE OF THE NIGHT; FEELING BOTH HOT AND COLD; AWFUL; TEETH CHATTERING; TERRIBLE FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) 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 shaking uncontrollably, woke up in the middle of the night, feeling both hot and cold, awful, teeth chattering, and terrible fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shaking uncontrollably, woke up in the middle of the night, feeling both hot and cold, terrible fever, teeth chattering and awful was not reported. This report was non-serious.
She later said it made her arm hurt.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Jul2021 (Lot number: EW0185) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "low potassium" (unspecified if ongoing), notes: She takes medication for low potassium. She also takes a water pill. She does not know the names. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "She later said it made her arm hurt.". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
pericarditist; dizziness; block head; muscle pain/ body aches; soreness in the injected arm; fever; tiredness; flu like; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERICARDITIS (pericarditist) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis since 1999, Blood pressure high since 2000 and Food allergy (lobster, crab). Concomitant products included AMLODIPINE and QUINAPRIL for Blood pressure high, METHOTREXATE for RA, IBUPROFEN for Rheumatoid arthritis, FOLIC ACID for an unknown indication.   On 26-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2002, the patient experienced INFLUENZA LIKE ILLNESS (flu like). On 24-Feb-2021, the patient experienced DIZZINESS (dizziness), MYALGIA (muscle pain/ body aches) and VACCINATION SITE PAIN (soreness in the injected arm). 24-Feb-2021, the patient experienced HEAD DISCOMFORT (block head), PYREXIA (fever) and FATIGUE (tiredness). On 10-Apr-2021, the patient experienced PERICARDITIS (pericarditist) (seriousness criterion hospitalization). The patient was hospitalized from 10-Apr-2021 to 11-Apr-2021 due to PERICARDITIS. On 25-Feb-2021, INFLUENZA LIKE ILLNESS (flu like), DIZZINESS (dizziness), HEAD DISCOMFORT (block head), MYALGIA (muscle pain/ body aches), VACCINATION SITE PAIN (soreness in the injected arm), PYREXIA (fever) and FATIGUE (tiredness) had resolved. At the time of the report, PERICARDITIS (pericarditist) had resolved.            The patient did not seek medical attention for the events that occurred on 24 Feb 2021.   On 10 Apr 2021, the patient was hospitalized overnight with "pericarditist from unknown source".  Treatment information for this event was not provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot e excluded.   This case was linked to MOD-2021-026045 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Case upgraded per hospitalization for event of pericarditis.  Patient completed the vaccine adverse event reporting form.  Multiple fields updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot e excluded.
Initial report received from the pharmacist on 20 May 2010: This patient was bitten by a skittish house cat in the left hand on 16 May 2010. He began to develop cellulitis around the wound and for the treatment of which the patient was hospitalized on 18 May 2010. On 19 May 2010 (at around 10:00), the patient was vaccinated with first dose RABAVERT (batch number: unknown) dose unspecified intramuscularly in the left arm. On 19 May 2010 (10:30), the patient also received two injections of Human Rabies immune Globulin, total 06 ml in the right arm. On 19 May 2010 (at 14:00), the patient went in to the surgery for treatment of cellulitis at wound site (left hand). It was reported that, during surgery 05 mg HRIG were infiltrated around the wound & an additional 1.6 ml of HRIG was administered intramuscularly to the left arm, which was the same as the RABAVERT administration. The outcome of the event surgery was not reported.
Client described feeling abdominal pain, burning all over, bleeding and headache on Saturday.  Went to Emergency room on Sunday and after receiving treatment felt better. Monday, May 11, 2010, client reported (on phone) that she still felt ill- fatigue, abdominal pain, unble to eat or drink.  Client instructed to go to ER again today and to Ob/GYN appointment tomorrow.
This case was reported by a pharmacist via call center representative and described the occurrence of kidney transplant rejection in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced kidney transplant rejection (serious criteria GSK medically significant). On an unknown date, the outcome of the kidney transplant rejection was unknown. It was unknown if the reporter considered the kidney transplant rejection to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The healthcare professional was a retail pharmacist. The healthcare professional stated receiving a call regarding the administration of SHINGRIX to the patient who had an organ transplant. The healthcare professional stated that a staff member at a physician's office stated that the patient there recently lost their kidney transplant due to receiving a shingles vaccine but that the patient also had multiple other issues that likely led to the loss of the kidney transplant. The healthcare professional did not have access to this patient, did not know this patient. Retail pharmacy did not administer this vaccine. The healthcare professional did not have any additional information to document for this adverse event. No vaccine or patient information available, only information was received by the healthcare professional in passing conversation over the phone while discussing the different patient.
Had mammogram the next week and got false reading because of swollen lymph node; This non-serious case was reported by a consumer and described the occurrence of swollen lymph nodes in a 72-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 08-SEP-2023, the patient received RSV vaccine. On 12-SEP-2023, 4 days after receiving RSV vaccine, the patient experienced swollen lymph nodes (Verbatim: Had mammogram the next week and got false reading because of swollen lymph node). On 04-OCT-2023, the outcome of the swollen lymph nodes was resolved (duration 22 days).   It was unknown if the reporter considered the swollen lymph nodes to be related to RSV vaccine.     It was unknown if the company considered the swollen lymph nodes to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 27-OCT-2023 The patient self-reported this case. This report was submitted via the online direct entry reporting system.  The patient received RSV vaccine and had mammogram the next week after vaccination and got false reading because of swollen lymph node. The symptoms were treated. The reporter gave permission to contact her.
Moderna COVID-19 Vaccine EUA administered.  Observed at facility for 30mins, with nly soreness at injection site present.  Itchiness, Urticaria, tachycardia, and shortness of breath/wheezing developed approximately 45min-1hr after administration of vaccination and slowly got progressively worse.  Minimal relief of symptoms after taking 50mg liquid Benedryl PO and prescribed rescue Albuterol Inhaler.  Epi pen administered and symptoms improved, other than minor itching.  Medical evaluation obtained at urgent care center for anaphylactic reaction.
Ichyness on tonsils and back of nasal passage similar to inhaling vapors from spicy food.  Popped blood vessel in left eye small pink area around bottom of retina. Eye still has vision
REDNESS AND SWELLING AT THE SITE OF INJECTION. OVAL AREA OF ERYTHEMA MEASURING 9X12 CM ON RIGHT THIGH SEEN TODAY.
This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 04-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Patient received Johnson & Johnson COVID -19 vaccine on 4/12/21. On 4/16/21, patient presented with elevated blood pressure and some tingling in her arm. Patient reported fever and body aches for about 2 days after received the vaccine. Per ED visit, provider documented this was a reaction related to COVID vaccine. File this incident for record keeping.
pain in the sternum; Vertigo; Dizziness; headache; pressure in sinuses & ears; pressure in sinuses & ears; tinnitus worse; blurry vision; body aches; joint aches; fatigue (especially hard getting out of bed in the morning); brain fog; problem concentrating; tingling in my foot on injection side; nausea; calves occasionally feel like popcorn popping; legs go weak; shortness of breath when walking; This is a spontaneous report from a contactable consumer or other non hcp (herself).   A 56-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0196 and expiration date was not reported), via an unspecified route of administration, administered in right arm on 16Jul2021 (Age at vaccination was 56 years) as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have covid prior to vaccination. The patient's concomitant medication(s) included clonazepam (CLONOPIN), buspirone hydrochloride (BUSPAR), loratadine, pseudoephedrine sulfate (CLARITIN-D), sertraline hydrochloride (ZOLOFT) all taken for an unspecified indication, start and stop date were not reported. The patient previously took cephalexine and experienced drug hypersensitivity. The patient did not take any vaccine in four weeks. On 28Jul2021 the patient experienced pain in the sternum, vertigo, dizziness, headache, pressure in sinuses & ears, tinnitus worse, blurry vision, body aches, joint aches, fatigue especially hard getting out of bed in the morning, brain fog, problem concentrating, tingling in my foot on injection side, nausea, calves occasionally feel like popcorn popping, legs go weak, shortness of breath when walking. The patient also stated that while some of these effects were getting better/less severe, there are many still effecting my daily life. The patient have not driven since this started. Doctors did not think it was anything to worry about. The patient extremely worried that I will not get back to normal and am very afraid to get the second shot. The patient was sensitive to medication and have often wondered if a lesser dosage would have been a better option for people like me. The patient underwent lab tests and procedures which included polymerase chain reaction with nasal swab having result negative on 01Aug2021 and on 08Aug2021. The patient did not receive the treatment. The outcome of event was not recovered.  No follow up attempts are needed . No further information is expected
Itchy hand, wrist and ankles, small lumps 50+ size of pea or smaller started 6 days after vaccination.  Continued 4 more days (today) as they turned red, blistery, bubbled, popped, skin pealed on the larger areas (less than the size of a dime). Moved up to shoulders, and on legs up to thighs.  Possible one on tongue.  Antihistamine will take down the itchiness although initially adding Benadryl too.
Severe itching both sides of both hands, plus both Elbows; Initial information was received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional under reference number - US-SA-SAC20211015000955  This case involves a 74-years old female patient who experienced severe itching both sides of both hands, plus both elbows (pruritus), after receiving vaccines BOOSTRIX and INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  Concomitant medications included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  On 27-Sep-2021 at 11:45 AM, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] (lot number and expiry date not reported) via an unknown route in the left arm for prophylactic vaccination.  On 27-Sep-2021 at 11:45 AM, the patient received a dose of suspect BOOSTRIX not produced by Sanofi Pasteur (lot number and expiry date not reported) via an unknown route in the left arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious severe itching both sides of both hands, plus both elbows (pruritus) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] and BOOSTRIX VACCINE.  It was unknown if the patient experienced any additional symptoms/events  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, event outcome was unknown.  There will be no information available on batch number for this case.
Breakthrough case of Covid 05/15/2022 I started with sx of headaches, loss of taste and smell, stuffiness, my ears were plugged up , cough, aches and a lot of fatigue.  It got better on Saturday it got pretty good and it's better everyday and I think I coughed once today.  I did not have side effects from any of the vaccinations I got.
red raised rash on face, head (in hair), neck, back & spreading down to waist line & buttocks & groin & now to upper legs;
Headache, Myalgia, Palpitations CHILLS, FATIGUE, LOSS OF APPETITE Narrative: STAYED HOME FROM WORK DUE TO SYMPTOMS
Patient reports that she was given the flu vaccine to upper right arm (about less than 1 finger below the acromion process and off to the side), and 6 to 7 hours experienced significant pain to the point that she could not raise her arm above the lower clavicle areas. She trying to do range of motion with right arm and took NSAIDS around to clock since 10/4/23.
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  The Nurse is providing information for 35 patients. A vial at their clinic was punctured 30 times
vaccination was given after 12 hour expiration time out of fridge.  called manufacturer, they said vaccination should still be viable due to proper container, proper temp, and use of aseptic technique, and given within a 24-hour period.
lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded to the point of nearly passing out; cold sweat; loss of appetite; pain in upper shoulder/back area; pain in upper shoulder/back area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL-9265), via an unspecified route of administration on 29Jan2021 12:30 in left arm, at single dose for covid-19 immunization. Medical history included chronic low BP, hypothyroidism, HRT, nasal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), multivitamin NOS (MULTIVITAMIN). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and known allergies: Augmentin, being treated for nasal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, general feeling of being unwell, lightheaded to the point of nearly passing out; cold sweat, loss of appetite, pain in upper shoulder/back area, on 01Feb2021 06:30. No treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
G40.109 PARTIAL EPILEPSY 2/2/2023 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 5/2/2023 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN I82.409 ACUTE DVT, UNSPECIFIED VEIN 4/21/2023 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN
Upon re-evaluation of the case on 10 February 2015, the case was upgraded to serious from non-serious. Based on the follow-up information received on 19 Dec 2014, this case initially considered as serious was downgraded to non-serious. Initial unsolicited report received on 02 December 2014 from a nurse practitioner.  An 8 year-old female patient, with no reported medical history, had received an intramuscular dose of FLUZONE QIV (batch number and site of administration not reported), on an unspecified date. Four hours post vaccination, the patient developed a large red area at the injection site. She also experienced vomiting, facial and lip swelling as well as SOB. She was taken to the ER. Concomitant therapies, corrective treatment and complementary investigations were not reported. The patient recovered from the events on an unspecified date. Document held by senders: none. Based on the follow-up information received on 19 Dec 2014 and upon medical review the case is downgrade serious to non-serious due to other medically important condition. Follow-up information received from healthcare professional on 19 Dec 2014. Patient was vaccinated at 4 PM and experienced hives at 8 PM and eye swelling, facial swelling, lip swelling, hypersensitivity to FLUZONE vaccine, SOB which required emergency doctor visit. Patient concomitantly received Flintstones vitamins and Benadryl as needed. Skin test was positive for vaccination and formaldehyde test was performed and result awaited. Skin test was positive for vaccination and formaldehyde test was performed and result awaited. Patient was treated with Benadryl, Steroid (oral) and prednisolone. Follow-up information was received from this unsolicited case on 10 February 2015 from a healthcare professional. Upon medical review of the case, the case was upgraded to serious due to seriousness criteria other: important medical event. Patch testing to formaldehyde was also negative. The reporter was unable to determine what part of the vaccine she was sensitive to based on ingredient list online and would like a more comprehensive list for evaluation. Follow-up information received for this unsolicited case on 23 March 2015 from a healthcare professional. The patient was seen on 18 November 2014 and had recovered from the events (exact date of recovery was not provided). He had received the vaccine in October (no details). Results from allergy testing came back negative for formaldehyde and for FLUVIRIN. The patient was still continuing his treatment for Flintstones multiple vitamins and Benadryl without difficulty. Documents held by sender: none. Follow-up information received from a Physician on 7-May-2015. There was no other vaccination 4 weeks prior to the vaccination date. It was reported that the patient was tested negative for FLUVIRIN so the allergen was assumed to be in FLUZONE and FLUVIRIN. The formaldehyde test was negative. She continued to take the test without difficulty. She continued to take Benadryl and multivitamins as corrective treatment without difficulty. The patient had recovered from the events on 18-Nov-2014.
Soreness at the injection site turned to a warm welt. Over 48 hours later, the welt is still warm and is distractingly itchy. The welt is about 1.5 inches in diameter.
Patient reported nausea, chills, headache, throbbing arm and armpit, tender to touch, tight chest relieved by nebulizer.  Patient encouraged to continue taking Tylenol or Motrin and use cold compress.
Fever 101-102 for 3 days. Treated with Tylenol and ibuprofen.  Follow up: No site reaction.
onlydiluent portion was used; only the diluent portionwas administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA756A, expiry date 31st October 2023) for prophylaxis.   On 15th December 2022, the patient received Menveo. On 15th December 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 16-Dec-2022 Reporter's comment: The reporter consented to follow-up via postal. Additional supportive information: The patient received only diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.