chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, anatomical location and route of administration were not specified), as prescribed and/or administered by a physician for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a health care provider for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was reported as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
16JUN93 had sz, eyes rolled back, lips went blue; jaw clamped down, hands were in fists; lasted 45 sec; took to ER via ambulance;
BUD date excursion, BUD date was 4-7-23 and vaccine was administered. 4-21-23.
Hurt as bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Hurt as bad). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the first of two shots on the ninth, hope the second shot don't hurt as bad as the first one. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
I am coughing out a lot of mucus; Sneezing; mucus /I am coughing out a lot of mucus; Headache; My arm was hurting; My body felt hot but I didn't have temperature; Chills; Feeling lousy; Light-headed/dizzines; Ache; This is a spontaneous report from contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EWASL) via unknown route of administration at left arm on 15Apr2021 (age at vaccination 56-year-old) as single dose for COVID-19 immunisation. The patient medical history included hysterectomy on 08Mar2021 and concomitant medications were reported as none. On an unspecified date in Apr2021, the patient experienced headache, dizziness/light-headed, ache, feeling lousy, chills, my arm was hurting, my body felt hot but didn't have temperature and after fourth day on 17Apr2021, sneezing, the patient coughing out a lot of mucus. The patient received treatment included Tylenol and Motrin. The second dose was scheduled at 06May2021. The outcome of the event I am coughing out a lot of mucus, sneezing was not recovered and outcome of the other events was unknown.   No follow-up attempts are needed. No further information is expected.
low platelet county, abdominal pain, excessive bleeding of gums with dental visit, petechial of lower extremities.
Approximately 10 hours after receiving the second shot of the Pfizer COVID 19 vaccine, I started to experience 'ringing' or a 'buzzing noise in my ears.  The noise has been CONSTANT / never ending since that time, which has been over 4 months.
I lost my taste 5 days after receiving my 2d covid 19 vaccination; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on unspecified date as single dose for COVID-19 immunization. The patient lost his/her taste 5 days after receiving the 2nd dose of COVID-19 vaccination on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible; information on batch/lot number cannot be obtained. No further information expected.
9pm same day. Body felt like it was on fire. Couldn?t feel hands/arms/ legs. Everything was tingling and felt like I was getting burned. Could not stand or walk. For 6 hours. Called ER and they gave no guidance. I then had a 103 fever that did not go down for 6 hours despite taking Tylenol and Advil.  Next day symptoms lessened but had to take 2 days off of work due to fatigue and skin tingling.
local rxn rt thigh 1x1cm redness, swelling;no tenderness;no other sx;
ADR: decreased HR, decreased BP, and Altered mental status Treatment: Benadryl and EPI Pen Outcome: Resident was not transferred and remains in facility
Swelling at site, with erythema and increased warmth and pain, along with vesicles in area of vaccine site. Seen by dermatologist also, not zoster.
C/o light headedness, declined option to lay down with feet up, sat and drank water, vitals stable, pt opted to leave after 5 min of "feeling better"
The day after the vaccine on 03/25, had some mild pain left arm where vaccination received that went away after 2-3 days. Today, on day 12 I've started experiencing significant pain in my left arm, radiating down from shoulder and numbing my fingers, and  where and RED RASH  that are also itchy, several spot on left arm.
Hives developed 6 days afterward, treated with BENADRYL with resolution on 2 different occasions. Child developed cold 2 days after hives.
No adverse event; Dose of PROQUAD was administered to the patient on 10AUG2022 after experiencing a temperautre excursion.; Spontaneous information has been received from a medical assistant regarding a patient of unknown age or gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) experiences temperature excursion during 30 minutes with a temperature of 18.6-degree Fahrenheit. This vaccine had experienced a previous temperature excursion of 30 minutes at 9.8-degree Fahrenheit.  On 10-AUG-2022, the patient received measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (valid lot # U031560 with expiration date on 06-APR-2023) 0.5 mL as prophylaxis (route of administration was not reported). No additional information or adverse events were reported.   This is one of several reports from the same reporter; Sender's Comments:  US-009507513-2208USA005325: #02224322 US-009507513-2208USA004819: US-009507513-2208USA004963: US-009507513-2208USA005325: US-009507513-2208USA005345:
trouble lifting arm; pain in arm; Rph said there was only maybe 1 drop of blood at site when she did the injection; Initial information received on 17-Jan-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 57 years old female patient who experienced rph said there was only maybe 1 drop of blood at site when she did the injection (vaccination site haemorrhage), pain in arm (vaccination site pain) and trouble lifting arm (mobility decreased), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Nov-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ311AA (Expiry date 30-Jun-2020) via intramuscular route in the left arm.  On 20-Nov-2019, the patient developed a non-serious rph said there was only maybe 1 drop of blood at site when she did the injection (vaccination site haemorrhage) same day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient developed a non-serious pain in arm (vaccination site pain) and trouble lifting arm (mobility decreased) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Detailed laboratory examination was not provided.  Final diagnosis Vaccination site pain, Mobility decreased and Vaccination site bleeding.  An anti inflammatories use as corrective treatment.  The event outcome is reported as Not Recovered for pain in arm, as Unknown for trouble lifting arm and as Unknown for Mobility decreased and Vaccination site bleeding.
pt recv vax 10AM on 8OCT98 approx 1045AM felt hot & itched-generalized;reported to med clinic @ work & recv treatment;returned to work p/leaving med clinic;
Mid-grade fever until Ibuprofen broke the fever, Red eyes, Overly tired, Very fussy,
Employee presented to employer seasonal flu vaccination clinic. Requested/inquired if vaccine was "preservative free" confirmed vaccine "preservative free". Received vaccination 10/02/09 at 0900, around 10:00 AM experienced sore throat - scratchy feeling - slight tightness. Took BENADRYL 50 mg P.O. with relief of symptom.
Information has been received from a pharmacist referring to a patient of unknown age and gender. In the Fall of 2014 (approximately in September 2014), the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot# unknown). On an unknown date the patient developed a severe injection site reaction. The patient made an office visit, was evaluated by an unspecified physician and was prescribed unspecified corticosteroid medication. The outcome of injection site reaction was reported as recovered on an unknown date. Additional information is not expected as the reporter refused to be contacted.
Information has been received from a Registered Nurse (R.N.) concerning an 87 year old female with an allergy to BENADRYL and a history of chickenpox and all childhood diseases, who on 24-JUL-2007 was vaccinated subcutaneously in the left arm with a dose of 0.65 milliliters of Zostavax (Oka/Merck) (Lot #656858/0356U).  Concomitant therapy included hydrochlorothiazide (manufacturer unknown), simvastatin (manufacturer unknown), omeprazole (MSD) and PREMARIN.  On 06-AUG-2007 prodromal symptoms began and she developed 40+ vesicles (previously reported as 09-Aug-2007).  The patient experienced a varicella like rash on both legs buttocks and arms, upset stomach and didn't feel well.  The lesions were extremely itchy.  As of 13-AUG-2007, the patient was recovering.  Follow-up information received from nurse indicating that the patient was enrolled in a program to identify of VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  The date that the herpes zoster was diagnosed and sample of the lesion was collected from a vesicle on 14-AUG-2007.  Follow-up results indicate the sample of the lesion was collected on 14-Aug-2007.  The sample was taken from a vesicle.  the PCR results for the specimen from the vesicle was negative for both the wild type varicella zoster virus and the vaccine strain virus. Follow-up information received indicates that the patient is a retired female. She was vaccinated on 24-JUL-2007 with a first dose of ZOSTAVAX. There was no illness at the time of vaccination. On an unspecified date, the patient recovered.  No more information is expected.
pain in arm after injection, red raised rash 4x4 inches 2 days later,  3 days later the redness had improved but the area was tender with a hardened area at injection site.  patient called her doctor about this  but  never made an office visit that was noted.
Breakthrough case admission after 3 vaccines Moderna 2/9/21 lot# 031L20A;  Moderna 3/9/21 lot# 032M20A;  Moderna 10/27/21 lot# 076C21A
Initial unsolicited report received from a nurse via phone on 14-SEP-2018. This case involves a 3 year 8 months male child who was vaccinated with 0.5 ml (25 gauge needle 1 inch in size) expired dose of PENTACEL (batch number C5421AA, expiry date 02 Sep 2018, intramuscularly in left thigh (Left vastus laterus) and diluent (lot number C5230AA, expiry date 02 Sep 2018) on an unspecified date. It was a case of actual medication error as expired vaccine used. It was reported patient did not go to Emergency room. 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 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. Documents held by sender: none.
Patient's left arm felt stiff the night after the injection. The next morning she was not able to move her arm due to pain. Two days after the injection, patient noticed erythema, swelling and warm at the injection site. She rates the pain as 10/10 the day after the injection and 7/10 currently, 4 days later. She also states that her left upper eyelid was swollen the next morning after the injection. No conjunctivitis, discharge or erythema around the eyelid noted. Nasal congestion present. Patient reported to doctors office on 3/6/17.
Developed newly diagnosed autoimmune hemolytic anemia requiring hospitalization and blood transfusion. Anemia started shortly after second dose and was hospitalized about 12 days after 2nd dose.
Aches, nasal congestion, feeling of heaviness on chest, difficult to take deep breaths.
PATIENT REPORTS: SEVERE HEADACHE LASTING SEVERAL DAYS, HOT/RED/BURNING RASH ON ARM OF INJECTION THAT TURNED PURPLE (NO RAISED LESIONS ON THE ARM), FEELING "PINS AND NEEDLES" ALL OVER HER BODY, RAISED RASH WITH BLISTERS ON NECK - PER PATIENT HER PHYSICIAN DIAGNOSED HER WITH SHINGLES IN THAT AREA; PATIENT STATES THE RASH IS STILL NOT CLEARED UP (11 DAYS LATER) AND IS STILL RED AND ITCHY.
Patient received vaccines 11/13/18. Pt was seen at the ER on 11/14/18 for blurred vision, dizziness, nausea, diarrhea, abdominal cramping, cold sweats. Patient was treated with IV fluids and her headache and abdominal pain improved. Labs improved. Patient was discharged from the ER later that day. Patient was seen at primary care office 11/16/18, reported feeling much better.
Arm Pain; Chills; Fever; Headache; Nausea; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Body Aches). At the time of the report, PAIN IN EXTREMITY (Arm Pain), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Body Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This case was reported by a nurse practitioner and described the occurrence of gout in a 35-year-old male subject who was vaccinated with Engerix-B plus a separate injection of hepatitis A vaccine inactivated  (Havrix). The subject's medical history included high blood pressure, penicillin allergy and seasonal allergy. Medical history also included "slightly elevated uric acid levels' on 23 October 2003 at 7.5 mg/dl and on 25 August 2005 at 8.3 mg/dl (normal range 2.7 to 8.2). Concurrent medications included Losarten potassium (Cozaar). On 09 March 2006 at 09:20 am, the subject received 1st dose of Engerix-B in the left deltoid (lot AHBVB135AA). On 09 March 2006 the subject also received 2nd dose of Havrix in the right deltoid (lot AHAVB078AJ). On 10 March 2006, 1 day after vaccination with Engerix-B and Havrix, the subject experienced "redness and swelling in the metatarsal and phylargneal area of toes 3, 4, and 5 in the left foot". The subject was seen at a physician's office and was treated with ibuprofen (Advil). He was subsequently diagnosed with gout and treated with allopurinol and nabumetone (Relafen). The events resolved on 22 March 2006. The nurse practitioner considered the events to not be related to vaccination with Engerix-B or Havrix.
day of and day after, very tired every day since vaccine headaches Day 7- Covid Arm....started as the size of a penny, raised as if stung by a horsefly, slightly itched Day 8- red, warm, raised area is bigger than a golfball...seems to be steadily getting bigger
Pt recvd 2nd dose of vax & 36 hrs p/vax devel maculopapular rash that begaan on lower extremities; devel petechial lesions around ankles; exp joint stiffness, joint swelling & malaise;
Chills, high Fever, severe body aches, blisters all over both hands which burst and fell off the next day, severe depression and anxiety. Symptoms lasted for 2-3 days followed by malaise and extreme fatigue continuing till present. No medical treatments or medication was given, just bed rest, liquids, and supplements (zinc, vit D3)
Fever, right upper arm pain & swelling & chills (10 cm x 13.2 redness & swelling). Dx Cellulitis, on cephalexin 500 mg QID x 10 days.
in late Feb/early March 2022 started experiencing some intermittent palpitations, chest discomfort/squeezing sensation; one episode of tingling in chest and blood pressure fluctuations; seen in ER early March 2022 for chest pressure and had cardiac workup done; sent to cardiologist for abnormal EKG showing Qwave; ECHO completed; stress test scheduled and pending; no prior cardiac history or family history; concern that vaccine could possibly be related to the events/symptoms; unknown etiology.
Information has been received from a physician concerning her father who is around 70 years old and on 15-JUN-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included (FLOMAX). The physician reported that her father received zoster vaccine live and on 17-JUN-2008, developed a red and swollen area at the injection site that was the size of his palm. The physician told her father to put on unspecified corticosteroid on it. The patient sought medical attention by phone. Additional information has been requested.
I was asleep on Thursday night and my heart started to race.   I had fast heart palpitations that it woke me up,  when I woke up I had difficulty breathing and felt Severe chess pain. I felt pressure and started coughing a lot. My husband helped me with some breathing exercises and helped me call online 24 hour Kaiser nurse. My chest hurt a lot and  they recommended I went to emergency. I did and they said x-ray and cardiogram was ok. They injected a pain killer and left me there until morning. Then I was released. Pain killer helped. On Friday evening I had no more chest pain, but I felt nauseous, had chills, body aches, headache and no appetite. These symptoms lasted until Monday. I started to eat again bread and butter by Tuesday, I deleted better on Tuesday, I was still  very fatigue, low energy and sensitive stomach, mild nausea. Nausea  stopped Wednesday, stomach was still mild sensitive still.
dizziness, felt very dizzy; vaccination site pain; threw up; severe headache; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness, felt very dizzy), VACCINATION SITE PAIN (vaccination site pain), VOMITING (threw up), HEADACHE (severe headache) and NAUSEA (nauseous) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced DIZZINESS (dizziness, felt very dizzy), VACCINATION SITE PAIN (vaccination site pain), VOMITING (threw up), HEADACHE (severe headache) and NAUSEA (nauseous). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness, felt very dizzy), VACCINATION SITE PAIN (vaccination site pain), VOMITING (threw up), HEADACHE (severe headache) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
monovalent vaccine was kept in fridge the after the vial was punctured, dose was administered more than 12 hours post puncture; No adverse event; A Dose was administered more than 12 hours post puncture as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A Dose was administered more than 12 hours post puncture as a second dose), PRODUCT STORAGE ERROR (monovalent vaccine was kept in fridge the after the vial was punctured, dose was administered more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 25-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Dec-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A Dose was administered more than 12 hours post puncture as a second dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (monovalent vaccine was kept in fridge the after the vial was punctured, dose was administered more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A Dose was administered more than 12 hours post puncture as a second dose), PRODUCT STORAGE ERROR (monovalent vaccine was kept in fridge the after the vial was punctured, dose was administered more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (A Dose was administered more than 12 hours post puncture as a second dose) and PRODUCT STORAGE ERROR (monovalent vaccine was kept in fridge the after the vial was punctured, dose was administered more than 12 hours post puncture).    No concomitant drug was reported. Reporter stated that the monovalent vaccine was kept in fridge after the vial was punctured. No treatment drug was reported.