chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She said they give this vaccine to pregnant women with no AE; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (exposure during pregnancy). Data regarding this pregnancy were received prospectively. The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, (unknown latency) the patient was exposed to dose of suspect INFLUENZA QUADRIVAL A-B VACCINE prefilled syringe [lot UJ471AB and Expiration date unknown] via unknown route in unknown administration site for prophylactic vaccination (exposure during pregnancy) with no adverse event.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Not Applicable.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Pt complains of soreness across her shoulders and very fatigued. Legs feel weak. Also complains of HA.
Pt received varicella vaccine to (R) upper arm on 11/29/14. She reports that on 11/29/14 she developed pain to site of injection and a painful rash on 11/30/14. Pt seen in clinic on 11/30/14 and dx with varicella rash at site of injection. VALTREX rx to alleviate symptom.
Began experiencing severe arthritic-type pain in my hips, several months after receiving 1st and 2nd doses of Lymerix.
request information about the presence of saliva discoloration; itchiness after an administration of a dose of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of saliva discoloration in a 88-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number ET5FD, expiry date 07-DEC-2024) for prophylaxis.   On 16-SEP-2023, the patient received the 1st dose of Arexvy. On 16-SEP-2023, less than a day after receiving Arexvy, the patient experienced saliva discoloration (Verbatim: request information about the presence of saliva discoloration) and pruritus (Verbatim: itchiness after an administration of a dose of Arexvy).  The outcome of the saliva discoloration and pruritus were unknown.   It was unknown if the reporter considered the saliva discoloration and pruritus to be related to Arexvy.     It was unknown if the company considered the saliva discoloration and pruritus to be related to Arexvy.   Additional Information: GSK receipt date: 02-OCT-2023 A pharmacist called in to request information about the presence of saliva discoloration and itchiness after an administration of a dose of Arexvy.  Partial information given. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
received their 2nd dose 8 months later; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in 2021, 8 months before receiving 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 8-Jun-2022 Reporter's Comments:  HCP reported that patient came into pharmacy after their doctor told them that they might need to receive a 3rd dose of Shingrix because they received their 2nd dose 8 months later. No reactions reported. The reporter consented to follow up via email. Additional Supportive Information: The patient received 2nd dose of Shingrix, 8 months after receiving 1st dose, later than the recommended standard interval, which led to lengthening of the vaccination schedule.
This health authority case was initially received on 26-Oct-2015. The case report was received from a Health Professional and concerns a 26 years old female patient. The patient disclosed no illness or illness at the time of vaccination. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFULRIA for indication not reported on 26-Aug-2016- unknown stop date, Batch no: U55806, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): BOOSTRIX, Indication: not provided. Reaction (s)/event (s) and outcome: On 26-Aug-2015, 1 day after starting/treatment with AFLURIA the patient experienced soreness of upper left arm (injection site)/Injection site pain (non serious, outcome: Unknown), X-ray limb normal (non serious, outcome: Unknown). Event treatment: The patient was taken to a walk-in clinic and prescribed a MEDROL dose pack on 04-Sep-2015. The patient underwent an X-ray which revealed no damage to bone or surrounding area. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: other medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took Paxlovid (start date and stop date: May2022) the day patient received a positive COVID test in May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax 29APR98 & 30APR98 pt devel 3"x4" wheal @ the inj site; 2 days later pt recovered;
Client reported dizziness and dry mouth. Reported having swelling in mouth, but no observable swelling. Taken to treatment area, put in wheelchair. Vital signs taken. Pulse oximetry 97 % on room air.
Hives, rashes, itching and dermatographia started 9 days after Moderna booster. The morning after, 100% of my back was red. I started taking Claritin and Zyrtec. Symptoms developed on my scalp to my toes. Everyday, throughout the day, they appeared in different areas of my body. Symptoms were severe for 3.5 weeks. I am now itching at various parts of my body from head-to-toe. This moves everyday. The spots where I itch or rub too hard, turn into red rashes (dermatographia). The redness lasts for 1 to several hours. I took Claritin once a day for 1.5 months. The last two weeks, I have been taking Claritin once every 2 days. Itching, rashes and dermatographia still occur everyday throughout the day and move over various parts of my body.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The nurse reported that since 17-OCT-2014, the patient was vaccinated with a dose of PROQUAD (Merck) (dose and lot # not reported) subcutaneously that was improperly stored. This was supported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
The patient is currently not having any symptoms or complaints; intramuscular injection into their thigh instead of the proper subcutaneous administration in the back of the arm; This spontaneous report was received from a registered nurse and refers to a 12-month-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 19-FEB-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T024283, expiration date: 15-JUL-2022) and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S028914, expiration date: 16-SEP-2021) both 0.5 milliliter, intramuscularly injection into their thigh instead of the proper subcutaneous administration in the back of the arm for prophylaxis.  The patient was not having any symptoms or complaints.
Starting at 1 hour post injection: severe headache, fever, vomiting, hives covering left arm Resolved at 72 hours post injection
Runny and itchy eyes which progressed to palm and sole itching, an urticarial rash, eyelid angioedema and subjective swelling in the back of her throat.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020). On 23rd May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site warmth and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site warmth and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. Beginning on an unknown date, the patient began to experience erythema, swelling, warm to the touch, and pain to the touch at the injection site. Further described as, the size of a softball, worsening, and starting to go around the patient's arm. The patient did not require any hospitalization, emergency room or doctor's visit, and the symptoms were not considered life threatening or disabling.
Information has been received from a nurse and/or physician concerning an 18 month old male who was vaccinated SC with a 0.5ml dose varicella virus vaccine live at 12 months of age (in approximately April 2004). Subsequently, the patient became deaf 6 months after vaccination (in approximately October 2004). Unspecified medical attention was sought and the patient's family thinks it could be from the vaccine. It was reported that the patient did not recover though he is presently seen by another pediatric practice. At the time of this report, April 2005, the child was believed to be about 2 years old now. No product quality complaint was involved. Upon internal review, deafness was considered to be an other important medical event (OMIC). Additional information has been requested.
A 47 year old female patient with a history of migraines received an initial dose of Adacel (lot number C3097AA) intramuscular in the left Gluteal and HAVRIX (manufacturer GSK, lot number AHAV3251DA) Intramuscularly in the right gluteal on 24 April 2009. Concomitant therapy included Topamax and Maxalt. On 25 April 2009 the patient had vomiting, a temperature of 100, chills, diarrhea, and fatigue. The patient had a large, tender, red lump in the left gluteal area. On 28 May 2009 the patient had a doctor's visit, however details were not provided. On 01 May 2009 the patient called the reporter to state that she was getting better. The recovery status was reported as unknown. On 28 May 2009 the patient is scheduled for a doctor's visit.
-Deep dark pox, measuring 2cm across in Left Upper Arm. Circumfrential erythema measured 3-4cm around pox. -Papules/Pustules noted at edges of latex bandage -Separate, 4x5cm area of red, raised,"itchy" rash, mid-upperarm, below vaccination site.
pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma exercise induced (more of a problem in childhood). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 26-Jun-2021. On 29-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 29-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.  The patient's previous pregnancy included a full term birth on an unknown date.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Mother called to report that the day after the varicella vaccine 1 inch below the injection site developed blotchy redness down the width of his R arm down to elbow and that area is warmer than the surrounding skin, not hard. Tender only at injection site. Able to use his arm wnl. Mom states has remained the same since 1st noticed 08/07/08.
weak; hurt in the back of her neck; cold sweats; feels like she was going to die; nauseated; threw up; body aches; sick all night; fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick all night), COLD SWEAT (cold sweats), FEELING ABNORMAL (feels like she was going to die), ASTHENIA (weak) and NECK PAIN (hurt in the back of her neck) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN A [RETINOL] and PROBIOTICS NOS for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (fever). On 06-Feb-2021, the patient experienced ILLNESS (sick all night) and MYALGIA (body aches). On 08-Feb-2021, the patient experienced COLD SWEAT (cold sweats), FEELING ABNORMAL (feels like she was going to die), NAUSEA (nauseated) and VOMITING (threw up). On 09-Feb-2021, the patient experienced ASTHENIA (weak) and NECK PAIN (hurt in the back of her neck). At the time of the report, ILLNESS (sick all night), COLD SWEAT (cold sweats), FEELING ABNORMAL (feels like she was going to die), ASTHENIA (weak), NECK PAIN (hurt in the back of her neck), MYALGIA (body aches), PYREXIA (fever), NAUSEA (nauseated) and VOMITING (threw up) outcome was unknown.
Severe fatigue onset at approx 23 hours post-injection. Nausea onset at approx 44 hours post-injection. Treated with rest and ginger ale.  Symptoms persist 75 hours post-injection.
Received second booster dose from a vial that was already expired.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received second booster dose from a vial that was already expired.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received second booster dose from a vial that was already expired.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received second booster dose from a vial that was already expired.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Patient received second booster dose on 11-APR-2022. HCP explained that all the previous doses that the patient received were from Moderna and that the patient had not reported any side effects. Treatment details was not reported by the reporter.
Flat, red rash and spots on chest; increased in 24 hours; resolved without treatment
Patient received the incorrect second dose. Patient should have received Pfizer 2nd dose but the vaccinator made an error and administered the moderna vaccine.
Pt recvd 3 doses of Engerix-B & did not convert; Pt recvd 2 booster doses of Hep B (last booster about a month ago) & 2nd titer (1 wk ago) still neg;
Day 2 deep red circle about 2 inch. Swollen Hurt to touch, very hot. Last 3 days. On 7th day same circle but darker red, very hot to touch, itchy, very hard.
Initial and follow up information has been received from a medical assistant concerning an 18 year old female who in approximately February 2008 (also reported as 2 months ago), was vaccinated with her first dose of GARDASIL (Lot #, site and route not reported).  On 24-APR-2008 the patient was at the physician's office for her second vaccination with GARDASIL and noted that she was one day late for her menstrual period.  A urine pregnancy test was performed which was negative.  The patient was not pregnant, so the second dose of GARDASIL (Lot #, site and route not reported) was administered.  The patient sought unspecified medical attention when she was seen by the physician.  The patient's outcome was not reported.  No further information was provided.  Additional information has been requested.
Heart beating faster and not a regular rhythm.  Felt like missing beats, and gradually slowing.  Shortness of breath upon minimal exertion.  Took diltiazem and ingested soy milk to increase Mg+2 and K+.  As of time report being submitted, symptoms are residing but not completely gone.
Information has been received from a physician concerning a male who on 30-JUL-2008 was vaccinated with the first dose of ROTATEQ (lot #660681/0210X).  Concomitant suspect vaccine therapy included a dose of PEDVAXHIB (manufacturer unknown) and a dose of RECOMBIVAX HB (manufacturer unknown).  Other concomitant vaccine therapy included a dose of DTAP, IPOL and a dose of PREVNAR.  It was reported that the patient was admitted to the hospital and operated on immediately for intussusception (on an unspecified date between 30-JUL-2008 and 24-SEP-2008).  The patient has recovered (date not reported).  Additional information has been requested.
Shot was administered then several hours later patient's muscles started cramping up around neck through shoulders. By Tues morning she was confused. Had trouble focusing. By 12:00 PM Tues she started to shake and a fever developed and she was having a hard time breathing. 3:00 PM we took her to the emergency room where her fever spiked close to 104.0. She was having a hard time breathing. She was given intravenously ADVIL, TORADOL, ZOFRAN, Sodium Chloride and TYLENOL (orally). Patient also had an xray which shown she developed pneumonia in her RT lung. Patient has not had a cold, flu, running nose, sneezing, coughing etc. prior to these vaccinations. She was sent home with azithromycin for 5 days. Patient has not developed anything that would lead to this being the start of a cold. She was also tested for influenza A, B, AG screen, basic metabolic panel, complete blood count with auto diff, IP Post urine pregnancy, mono, procalcitonin, strep A, strep plate, urinalysis with reflex to culture. These test were normal. CR chest single view 71045 showed pneumonia.
patient developed a hive on right arm (opposite to arm it was given). patient was given 50 mg of diphenhydramine and observed for 30 additional minutes (about 45 minutes in total). Hive started to disappear
Day after vaccine given. 5 inch swollen area to vacc. admin. site (Lt thigh), reddened, sore, h/a, achy - just felt bad x 5 days - in bed, took BENADRYL, ice pk, & TYLENOL.
8/8/12 received telephone call from mom stating child's arm swollen, hot, and red from elbow to shoulder.  States looks "burned" has a hard knot in it with a small red dot in center. Instructed mom to have child evaluated by pediatrician or ER. Mom took child to ER 8/8/12. Diagnoses with cellulitis vs arteritis reaction.  Given antibiotics, steroid cream, and Benadryl.  8/9/12 Nurse spoke with mom who states am not any better. Informed may take 2-3 days to improve. Mom states will follow up with phone call to report child's status.
12/3/2022 Felt like getting a cold, headache, cough sore throat.  Tested with At Home COVID-19 Test, positive on 12/6.  Televisit with Doctor who proscribed Paxlovid and to treat symptomatically.  Symptoms gradually diminished until about 12/13.
December 2022,  mainly pain in the lower abdomen area and the discomfort from the middle section, up to my lower back, on the left-hand side.  The discomfort became worse in January 2023, I could not sit down. I could not put pressure on that side. I could not lie down on my back because it was uncomfortable. That is when I decided to see my doctor. I went to see the nephrologist and then I went to see my primary care and he referred me to the urologist.  My nephrologist told me my kidney function was fine. My gastroenterologist found a UTI in December 2022. She ordered a lower CAT scan of my stomach which I had on 2/2023 I was told I had a UTI. I was put on another antibiotics, Cipro. The CAT scan showed I had a cyst on my kidney.  I was put on Herbal supplement, D-mannose and they changed my probiotics. The Herbal supplement, D-mannose, help manage, keeping my bladder clean so I do not have another UTI. I have had 3 UTI's since December 2022. The first UTI I had ever had in my life was in 2016.
ARM PAIN; HUGE HEADACHE; MINI FEVER; This spontaneous report received from a patient . The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 07-JUL-2021, the subject experienced arm pain. On 07-JUL-2021, the subject experienced huge headache. On 07-JUL-2021, the subject experienced mini fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain, huge headache, and mini fever. This report was non-serious.
Menstrual cycle disruption - Received shot 4/8, started spotting 4/10.  Started period 4/12.  Lasted until 4/16.  Then started spotting again on 4/24, spotting continues to today 4/29, where started period-heaviness bleeding again this morning.