chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; Trigeminal neuralgia; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and TRIGEMINAL NEURALGIA (Trigeminal neuralgia) in an 81-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunisation.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles) and TRIGEMINAL NEURALGIA (Trigeminal neuralgia). At the time of the report, HERPES ZOSTER (Shingles) and TRIGEMINAL NEURALGIA (Trigeminal neuralgia) outcome was unknown.            No concomitant products reported.  It was reported that a patient started treatment on an unspecified date in 2021 with primary series of Moderna COVID-19 Vaccine (elasomeran) and a booster dose on an unspecified date in 2022 for COVID-19 immunization. It was reported that after the booster dose, the patient had a neurologic event in which the vaccine attacked her nervous systemand she developed shingles and trigeminal neuralgia. She did see her HCP who advised her to discontinue further Moderna mRNA vaccines and get Novavax as her second booster.
Their arm really hurt; Having a little fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Their arm really hurt) and PYREXIA (Having a little fever) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure abnormal (High blood pressure).    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Their arm really hurt) and PYREXIA (Having a little fever). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Their arm really hurt) and PYREXIA (Having a little fever) outcome was unknown.      Concomitant medication includes: Oral medication for diabetes, high cholesterol medication and high blood pressure medication since 2 months ago  Patient stated they usually had low blood pressure but since a couple of month ago their HCP indicated they start taking high blood pressure medication. When ask if they were immunocompromised the patient replied that being diabetic they thought the were immunocompromised to get the third dose. Patient provides consent for Safety to follow up with them or their HCP. Patient inquires if this side effects is common and how long could it last, Patient also inquires if the third dose is a full dose or half a dose, because their niece saw on line it should be half a dose but the vaccine provider told them they got a full dose.   This case was linked to MOD-2021-325664 (Patient Link).
Pt woke with temp max of 100.9r and rash on trunk and back and neck red and raised. Pt treated in office and to be treated every 6 hours at home with Benadryl for itching.
Information has been received from a pharmacist concerning a 63 year old female with no pertinent medical history who on 11:00 am on 06-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot# 659614/0161X) at left arm, SQ, single dose, once. There was no concomitant medication. On 07-JUN-2008 at 1:00 PM the patient developed an injection site reaction. The injection site area was warmth and the size of a lemon. The patient took BENADRYL (manufacturer unknown) for the treatment. The patient called the office and the office told the patient to contact the health department.This is in follow-upto report (s) previously submitted on 9/24/2008. Follow-up information was reported that the patient also got cold sores on her mouth, which occurred on 15-Jun-2008 or 16-Jun-2008 (previous reported as about a week after being vaccinated). The patient reported that she has never had cold sores before. The patient had been treated with ZOVIRAX ointment. The patient had seen a dermatologist since "It's not quite right on her lip." The patietn called the physician to seek medical attention. The patient was recovered. Additional information is not expected. The patient is recovering for the events. Additional information has been requested.
feeling unwell; fever that got as high as 104; Sore throat; Headache; Swollen tongue; painful blisters on the tongue; suffering from oral Shingles; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included throat cancer and covid-19 (was diagnosed within the last year). Previously administered products included Monoclonal antibodies and Shingrix with an associated reaction of malaise (received 1st dose 120 days before the 2nd vaccine. Refer case US2022AMR136887). Concurrent medical conditions included kidney transplant rejection and skin cancer. Concomitant products included immunosuppressants nos (Immunosuppressants).   On 15th September 2022, the patient received the 2nd dose of Shingrix. In September 2022, less than a week after receiving Shingrix, the patient experienced fever (serious criteria hospitalization), sore throat (serious criteria hospitalization), headache (serious criteria hospitalization), swollen tongue (serious criteria hospitalization), tongue blistering (serious criteria hospitalization) and oral herpes (serious criteria hospitalization). On 18th September 2022, the patient experienced feeling unwell (serious criteria hospitalization). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling unwell was recovered/resolved and the outcome of the fever, sore throat, headache, swollen tongue, tongue blistering and oral herpes were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, fever, sore throat, headache, swollen tongue, tongue blistering and oral herpes to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comments:  The reporter was sister in law of patient.  The reporter stated that reported patient received first dose of Shingrix approximately 120 days before the second dose but was unsure of the date.  The reporter stated 3 days after Shingrix patient began feeling unwell on 18th Sep 2022.  The patient developed a fever that got as high as 104, sore throat, headache, a swollen tongue, and painful blisters on the tongue. The patient was taking immunosuppressant drugs to prevent rejection of kidney transplant.  The reporter mentioned patient was previously battled throat cancer and was currently battling skin cancer and was very immunocompromised.  The patient was diagnosed with COVID within the last year and received monoclonal antibody treatment.  The reporter stated patient might be suffering from oral Shingles based on symptoms but notes patient has not been diagnosed with Shingles. The reporter stated patient was currently hospitalized due to symptoms. The reporter did not give consent to follow-up.; Sender's Comments:  US-GSK-US2022AMR136887:for 1st dose
Breakthrough case admission after 4 vaccines  Pfizer 2/25/21 lot# EN6202;  Pfizer 3/18/21 lot# EN6207;  Pfizer 6/29/22 lot# FM0173;  Moderna 1/23/23 lot# AS7148B
Pt in for vaccines 9/25/03 given a/o. No illnesses, no concerns. Returned to clinic 9/26/03, no temp (97 axillary). Seen by NP. 8cm circumference, left anterior thigh. Red, swollen area. Child eating, sleeping, acting well. Localized reaction. Cool compress, Tylenol, Benadryl if needed. To call if Sx worsened.
No symptoms until 1 week after vaccine received.  On 1/6/2020 at 8 pm, I noticed a nickel-size raised area at injection site. It was tender, itchy and moderately hard to the touch.  No visible rash.  Right upper arm appeared slightly swollen.   It continued to increase in size, tenderness and itchiness for approximately 48 hours.  On 1/8/2020 at approx 8 pm I noticed it was then a quarter-sized raised area at the injection site,  It was more tender, itchy and hard than it had been.  That was the worst it became.  By the next morning, 1/9/2020, symptoms were significantly decreased.  Currently, 1/9/2020 7:08 pm, the area is no longer visibly raised, tender or itchy. However, I can still feel a very slightly firm dime-sized area at the injection site.   No fever, breathing problems or other side effects noted since getting the vaccine.
Syringe malfunction. most of dose leaked out of the syringe where it meets the needle. A second dose was administered per the CDC recommendations. Patient over 65 but wanted to get the regular strength vaccine.
Child received Varivax vaccine at approx 2pm on 04/13/2005.  By "bedtime" on 04/14/05, arm was becoming reddened and sore to touch.  This morning area of approx 50mm had become reddened and hot to touch.
pt recv vax 27NOV96 & 28NOV96 pt exp soreness @ the inj site, sl h/a, inability to raise arm for a few days d/t pain in lt arm & soreness in lt shoulder & neck;pt also exp bone pain;
Pt felt dizzy after receiving the flu shot, but went home. Later that day, she felt weak/pale & felt pain in her legs (heels), wrist, neck. Next am, she had fever (102 F) & pain in her shoulders & knees. Also head headache. She went to see her PMD for follow-up.
some cough, congestion and shortness of brath; no other symptoms or concerns; high risk for complications
chills; trouble sleeping; feeling general body aches; This is a spontaneous report from a non-contactable consumer received via COVID-19 Vaccine Adverse Event Reporting System. An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 12Feb2021 (Lot Number unknown, at the age of 82 years old) as dose 2, single for COVID-19 immunisation. The vaccine was received in a hospital facility. The patient's medical history and concomitant medications were not reported. She was not pregnant at the time of vaccination and she did not receive any other vaccines within four weeks prior to vaccination. The patient previously received first dose of BNT162B2 on 22Jan2021 (Lot Number: EL3247, at the age of 82 years old) for COVID-19 immunisation. On 13Feb2021, the patient described chills and trouble sleeping the day after receiving her vaccination, as well as feeling general body aches. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of the events. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2015US019856, is an initial spontaneous report received from a pharmacist on 02 Oct 2015. This report refers to a 54 year old male patient. Historical conditions and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514801) intramuscularly at a dose of 0.5 ml on 02 Oct 2015. The pharmacist reported that the vaccine FLUVIRIN that had reached 52 degree for 30 minutes was administered to the patient. No adverse event was reported following the medication error.
headache; arm pain at the injection; body ache; joint ache; nausea; fatigue; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), VACCINATION SITE PAIN (arm pain at the injection), MYALGIA (body ache), ARTHRALGIA (joint ache) and NAUSEA (nausea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event reported.).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced HEADACHE (headache), VACCINATION SITE PAIN (arm pain at the injection), MYALGIA (body ache), ARTHRALGIA (joint ache), NAUSEA (nausea), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever). On 03-Apr-2021, HEADACHE (headache), VACCINATION SITE PAIN (arm pain at the injection), MYALGIA (body ache), ARTHRALGIA (joint ache), NAUSEA (nausea), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment details included Tylenol.
Pts mother called office on 3/25/11 to report red bump/rash.  Mom gave pt Claritin and Bendaryl. No difficulty breathing at this time. Neg n/v. Was seen at the Urgent Care on 3/29/11 and given an epi injection.
Area about 2 square inches of redness and some itchiness.  Also feels warm.
Swelling of my fingers, could not close my hand.  Still after 6 months I can not close middle 2 fingers - middle and ring.  Dr did indicate there has been clotting issues so I have been taking low dose aspirin.
"frozen" shoulder after the shot; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient fears that he may had received the vaccine in his shoulder capsule rather than muscle because he ended up with a frozen shoulder after the shot. Antibody testing was not recommended to assess for immunity to SARS-CoV-2 following COVID-19 vaccination because the clinical utility of post-vaccination testing had not been established. In addition, antibody tests currently authorized under an Emergency Use Authorization (EUA) are not authorized for the assessment of immune response in vaccinated people. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
MY SON BROKE OUT IN WHAT APPEARED TO BE BUG BITES AND HE W AS REAL ITCHY THEN IT SPREAD FROM HIS NECK TO UNDERARMS CHEST SCALP STOMACH LEGS AND FEET
pt exp local redness & warmth @ the inj site & down the arm;pt recovered;
"Fever" didn't take temp. Chills -> hot. Sweating (facial). Severe headache. Loss of appetite. Fatigue. TYLENOL used. Temp today 98.3.
This spontaneous report as received from a pharmacist of unknown age regarding herself. Approximately on 20-AUG-2013 (reported as about 3 weeks ago), after reconstituting ZOSTAVAX (Lot number, and expiry date was not reported) she withdrew the syringe too early and got ZOSTAVAX on her hands (Topical). The effects did not show up for 5-7 days. Approximately on 27-AUG-2013 (reported as since 14 days), the patient experienced on the ring finger and pinky finger a feeling of it being frost bitten and numb. The patient was still experiencing these effects. The outcome of the event experiencing on the ring finger and pinky finger a feeling of it being frost bitten and numb was reported as not recovered/not resolved. Additional information has been requested.
1cm hive surrounded by 1cm area of redness @ site of SQ MMR vax to lt upper center arm; Observed 15 min p/1st noticing hive which formed approx 5 min p/vax; No other sx noted away from site; Instructed moc to contact MD if other sx arises;
dry throat; cough; head ache; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (dry throat), COUGH (cough) and HEADACHE (head ache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced DRY THROAT (dry throat), COUGH (cough) and HEADACHE (head ache). On 29-Apr-2021, DRY THROAT (dry throat), COUGH (cough) and HEADACHE (head ache) had resolved.            No concomitant medication was provided.  No treatment medication was provided.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-JAN-2106, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 lot # K005957, expiry date 08-MAR-2015, (dose and frequency not reported). The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further details provided. Additional information has been requested.
The afternoon of the shot my right arm and hand and my right leg and foot had some numbness.  I stayed active, kept walking and using my hand and arm; the numbness was fairly slight but definite.  When I went to bed that night I had a burning feeling along my whole spine approximately an inch and a half wide; and the whole right side of my body went numb.  The following day I had numbness in the lower part of my right arm and my right hand and the lower part of my right leg and my right foot.  Now, three months later,  I am still having this numbness; not as bad,  but still very annoying and at times it is so irritating I cannot sleep.
Since being vaccinated I have not felt well at all. Low grade fever on and off since 3/23, chest congestion, painful phlegmy cough, loss of taste and smell with the exception of metallic taste/smell, fatigue, low energy. Not feeling like myself at all. I am worried.
Inconsolable crying for just over 24 hrs.  Baby given acetaminophen. No permanent sequelae noted.
3 pts recvd Engerix-B & had flu-like sx; 5 pts recvd Engerix-B & 4 pts had nausea & vomiting & 1 pt had chest pain;
Joint pain, headaches, tremors, swollen in the face. Premature birth. Symptoms persist since vaccination.
dry mouth; feeling run down/tired; arm hurts; slight runny nose; she felt dehydrated/dehydration; she just took her temperature and it was 96.3 F; insomnia; felt thirsty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEHYDRATION (non-serious) with onset 12Mar2021, outcome "unknown", described as "she felt dehydrated/dehydration"; THIRST (non-serious) with onset Mar2021, outcome "unknown", described as "felt thirsty"; DRY MOUTH (non-serious) with onset 12Mar2021, outcome "unknown", described as "dry mouth"; FATIGUE (non-serious) with onset 12Mar2021, outcome "unknown", described as "feeling run down/tired"; PAIN IN EXTREMITY (non-serious) with onset 12Mar2021, outcome "unknown", described as "arm hurts"; RHINORRHOEA (non-serious) with onset 12Mar2021, outcome "unknown", described as "slight runny nose"; INSOMNIA (non-serious) with onset 11Mar2021, outcome "unknown", described as "insomnia"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 12Mar2021, outcome "unknown", described as "she just took her temperature and it was 96.3 F". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: "I did get 1st Pfizer vaccine dose yesterday. Today, I am feeling run down, arm hurts, slight runny nose, dehydration, dry mouth and insomnia last night. I just kept waking up." Patient wanted to know these side effects from the Pfizer vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tachycardia  started approximately 30 minutes after  receiving dose.  Seizures began approximately 6 hours after receiving dose
1 of 6 elderly pts devel inject site rxn with systems of swelling & erythema. Pt has received flu vax each of the past few yr.
No additional AE reported; products that experienced temperature excursion over the weekend were administered to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On13-FEB-2023, the patient was vaccinated with an improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot # W012118 has been verified to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live; expiration date: 24-DEC-2023; which was reconstituted with sterile diluent solution for injection/infusion (strength, dose description, lot #, and expiry date were not provided); and of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot # W029899 has been verified to be valid for hepatitis a vaccine, inactivated; expiration date: 16-MAY-2024, both administered for prophylaxis (strengths, and routes of administration were not provided).  The administered doses of the vaccines experienced a temperature excursion above 9 degrees Celsius (°C) (13.25 C) for 2 hours 32 minutes and 0 seconds. No previous temperature excursion was reported. There was no adverse event reported. No product quality complaint was involved.