chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site is warm; injection site is so itchy like a mosquito bite; injection site was raised - almost oval shape; injection site was dark/pink a little bit; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE INFLAMMATION (injection site was raised - almost oval shape), VACCINATION SITE DISCOLOURATION (injection site was dark/pink a little bit), VACCINATION SITE WARMTH (injection site is warm) and VACCINATION SITE PRURITUS (injection site is so itchy like a mosquito bite) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy, Penicillin allergy, Penicillin allergy (Amoxicillin ), Allergy to antibiotic (Keflex), Allergy to vaccine (Itchiness after getting the flu vaccine 30 years ago.) and Glaucoma. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE INFLAMMATION (injection site was raised - almost oval shape) and VACCINATION SITE DISCOLOURATION (injection site was dark/pink a little bit). On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site is warm) and VACCINATION SITE PRURITUS (injection site is so itchy like a mosquito bite). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. On 08-Jan-2021, VACCINATION SITE INFLAMMATION (injection site was raised - almost oval shape) and VACCINATION SITE DISCOLOURATION (injection site was dark/pink a little bit) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site is warm) and VACCINATION SITE PRURITUS (injection site is so itchy like a mosquito bite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Child upset and combative @ time of administration. Aide returned child to RN's 1 hr 10 min later and child exhibiting itching on head, watery eyes and sm welts around mouth and puffy eye orbits. Given EPI injection and ambulance called. Transported to hospital.
My daughter got her flu shot at school due to us not having insurance at this time.  This is not her first time getting a flu shot, but this is the first time she has had a reaction, the site of the shot is red, sore to touch and raised larger than golf ball size in diameter. The school nurse gave her ice for site due to pain, I gave her a Benadryl that night.  Now the 3rd day, site of injection has increased in size, redness and sore to touch.  We continue the ice & have notified doctor of this reaction.
This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 22Oct2021 11:00 (Lot number: 320308D) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "sulfonamide allergy" (unspecified if ongoing), notes: known allergies: sulfa. Concomitant medication(s) included: FLU taken for immunisation, administration date 12Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL0140, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 08Jan2021, when the patient was 63 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 26Jan2021, when the patient was 63 years old, for Covid-19 Immunization, reaction(s): "I didn't feel well with nonspecific symptoms", "Got a very unusual headache". The following information was reported: DIARRHOEA (non-serious) with onset 23Oct2021, outcome "recovering", described as "explosive watery diarrhoea x 2"; MYALGIA (non-serious) with onset 23Oct2021, outcome "recovering", described as "muscle aches"; CHILLS (non-serious) with onset 23Oct2021, outcome "recovering", described as "chills"; NAUSEA (non-serious) with onset 23Oct2021, outcome "recovering", described as "nausea"; FATIGUE (non-serious) with onset 23Oct2021, outcome "recovering", described as "fatigue"; LYMPHADENOPATHY (non-serious) with onset 23Oct2021, outcome "recovering", described as "I have bilateral, right > left axillary lymphadenopathy"; DECREASED APPETITE (non-serious) with onset 23Oct2021, outcome "recovering", described as "loss of appetite". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diarrhoea, myalgia, chills, nausea, fatigue, lymphadenopathy, decreased appetite. Additional information: Patient was not pregnant at the time of Vaccination. Patient received FLU vaccine in right arm (other vaccine in four weeks). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. In early Sep. patient was exposed to PCR proven COVID through someone who lived in their home. Patient subsequently developed a bad sinus infection but had a negative COVID test, nasal PCR. They went away for 4 days to an isolated place, so no more testing was done, but there was good chance they both had a mild case of breakthrough COVID. I did not feel well with nonspecific symptoms and got a very unusual headache for 2 days. Sinus infection was treated with 2 courses of antibiotics (As reported). Seriousness reported as no. Follow-up attempts are completed. No further information is expected.
Approx 26 hours after receiving the vaccine client started c/o "chest didn't feel right, and it could be my stomach. I also noticed a swollen lymph gland under my left armpit. It is 2inches wide by 4 inches long. I called my oncologist and they just said to watch it, take ibuprofen. I have a similar thing happen usually right before I take my chemotherapy." He denies fever, red streaks.
5 in x 4 in raised area of redness over right deltoid. Subcutaneous tissue is hard to touch, tender to palpation.
Initial report received from a nurse on 13 Jan 2010: This patient (under four years of age) was inadvertently vaccinated with 0.25 ml of FLUVIRIN (batch number: 102133P) intramuscularly on 13 Jan 2010. No adverse event was reported. The seriousness criteria of the patient was not reported. The reporter also reported two other companion cases (See case PHHY2010US01744 and PHHY2010US01693).
This spontaneous case, initially received from other non-healthcare professional on 03-Feb-2018, concerning an adult, male patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date in 1985, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, manufacturer, trade name, batch number and expiry date: not reported). On an unspecified date, after vaccination the patient was sick. At the time of the report, the outcome of the event (sickness) was not reported. The reporter assessed the event as non-serious.
rash had spread, nowpatches on both legs front and back that stay under control as long as she takes medicine; painful rash/ patches on both legs; shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (painful rash/ patches on both legs), HERPES ZOSTER (shingles) and RASH (rash had spread, nowpatches on both legs front and back that stay under control as long as she takes medicine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced RASH (painful rash/ patches on both legs) and HERPES ZOSTER (shingles). On 19-Apr-2021, the patient experienced RASH (rash had spread, nowpatches on both legs front and back that stay under control as long as she takes medicine). At the time of the report, RASH (painful rash/ patches on both legs), HERPES ZOSTER (shingles) and RASH (rash had spread, nowpatches on both legs front and back that stay under control as long as she takes medicine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided treatment medication included anti-viral medications.
Pt stated she had red, itchy face and neck, and stuffy nose. She did not say that she had any trouble breathing. She stated this started the morning after receiving the vaccine. I instructed her to take 1-2 diphenhydramine tablets and call her physician.
Approximately three to four hours after administration, pt was sweating, rapid heart rate, rapid, shot breathing, low blood pressure and feeling weak.
Patient was administered a dose from an expired vial. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided. Expiration date of vial was 11 Oct 2021.   This case was linked to MOD-2021-365891, MOD-2021-366043, MOD-2021-366595, MOD-2021-365742, MOD-2021-365543, MOD-2021-366925, MOD-2021-366226, MOD-2021-365600, MOD-2021-365692 (Patient Link).
Information has been received from a pharmacist referring to unspecified number of patients of unknown ages and gender human immunodeficiency virus (HIV). The patients always received 2 doses of ZOSTAVAX (started date, strength, lot#, dosage, frequency and route unspecified) (extra dose administered and medication error). This is one of several reports received from the same reporter. Additional information has been requested.
I had a headache all day the day after getting my second dose. I woke up with it and it lasted until I went to bed that day around 9 pm. I did not take any medicine. When I woke up the following morning, I felt a lot better.   I also had rash on my arm near the injection spot. It was not severe- the area turned red and was swollen. It is mostly gone now (4/3/2021).
Patient c/o headache light headed and tingle in left arm pain.  Feeling some palpitations.  No SOB, no N/V, No Diaphoresis
Patient was 17 years old at the time of the first COVID-19 vaccination.  Facility has a signed parental consent form on file.  At patient's second dose appointment, patient and mother were made aware that Moderna COVID-19 vaccines have not been FDA approved for anyone under 18 years old.  Per continuity of care and physician clearance with mother's consent , the patient received the second dose of Moderna vaccine.   Patient informed the Vaccine Coordinator that she only experienced a sore left arm and redness at the injection site after her first dose of Moderna Covid-19 vaccine.  The Vaccine Coordinator recognized the patient was a minor at appointment check-in time for her second dose, as her first dose was administered a month ago without realizing her age.    Vaccine coordinator spoke with the Medical Director regarding the situation and was given approval to have phamacist administer the second dose.
The day after my injection my right arm (at injection site) began to have a very hard knot and very red, itching and hot. It lasted about 2 weeks and seemed to be getting well. My arm began getting red and hurting again but was covering the upper part of my arm. I contacted  my doctor and went to see him and  he advised me NOT to take the 2nd injection until he contacted me and told me to put Cortisone Cream on the infected place on my arm. It is still as of today red with a knot at the site of the injection.
numbness to right side of face from cheek to jaw line, to right side of lips,  and also to the inside of the mouth on right side and  inside right side of throat.
Developed area of redness approx. 3cm round. Scantly raised and slightly warm to touch.
I had a fever after receiving the vaccine for about day. I have a history of migraine headaches, but they do not happen very often. On 11/08/2022, I developed a migraine headache with seeing flashing lights. To relieve my discomfort, I took ADVIL. I had this migraine for three days. I have not had another migraine since then.
06NOV17 after a week of no pain on this morning I proceed to get out of bed and could not move, after a couple days the soreness and stiffness progressed, 2 weeks later had DR. appointment, Dr says she do not know how I worked 2wks in the pain I was in. I have been on medication since 06Nov2017.
I had my second Shingrix shot on at the pharmacy, 10/11. On 10/12 in the AM, I woke up with vertigo, chills, and a fever of 101. As these are common side effects, I wasn't concerned. The symptoms - other than mild vertigo/dizziness - subsided by 10/13. The mild vertigo continued and mild left ear pain began on 10/14. Ear pain continued, and, believing it was (as is often the case) viral, I didn't go to urgent care until 10/19, as the pain had not resolved. I was diagnosed with a bacterial ear infection and given amoxycillin. On 10/20 I woke up with high-tone hearing loss in the left ear (I was unable to hear the beep of my phone alarm or determine the direction the sound was coming from) and tinnitus. I called the urgent care aftercare phone line and was prescribed a Medrol pack and Flonase. After I finished the Medrol pack, I still had hearing loss, though it was a little better, and I had some mild pain in my left ear and a feeling of fullness. So on 10/27 I saw an ENT. The ENT found no signs of infections, but the hearing test showed significant hearing loss in the left ear. He prescribed a 12-day course of high-dose prednisone to help reduce inflammation. I took 60 mg for 6 days, then tapered off. My follow-up hearing test showed only a very small improvement. At this point, the ENT sent me for blood work and an MRI. The bloodwork and the MRI were all normal. That was the end of treatment. I continue to have hearing loss and tinnitus in my left ear, as well as having bouts of dizziness if I move my head too quickly. I do not know that the Shingrix vaccine caused this hearing loss, but I've ultimately decided I should report my experience because of the timing of the two events was very close
Pt received hep A (L deltoid) and ADACEL (R deltoid) on 8/25 @ about 10 AM. By 8/26 @ about 2000 pt had marked swelling of L deltoid with erythema, warmth, of bruising @ needle injection site. No fevers or chills, resp difficulty.
Body Ache; Head ache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body Ache) and HEADACHE (Head ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body Ache) and HEADACHE (Head ache). At the time of the report, MYALGIA (Body Ache) and HEADACHE (Head ache) outcome was unknown.            No concomitant medication was reported. No treatment was given. Action taken with mRNA-1273 in response to the event was not applicable.
24 hr after injection, itching L deltoid at 48 hrs, 8 x 8 cm red indurated area
Patient's mother falsely informed us of patient's date of birth. Patient is under 12 years of age.
Abdominal cramps/really bad cramps in my abdomen; a bit of a headache; This is a spontaneous report from a consumer. A 67-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no:EN9581, expiration date:31May2021) as first dose, on left arm, via an unspecified route of administration on 28Jan2021 15:30 at single dose for covid-19 immunisation. Medical history included Kidney transplant recipient from 1995 and ongoing. There were no concomitant medications was not reported. This consumer reported that she was administered the first dose of Pfizer-BioNTech COVID-19 Vaccine 28Jan2021 about 15:30. On 28Jan2021 about 19:30 she had onset of abdominal cramps. Patient also reported that she received the Pfizer shot yesterday at around 3:30, then at around 7:30 she experienced really bad cramps in her abdomen, along with a bit of a headache. She asked if that is one of the side effects of the Pfizer-BioNTech COVID-19 Vaccine. She was a little concerned because she heard that if you had a reaction or side effects to the first dose of the Pfizer-BioNTech COVID-19 Vaccine that they would be worse with the second dose. She had abdominal cramps all night long off and on. She reported outcome as ongoing but a little bit better. She did better if she just stays still. When she gets up and starts doing things the abdominal cramps occur more. She described the abdominal cramps as being kind of like menstrual cramps, which she has not had in a long time, but they are low like that in the abdomen; not like stomach cramps that are up higher. Usually with something like this kind of abdominal cramps she would have diarrhea but she was not having any diarrhea. The abdominal cramps are weird feeling. Outcome of the event abdominal cramps/really bad cramps in my abdomen was recovering and outcome of other event was unknown.
RASH, SEVERE HEADACHES, EXCESSIVE BRUISING, FEVER-FROM TIME SHE RECEIVED VACCINE UNTIL PRESENT
Since the first shot I?ve experienced mild chills with low grade flu-like symptoms with no fever (temperature taken) every night. Once a sleep I awake in the middle of the night  every night with mild sweats.  Every day in the morning and throughout the day I am perfectly fine, only develops each evening and nights.
This spontaneous report as received from a pharmacist refers to a patient of unkonwn age and gender. On 20-SEP-2014 the patient was vaccinated with improperly stored dose of PNEUMOVAX 23, 0.5 ml, intramuscular (lot number not reported). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Adverse Reaction or Side effect: none; hepatitis Avaccine was administered on 29-DEC-2010, 28-JAN-2011 and 01-JUL-2011; This spontaneous report was received from a other health professional and a consumer referring to a 59-year-old female patient.   The patient's medical history included tobacco use. The patient's concurrent conditions included gastrooesophageal reflux disease. The patient's historical vaccine included hepatitis B vaccine (manufacturer unknown) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The patient's concomitant medications included omeprazole (PRILOSEC) and hepatitis B vaccine (manufacturer unknown).  On 29-DEC-2010, the patient was vaccinated with the first dose of hepatitis A vaccine vaccine (manufacturer unknown) for prophylaxis; and on 28-JAN-2011, with the second dose (inappropriate schedule of product administration). It was reported that the patient did not experience any adverse reaction or side effect with the vaccine.  On 08-DEC-2014, the patient experienced Vaccination failure and Herpes zoster (captured in # 1806USA007435).; Sender's Comments:  US-009507513-1806USA007435:
No additional AE was reported.; The consumer reported receiving her first dose of VARlVAX on 7/5/2020, and has yet to receive her 2nd dose. The AE awareness date is 8/30/2020, because that would be exactly 8 weeks (max allotted time) from the first dose.; This spontaneous report as received from a 52-year-old female patient referring to herself. The patient's pertinent concurrent conditions, medical history and concomitant medications were not reported.  On 05-JUL-2020, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck)(VARIVAX), 1 dose as prophylaxis (concentration, route of administration, anatomical location, lot number and expiration date were not reported.     On 30-AUG-2020 (8 weeks maximum time allowed), It was reported that the patient had not received yet the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (inappropriate schedule of product administration). The patient did not report any side effects.
report only the diluent portion of Arexvy was administered to a patient without the lyophilized component; report only the diluent portion of Arexvy was administered to a patient without the lyophilized component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 82-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2B775, expiry date 13-DEC-2024) for prophylaxis.   On 23-SEP-2023, the patient received Arexvy. On 23-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate dose of vaccine administered (Verbatim: report only the diluent portion of Arexvy was administered to a patient without the lyophilized component) and inappropriate preparation of medication (Verbatim: report only the diluent portion of Arexvy was administered to a patient without the lyophilized component).  The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 25-SEP-2023 The pharmacist reported patient was administered only the diluent portion of Arexvy without the lyophilized component which led to Inappropriate dose of vaccine administered and Inappropriate preparation of medication. The details patient and vaccine were asked and declined because reporter stated was not at the facility now of call. Reporter stated patients age to be 80 or 90 but was not sure about the exact age . The reporter consented to follow up.
Recvd DTP/OPV/HIB on 27AUG91 cried for 2.5 hrs p/shot w/o being able to be comforted; mom did not call MD or mention it until 2nd set of shots as it was 2.5 instead of the 3 hrs time frame mentioned in all the literature;
Information has been received concerning now a five year old female who on 11/17/1996 was vaccianted with one dose of varicella vaccine. On 11/21/2000 the pt experienced breakthrough varicella. On 11/24/2000 the pt recovered from breakthrough varicella. Other patients were reported with similar symptoms following varicella vaccine. No further info is available.