chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cold sores; This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number D924E, expiry date 8th March 2022) for prophylaxis.   On 22nd November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was not recovered/not resolved.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a cold sore and but it was not aware whether the patient is taking a medication for this infection or not, and she did not know when the patient developed the cold sore. The pharmacist was enquiring whether to administer 2nd dose since the patient had cold sore. The reporter consented to follow up.
Headache; Muscle ache; Mild flu symptons; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced headache, muscle pain and flu symptoms. On an unknown date, the outcome of the headache, muscle pain and flu symptoms were unknown.   It was unknown if the reporter considered the headache, muscle pain and flu symptoms to be related to Shingrix.  Additional details were provided as follows: The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient reported that, had headache, muscle pain and mild flu symptoms after vaccination with dose of Shingrix. The patient asked, if over the counter drugs was ok to take.
Patient under 18 years of age received the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age received the vaccine) in a 16-year-old male patient who received mRNA-1273 (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age received the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age received the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication  were not provided. Concomitant medication were not provided.
Numbness and weakness in both upper extremeties. Joint soreness in right shoulder. Extreme pain and warm/burning sensation both extremities.
Upper respiratory symptoms with cough and mild fever.  Anorexia.  1/28/21, initially returned from ER but sent back to ER 1/29/21, for persistent symptoms and poor oral intake.
Breakthrough case admission after 5 vaccines Pfizer 1/27/21 Lot# EL3249;  Pfizer 2/17/21 Lot# EM9810;  Pfizer 11/22/21 Lot# FG3527;  Pfizer 6/28/22 Lot# FJ4989;  Pfizer 10/17/22 Lot# GJ3277
Child began to develop a reddened area on the left thigh post vaccinations (same day of vaccinations 8/03/10).  Child experienced a fever of 102 in the pm of 8/3/10; he was treated with Tylenol and the fever returned on 8/04/10.  Child presented to clinic on 8/04/10 at 3:48 pm with a continued fever of 102.  He was in no acute distress. The left anterior thigh revealed a 4" x 3.75" area of cellulitis, irregular border with mild patchy induration palpated throughout the area of cellulitis with the largest induration being approx. one cm in size with two tiny puncture sites approx. in the middle of the erythematic area. There was no induration palpated under the puncture sites, no drainage observed; the left thigh is warmer to touch than the right thigh.  The child was treated with Keflex, Tylenol and ice; upon returning to the clinic on 8/5/10, it was noted that the child was in no acute distress, the cellulitis had diminished in size, was less erythematic, no induration palpated, the cellulitis was resolving and the parent was instructed to continue course of antibiotics, Tylenol and ice and to present child to clinic if not improving, or worsens.
vaccination site rash; vaccination site pain; vaccination site pruritus; vaccination site warmth; vaccination site swelling; A report was received from a consumer concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced rash at the injection site, pain at the injection site, itching at the injection site, warmth at the injection site and swelling at the injection site.  The patient's medical history was not reported . Concomitant medications were not reported.  On 08-Jan-2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for COVID-19 prophylaxis.  On an undisclosed date, the patient experienced rash at the injection site, pain at the injection site, itching at the injection site, warmth at the injection site and swelling at the injection site and went to the Dermatologist.  The treatment given was not reported.   Action taken with mRNA-1273 in response to the event(s) was not reported.  The outcome of the event was unknown. Patient consented to follow-up.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.Further information has been requested.
Joint and muscle aches throughout body; headache; fatigue; temperature slightly higher than normal (100 F, ear); poor sleep; chills; occasional nausea  Pain at injection site started within 3 hours. Other symptoms above started within 10 hours of injection  and lasted around 24-26 hours.  (Above is re the second dose. First dose was Only associated with 2-3 days of pain at injection site) (
My rt arm pit was sore the next day, then began to swell...today the 24th. 17 days later it is the size of a baseball.  Calling my Dr to have it looked at.
Not feeling good; pain in her upper shoulder; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling good) and ARTHRALGIA (pain in her upper shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Not feeling good) and ARTHRALGIA (pain in her upper shoulder). At the time of the report, FEELING ABNORMAL (Not feeling good) and ARTHRALGIA (pain in her upper shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Events start date was given on Aug 2021. No concomitant medication information was provided. No treatment medication were provided.
Left arm/deltoid 18 x 18 cm hard indurated red small blisters/pustules-like central oozing clear fluid.  Tenderness.  Augmentin given.
Pt vaccinated with DTP/OPV and developed fever of 101, local reaction - pain, swelling, induration, and continuous crying for 3 hrs.
A physician reported the occurrence of "symptoms of speech, language, and social delay" in a male child of unspecified age who was vaccinated with Infanrix and hep B vaccine for prophylaxis. This report was received from manufacturer (HQ6283021JAN2003). The subject's medical history, concurrent conditions, and concurrent medications were not included in the report from manufacturer. The subject received injections of Infanrix on 2/28/01, 4/28/01, 7/23/01 and 8/19/02. He received injections of Engerix B on 2/28/01 and 7/23/01. At an unspecified time post-immunization, he began to experience "symptoms of speech, language, and social delay." The outcomes of these events were unknown. The language and social delays in this report are considered medically serious (OMIC).   A 15-day follow up report received 6/18/2003 adds: The most recent info, received from the physician on 06/03/2003, indicated that the "symptoms of speech, language and social delay" had "improved" by 05/30/2003. The physician considered these events to be possibly related to immunization and to be serious because they "may" become disabling. The language and social delays in this report are considered GSK medically serious.
Flumist was inadvertently given to client who had indicated "asthma" on screening form. Discovered during forms review on the following day. Called (left voice message) and texted 11/22/19, 11/25/19, and 11/26/19 with no response. 11/27/19 sent letter to parent. Unable to reach parents; no adverse outcome known.
100.3 fever - took motrin nausea sore at injection site 4 days pelvic cramping/bladder discomfort lasting 24 hours
High fever over 102F and chills throughout night of vaccine and next day. Misery and could not sleep. Then on next day 5/27/2020, I felt weak and was trying to drink a lot of fluids and eat a little, yet I still fainted in the late morning on my kitchen floor (from a standing position). The feeling of light-headedness before it happened while I was sitting was scary. I don?t know how long I was unconscious, but it probably wasn?t too long. I don?t remember passing out, just woke up on the floor. I had no injuries from falling. I don?t have high or low blood pressure issues. I do get fevers easily, even with colds, and have fainted previously from viruses after using the toilet, but never fainted when I didn?t just use the bathroom. I was almost feeling normal on 5/28/2020 and okay by 5/29/2020 (which was weird that I could feel that sick and then be over it fairly quickly, because it was a vaccine and not an illness). I will not get this vaccine again. The first dose caused only a very mild fever for a few hours and fatigue.
1:45 driving home, started to notice weird feeling like I had an allergy shot. 2:30 I got home and breathing was aggravated. 2 puffs of inhaler, sat down and waited. Breathing worse, 2 more puffs. Breathing not improving enough, tongue started to feel weird. Went to ER. 3:45 went to ER. By 4:45 I was in a room, saw physician at 5:45. I had a heart rate in 140s in triage, and a low BP around 90/60. My tongue continued to feel funny and started to get hard to talk. It felt heavy, but medical staff didn't think swollen. I was given a breathing treatment, Benadryl, Pepcid, IV fluids and monitored. 8:15 I was asked to walk a bit to make sure oxygen was staying up. My chest tightness was getting worse but since my oxygen stayed at 95 when walking, was discharged. As of today, I still struggle to control my breathing and have an appointment with my allergist for tomorrow. I'm scheduling albuterol treatments every 4 hours around the clock and continue to take Pepcid and Benadryl in addition to my normal meds. 3/20 I developed uterine cramping, felt like I was having back labor as the result. Uterine cramping resolved 3/21 but severe soreness in back remained.
This is a spontaneous from a Pfizer sponsored program from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 05May2021 at first dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain in both shoulders and arms, burning muscles and painful eyes on 07May2021. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Hepatitis B pediatric vaccine was ordered and requested for a newborn. Hepatitis A pediatric vaccine was sent from pharmacy and administered to patient. Error was caught by pharmacy after administration of the vaccine. Age of patient at time of event: 2 days.
At 3:30 AM I woke with a fever that subsided an hour later after taking Advil. The next day I had chills and aches throughout my body. Today (2/1) I have redness at the vaccine site on my left arm.
Patient received the 1st dose of the Moderna vaccine on 04/26/2021 and was asymptomatic until 05/07/2021. Reported to provider on 05/10/2021. Initial Symptoms 05/07: rapid onset dyspnea "Elephant on chest", rash starting to form around injection site, traveling down arm. Date reported to provider, Reduced dyspnea with daily improvements, rash spreading down and around arm.
injection site discomfort; fingers and arm  numbness; This case was reported by a pharmacist and described the occurrence of injection site discomfort in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2019, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site discomfort and numbness of upper extremities. On an unknown date, the outcome of the injection site discomfort and numbness of upper extremities were unknown.   It was unknown if the reporter considered the injection site discomfort and numbness of upper extremities to be related to Shingrix.  Additional details were provided as follows: The reporter was a community pharmacist. The age at vaccination was not reported. The patient received the Shingrix in January this year and had been experiencing injection site discomfort, which was a common adverse reaction. The patient also experienced the numbness on her hands and fingers. The pharmacist wanted to know if these could also be a part of adverse reactions.
Developed a 5x3 cm area of swelling & redness at injection site (right thigh).
Called to observation area due to patient complaint of nausea, started about 15 minutes after injection. BP 102/58, HR 64, RRR no murmur, CTAB no wheezes. Patient was diaphoretic for less than a minute, then this resolved. She stated that the worst issue was feeling like she was going to have diarrhea. Confirmed patient has no allergies and she had taken zofran in the past with good relief and no adverse reaction and 4 mg ODT was given to patient. After a few minutes, patient felt able to ambulate to bathroom, we walked her to front lobby bathroom area and instructed her to wait another 15 minutes in observation area to make sure no further issues. She is going to have friends come to pick her up and lives with a friend and her fiance who will be able to monitor her.
Pfizer-BioNTech COVID-19 Vaccine EUA. Hives day after shot, all over body. Day after got worse went to hospital. Had to be put on 3 different medications. Prednisone 3 times a day for 5 days, hydroxyzine 3 times a day for 5 days and Cimetidine 1 time for 5 days. It is now May 4 and I broke out in hives all over again on the 3rd of May and I am now on Methylprednisolone.
11/18/22 presents to ED for "fever, diarrhea". PMHx of "CKD 3, MGUS, s/p renal transplant (x2), primary sclerosing cholangitis, NSTEMI"
This spontaneous report as received from a registered nurse via company representative refers to a 4 months old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 13-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # M014926 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Tachicardia which lasted about 15.  Overall sickness; upset stomach, lethargic, sore arm from injection site,chills and feeling cold.
Fever at the moment of the call Temperature 100; Muscle pain; Second dose march third dose august; Feeling Dizzy; Pain on left arm; Feeling some elbow hardness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling Dizzy), PAIN IN EXTREMITY (Pain on left arm), INDURATION (Feeling some elbow hardness), PYREXIA (Fever at the moment of the call Temperature 100) and MYALGIA (Muscle pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 022M20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced DIZZINESS (Feeling Dizzy), PAIN IN EXTREMITY (Pain on left arm), INDURATION (Feeling some elbow hardness), MYALGIA (Muscle pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose march third dose august). On 28-Aug-2021, the patient experienced PYREXIA (Fever at the moment of the call Temperature 100). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 27-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose march third dose august) had resolved. At the time of the report, DIZZINESS (Feeling Dizzy), PAIN IN EXTREMITY (Pain on left arm), INDURATION (Feeling some elbow hardness), PYREXIA (Fever at the moment of the call Temperature 100) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, Body temperature: 100 (High) 100.
Rash patient with mild myalgia and rash immediatly, followed by development of secondary cellulitis Narrative: secondary cellulitis overlying injection site. treated with abx.
Hemorrhage on right eye; A spontaneous report was received from a consumer concerning a 76-year-old, female patient who received Moderna's COVID-19 vaccine and experienced hemorrhage on the right eye.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.     On 29 Jan 2021, the day following her injection, the patient experienced a right eye hemorrhage. The patient also informed that she had a substance of unknown origin injected into her eye, when she visited the eye doctor. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported. The second dose is scheduled for 24 Feb 2021.  The outcome for the event hemorrhage on the right eye was not reported.; Reporter's Comments: This case concerns a 76-year-old, female, who experienced serious events of Eye haemorrhage after receiving first dose of mRNA-1273. Noting her recent visit (unknown date) to an eye doctor involved an injection into her eye may remain as confounder. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Follow-up information is expected.
The Shingrix shot caused a distinct area on my right wrist that appears to have an elevated temperature, and it is easy to see, for anyone who has eyes.   The other issue is the itchiness and the red spots reappearing on the exact area where the prior chicken pox scars are located.   This specifically points to the Shingrix shot being the culprit, since we all know that the Chickenpox virus and the Shingles outbreaks are related to each other.    Please  understand that the patient generally does not receive any information about lot numbers, or the specific name, version, etc of the vaccine.  Since the people who came up with this method of providing information, (such that one is forced to take a best guess at what the information might be), your very own system ensures that numerous potentially incorrect data is submitted.  This is really stupid, if you were to just THINK about it.   Are you?   Or is there no time to think?
Persistent headache 2 hours post vax. Refractory to Motrin and Tylenol.
sore arm; Little achy in my back; tired; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), BACK PAIN (Little achy in my back), FATIGUE (tired) and FATIGUE (fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Depression and Sleep disorder. Concomitant products included Metamucil and PROBIOTICS NOS for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), BACK PAIN (Little achy in my back), FATIGUE (tired) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm), BACK PAIN (Little achy in my back), FATIGUE (tired) and FATIGUE (fatigue) outcome was unknown.            Reporter did not allow further contact
Chills, fatigue, muscle aches, weakness, arms tingling elevated. During pts stay in the clinic, sx became worse and was referred to another clinic.
This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 15th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 15th May 2018, less than a day after receiving SHINGRIX, the patient experienced feeling bad. On 22nd May 2018, the outcome of the feeling bad was recovered/resolved. It was unknown if the reporter considered the feeling bad to be related to SHINGRIX. Additional details were provided as follows: The caller reported that, the patient was her son's mother-in-law. The age at vaccination was not reported. The patient received SHINGRIX on an unknown arm. The patient felt bad. No further descriptive information was provided about reported adverse event. This case has been linked to the US2018139533 and US2018139534, reported by the same reporter.