chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician, via company representative, regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies and concomitant therapies were unknown by the reporter. On unknown dates, the patient was vaccinated with two series of RECOMBIVAX HB (strength, dose, route, lot number and expiration date were not reported) for hepatitis B. On an unspecified date, serum hepatitis B surface antibody screen was performed (reported as "titers were drawn") and showed that the patient did not convert (Hepatitis B surface antibody negative). The patient sought medical attention due to the event. It was unknown if treatment was given for the event, or if other laboratories or intervention to prevent serious criteria were performed. The outcome of the event was unknown at the time of reporting.  The reporter did not provide a causality assessment between the event and the suspect vaccine. Additional information has been requested.
fever with tmax 105, chills, tachycardia to 150, moderate headache, cough, lightheaded, dizzy, somnolence
Swollen and tender lymph node in left armpit.  Headache.  Slight fever.  Muscle aches/pains.
Information has been received from a medical assistant concerning a patient who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (lot# 663012/1163X or 665300/1314Y). Subsequently the patient experienced cellulitis. The patient sought medical attention by an office visit. At the time of the report, the outcome of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a Pharmacy Technician refers to a patient of unknown age and gender. Concomitant medication, medical history, drug reactions and allergies were not reported. On 24-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 lot # J002646 expiry date 11-MAR-2014 (dose and route were not reported). On 24-SEP-2014, the patient was administered an expired dose of PNEUMOVAX 23. No adverse events were reported. The outcome of was administered an expired dose of PNEUMOVAX 23 was unknown. Additional information has been requested.
Sore mouth with blisters; Sore mouth with blisters; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ORAL PAIN (Sore mouth with blisters) and ORAL MUCOSAL BLISTERING (Sore mouth with blisters) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included MELOXICAM for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced ORAL PAIN (Sore mouth with blisters) and ORAL MUCOSAL BLISTERING (Sore mouth with blisters). The patient was treated with AMOXICILLIN ongoing since an unknown date for Symptomatic treatment, at a dose of 500 milligram. At the time of the report, ORAL PAIN (Sore mouth with blisters) and ORAL MUCOSAL BLISTERING (Sore mouth with blisters) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.
EXPOSURE headache, her ears are clogged, throat is sore,  cough (no fever or sob)
Within several days of my second Pfizer COVID-19 shot, my testicles started to become swollen and sweaty; they did not retract as previously; and soon developed a painful, red rash and dull pain.  (Date above is approximate.) I first tried over-the-counter jock itch treatments, but those did not have any impact.  I then had numerous visits to the urologist and dermatologist.  The dermatologist diagnosed the condition as "Red Scrotum Syndrome" and prescribed several different antibiotics and ointments over time.  The swelling has somewhat reduced in severity but the painful rash, dull pain and limited retraction has continued to this day.  I am continuing to be treated by the dermatologist for this condition.
Product Complaint; Large golf ball sized whelp at site; Erythema streak across chest and up neck; Feeling "drunk, like a weird state of awareness."; This case was reported by a pharmacist via call center representative and described the occurrence of injection site urticaria in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 3rd October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site urticaria, erythema and feeling drunk. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site urticaria, erythema, feeling drunk and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site urticaria, erythema and feeling drunk to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The age group selected as an adult, as the patient reported as employee. The pharmacy manager stated that, within minutes after vaccination, the patient experienced large golf ball sized whelp at site, erythema streak across chest and up neck and felt drunk like a weird state of awareness. The reporter stated that all 9 employees received dose from same batch number and was warm transferred to the glaxosmithkline response center for documentation of potential product complaint. The pharmacy manager did not have any patient-specific details available at the time of this call, but stated safety could follow up. The reporter consented to follow up. This case was 7 of 9 linked cases reported by same reporter.
Severe arm pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient was pharmacist. The patient experienced severe arm pain upon receiving a dose of Shingrix on 25th October 2019.  The reporter consented to follow up. The case has been linked with the case US2020071702 reported by same reporter for same patient.
Developed tinnitus after 2 days of vaccination. Prior to vaccination I was having mild ringing in my right ear due to moderate hearing loss caused by ear drum perforation.  2 days after vaccination I started having tinnitus on left side of my brain on and off and now it's continuous , also ringing in my right ear has increased , it is causing to me to have sleepless nights and groggy days. It has not improved even after a month. It could be  a permanent damage but I am not sure.
Post vaccine day: Day 2 left arm and left leg weakness and numbness, also had moderate Shortness of breath, more with exertion.  Day 3 had facial erythema with burning sensation and mild peeling on cheeks and nose.
(R) side of face (cheek & lips) started swelling at 1030AM. 120PM c/o itching & welts all over body. Instructed to take BENADRYL q4 hours for the next 24 hours - cool cloths on swelled areas. Hives were gone by next AM - still has some swelling in face.
pt recvd vax; T of 102.6 per mom; localized redness & swelling;
Hib given at 27 days of age leaving infant with a questionable immunity to Hib vaccine. Follow information dated 8/16/05 states there was no adverse event, other than the possibility of the child not obtaining immunity to Hib due to the vaccine being administered at 28 days of age.
p/vax area of erythema & induration of lt upper arm where inj was given; started to itch; it was elected to cover for possible cellulitis w/po antibiotic; felt this was a tissue react
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unspecified date in March and April 2014 doses of ROTATEQ were exposed to a supported temperature excursion. On an unknown date the doses of ROTATEQ oral, (strength, dose, frequency, lot and expiration date were not reported) were administered to an unspecified number of patients on an unspecified dates. No adverse events had been reported. The reporter indicated that there was no follow up information for this case. No additional information was available. Additional information is not expected, because the reporter did not wish to receive any additional correspondence for this case.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Did you/the patient previously receive a COVID-19 Vaccine?: Yes. Known allergies: No  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Disoriented, dizzy, EMS called, transported to hospital, have severe vertigo.
Fever and chills, with a temp reaching 104 degrees by midnight. Injection site on right leg is very swollen, red, sore to the touch. Needed 2 doses of ibuprofen to bring temp down to 100
Patient had an allergic reaction. Onsite EMS was called vitals BP 142/66 HR 98 99% O2 . Patient treated and released against medical advise.
Pain at site of injection - given 8/25/09. Now also with visible indentation and loss of muscle mass at site. Attended PT 2x/wk for 1 mo. with no improvement.
Ecchymosis, pain, lump Narrative:  1 - 2 days following vaccine, developed "bruise" that is persistent, and she feels is darkening. Also developed pain that has persisted, is intermittent, mild to moderate, and sometimes radiates distally. 6 months later (September), she noted "mass" under site of injection. Saw her provider in December. Had ultrasound imaging.
Pt developed red, swelling in leg, 1 week, post vax, lasting about a week.
The pt has had 2 doses of MMRII and has not developed any antibodies.  Additional info has been requested
Unable to go to work; Node remains swollen / enlarged tender lymph node; Local injection site pain mild; Shivering; Fatigue; Myalgia; GI discomfort; Headache on the left side; 4 cm axillary tender node on left same side as injection; Fever; This case was reported by a physician via sales rep and described the occurrence of fever in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th April 2019, the patient received the 1st dose of Shingrix. On 9th April 2019, less than a day after receiving Shingrix, the patient experienced fever, injection site pain, shivering, fatigue, myalgia, gastrointestinal discomfort, headache, lymph node tenderness and enlargement of lymph nodes. On 10th April 2019, the patient experienced inability to work. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever, injection site pain, shivering, myalgia, gastrointestinal discomfort and headache were recovered/resolved and the outcome of the fatigue, lymph node tenderness and enlargement of lymph nodes were not recovered/not resolved and the outcome of the inability to work was unknown.   The reporter considered the fever, injection site pain, shivering, fatigue, myalgia, gastrointestinal discomfort, headache and lymph node tenderness to be probably related to Shingrix. It was unknown if the reporter considered the inability to work and enlargement of lymph nodes to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix vaccine in left deltoid. The reactions began within 3 hours of receiving the first dose of Shingrix and consisted of fatigue, myalgia, headache, fever, gastrointestinal discomfort without vomiting or diarrhea, as well as a tender 4 cm axillary node on the left. On 10th April 2019, 1 day after receiving Shingrix the patient was unable to go to work on due to intensity of reactions. The patient responded to ibuprofen in general, but fatigue persisted into 11th April 2019 and the node remains swollen and tender. The symptoms worsened over the first 24 hours and then at 48 hours had largely resolved or improved. Less than a week after receiving Shingrix, the patient had the enlarged tender lymph node, injection site pain and shivering. The fatigue persisted but was improved whereas the rest of the systemic symptoms were resolved. The events did not cause the patient to be admit to the hospital overnight or prolong an existing hospitalization. The reporting health care professional did not consider the events to be life threatening. The reporting health care professional did not consider the events to result in persistent or significant disability/incapacity. The events did not result in a congenital anomaly or birth defect. The patient was alive. The patient agreed to have a follow up.
Rec'vd Tdap 2/23/12 - 2 days later noticed redness, itching 1 in below injection site - on 2-28-12 noticed more redness et itching. Pain only when scratches, area warm to touch. No fever - had blister lower lip - no other problems.
The influenza vaccine Fluarix and Pneumovax 23 were administered after a temperature excursion that the vaccines were not viable.
Her ferritin levels almost went up to 600; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1 single), administration date: 19Apr2021, for covid-19 immunization, reaction(s): "sick". The following information was reported: SERUM FERRITIN INCREASED (non-serious), outcome "unknown", described as "Her ferritin levels almost went up to 600". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Her sister also had a really strange reaction with the second shot Pfizer covid vaccine. Her ferritin levels almost went up to 600 which was really bad. States her sister reported this.   Follow-up attempts completed. No further information is expected.
Didn't feel well after the dose; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported.  The patient could be 57 or 58 years old of age. The patient received Shingrix at least 6 months ago.  The patient remembered that he did not feel well after the dose. This case is linked to the case US2020062417, reported for the 2nd dose.
Light fever ,whole body muscle pain,(for two days) Lymph nodes in the side of the vaccine are swollen and painfull to touch (still present)
Information has been received from a 26 year old female with an allergy to TYLENOL who in 2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) prior to a spinal fusion surgery in August 2007. Two weeks after the surgery she broke out in a serious rash all over her body that was red, itchy and oozy. She went back to her surgeon who thought she may have caught a bacterial infection while in the hospital. After the treatment for that, the rash did not go away and patient was thought to have a staph infection. The rash was getting worse and she started having difficulty breathing and had to be taken to ER. It was determined she may have an allergic reaction to the nickel hardware that was placed in her spine. After that she was sent to an allergist who performed some tests, however the patient was taking allergy medication at the time and the test came back inconclusive. She did receive a second and third dose of GARDASIL vaccine (yeast) and was also scheduled for a second spinal fusion to replace the hardware with stainless steel. The patient is still experiencing a rash, that comes and goes depending on whether she puts the cream on it or not. She will bring the package insert for GARDASIL vaccine (yeast) with her to the allergist office to look at the ingredients and perform some tests to see if she could be allergic to any of the components. At time of report, the patient had not recovered from her rash. The outcome of the difficulty breathing, bacterial staph infection and allergic reaction to nickel hardware is unknown. No further information is available.
Tenderness and aching in the arm; Swelled up; Vaccination site erythema; It was itchy, tender, and swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tenderness and aching in the arm), VACCINATION SITE SWELLING (Swelled up), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (It was itchy, tender, and swollen) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Tenderness and aching in the arm), VACCINATION SITE SWELLING (Swelled up), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (It was itchy, tender, and swollen). At the time of the report, VACCINATION SITE PAIN (Tenderness and aching in the arm), VACCINATION SITE SWELLING (Swelled up), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (It was itchy, tender, and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported Treatment includes: Patient reports icing her arm, but it made it worse. She also used a cool, wet cloth on her arm.
Case number PHEH2016US023388, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 24-year-old patient of an unknown gender. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into left arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error.
Pt experienced a reaction at site of injection on right thigh with blotches, and also on face. No other symptoms. Treated with Benadryl and cool compresses within minutes.
having trouble when trying to move or walk; Aching all over; Felt like throwing up; Dizziness; Weakness; Upset Stomach; Terrible headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), ABDOMINAL DISCOMFORT (Upset Stomach), GAIT DISTURBANCE (having trouble when trying to move or walk) and MYALGIA (Aching all over) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo. Concomitant products included MULTIVITAMIN [ASCORBIC ACID;COLECALCIFEROL;DEXPANTHENOL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN SODIUM PHOSPHATE;THIAMINE HYDROCHLORIDE] for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced HEADACHE (Terrible headaches). In July 2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), ABDOMINAL DISCOMFORT (Upset Stomach), MYALGIA (Aching all over) and NAUSEA (Felt like throwing up). On an unknown date, the patient experienced GAIT DISTURBANCE (having trouble when trying to move or walk). On 09-Jul-2021, DIZZINESS (Dizziness), ASTHENIA (Weakness), ABDOMINAL DISCOMFORT (Upset Stomach), MYALGIA (Aching all over), NAUSEA (Felt like throwing up) and HEADACHE (Terrible headaches) had resolved. At the time of the report, GAIT DISTURBANCE (having trouble when trying to move or walk) had resolved.            The patient's past medical history included blood clot due to taking of oral testosterone booster.  Concomitant medications included Nitric Oxide Booster.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: onset date of the events updated, Email  Address added and patient prefers follow up via phone
A few days after the vaccine was administered I started to get horrible read itching patches on my face, hands, head, and neck and arms. No matter what I did I couldn't get them to go away. I never formed a physical reaction from the smallpox vaccine itself in terms of a bump on my arm or anything, but I did get some pretty horrible itchy patches that I am still having on my scalp that I'm slowly getting rid of a year later.
30 minutes after receiving her 1st dose of the COVID vaccine, she started feeling a burning sensation in her nose and in her chest when she took a deep breath. Symptoms persisted overnight, today reports to have had chills and a sore throat. She was seen by her PCP today, 12/23 for further instruction. PCP told her to take benadryl and to follow up with an allergist prior to second dose for clearance. Patient reports she was COVID positive July 2020.
N&V, weakness, dizziness, coughing and HA, "aluminum foil taste" in his mouth continued during the night, some nausea the next day. Also felt dehydrated and weak the next day.
Sore arm x 24 hours.  Day 2 headache, nausea and body aches.  Day 3 nausea and body aches.  Day 4 extreme fatigue, nausea, diarrhea.  Day 5 fatigue and nausea.
I gave patient Tdap, which is not licensed for children her age instead of Dtap which I should have given her.