chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via a company representative refers to an 80 year old patient of unknown gender. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the patient experienced very bad shingles. The outcome of very bad shingles was unknown. The action taken with the therapy with ZOSTAVAX was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. No product quality issue was reported. This case is related to case number 1403USA007543 via same reporter link. Additional information has been requested.
08/15/2012 dizziness. 08/16/2012 headache, hands shaking. 08/17/2012 headache, hands shaking, dizziness. School nurse mother pick him up from school due to visible illness.
Patient began feeling light headed and dizzy after receiving the JnJ vaccine (201A21A) at 1550HRS. The patient was aided to a supine position on the ground by RN. Patient sustained no injuries. Patient declined EMS services. Vitals signs were stable as noted. Patient was AO x 4, no pain, no discomfort noted. Patient waited 30 minutes, vital signs were reassessed and stable as noted. Patient left without any injury or further incident.
Pt was fully vaccinated with both doses of the Moderna vaccine, on 3/22/21 and 4/19/21.  Pt developed a mild infection with COVID around 7/29/21, but was not ill enough to be hospitalized.
Sudden fever and sudden seizure... Stopped breathing was administered CPR and taken by ambulance to Hospital
Pt began with GI sx of loose stools on 6/14/23 and was diagnosed with intussusception on 6/19/23. He underwent surgical correction on 6/20/23.
taste became more intense; I lost another 10 lbs. Total loss in 10 months 32 lbs.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 01Nov2021 (Lot number: FE2590) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot no# EN6207), administration date: 13Mar2021, when the patient was 68 years old, for Covid-19 immunization, reaction(s): "Had a metallic taste in her mouth", "That it is interfering with her eating", "lost 10 pounds/Have lost 22 lbs", "Smell/Taste Loss became worse", "Smell/Taste Loss became worse", "Smell/Taste Loss became worse", "Parosmia"; Bnt162b2 (DOSE 2, SINGLE, Lot no# EW0150), administration date: 06Apr2021, when the patient was 68 years old, for Covid-19 immunization, reaction(s): "parosmia became substantially worse", "metallic taste got so severe/metallic taste got worse / metallic taste in her mouth/ metallic/sour taste started in mouth", "metallic taste got so severe/metallic taste got worse / metallic taste in her mouth/ metallic/sour taste started in mouth", "Smell was completely gone", "Everything tastes awful", "she could barely eat/ interfering with her eating", "lost 10 pounds/ continued to lose weight/ have lost 22lbs".  The following information was reported: TASTE DISORDER (non-serious) with onset 01Nov2021, outcome "unknown", described as "taste became more intense"; WEIGHT DECREASED (non-serious) with onset 01Nov2021, outcome "unknown", described as "I lost another 10 lbs. Total loss in 10 months 32 lbs.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After booster taste became more intense and lost another 10lbs. Total less in 10 months 32lbs.  Follow-up attempts are completed. No further information is expected.
Hospitalized 11/26/2021; COVID-19 positive 11/26/2021; fully vaccinated      Admission Date: 11/26/2021 Discharge Date: 11/29/2021   Admitting Diagnoses: COVID-19   Details of Hospital Stay PRESENTING PROBLEM:  Hypoxia [R09.02] Mild intermittent asthma with acute exacerbation [J45.21] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1] HOSPITAL COURSE: Patient is a 76 y.o. female with PMH COPD on 2L home O2, RA, tremor, Giant cell arteritis, Pulmonary embolism who presents today with cough, shortness of breath, for a few weeks. Pt also reports diarrhea for the past 2-3 days. Pt also reported generalized malaise. Her son-in-law tested positive for COVID-19 within the last few days. Upon arrival to the ED, pt was noted to be hypoxic with spO2 76% on room air (pt wears 2L O2 at baseline). Pt was paced on oxygen and spO2 stabilized and pt was returned to baseline O2 of 2L NC. COVID-19 swab performed was positive. CXR done showed mild peripheral opacities at the lung bases. Pt administered IV dexamethasone and admitted to the hospital for further management.  hospital course was mostly unremarkable, she was continued on dexamethasone, shortness of breath improved, was evaluated by Pulmonary rehab recommended 3 L oxygen at rest and 5 L with activity, PT and OT recommended discharge home with assist.  GI recommended outpatient follow-up for EGD for evaluation for dysphagia, Doing well discharge home today in stable condition, recommended follow-up with PCP in 1 week.  Instructions discussed in detail with patient she verbalized understanding.
I received the Moderna Booster 1 year after getting my two Pfizer vaccines. Approximately 6 weeks later I began losing a small patch of hair on the back of my head. Over the course of the next year, it grew larger and larger. I was diagnosed with Alopecia. I am currently undergoing steroid injections monthly in my scalp. They have not helped and my hair is continuing to fall out. The back of my head is now 3/4 bald.
I was vacationing abroad when on the afternoon of 8/24/2022, I began to feel more tired than usual and had a little bit of a sore throat. I wasn't concerned, because we had had a full day, so I just chalked it up to travel. The following day, I felt worse and more fatigued, but I went ahead with my itinerary. On the morning of 8/26/2022, I took a home antigen test and got a positive result. We flew back home the next day and isolated when we got home. With regard to my symptoms, I just had a mild sore throat, body aches, and a mild fever for about three days. This was followed by low-grade fatigue for about three weeks. I treated my symptoms with Tylenol, and I made sure to drink plenty of fluids. I have asthma, so I feel lucky that I didn't have any major respiratory issues. I also feel lucky to have not experienced loss of taste or smell. Also, I have friends who are dealing with long COVID-19 symptoms, and I feel fortunate to have recovered quickly from my symptoms.
Within minutes of receiving vaccine patient reported nausea and hot flashes. Patient was given a bottle of water and an ice pack, which he placed on his neck. After about 5 minutes he reported that he was feeling better. Patient was observed for a total of 30 minutes, at which point he said he was feeling totally normal again.
An area about 2" high X 4" long  and about 2" below the shot site became slightly pink, itchy , warm and sensitive to the touch. It gradually  went away after 2 to 3 days.  All is quiet since then....
Observed for 20 min-she talking talking and laughing. Talk mother she needed to co to bathroom. Dr noticed 45 min after vaccine given BP/P/ R ok - nausea emesis abdominal cramping.
The patient complained of tenderness at the left base of the neck, the left lateral chest wall and upper arm. After a medical exam, the patient was prescribed Darvocet N-100.
Sunday after vaccination developed a raised rash on her chest. It lasted two days and cleared up on its own. Sounds like a morbilliform rash. No heat, swelling, pain on rash. No reaction at site of injection
Intermediate headache started after 8 hours taking vaccine. Intermediate nausea started after 24 hours. Intermediate left arm pain after 4 days.
expired dose of FLUZONE HD QIV was administered to a patient/dose expired on 30JUN2023 with no reported adverse event; Initial information was received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 82 years old male patient who received expired dose of influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] was administered to a patient/dose expired on 30jun2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-Sep-2023, the patient received a dose of 0.7 ml of suspect influenza quadrival a-b high dose hv vaccine (lot UJ882AB, Expiry date : 30-Jun-2023, frequency : once, formulation, strength was unknown) via unknown route in the right deltoid for Influenza and Immunization and expired dose of fluzone hd qiv was administered to a patient/dose expired on 30jun2023 with no reported adverse event (expired product administered) (latency : same day).  Action taken with QUADRIVALENT influenza vaccine (Fluzone HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of fluzone hd qiv was administered to a patient/dose expired on 30jun2023 with no reported adverse event.  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.
Experienced numbness from head to toe on the side the vaccine was given.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (Experienced numbness from head to toe on the side the vaccine was given.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Experienced numbness from head to toe on the side the vaccine was given.). At the time of the report, HYPOAESTHESIA (Experienced numbness from head to toe on the side the vaccine was given.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No treatment medications were provided.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 12th August 2018 11:30, the patient received the 2nd dose of SHINGRIX (intramuscular). On 12th August 2018 18:30, 7 hrs after receiving SHINGRIX, the patient experienced injection site pain, appetite lost, fatigue, general body pain and fever. On an unknown date, the outcome of the injection site pain, appetite lost, fatigue, general body pain and fever were recovering/resolving. It was unknown if the reporter considered the injection site pain, appetite lost, fatigue, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient stated that the representative could not resolve his problem, because he still had achy pain and sort of a miasma. So to say that he resolved the problem with respect to the physical, how he felt physically, was an incorrect question. The patient had denied permission to contact their physician.  No further details were provided.
Starting on 03/01/2023 I experienced suicidal ideation. I am unsure if it is vaccination related. I did seek treatment at an emergency room. I have follow up appointments.
This spontaneous report was received from a physician refers to a 1 year old male patient without any medical history and drug reactions/allergies. The patient was vaccinated SQ with single 0.5 ml dose of M-M-R II (lot# not reported) on 20-AUG-2012. Second suspect medications included VARIVAX (Merck) (dose, route, lot# not reported) and concomitant therapy included PREVNAR 13 (dose, route, lot# not reported) on 20-AUG-2012. On 22-AUG-2012 the patient developed a febrile seizure after concomitant administration of VARIVAX (Merck) and M-M-R II. The patient was taken to the ER for the event, and given ROCEPHIN. Unspecified test was performed (result not reported). The AE was improved. At the time of reporting, the patient had recovered on an unspecified date. Upon internal review, febrile seizure was considered as an other important medical event. Additional information has been requested.
Blisters in mouth and tongue, sore throat, headaches, body aches, and pain.
Sore arm resolved in 24hrs Metallic taste began 24-48 hrs after vaccination lasting x 3 days......now resolved On 2/1/21 noticed a Round silver-dollar sized initially then size increased by 2/2/21 itchy lesion; appears like a "bullseye" with reddened circle around swollen area.  Site is warm, red to touch.   Advised by her PCP  via telehealth 2/2/21 to take: generic Zyrtec:10mg.  Site improved after medication: no longer itchy, or red circle. Size remain the same.
headache; chills; warm forehead; sore left arm; second shot on 21Apr2021; he has not been able to get good sleep; tiresome.; This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8729), via an unspecified route of administration in Arm Left on 21Apr2021 as single dose (at the age of 58-year-old) for precautionary measures. Medical history included left eye surgery for cataracts on 20Apr2021 and cataracts, had for over a year. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0158), on 09Apr2021 as single dose for precautionary measures and experienced Sore left arm. Reported that patient had second vaccine shot from Pfizer yesterday. Was on way to work and was tiresome. Stated that he has not been able to get good sleep. Stated that he woke up at 3am with a headache and warm forehead. On 28Apr2021, the patient had chills. Stated that he had no effects from first vaccine but a left sore arm. Stated that his left arm is sore from the second one. Later clarified as Pfizer Covid 19. Stated that he had cataracts before the vaccines. Stated that when he picks something up, strains or moves his left arm that its sore. Stated that the first time he had a sore left arm that it went away in 4-5 days. Stated that he did not take Ourezel and Besivence today. Started using Ourezel and Besivence on 18 Apr or 19 Apr. The outcome of events headache, chills, warm forehead, sore left arm was not recovered, and for other events it was unknown.  No follow-up attempts are needed. No further information is expected.
The pt experienced a local reaction which consisted of an 11 x 10 cm erythema to the right leg (bullous eye type" appearance flat, not raised, no swelling or induration.
This spontaneous report was received from a physician referring to a 4-year-old patient of an unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 20-MAR-2017, the patient was vaccinated with PROQUAD recombinant human albumin (rHA) (lot # M040141) (dose, route of administration, anatomical location and expiration date were not reported) for prophylaxis, which was stored in a freezer that was not monitored twice daily for temperature variability. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000004: US-009507513-1703USA014463: US-009507513-1705USA007310: US-009507513-1705USA007309: US-009507513-1705USA007310: US-009507513-1705USA010145: US-009507513-1705USA010144: US-009507513-1705USA010143: US-009507513-1705USA010142: US-009507513-1705USA010147.
Very sore arm, Right axilla lymph nodes very painful and swollen. Fever of 101.2 on second night after vaccination. Very tired and lethargic. Missed work on 3rd day.
Headache Narrative:  Staff member with 5/10 ha occurring approx. 30 minutes after injection. Provided 8 oz. h2o and crackers and stated felt improved 3/10. Denied any other sx. ie: palpitations, dizziness, etc..Five minutes later provided additional 8oz h2o and h/a sx reduced to 1/10. She also Informed she normally drinks more h2o in am hours but did not have any this a.m. Additionally, she just prior to Pfizer clinic appt, consumed nutritional drink then realized it contained caffeine. She is extremely sensitive to caffeine. Ten-15 minutes after occurrence of 5/10 h/a only sx, h/a down to 1/10 with no other sx present-before, during or after h/a sx.  Other Relevant History:
Father called and stated Arianna had hives and welts all over her body. Dad had no way of getting her to the doctor.
Information has been received from a physician's assistant concerning a female who was vaccinated with GARDASIL (date not provided). After this first vaccination, the patient developed a rash on her arm where injection was given, a rash on both legs and also in her mouth. The patient was treated with a dose of diphenhydramine hydrochloride (Benadryl). Subsequently, the patient recovered. Additional information has been requested.
Myalgia NUMBNESS, NUEropathy, tingling, pain bilateral calves Narrative:
Administered Moderna Bivalent Dark pink cap (yellow label) after being notified that monovalent covid vaccines were no longer authorized. Was administered prior to recommendation of using dark blue Moderna bivalent cap (gray label). Patient received one monovalent Moderna in the past and on this day received her 2nd dose as Moderna Dark Pink cap.
Pt recv vax on 3/19/99; w/ in 1 hr post vax pt exp hives; tx=Benadryl
7/3/2021 7:23:41 AM > phone call from Officer pt deceased. discussed with wife. she heard him make a loud breathing noise at 3am and then could not wake him. had been feeling well with no complaints. planned to run a road race this Sunday. offered support. pls mark chart and then FYI to Dr.
progressive illness  day 1:  dysesthesias lower extremities, fatigue, chills, low grade fever day 2:  worsened fatigue, headache, facial numbness and increased lower extremity/abdominal dysesthesias day 3:  diplopia and ataxia in addition to above-->came to hospital
Information has been received from a healthcare worker concerning a female patient who "last week" was vaccinated with pneumococcal 23v polysaccharide vaccine (lot#651321/1036P).  Subsequently, the patient experienced swelling of the injection arm, edema, redness, heat and itching.  The patient also had a rash.  Ice packs, ibuprofen (ADVIL) and acetaminophen (TYLENOL) were the recommended treatments.  Subsequently, the patient recovered.  Additional information has been requested.
patient was confused; This non-serious case was reported by a nurse via sales rep and described the occurrence of confusion in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.  On an unknown date, the patient received Shingrix and PNEUMONIA VACCINE. On an unknown date, less than a year after receiving Shingrix, the patient experienced confusion (Verbatim: patient was confused). The outcome of the confusion was unknown.  It was unknown if the reporter considered the confusion to be related to Shingrix.  It was unknown if the company considered the confusion to be related to Shingrix.  Additional Information: GSK Receipt Date: 28-MAY-2023 The reporter was the Nurse Practitioner (NP) who informed GSK Representative during lunch that patient received Shingrix and a Pneumonia vaccine the same day between 8 months and a year ago, in the medical office.  The nurse called the patient that same day and patient was confused, then patient was referred to emergency room (ER), EMS transported patient to ER. A stroke was ruled out at ER. The report back to NP was patient had a reaction to vaccine administered. The reporter consented to follow up. It was unknown if the reporter considered the confusion to be related to PNEUMONIA VACCINE.
Vaccinated with Pfizer in March 2021. Has cold and sneezing and headache. No fever-
PAINFUL MOVEMENT; WEAK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 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 painful movement, and weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the weak and painful movement was not reported. This report was non-serious.
2-3 days after 2nd vaccine I noticed a large olive-sized lump in my neck, left side, next to the collar bone. My 2nd vaccine was given on 2/26/21 in my left arm. Lump is swollen and painful
Initial soreness occurred first 2 days then resolved.  On 3/23/21, patient noticed injection was warm and itching. On 3/24/21, the area is a large, warm , hard and itchy at injection site. No pain or fever.
First dose: mild lethargy, mild body aches. lasted for 12 hours. Second dose: Injected at 8 a.m. 4 p.m.: lethargy, headache, earache, toothache 6 p.m.: severe body aches, severe lethargy, severe chills, temperature rose by 2 degrees,cough, headache, dehydration, dizziness, earache, nausea, woke up every hour, lasted till 12 p.m. next day.  12 p.m.: temperature (2 degrees), moderate chills, moderate body aches, dizziness, severe sweating, dehydration 7 p.m.: no temperature, dehydration, dizziness, mild body aches, no chills, moderate sweating 7 a.m.: no temperature, dehydration, dizziness (mild), no body aches, lethargy (mild), no chills, mild sweating Since then still tired but improving.
Hours after the vaccine the patient began to complain of pain and numbness and tingling to the right arm.  By the following morning the pain was very strong. She went to an urgent care where a physician diagnosed her with SIRVA. The physician advised that this often occurs when an immunization is not given in the correct location. She was given a sling to use for her Left Arm along with pain medications.
A customer came with questions regarding dizziness they have been having since receiving the second dose of the Moderna vaccine.  She states that any time she takes a step down (not up), she feels very dizzy.  She has started using a cane because of this which she is dissatisfied with.  This started after she got the second dose on the 10th of March, and has been continual for her since then.  She is not our patient and we do not have any real information about her except that she received both of her doses from the Health Department.
PATIENT PRESENTED FOR FIRST MODERNA .5ML WHICH IS A HIGHER DOSE THAN AUTHORIZED. DOCTOR WAS NOTIFIED.
pt recv vax & w/in 24hr post vax pt exp itching & a welt @ inj site;
Felt burst in head after receiving. Crummy still. Headache 30 minutes later. 128/80, pulse 80 reg.